USER’S MANUAL LUX-Dx™ Insertable Cardiac Monitor System R E F M301, 2925, 2935 C A U T I O N : Federal law (USA) restricts this device to sale by or on the order of a physician trained or experienced in device implant and follow-up procedures.
ABOUT THIS MANUAL This manual contains information about the LUX-Dx Insertable Cardiac Monitor system, which includes an insertable cardiac monitor, two mobile applications (one for the patient and one for the clinician), and the LATITUDE Clarity Data Management System.
Ab bre viat io n Definition MR Magnetic resonance MRI Magnetic Resonance Imaging PII Patient Initiated Interrogation RF Radio Frequency RRT Recommended Replacement Time S-ECG Subcutaneous Electrocardiogram TENS Transcutaneous electrical nerve stimulation VAD Ventricular assist device All intervals, rates, and durations have a tolerance of ± 5 milliseconds. The following are trademarks of Boston Scientific Corporation or its affiliates: LATITUDE, LATITUDE Clarity, LUX-Dx, and myLUX.
TABLE OF CONTENTS INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1 CHAPTER 1 System Overview..................................................................................................................1-2 System Limitations .......................................................................................
Product Reliability ........................................................................................................ 2-21 M O B I L E A P P L I C A T I O N S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3 - 1 CHAPTER 3 Overview...................................................................................................................
Generating and Printing Patient Reports ............................................................................ 4-22 Managing Patients.............................................................................................................. 4-23 Changing Patient Demographic and Equipment Information.................................................... 4-23 Changing Patient Groups................................................................................................
1-1 INTRODUCTION CHAPTER 1 This chapter contains the following topics: • “System Overview” on page 1-2 • “System Limitations” on page 1-3 • “Indications” on page 1-4 • “Contraindications” on page 1-4 • “Warranty Information” on page 1-5 • “Warnings” on page 1-5 • “Precautions” on page 1-6 • “Potential Adverse Events” on page 1-12 • “Patient Counseling Information” on page 1-12
1-2 Introduction System Over view SYS T EM OV E RV I EW The LUX-Dx Insertable Cardiac Monitor system (“ICM system”) is designed to monitor and record heart rates for clinical evaluation. The ICM system may be prescribed for patients with clinical syndromes, patients at increased risk of cardiac arrhythmias, or patients who experience symptoms such as dizziness, palpitation, syncope, and chest pain that may suggest a cardiac arrhythmia. It does not treat cardiac arrhythmias.
Introduction Sy s t em L i m i ta t i o n s 1-3 Mobile Applications The mobile applications (apps) are used to interrogate the device and transmit data between the device and the LATITUDE server. The patient app also allows patients to record S-ECGs of symptomatic events to be sent to the server. Both apps communicate with the device using Bluetooth Low Energy technology, and with the LATITUDE server using a Wi-Fi or cellular connection (Figure 1–1 ICM System Diagram on page 1-3).
1-4 Introduction Indications N OT E : Boston Scientific personnel may contact the clinic if a device uses too much telemetry to perform remote interrogations. • • M e t h o d o f co n n e c t io n t o t h e L A T I TU D E Cl a r i t y Sy s t e m : – C e l l u l a r d a t a s e r v i c e p l u s W i - F i — Actual coverage may be affected by such things as terrain, weather, foliage, buildings and other construction, signal strength, timely payment (as applicable), and other factors.
Introduction W a rran t y I n for m at i on 1-5 LATITUDE Clarity is contraindicated for use with any device other than a compatible Boston Scientific device. WARRANTY INFORMATION A limited warranty certificate for the insertable cardiac monitor is available at www.bostonscientific.com. For a copy, contact Boston Scientific using the information on the back cover.
1-6 Introduction P rec a u ti o n s Post Insertion • D i a t h e r m y. Do not expose a patient with an ICM system to diathermy. The interaction of diathermy therapy with an insertable cardiac monitor can damage the device and cause patient injury. • F i r m w a r e u p d a t e m u s t b e c o m p l e t e d . Once a firmware update begins, the patient will not be monitored until the update is completed. If the firmware update is skipped, the patient is still monitored.
Introduction Pre ca u t i on s 1-7 Cl in i c al Co n si d erat io n s • C h e c k d e v i c e b a t t e r y b e f o r e i n s e r t i o n . Check the device battery prior to insertion. If a low battery condition is indicated, do not insert the device. • D e v i c e d o e s n o t a l e r t p a t i e n t . The device cannot alert the patient to emergency situations. • M a g n e t u s e i m p a c t o n l o n g e v i t y.
1-8 Introduction P rec a u ti o n s • E v a l u a t e p a t i e n t f o r s u r g e r y. There may be additional factors regarding the patient's overall health and medical condition that, while not related to device function or purpose, could render the patient a poor candidate for insertion of this system. Cardiac health advocacy groups may have published guidelines that may be helpful in conducting this evaluation. • H a n d l i n g t h e d e v i c e .
Introduction Pre ca u t i on s • 1-9 • Electronic surveillance (antitheft) devices • An alternator on a car that is running • Medical treatments and diagnostic tests in which an electrical current is passed through the body, such as TENS, electrocautery, electrolysis/thermolysis, electrodiagnostic testing, electromyography, or nerve conduction studies • Any externally applied device that uses an automatic lead detection alarm system (e.g.
1-10 Introduction P rec a u ti o n s Prior to a course of therapeutic radiation treatment, the patient’s radiation oncologist and cardiologist or electrophysiologist should consider all patient management options, including increased follow-up and device replacement. Other considerations include: • Shielding the device with a radiation-resistant material, regardless of the distance between the device and the radiation beam. • Determining the appropriate level of patient monitoring during treatment.
Introduction Pre ca u t i on s – • • • 1-11 Do not change TENS settings until you have verified that the new settings do not interfere with device function. If TENS is medically necessary outside the clinical setting (at-home use), provide patients with the following instructions: – Do not change the TENS settings or electrode positions unless instructed to do so. – End each TENS session by turning off the unit before removing the electrodes. M a g n e t i c f i e l d s .
1-12 Introduction P otentia l Adverse Events • M a m m o g r a p h y p r o c e d u r e . During a mammography procedure, manipulation or angular stress of the device between the plates could cause tissue trauma, vascular trauma, or pain, or affect device sensing. Before scheduling a mammogram, the health care provider should weigh the potential risks against the benefits and evaluate other diagnostic options. Allow sufficient time for the incision to heal before performing a mammography procedure.
Introduction Patient Counseling Infor mation 1-13 • Protected environments—the patient should seek medical guidance before entering environments that could adversely affect the operation of the active implantable medical device, including areas protected by a warning notice that prevents entry by patients • Avoiding devices that generate a strong electric or magnetic interference (EMI) in home, work, and medical environments • Reliability of their device ("Product Reliability" on page 2-21) • Activ
1-14 Introduction P atient Co unseling Info rmation The magnet is required to set up the patient app. Use of the magnet with other features, such as recording symptoms or sending manual transmissions, is required unless Bluetooth Manual Connection is programmed to No Magnet.
2-1 INSERTABLE CARDIAC MONITOR CHAPTER 2 This chapter contains the following topics: • “Overview” on page 2-2 • “Device Insertion” on page 2-2 • “Medical Device ID Card” on page 2-10 • “R-wave Sensing” on page 2-11 • “Diagnostics” on page 2-11 • “Magnet Use” on page 2-18 • “Device Removal and Disposal” on page 2-18 • “Product Specifications” on page 2-19
2-2 Insertable Cardiac Monitor Over v iew OV ER V IE W The device is the inserted portion of the ICM system. This section of the manual provides instructions for insertion and removal, information about device functions, features, and specifications. It also contains information about the magnet used to initiate communication between the device and mobile applications.
Insertable Cardiac Monitor Items Included in P ackage 2-3 • To check the device battery and in preparation for performing an R-wave check during the insertion, it is recommended to establish communication between the device and the patient app prior to passing the device into the sterile field. See "Patient App" on page 3-2 for more information on establishing communication. • Retain the QR code on the device packaging; this will be used to enable features on the patient app used during insertion.
2-4 Insertable Cardiac Monitor Insertion Instructions [1] 4th intercostal space, 45° relative to the sternum (recommended); [2] 4th intercostal space, parallel to the sternum (recommended); [3] Anterolateral, inframammary between the 5th and 6th ribs (optional) F i g u re 2 – 2 . C o m m o n I n s e r t i o n L o c a t i o n s Surface mapping to qualify an optional insertion location Conduct surface mapping with clinic ECG equipment.
Insertable Cardiac Monitor Insertion Instructions 2-5 Inserting the Device Prepare the selected insertion site using local anesthetic and aseptic procedures. Use the insertion tools provided to insert the device. N OT E : Boston Scientific recommends retaining the insertion tools in the sterile field during the procedure in case device repositioning is required. To insert the device, complete the following steps.
2-6 Insertable Cardiac Monitor Insertion Instructions F ig ure 2–4. Tu nn el 3. R o t a t e . Rotate the insertion tool 180° in either direction, creating a pocket for the device to be inserted (Figure 2–5 Rotate on page 2-6). F ig ure 2–5. Ro t ate 4. P u l l b a c k . Hold the base of the insertion tool to the incision site and pull back the plunger until you feel a hard stop or until the blue line is visible (Figure 2–6 Pull Back on page 2-7).
Insertable Cardiac Monitor Insertion Instructions F i g u re 2 – 6 . 5. Pull Back I n s e r t . Lower the body of the tool close to the skin. F i r m l y h o l d t h e b a s e o f t h e i n s e r t i o n t o o l a t t h e i n c i s i o n s i t e while pushing the plunger in completely (Figure 2–7 Insert on page 2-7). N OT E : F i g u re 2 – 7 . 6. 2-7 The tool and the device may back out during insertion if the base of the insertion tool is not secured. Insert R e m o v e .
2-8 Insertable Cardiac Monitor Insertion Instructions F ig ure 2– 8. Remove Verifying R-wave Sensing Verify that the following device sensing performance requirements are met: • The R-wave amplitude should be a minimum of 0.2 mV when viewed on the patient or clinic app. • The peak-to-peak R-wave amplitude should be at least twice the peak T-wave or P-wave amplitude, whichever is greater. For more information on using the patient app to verify R-wave sensing, see "View Real-time S-ECG" on page 3-3.
Insertable Cardiac Monitor Insertion Instructions F i g u re 2 – 9 . 2. Expose Loadin g S urface Place the black end of the device onto the loading surface exactly as shown in Figure 2–10 Place Device on Loading Surface on page 2-9. The Boston Scientific logo and black square should be visible and facing up. F i g u re 2 – 1 0 . 3.
2-10 Insertable Cardiac Monitor P o s t- I n s e r t i o n I n f o r m a t i o n F i g u re 2 – 1 2 . D ev i ce L o a d e d i n T o o l 4. The device is reloaded and ready to be repositioned. See "Inserting the Device" on page 2-5. Closing the Incision After the device has been inserted and sensing performance requirements have been met, close the incision. Use standard surgical techniques to achieve good tissue contact with the device.
Insertable Cardiac Monitor R -wa ve Sensing 2-11 R-WAVE SENSING The ICM device automatically detects arrhythmias based on R-wave sensing. The cardiac signal for R-wave detection is filtered to remove noise and reduce the amplitude of T-waves and P-waves so they are not sensed. The device detects an R-wave when the amplitude of the filtered cardiac signal rises above a dynamically-adjusted sensing threshold.
2-12 Insertable Cardiac Monitor Arr hythmia Detection Monitoring and individual parameters can be changed after insertion; for example, during a follow-up. For a list of programmable parameters, see "Programmable Parameters: Arrhythmia Detection" on page B-1.
Insertable Cardiac Monitor Arr hythmia Detection 2-13 Each Brady event contains 30 seconds of annotated S-ECG data centered around the onset (15 seconds before and up to 15 seconds after) and up to 30 seconds of annotated S-ECG data at the end where the heart rate is no longer slow. If there are Brady events, the Patient Detail page displays the one with the slowest average heart rate in the current set of data being reviewed.
2-14 Insertable Cardiac Monitor Sym p t om Re cord e d E ve n t Each AF event contains 3 minutes of intervals before the start, 1 minute of annotated S-ECG data after the start, and up to 3 minutes of annotated S-ECG at the end. The average V-Rate and maximum V-Rate during the event are displayed, along with the time/date the event started and the duration. AT (Atrial Tachy) The device detects a potential AT event when there is an elevated ventricular rate for a user- programmable duration.
Insertable Cardiac Monitor Pre se n t i n g S - ECG s 2-15 If a symptom recorded event starts within 30 minutes of the start of a device-detected event, then the system correlates the two events. For example, if a Brady event is detected and then 10 minutes later the patient records symptoms, the server correlates the two events, capturing them in a single S-ECG. Symptom information collected from the patient is listed along with the S-ECG.
2-16 Insertable Cardiac Monitor A rr h yt h m i a Ev en t D at a a n d S - ECG St ora g e Table 2–1. S - E C G M a r k e r s (continued) Marker Definition P Ventricular pause (interval without a VS). The marker is positioned at the point where the user-programmed pause duration expired from the previous VS. End Pause Labels the VS at the end of a device-confirmed cardiac pause. Brady Labels the VS in a Brady event where four out of five beats were slow.
Insertable Cardiac Monitor Tre n d s Event T ype Priority Special Criteria AF 1 Longest Pause 1 Longest Tachy 1 Fastest AT 2 N/A Brady 2 Slowest Symptom 3 N/A 2-17 Trends Trends provide a graphical view of specific patient and device data. This data can be useful when evaluating a patient's condition and the effectiveness of programmed parameters. Unless otherwise noted below, data for all trends is reported every 24 hours.
2-18 Insertable Cardiac Monitor Ma gnet Use MAGNET USE The magnet feature allows a patient or clinician to initiate communication between the device and the patient or clinic app. The magnet is required to do the following: • Set up the patient app • Initiate communication between the patient app and the device when using Clinician Tools (e.g.
Insertable Cardiac Monitor P rod u c t S p e ci f i ca t i on s 2-19 Return all devices removed from patients to Boston Scientific. For a Returned Product Kit, contact Boston Scientific using the information on the back cover. N OT E : Examination of these devices can provide information for continued improvement in system reliability and warranty considerations.
2-20 Insertable Cardiac Monitor C h arac t e ri st i c s a s Sh i p p e d Table 2–3. Materials P a ra m e t e r Value Can Titanium Electrodes Titanium nitride Header Implantable Grade Polymer Coating Parylene Table 2–4. P a t i e n t- c o n t a c t i n g M a t e r i a l s Material % o f T o t a l E x p o s e d S u r f a ce A rea Cured epoxy 13% Titanium (with titanium nitride coating) 10% Parylene coating 77% Table 2–5.
Insertable Cardiac Monitor X- R a y I d e n t i f i e r 2-21 X- R a y I d e n t i f i e r The device has an identifier (ID) that is visible on x-ray film or under fluoroscopy. This ID provides noninvasive confirmation of the manufacturer and consists of the following: • The letters, BSC, to identify Boston Scientific as the manufacturer • The number, 301, to identify the device as a LUX-Dx device • The x-ray identifier is inside the device case (Figure 2–14 X-ray ID location on page 2-21).
2-22 Insertable Cardiac Monitor P rod u c t R el i a b il i t y
3-1 MOBILE APPLICATIONS CHAPTER 3 This chapter contains the following topics: • “Overview” on page 3-2 • “Patient App” on page 3-2 • “Clinic App” on page 3-3 • “Replacing a Boston Scientific Mobile Device” on page 3-8 • “Disposing of a Boston Scientific Mobile Device” on page 3-9
3-2 MOBILE APPLICATIONS Over v iew OV ER V IE W The ICM system uses two mobile applications (apps), one for patients and one for clinicians. Boston Scientific provides each of the apps pre-installed on a mobile device. This manual contains information regarding the use of the apps by clinicians. For specifications or other information about the mobile device on which the apps run, see the literature provided by the mobile device manufacturer.
MOBILE APPLICATIONS View Rea l-time S-ECG 6. 3-3 To view S-ECGs, tap V i e w R e a l - t i m e S - E C G . To end the session, tap the D I S C O N N E C T button. View Real-time S-ECG This feature is used by clinicians during insertion to verify that the insertion location provides adequate sensing amplitude.
3-4 MOBILE APPLICATIONS Setup Setup The clinic app must be registered in LATITUDE Clarity before it can be used. The following are required to complete the setup: • Wi-Fi or cellular connection • Registration code • Access to LATITUDE Clarity N OT E : You will be prompted to log on to LATITUDE Clarity to generate the registration code during the app setup process. To set up the clinic app: 1. Power on the mobile device. 2. Tap the L U X C l i n i c app icon to open the app.
MOBILE APPLICATIONS Using the Clinic App 3-5 F i g u re 3 – 1 . R e m o v e A d h e s i v e B a c k i n g 4. Place the back side of the magnet (the side with the Boston Scientific logo) on the adhesive and press firmly (Figure 3–2 Magnet Attached to Mobile Device Case on page 3-5). F i g u re 3 – 2 . M a g n e t A t t a c h e d t o M o b i l e D e v i ce C a s e Using the Clinic App This section of the manual describes clinic app features.
3-6 MOBILE APPLICATIONS C onnect to Wi-F i • View Real-time S-ECG Connect to Wi-Fi Connect to Wi-Fi at any time by completing the following steps: 1. Press the Home button on the mobile device. 2. Tap the down arrow in the upper right corner of the screen. 3. Tap the Settings icon. 4. Tap W i - F i . 5. If a list of available Wi-Fi networks displays, tap to select a network from the list. 6. Follow the instructions on the screen. You may be prompted to enter a network password to connect. 7.
MOBILE APPLICATIONS A p p l y Pro g ram m i n g 3-7 When the interrogation is complete, any programming changes downloaded from the server at the time the app connected to the device will be applied. A message on the app screen confirms that the interrogation was successful. Apply Programming Changes to programmed settings are made on the LATITUDE server. The A p p l y P r o g r a m m i n g feature allows the clinic app to send the changes to a patient’s device.
3-8 MOBILE APPLICATIONS D i s co n n ec t • C l i n i c R e s o u r c e s . Access education and training content related to use of the ICM system and the types of cardiac conditions it monitors. D i s co n n e c t To end a session: 1. Tap the D I S C O N N E C T button to end the session. All data related to the device is deleted from the clinic app and it can now connect to a new device.
MOBILE APPLICATIONS D i s p o s i n g o f a Boston Scientific M o b i l e D e v i ce 4. 3-9 Complete app setup on the new mobile device. D I S P O S I N G O F A BOSTON SCIENTIFIC M O B I L E D E V I C E If you no longer need to use your clinic app or any electronic accessories, contact your local authorities to learn how to dispose of electronic items. Electrical and electronic equipment should not be incinerated. Do not incinerate any device or component containing a battery or electronics.
3-10 MOBILE APPLICATIONS D i s p o s i n g o f a Boston Scientific M o b i l e D e v i ce
4-1 T H E L A T I T U D E C L A R I T Y D A T A M A N A G E M E N T SY S T E M CHAPTER 4 This chapter contains the following topics: • “Overview” on page 4-2 • “Getting Started” on page 4-2 • “System Setup” on page 4-6 • “Saving Settings” on page 4-6 • “Enrolling Patients” on page 4-7 • “Reason for Monitoring” on page 4-8 • “Device Interrogation” on page 4-8 • “Patient Group and Clinic Options” on page 4-10 • “Organization of Patient Information and Programming Options” on page 4-12 • “M
4-2 THE LATITUDE CLARITY DATA MANAGEMENT SYSTEM Over v iew OV ER V IE W LATITUDE Clarity enables authorized personnel to periodically monitor both patient and device status, as well as to program a patient’s device. LATITUDE Clarity also provides tools to analyze a patient’s data sent from their device in order to develop an informed understanding of their cardiac monitoring status. Patients may come into the office when clinically appropriate.
THE LATITUDE CLARITY DATA MANAGEMENT SYSTEM Mobile Application 4-3 Mobile Application Personnel authorized to use LATITUDE Clarity may also have the option of using the clinic app, a mobile application, to enable, apply programming to, or interrogate a patient’s device. See "Clinic App" on page 3-3 for more information.
4-4 THE LATITUDE CLARITY DATA MANAGEMENT SYSTEM R e qu i re m e n t s F i g u re 4– 1 . L A T I T U D E I n i t i a l A cce s s P a g e 2. 3. The first time you access the LATITUDE website or the first time you access the website from a different computer, select your country and language, as applicable. • During subsequent logins, country and language can be changed by clicking C h a n g e C o u n t r y / L a n g u a g e on the login page, as shown in the following figure.
THE LATITUDE CLARITY DATA MANAGEMENT SYSTEM Navigating the Site 4-5 (*) Click this link to change your country or language. F i g u re 4 – 2 . 4. Login Page Enter your U s e r I D and P a s s w o r d and click the L o g i n button. N OT E : Clicking the link for LATITUDE Customer Support provides a list of phone numbers to call for help. Users accessing the LATITUDE website for the first time are prompted to change their temporary password and complete a set of personal security questions.
4-6 THE LATITUDE CLARITY DATA MANAGEMENT SYSTEM System Setup F i g u re 4 – 3 . L A T I T U D E C l a r i t y Sy s t e m B a n n e r Table 4–2. (1) (2) (3) Navigating the Site Pa tient List The first page displayed after logging on to LATITUDE Clarity; provides a list of patients to which the current user has access. (See "Patient List Page" on page 4-12.) Enrol l Pat ie nt Links to an enrollment form that enables authorized personnel to enroll new patients. (See "Enrolling New Patients" on page 4-7.
THE LATITUDE CLARITY DATA MANAGEMENT SYSTEM En ro ll i n g Pa ti e n t s 4-7 N OT E : Changes to programming settings on the patient’s device may be updated immediately using the clinic app while the patient is in the clinic. See "Apply Programming" on page 3-7. ENROLLING PATIENTS This section provides information for enrolling patients in the ICM system. As a result of the enrollment and set-up process: • The patient is enrolled in LATITUDE Clarity.
4-8 THE LATITUDE CLARITY DATA MANAGEMENT SYSTEM E n rol li n g Ex i st i n g P at i e n t s E n ro l l i n g E x i s t i n g P a t i e n t s If a patient was previously enrolled in LATITUDE Clarity, re-enrollment is required before data can be sent to the new clinic. Follow the same process as the initial enrollment process (via E n r o l l P a t i e n t ). During re-enrollment, the patient’s date of birth must be the same date entered during initial enrollment.
THE LATITUDE CLARITY DATA MANAGEMENT SYSTEM Alerts 4-9 T a b l e 4 – 3 . D e v i ce I n t e r r o g a t i o n F e a t u r e s (continued) Int e rrog ati on Typ e/Re as on a F ull Int erro gat io n wit h P re s e n t i n g S - E C G Data Updated Reason Typically occurs when Daily Alert Checks detect a possible alert condition but LATITUDE Clarity determines that there is no new alert condition for the patient Typically yes.
4-10 THE LATITUDE CLARITY DATA MANAGEMENT SYSTEM P at i e n t I n i t i at e d I n te rro g at i on s Additional Alert Notification to the Clinician A d d i t i o n a l A l e r t N o t i f i c a t i o n is available through text (SMS) and email messages. These messages can only be configured at the Patient Group level. For more information, see the T e x t a n d E m a i l N o t i f i c a t i o n s section of "EEd i t / V i e w P a t i e n t G r o u p D e f a u l t s " on page 4-10.
THE LATITUDE CLARITY DATA MANAGEMENT SYSTEM P at i e n t G rou p an d Cl i n i c O p t i on s Section 4-11 Descr iption N OT E : One additional PII can be configured at any time for an individual patient. See "Patient Initiated Interrogations" on page 4-10 and "Viewing Patient Detail" on page 4-16, P R O G R A M M I N G tab, P a t i e n t I n i t i a t e d I n t e r r o g a t i o n s section.
4-12 THE LATITUDE CLARITY DATA MANAGEMENT SYSTEM O rg an i z at i on of Pa t i en t I n fo rm at i on an d P rog ram m i n g Op t i on s Ge ne ral Info rmat io n • Provides access to change N a m e , L a n g u a g e , and T i m e Z o n e , as applicable, for the clinic. • View the C l i n i c I D . • Provides check box to select or clear U s e r p a s s w o rd s e x p i r e e v e r y 1 8 0 d a y s . Contact Information Provides access to change the clinic’s contact information.
THE LATITUDE CLARITY DATA MANAGEMENT SYSTEM Patient List Page 4-13 Fig ure 4– 5. Pat ie nt Lis t Pa ge The following subsections describe the filtering and organizational tools available to efficiently navigate the P a t i e n t L i s t page: Vie w in g P at ien t G ro u p The V i e w i n g P a t i e n t G r o u p drop-down list provides a list of Patient Groups to which the user is assigned. A l l P a t i e n t G r o u p s is the default.
4-14 THE LATITUDE CLARITY DATA MANAGEMENT SYSTEM Patient List Page Filter Watch List Description • The M o n i t o r i n g S t a t u s / D a t e column on the P a t i e n t L i s t page is the default sort when the N o t M o n i t o r e d list is displayed. Patients are listed in order of when N o t M o n i t o r e d was determined, with the most recent listed first. • Custom list of patients who need to be monitored more closely.
THE LATITUDE CLARITY DATA MANAGEMENT SYSTEM Patient List Page Column Check box Patient Info Review Reason 4-15 Descr iption • Select the check box for one or more patients. • A selection from the A c t i o n menu is performed for all selected patients. Click on a patient’s name in the P a t i e n t I n f o column to see Patient Detail for that patient. (See "Viewing Patient Detail" on page 4-16.
4-16 THE LATITUDE CLARITY DATA MANAGEMENT SYSTEM Viewing Patient Detail Column Description Patient Notes Displays either P a t i e n t N o t e s entered by the user or . • P a t i e n t N o t e s are initially created by clicking • P a t i e n t N o t e s are also available in the N o t e s section in Patient Detail ("Viewing Patient Detail" on page 4-16). • . Clicking an existing note opens a window from which P a t i e n t N o t e s can be revised and saved.
THE LATITUDE CLARITY DATA MANAGEMENT SYSTEM Viewing Patient Detail 4-17 F unction Descr iption Reason for Monitoring • Displays the R e a s o n f o r M o n i t o r i n g selected for the patient. • Each R e a s o n f o r M o n i t o r i n g is color coded throughout LATITUDE Clarity for easier identification. C l in ic a l C on tex t Displays corresponding optional data entered on the Edit/View Patient and Equipment Information page; maintained by the clinic if deemed useful; may remain blank.
4-18 THE LATITUDE CLARITY DATA MANAGEMENT SYSTEM Viewing Patient Detail Tab Description M y A l e r t s — displays information for red or yellow alerts not yet dismissed. P r e s e n t i n g S - E C G , not dismissed when patient is dismissed. For more information, see the E V E N T S portion of this table. E v e n t L o g b o o k — displays the following events: • All undismissed events.
THE LATITUDE CLARITY DATA MANAGEMENT SYSTEM Viewing Patient Detail Tab Description N OT E : HEALTH: Provides detail about AF, trends, and heart rate. F O L L OW - U P H I S T O RY : Provides a list of past interrogations for the patient. The colored bar by the event remains after the patient is dismissed. – Displays a short description of the event.
4-20 THE LATITUDE CLARITY DATA MANAGEMENT SYSTEM Viewing Patient Detail Tab Description • For event alerts, first press the toggle key to enable each event, as applicable, and then select the desired values and alerts. • The individual patient settings for event alert configuration provide three options: • Toggle key to the O f f position: No alert or event detection. • Clear alert check boxes: Event detection with no alert.
THE LATITUDE CLARITY DATA MANAGEMENT SYSTEM Viewing Patient Detail 4-21 F unction Descr iption U ne nrol l Pat ie nt button Removes the patient from the primary Patient Group and discontinues monitoring. L a s t U p d a t e d B y link For each section of the page, provides the section name, date, and name of the user who last updated the section. G en eral In for mati on • P a t i e n t I n f o r m a t i o n , provides patient name, ID, gender, phone numbers, and date of birth.
4-22 THE LATITUDE CLARITY DATA MANAGEMENT SYSTEM E vent Detail Viewer Event Detail Viewer An E v e n t D e t a i l viewer provides enhanced viewing options and tools and is available from Patient Detail for from either the D A T A F O R P r e s e n t i n g S - E C G data and E v e n t L o g b o o k events. Click the Access Event Detail icon R E V I E W or E V E N T S tab.
THE LATITUDE CLARITY DATA MANAGEMENT SYSTEM Managing Patients 4-23 Multiple individual reports may be printed at one time. If attempting to print more than the maximum number of reports allowed, the system will advise to print fewer reports.
4-24 THE LATITUDE CLARITY DATA MANAGEMENT SYSTEM T ran sf e rri n g Pa ti e n t s T ra n s f e r r i n g P a t i e n t s Patients can be transferred from an existing clinic to a new clinic, based on patient consent. When a new clinic enrolls a patient, the user in the previous clinic will see an indication that the patient is being followed by a different clinic.
THE LATITUDE CLARITY DATA MANAGEMENT SYSTEM C l i n i c A cco u n t M a n a g em e n t 4-25 Note that Clinic Account Managers are assigned to all Patient Groups and cannot be removed from a Patient Group. CLINIC ACCOUNT MANAGEMENT The following sections explain clinic account management in LATITUDE Clarity.
4-26 THE LATITUDE CLARITY DATA MANAGEMENT SYSTEM M a n a g i n g U s e r A cco u n t s T a b l e 4 – 4 . F u n c t i o n s P e r m i t t e d f o r C l i n i c U s e r s b y P r i v i l e g e (continued) Function a.
THE LATITUDE CLARITY DATA MANAGEMENT SYSTEM Pas sw ord s • 4-27 A clinic user can access the U p d a t e C l i n i c U s e r page by clicking M y P r o f i l e , associated with their name at the top of every page. The following table shows the functions available on the U p d a t e C l i n i c U s e r page: Description Function User Information Includes name, phone number, and e-mail address. Website Language and Countr y Can also be changed on the login page.
4-28 THE LATITUDE CLARITY DATA MANAGEMENT SYSTEM Secur ity Questions Security Questions A clinic user is prompted to change their password the first time they log in with their temporary password. The clinic user must enter answers to three selected security questions. A clinic user is prompted for their answer to one of these security questions if they forget their password and need to reset it. Clinic users can also ask their Clinic Account Manager to reset their passwords.
THE LATITUDE CLARITY DATA MANAGEMENT SYSTEM E MR Sy s te m I n t e g ra t i o n 4-29 F i g u re 4 – 7 . F o rg o t P a s s w o rd ? L i n k EMR SYSTE M IN TE GRATI ON The optional LATITUDE Electronic Medical Record (EMR) system integration feature, if enabled, provides an automated way to export patient device data to a clinic’s internal EMR application.
4-30 THE LATITUDE CLARITY DATA MANAGEMENT SYSTEM E M R Sy s t em I n t e g ra t i o n • Allows selection of the data format for your EMR application. • Displays details of each data export including time stamps and export status. • Allows EMR data to be resent. N OT E S : • Connection difficulties may delay or prevent EMR file delivery to the EMR application. LATITUDE Clarity is the system of record for remote patient management.
THE LATITUDE CLARITY DATA MANAGEMENT SYSTEM E MR Sy s te m I n t e g ra t i o n 3. 4-31 Press the applicable toggle key for L A T I T U D E N X T O u t p u t or L A T I T U D E C l a r i t y O u t p u t (shown as follows): F i g u re 4 – 9 . E d i t / V i e w E M R C o n f i g u ra t i o n P a g e 4. For L A T I T U D E C l a r i t y O u t p u t , select a clinic identifier from the S e l e c t c l i n i c i d e n t i f i e r drop-down list (as shown in the previous figure).
4-32 THE LATITUDE CLARITY DATA MANAGEMENT SYSTEM View EMR Log 5. Click the c l i c k h e r e link (as shown in the previous figure) to download the EMR integration software. 6. A website for the EMR integration software that needs to be installed is provided. Follow the installation and setup instructions available on this website. 7. Before enabling EMR Integration, complete installation and registration of the software.
THE LATITUDE CLARITY DATA MANAGEMENT SYSTEM View EMR Log 4-33 Fig ure 4– 10. V ie w EM R Log Wi nd ow The EMR log is sorted by D e v i c e T r a n s m i s s i o n D a t e . The following table provides a description of each column of the V i e w E M R L o g window: Column Descr iption Patient Info Provides a list of patient names and identifiers for whom EMR transmission applies. Reason D e v i c e T ra n s m i s s i o n Date Status Provides the reason that the EMR export was initiated.
4-34 THE LATITUDE CLARITY DATA MANAGEMENT SYSTEM T rou b l e sh oot i n g T R O U B L E S H O OT I N G The H e l p / C o n t a c t U s section of LATITUDE Clarity is available in the drop-down list under the user’s name.
A-1 SY M B O L S O N P A C K A G I N G APPENDIX A The following symbols may be used on packaging and labeling (Table A–1 Symbols on packaging on page A-1): Tabl e A –1 . Symbo ls o n p acka gi ng Symbo l Description Reference Number Serial number Use by date Date of manufacture Sterilized using ethylene oxide Do not resterilize Do not reuse Do not use if package is damaged Implantable device, coated Temperature limitation MR Conditional Consult instructions for use on this website: www.
A-2 Symbols on Packaging T a b l e A – 1 .
B-1 PROGRAMMABLE PARAMETERS APPENDIX B T a b l e B – 1 . P ro g ra m m a b l e P a ra m e t e r s User Programmable Parameter Programmable values Blank After Sense (ms) 130 – 400, 10 ms intervals Sensitivity (mV) 0.025, 0.037, 0.05, 0.075, 0.1, 0.15, 0.
B-2 Programmable Parameters
C-1 DEFAULT PROGRAMMING VALUES PER REASON FOR MONITORING APPENDIX C The following table displays the default values for parameters based on the reason the patient is being monitored. T a b l e C – 1 .
C-2 Default Programming Values per Reason for Monitoring Table C–1. D e f a u l t P r o g r a m m i n g V a l u e s p e r R e a s o n f o r M o n i t o r i n g (continued) Reason for Monitoring Parameter Name Sensitivity Values (User Visible Names) Cryptogenic Stroke Post AF Ablation AF Management 0.025, 0.037, 0.05, 0.075, 0.1, 0.15, 0.
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