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Patient User Guide

LifeWatch Mobile Cardiac Telemetry 3 Lead


Patient User Guide LifeWatch MCT 3L

About This Guide

Carefully read this guide before monitoring is started. This patient user guide provides the information and instructions for the LifeWatch Mobile Cardiac Telemetry 3 Lead (LifeWatch MCT 3L) model CG-6108 ACT-3L. The LifeWatch MCT 3L is a 3 lead continuous ECG monitor and arrhythmia detector.

PERSCRIPTION ONLY Federal Law (USA) restricts this device to sale by or on the order of a practitioner licensed by the law of the State in which he/she practices to use or order the use of the device.

WARNING This manual should always accompany the unit. All personnel utilizing the LifeWatch MCT 3L must have read and be familiar with the contents of this manual.

Using this Guide For clarity, this section describes the conventions, symbols, and images used in this user guide and that may be located on the equipment, labeling, and accessories. TEXT For clarity, this user guide uses the following conventions: „

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Items on a Screen Display (Monitor screen) that are functions or active fields are in bold text. Items that are on the touchscreen names or names of passive functions/fields are in italics. Buttons and other physical item NAMES are shown in ALL CAPS text.

Images

Figures of a product and related components may be shown in specific colors for illustration purposes. Equipment, labeling, and accessories displayed as a particular color in this guide may not be the same color on the actual device.

Contact Information

Contact LifeWatch Services with any questions regarding this document. Contact

Phone

Patient Care & Activation

1-800-517-6330


Table of Contents Table of Contents

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Intended Use.....................................................................4 Description of Device (Overview) ................................... 4 Precautionary Information.............................................. 6 About the Equipment....................................................... 7 Box Contents.............................................................................. Monitor ....................................................................................... Sensor ......................................................................................... Electrodes ...................................................................................

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7 8 8 9

Preparing and Handling.................................................10 Preparing and Maintaining the Sensor ................................. 10 Preparing the Sensor......................................................... 10 Preparing and Maintaining the Electrodes........................... 14 Skin Preparation ................................................................ 15 Snapping Electrodes to Harness...................................... 15 Placing Electrodes.............................................................. 16 Helpful Tips for Comfort ................................................... 16 Maintaining and Replacing Electrodes ............................ 17 Preparing the Monitor ............................................................ 18 Charging the Monitor ........................................................ 18 Placement of the Monitor................................................. 20

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Operation ........................................................................20 Monitor Basics ......................................................................... 21 POWER ................................................................................ 22 Touchscreen ....................................................................... 22 Screen Field ........................................................................ 23 Volume ................................................................................ 23 911 Emergency................................................................... 24 First Time Use .......................................................................... 24 Monitoring Period ................................................................... 29 Manual Event Recording......................................................... 32 Manual Event with the Sensor ......................................... 33 Manual Event with the Monitor ....................................... 35

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Messages .........................................................................38 Sensor Battery ......................................................................... Monitor Battery ....................................................................... Sensor Connection .................................................................. Monitor Transmission............................................................. Electrode Connectivity ............................................................ Code Messages ........................................................................

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39 39 40 41 42 42

Maintenance ...................................................................44 Troubleshooting .............................................................44 Glossary ...........................................................................47 Safety Symbols and Information ..................................47 Warnings, Cautions, and Notices..................................49 Technical Specifications.................................................52 Monitor ..................................................................................... 52

Patient User Guide: LifeWatch MCT 3L

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Table of Contents Sensor ....................................................................................... 52 Bluetooth .................................................................................. 52 FCC............................................................................................. 53 FCC Hearing-Aid Compatibility (HAC) Regulations for Wireless Devices ................................................................ 54 Declaration of Conformity...................................................... 55 Parameters ............................................................................... 55 RF Specifications ...................................................................... 57 Alert Specifications .................................................................. 58 Calculations .............................................................................. 59 Heart Rate (HR) Calculation Method ............................... 59 Pause Calculation............................................................... 59

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Patient Financial Obligations.........................................60 Limited Warranty............................................................60 Software End User License Agreement .......................62 Legal .................................................................................65 Copyright and Intellectual Property ...................................... 65 FDA ............................................................................................ 65

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Contact Information.......................................................65 Manufacturer ........................................................................... 65

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Patient User Guide: LifeWatch MCT 3L


Intended Use Intended Use

The MCT 3L (CG-6108 ACT-3L) Continuous ECG Monitor and Arrhythmia Detector is intended for use by patients who experience transient symptoms that may suggest cardiac arrhythmia. The device continuously monitors patient ECG, automatically generates an alert triggered by an arrhythmia detection algorithm, or generates an alert manually triggered by the patient, and transmits the recorded data transtelephonically to a monitoring center. The monitoring center provides the ECG data to the medical practitioner for evaluation. The MCT 3L (CG-6108 ACT-3L) Continuous ECG Monitor and Arrhythmia Detector is intended to be prescribed for patients who have demonstrated a need for cardiac monitoring and are at low risk of developing life-threatening arrhythmias. Conditions where the system should not be used include patients likely to experience primary ventricular fibrillation (VF) or ventricular tachycardia (VT) and patients who have other co-morbid cardiovascular conditions where an arrhythmia could be potentially life threatening. The device has been validated for use on patients six years of age and older.

Description of Device (Overview)

This section describes the LifeWatch MCT 3L device and regimen. Figure 1 Sensor (A), Monitor (B).

A

B or

The LifeWatch MCT 3L is used in conjunction with a monitoring service that reviews the recorded transmissions and provides that information to the physician for a final diagnostic interpretation. The LifeWatch MCT 3L is not intended for use as an emergency response system for patients who may experience life-threatening arrhythmias.

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Description of Device (Overview) The following list represents patient populations for whom use of the LifeWatch MCT 3L is most appropriate. This list should be used in conjunction with Medicare and other payor medical necessity guidelines: „

Patients with dizziness or lightheadedness.

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Patients with palpitations.

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Patients with syncope of unknown etiology.

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Patients who require monitoring for non-life-threatening arrhythmias, such as Atrial Fibrillation, Supra-ventricular Arrhythmias, evaluation of various Brady arrhythmias. This includes post-operative monitoring for these rhythms. Patients recovering from coronary artery bypass graft (CABG) surgery who require monitoring for arrhythmias. Patients requiring monitoring for arrhythmias-including co-morbid conditions such as hyperthyroidism or chronic lung disease. Patients with obstructive sleep apnea to evaluate possible nocturnal arrhythmias. Patients requiring arrhythmia evaluation for etiology of stroke or transient cerebral ischemia, possibly secondary to Atrial Fibrillation.

To use the LifeWatch MCT 3L monitoring system, the patient or primary care provider must be able to perform all of the following: „

Understand the principle of operation and system messages described in this manual.

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Place the sensor and electrodes on the chest.

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Operate a handheld device (Monitor).

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Keep sensor nearby the user at all times.

The LifeWatch MCT 3L is safe for use by patients wearing an oxygen mask for breathing. The functionality of the LifeWatch MCT 3L is dependent on cellular service and Bluetooth technology. Limitations in data transmission may occur if there is limited cellular service in the area and/or interference to the Bluetooth signal. NOTE In patients with chronic or transient low amplitude ECG signal (0.5mV or lower) and wide-QRS durations, the MCT 3L may interpret resulting ECG signal as noise. This will trigger an event and require review by a clinician. Page 5 of 66

Patient User Guide: LifeWatch MCT 3L


Precautionary Information You may occasionally experience a delay in the ability to send recorded events due to unexpected cellular limitations. If this occurs, contact LifeWatch call LifeWatch Patient Care at 1-800-517-6330 as soon as possible. For minimal service interruption, any unresolved technical difficulties should be reported to resolve the issue.

Precautionary Information

Before using the LifeWatch MCT 3L Monitor, read this section to understand the limitations and responsibilities associated with the device and the documentation. „

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See Warnings, Cautions, and Notices on page 49 complete list of the major warnings and cautions relevant to the LifeWatch MCT 3L system. These warnings and cautions are also repeated, as appropriate, in sections of this manual. The information and screens provided in this manual are subject to change without notice. LifeWatch Technologies Ltd. and LifeWatch Services Inc. SHALL NOT BE LIABLE FOR TECHNICAL OR EDITORIAL ERRORS OR OMISSIONS CONTAINED HEREIN; NOR FOR INCIDENTAL OR CONSEQUENTIAL DAMAGES RESULTING FROM THE FURNISHING, PERFORMANCE, OR USE OF THIS MATERIAL CONTAINED HEREIN.

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About the Equipment About the Equipment

The LifeWatch MCT 3L is an automatically activated cardiac monitoring system that requires no patient intervention to capture or transmit an arrhythmia when it occurs. When an arrhythmia is detected, the LifeWatch MCT 3L utilizes an integrated Monitor to transmit the data to the monitoring center for analysis.

Box Contents

The following items are included in the box: Table 1 Items in the LifeWatch MCT 3L box. Item

Description LifeWatch MCT 3L sensor with lead wires

LifeWatch MCT 3L batteries (3.6V AA lithium-thionyl chloride)

Disposable electrodes

User Guides

LifeWatch MCT 3L Monitor

Monitor charger

Monitor carrying pouch

Pre-Paid return envelope

NOTE If the equipment is not returned or is damaged, a $1,745.00 (US) replacement fee will be charged to the credit card on file, or billed directly.

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Patient User Guide: LifeWatch MCT 3L


About the Equipment Monitor

The Monitor, Figure 2 and Figure 3, receives ECG data from the sensor via Bluetooth and can store up to 30 days of data. The Monitor has a special application that converts the raw ECG data and sends it using a cellular network to the monitoring center for interpretation. LifeWatch supports two models of Monitors -- the Universal Gateway and the Brigadier. One of these models are included in the kit. Figure 2 Universal Gateway Monitor provided with kit.

Figure 3 Brigadier Monitor provided with kit.

Sensor

The sensor, Figure 4, records and transmits data to the Monitor. It can hold up to six hours of data in its memory. This means that if a patient is away from the Monitor and wearing the sensor, the data is still being recorded. Once the patient is within an unobstructed 10 meters (30 feet) of the Monitor (closer the better), the data will start to be transmitted to the Monitor.

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About the Equipment The sensor is equipped with four (LifeWatch MCT 3L) electrodes on a harness, Figure 4 (A), and works in conjunction with the Monitor. Figure 4 Sensor: Connected with leads (A), back (B), battery compartment (C).

A

B

C

NOTE The Monitor automatically transmits the detected ECG events to the monitoring center and the user has the ability to send manually recorded events. The data is saved on the storage card in the Monitor and the event data is deleted after a successful transmission to the monitoring center.

Electrodes

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The LifeWatch MCT 3L includes ECG lead wires, Figure 4 (A), that have standard snap connectors for quick and easy connection/removal to ECG electrodes. To ensure maximum safety and performance of the LifeWatch MCT 3L monitoring system, use only the ECG lead wires and electrodes supplied with the LifeWatch MCT 3L box.

Patient User Guide: LifeWatch MCT 3L


Preparing and Handling Preparing and Handling

This section contains the procedures for preparing to use the LifeWatch MCT 3L and being ready to start the prescribed service period. Instructions are provided for activating the sensor, placing the electrodes, prepping the Monitor and preserving the setup. The performance of the Monitor, including data recording and transmission, may be adversely impacted if not adequately charged.

CAUTION Before starting the instructions in this guide, understand the following: „

Do not change the Monitor settings.

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Do not turn the Monitor sound off.

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Do not mute the volume so that it is inaudible.

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Do not use the Monitor for any reason outside of the designated monitoring function.

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The recommended ambient temperature for use of the LifeWatch MCT 3L System Monitor is between 50° F (10° C) and 104° F (40° C).

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Remove the lead wires and the Sensor before bathing.

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The Monitor and the sensor are not to be exposed to direct water contact. The sensor and the Monitor should not be in the bathroom while bathing or showering.

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Please consult your doctor or LifeWatch regarding the end of the service.

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You must take the fully charged Monitor with you and wear the sensor at all times (except when showering or bathing).

This section contains the procedures for readying and Preparing and Maintaining the sustaining the sensor throughout the service period. Sensor PREPARING THE SENSOR 1 In the box, locate and remove: Figure 5 Sensor and batteries. A

„ „

B

Sensor, Figure 5 (A) One of the LifeWatch MCT 3L batteries (3.6V AA lithium-thionyl chloride), Figure 5 (B)

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Preparing and Handling „

Lead wire

„

Neck strap

CAUTION Over-the-counter batteries should never be used as they can seriously damage the sensor. Only use the specialized batteries included in the box. If more batteries are needed, LifeWatch Patient Care at 1-800-517-6330. Provided batteries are not rechargeable. DO NOT RECHARGE BATTERIES. RECHARGING NON-RECHARGEABLE BATTERIES MAY LEAD TO FIRE, EXPLOSION, AND SEVERE BURN HAZARD. Do not recharge, short circuit, crush, disassemble, heat above 100oC, incinerate, or expose contents to water.

2 Place the sensor within 50 cm (20 inches) from the Monitor. 3 Hold the sensor with the battery compartment facing up, Figure 6. Figure 6 Sensor battery compartment.

D A

C B

4 Press the orange button, Figure 6 (A), to release the battery compartment cover, Figure 6 (B). CAUTION Do not attempt to remove the battery cover. If the battery cover becomes separated from the device, please refer to Battery cover separates from sensor on page 46 for replacing the battery cover.

5 If applicable, remove an existing battery by pulling on the battery strap, Figure 6 (C). NOTE Place only unused batteries in the return packaging provided and return to LifeWatch at the end of the monitoring period. Any used batteries should be recycled and not returned to LifeWatch.

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Preparing and Handling 6 Being mindful of the polarity symbols (+ and -), insert the LifeWatch MCT 3L battery (3.6V AA lithium-thionyl chloride) into the sensor, Figure 7. Figure 7 Sensor battery polarity.

-

+

+

The Monitor should beep once within 10 seconds of inserting a new battery. If no sound is heard after 10 seconds, verify that the battery has been placed in the correct position. CAUTION If the position is correct, try another battery. If the second battery fails, call LifeWatch Patient Care at 1-800-517-6330.

7 Close the battery compartment cover by pressing it until it clicks shut. The sensor is active. CAUTION The battery in the sensor should be changed when receiving low battery messages.

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Preparing and Handling 8 If applicable, connect the lead wire to the sensor by aligning the arrows and firmly pushing the cable into the socket, Figure 8 (A). Figure 8 Connecting the lead cable to the sensor.

A

9 Wear the sensor either around your neck (using the lanyard) or on your chest (using an electrode). If...

then...

using the lanyard,

wear the sensor around your neck. Adjust lanyard for personal comfort and reduced slack of lead wires.

removing the lanyard,

apply a new electrode to a cleaned, unirritated location on the chest or torso. Then, attach the sensor to the electrode using the snap on the back of the sensor, Figure 6 (D).

MAINTAINING SENSOR DURING RECORDING When a low sensor battery message first appears, there are three to six hours before the battery fails. Perform the following steps: a Place the sensor within 50 cm (20 inches) from the Monitor.

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Patient User Guide: LifeWatch MCT 3L


Preparing and Handling b Replace the battery as instructed in Preparing the Sensor on page 10, step 3 through step 7. Upon battery replacement, the sensor and Monitor reconnect (which may take up to five minutes) and the Monitor downloads stored ECG data. After the download is completed, the sensor starts recording again. CAUTION If the sensor battery is replaced when the sensor is out of Bluetooth range from the Monitor, the sensor will not be able to connect with the Monitor and will not be able to record until it reconnects with the Monitor.

Preparing and This section provides procedures for preparing, attaching, and Maintaining the maintaining the electrodes. Electrodes WARNING Minor skin irritation can occur with electrode use. Carefully, follow the instructions in this section. If skin irritation occurs, do not place the electrodes in the same location as the irritated skin. Instead, apply the replacement electrodes adjacent to the original sites to continue an accurate reading. If irritation worsens or becomes severe, contact LifeWatch to obtain an alternative type of electrode. If there are questions regarding treating irritated skin, please contact your prescribing physician or health or care professional.Alternative electrodes are available for patients with a history of sensitivity and/allergy to adhesives by calling LifeWatch Patient Care 1-800-517-6330.

Figure 9 Electrode locations Patient Right Side

Patient Left Side

White Electrode Red Electrode

The circle outside of each electrode indicates you may move each electrode by one inch above, down, left, or right of the default position. Patient User Guide: LifeWatch MCT 3L

Middle of armpit

Black Electrode

Green Electrode Page 14 of 66


Preparing and Handling SKIN PREPARATION 1 Using only scissors, remove any excess hair in the indicated electrode locations, Figure 9. 2 At the electrode sites, Figure 9, wash the skin with warm water and mild soap. With clean water, thoroughly rinse away any soap residue. 3 Confirm your skin is clean and completely dry before proceeding. Avoid the use of lotions, creams, or alcohol wipes at the electrode sites prior to and during the use of electrodes. WARNING Do not apply electrodes to skin that has an open cut or is already irritated. Apply the electrode in close proximity to the required location on clean, non-irritated skin.

SNAPPING ELECTRODES TO HARNESS 1 In the box, locate and remove the electrode pouch. 2 Open the electrode pouch and pull out the electrodes. 3 Snap an electrode onto each of the four lead wires that are attached to the Monitor, Figure 10 (A). Figure 10 Snapping leads onto electrodes.

A

B

4 Using the peel tab, strip each electrode from the backing, Figure 10 (B).

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Patient User Guide: LifeWatch MCT 3L


Preparing and Handling PLACING ELECTRODES 1 As shown in Figure 9, place the indicated color coded electrode on healthy, non-irritated skin. Apply each electrode by gently pressing down on the center and moving toward the edge in a circular motion to assure firm attachment to the skin. Table 2 Electrode placement. Item

Description On your right side, attach the white lead wire electrode three fingers width below the midpoint of the collarbone, Figure 9. On your left side, align the red lead wire electrode at the midpoint of the collarbone and place above your bottom rib, Figure 9. On your left side, in horizontal alignment with the red electrode, place the black lead wire electrode under the center of your left armpit. The black electrode should be 10 to 13 cm (4 to 5 inches) from the red electrode, Figure 9. On the left side of the abdomen, place the green lead wire electrode, Figure 9.

NOTE „

If necessary, lift the left breast to get the proper electrode placement of the red and black electrodes.

HELPFUL TIPS FOR COMFORT For added comfort, wear a tight-fitting or stretch-mesh shirt to keep the sensor and electrodes securely in place.

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Sensor wires can also be secured to your body using surgical tape or an adhesive bandage to prevent tugging/pulling of wires.

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Preparing and Handling MAINTAINING AND REPLACING ELECTRODES 1 Replace electrodes every 3 days or earlier if the electrodes are loose a Disconnect (unsnap) the leadwires from the electrodes. b To minimize skin irritation during electrode removal, using the peel tab, lift the electrode slowly and gently. For additional ease of removal, use a wet, warm washcloth to help extract the electrodes. c After electrode removal, discard the electrodes. d Using a wet, warm washcloth, gently clean away excess adhesive or dead skin and then allow skin to thoroughly dry. e Apply the new electrodes to skin near the location of the previous electrodes, Figure 9. To minimize skin irritation, electrodes can be replaced adjacently, in all four directions, within one inch of the original placement of the electrode. 2 Check the electrodes daily by pulling gently to verify that the adhesive is firmly attached to your skin. If an electrode is not firmly attached, you can: „ Remove and replace all of the electrodes to keep them on the same schedule, as instructed in step a to step e on page 17. OR „ Track the electrode that fell off separately and replace each of the other electrodes as necessary as instructed in step a to step e on page 17. WARNING Minor skin irritation can occur with electrode use. If skin irritation occurs, do not place the electrodes in the same location as the irritated skin. Instead, apply the replacement electrodes adjacent to the original sites to continue an accurate reading. If irritation worsens or becomes severe, contact LifeWatch to obtain an alternative type of electrode. If there are questions regarding treating irritated skin, please contact your prescribing physician or health or care professional.

CAUTION There are physiological conditions that may affect the Monitor from detecting the electrode connection and can last for several hours even though the electrodes seem to be in good contact with the body. Some examples are very dry skin or right after attaching the electrodes. If the condition does not resolve, contact LifeWatch. Page 17 of 66

Patient User Guide: LifeWatch MCT 3L


Preparing and Handling Preparing the Monitor

This section provides procedures for charging, and placing the Monitor. CHARGING THE MONITOR 1 In the box, locate and remove the Monitor and the charge cable, Figure 11 and Figure 12. Figure 11 Connecting the charge cable to the Monitor (Universal Gateway).

A

Figure 12 Connecting the charge cable to the Monitor (Kyocera Brigadier).

A

2 Plug the charge cable into the Monitor power socket, Figure 11 (A) and Figure 12 (A).

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Preparing and Handling 3 Plug the charger cable into standard wall outlet. While charging, the screen displays a lighting bolt symbol to indicate the device is charging, Figure 13. Figure 13 Lighting bolt symbol.

CAUTION Charge the Monitor every night (regardless of battery indicator status) and whenever possible during the day. Keep the Monitor within three meters (ten feet) of the sensor.

The status of the charge is indicated by percentage and color, Table 3. Table 3 Battery capacity. Indicator Description Green (80% to 100%) Yellow (60% to 79%) Orange (25% to 59%) Red (10% to 24%) White (0% to 9%)

CAUTION The Monitor energy consumption may be high during the first few days of monitoring (up to 72 hours). Keep the Monitor charged at all times.

4 Disconnect the charger from the wall outlet and then from the Monitor.

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Patient User Guide: LifeWatch MCT 3L


Operation PLACEMENT OF THE MONITOR For optimal system performance, the recommended distances between the Monitor and sensor should be as follows: „

Within 50 cm (20 inches) for normal operation, Figure 14 (A).

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Within 3 meters (10 feet) during Monitor charging, Figure 14 (B).

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Within 10 meters (30 feet) maximum distance, Figure 14 (C). Figure 14 Placement of the Monitor relative to sensor.

A

Operation

B

C

This section contains the procedures for actively using the LifeWatch MCT 3L during the prescribed service period. The device will not transmit to LifeWatch after the enrollment period has ended.

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Operation Monitor Basics

This section describes the basics for using the Monitor, Figure 15 and Figure 16. Figure 15 Major elements on the Monitor (Universal Gateway). POWER

911 VOLUME UP/DOWN

TOUCHSCREEN FIELD

Figure 16 Major elements on the Monitor (Kyocera Brigadier). POWER

911 VOLUME UP/DOWN

TOUCHSCREEN

FIELD

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Patient User Guide: LifeWatch MCT 3L


Operation POWER „ Turn on the Monitor by pressing and holding the POWER button for three seconds, Figure 15. „

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When the Monitor is on, and the screen is dark, light up the screen by pressing the POWER button. The MCT 3L (ACT) application home screen displays on the touchscreen, Figure 15. Power off the Monitor by pressing and holding the POWER button for three seconds, Figure 15.

TOUCHSCREEN The touchscreen, Figure 15, is the Monitor glass display that is sensitive to contact. Most functions are controlled by selecting them on the touchscreen. The primary interface displayed on the Monitor touchscreen is the MCT 3L (ACT) application, indicated with the ACT icon and/or name on the screen. CAUTION If the MCT 3L (ACT) application closes (is not displayed), it should auto-restore after 30 seconds. If necessary, on the touchscreen, restart the MCT 3L (ACT) application by selecting the ACT icon. If the MCT 3L (ACT) application does not restart, call LifeWatch Patient Care at 1-800-517-6330.

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Operation As necessary, the function buttons may be displayed or keys may be used when required to complete some tasks, Figure 17 and Figure 18. Figure 17 Function buttons on touchscreen (Universal Gateway). Overview Button

Back Button Home Button

Back Y: Returns to the previous screen or closes a dialog box, options menu, or the Notifications panel. Home c: Opens the home screen (MCT 3L (ACT) application). Overview Â…: Lists previous screens. Figure 18 Function buttons on touchscreen (Kyocera Brigadier).

Back Key

Home Key

Recent Apps Key

Back: Returns to the previous screen or closes a dialog box, options menu, or the Notifications panel. Home: Opens the home screen (MCT 3L (ACT) application). Recent Apps: Lists previous screens. SCREEN FIELD Most functions and items that require interaction are displayed as colored fields on the screen. VOLUME The VOLUME buttons UP and DOWN control the loudness of the Monitor sounds. Tones from the Monitor signal that attention is required.

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Operation 911 EMERGENCY In any situation that requires immediate assistance from emergency services, complete the following steps: 1 On the upper right corner of the touchscreen, select 911. 2 On the touchscreen, confirm the call to 911. 3 After confirming the emergency call, return to the MCT 3L (ACT) application by selecting Back Y. First Time Use

The first time the LifeWatch MCT 3L is attached to you (see Preparing and Handling on page 10) and activated, it will display screens that are not seen in regular use. These screens are calibration procedures the LifeWatch MCT 3L needs to perform to adjust its operation for first time use. During this procedure, you must call the LifeWatch Customer Support Center to receive instructions on how to proceed for the first time use. Using your own primary phone, please be prepared to call LifeWatch Patient Care at 1-800-517-6330.

CAUTION The Monitor cannot be used as a phone for calling the LifeWatch Customer Support Center.

1 Ready for first time use by performing the steps in: „

Preparing and Maintaining the Sensor on page 10.

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Preparing and Maintaining the Electrodes on page 14.

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Preparing the Monitor on page 18.

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Operation 2 Turn on the Monitor by pressing and holding the POWER button for three seconds, Figure 15. The Opening screen displays, Figure 19. Figure 19 Opening screen.

Within a few seconds, the Welcome screen displays, Figure 20. Figure 20 Welcome screen.

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Operation 3 Call the LifeWatch Customer Support Center and follow the instructions provided by the technician. Expect the following events: a After the first connection is established with LifeWatch (which can take up to five minutes), the Monitor displays the Monitoring screen, Figure 21. Figure 21 Monitoring screen.

A beating heart displays after the Monitor connects with the sensor. The heartbeat continues while the MCT 3L (ACT) application is running and the link to the sensor is active. NOTE The heartbeat that is displayed on the screen is not a representation of your actual heartbeat.

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Operation b The electrode contact is checked and prepared for calibration (this may take up to ten minutes), Figure 22. Figure 22 Electrode check screen.

c Data is collected and the Monitor sends a baseline recording. Please remain still and limit exertion until the baseline recording is sent, Figure 23. Figure 23 Baseline screen.

When the baseline recording is complete, the Monitoring screen may display for a few seconds, Figure 21.

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Operation d Once the first time activation is complete, the Success screen displays, Figure 24. Figure 24 Success screen.

The service automatically begins and the Monitoring screen displays, Figure 21. NOTE If you have any questions, call the LifeWatch Customer Support Center Patient Care 1-800-517-6330.

4 During the monitoring period, do not turn off the Monitor or exit from the MCT 3L (ACT) application. When the Monitor is active and the MCT 3L (ACT) application is running, events that are recorded automatically are also transmitted automatically. CAUTION Take the charged Monitor with you and wear the sensor at all times during the monitoring period (except when showering or bathing).

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Operation NOTE If the MCT 3L (ACT) application is not running, start the program by performing the following steps: 1

Select the Home c button. The Monitor desktop displays, Figure 25.

Figure 25 Monitor desktop. A

2

Select the ACT icon, Figure 25 (A). The MCT 3L (ACT) application starts.

Monitoring Period

During the monitoring period (except when showering or bathing), take the charged Monitor with you and wear the sensor at all times. This section is provides instructions for the placing the LifeWatch MCT 3L back into service if the components have been removed for bathing or other activities. 1 Prepare the MCT 3L by performing the steps in:

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Placing Electrodes on page 16.

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Placement of the Monitor on page 20.

Patient User Guide: LifeWatch MCT 3L


Operation 2 If applicable, turn on the Monitor by pressing and holding the POWER button for three seconds, Figure 15. The Opening screen displays, Figure 26. Figure 26 Opening screen.

After the connection is established with LifeWatch (which can take up to five minutes), the Monitor displays the Monitoring screen, Figure 27. Figure 27 Monitoring screen.

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Operation A beating heart displays after the Monitor connects with the sensor. The heartbeat continues while the LifeWatch MCT 3L (ACT) application is running and the link to the sensor is active. NOTE The heartbeat that is displayed on the screen is not a representation of your actual heartbeat.

CAUTION If the Monitor is not connecting with the sensor, replace the battery in the sensor (see Preparing and Maintaining the Sensor on page 10, step 2 to step 7). If the problem continues, call LifeWatch Patient Care at 1-800-517-6330.

3 During the monitoring period, do not turn off the Monitor or exit from the LifeWatch MCT 3L (ACT) application. When the Monitor is active and the LifeWatch MCT 3L (ACT) application is running, events that are recorded automatically are also transmitted automatically. NOTE If the LifeWatch MCT 3L (ACT) application is not running, start the program by performing the following steps: 1

Select the Home c button. The Monitor desktop displays, Figure 28.

Figure 28 Monitor desktop. A

2

Select the ACT icon, Figure 28 (A). The LifeWatch MCT 3L (ACT) application starts.

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Operation Manual Event Recording

If you experience dizziness, fatigue, chest pain, or any other symptom, record a manual event. There are two options for recording a manual event: „

Press the sensor side buttons (see Manual Event with the Sensor on page 33).

OR „

On the Monitor touchscreen, select Record Event (see Manual Event with the Monitor on page 35).

When a manual event is recorded, a tone is played on the Monitor and the displays a series of screens, as described in the following procedures. The Monitoring screen returns to the normal display when finished. NOTE If an electrode connectivity technical alert occurs when the manual event Patient Symptoms and Patient Activity screens are displayed, an audible sound will not activate until the screens are closed. The technical alert will become audible and visible after closing the forms (either because of the one minute timeout or the user selects Send).

CAUTION „

The manual event recording is not available during the baseline process, even though pressing the manual event buttons on the sensor will initiate the manual event recording tone.

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The manual event recording is not available after the sensor battery insertion as the sensor links to the Monitor and downloads data from the sensor.

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Operation MANUAL EVENT WITH THE SENSOR 1 Hold the sensor and simultaneously press the two side buttons, Figure 29. Figure 29 Sensor event buttons.

On the Monitor, the Send Manual Event (Symptoms) screen displays, Figure 30. Figure 30 Send Manual Event (Symptoms) screen.

2 Select all applicable symptoms or No Symptoms. Select Other if the symptom is not listed. NOTE After one minute of inactivity, the Monitor automatically forwards to the Send Manual Event (Patient Activity) screen.

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Patient User Guide: LifeWatch MCT 3L


Operation 3 Select Next. On the Monitor touchscreen, the Send Manual Event (Patient Activities) screen displays, Figure 31. Figure 31 Send Manual Event (Patient Activities) screen.

4 Select the activity at the time of the event. Select Not sure if the activity is not listed. 5 Select Send. NOTE After one minute of inactivity, the Monitor automatically sends the manual event.

The Monitor returns to the Monitoring screen. NOTE If there is a disconnection between the sensor and the Monitor, the manual event will be transmitted when there is reconnection to the Monitor.

Patient User Guide: LifeWatch MCT 3L

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Operation MANUAL EVENT WITH THE MONITOR 1 On the Monitor touchscreen, select Record Event, Figure 32. Figure 32 Monitoring screen.

A confirmation screen displays, Figure 33. Figure 33 Confirmation screen.

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Patient User Guide: LifeWatch MCT 3L


Operation 2 Select Yes to continue. NOTE After one minute of inactivity, the Monitor automatically cancels sending the manual event and returns to the Monitoring screen.

The Send Manual Event (Symptoms) screen displays, Figure 34. Figure 34 Send Manual Event (Symptoms) screen.

3 Select all applicable symptoms or No Symptoms. Select Other if the symptom is not listed. NOTE After one minute of inactivity, the Monitor automatically forwards to the Send Manual Event (Patient Activity) screen.

Patient User Guide: LifeWatch MCT 3L

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Operation 4 Select Next. On the Monitor touchscreen, the Send Manual Event (Patient Activities) screen displays, Figure 35. Figure 35 Send Manual Event (Patient Activities) screen.

5 Select the activity at the time of the event. Select Not sure if the activity is not listed. 6 Select Send. NOTE After one minute of inactivity, the Monitor automatically sends the manual event.

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Patient User Guide: LifeWatch MCT 3L


Messages The Monitor returns to the Monitoring screen. NOTE A manual event may not be able to be recorded with the Monitor during the following circumstances: „

During the process of collecting manual event data, it is not possible to initiate a new manual event, Figure 36.

Figure 36 Collecting data message.

„

When the sensor and the Monitor are disconnected, the manual event can only be recorded with the sensor. It will be transmitted when the connection to the Monitor is reestablished, Figure 37.

Figure 37 Collecting data previous event message.

„

During the process of downloading data from the Monitor (reconnection after battery replacement), the manual event recording is not available, Figure 38.

Figure 38 Manual event recording is not available message.

CAUTION A CAUTION with this symbol indicates a situation that the user must take into consideration to ensure the safe and effective operation of the equipment and associated accessories.

Messages

The Monitor displays images and messages to indicate that there is a problem. The message is accompanied by a sound prompt and Monitor vibration (optional). It might take a few minutes to remove a message after a correction has been resolved. This section defines the issues and the solutions.

Patient User Guide: LifeWatch MCT 3L

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Messages Sensor Battery

When the sensor battery requires replacement, a message and icon display on the Monitor touchscreen, Figure 39. Figure 39 Sensor battery replacement message and icon.

1 Replace the battery as instructed in Preparing the Sensor on page 10, step 3 through step 7. 2 On the Monitor, select OK. Upon battery replacement, the sensor and Monitor reconnect (which may take up to five minutes). Monitor Battery When the Monitor requires charging, a message and icon display on the Monitor touchscreen, Figure 40. Figure 40 Monitor charge message and icon.

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Patient User Guide: LifeWatch MCT 3L


Messages If the Monitor charge is less than 5%, the device will play a long tone and a short tone, then shut down the LifeWatch MCT 3L (ACT) application until the Monitor is charging. The LifeWatch MCT 3L (ACT) application automatically restarts when the Monitor is charging. 1 Charge the Monitor as instructed in Charging the Monitor on page 18. 2 On the Monitor, select OK. The icon may remain on the Monitor screen until the Monitor is charging. Sensor Connection

When the Monitor and the sensor lose their connection, a message and icon display on the Monitor touchscreen, Figure 41. Figure 41 Monitor connection message and icon.

1 Confirm that the Monitor is not 5% or below in power charge and in low power mode (see Monitor Battery on page 39). 2 Place the Monitor in range of the sensor as instructed in Placement of the Monitor on page 20. LifeWatch recommends that the Monitor be placed within 50 cm (20 inches) of the sensor. 3 On the Monitor, select OK. The icon may remain on the Monitor screen until the Monitor and sensor establish a link. CAUTION If the Monitor continues not to connect with the sensor, call LifeWatch Patient Care at 1-800-517-6330. Patient User Guide: LifeWatch MCT 3L

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Messages Monitor Transmission

When the Monitor loses the cellular connection, a message and icon display on the Monitor touchscreen, Figure 42. Figure 42 Monitor cellular message and icon.

1 Confirm that the Monitor is in an area of good cellular coverage by checking the cellular signal strength in the upper right corner. 2 On the Monitor, select OK. The icon may remain on the Monitor screen until the Monitor and cellular network establish a link. CAUTION If the issue does not resolve when in a good cellular location, perform the following steps: 1

Power off the Monitor by pressing and holding the POWER button for three seconds.

2

Turn on the Monitor by pressing and holding the POWER button for three seconds. If the Monitor continues not to connect with the cellular network, call LifeWatch Patient Care at 1-800-517-6330.

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Patient User Guide: LifeWatch MCT 3L


Messages Electrode Connectivity

When there are issues with the contact of one or more electrode, specific messages about the problem electrode(s) and icon display on the Monitor touchscreen, Figure 43. Figure 43 Electrode message examples and icon example (white disconnected).

1 Confirm that the Monitor lead wires are properly connected to the electrodes, as instructed in Maintaining and Replacing Electrodes on page 17. 2 Confirm the electrodes are properly attached, as instructed in Maintaining and Replacing Electrodes on page 17. 3 On the Monitor, select OK. The connection can take up to three minutes to link. The icon may remain on the Monitor screen until the electrodes issue is corrected. Code Messages

Code messages are displayed on the Monitor screen whenever an unexpected situation occurs, Figure 44. Please follow the instructions displayed in the screen or in Table 4. Figure 44 Code message example.

Patient User Guide: LifeWatch MCT 3L

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Messages Table 4 Monitor code messages. Code

Action

CODE 201

Please call LifeWatch Patient Care at 1-800-517-6330.

CODE 221

Please call LifeWatch Patient Care at 1-800-517-6330.

CODE 222

Please call LifeWatch Patient Care at 1-800-517-6330.

CODE 240

To resolve: Turn Monitor OFF and then ON. Please call LifeWatch Patient Care at 1-800-517-6330.

CODE 241

To resolve: Turn Monitor OFF and then ON. Please call LifeWatch Patient Care at 1-800-517-6330.

CODE 242

To resolve: Turn Monitor OFF and then ON. Please call LifeWatch Patient Care at 1-800-517-6330.

CODE 250

Please call LifeWatch Patient Care at 1-800-517-6330.

CODE 290

Please call LifeWatch Patient Care at 1-800-517-6330.

CODE 301

Please call LifeWatch Patient Care at 1-800-517-6330.

CODE 401

LifeWatch MCT 3L sensor will restart. Please call LifeWatch Patient Care at 1-800-517-6330.

CODE 404

Please charge your Monitor. The LifeWatch MCT 3L will be automatically closed in 10 sec until Monitor recharged.

CODE 700

Please remove and then re-insert battery into sensor. If this re-occurs, please call LifeWatch Patient Care at 1-800-517-6330.

CODE 701

Please remove and then re-insert battery into sensor. If this re-occurs, please call LifeWatch at 1-800-517-6330.

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CODE 702

Please call LifeWatch Patient Care at 1-800-517-6330.

CODE 901

Please call LifeWatch Patient Care at 1-800-517-6330.

Patient User Guide: LifeWatch MCT 3L


Maintenance Maintenance

The following simple preventive maintenance tasks should be performed monthly to ensure continued performance of the device at maximum capacity, and to reduce the possibility of a failure. Check for splits, cracks or other related flaws in the LifeWatch MCT 3L monitoring system. If you have any questions, call LifeWatch Patient Care at 1-800-517-6330. „

„ „

To clean the outside of the LifeWatch MCT 3L use a lint-free cloth lightly moistened with isopropyl alcohol. Never use abrasives such as wire wool or metal polish. During cleaning, make sure you do not expose the device to temperatures in excess of 104° F (40° C).

Troubleshooting If there is an issue, reference Table 5 to resolve the problem. If

the issue is not listed here or cannot be resolved with the steps in this table, contact LifeWatch Patient Care 1-800-517-6330.

Table 5 Troubleshooting. Issue No beep when the sensor is activated (up to 10 seconds after battery inserted). Displays an electrode problem (message).

Possible Cause(s) „

„

Solution

Battery not „ Check the battery placement and placed polarity. properly/reversed „ Sensor battery needs to be polarity. changed. The battery is Refer to Preparing the Sensor on page 10, very low or step 3 through step 7 for instructions depleted. on how to replace the battery.

Electrode connection 1 Confirm the sensor lead wire is does not provide properly connected to the proper contact electrodes and sensor (for (loose, disconnected attachable leads). or bad contact with 2 Confirm electrodes are properly skin). attached to the skin. 3 Check for physiological conditions that may affect the Monitor from detecting the electrode connection when the electrodes are in good contact with the body including very dry skin or not enough time has elapsed after attaching the electrodes. Please refer to Maintaining and Replacing Electrodes on page 17.

Patient User Guide: LifeWatch MCT 3L

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Troubleshooting Table 5 Troubleshooting...continued. Issue Sensor disconnection message.

Possible Cause(s) „

„

Solution

1 Make sure the sensor and Lack of Monitor are within 50 cm (20 communication inches). between sensor and Monitor. 2 Sensor battery needs to be Sensor low changed, please refer to Preparing battery can cause the Sensor on page 10, step 3 a communication through step 7 for instructions on disconnection. how to replace the battery. This is a safe 3 Monitor needs to be charged. guard against Please refer to Charging the corrupted Monitor on page 18 section for transmissions; instructions on charging the the recordings are Monitor. saved in memory until communication is restored.

Monitor low battery message.

The Monitor needs to be recharged.

Please refer to Charging the Monitor on page 18 section for instructions on charging the Monitor.

Sensor beeps one time.

Sensor activated.

Normal operation.

Monitor The Monitor communication transmission message. message appears when there are transmission problems that could be caused by poor cellular coverage, cellular network problems or communication problems. Sensor consecutively beeps three times.

1 Confirm you have good cellular coverage. 2 Check you are within 10 meters (30 feet) of the Monitor. 3 Monitor needs to be charged. Please refer to Charging the Monitor on page 18 section for instructions on charging the Monitor.

Critical system error. 1 Remove sensor battery for 30 seconds, then re-insert battery (see Preparing the Sensor on page 10, step 3 through step 7 for instructions on how to replace the battery). Allow up to five minutes for sensor and Monitor to reconnect. 2 Confirm that the sensor lead wire is properly connected to the sensor.

Sensor beeps one long beep then a short beep.

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Sensor battery low or critical.

Sensor battery needs to be replaced. Please refer to see Preparing the Sensor on page 10, step 3 through step 7 for instructions on how to replace the battery.

Patient User Guide: LifeWatch MCT 3L


Troubleshooting Table 5 Troubleshooting...continued. Issue

Possible Cause(s)

Battery cover separates from sensor.

Solution 1 Place battery cover on the sensor in the proper alignment, Figure 45. Figure 45 Align battery cover.

2 Press down firmly on battery cover latch side until it clicks, Figure 46. Figure 46 Press latch side.

3 Press down firmly on battery cover hinge side until it clicks, Figure 47. Figure 47 Press hinge side.

Sensor lead wire disconnected.

Patient User Guide: LifeWatch MCT 3L

Sensor lead wire detached from sensor.

Verify the sensor lead wire is connected to the LifeWatch MCT 3L socket as presented in Preparing the Sensor on page 10, step 8.

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Glossary Glossary

Terms that are used throughout this guide are defined in Table 6. Table 6 Glossary of Terms.

Safety Symbols and Information

Term

Definition

Arrhythmia

Irregular heartbeat.

Bluetooth (BT)

Wireless communication protocol.

Charger

Power supply for recharging Monitor.

Disposable electrode

Adhesive connector that connects the lead wire to the body.

ECG

Electrocardiogram. A representation of the heart's electrical activity recorded from electrodes on the body.

Elite

The cardiac event monitoring (Elite) service of arrhythmia detection using the LifeWatch MCT 3L.

Monitor

Hand held device/Monitor using LifeWatch MCT 3L monitoring software.

Heart Rate

Measured as number of heart beats per minute (bpm).

LifeWatch MCT 3L

Mobile Cardiac Telemetry 3 lead; Continuous ECG Monitor and Arrhythmia Detector.

LifeWatch MCT 3L Ex

The service of collecting and analyzing recorded ECG data (usually 24 hours) using the LifeWatch MCT 3L device (ACX).

Manual event

Event manually recorded by a patient when he/she feels it is necessary.

Sensor

LifeWatch MCT 3L device attached to patient with lead wires and electrodes.

Monitoring center

Monitoring center responsible for reviewing clinical data transmissions, and providing them to the physician.

When required, information is provided in procedures about potential dangers and challenges. The terms CAUTION and NOTE are used for specific safety reasons. This page lists notice format and icons used in this guide.

WARNING A CAUTION with this symbol indicates a potentially hazardous situation, which, if not avoided, could result in serious adverse reactions, potential safety hazards.

CAUTION A CAUTION with this symbol indicates a situation that the user must take into consideration to ensure the safe and effective operation of the equipment and associated accessories.

NOTE A NOTE with this symbol provides general information that emphasizes information or instructions.

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Patient User Guide: LifeWatch MCT 3L


Safety Symbols and Information The symbols in Table 7 are icons used on HTXLSPHQWODEHOLQJ DFFHVVRULHVDQGin this guide. Table 7 Symbols used on equipment, labeling, accessories, and in this guide. Symbol Description Magnetic resonance (MR) unsafe

Consult instructions for use

Serial number Date of manufacture

Type BF (body floating) applied part (electrically connected to patient but not directly to heart) Batch code Do not use if package is damaged

Use by

Keep dry

Store at specified temperatures

Dispose as electronic waste

Bluetooth wireless technology enabled product

Compliant with FCC Part 15

Patient User Guide: LifeWatch MCT 3L

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Warnings, Cautions, and Notices Warnings, Cautions, and Notices

This section contains a complete list of the major warnings and cautions relevant to the LifeWatch MCT 3L system.

WARNING „

If you have an implanted conventional pacemaker or Implantable Cardioverter Defibrillators (ICDs) of less than 30 Joules, LifeWatch recommends the following when using the Monitor component, Figure 48:

Figure 48 Monitor.

„ „ „

„

„

Keep a distance of at least 15 cm (six inches) between the Monitor and a pacemaker or ICD. Carry the Monitor on the opposite side of the body from the pacemaker or ICD. Do not carry a Monitor in a breast pocket or on a belt if that would place the Monitor within six inches (15 cm) of the pacemaker or ICD. Refer to the information from the pacemaker/ICD manufacturer for guidance regarding interference issues. Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the LifeWatch MCT 3L system, including the lead cables. Degradation of the performance of this equipment could result.

„

The LifeWatch MCT 3L is a diagnostic tool only and is not for emergency service.

„

The LifeWatch MCT 3L monitoring system is not intended for use in the diagnosis of myocardial infarction or for chest pain monitoring.

„

Keep the LifeWatch MCT 3L box contents away from children under six years of age.

„

Do not use the LifeWatch MCT 3L if you are likely to experience primary ventricular fibrillation (VF) or ventricular tachycardia (VT) or other co-morbid cardiovascular conditions where an arrhythmia could be potentially life threatening.The LifeWatch MCT 3L is intended to be prescribed for patients who have demonstrated a need for cardiac monitoring and are at low risk of developing life-threatening arrhythmias.

„

Due to the risk of ignition or fire, the LifeWatch MCT 3L monitoring system is not intended for use in a hyperbaric chamber, within an oxygen tent or in the presence of flammable anesthetics / medical gases.

„

Do not open or attempt to repair the sensor. Only authorized service personnel may repair the system components.

„

To avoid damage to the system, the system and accessories should be kept away from extreme heat including placement of the LifeWatch MCT 3L on the dashboard of a car or near a heater.

„

The system should not be subjected to severe impact or bending force. Exposure to these types of stresses can damage the system components.

„

Electrode disconnection might cause a faulty ECG analysis and/or false events due to noise created by the electrode disconnection.

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Patient User Guide: LifeWatch MCT 3L


Warnings, Cautions, and Notices WARNING „

Electromagnetic (EM) disturbance produced from other electrical devices in the vicinity of the LifeWatch MCT 3L may result in the following loss or degradation of performance: Disruption in communication between the sensor and Monitor that could prevent data from being sent to Monitor. However, the patient data will still be saved in the internal flash memory of the sensor for transfer to Monitor at a later time. „ Disruption in communication that may delay the transfer of data from Monitor to server. However, data will still be saved on the Monitor flash memory for transfer to the server at a later time. „ Production of a noisy ECG signal that in most cases will be rejected by the algorithm of the device as non-biological data. The noisy ECG data may also result in false event data to be transferred to the monitoring service. However, upon review, this false event data or signal will likely be rejected by the ECG technician due to the noisy ECG signal which is not similar to typical ECG signals. To prevent fire or shock hazard, do not expose the MCT 3L monitoring system to moisture, liquids or condensation. „

„ „

If you have known allergies to metal or nickel, please contact LifeWatch Services Customer Support prior to using the MCT 3L monitoring system to prevent an allergic reaction.

„

The MCT 3L monitoring system is not defibrillation proof. Exposure to defibrillation may damage the MCT 3L monitoring system, or the MCT 3L monitoring system may interfere with the operation of the defibrillator. The MCT 3L monitoring systems MUST be removed prior to defibrillation as it contains metals that could cause the defibrillator to arc.

„

The MCT 3L is MR unsafe.

„

The MCT 3L device is not intended to be used near active HF surgical equipment.

„

Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.

CAUTION „

If you should come into possession of your ECG recording do not take any actions of a medical nature based on your understanding UNLESS you are a medical professional.

„

The LifeWatch MCT 3L is intended to be worn during normal daily activities. If vigorous physical activity or exercise is part of your normal daily activity, the associated perspiration and lead wire movement can loosen the electrodes. Contact LifeWatch Services Patient Care 1-800-517-6330 to obtain special electrodes for vigorous physical activity.

„

Limitations in data transmission may occur if there is limited cellular service in the area. If you experience a delay in the ability to send recorded events due to unexpected cellular limitations, contact LifeWatch Services Patient Care 1-800-517-6330 as soon as possible.

„

Disposable electrodes must be changed according to instructions provided in this guide to assure optimal recording quality and limited skin irritation.

„

The impedance test (occurring every two minutes) overrides the ECG recording. The ECG will lack 1.6 seconds (LifeWatch MCT 3L) of recording at two minute intervals.

„

The LifeWatch MCT 3L employs Bluetooth and cellular technology. A transmission interruption or delay may be caused by the LifeWatch MCT 3L being in a location with a weak signal.

„

Do not make any changes to monitor settings.

„

Only use the Monitor for the designated monitoring function.

„

Over-the-counter batteries should never be used as they can seriously damage the sensor. Only use the specialized batteries included in the box. If more batteries are needed, contact LifeWatch Services Patient Care 1-800-517-6330.

„

Charge the Monitor every night and whenever possible during the day. Keep the Monitor within three meters (ten feet) of the sensor.

Patient User Guide: LifeWatch MCT 3L

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Warnings, Cautions, and Notices CAUTION „

The Monitor energy consumption may be high during the first few days of monitoring (up to 72 hours). Keep the Monitor charged at all times.

„

Do not turn the Monitor sound off or reduce the volume so that it is inaudible.

„

After exiting the LifeWatch MCT 3L sensor application, it will take up to three minutes for all the processes to end. Wait three minutes before restarting the LifeWatch MCT 3L sensor application.During the monitoring period, take the charged Monitor with you and wear the sensor at all times (except when showering or bathing).

„

A Bluetooth disconnection between the Monitor and the sensor might occur due to electromagnetic interference. During the interruption, the sensor will search for the Monitor device every three minutes.

„

If the Monitor Bluetooth communication is not available because the Bluetooth function has been disabled, the LifeWatch MCT 3L (ACT) application will immediately restart the function.

„

If the Monitor Bluetooth communication experiences a disconnection, the LifeWatch MCT 3L (ACT) application will restart the function every four minutes.

„

Always change the sensor battery when connected (Bluetooth) to the Monitor. A low sensor battery message indicates there are at least three to six hours before the battery fails.

„

The LifeWatch MCT 3L monitoring system generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instruction manual, may cause harmful interference to radio communications.

„

If the sensor battery is replaced when the sensor is out of Bluetooth range from the Monitor, the sensor will not be able to connect with the Monitor and will not be able to record until it reconnects with the Monitor.

„

The LifeWatch MCT 3L uses the same cellular network as other mobile devices and is subscribed to a network provider in the country of the patient. Patients traveling outside of their country during their enrollment period are responsible for any applicable roaming charges.

NOTE If the LifeWatch MCT 3L has been exposed to any of the above conditions remove the device, and immediately contact LifeWatch Services Patient Care 1-800-517-6330 to request a replacement device.

NOTE In patients with chronic or transient low amplitude ECG signal (0.5mV or lower) and wide-QRS durations, the MCT 3L may interpret resulting ECG signal as noise. This will trigger an event and require review by a clinician.

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Patient User Guide: LifeWatch MCT 3L


Technical Specifications Technical This sections describes the technical specifications of the Specifications systems and components of the LifeWatch MCT 3L. Monitor

The Monitor runs a proprietary application that is configured to process ECG recordings and transmit via a cellular network. The Monitor detects and stores physiological events in internal memory. When a physiological event is detected, the Monitor transmits the recorded ECG automatically via cellular link to a monitoring center for professional analysis. If the patient is out of the cellular network coverage area, the Monitor will send all events that were stored when the cellular link is re-established.

Sensor

The sensor houses a 3.6V AA lithium-thionyl chloride battery, an ECG channel circuit, an impedance measurement circuit, a pacemaker detection circuit, a flash buffer memory, a Bluetooth transceiver, and a buzzer. The ECG signals are received, filtered, and amplified in the input circuit, stored in the flash memory buffer, and transmitted via Bluetooth to the Monitor. The sensor loops up to 6 hours of ECG data into a cyclic buffer (internal flash memory) to preserve the ECG during instances when the Bluetooth link to the Monitor is down.

Bluetooth

Bluetooth is a wireless technology that enables the sensor and Monitor to communicate with each other. The LifeWatch MCT 3L system uses Bluetooth technology to transmit ECG data from the sensor to the Monitor. The Monitor internal Bluetooth component is on and running continuously (24 hours a day) for the entire monitoring period; therefore, the Monitor must be ON at all times. For optimal system performance, the recommended distances between the Monitor and sensor during the monitoring period should be as follows: „

Normal operation: Within 50 cm (20 inches).

„

During Monitor charging: Within three meters (ten feet).

Patient User Guide: LifeWatch MCT 3L

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Technical Specifications FCC

This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: 1 This device may not cause harmful interference, and 2 This device must accept any interference received, including interference that may cause undesired operation. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: „ „

„

„

Reorient or relocate the receiving antenna. Increase the separation between the equipment and receiver. Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. Consult the dealer technician for help.

or

an

experienced

radio/TV

CAUTION „

Modifications not expressly approved by the manufacturer could void the user authority to operate the equipment under FCC Rules. THE MANUFACTURER IS NOT RESPONSIBLE FOR ANY RADIO OR TV INTERFERENCE CAUSED BY UNAUTHORIZED MODIFICATIONS TO THIS EQUIPMENT. SUCH MODIFICATIONS COULD VOID THE USER'S AUTHORITY TO OPERATE THE EQUIPMENT.

„

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The LifeWatch MCT 3L generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instruction manual, may cause harmful interference to radio communications.

Patient User Guide: LifeWatch MCT 3L


Technical Specifications FCC HEARING-AID COMPATIBILITY (HAC) REGULATIONS FOR WIRELESS DEVICES On July 10, 2003, the U.S. Federal Communications Commission (FCC) Report and Order in WT Docket 01-309 modified the exception of wireless phones under the Hearing Aid Compatibility Act of 1988 (HAC Act) to require digital wireless phones be compatible with hearing-aids. The intent of the HAC Act is to ensure reasonable access to telecommunications services for persons with hearing disabilities. While some wireless phones are used near some hearing devices (hearing aids and cochlear implants), users may detect a buzzing, humming, or whining noise. Some hearing devices are more immune than others to this interference noise, and phones also vary in the amount of interference they generate. The wireless telephone industry has developed a rating system for wireless phones, to assist hearing device users find phones that may be compatible with their hearing devices. The ratings are not guarantees. Results will vary depending on the user's hearing device and hearing loss. M-Ratings: With the LifeWatch MCT 3L, both the Brigadier and Universal Gateway Monitors are rated M4. Phones rated M3 or M4 meet FCC requirements and are likely to generate less interference to hearing devices than phones that are not labeled. M4 is the better/higher of the two ratings. T-Ratings: With the LifeWatch MCT 3L, the Brigadier Monitor is rated T3 and the Universal Gateway Monitor is rated T4. Phones rated T3 or T4 meet FCC requirements and are likely to be more usable with a hearing aid's tele coil than phones that are not rated. T4 is the better/higher of the two ratings. Hearing devices may also be rated. Your hearing device manufacturer or hearing health professional may help you find this rating. Higher ratings mean that the hearing device is relatively immune to interference noise. The hearing aid and wireless phone rating values are then added together. A sum of 5 is considered acceptable for normal use. A sum of 6 is considered appropriate for best use. If the instructions above do not help you achieve satisfactory simultaneous LifeWatch MCT 3L and hearing aid use, we recommend that you consult your hearing aid manufacturer to discuss alternatives.

Patient User Guide: LifeWatch MCT 3L

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Technical Specifications Declaration of Conformity

The LifeWatch MCT 3L conforms to the applicable requirements of the following standards: Conformance to Standards - non-clinical testing demonstrated conformance to voluntary Safety standard „

„

IEC 60601-1:2005 3rd edition / Cor. 1:2006, Cor. 2:2007

„

EMC standard IEC 60601-1-2, Edition 4.0 (2014) Tested for

compliance with FCC 47 CFR Part 15, subpart B and subpart C

Parameters

This section lists the parameters of the LifeWatch MCT 3L Sensor. Table 8 LifeWatch MCT 3L parameters.

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Parameter

Min

Max

Typical

Units

Input operating DC voltage

3.0

3.6

3.5

V

Input Impedance

19.5

20.5

20

Input dynamic range

+/-4.5

+/-5.5

+/- 5

mV

Average current consumption

5

25

15

mA

Peak current consumption

N/A

80

75

mA

CMRR

60

N/A

75

dB

ADC sample Rate

246

254

250

samples/sec

DC offset correction

0

+/-150

+/-115

mV

LPF cutoff frequency

99.6

157.9

115.7

Hz

HPF cutoff frequency

.035

.055

.041

Hz

Impedance measurement range

0

793

N/A

Arrhythmia algorithm 0.5 detection voltage range

5

N/A

mV

System noise

0

50

35

ƉV

Pacemaker pulse width marking

0.2

2

N/A

msec

Pacemaker pulse amplitude marking

2

250

N/A

mV

ECG data buffer (storage memory)

32

32

32

MB

ECG buffering time

6:13

N/A

6:19

Hours:Minutes

Patient User Guide: LifeWatch MCT 3L


Technical Specifications Table 8 LifeWatch MCT 3L parameters. Parameter

Min

Max

Typical

Units

Manual ECG event triggering

N/A

N/A

Yes

None

PM detection

N/A

N/A

Yes

None

Bluetooth Transmission range open space

N/A

20

10

meters

Bluetooth protocol

SPP profile, Sniff mode, Auto-connection mode

None

Battery type / output

lithium-thionyl chloride AA

N/A

Battery life (dependent upon Bluetooth connectivity)

5

7

Use dependent

Days

MTBF (hours)

N/A

N/A

26,058

Hours

Operating temperature

10 (50)

40 (104)

N/A

째C (째F)

Transport & storage temperature

-20 (-4)

65 (149)

N/A

째C (째F)

Relative humidity (non-condensing)

30

85

N/A

%

Dimensions (max.)

N/A

N/A

75 x 58 x 23 mm

Net weight (w/o battery)

55

60

57

Patient User Guide: LifeWatch MCT 3L

gr.

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Technical Specifications RF Specifications This section lists the RF Specifications of the LifeWatch MCT 3L Monitor. Table 9 RF Specifications

Specification

Android Smartphone Based Universal Gateway Device (CD8100) US

Android Smartphone Kyocera Brigadier Device (E6782) US

Modulation Type

GFSK, ƍ/4-DQPSK, 8DPSK

GFSK, ƍ/4-DQPSK, 8DPSK

Transfer Rate

1/2/3 Mbps

1/2/3 Mbps

Operating Frequency 2402 ~ 2480 MHz

2402 ~ 2480 MHz

Number of channel

40 to 79

40 to 79

Channel Spacing

1 MHz or 2 MHz

1 MHz or 2 MHz

Output Power

1.616 mW to 16.565 mW

1.556 mW to 2.228 mW

Data Rate

24 Mbit

24 Mbit

TX Power

Class 1

Class 2

BT+WiFi Coexistence

Supported

Supported

Wi-Fi Description

802.11 b/g/n 2.4 GHz

802.11 a/b/g/n/ac 2.4 GHz/5GHz

RF Specifications (Nordic - Nordic RF connectivity not activated with MCT 3L sensor)

Page 57 of 66

Modulation Type

GFSK

N/A

Transfer Rate

2Mbps

N/A

Operating Frequency 2402 ~ 2480 MHz

N/A

Number of channel

40

N/A

Channel Spacing

2 MHz

N/A

Output Power

1 mW

N/A

Patient User Guide: LifeWatch MCT 3L


Technical Specifications Alert Specifications

This section lists the alert specifications of the LifeWatch MCT 3L Monitor. Table 10 Technical Alert Properties. Possible result of failure to respond to alert condition

Onset of potential harm (Immediate, Prompt, Delayed)

Technical Alert

Alert Condition

Electrodes Connectivity

Two or more Visual & electrodes Auditory are disconnected (high impedance).

ECG data is Delayed not recorded.

Sensor battery

Sensor battery level drops below warning thresholds.

Visual & Auditory

Bluetooth connection between Monitor and sensor is severed. Possible loss of ECG data.

Delayed

Monitor battery

Monitor battery level drops below 30%.

Visual & Auditory

Bluetooth connection between Monitor and sensor is severed. Possible loss of ECG data.

Immediate

Monitor Connection

No Bluetooth Visual & connection Auditory between the sensor and the Monitor.

Bluetooth connection between Monitor and sensor is severed. Possible loss of ECG data.

Delayed

Alert Signal

Cell No internet Visual & Transmission connection to Auditory the server.

Monitor will Delayed continue to record ECG data until in better cellular reception area. No loss of ECG data.

General Different Visual & device issues reasons – ECG Auditory Cable malfunction, storage issues (Flash), Hardware malfunction.

ECG data may Delayed not be recorded.

Patient User Guide: LifeWatch MCT 3L

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Technical Specifications Table 11 Alert Specifications. Alert Condition Delay (Minutes) Priority (High, Baseline/General Medium, Low) Work

ALERT PAUSED interval (Minutes) Baseline/General Work

Electrodes Connectivity

Low

Baseline = 0

Baseline = 60

General work = 7

General work = 3

Electrodes Connectivity

Medium

Baseline = 0

Baseline = 60

General work = 0

General work = 3

Sensor battery

Low

Baseline = 0

Baseline = 30

General work = 0

General work = 3

Monitor battery

Low

Baseline = 0

Baseline = 30

General work = 0

General work = 30

Technical Alert

Calculations

Monitor Connection

Low

Cell Transmission

Low

General device Issues

Medium

Baseline = 2

Baseline = 60

General work = 7

General work = 3

Baseline = 0

Baseline = 60

General work = 30

General work = 6

Baseline = 0

Baseline = 0

General work = 0

General work = 0

This section describes the calculations of the LifeWatch MCT 3L system. HEART RATE (HR) CALCULATION METHOD The HR is found by averaging eight consequent RR intervals. The momentary HR is the inverse of the time lasting between two consecutive heart beats. As the momentary HR fluctuates due to inaccuracies in detecting the exact R wave timing eight momentary HR values are averaged to generate the displayed HR; therefore the reported HR is the mean of the last momentary HR values WHICH CORRESPOND TO THE DETECTED R COMPLEXES FOR THE LAST 8 SECONDS. PAUSE CALCULATION Pause is considered a lack of Ventricular activity for more than three seconds. In order to detect a pause, one of two conditions needs to be detected: „ „

Lack of QRS detection for more than three seconds. A flat signal (P complexes can occur) for slightly less than three seconds.

Once one of the above conditions is detected, a pause event is sent to the remote monitoring center. Page 59 of 66

Patient User Guide: LifeWatch MCT 3L


Patient Financial Obligations Patient Financial Obligations

Limited Warranty

The costs of shipping, data transmissions, and use of the equipment is included in the enrollment charges. LifeWatch will bill your insurance carrier on your behalf. You may be responsible for a copay, coinsurance and/or deductible as determined by your insurance policy. You will be responsible for charges not covered by your insurance carrier. Any amount determined to be your responsibility will be charged to your credit card if on file, or billed to you directly. For questions or information regarding billing and insurance coverage, please call Patient Care 1-800-517-6330. 1 This LifeWatch TechnologiesÂŽ Device ("LWT Device") is warranted against defective material and workmanship for a warranty term of 1 year following shipment from LifeWatch Technologies facility of this product to the customer ("Warranty Term"). If this product or any part thereof, in the judgment of LifeWatch Technologies, is proven to be defective in material or workmanship within the warranty term, LifeWatch Technologies will at its sole discretion either repair the item or replace it with a similar one (refurbished device), to enable the designated use of the LifeWatch Technologies Device (the "Hardware Services") free of charge for parts or labor. 2 The Hardware Services shall not include any of the following: Replacement of consumable items, supplies or accessories (such as printer consumables, disks, paper, disposable electrodes, disposable mouthpieces etc.); Services required as a result of failure of electrical power, air conditioning, dust or humidity control; Services required as a result of the use of attachments or any other devices which are not compatible with the LWT Device or with the system in which they are installed and do not meet LifeWatch Technologies' specifications or standards; Services required as a result of fire, lightning, flood, wind, accident, theft, abuse, negligence, misuse, vandalism, corrosion, natural disaster, or any causes other than ordinary use for which the LWT Device was designed;

Patient User Guide: LifeWatch MCT 3L

Page 60 of 66


Limited Warranty LWT Device which has been damaged by accident or which has been misused, abused, altered or repaired by anyone other than LifeWatch Technologies; Customer abuse, such as, marks, scratches, broken parts corrosion etc.; and Electrical work the necessity of which is not related to the regular function of the LWT Device. LifeWatch Technologies holds the sole discretion to decide which of the LWT Devices will not validated under this warranty. 3 The warranty period for the repaired / refurbished LWT Device is for a three (3) month period following the Hardware Services' delivery to LifeWatch Technologies. 4 Without derogating from any other provisions of this warranty, the customer shall only use attachments or any other devices which, at LifeWatch Technologies' discretion and as approved by LifeWatch Technologies in writing, are compatible to the LWT Device in which they are installed or to which they are connected; this Section 4 pertains to the importance of liability for LifeWatch Technologies Products; 5 LIFEWATCH TECHNOLOGIES SHALL NOT BE LIABLE TO ANY PERSON FOR ANY SPECIAL, CONSEQUENTIAL OR INDIRECT DAMAGES, INCLUDING, BUT NOT LIMITED TO, DAMAGES TO OR LOSS OF PROPERTY OR EQUIPMENT, LOSS OF PROFIT, LOSS OF USE OF DATA, LOSS OF REVENUES OR DAMAGES TO BUSINESS OR REPUTATION ARISING FROM ANY CAUSE WHATSOEVER ARISING FROM OR IN ANY WAY CONNECTED WITH THE MANUFACTURE, SALE, HANDLING, REPAIRS MAINTENANCE OR USE OF THE LWT DEVICE, WHETHER OR NOT LIFEWATCH TECHNOLOGIES SHALL HAVE BEEN MADE AWARE OF THE POSSIBILITY OF SUCH LOSS PROVIDED THAT IT IS NOT OTHERWISE REGULATED BY THE APPLICABLE LAW. NOTWITHSTANDING ANY OF THE FOREGOING, LIFEWATCH TECHNOLOGIES'S LIABILITY FOR ANY CLAIMS ARISING OUT OF OR IN CONNECTION WITH THIS WARRANTY, SHALL IN THE AGGREGATE, BE LIMITED TO THE TOTAL PRICE PAID FOR THIS PRODUCT, IF SUCH LIABILITY DOES NOT ARISE FROM THE GROSS NEGLIGENCE OR FAULT OF LIFEWATCH TECHNOLOGIES. 6 This warranty is in lieu of all other warranties expressed or implied, including any implied warranty of merchantability or fitness for a particular purpose, and no person is authorized to assume for LifeWatch Technologies any other liability in connection with the sale of this product. Page 61 of 66

Patient User Guide: LifeWatch MCT 3L


Software End User License Agreement 7 To obtain factory service, this product should be shipped to LifeWatch Technologies. The customer shall bear the cost of shipment to LifeWatch Technologies, and similarly, LifeWatch Technologies shall bear the cost of shipment from LifeWatch Technologies. 8 All repaired or replaced parts will be released by LifeWatch Technologies within 30 days from receiving. 9 The customer may, 60 days prior to the end of the Warranty Term, notice LifeWatch Technologies of its request to receive from LifeWatch Technologies, post warranty services according to LifeWatch Technologies' policies and upon signing a Post Warranty Services Agreement.

Software End User License Agreement

Using any part of the enclosed LifeWatch Technologies Ltd. software (the "Software") indicates that you agree to the terms and conditions set forth below. If you do not agree to the terms of this Software License Agreement (the "License"), you are not allowed to use the Software. GRANT OF LICENSE: LifeWatch Technologies Ltd. grants you a non-exclusive, non-transferable (except as noted below) license to use the Software on a single computer or workstation. The Software may be executed from different workstations or computers only if you have licensed one copy of Software for each workstation or computer executing the Software. You may not sublicense, sell, lend, or lease any portion of the Software without LifeWatch Technologies Ltd.'s approval, or export the Software in any form from the country where the Software was originally furnished. COPYRIGHT: The Software is owned by LifeWatch Technologies Ltd. or its suppliers and is protected by United States and international copyright laws and international treaty provisions. Any rights not expressly granted to you herein are retained by LifeWatch Technologies Ltd. You may create one copy of the Software solely for backup purposes. You may not copy the accompanying documentation (the documentation).

Patient User Guide: LifeWatch MCT 3L

Page 62 of 66


Software End User License Agreement NO ASSIGNMENT; NO REVERSE ENGINEERING: You may not transfer the Software and this License to another party unless the other party agrees in writing to accept the terms and conditions of this License and you have received LifeWatch Technologies Ltd.'s prior written consent. Upon such transfer you must at the same time either destroy or transfer to the same party any copy of the Software and documentation. You may not modify, reverse engineer, reverse compile, disassemble or otherwise reduce the Software to a human-perceivable form. TERM: This License is effective until terminated. You may terminate it at any time by destroying the Software and documentation, together with any copy. This License automatically terminates if any terms or conditions are breached. Upon such termination you agree to destroy the Software and documentation, together with any copies. LIMITED WARRANTY: LifeWatch Technologies Ltd. warrants that the Software will perform substantially in accordance with the documentation and will be free from defects in materials and workmanship under normal use and service for a period of ninety (90) days from the date of receipt. This Limited Warranty is void if failure of the Software resulted from accident, abuse, or misapplication or if the Software was modified by any person other than LifeWatch Technologies Ltd. LifeWatch Technologies Ltd. MAKES NO OTHER EXPRESS OR IMPLIED WARRANTIES AND SPECIFICALLY DISCLAIMS THE IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NONINFRINGEMENT OF THIRD PARTY RIGHTS. No representation or statement not expressly contained in this agreement shall be binding upon LifeWatch Technologies Ltd. as a warranty or otherwise. If such disclaimer is not permitted by law, the duration of any such implied warranties is limited to the duration of the express warranty. Some jurisdictions do not allow the exclusion of implied warranties or limitations on the duration of an implied warranty, or the exclusion or limitation of incidental or consequential damages, so the above exclusions or limitations may not apply to you. This Limited Warranty gives you specific legal rights. You may have other rights which vary from jurisdiction to jurisdiction. CUSTOMER REMEDIES: LifeWatch Technologies Ltd.'s entire liability and your sole remedy shall be repair or replacement of the Software. Replacement Software will be warranted for the remainder of the original warranty period or thirty (30) days, whichever is longer. Page 63 of 66

Patient User Guide: LifeWatch MCT 3L


Software End User License Agreement NO LIABILITY FOR CONSEQUENTIAL DAMAGES: IN NO EVENT SHALL LifeWatch Technologies Ltd. OR ITS SUPPLIERS BE LIABLE FOR ANY CONSEQUENTIAL (including but not limited for any lost revenue, profit, or data, or punitive damages), SPECIAL, INCIDENTAL OR INDIRECT DAMAGES OF ANY KIND ARISING OUT OF THE USE OF THE SOFTWARE, EVEN IF LifeWatch Technologies Ltd. HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. IN NO EVENT WILL LifeWatch Technologies Ltd.'s LIABILITY FOR ANY CLAIM, WHETHER IN CONTRACT, TORT OR ANY OTHER THEORY OF LIABILITY, EXCEED THE LICENSE FEE PAID BY YOU. U.S. GOVERNMENT RESTRICTED RIGHTS: Any part of the Software and documentation that is delivered to or acquired by or on behalf of the United States Government shall be considered "computer software" or "computer software documentation" and/or provided with restricted rights so that, in the absence of a written agreement to the contrary, the United States Government's rights with respect to the use, duplication or disclosure of the Software by the United States Government are limited by the terms of this License pursuant, and otherwise subject, to the restrictions as set forth in the Rights in Technical Data provisions of 48 CFR ยง252.227-7013 or as set forth in the Commercial Computer Software Restricted Rights provisions at 48 CFR ยง52.227-19(c)(1)-(2). GOVERNING LAW: This License is governed by the laws of the State of New York and by the laws of the United States, excluding their conflicts of laws principles. The United Nations Convention on Contracts for the International Sale of Goods (1980) is specifically disclaimed. For more information about LifeWatch Technologies Ltd.'s licensing policies, please call LifeWatch Technologies Ltd. Customer Service at +972-8-9484000 or write to: LifeWatch Technologies Ltd. Customer Service, 2 Pekeris St, Rehovot, Israel 7670202. SEVERABILITY: In the event of the invalidity of any provision of this License, such invalidity shall not affect the validity of the remaining portions of this License. ENTIRE AGREEMENT: This License constitutes the entire agreement between you and LifeWatch Technologies Ltd, supersedes all prior agreements, whether written or oral, with respect to the Software, and may be amended only in writing signed by both parties.

Patient User Guide: LifeWatch MCT 3L

Page 64 of 66


Legal Legal

This section contains all the required legal and regulatory information required for this product.

Copyright and Intellectual Property

Š2018 LifeWatch Services, Inc. All rights reserved. LifeWatch is a trademark of LifeWatch Services, Inc. LifeWatch reserves the right to change specifications at any time without notice. CG-6108 and ACT III are trademarks or registered trademarks of the LifeWatchΠGroup of Companies. The Bluetooth trademarks are owned by Bluetooth SIG, Inc., U.S.A. and licensed to Taiyo Yuden Co., Ltd. Android is a trademark of Google Inc. All other brand names and product names used in this document are trade names, service marks, trademarks, or registered trademarks of their respective owners.

FDA

The LifeWatch Mobile Cardiac Telemetry 3 Lead has been cleared by the FDA under the name "CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia Detector", LifeWatch MCT 3L", "LifeWatch Mobile Cardiac Telemetry 3 Lead", "LifeWatch Mobile Cardiac Telemetry 3-Lead Monitor".

Contact Information

Contact the LifeWatch with any questions regarding the product or document.

Contact

Email

Phone

LifeWatch Client Care Center

info@lifewatch.com

1-800-517-6330

Manufacturer

The following is information about the manufacturer.

Contact Braemar Manufacturing, LLC 1285 Corporate Center Drive Suite 150 Eagan, MN 55121

Patient User Guide: LifeWatch MCT 3L

Page 65 of 66


SUP546 Rev H DCO-000196 LifeWatch Services, Inc. Toll-Free 877.774.9846 O‘Hare International Center II Phone 847.720.2100 10255 W. Higgins Road Fax 847.720.2111 Rosemont, IL 60018 info@lifewatch.com www.lifewatch.com

Š 2020 LifeWatch Services, Inc. All rights reserved. The LifeWatch logo is a registered trademark of LifeWatch Services, Inc. LifeWatch reserves the right to change specifications at any time without notice.

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MCT 3L Patient Education Guide  

MCT 3L Patient Education Guide