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Summary of Contents for Preventice Technologies BodyGuardian HEART
- Page 1 Instructions for Use AU BE CH DA DE 0086 This IFU document is available in other languages upon request.
- Page 2 Hereby, Preventice declares that this remote monitoring device is ® in compliance with the essential requirements and other relevant provisions of Directive 1999/5/EC. The declaration of conformity is available at: 3033 41 St NW Rochester, MN 55901...
- Page 3 CONFIDENTIAL AND PROPRIETARY The information contained in this document is confidential and proprietary to Preventice Technologies, Inc. This document may not be disclosed, copied, or distributed in any form to any third party without written permission of Preventice Technologies, Inc.
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Page 4: Table Of Contents
Removing a monitor from the Base Attaching a charged monitor to the Base Replacing the electrodes Daily usage Showering, bathing, or swimming Traveling on aircraft Undergoing an MRI Cleaning the monitor Storing the monitor and charging cradle BodyGuardian Heart Instructions for Use... - Page 5 Electromagnetic environment Index Figures Figure 1. BodyGuardian Connect smartphone Figure 2. BodyGuardian Heart Remote Monitoring System Figure 3. Monitor on Strip Figure 4. Monitor alignment on Base Figure 5. Monitor on Base with electrodes Figure 6. Monitor orientation on chest Figure 7.
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Page 6: Bodyguardian Heart Kit
Both versions operate identically. BodyGuardian Connect smartphone monitor charging cradle / power cord with adapter smartphone charger Your health care provider will supply you with either: BodyGuardian Strips BodyGuardian Base Base Strips standard ECG electrodes BodyGuardian Heart Instructions for Use... -
Page 7: About Bodyguardian Heart
Heart Remote Monitoring System is a ® wearable, remote cardiac monitoring system prescribed by your health care provider. Wearing BodyGuardian Heart allows your doctor to measure your electrocardiography (ECG) data, as well as other physiological information, such as breathing rate, heart rate, and activity level. -
Page 8: Figure 1. Bodyguardian Connect Smartphone
BodyGuardian Connect smartphone reference BodyGuardian Connect is configured to work as a component of BodyGuardian Heart. It cannot be used to make phone calls, including calls to 911 (US), 112 (EU), 000 (AU), or perform other smartphone functions. Power / Lock key... -
Page 9: How Bodyguardian Heart Works
Internet Patient Secure database Doctor Monitor on chest Smartphone sends Doctor views communicates cardiac data to patient data via with smartphone. secure database secure Internet servers. connection. Figure 2. BodyGuardian Heart Remote Monitoring System About BodyGuardian Heart... -
Page 10: Getting Started
BodyGuardian Heart for the first time. Before you begin Before you begin wearing BodyGuardian Heart: • Allow time for BodyGuardian Heart and all accessories to reach operating temperature (10 to 45 C). • Charge your devices, and, if necessary, shave the chest location where you will wear the monitor. -
Page 11: Begin Using Bodyguardian Heart
Charging a monitor just out of the kit can take approximately 2-3 hours. Begin using BodyGuardian Heart You are now ready to begin using BodyGuardian Heart. Do you have Strips or the Base? Your health care provider has supplied you with either BodyGuardian Strips or a BodyGuardian Base (with standard ECG electrodes). -
Page 12: Figure 3. Monitor On Strip
Tip: The snaps aren’t evenly spaced. The orientation of the logo on both the monitor and the Base must be the same. Figure 4. Monitor alignment on Base 2. Press firmly so all four snaps are connected. BodyGuardian Heart Instructions for Use... -
Page 13: Figure 5. Monitor On Base With Electrodes
• Dry your skin completely. • Do not apply anything to your skin, such as lotions, oils, sprays. Do not apply BodyGuardian Heart over open wounds, lesions, infected or inflamed areas. Apply only to intact, clean skin. If you have known skin allergies or hypersensitivities to adhesives, consult your doctor. -
Page 14: Figure 6. Monitor Orientation On Chest
Attach BodyGuardian Heart to your chest 1. Peel away the adhesive backing on the Strip or Base electrodes. 2. Place the monitor on your chest in one of the placement options shown at right. 3. Whether you wear the monitor horizontally or vertically, one of the arrows should be pointing up (Figure 6). - Page 15 Important Avoid placement over thick muscle and fatty tissue. Preferred placement options (vertical) Offset slightly to your left side, closer to your heart. Right Left Right Left You can angle this placement up to 30° clockwise from true vertical to avoid muscle, fat, and bra. Angle 0°...
- Page 16 Finish, the smartphone will automatically connect to the monitor on your chest. This may take up to 2 minutes. Tip: Stay within 3 feet of the phone, remain still, and watch the smartphone for contact errors. BodyGuardian Heart Instructions for Use...
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Page 17: Using The Smartphone
Using the smartphone The BodyGuardian Connect smartphone is specifically configured to work with BodyGuardian Heart. It cannot be used make phone calls, including calls to 911 (US), 112 (EU), and 000 (AU), or perform other functions outside of the BodyGuardian Heart. -
Page 18: If The Touch Screen Dims
Smartphone – home screen The smartphone home screen (Figure 7) is displayed when you power on or wake your phone. Figure 7. Smartphone – home screen BodyGuardian Heart Instructions for Use... - Page 19 Monitoring Status Tap to view monitor status and battery level, strength of skin contact with Strip or Base, as well as current heart rate, breathing rate, and activity level. Pause Tap to temporarily suspend the collection of data from the monitor.
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Page 20: Figure 8. Bodyguardian Connect - Status Screen
Heart Rate Breathing Rate Activity Level Note: These are optional features that may not be activated for you. Figure 8. BodyGuardian Connect – status screen The information on this screen refreshes automatically every 60 seconds. BodyGuardian Heart Instructions for Use... - Page 21 Back Tap to return to the previous screen. Status bar Displays the current status of the displayed monitor. Monitor toggle Tap to view your other monitor. Allows you to view the status of your other monitor while it is in the cradle downloading, for example.
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Page 22: Figure 9. Monitoring Status
BodyGuardian Connect has established contact with a monitor and will begin monitoring momentarily. Downloading data The phone is downloading your cardiac data from the monitor. Not available The monitor is not in use. BodyGuardian Heart is actively monitoring with another monitor. BodyGuardian Heart Instructions for Use... -
Page 23: Recording Symptoms
Recording symptoms This chapter describes the symptoms function. This feature may not be activated for you by your health care provider. If you experience any symptoms – such as trouble breathing, dizziness, or racing heartbeat – while wearing the monitor, it can be useful for your doctor to be able to identify when you experienced them. -
Page 24: Manually
When you feel any of these symptoms: 1. Press and release the button in the center of the monitor. 2. BodyGuardian Heart will record and send your cardiac information to your care team. This helps them understand your symptoms and review your information. -
Page 25: Selecting Your Symptoms
Selecting your symptoms When your BodyGuardian Connnect smartphone prompts you, either manually or automatically, select all of the symptoms you are feeling at the time (Figure 10). Scroll to see the entire list of symptoms. Figure 10. Selecting symptoms If you accidentally click the monitor button and are not feeling any symptoms, select: No symptoms Recording symptoms... -
Page 26: Switching Monitors With Strips
3. Snap the used monitor into the plugged-in charging cradle. Do not pause or power off the monitor. The monitor will automatically power off when it is done transferring data. Attaching a charged monitor to the Strip BodyGuardian Heart Instructions for Use... -
Page 27: Replacing The Strip
Remain near the phone when switching monitors. You can attach the fully charged monitor while the other monitor is in the charging cradle and transferring data before it powers off. 1. Snap the fully-charged monitor to Strip. 2. Power on the monitor by pressing and releasing the center button. -
Page 28: Switching Monitors With A Base
Do not pause or power off the monitor. The monitor will automatically power off when it is done transferring data. Note: Base is reusable for the duration of your study. BodyGuardian Heart Instructions for Use... -
Page 29: Attaching A Charged Monitor To The Base
Attaching a charged monitor to the Base Remain near the phone when switching monitors. You can attach the fully charged monitor while the other monitor is in the charging cradle and transferring data before it powers off. 1. While off your body, snap the fully-charged monitor to the Base. -
Page 30: Daily Usage
Base and monitor to the electrodes. 5. On the smartphone, tap OK to resume monitoring. 6. Verify that the status changes to Monitoring. Traveling on aircraft Do not wear the monitor when traveling on aircraft. BodyGuardian Heart Instructions for Use... -
Page 31: Undergoing An Mri
Power off your monitor by snapping it into the plugged-in charging cradle. This will automatically power off the monitor, though not necessarily immediately. You can also manually power off the monitor. To manually power off the monitor: 1. Press and hold down the center button for at least 15- 20 seconds until the green light is no longer flashing. -
Page 32: Bodyguardian Heart Monitor Lights
Phone may be out of range. Strip or Base electrodes do not have good contact with skin. Power on sequence. Stay within 3 feet of phone. Slow flash light blinks every :10 seconds Fast flash light blinks every :02 seconds BodyGuardian Heart Instructions for Use... -
Page 33: Indications For Use Intended Use
The Preventice BodyGuardian Remote Monitoring System does not provide any diagnosis. Intended use (EU / AU) The BodyGuardian Heart Remote Monitoring System detects and monitors biometric parameters in ambulatory patients, when prescribed by a physician or other qualified health care professional. -
Page 34: Warnings / Precautions
• Do not use lotions, oils or sprays on skin location where you will apply the Strip or electrodes. • This device is for single patient use only. • BodyGuardian Heart is not intended for infants weighing less than 10 kg. • Do not dispose of the monitors. Return monitors to your health care provider. -
Page 35: Appendix A: Specifications & Symbols
Appendix A: Specifications & symbols BodyGuardian Heart monitor specifications Expected Service Life 2 years Battery Capacity 350mAh minimum 380mAh typical Battery Charger Power Requirement 100-240 VAC, 50-60 Hz Battery Type Rechargeable Li-ion Battery Voltage 3.7 VDC Operating Temperature +10°C to +45°C Storage Temperature (Power Off) -10°C to +30°C... - Page 36 Water splashing against the enclosure from any direction shall have no harmful effect. Rx only US law restricts the device to sale by or on the order of a licensed practitioner or therapist. Do not dispose of in trash. Class II equipment BodyGuardian Heart Instructions for Use...
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Page 37: Electromagnetic Environment
Appendix B: Electromagnetic environment The BodyGuardian Heart monitor is suitable for use in the specified electromagnetic environment. The purchaser or user of the monitor should assure that it is used in an electromagnetic environment as described below: Emissions Emissions test... - Page 38 Power 3 A/m IEC 60601-1-2 Power frequency magnetic frequency Test level fields should be at levels (50/60 Hz) characteristic of a typical magnetic location in a typical commercial field or hospital environment. IEC 61000-4-8 BodyGuardian Heart Instructions for Use...
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Page 39: Index
BodyGuardian Heart Strip how it works 3 attaching monitor 20 overview 1 removing monitor 20, 22 replacing 21 BodyGuardian Heart monitor attaching to Strip 6 swimming 13, 24 attaching to your chest 7 symptoms 17 battery 20, 22 recording cleaning 25... - Page 40 Emergo Australia Level 20 Tower II Darling Park 201 Sussex Street Sydney, NSW 2000 Australia mrdcompany s.r.l. Viale dell’Unione Europea 8 21013 Gallarate (VA) Italy Preventice Technologies, Inc. 3033 41 St NW Rochester, MN 55901 For manufacturer comments or concerns: 866-712-6678...
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