Table of Contents
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Table of Contents
Summary of Contents for Preventice Technologies BodyGuardian One
- Page 1 Instructions for Use...
- Page 2 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 3: Table Of Contents
Table of Contents Equipment ....................................1 About BodyGuardian One ..............................1 BodyGuardian One menu options ..........................2 Getting started ..................................3 Prepare your skin ................................3 Attach electrodes to lead wires ............................. 4 Attach to your chest ................................4 Route lead wires under and around clothing ......................6 Power on the monitor ................................ -
Page 4: Equipment
About BodyGuardian One The BodyGuardian One is a portable, battery powered, wireless cardiac monitor which may be worn to record ECG data for up to 30 consecutive days. The BodyGuardian One captures patient activated and auto-triggered cardiac events, such as Bradycardia, Tachycardia, and Atrial Fibrillation, that are identified by an embedded arrhythmia detection algorithm. -
Page 5: Bodyguardian One Menu Options
BodyGuardian One menu options BodyGuardian One provides additional menu options that can assist you while you are operating the device. To access the menu options: 1. Unplug the ECG cable from the device to pause monitoring. The Insert ECG lead cable screen is displayed. -
Page 6: Getting Started
1. If hair is present, remove the hair where you will place the ECG electrodes. 2. Thoroughly clean the area with soap and water. Dry the area completely. 3. Do not apply lotions, oils or perfumes. BodyGuardian One – Instructions for Use... -
Page 7: Attach Electrodes To Lead Wires
2. Attach the LA - BLACK lead. Remove the adhesive backing from the Attach aligned with the left side of the neck, electrode. two to three inches below the left collarbone. 3. Attach the LL - RED lead. BodyGuardian One – Instructions for Use... - Page 8 5. Attach the RL - GREEN lead. Remove the adhesive backing from the Attach below the white lead, under the electrode. breast to the outer ribcage. 6. Attach the V1 - BROWN lead. BodyGuardian One – Instructions for Use...
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Page 9: Route Lead Wires Under And Around Clothing
Run the lead wires from the electrodes neatly under your clothing to your belt area, where you will clip the monitor. 5 Power on the monitor 1. Slide the battery cover off the back of the monitor. BodyGuardian One – Instructions for Use... - Page 10 3. Drop the cover (as pictured) back onto the monitor, then slide it into place. 4. After the battery is installed, wait 2-3 minutes for the Insert ECG Lead Cable screen. If that screen does not appear, do not insert the cable; call Preventice for assistance. BodyGuardian One – Instructions for Use...
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Page 11: Plug Lead Set Into Monitor
The monitor will alert you with a beep when the lead set is securely plugged into the monitor. 2. On the touchscreen, a spinning circle displays. Do not touch the screen. 3. After several seconds, the MONITORING message appears on the screen. You are now monitoring. BodyGuardian One – Instructions for Use... -
Page 12: Take An Initial Ecg Recording
1. Wait at least 1 minute after you first see the MONITORING screen, then press/hold the red RECORD button for 3 seconds. 2. On the touchscreen, tap NONE/ACCIDENTAL. Then tap SUBMIT. 3. On the touchscreen, tap RESTING. Then tap SUBMIT. BodyGuardian One – Instructions for Use... -
Page 13: Daily Usage
If you feel symptoms related to why the monitor was prescribed, such as dizziness, chest pain or shortness of breath, you can manually record these events. The BodyGuardian One will also be automatically recording and transmitting asymptomatic cardiac events as they occur without requiring you to press the Record button or interface with the monitor. -
Page 14: Charging The Bodyguardian One
Use only IEC 62133 certified lithium-ion batteries supplied by Preventice with the BodyGuardian One. It takes approximately 4 hours to charge the BodyGuardian One battery. Always unplug the lead set cable from the BodyGuardian One monitor prior to exchanging the battery to prevent any potential loss of data. -
Page 15: Replacing The Electrodes
To charge the BodyGuardian One monitor battery: 1. Place the rechargeable lithium-ion battery face down into the charger. 2. Plug the charger into the wall outlet (110 or 220V). 3. Once the battery is properly inserted, the charger displays either a solid blue light... - Page 16 1. Unplug the ECG lead set cable connection from the BodyGuardian One to disconnect the lead wires and pause monitoring. Note: Always unplug the cable before changing out electrodes to prevent ECG data loss 2. Unsnap the lead from the old electrode, and then snap the lead to a new electrode.
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Page 17: Showering, Bathing, Swimming
States. 7 Touchscreen dimming Even when the BodyGuardian One is collecting data, the monitor turns off the touchscreen to conserve battery. This is normal. The monitor is still performing its monitoring functions. It has simply turned off the touchscreen display. To activate the touchscreen, briefly press and release the Record button on the monitor. -
Page 18: Service
2 Service If there is a problem with BodyGuardian One monitor or accessories, first review Troubleshooting section for a solution. If you need further help, include monitor’s serial number and a problem description in an email message to Preventice Customer Support at: 888.500.3522 (press 1, 1, 4). -
Page 19: Indications For Use
Indications for Use BodyGuardian One is intended for use by patients who either have or are at risk of having cardiac disease and those that demonstrate intermittent symptoms indicative of cardiac disease and require cardiac monitoring on a continuing basis. -
Page 20: Appendix A: Symbols
Appendix A: Symbols Symbol Description Consult Instructions For Use. Manufacturer RxOnly Prescription Only Type CF Applied Part Serial Number Catalog Number IPX0 Non-protected against fluid ingress BodyGuardian One – Instructions for Use... -
Page 21: Appendix B: Technical Specifications
Operating Temperature Storage Temperature Relative Humidity Non-condensing 23 C Atmospheric Pressure 1060 Preventice Technologies reserves all rights to improve, change and modify the products and the contents of the Instructions for Use without prior notice. BodyGuardian One – Instructions for Use... -
Page 22: Appendix C: Wireless Compliance
FCC recommended limits. The BodyGuardian One contains a radio transmitter and receiver. It is designed and manufactured not to exceed the emission limits for exposure to radio frequency (RF) energy set by the Federal Communications Commission of the U.S. - Page 23 Canadian Regulations Compliance Statement IC ID: 11948A-10002 BodyGuardian One complied with the Canadian RSS – 102 Issue 4: 2010 and IEC 62209-2: 2010 requirements. This device complies with RSS 210 of Industry Canada. This Class B device meets all the requirements of the Canadian interference-causing equipment regulations.
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Page 24: Appendix D: Arrhythmia Detection Performance
Appendix D: Arrhythmia Detection Performance The BodyGuardian One incorporates a real-time embedded arrhythmia detection algorithm. The processing steps include signal bandpass and morphological filtering, estimation of the motion artifact, analysis of the slope, width and amplitude of the signal, decision making logic to determine location and length of the QRS complexes, atrial activity analysis and template matching for AF detection. -
Page 25: Appendix E: Handling Instructions For Lithium-Ion Battery
When charging the battery, do NOT use any battery charger NOT specified by the manufacturer. Always follow the charge conditions specified by the manufacturer. If the battery is charged under other conditions (a high temperature, a high voltage/current BodyGuardian One – Instructions for Use... - Page 26 Do NOT use battery in other than the following conditions: Discharge: -20° C to +60° C Store (less than 30 days): -20° C to +50° C Store (less than 90 days): -20° C to +35° C BodyGuardian One – Instructions for Use...
- Page 27 Do NOT use battery in other than the following conditions: Discharge: -20° C to +60° C Store (less than 30 days): -20° C to +50° C Store (less than 90 days): -20° C to +35° C BodyGuardian One – Instructions for Use...
- Page 28 MONITOR RhythMedix 5000 Atrium Way Suite #1 Mt Laurel Township, NJ 08054 DISTRIBUTOR / ASSEMBLER Preventice Technologies, Inc. 2900 37 Street NW Building 003 Rochester, MN 55901 For manufacturer comments or concerns: 866-712-6678 507-218-3437...
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