Instructions for Use
Страница 1: ...Instructions for Use...
Страница 2: ...l 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 Copyr...
Страница 3: ...rding 9 Daily usage 10 1 Recording your symptoms 10 2 Charging the BodyGuardian One 11 3 Replacing the electrodes 12 4 Showering bathing swimming 14 5 MRI 14 6 Air travel 14 7 Touchscreen dimming 14 M...
Страница 4: ...dycardia Tachycardia and Atrial Fibrillation that are identified by an embedded arrhythmia detection algorithm The device is capable of automatically delivering data to Preventice Important BodyGuardi...
Страница 5: ...ion INFO Press the INFO icon to display the following Device serial number Software version number SIM card ID IMEI ID Firmware version number FLIGHT MODE Press the FLIGHT MODE icon to disable network...
Страница 6: ...tions enabled LANGUAGE Press the LANGUAGE icon to open a screen where you can select the language to use in operator mode You can select English or Spanish The selection enables a green check mark Pre...
Страница 7: ...e electrodes then attach them to your chest 2 Attach the LA BLACK lead Remove the adhesive backing from the electrode Attach aligned with the left side of the neck two to three inches below the left c...
Страница 8: ...ribcage 4 Attach the RA WHITE lead Remove the adhesive backing from the electrode Attach aligned with the right side of the neck two to three inches below the right collarbone 5 Attach the RL GREEN l...
Страница 9: ...om 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 All five leads must remain s...
Страница 10: ...battery contacts enter the compartment first 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...
Страница 11: ...the lead set cable into the 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 scree...
Страница 12: ...RING screen displays you must take an initial ECG recording This will start your monitoring service 1 Wait at least 1 minute after you first see the MONITORING screen then press hold the red RECORD bu...
Страница 13: ...matic cardiac events as they occur without requiring you to press the Record button or interface with the monitor 1 Do one of the following to record an event Press the Record button Press the MONITOR...
Страница 14: ...tor Several factors including the cellular network coverage quality and the amount of data being transmitted can impact battery life Replace the rechargeable battery in the monitor every 24 hours or w...
Страница 15: ...g the attached battery is fully charged or no battery is attached to the charger a solid pink light indicating it is charging or a solid red light if there was an error in charging the battery as show...
Страница 16: ...y from the old electrode Make sure the electrodes are attached within the following placement zone 5 Peel the old electrodes off the skin Use soap and water to reduce irritation and to remove any resi...
Страница 17: ...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 pre...
Страница 18: ...w battery is used Noise artifacts on ECG signal Ensure all electrodes are securely attached and that electrodes used are of quality recommended Ensure ECG lead cable is inserted completely into monito...
Страница 19: ...fore using a defibrillator When viewing ECG data the presence of pacemaker signals in the ECG trace should NOT be considered true representations of the actual pacemaker stimulus amplitude Caution No...
Страница 20: ...nstructions for Use 17 Appendix A Symbols Symbol Description Consult Instructions For Use Manufacturer RxOnly Prescription Only Type CF Applied Part Serial Number Catalog Number IPX0 Non protected aga...
Страница 21: ...0 1745 0 MHz 0 380 W 1712 5 1752 5 MHz 0 257 782 0 782 0 MHz 0 129 779 5 784 5 MHz 0 101 Electrical CMRR 90 105 dB AC Range 6 mV DC Range 300 mV Input Impedance 10 MOhm Frequency Response 0 05 to 40 H...
Страница 22: ...exposure standard for wireless mobile devices employs a unit of measurement known as the Specific Absorption rate or SAR The SAR limit set by the FCC is 1 6W Kg Tests for SAR are conducted using stan...
Страница 23: ...e or more of the following measures Reorient or relocate receiving antenna Increase separation between equipment and receiver Connect equipment into an outlet on a circuit different from that to which...
Страница 24: ...rmine location and length of the QRS complexes atrial activity analysis and template matching for AF detection Algorithm performance testing was done according to the ANSI AAMI EC57 standard The MIT B...
Страница 25: ...and may cause heat generation explosion or fire due to an abnormal chemical reaction Do NOT let the battery terminals and come into contact with a wire or any metal like a metal necklace or a hairpin...
Страница 26: ...ation explosion or fire Caution If battery leaks and its electrolyte comes into contact with skin or clothes wash contact area well with tap water or other clean water right away Otherwise skin may br...
Страница 27: ...ry may leak electrolyte overheat explode or cause fire Do NOT charge the battery near fire or in a car under the blazing sun Such a high temperature may cause damage of the protecting device in the ba...
Страница 28: ...0 Atrium Way Suite 1 Mt Laurel Township NJ 08054 USA DISTRIBUTOR ASSEMBLER Preventice Technologies Inc 2900 37th Street NW Building 003 Rochester MN 55901 USA For manufacturer comments or concerns 866...
