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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

USA

Содержание BodyGuardian HEART

Страница 1: ...Instructions for Use This IFU document is available in other languages upon request 0086 AT AU BE CH DA DE FR GB IE IT LT LU NL PL...

Страница 2: ...es 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 41st St N...

Страница 3: ...stem is a registered trademark of Preventice Technologies Inc Copyright Preventice Technologies Inc November 2017 All rights reserved LA1001 D LL 60003 N Health care provider QUESTIONS AND CONCERNS Pr...

Страница 4: ...ne display 12 Recording symptoms 17 Manually 18 Automatically 18 Selecting your symptoms 19 Switching monitors with Strips 20 Removing a monitor from the Strip 20 Attaching a charged monitor to the St...

Страница 5: ...or on Base with electrodes 7 Figure 6 Monitor orientation on chest 8 Figure 7 Smartphone home screen 12 Figure 8 BodyGuardian Connect status screen 14 Figure 9 Monitoring status 16 Figure 10 Selecting...

Страница 6: ...power cord with adapter BodyGuardian Heart kit smartphone charger BodyGuardian Heart monitors 2 Note Your monitors may be white or black Both versions operate identically standard ECG electrodes Base...

Страница 7: ...ponents BodyGuardian Heart monitors 2 monitors 1 charging cradle 1 charging cradle power cord with adapter BodyGuardian Connect smartphone 1 cellular smartphone 1 charger Strips or Base and standard E...

Страница 8: ...uardian Heart It cannot be used to make phone calls including calls to 911 US 112 EU 000 AU or perform other smartphone functions Figure 1 BodyGuardian Connect smartphone Phone battery Cellular signal...

Страница 9: ...a That data is sent over the Internet and stored in secure databases available to be accessed and reviewed by your health care professionals Patient Monitor on chest communicates with smartphone Secur...

Страница 10: ...r 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 Use the following instr...

Страница 11: ...ord that is plugged into the charging cradle charging fully charged 3 Allow the monitor to charge completely All lights will go out when it is fully charged Charging a monitor just out of the kit can...

Страница 12: ...entation of the logo on both the monitor and the Strip must be the same 2 Press firmly so all four snaps are connected This section is for BASE patients only Attach charged monitor to Base Be sure you...

Страница 13: ...h care provider shave the area Clean the area with soap and water or an alcohol wipe Dry your skin completely Do not apply anything to your skin such as lotions oils sprays Do not apply BodyGuardian H...

Страница 14: ...ions shown at right 3 Whether you wear the monitor horizontally or vertically one of the arrows should be pointing up Figure 6 Figure 6 Monitor orientation on chest Horizontal Vertical 4 For Strip use...

Страница 15: ...his placement up to 30 clockwise from true vertical to avoid muscle fat and bra Orientation Angle Do not exceed 30 clockwise from vertical 30 0 Alternate placement options horizontal Two fingers below...

Страница 16: ...ging The amber battery light will come on Link monitor to the smartphone 1 Press and hold the Power Lock key to turn on the smartphone The Power Lock key is located in one of two locations depending o...

Страница 17: ...r data and automatically send it to the smartphone when the smartphone is available again If the smartphone goes out of cellular network range The monitor will continue to collect your data Once the c...

Страница 18: ...ied period If you need to turn on the screen press the Power Lock key on the right edge of the smartphone Smartphone display The smartphone has a dedicated interface to help you monitor system status...

Страница 19: ...ed to remove the monitor for a short time Example uses When showering bathing or swimming While undergoing an MRI Do Not Disturb Tap to turn off sound and vibration alerts associated with the BodyGuar...

Страница 20: ...ntact with Strip or Base electrodes Current heart rate breathing rate and activity level Back Status bar Contact strength Monitor battery indicator Heart Rate Breathing Rate Activity Level Monitor tog...

Страница 21: ...ECG information To achieve strong contact All four monitor snaps must securely fasten the monitor to the Strip or Base For Base users the standard ECG electrodes must be securely snapped to the Base...

Страница 22: ...of range Connecting The phone has found a monitor that is powered on and is establishing contact Re connecting The phone is re establishing contact with the monitor Checking contact BodyGuardian Conne...

Страница 23: ...them This allows your doctor to assess your cardiac information during the time you were feeling particular symptoms When symptoms occur you will be prompted on your BodyGuardian Connect smartphone t...

Страница 24: ...are team This helps them understand your symptoms and review your information BodyGuardian does not summon physicians or emergency assistance 911 US 112 EU 000 AU and does not replace direct communica...

Страница 25: ...one prompts you either manually or automatically select all of the symptoms you are feeling at the time Figure 10 If you accidentally click the monitor button and are not feeling any symptoms select N...

Страница 26: ...bed During the day if the battery is low Removing a monitor from the Strip You can switch monitors without removing the Strip from your body You do not need to perform any tasks on the phone when swit...

Страница 27: ...If prompted by the smartphone select the location where you positioned the monitor on your chest Replacing the Strip Change the Strip every three days OR when it no longer adheres to the skin 1 Remove...

Страница 28: ...uring the day if the battery is low Removing a monitor from the Base You can switch monitors without removing the electrodes from your body You do not need to perform any tasks on the phone when switc...

Страница 29: ...es on your chest 3 Power on the monitor by pressing and releasing the center button Do not hold the button down 4 If prompted by the smartphone select the location where you positioned the monitor on...

Страница 30: ...or swimming Remove the monitor from the Strip or the monitor and Base when you shower bathe or swim The monitor and the smartphone are not waterproof but the Strip and Base and electrodes are 1 Remov...

Страница 31: ...s 1 On the phone tap Pause 2 Remove the monitor then the Strip or Base and electrodes Cleaning the monitor If you see visible dirt on the monitor 1 Use a sterile 70 isopropyl alcohol IPA pad and thoro...

Страница 32: ...ss center button to power on When plugged into charger FULLY CHARGED Charging Battery is low Switch to other monitor and charge this one Actively monitoring cardiac data Checking skin contact and phon...

Страница 33: ...collect and transmit health parameters to healthcare professionals for monitoring and evaluation Health parameters are collected from a variety of commercially available external plug in devices such...

Страница 34: ...ctrodes 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 D...

Страница 35: ...C Operating Humidity 10 to 95 Storage Humidity 30 to 75 excluding condensation Operating Storage Pressure 700 1060 hPa ECG Sampling Rate Digital Resolution Input Dynamic range Input Offset Dynamic Ra...

Страница 36: ...rect contact with cardiac muscle Wireless transmission symbol Lot number SN Serial number REF Catalogue reference IPX4 Water splashing against the enclosure from any direction shall have no harmful ef...

Страница 37: ...gnetic Environment RF emissions CISPR 11 Group 1 The monitor uses RF energy only for its internal function Therefore the RF emission is very low and not likely to cause any interference in nearby elec...

Страница 38: ...mode 2 kV common mode IEC 60601 1 2 Test level Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power suppl...

Страница 39: ...from Base 22 removing from Strip 20 22 status 15 storing 25 switching 20 22 chest placement location alternate 9 incorrect 10 preferred 9 do not disturb 13 electrodes iv replacing 23 kit checklist iv...

Страница 40: ...MN 55901 mrdcompany s r l Viale dell Unione Europea 8 21013 Gallarate VA Italy For manufacturer comments or concerns 866 712 6678 507 218 3437 Australian Sponsor Emergo Australia Level 20 Tower II Dar...

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