InfoBionic MoMe 01854 Patient Manual

InfoBionic MoMe 01854 Patient Manual

Kardia system

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MoMe
Kardia System Patient Guide
®

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Summary of Contents for InfoBionic MoMe 01854

  • Page 1 MoMe Kardia System Patient Guide ®...
  • Page 2 Kardia System may be covered under one ® or more United States and International Patents. Please see the website: www.infobionic.com to satisfy the virtual patent marketing provisions including the America Invents Act and 35 U.S.C. § 287(a). Additional patents may be issued or pending in the US and elsewhere.
  • Page 3: Table Of Contents

    Table of Contents MoMe Kardia System Components ..........4 ® Unpacking MoMe Kardia Device ............. 5 ® Monitoring ..................6 Device Controls ................7 Notifications ..................8 Belt Clip .................... 9 Charging Battery Pack ................. 9 Installing Battery Pack ............... 10 Removing Battery Pack ..............
  • Page 4: Mome ® Kardia System Components

    MoMe Kardia System Components ® MoMe Kardia Kit Components ® Component Description Small, lightweight battery operated device that Monitor collects, stores, and transmits physiological data to the remote server via built in cellular module Attaches to the MoMe Kardia monitor and ®...
  • Page 5: Unpacking Mome Kardia Device

    Unpacking MoMe Kardia Device ® Unpack the MoMe ® Kardia Kit and locate components listed in the Kit Components chart above. Plug in the charger dock and place one of the two included battery packs in the charger. Insert the second battery pack into the back of the Monitor (for more detailed instructions, see diagram on page 10).
  • Page 6: Monitoring

    Monitoring Once the monitor is activated and operating, the system requires no intervention to capture or analyze data. However, your physician should instruct you about the following responsibilities: • Charge the battery pack every day • Report any symptomatic events by pressing the event record button as instructed by your physician •...
  • Page 7: Device Controls

    Device Controls The MoMe Kardia monitor has three buttons: ® Event Record, Wake, and Volume. Volume Button Wake Button Event Record Button Wake: Press the wake button at any time to display the current battery level status. Volume: Press the volume button to adjust the volume or silence alerts on the monitor.
  • Page 8: Notifications

    Device Controls continued Event Record: Press the event record button located on the face of the device to report a symptomatic event. The screen will display a solid heart when the event has been recorded. Press and hold the Event Record Button for 3 seconds to record Notifications Low Battery:...
  • Page 9: Belt Clip

    Belt Clip The MoMe Kardia Monitor must ® be used with the included belt clip. Slide the monitor up and into the belt clip holster to secure the monitor in place then slide the clip over your belt or waistband with the lead set attachment facing upwards.
  • Page 10: Installing Battery Pack

    Installing Battery Pack To install the Battery Pack, follow these steps: 1. Place the battery pack into the monitor, pushing down until it is fully seated. 2. Slide the battery pack towards the slide lever lock. 3. Battery is installed when you hear the slide lever lock “click”. Slide Lever Lock Slide Lever Lock Slide Lever Lock...
  • Page 11: Removing Battery Pack

    Removing Battery Pack To remove the Battery Pack, follow these steps: 1. Push the slide lever lock to the right and hold. 2. Push the battery pack away from the slide lever lock and release the slide lever lock. 3. Lift the battery pack up and remove from monitor. Slide Lever Lock Slide Lever Lock Slide Lever Lock...
  • Page 12: Warnings

    Warnings 1. Warning: MoMe Kardia is not intended for use on infants weighing less ® than 10kg (22 lb). 2. Warning: Use only specified MoMe Kardia cables and accessories. Use of ® any other cables and accessories may negatively affect EMC performance resulting in increased emissions and decreased immunity.
  • Page 13: Cautions

    Cautions 1. MoMe Kardia uses cellular phone technology, so the system operation and ® data transmission may be affected or interrupted by poor cellular coverage or electromagnetic interference. If data transmission is interrupted, MoMe Kardia ® will automatically cache the data until cellular coverage or communication between the two devices is restored and then send the stored data.
  • Page 14: Battery Information

    Battery Information 1. Do not dismantle, open or shred secondary cells or batteries. 2. Do not expose cells or batteries to heat or fire. Avoid storage in direct sunlight. 3. Do not short-circuit a cell or a battery. Do not store cells or batteries haphazardly in a box or drawer where they may short-circuit each other or be short-circuited by other metal objects.
  • Page 15: System Specifications

    System Specifications MoMe Kardia Monitor Specification (Model 01854 Rev B) ® Specification MoMe Kardia Monitor ® Battery Life Provides 24 hours of function before recharging Operating Temperature 5°C to 40°C Storage Temperature (power off) -25°C to 70°C Operating Humidity 15% to 93% non-condensing Storage Humidity 15% to 93% non-condensing Operating Pressure...
  • Page 16: Electromagnetic Emissions Compliance

    Electromagnetic Emissions Compliance The MoMe ® Kardia monitor has been tested and found to comply with the limits for medical devices to the IEC 60601-1-2:2007. These limits are designed to provide reasonable protection against harmful interference in a typical installation. 1.
  • Page 17 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity The MoMe Kardia is intended for use in the electromagnetic environment ® specified below. The customer or the user of MoMe Kardia should assure ® that it is used in such an environment IEC 60601 Immunity Test Compliance...
  • Page 18 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity The MoMe Kardia is intended for use in the electromagnetic environment ® specified below. The customer or the user of MoMe Kardia should assure ® that it is used in such an environment IEC 60601 Immunity Compliance...
  • Page 19: Sar Exposure Information

    Recommended separation distances between portable and mobile RF communications equipment and MoMe Kardia System ® The MoMe Kardia is intended for use in an electromagnetic environment ® in which radiated RF disturbances are controlled. The user of the MoMe ® Kardia can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the MoMe...
  • Page 20 Changes or modifications not expressly approved by InfoBionic could void the user's authority to operate the equipment Note: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules.

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