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Lifelens 2AXAK100006 Wireless ECG Monitor Kit

Lifelens 2AXAK100006 Wireless ECG Monitor Kit

Instructions for Use

 LifeLens Wireless ECG Monitor:

Lifelens Wireless ECG Monitor is an ultra-miniature, wireless, health monitor. It records your ECG, or heart rhythm, throughout the day without interfering with your regular activities. When prescribed or used under the care of a healthcare professional, it can be used to help diagnose and manage cardiac conditions.

Intended Use:

Lifelens Wireless ECG Monitor is intended to obtain an ECG from patients in a non-emergency or home setting. Lifelens Wireless ECG Monitor does not provide interpretative statements. provide a medical interpretation of your data. a U.S. board-certified cardiologist can

Intended Users:
Patients requiring an ECG, nurses, cardiologists and physicians.

Indications for Use:

Lifelens Wireless ECG Monitor is indicated for use with patients who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light headedness, pre-syncope, syncope, fatigue, chest pain and/or anxiety. The Lifelens Wireless ECG Monitor is intended for use by adults and all pediatric subgroupS.

CAUTION

LifeLens Wireless ECG Monitor is not an emergency response service and may not diagnose your condition in real-time. Contact your doctor immediately if your symptoms worsen. If You are Experiencing a Medical Emergency, Dial 911

Lifeless Wireless ECG Monitor Kit Components

  • Gateway-Recharger Carrying case and recharging dock
  • 2 HUBsS Reusable sensor hardware units; used one at a time
  • 5 Patches Single-use only, disposable patchesLifelens 2AXAK100006 Wireless ECG Monitor Kit 1

LifeLens Accessory Pack

USB Cable and Power Adapter
5 Alcohol Pads

Lifelens 2AXAK100006 Wireless ECG Monitor Kit 2

The LifeLens Patch Lifelens 2AXAK100006 Wireless ECG Monitor Kit 3

The LifeLens Gateway-Recharger & HUBsLifelens 2AXAK100006 Wireless ECG Monitor Kit 4

Power up the Gateway-Recharger & HUBs

  • Make sure the 2 HUBs are sitting in their charging dock in the Gateway-Recharger.Lifelens 2AXAK100006 Wireless ECG Monitor Kit 5Lifelens 2AXAK100006 Wireless ECG Monitor Kit 6
  • Connect the provided USB cable into the Gateway-Recharger and plug the adapter to a power Supply. The light on the Gateway-Recharger will glow BLUE.
  • The Gateway-Recharger will automatically power up and charge  the HUBs stored inside. Once the HUBs are fully charged, the light on the Gateway-Recharger will turn GREEN.

LED LIGHT  INDICATIONS

LED indications will only be present when Gateway-Recharger is open. If no LED indicators are visible on HUB(s) and/or Gateway-Recharger when recharging please discontinue use and contact prescribing health care provider.

  • Gateway-Recharger Light Indications
    • GREEN |Case is fully charged and ready for use*
    • YELLOW | Case needs to be recharged
    • BLUE Case is being recharged
  • HUB Light Indications
    • GREEN | HUBs are fully charged and ready for use
    • YELLOWHUBs need to be recharged
    • BLUE HUB is being recharged

PREPARE YOUR SKINLifelens 2AXAK100006 Wireless ECG Monitor Kit 7

  • Identify the area of your chest to prepare for PATCH placement
  •  Remove/Shave any hair where you will place the PATCH.
  • Wipe the desired area with an alcohol pad.
  •  Dry the area completely
  •  DO NOT Apply lotions, oils, or perfumes

Applying the LifeLens PATCH

  • Take the PATCH ouut of its packaging.
  • Remove liner 1 from the bottom side of the PATCH Apply the sticky side of the PATCH onto your prepared skin. Gently press the PATCH to your skin for 3 seconds.
  • Remove liner 2 from the bottom side of the PATCH Gently press the sticky side to your skin for 3 seconds. The Gateway-Recharger has a mirror you can use to help you apply the PATCH and HUB.Lifelens 2AXAK100006 Wireless ECG Monitor Kit 8

Applying the LifeLens HUB

  • Remove liner 3 from the topside of PATCH This exposes the HUB Connection point.
  • Open the Gateway- Recharger and take out ONE charged HUB. (Light is GREEN)
  • Align the HUB with the markings on the PATCH. The curved grips of the HUB should be at 900 degrees to the length of the PATCH.
  • Gently press the HUB onto the PATCH. The HUB will stick to the PATCH.
  • The HUB will blink GREEN for 30 seconds to indicate that the recording is started. The HUB is now recording.Lifelens 2AXAK100006 Wireless ECG Monitor Kit 9

Removing the LifeLens PATCH & HUB

  • With the HUB still attached to the PATCH, gently lifta corner of the PATCH, and proceed to stretch and pull the PATCH and HUB off your skin.
  • Once you have removed the PATCH from your chest, gently pull the HUB off of the PATCH. Alcohol Pad
  • Throw the PATCH in the garbage.
  • Wipe the HUB with an alcohol pad.
  • Once the HUB is dry, place it in its dock in the Gateway-Recharger.Lifelens 2AXAK100006 Wireless ECG Monitor Kit 10

DAILY  LIFE

LifeLens Wireless ECG Monitor has is designed to not interfere with your daily activities. You may exercise and shower the way you normally would. Keep the Gateway-Recharger within 3 feet of the HUB whenever possible to ensure accurate data transmission.

Continuing Your Heart Recording

  • Remove your PATCH and HUB. Follow Step 5 for instructions on how to remove the PATCH and HUB.
  •  Your HUB should be replaced whenever it flashes YELLOW, Or when the battery’s charge runs out. Immediately replace your HUB by following Step 4.
  • Your PATCH should be replaced every time you replace your HUB. Immediately replace your PATCH by following Step 2 and Step 3.

Discontinuing Your Heart Recording

  •  Remove your PATCH and HUB by following the Step 5 instructions.
  •  Return LifeLens Wireless ECG Monitor Kit to your prescribing physician.

Cleaning Instructions

  •  To clean the HUBs and Gateway-Recharger, use ONLY alchohol pads/wipes.
  •  Allow HUBs to fully dry before returning HUBs to the Gateway-Recharger.

Recording an Annotation

  • To record audio annotations or patient events, TAPTWICE on the HUB before speaking and describing the event.
  • The LED will flash GREEN rapidly for 10 seconds indicating that recording is in progress. The HUB records audio for 10 seconds. The audio recording will then be saved.

WARNING

  • .DO NOT use the LifeLens Wireless ECG Monitor for any other purpose besides those outlined in this User Manual.
  • DO NOT place the PATCH over dry skin, wounds, sores, or abrasions.
  • DO NOT excessively bend or twist the PATCH prior to application.
  • DO NOT use the PATCH if it appears damaged.
  • .DO NOT put any part of the HUB or PATCH in your mouth
  • DO NOT attempt to take the HUB, Gateway-Recharger, or the PATCH apart; there are no user serviceable parts.
  • .DO NOT attempt to pull the HUB off your skin.
  • DO NOT wear the LifeLens Wireless ECG Monitor during air travel.
  • .DO NOT use any parts that appear damaged or contaminated.
  • DO NOT Iimmerse in water. Prolonged exposure to standing water may damage the device.
  • DO consult your doctor if you have skin irritation or inflammation around the PATCH.
  • KEEP OUT OF REACH of children. The HUB is a potential choking hazard.
  • May interfere with defibrillation therapy. Remove Hub and Patch prior to defibrillation therapy.
  • May interfere with MRI scanning. Remove Hub and Patch prior to MRI scanning.
  • Battery/Electronic waste may present environmental hazard. Do not dispose of device with household waste.
  • Battery Warning. These device(s) use rechargeable lithium-ion batteries, and with any battery, a risk of overheating can occur. If any device feels warm to the touch, discontinue use and return to prescribing healthcare provider.
  • Electrical shock warning. Do not allow conductive parts on this device to come in contact with other conductive parts.

FCC Warning

This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions:

  •  this device may not cause harmful interference, and
  •  this device must accept any interference received, including interference that may cause undesired operation.

THE GRANTEE IS NOT RESPONSIBLE FOR ANY CHANGES OR MODIFICATIONS NOT EXPRESSLY APPROVED BY THE PARTY RESPONSIBLE FOR COMPLIANCE. SUCH MODIFICATIONS COULD VOID THE USER’S AUTHORITY TO OPERATE THE EQUIPMENT.

Symbol GlossaryLifelens 2AXAK100006 Wireless ECG Monitor Kit 11

Documents / Resources

Lifelens 2AXAK100006 Wireless ECG Monitor Kit [pdf] Instruction Manual
100006, 2AXAK-100006, 2AXAK100006, Wireless ECG Monitor Kit, Wireless ECG Monitor

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