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ePatch PATIENT EDUCATION GUIDE

ePatch PATIENT EDUCATION GUIDE
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ePatch PATIENT EDUCATION GUIDE

Product catalog summary
About Our Service
The ePatch is a device prescribed by physicians to continuously record heartbeats for analysis by certified cardiac technicians. Clinical reports are provided to healthcare professionals at the end of the service.
What to Expect During Service
BioTel Heart may contact you for insurance confirmation, service initiation, or troubleshooting. Billing starts with monitoring, and you will receive an Explanation of Benefits (EOB) from your insurance, which is not a bill. Prompt return of equipment is necessary to avoid delays and additional charges.
Getting Started
Prepare the skin by shaving, washing, and drying the area for the ePatch Flex. Insert the sensor into the ePatch Flex and attach electrodes as instructed. Place the ePatch Flex on your chest below the collarbone.
Record Symptoms
Use the symptom/event diary to record heart-related symptoms by double-tapping the sensor. Note the symptom, activity, and time in the diary.
Important Information
Continue wearing the ePatch as prescribed. Contact customer service if mild skin irritation persists.
Wear & Care Tips
The Flex accessory is not waterproof; remove it before showering. Replace electrodes every 48 hours and after each shower. Record all symptoms in the diary.
Showering/Replacing Electrodes
Change electrodes every other day or after showering. Ensure skin is clean and dry before applying new electrodes.
Returning the Equipment
Return the sensor, unused patches, and diary in the provided kit via UPS using the pre-paid label for free return shipping.
Appendix
The ePatch is for patients with transient symptoms like palpitations or dizziness. It is not for use with pacemakers or on irritated skin. Federal law restricts this device to sale by or on the order of a physician.
Warnings and Precautions
Avoid using broken sensors, touching terminals, and minimize connected devices to prevent leakage current. Do not expose the sensor to liquids or use it in environments with X-ray, CT, or MRI equipment.
Specifications
The sensor is internally powered, with options for 1, 2, or 3 channel ECG data acquisition. It has a default recording time of 5 days and a sampling rate ranging from 128 to 1024 Hz. The device includes a 2 GB internal storage and is expected to last for a minimum of 500 lifecycles or two years.
Battery Information
The sensor is powered by a non-replaceable rechargeable lithium-ion polymer battery with a capacity of 350 mAh. It should be charged using the provided USB power adapter or a computer via the provided Micro USB cable.
Environmental Conditions
The sensor and its accessories have specific operating, storage, and transportation conditions, including temperature, pressure, and humidity ranges.
System Requirements
A computer with at least Windows 7 or Mac OS X 10.7, a 1.5 GHz processor, 512 MB RAM, and a USB 2.0 port is required to read recorded data.
Compliance and Standards
The sensor complies with various medical device standards, including IEC 60601-1 and EN 60601-1-2.
Service Agreement
Includes terms for financial responsibility, privacy, and operational notices related to the BioTelemetry service. Users are responsible for co-payments and returning the monitoring system after use.
Privacy Practices
BioTelemetry's privacy practices ensure compliance with HIPAA, detailing how medical information may be used and disclosed.
Privacy Practices Overview
BioTelemetry is committed to maintaining the privacy of your health information and provides a notice of their privacy practices, legal duties, and your rights.
Uses and Disclosures Without Authorization
Your health information may be used or disclosed without your authorization for various purposes, including treatment, payment, and healthcare operations.
Uses and Disclosures With Your Agreement
With your agreement, your health information may be disclosed to family members or others involved in your care.
Uses and Disclosures Requiring Written Authorization
Your written authorization is required for marketing, sale of health information, and other uses not described in the notice.
Individual Rights
You have rights to access, amend, and receive an accounting of disclosures of your health information.
Questions and Complaints
Contact BioTelemetry's Privacy Officer for more information or to file a complaint.
Terms and Conditions for Cardiac Monitoring System
BioTelemetry grants a nonexclusive, nontransferable license to use their cardiac monitoring system and service, subject to compliance with terms.
Agreement Termination
The agreement can be terminated by either party with thirty days' written notice.
No Warranty
The system and service are provided "as-is" without any warranties.
Limitation of Liability
BioTelemetry is not liable for indirect, incidental, or consequential damages.
Indemnity
The patient agrees to indemnify BioTelemetry against third-party claims related to the misuse of the system or service.
General Provisions
The agreement can only be modified in writing and is governed by Pennsylvania law.
Important Reminder
The device is for diagnostic purposes and not an emergency response service. In emergencies, dial 911.
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Catalog excerpts

ePatch PATIENT EDUCATION GUIDE-1

Extended Holter FLEX PATIENT EDUCATION GUIDE Need help or have questions? Contact Customer Service Toll Free at 1.877.593.6421 or visit myheartmonitor.com for online support. CardioNet, LifeWatch and BioTel Heart are trademarks of BioTelemetry, Inc. BioTelemetry reserves the right to change specifications at any time without notice.

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ePatch PATIENT EDUCATION GUIDE-2

About Our Service What to Expect during Service Getting Started Record Symptoms Important Information Wear & Care Tips Showering/Replacing Electrodes Returning the Equipment Appendix • Addendum to the Patient Education Guide • Terms and Conditions • Notice of Confidentiality and Privacy Practices Your physician has prescribed for you. ePatch continuously records and stores heartbeats that are analyzed by certified cardiac technicians at BioTel Heart. Clinical reports are made available to your healthcare professional at the end of service. TM To get started, review the important information in...

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ePatch PATIENT EDUCATION GUIDE-3

Before You Begin Before you Begin What to Expect During Service Contacting You We may contact you via automated and live messages for the following reasons: • Confirm insurance information • On behalf of your physician • Assist with starting service • Troubleshooting (Please note, we will not contact you regarding heart-related findings, unless specifically instructed by your physician.) Billing for Service Charges are incurred when you begin monitoring. After your service, your insurance company will send you an Explanation of Benefits (EOB). An EOB from your insurance carrier is NOT a bill....

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ePatch PATIENT EDUCATION GUIDE-4

Getting Started LEFT Side If needed, SHAVE the area where the ePatch Flex will be placed. Getting Started Slide the sensor into the ePatch Flex. A green light on the sensor will flash when it is completely inserted. LEFT Side WASH the area with soap and water and DRY thoroughly with a towel. DO NOT apply lotions or oils. Remove two electrodes from the electrode pouch. Leave the plastic backing on the electrodes.

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ePatch PATIENT EDUCATION GUIDE-5

LEFT Side LEFT Side TM Place the ePatch Flex in the center of your chest approximately three fingerwidths below your collarbone. Remove plastic backing from electrodes. Be careful not to touch the adhesive. LEFT Side LEFT Side TM Press the second electrode firmly so that the arm lays flat against your chest. You have now completed the set-up process. For assistance, please call Customer Service at 1-877-593-6421 Getting Started While the electrode is still on the plastic backing, snap it to the back of the ePatch Flex (A). Repeat this step by snapping the second electrode onto the back of the...

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ePatch PATIENT EDUCATION GUIDE-6

Record Symptoms Recording a Symptom • ocate the diary in your kit and fill in your name, address, L physician's name, and the start date. Make sure to fill in the date you removed ePatch once your monitoring period has ended. • henever you feel a heart-related symptom, double tap W the middle of the sensor to record the symptom. When the sensor has registered the symptom, the status indicator will show a constant green light for one second. EVENT DIARY SYMPTOM/EVENT DIARY Check any feelings that apply: button/sensor to record a symptom Anxiety Chest pain or pressure Dizziness Fainting Light-headedness...

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ePatch PATIENT EDUCATION GUIDE-7

Important Information • Continue to wear ePatch for the duration prescribed by your physician. TM • Mild itching or irritation underneath the electrodes may occur, and is usually temporary. If more significant itching or irritation develops or persists, contact Customer Service at 1-877-593-6421, they may direct you to contact your physician. For assistance, please call Customer Service at 1-877-593-6421

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ePatch PATIENT EDUCATION GUIDE-8

Wear and Care Tips: 1. he Flex accessory is not waterproof. T Remove before showering, bathing or swimming. 2. eplace the electrodes every 48 hours and R after every shower. 3. ear ePatch only for as long as prescribed W by your doctor. Your prescription ends on: _______________________________ Electrodes should be Wear ePatch only for as long as prescribed by your doctor. Your prescription ends on: The lead wire adapter is not waterproof. Remove before showering, bathing or swimming. changed every 48 hours. Write any and all symptoms you are feeling into your patient diary, including the date...

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ePatch PATIENT EDUCATION GUIDE-9

Showering and Replacing Electrodes The ePatch sensor worn with the Flex is NOT water-resistant. It is recommended you change your electrodes every other day or after showering, whichever comes first. Follow these steps to ensure an easy transition when removing old electrodes and attaching new ones. Before Showering or Removing Electrodes: 1. Remove the sensor from the Flex. 2. Unsnap the Flex from the electrodes. Showering/Removing Electrodes: 1. Use soap and water to gently remove the electrodes from skin. 2. Shower normally. Replacing Electrodes: 1. Dry skin thoroughly 2. ollow the set-up...

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ePatch PATIENT EDUCATION GUIDE-10

Returning the Equipment Important: Do not throw the box away. You will need to use it to return the equipment and supplies. Step 1 ePatch ™ LEFT Side LEFT Side LEFT Side TO EXPOSE ADHESIVE REMOVE LINER TO EXPOSE ADHESIVE REMOVE LINER TO EXPOSE ADHESIVE REMOVE LINER TO EXPOSE ADHESIVE REMOVE LINER TO EXPOSE ADHESIVE REMOVE LINER TO EXPOSE ADHESIVE REMOVE LINER TO EXPOSE ADHESIVE REMOVE LINER TO EXPOSE ADHESIVE REMOVE LINER TO EXPOSE ADHESIVE REMOVE LINER TO EXPOSE ADHESIVE REMOVE LINER TO EXPOSE ADHESIVE REMOVE LINER TO EXPOSE ADHESIVE REMOVE LINER TO EXPOSE ADHESIVE REMOVE LINER TO EXPOSE ADHESIVE...

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ePatch PATIENT EDUCATION GUIDE-11

ePatch® ADDENDUM TO THE PATIENT EDUCATION GUIDE Indications for use ePatch is indicated for use on patients who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light headedness, presyncope, syncope, fatigue, chest pain and/or anxiety. ePatch is intended for use by adolescents 18-21 and adults. Contraindications The sensor is not intended for use on: •Patients with implanted pacemakers. The compatible ECG patch is not intended for use in the following cases: •The compatible ECG patch is not intended for use on patients with known...

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