ePatch

ePatch
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ePatch

Product catalog summary
Introduction
This guide provides comprehensive instructions for using the ePatch™ heart monitoring service, including kit contents, usage instructions, and customer support contact information.
Kit Contents
The kit includes a sensor, patch pouches, a scrub pad, a patient education guide, a return label, and a diary for recording symptoms.
Getting Started
Instructions for applying the ePatch involve preparing the skin by shaving, washing, and drying, then scrubbing with the provided pad. The sensor is attached to the patch and applied to the chest using a template.
Recording Symptoms
Users should log heart-related symptoms in the diary, double-tap the sensor to record, and note the date, time, and activity during occurrences.
Removing and Returning the Patch
Instructions are provided for removing the sensor and patch, with all equipment returned using the original box and pre-paid UPS label.
Showering Instructions
The ePatch is water-resistant but not waterproof; avoid swimming or bathing while wearing it.
Important Information
Wear the ePatch for the prescribed duration. Contact customer service if irritation occurs and record all symptoms in the diary.
Appendix
Indications for Use: Suitable for patients with transient symptoms like palpitations or dizziness. Not for use with pacemakers or on damaged skin.
Precautions: Avoid contact with eyes or mucous membranes. Do not use broken sensors. Store within specified environmental conditions.
Warnings: Do not use in MRI or CT environments. Do not modify the sensor or use incompatible accessories.
Device Specifications
The device is internally powered, Type BF applied parts, not protected against defibrillator shocks, and can acquire data from 1, 2, or 3 ECG channels. It has a configurable recording time, defaulting to 5 days, with a sampling rate of 128 to 1024 Hz and a resolution of 12 or 16 bits. The frequency response is 0.05 Hz High Pass, with an input range of 180 mVpv and a CMRR of >80 dB. It uses an 8-terminals connector and has 2 GB internal storage.
Battery Specifications
The sensor is powered by a non-replaceable rechargeable lithium-ion polymer battery with a capacity of 500 mAh and a nominal voltage of 3.7 V. It requires a USB 5.0 VDC, 250 mA charger, with a battery life of at least 500 recharges.
Environmental Conditions
The sensor operates between +5°C to +40°C, with a pressure range of 700 – 1060 hPa and relative humidity of 15% - 90%. Storage conditions vary slightly, with a temperature range of 5°C to +27°C and relative humidity up to 93%.
System Requirements
A standard computer with Microsoft® Windows 7 or Mac OS X 10.7, a 1.5 GHz processor, 512 MB RAM, USB 2.0 port, and 1 GB of free hard-drive space is required to read the recorded data.
Compliance and Standards
The sensor complies with DS/EN ISO 13485 and council directive 93/42/EEC, meeting standards such as IEC 60601-1, EN 60601-1-2, EN 62366, EN 60601-1-11, IEC 60601-2-47, and DS/EN ISO 14971.
Privacy and Service Agreement
Activating the monitoring service indicates acceptance of terms, including privacy practices under HIPAA. Users consent to data sharing with healthcare providers and emergency services, acknowledge financial responsibility for co-payments and non-covered services, and must return the monitoring system after use.
Operational Notices
The system may not always provide continuous transmission due to cellular coverage variability. It is intended for diagnostic aid only and not for treatment. Users should report any discomfort and discontinue use if necessary.
Indemnity
The patient agrees to indemnify BioTelemetry, Inc. and its affiliates against third-party claims related to the patient's use or misuse of the system or service. BioTelemetry will manage the defense and settlement of such claims, with the patient's cooperation.
General Provisions
Modifications to the agreement require a written instrument signed by both parties. Terms issued by the patient are not binding on BioTelemetry. Neither party is liable for non-performance due to uncontrollable events like natural disasters or governmental actions. The agreement is governed by Pennsylvania law, and legal proceedings must occur in Chester County, Pennsylvania. BioTelemetry can seek injunctive relief for violations without posting a bond. If any provision is unenforceable, it will be adjusted minimally to remain effective.
Important Reminder
The device is for diagnostic purposes only and not an emergency service. In emergencies, patients should call 911.
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Catalog excerpts

ePatch-1

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-2

Getting Started • About our Service • Kit Contents • What to Expect During Service • Quick Start Instructions • Record Symptoms • Removing the Patch • Returning ePatch • Showering Instructions • Important Information • Addendum to the Patient Education Guide • Terms and Conditions • Notice of Confidentiality

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ePatch-3

Your physician has prescribed ePatch™ 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 provider at the end of service. To get started, review the important information in this guide or visit myheartmonitor.com. If you have any questions, please contact us: Customer Service: 1-877-593-6421 (toll-free) email: [email protected] Hours: Mon-Fri 8am - 8:30pm EST; Sat 8am - 4:30pm EST For assistance, please call Customer Service at 1-877-593-6421

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ePatch-4

5 SYMPTOM/EVENT DIARY Date PATIENT EDUCATION GUIDE RETURNS 10255 W. HIGGINS ROAD ROSEMONT IL 60018 Extended Holter Monitoring Check any feelings that apply: 4 Patient Education Guide PATIENT DIARY 10255 W. HIGGINS ROAD ROSEMONT IL 60018 Patient Name: 5 ePatch kit with return label attached to the box SAVE THE BOX! Patient Address: Physician Name: Start Date: Did you push the button/sensor to record a symptom Start Time: Date Removed: ____ Yes ____ No For assistance, contact Customer Service: What were you doing when the symptom(s) occurred? Activity: ____ Normal daily routine Need help or have...

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ePatch-5

Contacting You Before, during or after your service, we may contact you for any of the following reasons: • Confirm insurance information • Assist with starting service • Confirm a break in service • Troubleshooting • On behalf of your physician (please note, we will not contact you regarding heart-related findings, unless specifically instructed by your physician) Your insurance company will send you an Explanation of Benefits (EOB). An EOB from your insurance carrier is NOT a bill. You will be responsible for any out-of-pocket cost associated with deductibles, co-insurances, etc. If there is...

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ePatch-6

Getting Started Quick Start Instructions Step 1 LEFT Side SHAVE (If needed), then WASH and DRY area shown in diagram thoroughly. LEFT Side Once skin is dry, SCRUB area with the SCRUB PAD for one minute. DO NOT apply lotions or oils. Remove a patch from the patch pouch. Place sensor into patch and PRESS down firmly to snap it in place. Locate the Patch Placement Template in the kit and follow its instructions for use. REMOVE CLEAR BACKING and apply the patch to your chest using the template as a guide as shown. Use a mirror for guidance. Remove template when finished. Press the patch firmly against...

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ePatch-7

Record Symptoms SYMPTOM/EVENT DIARY Date Check any feelings that apply: Check any feelings that apply: Did you push the button/sensor to record a symptom ____ Yes ____ No Anxiety Chest pain or pressure Dizziness Fainting Light-headedness Heart fluttering, racing or pounding Heart skips beat(s); irregular beats Neck or arm pain/ tingling Shortness of breath Other (describe) Anxiety Chest pain or pressure Dizziness Fainting Light-headedness Heart fluttering, racing or pounding Did you push the button/sensor to record a symptom What were you doing when the symptom(s) occurred? Activity: ____ Normal...

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ePatch-8

How to REMOVE the SENSOR from the PATCH Step 1 Remove the patch by pulling the clear adhesive away from your body. Apply downward pressure on the tab to snap/break it off. This will require some force. Hold the sensor as shown and slide the sensor forward to remove it from the patch. Discard the used patch, NOT the SENSOR. How to apply a NEW PATCH Additional patches are provided in the kit if you plan to wear ePatch for a longer duration, or if you are experiencing discomfort. Please refer to the Getting Started section of this guide to set up and apply a new patch.

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ePatch-9

Returning ePatch 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 REMOVE...

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ePatch-10

Showering Instructions Shower or exercise as normal while wearing ePatch. Do NOT swim or bathe. Patch is water-resistant, not waterproof.

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ePatch-11

Important Information • Continue to wear ePatch for the duration prescribed by your physician. • Mild itching or irritation underneath the patch area may occur, and is usually temporary. If more significant itching or irritation develop or persists, contact Customer Service at 1-877-593-6421. • Write down any symptoms as they occur in your diary. For assistance, please call Customer Service at 1-877-593-642

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ePatch-12

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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