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USES AND DISCLOSURES THAT MAY BE MADE EITHER WITH YOUR AGREEMENT OR THE 
OPPORTUNITY TO OBJECT

Unless you object, we may disclose to a member of your family, a relative, a close friend or any other 

person you identify, orally or in writing, your health information that directly relates to that person's 

involvement in your health care. If you are unable to agree or object to such disclosure, we may disclose 

such information as necessary if we determine that it is in your best interest based on our professional 

judgment. We may use or disclose your health information to notify or assist in notifying a family 

member, personal representative or any other person that is responsible for your care of your location or 
general condition. 

USES AND DISCLOSURES BASED ON YOUR WRITTEN AUTHORIZATION

Marketing:

 We must obtain your written authorization to use and disclose your health information for 

most marketing purposes.

Sale of Health Information:

 We must obtain your written authorization for any disclosure of your health 

information which constitutes a sale of health information.

Other Uses:

 Other uses and disclosures of your health information will be made only with your written 

authorization, except as described in this notice or as otherwise required or allowed by applicable law. 
In the event that we ask for your authorization to use or disclose your health information, we will provide 
you with an appropriate authorization form. Once you've given us a written authorization, you can 
revoke that authorization at any time, except to the extent that we have taken action in reliance on your 
authorization. 

INDIVIDUAL RIGHTS

Access:

 You have the right to see or get an electronic or paper copy of your health information by 

submitting a request to us in writing using the information listed at the end of this notice.  There are 
certain exceptions to your right to obtain a copy of your health information.  For example, we may deny 
your request if we believe the disclosure will endanger your life or that of another person.  Depending on 
the circumstances of the denial, you may have a right to have this decision reviewed. We will charge you 
a fee to cover the costs incurred by us in complying with your request.

Disclosure Accounting:

 You have the right to an accounting of disclosures of your health information 

made by us by submitting a request to us in writing using the information listed at the end of this 
notice. This right only applies to instances when we or our business associates disclosed your health 
information for purposes other than treatment, payment, health care operations, upon your written 

authorization, and certain other activities. The right to receive this information is subject to certain 

exceptions, restrictions and limitations.  You must specify a time period, which may not be longer than 6 
years. You may request a shorter timeframe.  You have the right to one free request within any 12-month 
period, but we may charge you for any additional requests in the same 12-month period.  We will notify 
you about any such charges, and you are free to withdraw or modify your request in writing before any 
charges are incurred.  

Restriction Requests:

 You have the right to request restrictions on the use and disclosure of your health 

information by submitting a request to us in writing using the information listed at the end of this notice. 

Your request must state the specific restriction requested and to whom you want the restriction to apply. 

We are not required to agree to these additional restrictions, except we must agree not to disclose your 
health information to your health plan if the disclosure (1) is for payment or health care operations and 
is not otherwise required by law, and (2) relates to a health care item or service which you paid for in 
full out of pocket.  If we agree to a restriction, we will abide by our agreement (except in an emergency).

Confidential Communication:

 You have the right to receive certain communications confidentially.  That 

means you can request that we communicate with you by alternative means or to an alternative location 
by submitting a request to us in writing using the information listed at the end of this notice. We will 

accommodate your request if it is reasonable and specifies the alternative means or location.  We may 

also condition this accommodation by asking you for information as to how payment will be handled.  

Amendment:

 You have the right to amend your health information in our records for as long as we 

maintain the information.  You must make a request in writing, using the information listed at the end 
of this notice, to obtain an amendment.  Your written request must explain why the information should 
be amended.  If we agree to amend your health information we will make reasonable efforts to inform 
others of the amendment and to include the changes in any future disclosures of that information.  
We may deny your request if, for example, we determine that your health information is accurate and 
complete.  If we deny your request, we will send you a written explanation and allow you to submit a 
written statement of disagreement to be appended to the information you want amended.

Paper Notice:

 If you receive this notice electronically you are entitled to receive this notice in written 

form. Please contact us using the information listed at the end of this notice to obtain this notice in 
written form.

Breach:

 You have the right to be notified if you are affected by a breach of unsecured health information.

QUESTIONS AND COMPLAINTS

If you want more information about our privacy practices or have questions or concerns, please contact 
us using the information listed at the end of this notice. If you are concerned that we may have violated 
your privacy rights, or you disagree with a decision we made about your rights to your health information 
you may complain to us using the information listed at the end of this notice. You may also complain to 
the U.S. Department of Health and Human Services. We support your right to protect the privacy of your 

health information. We will not retaliate against you in any way if you choose to file a complaint with us 

or with the U.S. Department of Health and Human Services.

CONTACT INFORMATION

BioTelemetry, Inc.

Privacy Officer

1000 Cedar Hollow Road, Suite 102 
Malvern, PA  19355
Telephone: 610.729.7000 
Email: [email protected] 

Update Effective date: August 30, 2017

Summary of Contents for MCOT Patch

Page 1: ...ETRY PATIENT EDUCATION GUIDE Need help or have questions Contact Customer Service Toll Free at 1 866 426 4401 or visit www gobio com patients for online support CardioNet LifeWatch and BioTel Heart are trademarks of BioTelemetry Inc ...

Page 2: ...ient Consent 12 Step 6 Placement and Skin Preparation 13 Step 7 Apply the Patch to Your Skin 15 Step 8 Record a Baseline 17 Getting Started 5 2 Record a Baseline Manual Recording Option 18 Record Symptoms 19 Removing the Sensor from the Patch 21 Replacing the Patch 24 Deactivation Return the Equipment 25 Important Information 26 Wear Care Charging the Sensor 27 Wear Care Charging the Monitor 28 We...

Page 3: ... day 7 days a week and in some cases may contact your physician Clinical reports are made available to your healthcare professional during and at the end of your service To get started review the important information in this guide or view the instructional videos on the monitor or visit www gobio com patients If you have any questions about your monitoring service or billing please contact us Cus...

Page 4: ...m patients 4 Kit Contents Monitor Charger Sensor Sensor Charger Monitor Monitor Case Patch Pouch MCOT Skin Prep Pack 2 1 3 4 5 6 7 8 9 Patient Education Guide Return Envelope 1 3 4 7 8 9 2 6 5 Before you Begin ...

Page 5: ... the monitor Depending on the model of the monitor the Power button is located at the top or on the side of the monitor Depending on type of monitor the buttons at the bottom may be used to wake your monitor from sleep mode The monitor will run through a few screens It may take up to two minutes to get to the starting screen The text on this screen confirms the monitor is ready for set up Disabled...

Page 6: ...row on the image that says Patch When you finish watching the video set the monitor aside and proceed to Step 3 Attach Sensor to the Patch Select the appropriate language option and press continue Note If your screen goes dark now or anytime throughout your monitoring process it is in sleep mode To wake press and release the power button Getting Started ...

Page 7: ... patients For assistance please call Customer Service at 1 866 426 4401 7 STEP 3 Attach the Sensor to the Patch Getting Started 1 Open the pouch Tear open one of the pouches and remove the patch 2 Place patch on a flat hard surface 3 Locate the sensor in your kit ...

Page 8: ...arted 4 Place sensor in the patch 5 While standing place the palm of your hand on top of the sensor and apply pressure to snap the sensor into the patch You may hear several clicks 6 Rotate patch 180 degrees Flashing green lights will appear if connected properly ...

Page 9: ...4401 9 Attach the Sensor to the Patch Getting Started 7 With the patch rotated again place the palm of your hand on top of the sensor and apply pressure to snap the sensor into the patch 8 Inspect all four sides of the sensor for gaps The sensor is attached correctly if there are no visible gaps 9 Correct No Gap 10 Incorrect Gap ...

Page 10: ...and press Continue Attach Sensor to the Patch Getting Started 11 Apply pressure to any gaps to seal the gap 12 Ensure that sensor is sealed and there are no gaps It is very important that all gaps are closed or damage to the sensor could occur ...

Page 11: ...begin Read the text on each screen and select the appropriate response Pick up the patch so it is near the monitor The sensor and monitor should automatically link to each other via Bluetooth Some monitor models may differ if prompted with a Bluetooth pairing request tap OK to start a connection If the pairing process is successful a green checkmark will be displayed on the screen Press Continue t...

Page 12: ... on the Patient Consent screen is required to start monitoring If you select No the following screen will instruct you to contact BioTel Heart The Processing screen will appear while your enrollment is being processed through BioTel Heart s internal system The Confirm Identity screen will ask you to confirm that the name on the screen is yours If your name appears correctly select Yes If the name ...

Page 13: ...vailable in your MCOT Skin Prep Pack Start at the center of your chest and shave the entire area marked in the red circle of the diagram Clean Skin Clean the area with soap and water STEP 6 Placement and Skin Preparation Now that you ve finished the questions set aside the monitor and proceed to Step 6 Placement and Skin Preparation Determine the area of your chest to prepare by referring to the d...

Page 14: ...oroughly using a towel Abrade Skin Remove the Prep Scrub Pad from your MCOT Skin Prep Pack Scrub the cleaned area with firm pressure in a circular motion for one minute This important step will improve the quality of the recording Do not apply lotions or oils Getting Started ...

Page 15: ... patch should be three finger widths down from your collarbone 3 Place patch on a slight angle as shown in the illustration with the wide end of the patch slightly over the center of your chest Press all sides of the patch so it will adhere to your skin Getting Started 2 Pick up the patch with the attached sensor peel the clear plastic backing off Patch Application LEFT LEFT RIGHT RIGHT ...

Page 16: ... of the patch firmly and on the sensor so the patch will adhere to your skin Smooth out any wrinkles by pressing the patch Wait 10 15 minutes to allow the patch to fully adhere to your skin before proceeding to the next step Getting Started LEFT RIGHT Minor discomfort may occur when the patch is attached to the skin If you have sensitive skin this product may not be appropriate for use ...

Page 17: ...ecord Symptom will appear This means the baseline ECG is complete and you can go about your normal daily activities The BioTel Heart Monitoring Center will send a text later in the day to confirm that your monitoring service has begun Please Note if you press Continue prior to applying the patch to your chest the Activating screen may appear for an extended period of time If this message appears f...

Page 18: ...est will be recorded Sending a baseline should occur automatically and the data will be sent wirelessly to BioTel Heart If you do not have cellular coverage the baseline will store in the monitor until service is available You may be asked to transmit a baseline recording The steps to complete a manual baseline recording are as follows Good to Know ...

Page 19: ...ord Symptoms Recording a Symptom The MCOT Patch will monitor your heart and send data to the Monitoring Center However you can record symptoms as you feel them and your recordings will appear on the reports provided to your physician To record a symptom press Record Symptom on the main monitor screen and enter the information Good to Know ...

Page 20: ... box will ask if you would like to record a symptom Select Yes to continue If you do not wish to record a symptom select No The Select Activity screen allows you to record your level of activity when the symptom occurred Select your activity level and press Done The Symptom Recorded screen confirms that your symptom was recorded Press OK to return to HOME screen Good to Know ...

Page 21: ...t of way for next step 3 Locate patch Tab Start at one end and pull the patch material away from your body to remove the patch Before removing the MCOT Patch turn off the monitor Depending on the duration of your prescription you may need to change the patch several times throughout your monitoring period Remove the patch when the sensor battery is low and requires charging or if the patch is loos...

Page 22: ...m patients 22 Removing the Sensor from the Patch 4 Apply downward pressure on tab to snap open the tab This will require some force 5 Pull down on the tab 6 Place sensor in hand as shown above Good to Know TAB ...

Page 23: ...moving the Sensor from the Patch 7 Place thumb on top of sensor 8 Push thumb forward to dislodge the sensor from the patch It may take some force to dislodge the sensor 9 Discard the used patch NOT the sensor If you need to charge the sensor follow the instructions on page 27 The sensor is reusable and should not be discarded Good to Know ...

Page 24: ...ensor Wait until the sensor is fully charged and the light has turned green before applying another patch to your skin After the sensor is charged and your skin has been properly cleaned repeat the steps to attach the sensor to the patch as shown on page 7 Once sensor is attached to the patch follow the steps on page 15 to apply the patch to your skin Good to Know ...

Page 25: ... on the monitor to return the equipment immediately Turn off the monitor by pressing the power button Remove shipping envelope from kit Pack up the monitor sensor chargers and any extra patch pouches and place into the kit Place the kit into the large postage paid envelope and mail back to BioTel Heart via UPS There is no cost to you to mail back the equipment Deactivation Return the Equipment RET...

Page 26: ... itching or irritation underneath the patch area may occur and is usually temporary If more significant itching or irritation develops or persists contact Customer Service at 1 866 426 4401 they may direct you to contact your physician Keep the monitor and sensor within close range of each other throughout your monitoring period To avoid getting alert messages on the monitor keep the monitor withi...

Page 27: ...ery is low Locate the charger and cable wire from your kit Only use the supplied charger to charge the sensor Insert sensor into charger as shown in illustration Insert the other end of the cable into the wall charger and insert the wall charger into a functioning outlet Fully Charged Charging Keep the sensor plugged into the charger until the unit is fully charged and the light turns green It may...

Page 28: ...wipe down on the battery images to determine battery level percentages Charging the Monitor Charge the monitor every night It may take up to 4 hours to fully charge the monitor Insert the small end of the charging cable into the monitor as shown Insert the other end of the cable into the black charger Insert the charger into a functioning outlet TIP Good to Know ...

Page 29: ...ing Instructions Showering The MCOT Patch components are water resistant not waterproof You can shower normally however for optimal results avoid spraying water directly onto the sensor While showering it is recommended to face away from the shower head Do not swim or take baths while wearing the MCOT Patch KEEP THE MONITOR AWAY FROM WATER Good to Know ...

Page 30: ...a high medium or low setting Select Vibrate if you would not like the monitor to ring Please Note Vibrate mode must be on if monitor volume is turned off You have the ability to change volume and vibrate settings for the monitor You can also send a baseline ECG or check cell coverage Good to Know Options ...

Page 31: ... you receive this warning message follow the instructions for removing the patch and charge the sensor The message can be dismissed by pressing the OK button however the message will appear again A Battery Alarm symbol indicates that the sensor battery life is critically low If you receive this alarm the sensor must be removed from the patch to be charged The battery alarm message can be silenced ...

Page 32: ...sor and monitor are within range make sure you are not lying on the sensor or blocking its communication to the monitor Transmit Data This warning indicates that the monitor is not able to locate cellular service To resolve move to an area with cellular coverage If you are unable to locate cellular service the monitor will store the data and transmit it when cellular service becomes available Trou...

Page 33: ...e alarm If it has been more than five days the patch may be loose and require replacing If the sensor has been removed in order to be charged the monitor should be turned off as well If the above scenarios do not apply follow the next steps to resolve the issue Press firmly on all of the edges and center of the patch to ensure proper adhesion Wait 5 minutes to see if the issue is resolved If the e...

Page 34: ...observer using diagnostic 12 lead ECG in a clinical environment This device is not intended to sound any alarms for QT interval changes 5 The device does not annotate QT interval for QRS durations 160ms or for T wave amplitudes 5 of the peak QRS amplitude PRECAUTIONS AVOID ELECTROMAGNETIC INTERFERENCE For the best recording results you should avoid close proximity to heavy equipment or other sourc...

Page 35: ... the supplied Sensor DO NOT STACK The MCOT Patch System should not be stacked with other equipment Stacking other equipment on top of the devices may damage enclosure or inner components CAUTIONS DO NOT TAKE THE MONITOR INTO THE SHOWER The MCOT Patch System Monitor is water resistant not waterproof do not take the Monitor into the shower AVOID SPRAYING WATER DIRECTLY ONTO THE SENSOR The MCOT Patch...

Page 36: ... provide your monitoring data to your physician and his her staff and to Emergency Medical Services by phone e mail fax or through secure Internet access You will also be asked to give BioTelemetry permission to use your monitoring data without your identity in clinical research and case studies This is an option and not required to continue to receive BioTelemetry monitoring service Service You c...

Page 37: ...MATION USES AND DISCLOSURES THAT MAY BE MADE WITHOUT YOUR AUTHORIZATION OR OPPORTUNITY TO OBJECT We may use and disclose your health information without your authorization in the following ways Treatment We may use and disclose your health information to provide coordinate or manage your treatment For example we may disclose your health information to a provider who requests this information to tr...

Page 38: ...equest in writing before any charges are incurred Restriction Requests You have the right to request restrictions on the use and disclosure of your health information by submitting a request to us in writing using the information listed at the end of this notice Your request must state the specific restriction requested and to whom you want the restriction to apply We are not required to agree to ...

Page 39: ...F NOR ANY MATERIAL AVAILABLE THROUGH PATIENT S USE OF THE SYSTEM OR SERVICE IS INTENDED TO PROVIDE PATIENT WITH MEDICAL ADVICE A DIAGNOSIS OR TREATMENT PATIENT MUST ALWAYS SEEK THE ADVICE OF PATIENT S PHYSICIAN OR OF ANOTHER QUALIFIED MEDICAL PRACTITIONER WITH ANY QUESTIONS PATIENT MAY HAVE REGARDING A SPECIFIC MEDI CAL CONDITION OR PERCEIVED CONDITION 4 LIMITATION OF LIABILITY TO THE MAXIMUM EXTE...

Page 40: ... at any time you experience a symptom that you feel is a medical emergency you should immediately dial 911 for medical assistance 1000 Cedar Hollow Road Suite 102 Malvern PA 19355 Toll free 1 866 426 4401 customerservice gobio com www gobio com Copyright 2017 All rights reserved Doc 220 0306 01 Rev C ...

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