Best CGM Supplies

THIS NOTICE DESCRIBES HOW MEDICAL INFORMATION ABOUT YOU MAY BE USED AND DISCLOSED AND HOW YOU CAN ACCESS THIS INFORMATION. PLEASE REVIEW THIS NOTICE CAREFULLY.

Effective April 25, 2012

We are required by law to protect the privacy of your health information. We are also required to send you this notice, which explains how we may use information about you and when we can share or “disclose” that information to others. You also have rights regarding your health information that are described in this notice. We are required by law to abide by the terms of this notice.

The terms “information” or “health information” in this notice include any information we maintain that reasonably can be used to identify you and that relates to your physical or mental health condition, the provision of health care to you, or the payment for such health care.

We have the right to change our privacy practices and the terms of this notice. If we make a material change to our privacy practices, we will provide to you a revised notice by direct mail or electronically as permitted by applicable law. In all cases, we will post the revised notice on our website, bestcgmsupplies.com. We reserve the right to make any revised or changed notice effective for information we already have and for information that we receive in the future.

Who Must Abide by this Notice

CCS Medical, Inc. and its related entities, their employees, staff, and other personnel (collectively “CCS Medical”), including:

DEGC Enterprises (U.S.), Inc. MP TotalCare Services, Inc.
MedStar Diabetic Supply, LP Medical Express Depot, Inc.

What Are Your Rights

The following are your rights with respect to your health information:

You have the right to ask to restrict uses or disclosures of your information for treatment, payment, or health care operations. You also have the right to ask to restrict disclosures to family members or to others who are involved in your health care or payment for your health care. We may also have policies on dependent access that authorize your dependents to request certain restrictions. Please note that while we will try to honor your request and will permit requests consistent with our policies, we are generally not required to agree to any restriction.
You have the right to ask to receive confidential communications of information in a different manner or at a different place (for example, by sending information to a P.O. Box instead of your home address). We will accommodate reasonable requests where a disclosure of all or part of your health information otherwise could endanger you. We will accept verbal requests to receive confidential communications, but requests to modify or cancel a previous confidential communication request must be made in writing. Mail your request to the address listed below.
You have the right to see and obtain a copy of health information that may be used to make decisions about you such as claims and case or medical management records. You also may in some cases receive a summary of this health information. You must make a written request to inspect and copy your health information. Mail your request to the address listed below. In certain limited circumstances, we may deny your request to inspect and copy your health information. We may charge a reasonable fee for any copies. If we deny your request, you have the right to have the denial reviewed. If we maintain an electronic health record containing your health information, when and if we are required by law, you will have the right to request that we send a copy of your health information in an electronic format to you or to a third party that you identify. We may charge a reasonable fee for sending the electronic copy of your health information.
You have the right to ask to amend information we maintain about you if you believe the health information about you is wrong or incomplete. Your request must be in writing and provide the reasons for the requested amendment. Mail your request to the address listed below. If we deny your request, you may have a statement of your disagreement added to your health information.
You have the right to receive an accounting of certain disclosures of your information made by us during the six years prior to your request. This accounting will not include disclosures of information made: (i) prior to April 14, 2003; (ii) for treatment, payment, and health care operations purposes; (iii) to you or pursuant to your authorization; and (iv) to correctional institutions or law enforcement officials; and (v) other disclosures for which federal law does not require us to provide an accounting.
You have the right to and will be notified of breaches of your unsecured protected health information.
You have the right to give your authorization before the use or disclosure of protected health information for psychotherapy notes or records other than for payment, treatment or health care operations.
You have the right to give your authorization before the use of your protected health information for marketing, disclosures that constitute a sale of protected health information or other uses and disclosures not described in this notice.
You have the right to restrict disclosures of protected health information to a health plan for health care services you have personally paid for out of pocket and in full unless the disclosure is required by law.
You have the right to a paper copy of this notice. You may ask for a copy of this notice at any time. Even if you have agreed to receive this notice electronically, you are still entitled to a paper copy of this notice. You also may also obtain a copy of this notice on our website bestcgmsupplies.com.

How We Use or Disclose Information

We must use and disclose your health information to provide that information:

To you or someone who has the legal right to act for you (your personal representative) in order to administer your rights as described in this notice; and
To the Secretary of the Department of Health and Human Services, if necessary, to make sure your privacy is protected.

We have the right to use and disclose health information for your treatment, to pay for your health care and to operate our business. For example, we may use or disclose your health information:

For Payment of fees due us, to determine your coverage, and to process claims for health care insurance you may have.
For Treatment. We may use or disclose health information to aid in your treatment or the coordination of your care.
For Health Care Operations. We may use or disclose health information as necessary to operate and manage our business activities related to providing and managing your health care coverage.
To Provide You Information on Health Related Programs or Products such as alternative medical treatments and programs or about health-related products and services, subject to limits imposed by law.
For Reminders. We may use or disclose health information to send you reminders about your benefits or care.

We may use or disclose your health information for the following purposes under limited circumstances:

As Required by Law. We may disclose information when required to do so by law.
To Persons Involved With Your Care. We may use or disclose your health information to a person involved in your care or who helps pay for your care, such as a family member, when you are incapacitated or in an emergency, or when you agree or fail to object when given the opportunity. If you are unavailable or unable to object, we will use our best judgment to decide if the disclosure is in your best interests.
For Public Health Activities such as reporting or preventing disease outbreaks.
For Reporting Victims of Abuse, Neglect or Domestic Violence to government authorities that are authorized by law to receive such information, including a social service or protective service agency.
For Health Oversight Activities to a health oversight agency for activities authorized by law, such as licensure, governmental audits and fraud and abuse investigations.
For Judicial or Administrative Proceedings such as in response to a court order, search warrant or subpoena.
For Law Enforcement Purposes. We may disclose your health information to a law enforcement official for purposes such as providing limited information to locate a missing person or report a crime.
To Avoid a Serious Threat to Health or Safety to you, another person, or the public, by, for example, disclosing information to public health agencies or law enforcement authorities, or in the event of an emergency or natural disaster.
For Specialized Government Functions such as military and veteran activities, national security and intelligence activities, and the protective services for the President and others.
For Workers’ Compensation as authorized by, or to the extent necessary to comply with, state workers compensation laws that govern job-related injuries or illness.
For Research Purposes such as research related to the evaluation of certain treatments or the prevention of disease or disability, if the research study meets privacy law requirements.
To Provide Information Regarding Decedents. We may disclose information to a coroner or medical examiner to identify a deceased person, determine a cause of death, or as authorized by law. We may also disclose information to funeral directors as necessary to carry out their duties.
To Correctional Institutions or Law Enforcement Officials if you are an inmate of a correctional institution or under the custody of a law enforcement official, but only if necessary (1) for the institution to provide you with health care; (2) to protect your health and safety or the health and safety of others; or (3) for the safety and security of the correctional institution.
To Business Associates that perform functions on our behalf or provide us with services if the information is necessary for such functions or services. Our business associates are required, under contract with us, to protect the privacy of your information and are not allowed to use or disclose any information other than as specified in our contract.
For Data Breach Notification Purposes. We may use your contact information to provide legally-required notices of unauthorized acquisition, access, or disclosure of your health information.
Additional Restrictions on Use and Disclosure. Certain federal and state laws may require special privacy protections that restrict the use and disclosure of certain health information, including highly confidential information about you. “Highly confidential information” may include confidential information under Federal laws governing alcohol and drug abuse information and genetic information as well as state laws that often protect the following types of information:
HIV/AIDS
Mental health
Genetic tests
Alcohol and drug abuse
Sexually transmitted diseases and reproductive health information
Child or adult abuse or neglect, including sexual assault

If a use or disclosure of health information described above in this notice is prohibited or materially limited by other laws that apply to us, it is our intent to meet the requirements of the more stringent law.

Except for uses and disclosures described and limited as set forth in this notice, we will use and disclose your health information only with a written authorization from you. Once you give us authorization to release your health information, we cannot guarantee that the person to whom the information is provided will not disclose the information. You may take back or “revoke” your written authorization at anytime in writing, except if we have already acted based on your authorization. To find out where to mail your written authorization and how to revoke an authorization, contact the phone number listed below.

Exercising Your Rights

Contacting us. If you have any questions about this notice or want to exercise any of your rights, please call the phone number below.
Submitting a Written Request. Mail to us your written requests for modifying or cancelling a confidential communication, for copies of your records, or for amendments to your record, at the following address:

CCS Medical, Inc.
Attn: Privacy Officer
1505 LBJ Freeway, Suite 550
Farmers Branch, TX 75234
Toll-Free: 1.866.885.9087
Hours: 9am-5pm CST

To Report a Problem or File a Complaint Concerning Your Rights, Please Contact:

CCS Medical at the information listed above;
The Secretary of the U.S. Department of Health and Human Services;
Community Health Accreditation Program (CHAP) at 1.800.656.9656, available between 8am-6pm EST;
The Joint Commission at 1.800.994.6610;
The Compliance Team at 1.888.291.5353; or
For Florida Residents only; Florida’s Agency for Healthcare Administration (AHCA) at 1.888.419.3456.

We will not take any action against you for filing a complaint concerning your rights.

Please check this website or visit https://www.hhs.gov/ for the most up-to-date Notice of Privacy Practices.

Revised June 2019

MEDICARE DMEPOS SUPPLIER STANDARDS

Note: This is an abbreviated version of the supplier standards every Medicare DMEPOS supplier must meet in order to obtain and retain their billing privileges. These standards, in their entirety, are listed in 42 C.F.R. 424.57(c).

1. A supplier must be in compliance with all applicable Federal and State licensure and regulatory requirements.

2. A supplier must provide complete and accurate information on the DMEPOS supplier application. Any changes to this information must be reported to the National Supplier Clearinghouse within 30 days.

3. A supplier must have an authorized individual (whose signature is binding) sign the enrollment application for billing privileges.

4. A supplier must fill orders from its own inventory, or contract with other companies for the purchase of items necessary to fill orders. A supplier may not contract with any entity that is currently excluded from the Medicare program, any State health care programs, or any other Federal procurement or non-procurement programs.

5. A supplier must advise beneficiaries that they may rent or purchase inexpensive or routinely purchased durable medical equipment, and of the purchase option for capped rental equipment.

6. A supplier must notify beneficiaries of warranty coverage and honor all warranties under applicable State law, and repair or replace free of charge Medicare covered items that are under warranty.

7. A supplier must maintain a physical facility on an appropriate site and must maintain a visible sign with posted hours of operation. The location must be accessible to the public and staffed during posted hours of business. The location must be at least 200 square feet and contain space for storing records.

8. A supplier must permit CMS or its agents to conduct on-site inspections to ascertain the supplier’s compliance with these standards.

9. A supplier must maintain a primary business telephone listed under the name of the business in a local directory or a toll free number available through directory assistance. The exclusive use of a beeper, answering machine, answering service or cell phone during posted business hours is prohibited.

10. A supplier must have comprehensive liability insurance in the amount of at least $300,000 that covers both the supplier’s place of business and all customers and employees of the supplier. If the supplier manufactures its own items, this insurance must also cover product liability and completed operations.

11. A supplier is prohibited from direct solicitation to Medicare beneficiaries. For complete details on this prohibition see 42 CFR § 424.57 (c) (11).

12. A supplier is responsible for delivery of and must instruct beneficiaries on the use of Medicare covered items, and maintain proof of delivery and beneficiary instruction.

13. A supplier must answer questions and respond to complaints of beneficiaries, and maintain documentation of such contacts.

14. A supplier must maintain and replace at no charge or repair cost either directly, or through a service contract with another company, any Medicare-covered items it has rented to beneficiaries.

15. A supplier must accept returns of substandard (less than full quality for the particular item) or unsuitable items (inappropriate for the beneficiary at the time it was fitted and rented or sold) from beneficiaries.

16. A supplier must disclose these standards to each beneficiary it supplies a Medicare-covered item.

17. A supplier must disclose any person having ownership, financial, or control interest in the supplier.

18. A supplier must not convey or reassign a supplier number; i.e., the supplier may not sell or allow another entity to use its Medicare billing number.

19. A supplier must have a complaint resolution protocol established to address beneficiary complaints that relate to these standards. A record of these complaints must be maintained at the physical facility.

20. Complaint records must include: the name, address, telephone number and health insurance claim number of the beneficiary, a summary of the complaint, and any actions taken to resolve it.

21. A supplier must agree to furnish CMS any information required by the Medicare statute and regulations.

22. All suppliers must be accredited by a CMS-approved accreditation organization in order to receive and retain a supplier billing number. The accreditation must indicate the specific products and services, for which the supplier is accredited in order for the supplier to receive payment for those specific products and services (except for certain exempt pharmaceuticals).

23. All suppliers must notify their accreditation organization when a new DMEPOS location is opened.

24. All supplier locations, whether owned or subcontracted, must meet the DMEPOS quality standards and be separately accredited in order to bill Medicare.

25. All suppliers must disclose upon enrollment all products and services, including the addition of new product lines for which they are seeking accreditation.

26. A supplier must meet the surety bond requirements specified in 42 CFR § 424.57 (d).

27. A supplier must obtain oxygen from a state-licensed oxygen supplier.

28. A supplier must maintain ordering and referring documentation consistent with provisions found in 42 CFR § 424.516(f).

29. A supplier is prohibited from sharing a practice location with other Medicare providers and suppliers.

30. A supplier must remain open to the public for a minimum of 30 hours per week except physicians (as defined in section 1848(j) (3) of the Act) or physical and occupational therapists or a DMEPOS supplier working with custom made orthotics and prosthetics.

MEDICARE DMEPOS SUPPLIER STANDARDS

DMEPOS suppliers have the option to disclose the following statement to satisfy the requirement outlined in Supplier Standard 16 in lieu of providing a copy of the standards to the beneficiary.

The products and/or services provided to you by CCS Medical are subject to the supplier standards contained in the Federal regulations shown at 42 Code of Federal Regulations Section 424.57(c). These standards concern business professional and operational matters (e.g. honoring warranties and hours of operation). The full text of these standards can be obtained at ecfr.gov. Upon request we will furnish you a written copy of the standards.

PLEASE READ THESE TERMS OF USE CAREFULLY. These Terms of Use describe rules for visitors to this CCS Medical, Inc. (“CCS Medical”) website. This website (“Site”) is owned and operated by CCS Medical. Your access to bestcgmsupplies.com is subject to the following Terms and Conditions, which may be updated by us from time to time without notice to you. We may change these Terms of Use at any time. Please review the Terms of Use each time you visit the Site. By using this Site, it means you accept the most recent version of the Terms of Use. If you disagree with these Terms and Conditions (as they may be amended from time to time), or are dissatisfied with this Site, your sole and exclusive remedy is to discontinue using this Site.

DISCLAIMER. THE INFORMATION ON THIS SITE IS PROVIDED “AS IS” WITHOUT ANY WARRANTIES, EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO THE IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR NON-INFRINGEMENT. CCS MEDICAL MAKES NO REPRESENTATION OR WARRANTY THAT THE INFORMATION CONTAINED ON THIS SITE WILL BE UNINTERRUPTED, TIMELY OR ERROR-FREE. YOU ARE RESPONSIBLE FOR TAKING ALL PRECAUTIONS NECESSARY TO ENSURE THAT ANY CONTENT YOU MAY OBTAIN FROM THIS SITE IS FREE OF VIRUSES AND ANY OTHER POTENTIALLY DESTRUCTIVE COMPUTER CODE.

Some jurisdictions do not permit the exclusion or limitation of implied warranties. Therefore, only if required by applicable law, some or all of the exclusions above may not apply to you. You may have other rights from jurisdiction to jurisdiction.

EXCLUSION OF DAMAGES. IN NO EVENT SHALL CCS MEDICAL BE LIABLE FOR ANY DAMAGES OF ANY KIND OR NATURE, INCLUDING, WITHOUT LIMITATION, DIRECT, INDIRECT, SPECIAL (INCLUDING LOSS OF PROFIT), EXEMPLARY, PUNITIVE, CONSEQUENTIAL (INCLUDING PERSONAL INJURY/WRONGFUL DEATH) OR INCIDENTAL DAMAGES ARISING FROM OR IN CONNECTION WITH THE EXISTENCE OR USE OF THIS INTERNET SITE AND/OR THE INFORMATION OR CONTENT POSTED ON THIS WEB SITE, REGARDLESS OF WHETHER CCS MEDICAL HAS BEEN ADVISED AS TO THE POSSIBILITY OF SUCH DAMAGES.

Some jurisdictions do not permit the exclusion of certain types of damages. Therefore, only if required by applicable law, some or all of the exclusions above may not apply to you. You may have other rights from jurisdiction to jurisdiction.

YOUR USE. You understand, acknowledge and agree to the following:

By using this Site, you agree not to disrupt or intercept our electronic information posted on this Site or any of our servers. You also agree not to attempt to circumvent any security features of our Site, and to abide by all applicable local, state, federal and international laws, rules and regulations.

You grant CCS Medical the right to use all content you upload or otherwise transmit to this Site, subject to these Terms and Conditions and CCS Medical’s Privacy Policy in any manner CCS Medical chooses, including, but not limited to, copying, displaying, performing or publishing it in any format whatsoever, modifying it, incorporating it into other material or making a derivative work based on it.
Except as expressly stated and agreed upon in advance by CCS Medical, no confidential relationship shall be established in the event that any user of this Site should make any oral, written or electronic communication to CCS Medical. If any CCS Medical site requires or requests that such information be provided, and that such information contains personal identifying information (e.g. name, address, phone number, etc.), CCS Medical shall use and maintain it in a manner consistent with our Privacy Policy.

AMERICANS WITH DISABILITIES ACT WEBSITE ACCESSIBILITY STATEMENT.

INTELLECTUAL PROPERTY. The materials on this website (“Information”) are the sole property of CCS Medical, except for information provided by third-party providers under contract to CCS Medical. Permission to use the Information is granted, provided that (1) the above copyright notice appears on all copies; (2) use of the Information is for informational and non-commercial or personal use only; (3) the Information is not modified in any way; and (4) no graphics available from this Site are used separate from accompanying text. CCS Medical is not responsible for content provided by third-party providers, and you are prohibited from distribution of such material without permission of the owner of the copyright therein. Except as permitted above, no license or right, express or implied, is granted to any person under any patent, trademark or other proprietary right of CCS Medical.

LINKS TO OTHER WEBSITES. This Site may contain links to websites not operated by CCS Medical. We provide these links for your convenience, but we do not review, control, or monitor the materials on any other websites. These websites may contain information about uses of CCS Medical products or therapies that have not been approved in the United States. We do not control or endorse this type of information. Your use of other websites is subject to the terms of use of those websites, including the privacy policies of those websites.

MEDICAL DISCLAIMERS. CCS MEDICAL DOES NOT GIVE MEDICAL ADVICE, NOR DO WE PROVIDE MEDICAL OR DIAGNOSTIC SERVICES. The materials on this Site are for your general educational information only. Information you read on this Site cannot replace the relationship that you have with your health care professional. CCS Medical does not practice medicine or provide medical services or advice and the information on this website should not be considered medical advice. You should always talk to your health care professional for diagnosis and treatment. Your reliance upon content obtained by you at or through this Site is solely at your own risk.

Health information changes quickly. Therefore, it is always best to confirm information with your health care professional if you have questions regarding a medical condition. IN A MEDICAL EMERGENCY, CALL YOUR PHYSICIAN OR 911 IMMEDIATELY.

This Site contains information about products and therapies authorized in the United States, and is intended for a United States audience. If you live outside the U.S., you may see information on this website about products or therapies that are not available or authorized in your country.

PRIVACY AND SECURITY. CCS Medical is committed to safeguarding your privacy online. CCS Medical understands the importance of privacy to our customers and visitors to our Site. CCS Medical’s use of personally identifiable information is governed by our Privacy Policy and by accessing and using our Site, you agree to be bound by that policy in its entirety.

ELECTRONIC COMMUNICATIONS AND CONFIDENTIALITY. When you visit this Site or send us electronic communications, including but not limited to, emails and text messages, you are communicating with us electronically. You, therefore, consent to receive these electronic communications from us. We may communicate with you via email, text message, or by posting notices on this Site. You agree that any communications we provide to you electronically through this Site (e.g. agreements, notices, disclosures) satisfy any legal requirement that such communications be in writing. Please be advised that the confidentiality of any communication or material transmitted using the Internet or unsecured/unencrypted electronic communication cannot be guaranteed. We implement various safeguards to help ensure the confidentiality and security of communications transmitted through this Site. However, CCS Medical cannot guarantee the confidentiality and security of such electronic communications.

YOUR ACCOUNT AND CONDUCT. You may need to set up an account to use the services on this Site. You agree to keep your username and password confidential. You further agree that you are responsible for any activity occurring through your account on this Site. You agree to use this Site in accordance with all applicable laws and regulations. We may suspend, modify, or terminate your use of this Site, without prior notice, for any conduct that violates applicable law, or is otherwise harmful, to our interests or the interests of a third party.

INDEMNIFICATION. You agree to defend, indemnify, and hold harmless CCS Medical, its affiliates, parents, and subsidiaries and all of their respective directors, officers, employees, representatives, partners, shareholders, principals, agents, predecessors, successors, assigns, and attorneys from and against any and all claims, proceedings, damages, injuries, liabilities, losses, costs, and expenses (including attorneys’ fees and expenses) relating to, or arising from, your use of this Site and any breach by you of these Terms and Conditions.

LIMITATION OF LIABILITY. YOU AGREE THAT NEITHER CCS MEDICAL NOR ANY PERSON OR COMPANY ASSOCIATED WITH CCS MEDICAL SHALL BE LIABLE FOR ANY DAMAGE RESULTING FROM YOUR USE OR INABILITY TO USE THIS WEBSITE OR THE MATERIALS ON THIS WEBSITE. THIS PROTECTION COVERS CLAIMS BASED ON WARRANTY, CONTRACT, TORT, STRICT LIABILITY, AND ANY OTHER LEGAL THEORY. THIS PROTECTION COVERS CCS MEDICAL, ITS OFFICERS, DIRECTORS, EMPLOYEES, AGENTS, AND SUPPLIERS MENTIONED ON THIS WEBSITE. THIS PROTECTION COVERS ALL LOSSES INCLUDING, WITHOUT LIMITATION, DIRECT OR INDIRECT, SPECIAL, INCIDENTAL, CONSEQUENTIAL, EXEMPLARY, AND PUNITIVE DAMAGES, PERSONAL INJURY/WRONGFUL DEATH, LOST PROFITS, OR DAMAGES RESULTING FROM LOST DATA OR BUSINESS INTERRUPTION.

THE TOTAL LIABILITY OF CCS MEDICAL, ITS OFFICERS, DIRECTORS, EMPLOYEES, AGENTS, SUPPLIERS, IF ANY, FOR LOSSES OR DAMAGES SHALL BE LIMITED TO THE AMOUNT OF YOUR ACTUAL DAMAGES, NOT TO EXCEED U.S. $100.00. THE LIMIT OF LIABILITY MAY NOT BE EFFECTIVE IN SOME STATES. IN NO EVENT SHALL CCS MEDICAL, ITS OFFICERS, DIRECTORS, EMPLOYEES, AGENTS, OR SUPPLIERS BE LIABLE TO YOU FOR ANY LOSSES OR DAMAGES OTHER THAN THE AMOUNT DESCRIBED ABOVE. ALL OTHER DAMAGES, DIRECT OR INDIRECT, SPECIAL, INCIDENTAL, CONSEQUENTIAL, EXEMPLARY, OR PUNITIVE, RESULTING FROM ANY USE OF THE WEBSITE OR MATERIALS ARE EXCLUDED EVEN IF CCS MEDICAL HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.

OUTSIDE THE U.S. CCS Medical makes no claims that the Site is appropriate for access or use outside the U.S. Your access and/or use of our Site is at your own risk, and you are responsible for compliance with the laws of your jurisdiction.

OTHER RULES ABOUT THIS WEBSITE. If any provision of these Terms of Use is found to be invalid by any court having competent jurisdiction, the invalidity of such provision shall not affect the validity of the remaining provisions of these Terms of Use, which shall remain in full force and effect. No waiver of any of these Terms of Use shall be deemed a further or continuing waiver of such term or condition or any other term or condition.

You agree that these Terms and Conditions describe the entire relationship between CCS Medical with respect to its subject matter. bestcgmsupplies.com was created and is operated under the laws of the State of Florida. The laws of the State of Florida will control the terms and conditions provided in these Terms and Conditions, without giving effect to any principles of conflict of laws. If a court of competent jurisdiction finds that any provision of these Terms and Conditions is invalid or unenforceable, you agree that the other provisions of these Terms and Conditions will remain in full force and effect. You agree that regardless of any applicable law to the contrary, you cannot file a claim or cause of action arising out of or related to bestcgmsupplies.com or these Terms and Conditions more than one (1) year after such claim or cause of action arose.

By accepting the Terms & Conditions, you agree that you wish to be contacted regarding potential services or other useful information related to the content of this website. CCS Medical may call, email, or text you by using the contact information you’ve provided, which may include prerecorded communications, SMS messages, and automatic dialing systems. Your telephone carrier’s standard message rates may apply to these communications. You can tell us you no longer wish to receive these communications at any time.

FreeStyle Libre Indications and Important Safety Information

The FreeStyle Libre Flash Glucose Monitoring System is a continuous glucose monitoring (CGM) device indicated for the management of diabetes in persons age 18 and older. It is designed to replace blood glucose testing for diabetes treatment decisions.

The System detects trends and tracks patterns aiding in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. Interpretation of the System readings should be based on the glucose trends and several sequential readings over time. The System is intended for single patient use and requires a prescription.

CONTRAINDICATIONS:

The FreeStyle Libre Flash Glucose Monitoring System must be removed prior to Magnetic Resonance Imaging (MRI), Computed Tomography (CT) scan, or high-frequency electrical heat (diathermy) treatment. The effect of MRI, CT scans, or diathermy on the performance of the System has not been evaluated. The exposure may damage the Sensor and may impact proper function of the device which could cause incorrect readings.

WARNINGS:

Do not ignore symptoms that may be due to low or high blood glucose: If you are experiencing symptoms that are not consistent with your glucose readings, consult your health care professional.
Checking Sensor glucose readings with a blood glucose meter: Under the following conditions, Sensor glucose readings may not be accurate and you should conduct a fingerstick test using a blood glucose meter. You should not use Sensor glucose readings to make a diabetes treatment decision:
- If you suspect that your reading may be inaccurate for any reason
- When you are experiencing symptoms that may be due to low or high blood glucose
- When you are experiencing symptoms that do not match FreeStyle Libre System readings
- During times of rapidly changing glucose (more than 2 mg/dL per minute), when interstitial fluid glucose levels as measured by the Sensor may not accurately reflect blood glucose levels
- When the Sensor glucose reading does not include a Current Glucose number or Glucose Trend Arrow
- In order to confirm hypoglycemia or impending hypoglycemia as reported by the Sensor
When you see the Check Blood Glucose symbol, you must check your blood glucose with a blood glucose meter before making any treatment decisions. Sensor readings may not accurately reflect blood glucose levels.
Hypoglycemic unawareness: The FreeStyle Libre System has not been evaluated for use in patients with hypoglycemic unawareness and will not automatically alert you of a hypoglycemic event without you scanning your Sensor.
No alarms without a Sensor scan: The FreeStyle Libre System does not have alarms that will automatically notify you when you are having a severe low (hypoglycemic) or high (hyperglycemic) glucose event unless you scan your Sensor. For example, the System does not have an alarm that can alert or wake you when you are sleeping in the case of low or high glucose.
Choking hazard: The FreeStyle Libre System contains small parts that may be dangerous if swallowed.

CAUTIONS AND LIMITATIONS:

What to know about Alarms/Alerts:

There are NO alarms or alerts unless you scan the Sensor.

What to know before using the System:

Review all product information before use.
Take standard precautions for transmission of blood borne pathogens to avoid contamination.

Who should not use the System:

Do not use the System in people less than 18 years of age. The System is not approved for use in people under 18 years of age and Sensor readings in this population may be inaccurate. In general, continuous glucose monitoring systems are recognized to be less accurate in children than in adults.
Do not use the System in critically ill patients. The System is not approved for use in these patients. It is not known how different conditions or medications common to the critically ill population may affect performance of the System. Sensor glucose readings may be inaccurate in critically ill patients.
Do not use the System in pregnant women or persons on dialysis. The System is not approved for use in pregnant women or persons on dialysis and has not been evaluated in these populations.
Performance of the System when used with other implanted medical devices, such as pacemakers, has not been evaluated.

What should you know about wearing a Sensor:

After the 12 hour start-up period, the Sensor can be worn for up to 10 days.
Some individuals may be sensitive to the adhesive that keeps the Sensor attached to the skin. If you notice significant skin irritation around or under your Sensor, remove the Sensor and stop using the FreeStyle Libre System. Contact your health care professional before continuing to use the FreeStyle Libre System.
Intense exercise may cause your Sensor to loosen due to sweat or movement of the Sensor. Remove and replace your Sensor if it starts to loosen and follow the instructions to select an appropriate application site.
Do not reuse Sensors. The Sensor and Sensor Applicator are designed for single use. Reuse may result in no glucose readings and infection. Not suitable for re-sterilization. Further exposure to irradiation may cause inaccurate results.
If a Sensor breaks inside your body, call your health care professional.

How to Store the Sensor Kit:

Store the Sensor Kit between 39°F and 77°F. Storage outside of this range may cause inaccurate Sensor glucose readings. While you don’t need to keep your Sensor Kit in a refrigerator, you can as long as the refrigerator is between 39°F and 77°F. Do not freeze.
Store the Sensor Kit between 10-90% non-condensing humidity.

When not to use the System:

Do NOT use if the Sensor Kit package, Sensor Pack, or Sensor Applicator appear to be damaged or already opened due to risk of no results and/or infection.
Do NOT use if Sensor Kit contents are past expiration date.
Do NOT use if the Reader appears to be damaged due to risk of electric shock and/or no results.

What to know before you Apply the Sensor:

The Sensor Pack and Sensor Applicator are packaged as a set (separately from the Reader) and have the same Sensor code. Check that the Sensor codes match before using your Sensor Pack and Sensor Applicator. Do not use Sensor Packs and Sensor Applicators with different Sensor codes together as this will result in incorrect glucose readings.
Clean the application site and ensure that it is dry prior to Sensor insertion. This helps the Sensor stay attached to your body.
Clean hands prior to Sensor handling/insertion to help prevent infection.
Change the application site for the next Sensor application to prevent discomfort or skin irritation.
Sensor placement is not approved for sites other than the back of the arm. If placed in other areas, the Sensor may not function properly.
Select an appropriate Sensor site to help the Sensor stay attached to the body and prevent discomfort or skin irritation. Avoid areas with scars, moles, stretch marks, or lumps. Select an area of skin that generally stays flat during normal daily activities (no bending or folding). Choose a site that is at least 1 inch away from an insulin injection site.

When is Sensor Glucose different from Blood Glucose:

Physiological differences between the interstitial fluid and capillary blood may result in differences in glucose readings between the System and results from a fingerstick test using a blood glucose meter. Differences in glucose readings between interstitial fluid and capillary blood may be observed during times of rapid change in blood glucose, such as after eating, dosing insulin, or exercising.

What to know about interfering substances such as Vitamin C and Aspirin:

Taking ascorbic acid (vitamin C) while wearing the Sensor may falsely raise Sensor glucose readings. Taking salicylic acid (used in some pain relievers such as aspirin and some skin care products) may slightly lower Sensor glucose readings. The level of inaccuracy depends on the amount of the interfering substance active in the body.
Test results did not indicate interference for methyldopa (used in some drugs to treat high blood pressure) or tolbutamide (infrequently used in some drugs to treat diabetes in the US) at maximum circulating levels. However, concentrations of potential interferents in interstitial fluid are unknown compared to circulating blood.

What to know about X-Rays:

The Sensor should be removed prior to exposing it to an X-ray machine. The effect of X-rays on the performance of the System has not been evaluated. The exposure may damage the Sensor and may impact proper function of the device to detect trends and track patterns in glucose values during the wear period.

When to remove the Sensor:

If the Sensor is becoming loose or if the Sensor tip is coming out of your skin, you may get no readings or unreliable readings, which may not match how you feel. Check to make sure your Sensor has not come loose. If it has come loose, remove it and apply a new one.
If you believe your glucose readings are not correct or are inconsistent with how you feel, perform a blood glucose test on your finger to confirm your glucose. If the problem continues, remove the current Sensor and apply a new one.

What to do if you are dehydrated:

Severe dehydration and excessive water loss may cause inaccurate Sensor glucose readings. If you believe you are suffering from dehydration, consult your health care professional immediately.

What to know about the Reader’s Built-in Meter:

The FreeStyle Libre Flash Glucose Monitoring System has a built-in blood glucose meter that is designed to be used only with FreeStyle Precision Neo blood glucose test strips and MediSense Glucose and Ketone Control Solution. Using other test strips with the Reader’s built-in meter will produce an error or cause the Reader’s built-in meter to not turn on or start a test. The Reader's built-in meter does not have ketone testing functionality.
The Reader’s built-in meter is not for use on people who are dehydrated, hypotensive, in shock, or for individuals in hyperglycemic-hyperosmolar state, with or without ketosis.
The Reader’s built-in meter is not for use on neonates, in critically-ill patients, or for diagnosis or screening of diabetes.
See Using the Reader’s Built-in meter section of the User’s Manual for additional important information on the use of the Reader’s built-in meter.

Where to charge your Reader:

Be sure to select a location for charging that allows the power adapter to be easily unplugged. Do NOT block access to the charger due to the potential risk of electrical shock.

FreeStyle Libre 14 day Indications and Important Safety Information

The FreeStyle Libre 14 day Flash Glucose Monitoring System is a continuous glucose monitoring (CGM) device indicated for the management of diabetes in persons age 18 and older. It is designed to replace blood glucose testing for diabetes treatment decisions. The System detects trends and tracks patterns aiding in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. Interpretation of the System readings should be based on the glucose trends and several sequential readings over time. The System is intended for single patient use and requires a prescription.

CONTRAINDICATIONS:

The FreeStyle Libre 14 day Flash Glucose Monitoring System must be removed prior to Magnetic Resonance Imaging (MRI), Computed Tomography (CT) scan, or high frequency electrical heat (diathermy) treatment. The effect of MRI, CT scans, or diathermy on the performance of the System has not been evaluated. The exposure may damage the Sensor and may impact proper function of the device which could cause incorrect readings.

WARNINGS:

Do not ignore symptoms that may be due to low or high blood glucose: If you are experiencing symptoms that are not consistent with your glucose readings, consult your health care professional.
Check Sensor glucose readings by conducting a fingerstick test with a blood glucose meter under the following conditions, when Sensor glucose readings may not be accurate and should not be used to make a diabetes treatment decision:
- If you suspect that your reading may be inaccurate for any reason
- When you are experiencing symptoms that may be due to low or high blood glucose
- When you are experiencing symptoms that do not match the Sensor glucose readings
- During the first 12 hours of wearing a FreeStyle Libre 14 day Sensor
- During times of rapidly changing glucose (more than 2 mg/dL per minute)
- When the Sensor glucose reading does not include a Current Glucose number or Glucose Trend Arrow
- In order to confirm hypoglycemia or impending hypoglycemia as reported by the Sensor
When you see the Check Blood Glucose symbol, you must check your blood glucose with a blood glucose meter before making any treatment decisions. Sensor readings may not accurately reflect blood glucose levels.
Hypoglycemic unawareness: The System has not been evaluated for use in patients with hypoglycemic unawareness and will not automatically alert you of a hypoglycemic event without you scanning your Sensor.
No alarms without a Sensor scan: The System does not have alarms that will automatically notify you when you are having a severe low (hypoglycemic) or high (hyperglycemic) glucose event unless you scan your Sensor. For example, the System does not have an alarm that can alert or wake you when you are sleeping in the case of low or high glucose.
Choking hazard: The FreeStyle Libre System contains small parts that may be dangerous if swallowed.

CAUTIONS AND LIMITATIONS:

Below are important cautions and limitations to keep in mind so you can use the System safely. They are grouped into categories for easy reference.

What to know about Alarms/Alerts:

There are NO alarms or alerts unless you scan the Sensor.

What to know before using the System:

Review all product information before use.
Take standard precautions for transmission of blood borne pathogens to avoid contamination.

Who should not use the System:

Do not use the System in people less than 18 years of age. The System is not approved for use in people under 18 years of age and Sensor readings in this population may be inaccurate. In general, continuous glucose monitoring systems are recognized to be less accurate in children than in adults.
Do not use the System in critically ill patients. The System is not approved for use in these patients. It is not known how different conditions or medications common to the critically ill population may affect performance of the System. Sensor glucose readings may be inaccurate in critically ill patients.
Do not use the System in pregnant women or persons on dialysis. The System is not approved for use in pregnant women or persons on dialysis and has not been evaluated in these populations.
Performance of the System when used with other implanted medical devices, such as pacemakers, has not been evaluated.

What should you know about wearing a Sensor:

The Sensor can be worn for up to 14 days.
Some individuals may be sensitive to the adhesive that keeps the Sensor attached to the skin. If you notice significant skin irritation around or under your Sensor, remove the Sensor and stop using the System. Contact your health care professional before continuing to use the System.
Intense exercise may cause your Sensor to loosen due to sweat or movement of the Sensor. Remove and replace your Sensor if it starts to loosen and follow the instructions to select an appropriate application site.
The System uses all available glucose data to give you readings so you should scan your Sensor at least once every 8 hours for the most accurate performance. Scanning less frequently may result in decreased performance.
Do not reuse Sensors. The Sensor and Sensor Applicator are designed for single use. Reuse may result in no glucose readings and infection. Not suitable for re-sterilization. Further exposure to irradiation may cause inaccurate results.
If a Sensor breaks inside your body, call your health care professional.

How to Store the Sensor Kit:

Store the Sensor Kit between 39°F and 77°F. Storage outside of this range may cause inaccurate Sensor glucose readings. While you don’t need to keep your Sensor Kit in a refrigerator, you can as long as the refrigerator is between 39°F and 77°F. Do not freeze.
Store the Sensor Kit between 10-90% non-condensing humidity.

When not to use the System:

Do NOT use if the Sensor Kit package, Sensor Pack, or Sensor Applicator appear to be damaged or already opened due to risk of no results and/or infection.
Do NOT use if Sensor Kit contents are past expiration date.
Do NOT use if the Reader appears to be damaged due to risk of electric shock and/or no results.

What to know before you Apply the Sensor:

The Sensor Pack and Sensor Applicator are packaged as a set (separately from the Reader) and have the same Sensor code. Check that the Sensor codes match before using your Sensor Pack and Sensor Applicator. Do not use Sensor Packs and Sensor Applicators with different Sensor codes together as this will result in incorrect glucose readings.
Clean the application site and ensure that it is dry prior to Sensor insertion. This helps the Sensor stay attached to your body.
Clean hands prior to Sensor handling/insertion to help prevent infection.
Change the application site for the next Sensor application to prevent discomfort or skin irritation.
Sensor placement is not approved for sites other than the back of the arm. If placed in other areas, the Sensor may not function properly.
Select an appropriate Sensor site to help the Sensor stay attached to the body and prevent discomfort or skin irritation. Avoid areas with scars, moles, stretch marks, or lumps. Select an area of skin that generally stays flat during normal daily activities (no bending or folding). Choose a site that is at least 1 inch away from an insulin injection site.

When is Sensor Glucose different from Blood Glucose:

Physiological differences between the interstitial fluid and capillary blood may result in differences in glucose readings between the System and results from a fingerstick test using a blood glucose meter. Differences in glucose readings between interstitial fluid and capillary blood may be observed during times of rapid change in blood glucose, such as after eating, dosing insulin, or exercising.

What to know about interfering substances such as Vitamin C and Aspirin:

Taking ascorbic acid (vitamin C) while wearing the Sensor may falsely raise Sensor glucose readings. Taking salicylic acid (used in some pain relievers such as aspirin and some skin care products) may slightly lower Sensor glucose readings. The level of inaccuracy depends on the amount of the interfering substance active in the body.
Test results did not indicate interference for methyldopa (used in some drugs to treat high blood pressure) or tolbutamide (infrequently used in some drugs to treat diabetes in the US) at maximum circulating levels. However, concentrations of potential interferents in interstitial fluid are unknown compared to circulating blood.

What to know about X-Rays:

The Sensor should be removed prior to exposing it to an X-ray machine. The effect of X-rays on the performance of the System has not been evaluated. The exposure may damage the Sensor and may impact proper function of the device to detect trends and track patterns in glucose values during the wear period.

When to remove the Sensor:

If the Sensor is becoming loose or if the Sensor tip is coming out of your skin, you may get no readings or unreliable readings, which may not match how you feel. Check to make sure your Sensor has not come loose. If it has come loose, remove it and apply a new one.
If you believe your glucose readings are not correct or are inconsistent with how you feel, perform a blood glucose test on your finger to confirm your glucose. If the problem continues, remove the current Sensor and apply a new one.

What to do if you are dehydrated:

Severe dehydration and excessive water loss may cause inaccurate Sensor glucose readings. If you believe you are suffering from dehydration, consult your health care professional immediately.

What to know about the Reader’s Built-in Meter:

The FreeStyle Libre 14 day Reader has a built-in blood glucose meter that is designed to be used only with FreeStyle Precision Neo blood glucose test strips and MediSense Glucose and Ketone Control Solution. Using other test strips with the Reader’s built-in meter will produce an error or cause the Reader’s built-in meter to not turn on or start a test. The Reader's built-in meter does not have ketone testing functionality.
The Reader’s built-in meter is not for use on people who are dehydrated, hypotensive, in shock, or for individuals in hyperglycemic-hyperosmolar state, with or without ketosis.
The Reader’s built-in meter is not for use on neonates, in critically-ill patients, or for diagnosis or screening of diabetes.
See Using the Reader’s Built-in meter section for additional important information on the use of the Reader’s built-in meter.

Where to charge your Reader:

Be sure to select a location for charging that allows the power adapter to be easily unplugged. Do NOT block access to the charger due to the potential risk of electrical shock.

FreeStyle Libre 2 Indications and Important Safety Information

Indications and Important Safety Information

The FreeStyle Libre 2 Flash Glucose Monitoring System is a continuous glucose monitoring (CGM) device with real time alarms capability indicated for the management of diabetes in persons age 4 and older. It is intended to replace blood glucose testing for diabetes treatment decisions, unless otherwise indicated.

The System also detects trends and tracks patterns and aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. Interpretation of the System readings should be based on the glucose trends and several sequential readings over time.

The System is also intended to autonomously communicate with digitally connected devices. The System can be used alone or in conjunction with these digitally connected devices where the user manually controls actions for therapy decisions.

CONTRAINDICATIONS

Automated Insulin Dosing: The System must not be used with automated insulin dosing (AID) systems, including closed loop and insulin suspend systems.

MRI/CT/Diathermy: The System must be removed prior to Magnetic Resonance Imaging (MRI), Computed Tomography (CT) scan, or high-frequency electrical heat (diathermy) treatment. The effect of MRI, CT scans, or diathermy on the performance of the System has not been evaluated. The exposure may damage the Sensor and may impact proper function of the device which could cause incorrect readings.

WARNINGS

Before you use the FreeStyle Libre 2 System, review all the product instructions and the Interactive Tutorial. The Quick Reference Guide and Interactive Tutorial give you quick access to important aspects and limitations of the System. The User’s Manual includes all safety information and instructions for use. Talk to your health care professional about how you should use your Sensor glucose information to help manage your diabetes.

Failure to use the System according to the instructions for use may result in you missing a severe low blood glucose or high blood glucose event and/or making a treatment decision that may result in injury. If your glucose alarms and readings from the System do not match symptoms or expectations, use a fingerstick blood glucose value from a blood glucose meter to make diabetes treatment decisions. Seek medical attention when appropriate.

Do not ignore symptoms that may be due to low or high blood glucose: If you are experiencing symptoms that are not consistent with your glucose readings, consult your health care professional.
Use your blood glucose meter to make diabetes treatment decisions when you see the Check Blood Glucose symbol during the first 12 hours of wearing a Sensor, if your Sensor glucose reading does not match how you feel, or if the reading does not include a number.
Choking hazard: The System contains small parts that may be dangerous if swallowed.

CAUTIONS AND LIMITATIONS

Below are important cautions and limitations to keep in mind so you can use the System safely. They are grouped into categories for easy reference.

What to know about Glucose Alarms:

For you to receive alarms, they must be on and your Reader should be within 20 feet of you at all times. The transmission range is 20 feet unobstructed. If you are out of range, you may not receive glucose alarms.
To prevent missed alarms, make sure the Reader has sufficient charge and that sound and/or vibration are turned on.
Alarms you receive do not include your glucose reading so you must scan your Sensor to check your glucose.

What to know before using the System:

Review all product information before use.
Take standard precautions for transmission of blood borne pathogens to avoid contamination.
Make sure that your Reader and Sensor kits are kept in a safe place, under your control. This is important to help prevent anyone from accessing or tampering with the System.

Who should not use the System:

Do not use the System in people less than 4 years of age. The System is not cleared for use in people under 4 years of age.
Do not use the System if you are pregnant, on dialysis, or critically ill. The System is not cleared for use in these groups and it is not known how different conditions or medications common to these populations may affect performance of the System.
Performance of the System when used with other implanted medical devices, such as pacemakers, has not been evaluated.

What should you know about wearing a Sensor:

Wash application site on the back of your upper arm using a plain soap, dry, and then clean with an alcohol wipe. This will help remove any oily residue that may prevent the Sensor from sticking properly. Allow site to air dry before proceeding. Carefully preparing the site according to these instructions will help the Sensor stay on your body for the full 14 day wear period and help prevent it from falling off early.
The Sensor can be worn for up to 14 days. Remember to always have your next Sensor available before your current one ends so you can keep getting your glucose readings.
You must scan the Sensor to get your real-time current glucose level as the Reader will not provide this information without a scan.
In the event that your Sensor stops working and you do not have another Sensor readily available, you must use an alternate method to measure your glucose levels and inform your treatment decisions.
The System is designed to detect certain conditions which may occur where the Sensor is not working as intended and shut it off, telling you to replace your Sensor. This may occur if the Sensor gets knocked off from the skin or if the System detects that the Sensor may not be performing as intended. Contact Customer Service if you receive a Replace Sensor message before the end of the 14 day wear period. Customer Service is available at 1-855-632-8658 7 Days a Week from 8AM to 8PM Eastern Standard Time.
Some individuals may be sensitive to the adhesive that keeps the Sensor attached to the skin. If you notice significant skin irritation around or under your Sensor, remove the Sensor and stop using the System. Contact your health care professional before continuing to use the System.
Intense exercise may cause your Sensor to loosen due to sweat or movement of the Sensor. If the Sensor is becoming loose or if the Sensor tip is coming out of your skin, you may get no readings or unreliable low readings. Remove and replace your Sensor if it starts to loosen and follow the instructions to select an appropriate application site. Do not attempt to reinsert the Sensor. Contact Customer Service if your Sensor becomes loose or falls off before the end of the wear period. Customer Service is available at 1-855-632-8658 7 Days a Week from 8AM to 8PM Eastern Standard Time.
Do not reuse Sensors. The Sensor and Sensor Applicator are designed for single use. Reuse may result in no glucose readings and infection. Not suitable for re-sterilization. Further exposure to irradiation may cause unreliable low results.
If a Sensor breaks inside your body, call your health care professional.

How to Store the Sensor Kit:

Store the Sensor Kit between 36°F and 82°F. Storage outside of this range may cause inaccurate Sensor glucose readings.
If you suspect that the temperature may exceed 82°F (for example, in an un-airconditioned home in summer), you should refrigerate your Sensor Kit. Do not freeze your Sensor Kit.
Store your Sensor Kit in a cool, dry place. Do not store your Sensor Kit in a parked car on a hot day.
Store the Sensor Kit between 10-90% non-condensing humidity.

When not to use the System:

Do NOT use if the Sensor Kit package, Sensor Pack, or Sensor Applicator appear to be damaged or already opened due to risk of no results and/or infection.
Do NOT use if Sensor Kit contents are past expiration date.
Do NOT use if the Reader appears to be damaged due to risk of electric shock and/or no results.

What to know before you Apply the Sensor:

The Sensor Pack and Sensor Applicator are packaged as a set (separately from the Reader) and have the same Sensor code. Check that the Sensor codes match before using your Sensor Pack and Sensor Applicator. Do not use Sensor Packs and Sensor Applicators with different Sensor codes together as this will result in incorrect glucose readings.
Wash application site on the back of your upper arm using a plain soap, dry, and then clean with an alcohol wipe. This will help remove any oily residue that may prevent the Sensor from sticking properly.
Allow site to air dry before proceeding. Carefully preparing the site according to these instructions will help the Sensor stay on your body for the full 14 day wear period and help prevent it from falling off early.
Clean hands prior to Sensor handling/insertion to help prevent infection.
Change the application site for the next Sensor application to prevent discomfort or skin irritation.
Only apply the Sensor to the back of the upper arm. If placed in other areas, the Sensor may not function properly.
Select an appropriate Sensor site to help the Sensor stay attached to the body and prevent discomfort or skin irritation. Avoid areas with scars, moles, stretch marks, or lumps. Select an area of skin that generally stays flat during normal daily activities (no bending or folding). Choose a site that is at least 1 inch away from an insulin injection site.

When is Sensor Glucose different from Blood Glucose:

Physiological differences between the interstitial fluid and capillary blood may result in differences in glucose readings between the System and results from a fingerstick test using a blood glucose meter.
Differences in glucose readings between interstitial fluid and capillary blood may be observed during times of rapid change in blood glucose, such as after eating, dosing insulin, or exercising.

What to know about X-Rays:

The Sensor should be removed prior to exposing it to an X-ray machine. The effect of X-rays on the performance of the System has not been evaluated. The exposure may damage the Sensor and may impact proper function of the device to detect trends and track patterns in glucose values during the wear period.

When to remove the Sensor:

If the Sensor is becoming loose or if the Sensor tip is coming out of your skin, you may get no readings or unreliable readings, which may not match how you feel. Check to make sure your Sensor has not come loose. If it has come loose, remove it, apply a new one, and contact Customer Service.
If you believe your glucose readings are not correct or are inconsistent with how you feel, perform a blood glucose test on your finger to confirm your glucose. If the problem continues, remove the current Sensor, apply a new one, and contact Customer Service. Customer Service is available at 1-855-632-8658 7 Days a Week from 8AM to 8PM Eastern Standard Time.

What to know about the Reader’s Built-in Meter:

The FreeStyle Libre 2 Reader has a built-in blood glucose meter that is designed to be used only with FreeStyle Precision Neo blood glucose test strips and MediSense Glucose and Ketone Control Solution. Using other test strips with the Reader’s built-in meter will produce an error or cause the Reader’s built-in meter to not turn on or start a test. The Reader’s built-in meter does not have ketone testing functionality.
The Reader’s built-in meter is not for use on people who are dehydrated, hypotensive, in shock, or for individuals in hyperglycemic-hyperosmolar state, with or without ketosis.
The Reader’s built-in meter is not for use on neonates, in critically-ill patients, or for diagnosis or screening of diabetes.
See Using the Reader’s Built-in meter section for additional important information on the use of the Reader’s built-in meter.

Where to charge your Reader:

Be sure to select a location for charging that allows the power adapter to be easily unplugged. Do NOT block access to the charger due to the potential risk of electrical shock.

Interfering Substances

Taking ascorbic acid (vitamin C) supplements while wearing the Sensor may falsely raise Sensor glucose readings. Taking more than 500 mg of ascorbic acid per day may affect the Sensor readings which could cause you to miss a severe low glucose event. Ascorbic acid can be found in supplements including multivitamins. Some supplements, including cold remedies such as Airborne® and Emergen-C®, may contain high doses of 1000 mg of ascorbic acid and should not be taken while using the Sensor. See your health care professional to understand how long ascorbic acid is active in your body.

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At this time, you do not qualify for a CGM System. Speak with your doctor to learn more about CGM system eligibility requirements.

FreeStyle Libre Indications and Important Safety Information

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