Does Taking Vancomycin Antibiotic Effect Libre Sensor Readings
Total INDICATIONS AND Of import SAFETY INFORMATION
FREESTYLE LIBRE xiv 24-hour interval
The FreeStyle Libre fourteen solar day Flash Glucose Monitoring System is a continuous glucose monitoring (CGM) device indicated for the direction of diabetes in persons historic period 18 and older. It is designed to replace claret 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 astute 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 exist 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 Arrangement has not been evaluated. The exposure may damage the Sensor and may affect proper function of the device which could crusade incorrect readings.
WARNINGS:
- Do not ignore symptoms that may be due to low or loftier blood glucose: If yous are experiencing symptoms that are not consequent with your glucose readings, consult your healthcare professional person.
- Check Sensor glucose readings by conducting a fingerstick test with a blood glucose meter under the post-obit conditions, when Sensor glucose readings may not be accurate and should not be used to make a diabetes treatment decision:
- If yous doubtable that your reading may be inaccurate for whatever reason
- When you are experiencing symptoms that may be due to low or high claret glucose
- When you are experiencing symptoms that practise not friction match the Sensor glucose readings
- During the outset 12 hours of wearing a FreeStyle Libre xiv mean solar 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 Tendency Arrow
- In lodge to confirm hypoglycemia or impending hypoglycemia as reported by the Sensor
- When you come across the Check Blood Glucose symbol, you must check your claret glucose with a blood glucose meter before making any treatment decisions. Sensor readings may non accurately reflect blood glucose levels.
- Hypoglycemic unawareness: The System has non been evaluated for utilise in patients with hypoglycemic unawareness and will non automatically alert you of a hypoglycemic event without you scanning your Sensor.
- No alarms without a Sensor scan: The System does not take alarms that will automatically notify you when you are having a severe low (hypoglycemic) or high (hyperglycemic) glucose outcome unless you lot scan your Sensor. For case, the System does non take an alarm that can alert or wake you when y'all are sleeping in the example of low or high glucose.
- Choking hazard: The FreeStyle Libre 14 day system contains small parts that may be unsafe if swallowed.
CAUTIONS AND LIMITATIONS:
Below are important cautions and limitations to continue in mind so you can use the Organization safely. They are grouped into categories for easy reference.
What to know about Alarms/Alerts:
- There are NO alarms or alerts unless you browse the Sensor.
What to know before using the System:
- Review all production information before utilise.
- Take standard precautions for transmission of blood borne pathogens to avoid contamination.
Who should not use the System:
- Do non utilise the Organization in people less than xviii years of age. The Arrangement is not approved for apply in people nether 18 years of age and Sensor readings in this population may be inaccurate. In general, continuous glucose monitoring systems are recognized to be less authentic in children than in adults.
- Exercise not use the System in critically sick patients. The Organization is non approved for employ in these patients. It is not known how different atmospheric condition or medications mutual to the critically ill population may affect performance of the System. Sensor glucose readings may be inaccurate in critically ill patients.
- Practise non utilize the System in pregnant women or persons on dialysis. The System is not approved for use in meaning women or persons on dialysis and has not been evaluated in these populations.
- Performance of the Organisation when used with other implanted medical devices, such as pacemakers, has not been evaluated.
What should you lot know about wearing a Sensor:
- The Sensor can be worn for upward to 14 days.
- Some individuals may be sensitive to the adhesive that keeps the Sensor attached to the peel. If you notice significant pare irritation effectually or under your Sensor, remove the Sensor and terminate using the Organization. Contact your healthcare professional person before continuing to apply the System.
- Intense do may crusade your Sensor to loosen due to sweat or move of the Sensor. Remove and replace your Sensor if it starts to loosen and follow the instructions to select an advisable application site.
- The System uses all available glucose information to give you readings so you should scan your Sensor at to the lowest degree one time every 8 hours for the most authentic performance. Scanning less oft may result in decreased performance.
- Exercise not reuse Sensors. The Sensor and Sensor Applicator are designed for unmarried utilise. Reuse may effect 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, telephone call your healthcare professional.
How to Store the Sensor Kit:
- Shop 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 go along your Sensor Kit in a refrigerator, you can as long as the refrigerator is between 39°F and 77°F. Do non freeze.
- Store the Sensor Kit between 10-90% non-condensing humidity.
When not to use the Organisation:
- Do Non utilize if the Sensor Kit package, Sensor Pack, or Sensor Applicator appear to exist damaged or already opened due to risk of no results and/or infection.
- Do Not use if Sensor Kit contents are past expiration date.
- Practise NOT apply if the Reader appears to be damaged due to gamble 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 aforementioned Sensor code. Check that the Sensor codes match before using your Sensor Pack and Sensor Applicator. Do not utilize Sensor Packs and Sensor Applicators with unlike Sensor codes together as this volition result in incorrect glucose readings.
- Clean the awarding 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 forbid 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 preclude 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 to the lowest degree i 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 exam using a blood glucose meter. Differences in glucose readings between interstitial fluid and capillary claret 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 every bit Vitamin C and Aspirin:
- Taking ascorbic acid (vitamin C) while wearing the Sensor may falsely raise Sensor glucose readings. Taking salicylic acrid (used in some pain relievers such equally aspirin and some pare care products) may slightly lower Sensor glucose readings. The level of inaccuracy depends on the amount of the interfering substance active in the body.
- Examination results did not point interference for methyldopa (used in some drugs to treat high blood pressure) or tolbutamide (infrequently used in some drugs to care for diabetes in the United states of america) 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 information technology to an X-ray automobile. The effect of X-rays on the performance of the System has not been evaluated. The exposure may damage the Sensor and may affect proper function of the device to detect trends and track patterns in glucose values during the wearable menstruum.
When to remove the Sensor:
- If the Sensor is condign loose or if the Sensor tip is coming out of your skin, yous may go no readings or unreliable readings, which may non match how you feel. Check to brand sure your Sensor has non come up loose. If it has come up loose, remove information technology and apply a new one.
- If you lot believe your glucose readings are not correct or are inconsistent with how you lot feel, perform a blood glucose exam 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 aridity and excessive water loss may cause inaccurate Sensor glucose readings. If you believe you are suffering from dehydration, consult your healthcare professional person immediately.
What to know most the Reader's Built-in Meter:
- The FreeStyle Libre 14 24-hour interval Reader has a built-in blood glucose meter that is designed to be used but with FreeStyle Precision Neo claret glucose test strips and MediSense Glucose and Ketone Control Solution. Using other test strips with the Reader's born meter will produce an mistake or cause the Reader'southward built-in meter to not turn on or start a test. The Reader'southward congenital-in meter does not take ketone testing functionality.
- The Reader'due south congenital-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 born meter is non for use on neonates, in critically-sick patients, or for diagnosis or screening of diabetes.
- SeeUsing the Reader'due south Congenital-in meter section for additional of import 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 cake access to the charger due to the potential risk of electrical stupor.
Total INDICATIONS AND Important Rubber INFORMATION
FREESTYLE LIBRE two
IMPORTANT Use Data
INDICATIONS FOR USE:
The FreeStyle Libre 2 Wink Glucose Monitoring Organisation is a continuous glucose monitoring (CGM) device with existent time alarms capability indicated for the management of diabetes in persons age 4 and older. It is intended to replace claret glucose testing for diabetes treatment decisions, unless otherwise indicated.
The Arrangement likewise detects trends and tracks patterns and aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. Estimation of the Organization 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 Organization can exist used alone or in conjunction with these digitally connected devices where the user manually controls actions for therapy decisions.
Uniform DEVICES, APPS, AND SOFTWARE:
For a list of compatible devices, apps, and software that tin be used with the FreeStyle Libre 2 Sensor, delight go to:
www.FreeStyleLibre.united states of america/support/overview.html
Use of the Sensor with devices, apps, and software that are not listed may cause inaccurate glucose readings.
FreeStyle Libre two app is only compatible with certain mobile devices and operating systems. Please check www.FreeStyleLibre.com for more information about device compatibility before upgrading your phone or its operating organisation.
CONTRAINDICATIONS:
Automated Insulin Dosing: The System must non be used with automated insulin dosing (AID) systems, including airtight loop and insulin suspend systems.
MRI/CT/Diathermy: The System must be removed prior to Magnetic Resonance Imaging (MRI), Computed Tomography (CT) browse, or high-frequency electric estrus (diathermy) treatment. The effect of MRI, CT scans, or diathermy on the functioning of the Arrangement has not been evaluated. The exposure may damage the Sensor and may impact proper function of the device which could cause wrong readings.
WARNINGS:
CAUTION:Federal police restricts this device to sale by or on the lodge of a physician.
Before you lot use the FreeStyle Libre two System, review all the product instructions and the Interactive Tutorial. The Quick Reference Guide and Interactive Tutorial give you quick access to of import aspects and limitations of the System. The User's Manual includes all safety information and instructions for employ. Talk to your health care professional about how you lot should utilise your Sensor glucose information to help manage your diabetes.
Failure to apply the Organization co-ordinate to the instructions for use may result in you missing a severe low blood glucose or high claret glucose issue and/or making a treatment determination that may result in injury. If your glucose alarms and readings from the System do not friction 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 claret glucose: If you are experiencing symptoms that are not consistent with your glucose readings, consult your health intendance professional.
- Utilize your blood glucose meter to make diabetes treatment decisions when you see thesymbol during the first 12 hours of wearing a Sensor, if your Sensor glucose reading does not friction match how you lot feel, or if the reading does not include a number.
- If you are using FreeStyle Libre 2 app, you must accept access to a blood glucose monitoring arrangement as the App does non provide ane.
- Choking hazard: The System contains small parts that may be unsafe if swallowed.
CAUTIONS AND LIMITATIONS:
Below are important cautions and limitations to keep in heed so you can employ the Arrangement safely. They are grouped into categories for piece of cake reference.
What to know virtually Reader Alarms:
- For you to receive alarms, they must exist on and your Reader should be inside twenty feet of yous at all times. The transmission range is twenty anxiety unobstructed. If you lot are out of range, you may not receive glucose alarms.
- To forestall missed alarms, make sure the Reader has sufficient charge and that sound and/or vibration are turned on.
- Alarms y'all receive do not include your glucose reading so you must scan your Sensor to check your glucose.
What to know most App Alarms:
- For yous to receive alarms, your phone should be within 20 feet of yous at all times. The transmission range is 20 feet unobstructed. If y'all are out of range, you may not receive alarms. If you want to receive the App'southward optional alarms, make sure these are turned on.
- Do not force close the App. The App must exist running in the background to receive alarms. If you strength close the App you will not receive alarms.
Re-open the App to ensure you volition receive alarms. - If yous restart your phone, open your App to make sure it'southward working properly.
- Glucose alarms you receive do non include your glucose reading and so you must scan your Sensor to check your glucose.
- The App volition ask for telephone permissions which are needed to receive alarms. Allow these permissions when requested.
- Check to make sure that you have the correct phone settings and permissions enabled. If your phone is not configured properly, you volition not be able to use the App, so you will non receive alarms or be able to check your glucose.
- iPhonesare to exist configured as follows:
- In the phone settings, go on BluetoothON
- In the phone settings for the App, allow the App to access Bluetooth
- In the phone settings for the App nether Notifications, keep Allow Critical Alerts ON
- Android Phones are to be configured as follows:
- In the phone settings, continue Bluetooth ON
- In the telephone settings for the App, go on Exercise Not Disturb Admission permission ON
- iPhonesare to exist configured as follows:
- If your phone is not configured correctly, the App will be in "Alarms Unavailable" land and you will not be able to check your glucose or receive any alarms, including the Urgent Depression Glucose Alarm.
- To turn on Critical Alerts, Do Not Disturb Permission, and Bluetooth, follow the instructions in the App.
- For Android, you may demand to add the FreeStyle Libre two app to the list of the apps that volition non exist restricted or put to slumber.
- If you adjust the phone ringer volume (iPhone) or Media book (Android) to silent or use the phone do non disturb setting, proceed 'Override Do Not Disturb' setting in the App ON for Low Glucose, Loftier Glucose, and Bespeak Loss Alarms to ensure you receive audible alarms.
- You should disconnect headphones or speakers from your telephone when you are non using them every bit you may not hear audio for alarms. If using headphones, go on them in your ears.
- If you are using peripheral devices connected to your telephone, such equally wireless headphones or a smartwatch, you may receive alarms on just one device or peripheral, not all.
- Keep your telephone well charged and turned on.
- Disable your telephone's automatic operating system updates. After an operating system update, open your App and check your device settings to brand sure it's working properly.
- Some operating system features may impact your power to receive alarms. For example, if you lot utilise an iPhone and the iOS Screen Time characteristic, add FreeStyle Libre ii to the listing of ever allowed apps to ensure that you lot receive alarms or if you lot utilise an Android Phone do not utilise the Android Digital Wellbeing app.
What to know earlier using the System:
- Review all production information before use.
- Take standard precautions for transmission of blood borne pathogens to avoid contamination.
- Make sure that your devices and Sensor kits are kept in a safe place, and maintain your devices under your command during use. This is of import to help forestall anyone from accessing or tampering with the System.
Who should non utilize the System:
- Exercise not utilize 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 sick. The System is not cleared for utilise in these groups and it is not known how unlike conditions or medications common to these populations may impact performance of the Organization.
- Performance of the System when used with other implanted medical devices, such as pacemakers, has not been evaluated.
What should you lot know about wearing a Sensor:
- Wash awarding site on the dorsum of your upper arm using a plain lather, dry out, so clean with an alcohol wipe. This will help remove whatever oily residue that may prevent the Sensor from sticking properly. Let site to air dry before proceeding. Carefully preparing the site according to these instructions volition help the Sensor stay on your body for the total wearable duration specified by your Sensor insert and assistance prevent it from falling off early.
- The Sensor can exist worn for upwardly to the vesture elapsing specified by your Sensor insert. Remember to always have your next Sensor available before your current one ends and then you can keep getting your glucose readings.
- You must scan the Sensor to go your real-fourth dimension current glucose level as both the Reader and App will not provide this information without a scan.
- In the upshot 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 handling decisions.
- The Arrangement is designed to observe certain atmospheric condition which may occur where the Sensor is non working every bit intended and shut it off, telling yous to supplant your Sensor. This may occur if the Sensor gets knocked off from the skin or if the System detects that the Sensor may non be performing as intended. Contact Customer Service if you lot receive a Replace Sensor bulletin before the end of the habiliment duration specified past your Sensor insert. Customer Service is available at 1-855-632-8658 7 Days a Calendar week from 8AM to 8PM Eastern Fourth dimension; excluding holidays.
- 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 end using the System. Contact your health intendance professional before standing to utilise the System.
- Intense practise may cause your Sensor to loosen due to sweat or movement of the Sensor. If the Sensor is condign loose or if the Sensor tip is coming out of your skin, you may go no readings or unreliable depression readings. Remove and supercede your Sensor if it starts to loosen and follow the instructions to select an appropriate application site. Exercise not effort 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 bachelor at 1-855-632-8658 seven Days a Week from 8AM to 8PM Eastern Standard Fourth dimension.
- Do not reuse Sensors. The Sensor and Sensor Applicator are designed for unmarried use. Reuse may result in no glucose readings and infection. Non suitable for re-sterilization. Further exposure to irradiation may cause unreliable depression results.
- If a Sensor breaks within your trunk, call your health care professional person.
How to Shop the Sensor Kit:
- Shop the Sensor Kit between 36°F and 82°F. Storage outside of this range may crusade inaccurate Sensor glucose readings.
- If you doubtable that the temperature may exceed 82°F (for example, in an unairconditioned abode in summertime), 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 twenty-four hours.
- Store the Sensor Kit between 10-90% not-condensing humidity.
When not to use the Organisation:
- Practise NOT utilize if the Sensor Kit package, Sensor Pack, or Sensor Applicator announced to exist damaged or already opened due to risk of no results and/or infection.
- Do NOT use if Sensor Kit contents are past expiration date.
- Exercise NOT apply if the Reader appears to be damaged due to chance of electric daze and/or no results.
What to know well-nigh the System:
- The FreeStyle Libre 2 System is intended for use by a single person. It must non exist used past more than than one person due to the risk of misinterpreting glucose data.
- FreeStyle Libre 2 app and FreeStyle Libre ii Readers practice not share data.
What to know before you Utilise the Sensor:
- The Sensor Pack and Sensor Applicator are packaged equally a ready (separately from the Reader) and have the same Sensor code. Cheque that the Sensor codes friction match before using your Sensor Pack and Sensor Applicator. Exercise not use Sensor Packs and Sensor Applicators with unlike Sensor codes together every bit this volition result in wrong glucose readings.
- Wash application site on the back of your upper arm using a plain soap, dry out, and then clean with an booze wipe. This will help remove any oily residue that may prevent the Sensor from sticking properly. Permit site to air dry out before proceeding. Carefully preparing the site according to these instructions will assistance the Sensor stay on your trunk for the full clothing duration specified by your Sensor insert and help prevent information technology from falling off early.
- Clean easily prior to Sensor treatment/insertion to help prevent infection.
- Alter the application site for the adjacent Sensor application to prevent discomfort or skin irritation.
- Just 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 torso and prevent discomfort or skin irritation. Avoid areas with scars, moles, stretch marks, or lumps. Select an expanse of skin that more often than not stays apartment 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 unlike from Claret Glucose:
- Physiological differences betwixt the interstitial fluid and capillary blood may result in differences in glucose readings between the System and results from a fingerstick test using a claret glucose meter. Differences in glucose readings betwixt interstitial fluid and capillary blood may exist observed during times of rapid alter in claret glucose, such as after eating, dosing insulin, or exercising.
What to know about Ten-Rays:
- The Sensor should exist removed prior to exposing it to an X-ray machine. The event of Ten-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 observe trends and rail patterns in glucose values during the habiliment period.
When to remove the Sensor:
- If the Sensor is condign loose or if the Sensor tip is coming out of your skin, you may go no readings or unreliable readings, which may not lucifer how you lot feel. Check to brand sure your Sensor has not come loose. If it has come up loose, remove it, apply a new 1, and contact Client Service.
- If you believe your glucose readings are non 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 electric current Sensor, apply a new 1, and contact Customer Service. Customer Service is available at i-855-632- 8658 7 Days a Week from 8AM to 8PM Eastern Standard Fourth dimension.
What to know virtually the Reader's Congenital-in Meter:
- The FreeStyle Libre two Reader has a congenital-in blood glucose meter that is designed to be used but with FreeStyle Precision Neo claret glucose exam strips and MediSense Glucose and Ketone Control Solution. Using other test strips with the Reader's built-in meter will produce an error or crusade the Reader'due south congenital-in meter to non plough on or commencement a test. The Reader's born meter does not take ketone testing functionality.
- The Reader's built-in meter is not for utilise on people who are dehydrated, hypotensive, in shock, or for individuals in hyperglycemic-hyperosmolar land, with or without ketosis.
- The Reader's born meter is not for utilize on neonates, in critically ill patients, or for diagnosis or screening of diabetes.
- See Using the Reader's Congenital-in Meter for additional important data on the use of the Reader's congenital-in meter.
What to know nearly charging your Reader:
- Exist certain to select a location for charging that allows the power adapter to be easily unplugged. Do NOT cake admission to the charger due to the potential hazard of electrical shock.
- The maximum surface temperature of the Reader and/or the power adapter could go as warm as 120 °F when it'southward charging or 117 °F during normal use. Under these weather condition, do not hold the Reader or the ability adapter for five minutes or more. People with disorders of peripheral circulation or sensation should use circumspection at this temperature.
INTERFERING SUBSTANCES:
Taking ascorbic acrid (vitamin C) supplements while wearing the Sensor may falsely heighten Sensor glucose readings. Taking more 500 mg of ascorbic acid per day may bear upon the Sensor readings which could cause you to miss a astringent depression glucose event. Ascorbic acid can be plant in supplements including multivitamins. Some supplements, including cold remedies such as Airborne® and Emergen-C®, may contain loftier doses of 1000 mg of ascorbic acrid and should non be taken while using the Sensor. See your healthcare professional to understand how long ascorbic acid is active in your body.
Does Taking Vancomycin Antibiotic Effect Libre Sensor Readings
Source: https://www.freestyle.abbott/us-en/safety-information.html