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Ava Flores
• Friday, 08 January, 2021
• 47 min read

Resonance imaging (MRI), computed tomography (CT) scan, or high-frequency Without G6 readings or alarm/alert notifications, you might miss a severe low or high glucose event.

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Contents

After using skin care products, wash your hands before touching your G6. If any skin care products get on your G6, immediately wipe with a clean cloth.

When you start a new sensor, you must enter a code into your display device to use Using values obtained from a blood glucose meter and finger sticks daily.

Clean your insertion site with alcohol wipes to prevent infections. You run the risk of infection or the transmitter holder not sticking well.

• At least 3 inches from insulin pump infusion set or injection site A damaged transmitter could cause injuries from electrical shocks and may make the G6 not work correctly.

Hydroxyurea is a medication used in the treatment of diseases including cancer and sickle cell anemia; it is known to interfere with readings from your sensor. If you are taking hydroxyurea, your sensor glucose readings will be higher than your actual glucose, which could result in missed hypoglycemia alerts or errors in diabetes management, such as giving yourself a higher dose of insulin due to falsely high sensor glucose values.

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The level of inaccuracy depends on the amount of hydroxyurea in your body. Do not use your Deacon CGM System for diabetes treatment decisions if you are taking hydroxyurea.

If the receiver or smart device is turned off (shut down), it will not show G6 Android users must allow To Do Not Disturb Permission to use the app.

Make sure your smart device settings allow Deacon app notifications to show on your Lock screen. Apple: During G6 setup, enable Deacon app notifications, or you won’t get alarm/alerts.

Compatibility: Before upgrading your smart device or its operating system, Operating system can change settings or shut down the app.

Speaker and vibrations regularly (see your smart device product instructions). They don’t work, contact your smart device’s product support.

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Important User Information The Deacon Share (Share) app lets you send your sensor information from your app to your Followers’ smart devices! Read the indications, warnings, and precautions below to find out how toucan safely use this app feature.

If either your or your Followers’ smart device batteries aren’t charged, Share won’t work. If the app isn’t open, Share won’t work.

Sharing gaps: Followers won’t get your sensor information when their smart device is off, not connected to the Internet, or in Do Not Disturb or Airplane mode. Cell carrier supports simultaneous voice and data: Most cell service carriers support using voice and data at the same time.

If it’s not supported, Share won’t work during phone calls. Share will restart when the call is over and send any waiting notifications.

Deacon G5 Mobile Continuous Glucose Monitoring System Indications for Use The Deacon G5 Mobile Continuous Glucose Monitoring System (Deacon G5) is a glucose monitoring system indicated for the management of diabetes in persons age 2 years and older.

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The Deacon G5 is designed to replace finger stick blood glucose testing for diabetes treatment decisions. Interpretation of the Deacon G5 results should be based on the glucose trends and several sequential readings over time.

The Deacon G5 also aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. The Deacon G5 is intended for single patient use and requires a prescription.

Important User Information Failure to use the Deacon G5 and its components according to the instructions for use and all indications, contraindications, warnings, precautions, and cautions may result in you missing a severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) occurrence and/or making a treatment decision that may result in injury. Indications, contraindications, warnings, precautions, cautions, and other important user information can be found in the product instructions that are included with, or accompany, the Deacon G5.

Discuss with your healthcare professional how you should use the information displayed on the Deacon G5 to help manage your diabetes. The product instructions contain important information on troubleshooting the Deacon G5 and on the performance characteristics of the system.

MRI/CT/ Diathermy Remove the Deacon G5 sensor, transmitter, and receiver before Magnetic Resonance Imaging (MRI), Computed Tomography (CT) scan, or high-frequency electrical heat (diathermy) treatment. The Deacon G5 has not been tested during MRI or CT scans or with diathermy treatment.

The magnetic fields and heat could damage the components of the Deacon G5, which may cause it to display inaccurate blood glucose readings or may prevent alerts. The Deacon G5 has not been tested during MRI or CT scans or with diathermy treatment.

The magnetic fields and heat could damage the components of the Deacon G5, which may cause it to display inaccurate blood glucose readings or may prevent alerts. The level of inaccuracy depends on the amount of acetaminophen active in your body and is different for each person.

Do not rely on continuous glucose monitoring (CGM) data produced by the Deacon G5 if you have recently taken acetaminophen. If a sensor breaks and no portion of it is visible above the skin, do not attempt to remove it.

Choking Do not allow young children to hold the sensor or transmitter without adult supervision. The sensor and transmitter include small parts that may pose a choking hazard.

The following warnings may result in the consequence of missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) or making a treatment decision that results in injury: Diabetes Treatment Decisions If your Deacon G5 does not display a sensor glucose reading and an arrow or if you are getting inaccurate or inconsistent readings, use a finger stick blood glucose value from your blood glucose meter to make diabetes treatment decisions.

Who Should Not Use The Deacon G5 was not evaluated or approved for the following persons: Do not use the Deacon G5 Mobile CGM System in critically ill 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.

The Deacon G5’s accuracy has not been tested in people within these groups and the system’s glucose readings may be inaccurate. The Deacon G5 needs to be calibrated in order to provide accurate readings.

The placement and insertion of the sensor component of the Deacon G5 is not approved for other sites. Initial Calibration: Data/Alarm/Alert Do not expect sensor glucose readings or Alarms/Alerts from the Deacon G5 until after the 2-hour startup.

Make sure the notifications for the G5 Mobile app are turned on in the setting’s menu of your smart device. Check that the G5 Mobile app hasn’t been shut down by your smart device.

Turn off the Do Not Disturb feature on your smart device (if available). Set the volume on your smart device at a level you can hear.

If the settings on your smart device are incorrect, your Deacon G5 may not function properly. An Alarm or Alert from the G5 Mobile app cannot be heard through your smart device’s speakers if headphones are plugged in.

Make sure you unplug your headphones when you are done using them, otherwise you might not hear an Alarm or Alert from the Deacon G5. If you are taking hydroxyurea, your sensor glucose readings will be higher than your actual glucose, which could result in missed hypoglycemia alerts or errors in diabetes management, such as giving yourself a higher dose of insulin due to falsely high sensor glucose values.

The level of inaccuracy depends on the amount of hydroxyurea in your body. Do not use your Deacon CGM System for diabetes treatment decisions if you are taking hydroxyurea.

The following precautions may result in the consequence of missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) or making a treatment decision that results in injury: Treatment Decisions Make diabetes treatment decisions based on the combination of the sensor glucose reading, trend arrow, and/or actionable alerts generated by the Deacon G5.

Before inserting a sensor, confirm the expiration date that is listed on the package label in the following format: YYYY-MM-DD. Avoid inserting the sensor in areas that are likely to be bumped, pushed, or compressed or areas of skin with scarring, tattoos, or irritation as these are not ideal sites to measure glucose.

Insertion in these areas might affect sensor accuracy. The Deacon G5 will not work if you mix the transmitter and receiver from different generations.

Communication Range Avoid separating the transmitter and receiver by more than 20 feet. Wireless communication does not work well through water, so the range is much less if you are in a pool, shower, etc.

Alarm or Alerts might vibrate or be heard on the accessory instead of your smart device. If the receiver or smart device is turned off (Shut Down), it will not display sensor data, information, Alarm or Alerts generated by the Deacon G5.

Make sure the display devices are turned on; otherwise you won’t get sensor glucose readings or Alarm or Alerts. If water gets into the USB port, the receiver could become damaged and stop displaying readings or providing alerts.

Using alternative site blood glucose values for calibration might affect Deacon G5 accuracy. Do not calibrate when your receiver screen is showing the rising or falling single arrow or double arrow, which indicates that your blood glucose is rapidly rising or falling.

Calibrating during rapid rise or fall of blood glucose may affect sensor accuracy. Calibrating during rapid rise or fall of blood glucose may affect sensor accuracy.

The Deacon G5 is a prescription-only medical device and is meant, or indicated, for individual use only. If the transmitter is used by more than one person, the glucose readings, alerts, and reports may be wrong.

The Deacon G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System is a glucose monitoring device indicated for detecting trends and tracking patterns in persons ages 2 to 17 years with diabetes. The system is intended for single patient use and requires a prescription.

The Deacon G4 PLATINUM (Pediatric) System is indicated for use as an adjunctive device to complement, not replace, information obtained from standard home glucose monitoring devices. The Deacon G4 PLATINUM (Pediatric) System aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments, which may minimize these excursions.

Interpretation of the Deacon G4 PLATINUM (Pediatric) System results should be based on the trends and patterns seen with several sequential readings over time. (Pediatric) System results should be based on the trends and patterns seen with several sequential readings over time.

Important User Information Please review your product instructions before using your continuous glucose monitoring system. Indications, contraindications, warnings, precautions, cautions, and other important user information can be found in your product instructions.

Discuss with your healthcare professional how you should use your sensor trend information to help manage your diabetes. Your product instructions contain important information on troubleshooting your system and on the performance characteristics of the device.

Remove the Deacon G4 PLATINUM sensor, transmitter, and receiver before Magnetic Resonance Imaging (MRI), Computed Tomography (CT) scan, or diathermy treatment. The Deacon G4 PLATINUM (Pediatric) System has not been tested during MRI or CT scans or with diathermy treatment.

The magnetic fields and heat could damage the device so that it might not display sensor glucose readings or provide alerts, and you might miss a low or high blood glucose value. The level of inaccuracy depends on the amount of acetaminophen active in your body and may be different for each person.

Do not use the Deacon G4 PLATINUM (Pediatric) CGM System until you have thoroughly reviewed the training materials. Incorrect use might lead you to misunderstand the CGM information or affect system accuracy.

Do not use the Deacon G4 PLATINUM (Pediatric) System for treatment decisions, such as how much insulin you should take. The Deacon G4 PLATINUM (Pediatric) System does not replace a blood glucose meter.

In a pediatric clinical study, larger differences were observed between this CGM device and actual blood glucose values compared to those differences observed in the adult clinical study. In a pediatric clinical study, a significant number of low glucose events were not detected by CGM.

Do not rely solely on CGM alerts to detect low glucose. If a sensor breaks and no portion of it is visible above the skin, do not attempt to remove it.

Do not use the Deacon G4 PLATINUM (Pediatric) 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.

Do not use the Deacon G4 PLATINUM (Pediatric) System in critically ill patients. It is not known how different conditions or medications common to the critically ill population may affect the performance of the system.

Do not insert the sensor in sites other than the belly (abdomen) or upper buttocks. Do not expect alerts from the Deacon G4 PLATINUM (Pediatric) System until after the 2-hour startup.

The sensor and transmitter include small parts that may pose a choking hazard. Keep the transmitter kit box away from young children; it contains a magnet that should not be swallowed.

Hydroxyurea is a medication used in the treatment of diseases including cancer and sickle cell anemia; it is known to interfere with readings from your sensor. The level of inaccuracy depends on the amount of hydroxyurea in your body.

Do not open the sensor package until you have washed your hands with soap and water, and let them dry. Avoid inserting the sensor in areas that are likely to be bumped, pushed or compressed or areas of skin with scarring, tattoos, or irritation as these are not ideal sites to measure glucose.

Insertion in those areas might affect sensor accuracy and could result in you missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) events. The insulin might affect sensor accuracy and could result in you missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) events.

Do not calibrate if your blood glucose is changing at a significant rate, typically more than 2 mg/DL per minute. Do not calibrate when your receiver screen is showing the rising or falling single arrow or double arrow, which indicates that your blood glucose is rapidly rising or falling.

The system accuracy may be affected when your glucose is changing at a significant rate (e.g., 2-3 mg/DL/min or more than 3 mg/DL each minute), such as during exercise or after a meal. If your transmitter and receiver are farther than 20 feet apart or are separated by an obstruction, they might not communicate or the communication distance may be shorter and result in you missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) events.

If water gets into the USB port, the receiver could become damaged and stop displaying readings or providing alerts and result in you missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) events. Indications For Use The Deacon G4 PLATINUM Continuous Glucose Monitoring System is a glucose monitoring device indicated for detecting trends and tracking patterns in persons (age 18 and older) with diabetes.

The system is intended for single patient use and requires a prescription. The Deacon G4 PLATINUM System is indicated for use as an adjunctive device to complement, not replace, information obtained from standard home glucose monitoring devices.

The Deacon G4 PLATINUM System aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments, which may minimize these excursions. Interpretation of the Deacon G4 PLATINUM System results should be based on the trends and patterns seen with several sequential readings over time.

Important User Information Please review your product instructions before using your continuous glucose monitoring system. Contraindications, warnings, precautions, cautions, and other important user information can be found in your product instructions.

Discuss with your healthcare professional how you should use your sensor trend information to help manage your diabetes. Your product instructions contain important information on troubleshooting your system and on the performance characteristics of the device.

Remove the Deacon G4 PLATINUM sensor, transmitter, and receiver before Magnetic Resonance Imaging (MRI), Computed Tomography (CT) scan, or diathermy treatment. The Deacon G4 PLATINUM System has not been tested during MRI or CT scans or with diathermy treatment.

The magnetic fields and heat could damage the device so that it might not display sensor glucose readings or provide alerts, and you might miss a low or high blood glucose value. The level of inaccuracy depends on the amount of acetaminophen active in your body and may be different for each person.

The level of inaccuracy depends on the amount of acetaminophen active in your body and may be different for each person. Incorrect use might lead to you misunderstanding the information provided by your system, or might affect system performance, and you might miss a low or high blood glucose value.

Do not use the Deacon G4 PLATINUM System for treatment decisions, such as how much insulin you should take. The Deacon G4 PLATINUM System does not replace a blood glucose meter.

If you experience a broken sensor, please report this to our Technical Support department at 1.877.339.2664 or 1.858.200.0200. The Deacon G4 PLATINUM System is not approved for use in children or adolescents, pregnant women or persons on dialysis.

It is not known how different conditions or medications common to the critically ill population may affect the performance of the system. Sensor placement and insertion is not approved for sites other than the belly (abdomen).

Hydroxyurea is a medication used in the treatment of diseases including cancer and sickle cell anemia; it is known to interfere with readings from your sensor. The level of inaccuracy depends on the amount of hydroxyurea in your body.

Before opening the sensor package, wash your hands with soap and water, and let them dry. Before inserting the sensor, clean the skin with a topical antimicrobial solution, such as isopropyl alcohol, and allow drying.

Avoid inserting the sensor in areas that are likely to be bumped, pushed or compressed or areas of skin with scarring, tattoos, or irritation as these are not ideal sites to measure glucose. Insertion in those areas might affect sensor performance, and you might miss a low or high blood glucose value.

The insulin might affect sensor performance, and you might miss a low or high blood glucose value. Do not calibrate if your blood glucose is changing at a significant rate, typically more than 2 mg/DL per minute.

The system accuracy may be affected when your glucose is changing at a significant rate (e.g., 2-3 mg/DL/min or more than 3 mg/DL each minute), such as during exercise or after a meal. If your transmitter and receiver are farther than 20 feet apart or are separated by an obstruction, they might not communicate or the communication distance may be shorter, and you might miss a low or high blood glucose value.

If water gets into the USB port, the receiver could become damaged and stop displaying readings or providing alerts, and you might miss a low or high blood glucose value. Alternative site blood glucose values might affect sensor performance, and you might miss a low or high blood glucose value.

The relevant safety information in the instructional material is dependent on the intended user. The following safety information is provided as relevant for each intended user.

Contraindications, warnings, precautions, and cautions may result in your patient Glucose) occurrence and/or making a treatment decision that may result in injury.

Use the information displayed on the G6 Pro to help manage their diabetes. The product instructions contain important information on troubleshooting the G6 Pro and on the performance characteristics of the system.

Before using G6 Pro, carefully read the included materials with your patient. Diabetes treatment decisions or, if needed, seek immediate medical attention.

If the smart device is on mute, only these notifications make a sound: Glucose Alarm: Android users must allow To Do Not Disturb Permission to use the app.

Use as Directed The transmitter is small part and poses a choking hazard, particularly for children. Use meter to make treatment decisions during the 2-hour sensor warm up period.

Some skin care products, such as lotions, sunscreens and insect repellents, can make Do not allow these skin care products to contact the G6 Pro.

Don’t start a sensor past Use By date because it may give incorrect results. Clean and dry hands and put on gloves before inserting sensor on patient.

Make sure patient doesn’t have insect repellent, sunscreen, perfume, or lotion on their Don’t remove sensor or transmitter from packaging until you are ready to use.

• At least 3 inches from insulin pump infusion set or injection site G6 Pro components are not compatible with any previous Deacon products.

Pro, patient can take a standard or maximum acetaminophen dose of 1 gram (1,000 Mg) every 6 hours and still use the G6 Pro readings to make treatment decisions.

Hydroxyurea is a medication used in the treatment of diseases including cancer and sickle cell anemia. The level of inaccuracy in sensor glucose readings is based on the amount of hydroxyurea in the body.

Relying on sensor glucose results while taking hydroxyurea could result in missed hypoglycemia alerts or errors in diabetes management, such as giving a higher dose of insulin than necessary to correct falsely high sensor glucose values. It can also result in errors when reviewing, analyzing and interpreting historical patterns for assessing glucose control.

Make sure the display device is turned on, the battery is charged, the screen is Device settings still allow for receiving alarms or alerts.

With these digitally connected medical devices for managing diabetes or assessing Important User Information Failure to use the Deacon G6 Pro Continuous Glucose Monitoring System (G6 Pro) and its components according to the instructions for use and all indications, contraindications, warnings, precautions, and cautions may result in missed glucose data.

Indications, contraindications, warnings, precautions, cautions, and other important user information can be found in the product instructions that are included with, or accompany, the G6 Pro. Discuss with your healthcare professional how you should use the information recorded by G6 Pro to help manage your diabetes.

The product instructions contain important information on troubleshooting the G6 Pro and on the performance characteristics of the system. Don’t wear your CGM (sensor, transmitter, or smart device) for magnetic resonance imaging (MRI), computed tomography (CT) scan, or high-frequency electrical heat (diathermy) treatment.

Don’t use G6 Pro if pregnant, on dialysis, or critically ill It is not known how different conditions or medications common to these populations may affect performance of the system. A damaged transmitter could cause injuries from electrical shocks and may make the G6 Pro not work correctly.

The transmitter is a small part and poses a choking hazard, particularly for children. Don’t ignore broken or detached sensor wires.

In previous generations of Deacon CGM systems (G4/G5), acetaminophen could affect sensor readings, making them look higher than they really were. Pro, patient can take a standard or maximum acetaminophen dose of 1 gram (1,000 mg) every 6 hours and still use the G6 Pro readings to make treatment decisions.

Hydroxyurea is a medication used in the treatment of diseases including cancer and sickle cell anemia; it is known to interfere with values from your sensor. The level of inaccuracy depends on the amount of hydroxyurea in your body.

The Use By date is in YYYY-MM-DD (Year-Month-Day) format on the sensor package label beside the hourglass symbol. Clean and dry your hands, then put on your gloves before inserting sensor on patient.

Clean insertion site with alcohol wipes to prevent infections. If insertion site is not clean and completely dry, there’s a risk of infection or the transmitter holder not sticking well.

Make sure patient doesn’t have insect repellent, sunscreen, perfume, or lotion on their skin. Keep the safety guard on until you put the G6 Pro applicator against the patient’s skin.

Use Correct Transmitter, and Sensor G6 Pro components are not compatible with any previous Deacon products. Some skin care products, such as sunscreens and insect repellents, can make the plastic used in G6 Pro crack.

Do not allow these skin care products to contact the G6 Pro. After using skin care products, wash hands before touching G6 Pro.

Diabetes in persons age 2 years and older in a home environment while under the Replace finger stick blood glucose testing for diabetes treatment decisions.

Failure to use the G6 Pro and its components according to the instructions for use and all indications, contraindications, warnings, precautions, and cautions may result in missing a severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) occurrence and/or making a treatment decision that may result in injury. Indications, contraindications, warnings, precautions, cautions, and other important user information can be found in the product instructions that are included with, or accompany, the G6 Pro.

Discuss with your healthcare professional how you should use the information displayed on the G6 Pro to help manage your diabetes. The product instructions contain important information on troubleshooting the G6 Pro and on the performance characteristics of the system.

Don’t wear your CGM (sensor, transmitter, or smart device) for magnetic resonance imaging (MRI), computed tomography (CT) scan, or high-frequency electrical heat (diathermy) treatment. Without G6 Pro readings or alarm/alert notifications, you might miss a severe low or high glucose event.

A damaged transmitter could cause injuries from electrical shocks and may make the G6 Pro not work correctly. If glucose alerts and G6 Pro readings don’t match what they’re feeling, use blood glucose meter (meter) to make diabetes treatment decisions or, if needed, seek immediate medical attention.

It is not known how different conditions or medications common to these populations may affect performance of the system. When using smart device, confirm that volume is turned up, phone is not muted, and headphones aren’t plugged in.

Android users must allow To Do Not Disturb Permission to use the app. Make sure smart device settings allow Deacon app notifications to show on Lock screen.

Apple®: During G6 Pro setup, enable Deacon app notifications, or you won’t get alarm/alerts. If the Deacon app is closed, patient won’t get sensor glucose information.

Before upgrading smart device or its operating system, always check deacon .com/compatibility. Don’t manually change smart device time.

It can make the time on the trend screen wrong and the app may stop displaying data. Use as Directed The transmitter is a small part and poses a choking hazard, particularly for children.

Use meter to make treatment decisions during the 2-hour sensor warm up period. Don’t ignore broken or detached sensor wires.

The Use By date is in YYYY-MM-DD (Year-Month-Day) format on the sensor package label beside the hourglass symbol. Clean and dry your hands, when put on your gloves before inserting your sensor.

Clean your insertion site with alcohol wipes to prevent infections. If insertion site is not clean and completely dry, there’s a risk of infection or the transmitter holder not sticking well.

Make sure you don’t have insect repellent, sunscreen, perfume, or lotion on your skin. Keep the safety guard on until you put the G6 Pro applicator against the patient’s skin.

Use Correct Transmitter, and Sensor G6 Pro components are not compatible with any previous G6 products. Some skin care products, such as sunscreens and insect repellents, can make the plastic used in G6 Pro crack.

Do not allow insect repellent, sunscreen, perfume or lotion to contact the G6 Pro. After using skin care products, wash hands before touching G6 Pro.

Patient can wear the G6 Pro for the walkthrough metal detector. In previous generations of Deacon CGM systems (G4/G5), acetaminophen could affect sensor readings, making them look higher than they really were.

However, with the G6 Pro, patient can take a standard or maximum acetaminophen dose of 1 gram (1,000 mg) every 6 hours and still use the G6 Pro readings to make treatment decisions. Hydroxyurea is a medication used in the treatment of diseases including cancer and sickle cell anemia; it is known to interfere with readings from your sensor.

If you are taking hydroxyurea, your sensor glucose readings will be higher than your actual glucose, which could result in missed hypoglycemia alerts or errors in diabetes management, such as giving yourself a higher dose of insulin due to falsely high sensor glucose values. The level of inaccuracy depends on the amount of hydroxyurea in your body.

Do not use your Deacon CGM System for diabetes treatment decisions if you are taking hydroxyurea. Know Your System Don’t rely on the G6 Pro app until your patient understands how to use it and their device’s Bluetooth®.

Make sure the display device is turned on, the battery is charged, the screen is not broken and the speaker works. Caution US Federal law restricts the sale of G6 Pro to be made by or on the order of a physician.

The purpose of Deacon Share Direct Secondary Displays is to notify another person, the Follower, of the patient’s Deacon G4 PLATINUM Continuous Glucose Monitoring System sensor glucose information. The Secondary Displays is intended for providing secondary notification of a continuous glucose monitoring system and does not replace real time continuous glucose monitoring (G4 PLATINUM System) or standard home blood glucose monitoring.

The Deacon Share Direct Secondary Displays is not intended to modify or analyze data received from the continuous glucose monitor system. Nor is it intended to instruct, or to transmit information to the continuous glucose monitor system.

The Deacon Share Direct Secondary Displays is not intended to serve as a replacement for a primary display device for a continuous glucose monitoring system. The Deacon Share Direct Secondary Displays is not intended to receive information directly from the sensor or transmitter of a continuous glucose monitoring system.

Please review the indications, contraindications, warnings, precautions, cautions and other important information in the Deacon G4 PLATINUM System User’s Guide. If you do not have the Deacon G4 PLATINUM System User’s Guide, toucan view it on WWW.

Please contact your healthcare professional during hours the line is unavailable. Do not bring the Deacon G4 PLATINUM Receiver with Share, iPhone, or iPod touch into a room containing medical equipment such as Magnetic Resonance Imaging (MRI), Computed Tomography (CT), or diathermy.

Exposure to these types of equipment could heat and damage the receiver, iPhone, or iPod touch so that they are unable to send or receive glucose information. The user should follow instructions on the continuous glucose monitoring system.

You cannot use Deacon Share to make treatment decisions, such as how much insulin to take. Do not use Deacon Share as the main source of CGM glucose trend information.

Use the Deacon G4 PLATINUM Receiver as the main device to track sensor glucose information, notifications and alarms. At times, the patient will be unable to share data using Deacon Share, and the Follower might miss helping the patient in the event of low or high blood glucose values.

Do not rely solely on the Follower to alert the patient of low or high glucose events or other important information. At times, the Follower may not receive data, and the patient will not be notified of this fact.

The Bluetooth range can vary and depends on the distance and obstructions between the receiver and the iPhone or iPod touch. If either the patient or the Follower does not have a connection, loses their connection, turns off the connection (“Airplane Mode”) or if either the iPhone or iPod touch is in Do Not Disturb mode, the patient will be unable to share data and the Follower might miss helping the patient in the event of low or high blood glucose values.

To check this, make sure that the Follower’s iPhone or iPod touch can receive text messages. Follow notifications and text messages work by a similar process on iPhone or iPod touch.

Make sure the patient’s and Follower’s iPhone or iPod touch have charged batteries or are connected to electrical outlets. If the iPhone or iPod touch shuts down due to low battery, the patient will be unable to share data, and the Follower might miss helping the patient in the event of low or high blood glucose values.

If the patient’s iPhone or iPod touch is powered off or restarted, make sure the Deacon Share2 app is reopened after the iPhone or iPod touch is turned back on in order to resume sharing. If the Deacon Share2 app is not reopened, the patient will be unable to share data, and the Follower might miss helping the patient in the event of low or high blood glucose values.

Check the delay settings on the patient’s iPhone or iPod touch to make sure they are not too long. The Follower will not receive notifications until after the time period in the delay has passed, and the Follower might miss helping the patient in the event of low or high blood glucose values if the delay is too long.

During the time the patient chooses to “Not Share”, the Follower will not receive notifications and might miss helping the patient in the event of low or high blood glucose values. Check the Deacon Follow app’s trend graph if the Follower’s iPhone or iPod touch has been off or if there is no data connection (e.g., Internet/Wi-Fi or mobile data service/3G/4G/LTE is lost, connection is turned off in Airplane Mode, or iPhone or iPod touch is placed in Do Not Disturb mode).

When the iPhone or iPod touch is turned back on, the Follower will only receive the most recent notification and might miss helping the patient in the event of prior low or high blood glucose values. If their carriers do not support simultaneous voice and data, the Deacon Share2 app may not be able to share glucose readings and the Deacon Follow app may not be able to receive notifications or glucose readings during phone calls.

Deacon Share will resume sharing after the phone call has ended, and the Follower will receive any waiting notifications after the phone call has ended. The Deacon Glucose Program System is intended to replace finger stick blood glucose testing for diabetes treatment decisions for persons with diabetes who are not at significant risk of severe hypoglycemia.

The Deacon Glucose Program System also aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating long-term therapy adjustments. The Deacon Glucose Program System is also intended to autonomously communicate with digitally connected devices.

Prescriber Considerations The Deacon Glucose Program System may not be appropriate for persons using intensive insulin therapy regimens (3 or more injections per day or insulin pump therapy), with hypoglycemia unawareness, and/or a documented history of severe hypoglycemic events. Follow Deacon Glucose Program System instructions.

Follow Deacon Glucose Program System instructions. Each sensor has its own code printed on the back of the adhesive patch.

Wash your hands with soap and water, not gel cleaners, and then dry them before opening the sensor package. Clean your insertion site with alcohol wipes to prevent infections.

If your insertion site is not clean and completely dry, you run the risk of infection or the transmitter holder not sticking well. Make sure you don’t have insect repellent, sunscreen, perfume, or lotion on your skin.

Where to Insert: Things to Check Keep the safety guard on until you put the applicator against your skin. If you remove the safety guard first, you may hurt yourself by accidentally pushing the button that inserts the sensor before you mean to.

At least 3 inches from insulin pump infusion set or injection site Away from waistband, scarring, tattoos, irritation, and bones Unlikely to be bumped, pushed, or laid on while sleeping Follow Deacon Glucose Program System instructions.

A damaged transmitter could cause injuries from electrical shocks and may make the Deacon Glucose Program System not work correctly. Use as Directed The transmitter is small and may pose a choking hazard.

Don’t put it in your mouth or let children hold it without adult supervision. Follow Deacon Glucose Program System instructions.

The Deacon Glucose Program System is a prescription-only medical device and is meant for your use only. Follow Deacon Glucose Program System instructions.

Interfering Substance Risks Hydroxyurea Precaution Hydroxyurea is a medication used in the treatment of diseases including cancer and sickle cell anemia; it is known to interfere with readings from your sensor. The level of inaccuracy depends on the amount of hydroxyurea in your body.

Do not use your Deacon CGM System for diabetes treatment decisions if you are taking hydroxyurea. In previous generations of Deacon CGM systems (G4/G5), acetaminophen could affect your sensor readings, making them look higher than they really were.

However, with the Deacon Glucose Program System, toucan take a standard or maximum acetaminophen dose of 1 gram (1,000 mg) every 6 hours and still use the Deacon Glucose Program System readings to make treatment decisions. Taking higher than the maximum dose of acetaminophen (e.g. > 1 gram every 6 hours in adults) may affect the Deacon Glucose Program System readings and make them look higher than they really are.

Follow Deacon G6 Glucose Program System instructions. Avoid Sunscreen and Insect Repellent Some skin care products, such as sunscreens and insect repellents, can make the plastic used in your transmitter crack.

Do not allow these skin care products to contact your Deacon Glucose Program System. After using skin care products, wash your hands before touching your Deacon Glucose Program System.

If the smart device is turned off (shut down) or the app closed, it will not show readings or provide system alerts. Make sure your display device is turned on and the app remains open.

Check Settings When using your smart device, check: • Volume/muted/headphones When a system alert is triggered, you get a visual notification and a vibration (if your device has a vibration feature). Depending on your smart device settings, you may not hear the sound/feel the vibration.

Ensure your smart devices settings allow you to feel/hear important system alerts. Sensor Expired Replace Sensor Transmitter (not working) No Storage Error App Stopped Optional Blood Glucose Entry Error (only appears when a user enters an optional blood glucose value; blood glucose entry isn’t required) When you have headphones connected to your smart device, system alerts will sound through the headphones and the speaker.

Compatibility: Before upgrading your smart device or its operating system, check deacon .com/compatibility. Always update manually and verify correct device settings afterward.

Don’t manually change your smart device time because it can make the time on the trend screen wrong and the app may stop displaying data. Passcode Lock: Use the passcode lock feature on your smart device to prevent unauthorized users from viewing your health data Check Settings • Change Settings: If needed, check smart device’s product instructions to change its settings.

• Use BG Meter: If your smart device fails and your display isn’t showing data, or if you lose or break your smart device, use a BG meter for glucose information. Follow Deacon G6 Glucose Program System instructions.

Follow Deacon G6 Glucose Program System instructions. Check Peripheral Devices Requires Prescription U.S. law restricts the sale of the Deacon Glucose Program System to sale by, or on the order of, a physician.

24 Prescriber Considerations The Deacon Glucose Program System may not be appropriate for persons using intensive insulin therapy regimens (3 or more injections per day or insulin pump therapy), with hypoglycemia unawareness, and/or a documented history of severe hypoglycemic events. Read the indications, warnings, and precautions below to find out how toucan safely use this app feature.

Use as Secondary Notice The information on your smart device is sent directly from your Deacon Glucose Program System transmitter. The web-based Deacon CLARITY software is intended for use by both home users and healthcare professionals to assist people with diabetes and their healthcare professionals in the review, analysis, and evaluation of CGM data to support effective diabetes management.

Warning: Treatment decisions, like treating for a low or dosing for a high, should not be made based on this software. Home users should follow instructions on the CGM system.

Warning: The software is not intended to replace self-monitoring practices as advised by a healthcare professional. Caution: The software does not provide any medical advice and should not be used for that purpose.

Home users must consult a healthcare professional before making any medical interpretation and therapy adjustments from the information in the software. Caution: Federal (US) law restricts this device to sale by or on the order of a licensed healthcare professional.

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