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MINIMED® 780G INSULIN PUMP KIT |
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| Precautions and Warnings |
Important safety information: MiniMed" 780G system with SmartGuard" technology with Guardian" 4 sensor The MiniMed" 780G system is intended for continuous delivery Important safety information: MiniMed" 780G system with SmartGuard" technology with Guardian" 4 sensor The MiniMed" 780G system is intended for continuous delivery Important safety information: MiniMed" 780G system with SmartGuard" technology with Guardian" 4 sensor The MiniMed" 780G system is intended for continuous delivery Important safety information: MiniMed" 780G system with SmartGuard" technology with Guardian" 4 sensor The MiniMed" 780G system is intended for continuous delivery of basal insulin at selectable rates, and the administration of insulin boluses at selectable amounts for the management of type 1 diabetes mellitus in persons seven years of age a of basal insulin at selectable rates, and the administration of insulin boluses at selectable amounts for the management of type 1 diabetes mellitus in persons seven years of age a of basal insulin at selectable rates, and the administration of insulin boluses at selectable amounts for the management of type 1 diabetes mellitus in persons seven years of age a of basal insulin at selectable rates, and the administration of insulin boluses at selectable amounts for the management of type 1 diabetes mellitus in persons seven years of age a nd older requiring insulin as well as for the continuous monitoring and trending of glucose levels in the fluid under the skin. The MiniMed" 780G system includes SmartGuard" techno nd older requiring insulin as well as for the continuous monitoring and trending of glucose levels in the fluid under the skin. The MiniMed" 780G system includes SmartGuard" techno nd older requiring insulin as well as for the continuous monitoring and trending of glucose levels in the fluid under the skin. The MiniMed" 780G system includes SmartGuard" techno nd older requiring insulin as well as for the continuous monitoring and trending of glucose levels in the fluid under the skin. The MiniMed" 780G system includes SmartGuard" techno logy, which can be programmed to automatically adjust insulin delivery based on the continuous glucose monitoring (CGM) sensor glucose values and can suspend delivery of insulin wh logy, which can be programmed to automatically adjust insulin delivery based on the continuous glucose monitoring (CGM) sensor glucose values and can suspend delivery of insulin wh logy, which can be programmed to automatically adjust insulin delivery based on the continuous glucose monitoring (CGM) sensor glucose values and can suspend delivery of insulin wh logy, which can be programmed to automatically adjust insulin delivery based on the continuous glucose monitoring (CGM) sensor glucose values and can suspend delivery of insulin wh en the sensor glucose (SG) value falls below or is predicted to fall below predefined threshold values. The Medtronic MiniMed" 780G system consists of the following devi en the sensor glucose (SG) value falls below or is predicted to fall below predefined threshold values. The Medtronic MiniMed" 780G system consists of the following devi en the sensor glucose (SG) value falls below or is predicted to fall below predefined threshold values. The Medtronic MiniMed" 780G system consists of the following devi en the sensor glucose (SG) value falls below or is predicted to fall below predefined threshold values. The Medtronic MiniMed" 780G system consists of the following devi ces: MiniMed" 780G insulin pump, the Guardian" 4 transmitter, the Guardian" 4 sensor, One-press serter, the Accu-Chek" Guide Link blood glucose meter, and the Accu-Chek" Guide test ces: MiniMed" 780G insulin pump, the Guardian" 4 transmitter, the Guardian" 4 sensor, One-press serter, the Accu-Chek" Guide Link blood glucose meter, and the Accu-Chek" Guide test ces: MiniMed" 780G insulin pump, the Guardian" 4 transmitter, the Guardian" 4 sensor, One-press serter, the Accu-Chek" Guide Link blood glucose meter, and the Accu-Chek" Guide test ces: MiniMed" 780G insulin pump, the Guardian" 4 transmitter, the Guardian" 4 sensor, One-press serter, the Accu-Chek" Guide Link blood glucose meter, and the Accu-Chek" Guide test strips. The system requires a prescription from a healthcare professional. The Guardian" 4 sensor is intended for use with the MiniMed" 780G system and the Guardian 4 t strips. The system requires a prescription from a healthcare professional. The Guardian" 4 sensor is intended for use with the MiniMed" 780G system and the Guardian 4 t strips. The system requires a prescription from a healthcare professional. The Guardian" 4 sensor is intended for use with the MiniMed" 780G system and the Guardian 4 t strips. The system requires a prescription from a healthcare professional. The Guardian" 4 sensor is intended for use with the MiniMed" 780G system and the Guardian 4 t ransmitter to monitor glucose levels for the management of diabetes. The sensor is intended for single use and requires a prescription. The Guardian" 4 sensor is indicated for up t ransmitter to monitor glucose levels for the management of diabetes. The sensor is intended for single use and requires a prescription. The Guardian" 4 sensor is indicated for up t ransmitter to monitor glucose levels for the management of diabetes. The sensor is intended for single use and requires a prescription. The Guardian" 4 sensor is indicated for up t ransmitter to monitor glucose levels for the management of diabetes. The sensor is intended for single use and requires a prescription. The Guardian" 4 sensor is indicated for up t o seven days of continuous use. The Guardian" 4 sensor is not intended to be used directly to make therapy adjustments while the MiniMed" 780G is operating in manual mod o seven days of continuous use. The Guardian" 4 sensor is not intended to be used directly to make therapy adjustments while the MiniMed" 780G is operating in manual mod o seven days of continuous use. The Guardian" 4 sensor is not intended to be used directly to make therapy adjustments while the MiniMed" 780G is operating in manual mod o seven days of continuous use. The Guardian" 4 sensor is not intended to be used directly to make therapy adjustments while the MiniMed" 780G is operating in manual mod e. All therapy adjustments in manual mode should be based on measurements obtained using a blood glucose meter and not on values provided by the Guardian" 4 sensor. The Guardian" 4 e. All therapy adjustments in manual mode should be based on measurements obtained using a blood glucose meter and not on values provided by the Guardian" 4 sensor. The Guardian" 4 e. All therapy adjustments in manual mode should be based on measurements obtained using a blood glucose meter and not on values provided by the Guardian" 4 sensor. The Guardian" 4 e. All therapy adjustments in manual mode should be based on measurements obtained using a blood glucose meter and not on values provided by the Guardian" 4 sensor. The Guardian" 4 sensor has been studied and is approved for use in patients ages 7 years and older and in the arm insertion site only. Do not use the Guardian" 4 sensor in the abdomen or other bo sensor has been studied and is approved for use in patients ages 7 years and older and in the arm insertion site only. Do not use the Guardian" 4 sensor in the abdomen or other bo sensor has been studied and is approved for use in patients ages 7 years and older and in the arm insertion site only. Do not use the Guardian" 4 sensor in the abdomen or other bo sensor has been studied and is approved for use in patients ages 7 years and older and in the arm insertion site only. Do not use the Guardian" 4 sensor in the abdomen or other bo dy sites including the buttocks, due to unknown or different performance that could result in hypoglycemia or hyperglycemia. WARNING: Do not use the SmartGuard" feature fo dy sites including the buttocks, due to unknown or different performance that could result in hypoglycemia or hyperglycemia. WARNING: Do not use the SmartGuard" feature fo dy sites including the buttocks, due to unknown or different performance that could result in hypoglycemia or hyperglycemia. WARNING: Do not use the SmartGuard" feature fo dy sites including the buttocks, due to unknown or different performance that could result in hypoglycemia or hyperglycemia. WARNING: Do not use the SmartGuard" feature fo r people who require less than 8 units or more than 250 units of total daily insulin per day. A total daily dose of at least 8 units, but no more than 250 units, is required to ope r people who require less than 8 units or more than 250 units of total daily insulin per day. A total daily dose of at least 8 units, but no more than 250 units, is required to ope r people who require less than 8 units or more than 250 units of total daily insulin per day. A total daily dose of at least 8 units, but no more than 250 units, is required to ope r people who require less than 8 units or more than 250 units of total daily insulin per day. A total daily dose of at least 8 units, but no more than 250 units, is required to ope rate in the SmartGuard" feature. WARNING: Do not use the MiniMed" 780G system until appropriate training has been received from a healthcare professional. Training is rate in the SmartGuard" feature. WARNING: Do not use the MiniMed" 780G system until appropriate training has been received from a healthcare professional. Training is rate in the SmartGuard" feature. WARNING: Do not use the MiniMed" 780G system until appropriate training has been received from a healthcare professional. Training is rate in the SmartGuard" feature. WARNING: Do not use the MiniMed" 780G system until appropriate training has been received from a healthcare professional. Training is essential to ensure the safe use of the MiniMed" 780G system. WARNING: Do not use SG values to make treatment decisions, including delivering a bolus, while the pump i essential to ensure the safe use of the MiniMed" 780G system. WARNING: Do not use SG values to make treatment decisions, including delivering a bolus, while the pump i essential to ensure the safe use of the MiniMed" 780G system. WARNING: Do not use SG values to make treatment decisions, including delivering a bolus, while the pump i essential to ensure the safe use of the MiniMed" 780G system. WARNING: Do not use SG values to make treatment decisions, including delivering a bolus, while the pump i s in Manual Mode. When the SmartGuard" feature is active and you are no longer in Manual Mode, the pump uses an SG value, when available, to calculate a bolus amount. However, if y s in Manual Mode. When the SmartGuard" feature is active and you are no longer in Manual Mode, the pump uses an SG value, when available, to calculate a bolus amount. However, if y s in Manual Mode. When the SmartGuard" feature is active and you are no longer in Manual Mode, the pump uses an SG value, when available, to calculate a bolus amount. However, if y s in Manual Mode. When the SmartGuard" feature is active and you are no longer in Manual Mode, the pump uses an SG value, when available, to calculate a bolus amount. However, if y our symptoms do not match the SG value, use a BG meter to confirm the SG value. Failure to confirm glucose levels when your symptoms do not match the SG value can result in the inf our symptoms do not match the SG value, use a BG meter to confirm the SG value. Failure to confirm glucose levels when your symptoms do not match the SG value can result in the inf our symptoms do not match the SG value, use a BG meter to confirm the SG value. Failure to confirm glucose levels when your symptoms do not match the SG value can result in the inf our symptoms do not match the SG value, use a BG meter to confirm the SG value. Failure to confirm glucose levels when your symptoms do not match the SG value can result in the inf usion of too much or too little insulin, which may cause hypoglycemia or hyperglycemia. usion of too much or too little insulin, which may cause hypoglycemia or hyperglycemia. usion of too much or too little insulin, which may cause hypoglycemia or hyperglycemia. usion of too much or too little insulin, which may cause hypoglycemia or hyperglycemia. |
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