Eversense XL Manuel utilisateur

CGM Sensor Insertion and Removal Instructions

Pokyny pro zavedení avyjmutí senzoru pro kontinuální sledování

hladiny glukózy

Instrucciones de inserción y extracción del sensor de MCG

Instrukcja wszczepiania i usuwania czujnika CGM

Eversense XL CGM Sensor Insertion and Removal Instructions

Contents | Obsah | Contenido | Spis treści

British English CGM Sensor Insertion and Removal Instructions ............................................................ 5

Čeština Pokyny pro zavedení a vyjmutí senzoru pro kontinuální

sledování hladiny glukózy ............................................................................................... 45

Español Instrucciones de inserción y extracción del sensor de MCG ........................................85

Polskie Instrukcja wszczepiania i usuwania czujnika CGM ......................................................125

4Eversense XL CGM Sensor Insertion and Removal Instructions

CGM Sensor Insertion and Removal Instructions

IMPORTANT:

• Only GPs who have successfully completed the Eversense XL CGM Insertion and Removal Training Programme and have read and understood the Eversense XL CGM Sensor Insertion and Removal

Instructions may perform the insertion and removal procedure on patients. For more information on local distributors, please see the back cover.

• All symptoms of infection (e.g. increased temperature, inﬂammation, redness, pain, tenderness, warmth, swelling or purulence) at the insertion or removal area should be reported. If any of the

above occurs, please advise patients to contact their GP immediately.

• Store the sensor pack refrigerated at the labelled temperature range.

Eversense XL CGM Sensor Insertion and Removal Instructions

1. Overview of the Eversense XL Continuous Glucose Monitoring

(CGM) System

Congratulations on having the latest diabetes technology from Senseonics to assist your patients in managing their diabetes. The Eversense XL CGM System is for people with diabetes to continually

measure glucose levels for the operating life of the sensor.

Some of the features of the Eversense XL CGM System:

• Wireless communication with the sensor, smart transmitter and app.

• Long-term sensor wear in the upper arm for the operating life of the sensor.

• Alerts when pre-set Low or High Glucose Alert levels (hypoglycaemia or hyperglycaemia) are reached.

• Predictive alerts to alert the patient before reaching pre-set Low or High Glucose Alert levels.

• Use of mobile device (e.g., smartphone) to display glucose readings.

• On-body vibe alerts with the smart transmitter even when mobile device is not nearby.

• Provides readings within 2.2 – 22.2 mmol/L (40 – 400 mg/dL) range every 5 minutes.

• Trend arrows that show whether glucose values are rising or falling and how fast.

• Graphs and statistics that show glucose results in easy-to-understand formats.

• Removable and rechargeable smart transmitter.

• Event entry capabilities (like meals, exercise and insulin).

• Stores glucose data in the app and on the smart transmitter.

8Eversense XL CGM Sensor Insertion and Removal Instructions

Eversense XL CGM System Components

The System includes:

1) a small sensor inserted subcutaneously by a GP,

2) a removable smart transmitter worn over the sensor, and

3) a mobile app to display the glucose readings.

Eversense XL Sensor

The sensor is inserted under the skin (upper arm) and measures glucose in interstitial ﬂuid. These glucose levels are then calculated by the smart

transmitter and sent to the app.

The Eversense XL Sensor lasts up to 180 days. The sensor has a silicone ring that contains a small amount of dexamethasone acetate, an anti-inﬂammatory

steroid drug. The dexamethasone acetate minimises inﬂammatory responses, very similar to common medical devices, such as pacemakers.

Specially designed sensor insertion tools are provided for subcutaneous insertion of the senso r. Other equipment necessary for the procedure, but not

included in the Eversense XL Insertion Tool Pack, is listed in Section 4.

Eversense XL Smart Transmitter

The removable smart transmitter is worn externally over the sensor and powers the sensor. It wirelessly sends glucose data (via Bluetooth) to the mobile

device app. The smart transmitter also provides on-body vibe alerts based on the pre-set glucose level settings. It has a rechargeable battery and is

reusable for up to one year. Adhesive patches included with the Eversense XL Insertion Tools Pack are provided for the patient to replace daily.

Eversense App

The Eversense App is a software application that runs on a mobile device (e.g., smartphone) and displays glucose data in a variety of ways. It also provides

alerts based on the pre-set glucose level settings.

Sensor

Smart Transmitter Eversense App

Note: Not actual size

Eversense XL CGM Sensor Insertion and Removal Instructions

Continuous glucose monitoring aids in the management of diabetes and glucose control, which can improve your patient’s quality of life. Best results are achieved when you are fully informed about the

risks and beneﬁts, insertion procedure, follow-up requirements, and self-care responsibilities. You should not have the sensor inserted if you cannot properly operate the CGM System.

The CGM System measures glucose in interstitial ﬂuid (ISF) between the body’s cells. Physiologic dierences between ISF and blood from a ﬁngerstick may result in dierences in glucose measurements. These

dierences are especially evident during times of rapid change in blood glucose (e.g., after eating, dosing insulin, or exercising). Glucose levels in ISF lag behind glucose levels in blood by several minutes.

The sensor has a silicone ring that contains a small amount of an anti-inﬂammatory drug (dexamethasone acetate). It has not been determined whether the risks associated with injectable dexamethasone

acetate apply to the dexamethasone acetate elution ring inside the sensor. The elution ring releases a small amount of dexamethasone acetate when the sensor comes in contact with body ﬂuids and serves

to minimise the body’s inﬂammatory response to the inserted sensor. Dexamethasone acetate in the ring may also cause other adverse events not previously seen with the injectable form.

Indications for Use

The Eversense XL CGM System is indicated for continually measuring interstitial ﬂuid glucose levels in adults (18 years and older) with diabetes for the operating life of the sensor.

The system is intended to:

• Aid in the management of diabetes.

• Provide real-time glucose readings.

• Provide glucose trend information.

• Provide alerts for the detection and prediction of episodes of low blood glucose (hypoglycaemia) and high blood glucose (hyperglycaemia).

Historical data from the system can be interpreted to aid in providing therapy adjustments. These adjustments should be based on patterns and trends seen over time.

The system is indicated for use as an adjunctive device to complement, not replace, information obtained from standard home blood glucose monitoring devices.

2. Benets and Risks

10 Eversense XL CGM Sensor Insertion and Removal Instructions

Contraindications

• The system is contraindicated in people for whom dexamethasone or dexamethasone acetate may be contraindicated.

• The sensor and smart transmitter are incompatible with magnetic resonance imaging (MRI) procedures. Patients should not undergo an MRI procedure while the sensor is inserted or when wearing the

smart transmitter. Should an MRI be required the sensor must be removed before the procedure.

• Mannitol or sorbitol, when administered intravenously, or as a component of an irrigation solution or peritoneal dialysis solution, may increase blood mannitol or sorbitol concentrations and cause falsely

elevated readings of your sensor glucose results. Sorbitol is used in some artiﬁcial sweeteners, and concentration levels from typical dietary intake do not impact sensor glucose results.

Risks and Side Eects

The glucose alerts and notiﬁcations will not audibly notify the user when the sound on the user’s mobile device is turned o. If the system cannot display a glucose value, it also cannot provide glucose

alerts. If the patient is unable to feel the vi bration of the smart transmitter he/she may not notice the alerts. The system’s calculated glucose can be slightly dierent from a blood glucose meter. This may

cause an alert to activate at a dierent time than they would have if the system’s values always matched the blood glucose meter values. If the patient does not take frequent blood glucose measurements

and misses an alert, he/she may not be aware of high or low glucose levels. Medical attention may be needed in the event that he/she has high or low glucose and is unaware of it. If the patient does not

test their glucose with a blood glucose meter when symptoms of a low or high blood glucose level appear OR when symptoms are not consistent with the sensor glucose readings, he/she may miss a high

or low glucose event. If a patient does not always test glucose with a blood glucose meter before making a treatment decision, he/she may inadvertently cause a high or low blood glucose value because

actual glucose values can be slightly dierent than the system’s displayed values.

The sensor is inserted by making a small incision and placing it under the skin. This process may cause infection, pain or skin irritation. Additionally, the adhesive may cause a reaction or skin irritation.