Accu-Chek SmartGuide Device Package Insert

Intended Use

The continuous glucose monitoring (CGM) device is intended for the continuous measurement of real-time glucose levels in the subcutaneous interstitial fluid.

Intended Users

• Adults, 18 years of age and older
• People with diabetes mellitus
• Caregivers of people with diabetes mellitus

Indications

The device is indicated for people with diabetes mellitus (not in a clinical setting).

Contraindications

• The device shall not be used by critically ill patients or patients on dialysis.
• The sensor must be removed prior to entering environments with strong electromagnetic fields, according to IEC 60601-1-2. Such environments include military areas, heavy industrial areas, and medical treatment areas with high-powered medical electric equipment (e.g., magnetic resonance imaging (MRI), computed tomography (CT), X-ray, radiotherapy, or diathermia).

Contents of the Pack

• 1 device (sensor applicator with 1 sensor inside)
• 1 package insert

Additional Materials Required

1. A compatible app installed on your mobile device
2. A compatible mobile device
3. An alternate method for glucose testing (e.g., for emergencies when the app or sensor is not working)

General Safety Information

• The product is intended for single use only.
• Apply the sensor only once.
• Apply the sensor only in trusted environments.
• Visually inspect the packaging and product for damages or manipulation. If the pull tab is sticking out before use, the sterile barrier is broken, and the product is unsterile. Discard damaged products.
• Visually inspect the sensor and the needle for damages. Do not use the sensor if anything unusual is noticed; use a new sensor.
• Do not use the product if you have known allergic reactions to adhesive pads on your skin.
• In rare cases, the needle can remain in your body after sensor application, potentially leading to adverse reactions to a foreign body, encapsulations, infections, or abscesses. Seek medical attention in case of an adverse reaction.

⚠️ WARNING

• Risk of serious harm: Do not modify the product. Always follow the instructions. Failure to do so may result in malfunctions and adverse reactions, including skin reactions, foreign body reactions, encapsulations, infections, or abscesses.
• Risk of suffocation: This product contains small parts that can be swallowed. Keep small parts away from small children and individuals who might swallow them.
• Risk of pain: Applying and removing the sensor may cause slight pain, which usually stops after application. If pain persists, seek medical attention.

❗ PRECAUTION

• Risk of prolonged bleeding: Coagulation disorders or anticoagulant medications can lead to prolonged bleeding at the application site. Consult your healthcare professional before using the product.
• Inspect the application site regularly for skin irritation or inflammation. If the application site becomes inflamed or localized skin reactions (e.g., allergic reaction, eczema) occur, remove the sensor immediately and consult your healthcare professional.

Component Overview

Refer to the illustrations at the end of this package insert for visual guidance.

• A Pull tab: Used to open the device. Apply the sensor immediately after removing the twist cap.
• B Twist cap: The label on the bottom shows the 6-digit PIN required to pair your sensor with the app.
• C Sensor applicator: Contains the sensor with a needle. The sensor is sterilized by irradiation. The needle retracts into the applicator after application. Keep used applicators away from children. If the applicator housing is damaged and the needle is accessible, discard it according to local regulations to prevent injury. Discard if dropped or if something has fallen on it after the twist cap is removed.
• D Application sites: Select a site on the back of your upper arm.

Applying the Sensor

Follow these steps for sensor application:

1. Download the App: Download a compatible app from go.roche.com/smartguideapp or scan the QR code (if available) with your mobile device's camera. Open the app and follow the on-screen instructions.
2. Prepare the Device: Hold the device upright. Identify the pull tab (A), the white sensor applicator (C) at the top, and the blue twist cap (B) at the bottom.
3. Select and Prepare Application Site: Choose a site on the back of your upper arm (D). If the area has hair, shave it. Wash the site to clean the skin. Disinfect the site with an alcohol wipe and let the skin dry completely. Avoid recently used sites, scars, stretch marks, liver spots, knots, or blood vessels. Ensure the site is at least 7.5 cm (3 inches) away from insulin injection sites.
4. Open the Sterile Barrier: Slightly flip the pull tab (A) open. If the pull tab is already open, discard the device and use a new one.
5. Prepare the Applicator: Do not press on the device. Turn the blue twist cap (B) of the white sensor applicator (C) to open the sterile barrier. You will feel slight resistance and hear a cracking sound. Pull the blue twist cap off the white sensor applicator. Do not touch the needle inside. Do not put the blue twist cap back on after removal.
6. Position for Application: Place the hand of the disinfected arm on your opposite shoulder to tighten the skin.
7. Place the Applicator: Reach under your arm and place the white sensor applicator (C) on the prepared application site (D). Do not touch the inner part. Hold the applicator by its external housing. Ensure the entire bottom of the applicator is flat against your skin.
8. Apply the Sensor: Press down firmly to apply the sensor.
9. Remove the Applicator: Remove the white sensor applicator in the same direction without rotating or wiggling it.
10. Secure the Adhesive: Swipe over the adhesive pad firmly with your finger to ensure it is properly attached.

After applying the sensor, follow the instructions in the app. The sensor can be used for up to 14 days. After this period, remove and dispose of the sensor.

Note: Normally, the sensor applicator can be removed easily. If you have difficulty, press it back down firmly and try again.

Pairing and Calibration

The sensor is now ready to be paired to the app on your mobile device. Follow the instructions in the app to pair and calibrate your sensor.

Notes:

• After applying a new sensor, pair it with the app within 30 minutes. Pairing may take longer after 30 minutes to save battery life. The sensor should also be paired within 30 minutes after a connection loss.
• The sensor requires a warm-up period to become active before CGM values are displayed and calibration is possible.

Before You Get Started

If the use-by date has passed, the sensor can no longer be paired with the app. Do not use an expired device as it may cause infections and abscesses. The use-by date is printed next to the ? symbol on the product packaging and applies to new, unopened products.

Environmental Conditions

The sensor is protected against temporary immersion in water at a depth of 1 meter for up to 60 minutes (IP28).

Transport and Storage Conditions (unopened packaging):

• Temperature range: 2 to 27 °C
• Humidity range: 10 to 90 % (non-condensing)
• Air pressure range: 549 to 1,060 hPa

Operating Conditions:

• Temperature range: 10 to 40 °C
• Humidity range: 15 to 90 % (non-condensing, water vapor partial pressure less than 50 hPa)
• Air pressure range: 700 to 1,060 hPa
• Maximum altitude: 3,000 m (9,842 ft)

Removal and Disposal of Components

Refer to the User's Manual of the Accu-Chek SmartGuide device for removal and disposal instructions.

Declaration of Conformity

Roche hereby declares that the radio equipment type Accu-Chek SmartGuide sensor complies with Directive 2014/53/EU. The full text of the EU declaration of conformity is available at: http://declarations.accu-chek.com

Contact Information

Central America and the Caribbean: Local contact information at: www.accu-chekcac.com/es

Chile: Imported by Roche Chile Ltda. Distributed by BOMI Group. Service: 800 471 350. Email: smartguide.cl@roche.com

Colombia: Imported and Distributed by Productos Roche S.A. INVIMA Registration: 2024DM-0029741. Service: 018000412600. Email: smartguide.co@roche.com

Ecuador: Roche Ecuador S.A. Phone: 1800 732246

Paraguay: Roche Diagnostics Paraguay S. A. Website: www.roche.com.py

Peru: Customer Service: 0800 001 96

Uruguay: Service: 08001196. Tel: +598 26261400. Website: www.accu-chek.com.uy

Brazil: Roche Diagnóstica Brasil Ltda. Consumer Service: 0800 7197210. Email: smartguide.br@roche.com

General Website: www.accu-chek.com

Regulatory Information

Use in vitro diagnostic. This equipment does not have the right to protection against harmful interference and cannot cause interference in properly authorized systems. For more information, consult the ANATEL website: www.anatel.gov.br.

Manufactured in Romania.