Disposable Sensor User Guide CAUTION: Investigational Device Limited by Federal Law to Investigational Use Exclusively for Clinical Investigation
English Introduction The DS5 is designed to detect, measure, store the interstitial glucose signal, and sensor diagnostic data throughout the duration of sensor wear. At the end of the study, the sensor is removed from the patient and the stored data is downloaded using a personal computer (PC) download application. The DS5 sensor is preloaded into the disposable inserter.
has been broken. Do not use the DS5 if the device is damaged or the tamper evidence tape is broken. Use of an unsterile DS5 can cause site infection. Do not change or modify the DS5. Changing or modifiying the DS5 can result in improper insertion, pain, or injury. Do not allow children to put the small parts in their mouth. This product poses a choking hazard for young children. Watch for bleeding at the insertion site on top of the sensor.
IEC 60601-1-2: 4th Edition; Special EMC Precautions for Medical Electrical Equipment • Special Precautions regarding Electromagnetic Compatibility (EMC): This body worn device is intended to be operated within a reasonable residential, domestic, public or work environment where common levels of radiated “E” (V/m) or “H” fields (A/m) exist, such as cellular phones, Wi-Fi™*, Bluetooth™* wireless technology, electric can openers, microwave and induction ovens.
Approximately 3 μg of glucose oxidase and approximately 10 μg of HSA are used to manufacture each DS5. HSA is approved for IV infusion in humans at quantities much larger than in the DS5.
Where to insert the DS5 Choose an insertion site that has an adequate amount of fatty tissue. The DS5 is being investigated for use in particular insertion sites for specific age ranges. DS5 insertion sites The following table and images show the DS5 insertion sites for each age range.
For the best sensor performance, and to avoid accidental sensor removal, do not insert the DS5 into the following places. • • • • Muscle Areas with tough skin or scar tissue Areas subjected to rigorous movement during exercise Areas under a belt or on the waistline Inserting the DS5 WARNING: Wear gloves when inserting the DS5 into someone other than yourself to avoid contact with patient blood. Minimal bleeding can occur. Contact with patient blood can cause infection.
4 4. Unscrew the cap from the inserter, breaking the tamper evidence tape. 5 5. Place the inserter on top of the prepared insertion site. 6 6. Press the inserter firmly against the body until you hear a click. 7 7. Gently pull the inserter away from the body.
8 8. Smooth down the sensor adhesive with your finger, to ensure the sensor stays on the body for the entire length of wear. Note: Use over-the-counter (OTC) tape if needed for additional adhesion. Removing the sensor Warning: Wear gloves when removing the sensor from another person to avoid contact with patient blood. Minimal bleeding can occur. Contact with patient blood can cause infection. Carefully peel off the sensor adhesive and the sensor from the skin.
104°F (2°C to 40°C). The sensor has an air pressure range from 700 hPa to 1060 hPa (10.2 psi to 15.4 psi). The sensor has an operating relative humidity (RH) range of 15% to 90%. Storage CAUTION: Do not freeze the sensor, or store it in direct sunlight, extreme temperatures, or humidity. These conditions may damage the sensor. Only store sensors at room temperature between 36°F to 86°F (2°C to 30°C). Do not store the sensor above its relative humidity (RH) of 95%.
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MMT-5100CL M811476A011DOC_3
