MP6025977-021 / 1 GST3C Transmitter D E S A E L RE CAUTION: Investigational Device. Limited by Federal Law to Investigational Use.
MP6025977-021 / 1 D E S RE A E L
MP6025977-021 / 1 Contacts: Africa: Medtronic Africa (Pty) Ltd. Tel: +27 (0) 11 677 4800 Australia: Medtronic Australasia Pty. Ltd. Tel: 1800 668 670 (product orders) Tel: 1800 777 808 (customer help) Deutschland: Medtronic GmbH Geschäftsbereich Diabetes Telefon: +49 2159 8149-370 Telefax: +49 2159 8149-110 24-Stdn-Hotline: 0800 6464633 Eire: Accu-Science LTD. Tel: +353 45 433000 Azerbaijan: Albatros Health Care Tel: +994 12 498 9537 España: Medtronic Ibérica S.A.
MP6025977-021 / 1 Kazakhstan: Medtronic Kazakhstan B.V. Tel: +77273110580 Puerto Rico: Medtronic Puerto Rico Tel: 787-753-5270 Latin America: Medtronic, Inc. Tel: 1(305) 500-9328 Fax: 1(786) 709-4244 Republic of Korea: Medtronic Korea, Co., Ltd. Tel: +82.2.3404.3600 Romania: Trustmed SRL Tel: +40 (0) 21 220 6477 Latvija: Ravemma Ltd.
MP6025977-021 / 1 USA: Medtronic Diabetes Global Headquarters Tel: +1-800-646-4633 24 Hour HelpLine: +1-800-826-2099 To order supplies: +1-800-843-6687 Ukraine: Med EK Service Ltd. Tel: +380445457705 United Kingdom: Medtronic Ltd. Tel: +44 1923-205167 Österreich: Medtronic Österreich GmbH Tel: +43 (0) 1 240 44-0 24 – Stunden – Hotline: 0820 820 190 Česká republika: Medtronic Czechia s.r.o.
MP6025977-021 / 1 D E S RE A E L
MP6025977-021 / 1 Transmitter kit components A complete GST3C transmitter kit includes the following components: • • GST3C transmitter (MMT-7811) Watertight Tester (MMT-7726) • Indications for use Charger (MMT-7715) D E S The transmitter is indicated for single-patient use as a component of select Medtronic continuous glucose sensing systems and MiniMed sensor-enabled pump systems.
MP6025977-021 / 1 Magnetic fields Do not expose your transmitter to MRI equipment, diathermy devices, or other devices that generate strong magnetic fields. If your transmitter is inadvertently exposed to a strong magnetic field, discontinue use and contact the 24 Hour HelpLine for further assistance.
MP6025977-021 / 1 D E S A E L This device can generate, use, and radiate radio frequency energy and, if installed and used in accordance with the instructions, may cause harmful interference to radio communications. If the device does cause interference to radio or television reception, you are encouraged to try to correct the interference by one or more of the following measures: • Decrease the distance between the transmitter and the insulin pump to 6 feet (1.8 meters) or less.
MP6025977-021 / 1 For Canada only This device complies with Industry Canada licence-exempt RSS standard(s). Operation is subject to the following two conditions: (1) this device may not cause interference, and (2) this device must accept any interference, including interference that may cause undesired operation of the device. Le présent appareil est conforme aux CNR d'Industrie Canada applicables aux appareils radio exempts de licence.
MP6025977-021 / 1 3 Insert a new alkaline AAA or LR-03 battery. Make sure the + and - symbols on the battery align with these same symbols shown on the charger. Slide the cover back on the charger until it clicks into place. Charging the transmitter Caution: Charge the transmitter after each sensor use. A fully charged transmitter works at least seven days without recharging. A depleted transmitter can take up to one hour to recharge.
MP6025977-021 / 1 Connecting the transmitter to the sensor Before proceeding, have available your pump user guide. To connect the transmitter to the sensor: 1 2 3 4 5 6 7 8 After the sensor is inserted, consult your serter user guide for details on applying the required overtape. Hold the rounded end of the inserted sensor to prevent it from moving during connection. Hold the transmitter as shown. Line up the two notches on the transmitter with the side arms of the sensor.
MP6025977-021 / 1 Before proceeding, have available your pump user guide. To disconnect the transmitter from the sensor: 1 2 3 4 5 Carefully remove any occlusive dressing from the transmitter and sensor. For the Enlite sensor, remove the adhesive tab from the top of the transmitter. Hold the transmitter as shown, and pinch the flexible side arms of the sensor between your thumb and forefinger. Gently pull the transmitter away from the sensor.
MP6025977-021 / 1 Caution: Only use the Watertight Tester with the transmitter. Do not use any other test plug. ✓ i Inspecting the transmitter connector pins This image is an example of how the connector pins should look. connector opening connector pins D E S housing A E L Look inside the transmitter’s connector opening to make sure that the connector pins are not damaged or corroded. If the connector pins are damaged or corroded, the transmitter cannot communicate with the charger or pump.
MP6025977-021 / 1 To connect the tester: 1 2 3 4 5 6 Hold the transmitter and the tester as shown. Line up the flat side of the tester with the flat side of the transmitter. Push the tester into the transmitter until the flexible side arms of the tester click into the notches on both sides of the transmitter. Within five seconds, when properly connected, the green light on the transmitter flashes for about 10 seconds.
MP6025977-021 / 1 Warning: Cracking, flaking, or damage of the housing are signs of deterioration and the performance of the device may be compromised. This may affect the ability to properly clean and disinfect the transmitter. If these signs are noted, stop using the device and call the 24 Hour HelpLine. The device must be discarded according to local regulations for battery disposal (non-incineration). To clean the transmitter: 1 Wash your hands thoroughly. 2 Attach the tester to the transmitter.
MP6025977-021 / 1 7 Holding the tester, brush the entire surface of the transmitter using a soft-bristled toddler toothbrush. Make sure to brush all hard-to-reach areas until visibly clean. A E L D E S 8 Rinse the transmitter under running room temperature tap water for at least one minute, and until all visible liquid soap is gone. RE -11- English 6 With tester still attached, submerge the transmitter in the cleaning solution and soak for one minute.
MP6025977-021 / 1 9 Dry the transmitter and tester with a clean, dry cloth. 10 Holding the tester, wipe the transmitter with 70% isopropyl alcohol. D E S A E L 11 Place the transmitter and tester on a clean, dry cloth and air dry them completely. 12 Disconnect the tester from the transmitter. RE Removing adhesive residue You may need to perform this procedure only if you have used optional occlusive dressing, which may leave adhesive residue on the transmitter.
MP6025977-021 / 1 To remove adhesive residue: 1 2 Make sure the tester is attached to the transmitter. Holding the tester, saturate a cotton swab in the Detachol solution and gently rub the adhesive residue on the transmitter until it is fully removed. 3 Continue with the cleaning procedure above. D E S Cleaning the charger This procedure is for general cleaning as required, based on physical appearance. A E L Caution: The charger is NOT waterproof.
MP6025977-021 / 1 Problem You connected the transmitter to the charger and no lights came on. Likely Cause(s) Resolution The transmitter connector pins are damaged or corroded. 1 Check the transmitter connector pins for damage or moisture. For more information about your connector pins, see Inspecting the transmitter connector pins, on page 8. If the pins are damaged or corroded, contact the 24 Hour HelpLine or your local representative. It may be time to replace your transmitter.
MP6025977-021 / 1 The green light on the transmitter does not flash when you connect it to the sensor. Likely Cause(s) Resolution Your transmitter is not fully connected. 1 Disconnect the transmitter from the sensor. Your transmitter is low on power. 2 Wait for five seconds and reconnect them. If the green light still does not flash, proceed to step 3. 3 Fully charge the transmitter. If the green light still does not flash, proceed to step 4.
MP6025977-021 / 1 Problem Your transmitter has lost connection with your pump. Likely Cause(s) Resolution Your pump is out of range. 1 Move away from any device that can cause RF interference. For more information on RF interference, see Radio Frequency (RF) communication, on page 2. If your transmitter is still not communicating with your pump, proceed to step 2. 2 Make sure your pump and your transmitter are located on the same side of your body to minimize any RF interference.
MP6025977-021 / 1 Transmitter temperature: -13°F to 131°F (-25°C to 55°C) Transmitter relative humidity: 10% to 100% with condensation Transmitter pressure: 8.9 to 15.4 psi (61.36 to 106.
MP6025977-021 / 1 The MiniMed 640G insulin pump and system components (meters and transmitters) ensure data security via proprietary means and ensures data integrity using error checking processes, such as cyclic redundancy checks. Guidance and manufacturer's declaration Guidance and Manufacturer's Declaration - Electromagnetic Emissions The GST3C transmitter is intended for use in the electromagnetic environment specified below.
MP6025977-021 / 1 The GST3C transmitter is intended for use in the electromagnetic environment specified below. The customer or the user of the GST3C transmitter should assure that it is used in such an environment. Immunity Test Voltage dips, short interruptions and voltage variations on power supply lines IEC 60601 Test Level Compliance Level Electromagnetic Environment - Guidance <5% UT (>95% dip in UT) for 0.5 cycle Not applicable Requirement does not apply to this battery powered device.
MP6025977-021 / 1 Guidance and Manufacturer's Declaration - Electromagnetic Immunity The GST3C transmitter is intended for use in the electromagnetic environment specified below. The customer or user of the GST3C transmitter should assure that it is used in such an electromagnetic environment. Immunity Test Radiated RF IEC 61000-4-3 IEC 60601 Level 3 V/m 80 MHz to 6 GHz Compliance Lev- Electromagnetic Environel ment Guidance 10 V/m 80 MHz to 6 GHz d = 0.35 P 80 MHz to 800 MHz d = 0.
MP6025977-021 / 1 Household RF Transmitter Frequency Recommended Separation Distance (meter) Recommended Separation Distance (inch) Telephones Cordless Household 2.4 GHz 0.3 12 Cordless Household 5.8 GHz 0.3 12 TDMA-50 Hz (cell phone) 1.9 GHz 0.3 12 TDMA-50 Hz (cell phone) 800 MHz 0.3 12 PCS (cell phone) 1.9 MHz 0.3 12 DCS (cell phone) 1.8 MHz 0.3 12 GSM (cell phone) 900 MHz 0.3 12 GSM (cell phone) 850 MHz 0.3 12 CDMA (cell phone) 800 MHz 0.
MP6025977-021 / 1 Recommended separation distances between portable and mobile RF communications equipment and the GST3C transmitter The GST3C transmitter is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
MP6025977-021 / 1 Configuration Type BF equipment (protection from electrical shock) IP48 Transmitter: Protected against the effects of continuous immersion in water (8 feet (2.4 meters) immersion for 30 minutes). Attention: Read all warnings and precautions in instructions for use. Storage humidity range ©2014 Medtronic MiniMed, Inc. All rights reserved. MiniMed™, Enlite™, and Guardian™ are trademarks of Medtronic MiniMed, Inc.
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MP6025977-021 / 1 D E S RE A E L
MP6025977-021 / 1 D E S A E L RE MMT-7811 MMT-7726 MMT-7715 6025977-021_1
