CAUTION: Investigational Device Limited by Federal Law to Investigational Use.
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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 Latvija: Ravemma Ltd. Tel: +371 7273780 Macedonia: Kemofarm Tel: +389 2 260 36 03 Fax: +389 2 260 36 49 Magyarország: Medtronic Hungária Kft. Tel: +36 1 889 0688 Malaysia: Medtronic International Ltd.
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.
Guardian Link transmitter kit components A complete Guardian Link transmitter kit includes the following components: • • Guardian Link transmitter (MMT-7763) Watertight Tester (MMT-7726) • • Charger (MMT-7715) Enlite Serter (MMT-7510) Indications for use The transmitter is indicated for single-patient use as a component of select Medtronic continuous glucose sensing systems and MiniMed sensor-enabled pump systems.
Contact the 24 Hour HelpLine if you experience any adverse reactions associated with the transmitter or sensor. 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.
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.
Caution: Changes or modifications to the internal RF transmitter or antenna not expressly approved by Medtronic could void the user's authority to operate this insulin delivery system. 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.
To install a battery in the charger: 1 2 3 Push the battery cover in and slide it off (as shown in the following illustration). 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 six days without recharging.
Inserting the sensor Always refer to the serter user guide for instructions on how to insert the sensor. 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.
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.
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 housing 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.
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.
2 3 4 5 6 7 8 9 Rinse the transmitter under room temperature tap water for at least one minute, and until visibly clean. Make sure all hard-to-reach areas are rinsed completely. Prepare a mild liquid soap solution using one (1) teaspoon of mild liquid soap per one (1) gallon of room temperature tap water. With tester still attached, submerge the transmitter in the mild liquid soap solution and soak for one minute.
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.
Problem The green light on the transmitter does not flash when you connect it to the sensor. Likely Cause(s) 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. 4 The sensor may not be properly inserted into your body.
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.
Battery life Transmitter: Six days of continuous glucose monitoring immediately following a full charge Charger: Completes 40 typical charging operations using a new AAA alkaline battery Transmitter frequency 2.4 GHz, 2M65G1D modulation, less than 1mW ERP Transmitter expected life The transmitter expected life is 1 year depending on patient usage. Guardian Link wireless communication Quality of service The Guardian Link transmitter and the MiniMed 640G insulin pump are associated as part of an 802.15.
Guidance and Manufacturer's Declaration - Electromagnetic Emissions The Guardian Link transmitter is intended for use in the electromagnetic environment specified below. The customer or the user of the Guardian Link should make sure that it is used in such an environment. Emissions Test Compliance RF emissions Group 1 The Guardian Link must emit electromagnetic energy in order to perform its intended function. Nearby electronic equipment may be affected.
Guidance and Manufacturer's Declaration - Electromagnetic Immunity The Guardian Link is intended for use in the electromagnetic environment specified below. The customer or the user of the Guardian Link should assure that it is used in such an environment.
The Guardian Link is intended for use in the electromagnetic environment specified below. The customer or user of the Guardian Link 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.
Recommended separation distances between the Guardian Link and common household radio transmitters 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.
The Guardian Link is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the Guardian Link users can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment and the Guardian Link as recommended below, according to the maximum output power of the communications equipment.
Radio communication 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 ©2013 Medtronic MiniMed, Inc. All rights reserved. MiniMed™, Enlite™, and Guardian™ are trademarks of Medtronic MiniMed, Inc.
MMT-7763 MMT-7726 MMT-7715 MMT-7510 6025955-011_1
