Guardian™ Link (3) Transmitter

Product Overview

The Guardian™ Link (3) transmitter is a component of the continuous glucose monitoring (CGM) system for the MiniMed® 670G insulin pump. The transmitter is compatible only with the Guardian™ Sensor (3) glucose sensor. The transmitter collects data from the sensor and wirelessly sends it to the insulin pump.

Components:

• Guardian Link (3) transmitter (MMT-7811)
• Two testers (MMT-7736L)
• Charger (MMT-7715)
• One-press serter (MMT-7512)

Indications for Use

The Guardian Link (3) transmitter is intended for use with the MiniMed 670G System. It powers the glucose sensor, collects and calculates sensor data, and wirelessly sends the data to the MiniMed 670G pump. The transmitter is intended for single-patient, multi-use.

Contraindications

None known.

Warnings

• Do not use the transmitter adjacent to other electrical equipment that may cause interference. This includes mobile communication devices, GPS navigation systems, and devices with an output transmitter power greater than 1W.
• Do not allow children to put small parts in their mouth, as this product poses a choking hazard.
• Do not change or modify the device without express approval from Medtronic Diabetes, as this can cause injury, interfere with operation, and void the warranty.
• Do not use the tester if it comes into contact with blood, as this can cause infection. Dispose of the tester according to medical waste disposal regulations.
• Bleeding may occur after sensor insertion. Ensure the site is not bleeding before connecting the transmitter. Blood can damage the transmitter connector. If damaged, discard the device. Apply pressure with a sterile gauze or clean cloth until bleeding stops.
• Contact the 24 Hour HelpLine if you experience any adverse reactions.
• Do not expose the transmitter to Magnetic Resonance Imaging (MRI) equipment, diathermy devices, or other devices that generate strong magnetic fields. Exposure to strong magnetic fields has not been evaluated and can cause malfunction, serious injury, or be unsafe. If exposed, discontinue use and contact the 24 Hour HelpLine.
• Always remove your sensor and transmitter before entering a room with x-ray, MRI, diathermy, or CT scan equipment.
• Always carry the Medical emergency card when traveling. It provides critical information about airport security systems and using your transmitter on an airplane.

Precautions

• Only use the Guardian Sensor (3) (MMT-7020) glucose sensor with the transmitter.
• Only use the green colored tester (MMT-7736L) with the transmitter.
• Always use the tester when cleaning the transmitter.
• Do not twist the tester or sensor while attached to the transmitter.
• Do not allow the tester to come into contact with any liquid when not connected to the transmitter.
• Do not allow the transmitter to come into contact with any liquid when not connected to a sensor or tester.
• Do not clean the o-rings on the tester with any substances.

Radio Frequency (RF) Communication

This device complies with United States Federal Communications Commission (FCC) and international standards for electromagnetic compatibility, including Part 15 of the FCC Rules. Operation is subject to two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. This device has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC rules, designed to provide reasonable protection against harmful interference in a residential installation. If interference occurs, try to correct it by reorienting or relocating the receiving antenna, increasing the separation between the device and the receiver, decreasing the distance between the transmitter and the insulin pump to 6 feet (1.8 meters) or less, or increasing the separation between the transmitter and the interfering equipment.

Note: Harmful interference is defined by the FCC as any emission, radiation, or induction that endangers the functioning of a radio navigation service or other safety services, or seriously degrades, obstructs, or repeatedly interrupts a radio communications service operating in accordance with FCC rules.

Changes or modifications not expressly approved by Medtronic Diabetes could void the user's authority to operate the equipment.

Directive 1999/5/EC: Medtronic declares that this product is in conformity with the essential requirements of Directive 1999/5/EC on Radio and Telecommunications Terminal Equipment.

IEC60601-1-2:2007; Special EMC Precautions for Medical Electrical Equipment: This body worn device is intended for use in residential, domestic, public, or work environments. It generates, uses, and can radiate radio frequency energy. Portable and mobile RF communications equipment can affect Medical Electrical Equipment. If RF interference is encountered, move away from the RF transmitter causing the interference.

Assistance

Medtronic MiniMed provides a 24 Hour HelpLine. When calling, have your device's serial number available. The serial number and HelpLine phone number are listed on the back of your device.

Charger

The transmitter contains a non-replaceable, rechargeable battery. The charger has a green light for charging status and a red light for problems. The charger requires one AAA alkaline battery.

Note: If the battery is installed incorrectly or is low, the charger will not work.

Installing a battery in the charger:

1. Push the battery cover in and slide it off.
2. Insert a new AAA alkaline battery, ensuring the + and - symbols align with those on the charger.
3. Slide the cover back on the charger until it clicks into place.

Charging the transmitter

Caution: Always charge the transmitter before inserting your sensor. A depleted transmitter does not function. A fully charged transmitter works for at least seven days. A depleted transmitter can take up to two hours to recharge.

Caution: Do not store the transmitter on the charger for more than 60 days. Disconnect and reconnect to the charger to re-charge before use. If left on the charger for over 60 days, the battery will be permanently damaged.

To charge the transmitter:

1. Push the transmitter and charger components together.
2. Within 10 seconds, a green light on the charger will flash for one to two seconds as it powers on. During charging, the green light will flash in a pattern of four flashes with a pause.
3. When charging is complete, the green light on the charger will stay on, without flashing, for 15 to 20 seconds, then turn off.
4. After the green charger light turns off, disconnect the transmitter. The green light on the transmitter will flash 10 times and then turn off.

Pairing Your Transmitter

Always refer to the system user guide for instructions on how to pair your transmitter to your pump.

Inserting the Sensor

Always refer to your sensor user guide for instructions on how to insert the sensor.

Connecting the Transmitter to the Sensor

Before proceeding, have your system user guide available.

To connect the transmitter to the sensor:

1. After the sensor is inserted, consult your sensor user guide for details on applying the required tape before connecting the transmitter.
2. Hold the rounded end of the inserted sensor to prevent it from moving during connection.
3. Hold the transmitter as shown. Line up the two notches on the transmitter with the side arms of the sensor. The flat side of the transmitter should face the skin.
4. Slide the transmitter onto the sensor connector until the sensor arms snap into the notches on the transmitter. If the transmitter is properly connected and the sensor has had enough time to become hydrated, the green light on the transmitter will flash 6 times.

Note: If the transmitter does not flash, see Troubleshooting, on page 14.

5. When the transmitter light flashes green after connecting to the sensor, use your pump to start the sensor. For more instructions, see your system user guide.
6. Attach the adhesive tab of the sensor to the transmitter.
7. Refer to the sensor user guide for instructions on how to apply a second tape.
8. Follow the instructions that appear on the pump screen or in your system user guide.

Disconnecting the Transmitter from the Sensor

Before proceeding, have your system user guide available.

To disconnect the transmitter from the sensor:

1. Carefully remove any tape from the transmitter and sensor.
2. Remove the adhesive tab from the top of the transmitter.
3. Hold the transmitter as shown, and pinch the flexible side arms of the sensor between your thumb and forefinger.
4. Gently pull the transmitter away from the sensor.
5. Follow the instructions that appear on the pump or in your system user guide.

Removing the Sensor

Always refer to the sensor user guide for instructions on how to remove the sensor.

Bathing and Swimming

After the transmitter and sensor are connected, they form a waterproof seal to a depth of 8 feet (2.4 meters) for up to 30 minutes. You can shower and swim without removing them.

Tester

The tester is used to test the transmitter to ensure it is working and is a required component for cleaning the transmitter. Properly connecting the tester to the transmitter prevents fluids from contacting the connector pins. Fluids can cause corrosion and affect performance.

Do not twist the tester while attached to the transmitter, as this will damage it. The tester can be used for one year. Continued use beyond one year may damage the transmitter's connector pins due to the tester's inability to provide a waterproof seal.

Caution: Only use the green colored tester (MMT-7736L) with the transmitter. Pockets on the transmitter are visible when connected to the tester. Do not use any other test plug, as they are not intended for use with the transmitter and will damage both the transmitter and the tester.

Inspecting the Transmitter Connector Pins

Look inside the transmitter's connector opening to ensure the connector pins are not damaged or corroded. Damaged or corroded pins prevent communication with the charger or pump. Contact the 24 Hour HelpLine; it may be time to replace your transmitter.

Also check for moisture inside the connector opening. If moisture is present, allow the transmitter to dry for at least one hour. Moisture can cause the transmitter to malfunction and lead to corrosion and damage over time.

Connecting the tester for testing or cleaning

Before proceeding, have your system user guide available.

To connect the tester:

1. Hold the transmitter and tester as shown. Line up the flat side of the tester with the flat side of the transmitter.
2. Push the tester into the transmitter until the flexible side arms of the tester click into the notches on both sides of the transmitter. When properly connected, the green light on the transmitter flashes 6 times.
3. To test the transmitter, check the sensor icon on the pump to ensure it is sending a signal (see your system user guide).
4. To clean the transmitter, see Cleaning the transmitter, on page 10.
5. After testing or cleaning, disconnect the tester from the transmitter.

Disconnecting the Tester

To disconnect the tester:

1. Hold the transmitter body as shown and pinch the side arms of the tester.
2. With the tester arms pinched, gently pull the transmitter away from the tester.

Note: To save transmitter battery life, do NOT leave the tester connected after cleaning or testing.

Cleaning the Transmitter

The transmitter is a single-patient use device and not intended for multi-patient use.

Warning: Do not discard the transmitter in a medical waste container or expose it to extreme heat. The transmitter contains a battery that may ignite and result in serious injury.

Note: The tester is a required component for cleaning the transmitter.

Always clean the transmitter after each use.

To clean the transmitter, you need:

• Mild liquid soap (e.g., Ivory® liquid soap)
• Soft-bristled toddler toothbrush
• Container
• Clean, lint-free dry cloths

These supplies can be found at Walmart, Target, or http://www.amazon.com/.

Use life:

The transmitter can be cleaned up to 122 times or one year, whichever comes first. Discard the transmitter at this point. Continued use beyond 122 times or one year may damage the device. Contact Medtronic to order a new transmitter.

To clean the transmitter:

1. Wash your hands thoroughly.
2. Attach the tester to the transmitter.
3. If there is adhesive residue on the transmitter, see Removing adhesive residue, on page 13.
4. Rinse the transmitter under room temperature tap water for at least one minute, until visibly clean. Ensure all hard-to-reach areas are rinsed completely.
5. Prepare a mild liquid soap solution using 1 teaspoon (5 milliliters) of mild liquid soap per 1 gallon (3.8 liters) of room temperature tap water.
6. With the tester still attached, submerge the transmitter in the mild liquid soap solution and soak for one minute.
7. Holding the tester, brush the entire surface of the transmitter using a soft-bristled toddler toothbrush. Brush all hard-to-reach areas until visibly clean.
8. Rinse the transmitter under running room temperature tap water for at least one minute, until all visible liquid soap is gone.
9. Dry the transmitter and tester with a clean, dry cloth.
10. Place the transmitter and tester on a clean, dry cloth and air dry them completely.
11. Disconnect the tester from the transmitter by gently squeezing the arms of the tester.

Removing Adhesive Residue

If adhesive residue is present on the transmitter, follow these instructions:

To remove adhesive residue:

1. Make sure the tester is attached to the transmitter.
2. 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. See Cleaning the transmitter, on page 10 for details.

Cleaning the Charger

This procedure is for general cleaning as required, based on physical appearance.

Caution: Do not immerse the charger in water or any other cleaning agent. The charger is not waterproof. Water can damage the charger and cause malfunction.

Warning: Dispose the charger according to local regulations for battery disposal, or contact your healthcare professional for disposal information. The charger may ignite upon incineration.

To clean the charger:

1. Wash your hands thoroughly.
2. Use a damp cloth with mild cleaning solution (e.g., dishwashing detergent) to clean any dirt or foreign material from the outside of the charger. Never use organic solvents like paint thinner or acetone.
3. Place the charger on a clean, dry cloth and air dry for two to three minutes.

Troubleshooting

Storing the Devices

Store the transmitter, charger, and tester in a clean, dry location at room temperature. If the transmitter is not in use, charge it at least once every 60 days. You may store the transmitter on the charger, but disconnect and reconnect the charger and transmitter at least once every 60 days. If the transmitter is left on the charger for more than 60 days, the battery will be permanently damaged.

Disposal

Discard the transmitter according to local regulations for battery disposal, or contact your healthcare professional for disposal information.

Specifications

Transmitter Wireless Communication

Quality of service

The transmitter and the MiniMed 670G insulin pump are part of an 802.15.4 network. In an adverse RF environment, the pump assesses channel changing needs based on detected "noise" levels. The pump performs an energy scan if no CGM transmitter signal is received after 10 minutes. If a channel change occurs, the pump sends beacons on the new channel. The transmitter initiates a channel search when beacon detection fails. The search covers all five channels. Upon re-association, any missed packets (up to 10 hours) will be transmitted. In normal operation, the transmitter sends a packet every 5 minutes and retransmits if the data is corrupted or missed.

Data security

The MiniMed 670G insulin pump accepts only RF communications from recognized and linked devices. Program your pump to accept information from a specific device.

The MiniMed 670G insulin pump and system components ensure data security via proprietary means and data integrity using error checking processes.

Traveling by Air

Your transmitter is safe for use on commercial airlines. If questioned by airline personnel, show them your Medical emergency card. Comply if requested to turn off your system.

Guidance and Manufacturer's Declaration

Guidance and Manufacturer's Declaration - Electromagnetic Emissions

The transmitter is intended for use in the electromagnetic environment specified below. The customer or user should ensure it is used in such an environment.

Guidance and Manufacturer's Declaration - Electromagnetic Immunity

The transmitter is intended for use in the electromagnetic environment specified below. The customer or user should assure that it is used in such an environment.

Note: At 80 MHz and 800 MHz, the higher frequency range applies. These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption, and reflection from structures, objects and people.

Recommended separation distances between portable and mobile RF communications equipment and the transmitter

The transmitter is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the transmitter users can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment and the transmitter as recommended below, according to the maximum output power of the communications equipment.

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where p is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

Warranty

Medtronic MiniMed, Inc. warrants the Medtronic transmitter and charger against defects in material and workmanship for a period of one (1) year from the date of purchase. During the warranty period, Medtronic MiniMed will replace or repair, at its discretion, any defective transmitter or charger, subject to the conditions and exclusions stated herein. This warranty applies only to new devices. If a transmitter or charger is replaced, the warranty period will not be extended past its original expiration date.

This warranty is valid only if the Medtronic transmitter or charger is used in accordance with the manufacturer's instructions. This warranty will not apply:

• If damage results from changes or modifications made by the user or third parties after purchase.
• If damage results from service or repairs performed by anyone other than the manufacturer.
• If damage results from a Force Majeure or other event beyond the manufacturer's control.
• If damage results from negligence or improper use, including improper storage, submersion in water, or physical abuse (such as dropping).
• If damage results from use of the device in a manner other than according to the manufacturer's product labeling, instructions for use, or regulatory notifications.

This warranty is personal to the original purchaser. Any sale, rental, or transfer of the product covered by this warranty to a user other than the original purchaser terminates this warranty immediately. This warranty does not apply to Glucose Sensors and other accessories.

The remedies provided herein are the exclusive remedies available for any breach. Medtronic MiniMed, its suppliers, or distributors shall not be liable for any incidental, consequential, or special damage of any nature or kind caused by or arising out of a defect in the product.

All other conditions and warranties, other than mandatory statutory warranties, expressed or implied, are excluded, including the warranties of merchantability and fitness for a particular purpose.

This warranty gives the purchaser specific legal rights, and the purchaser may also have other rights that vary under local law. This warranty does not affect the purchaser's statutory rights.

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