Medtronic Confidential mdvtldct_R1.5 M958549A_fc.fm 3/12/15 2:34 pm 4" x 8" (101 mm x 203 mm) SEEQ™ Mobile Cardiac Telemetry (MCT) System _______________________________________ Draft for Radio Regulatory submission to FCC Created March 12, 2015 _______________________________________ Instructions for use Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. M958549A001 Rev B Refer to doc # A73903 for Printing Instructions.
M958549A_fc.fm 3/12/15 2:34 pm 4" x 8" (101 mm x 203 mm) Medtronic Confidential mdvtldct_R1.5 The following list includes trademarks or registered trademarks of Medtronic in the United States and possibly in other countries. All other trademarks are the property of their respective owners. Medtronic, SEEQ M958549A001 Rev B Refer to doc # A73903 for Printing Instructions.
Medtronic Confidential mdvtldct_R1.5 M958549A_ch.
Medtronic Confidential mdvtldct_R1.5 M958549A_ch.fm 3/12/15 2:34 pm 4" x 8" (101 mm x 203 mm) ▪ The SEEQ MCT System is not intended to replace direct communication with healthcare providers. Medtronic does not provide medical advice to patients. Patients should communicate with their prescribing physician to obtain medical advice. ▪ Data provided by the system should be used by physicians along with all other clinical findings and exams to come to a diagnosis.
Medtronic Confidential mdvtldct_R1.5 M958549A_ch.fm 3/12/15 2:34 pm 4" x 8" (101 mm x 203 mm) The Transmitter Charger is used to charge the Transmitter. The Prep Wipes are used for cleaning skin before applying the Wearable Sensor. Product Literature Literature includes these instructions and other information for patients. Step 2: Charge the Transmitter ▪ Connect the Transmitter Charger connector to the Transmitter and plug it into a standard electrical outlet.
Medtronic Confidential mdvtldct_R1.5 M958549A_ch.fm 3/12/15 2:34 pm 4" x 8" (101 mm x 203 mm) Step 3: Prepare for Wearable Sensor application • Trim as much hair as possible from the intended location (for men) on the upper left chest, as seen in the diagram (for example, using an electric razor or hair trimmer). Trim an area slightly larger than the Wearable Sensor.
Medtronic Confidential mdvtldct_R1.5 M958549A_ch.fm 3/12/15 2:34 pm 4" x 8" (101 mm x 203 mm) Step 4: Apply the Wearable Sensor to your chest ▪ Bring the Wearable Sensor close to your upper left chest, taking care to hold it only as described in Step 3. ▪ As seen in the diagrams below, position the end of the Wearable Sensor with the Medtronic logo pointing upwards just below the collarbone and angle the device towards the nipple.
Medtronic Confidential mdvtldct_R1.5 M958549A_ch.fm 3/12/15 2:34 pm 4" x 8" (101 mm x 203 mm) ▪ Petite patients can angle the Wearable Sensor slightly away from the nipple and towards the left arm for a comfortable fit, as seen below. Collarbone Sternum ▪ Once applied, use the palm of your hand to firmly apply pressure across the surface of the Wearable Sensor. Then, use your fingers to press the edges of the Wearable Sensor onto your skin.
M958549A_ch.fm 3/12/15 2:34 pm 4" x 8" (101 mm x 203 mm) Medtronic Confidential mdvtldct_R1.5 Step 5: Confirm the Wearable Sensor has activated • If you see a single blinking green light within the circle symbol, it means the Wearable Sensor is working properly. • If you DO NOT see this light within 15 minutes of application, please call Medtronic Customer Support at 1-877-247-7449. Key things to remember ▪ Do not dispose of the SEEQ MCT System box or the postal return label.
Medtronic Confidential mdvtldct_R1.5 M958549A_ch.fm 3/12/15 2:34 pm 4" x 8" (101 mm x 203 mm) IMPORTANT: You may be contacted by a technician from the Medtronic Monitoring Center to discuss symptoms when the Patient Trigger Button is used.
Medtronic Confidential mdvtldct_R1.5 M958549A_ch.fm 3/12/15 2:34 pm 4" x 8" (101 mm x 203 mm) How to charge the Transmitter ▪ Charge the Transmitter daily (for example, every night while you sleep). ▪ The Transmitter may take up to 6 hours to fully charge. ▪ With an adequate charge, the Transmitter can be used for up to 12 hours before needing to be recharged. ▪ The Linked, Cell, and Send lights on the Transmitter are utilized by Medtronic Customer Support for troubleshooting.
Medtronic Confidential mdvtldct_R1.5 M958549A_ch.fm 3/12/15 2:34 pm 4" x 8" (101 mm x 203 mm) • If you see a single blinking green light within the filled circle symbol , this means the Wearable Sensor is working properly. You should continue to wear the device. • If you also see two red lights within the circle with a crossed line symbol , you should remove and replace the device with a new Wearable Sensor (unless your monitoring period is over).
Medtronic Confidential mdvtldct_R1.5 M958549A_ch.fm 3/12/15 2:34 pm 4" x 8" (101 mm x 203 mm) ▪ Place the Wearable Sensors, the Transmitter, the Transmitter Charger, and the Transmitter Case in the original box. ▪ Attach the postal return label to the outside of the package. ▪ Place the package in the mail. No additional postage is required. IMPORTANT: Please return the components only when your prescription is complete.
Medtronic Confidential mdvtldct_R1.5 M958549A_ch.fm 3/12/15 2:34 pm 4" x 8" (101 mm x 203 mm) Indications for use, contraindications, and precautions Indications for use The SEEQ Mobile Cardiac Telemetry (MCT) System is intended to continuously measure, record, and periodically transmit physiological data.
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Medtronic Confidential mdvtldct_R1.5 M958549A_ch.fm 3/12/15 2:34 pm 4" x 8" (101 mm x 203 mm) Services for physicians Prescription duration: After registering with Medtronic, physicians can prescribe the SEEQ MCT System for up to 30 days at a time. As each Wearable Sensor is designed to last for up to 7.5 days, prescription lengths greater than one week will be enabled through the use of more than one Wearable Sensor.
Medtronic Confidential mdvtldct_R1.5 M958549A_ch.fm 3/12/15 2:34 pm 4" x 8" (101 mm x 203 mm) Specifications, compliance, and symbols Specifications The following performance specifications are at 68 °F (20 °C) unless otherwise stated. Wearable Sensor Transmitter Shelf life Refer to Wearable N/A Sensor pouch label Battery Charger power requirement N/A 100-240 VAC, 50/60 Hz Battery life 7.
Medtronic Confidential mdvtldct_R1.5 M958549A_ch.fm 3/12/15 2:34 pm 4" x 8" (101 mm x 203 mm) Arrhythmia Detection Algorithms and Automatic ECG Collection In addition to patient-triggered collection of ECGs using the Patient Trigger Button, the SEEQ MCT System also uses proprietary algorithms based on rate, rhythm, and morphology to continuously analyze rhythm abnormalities and to initiate automatic ECG transmission.
Medtronic Confidential mdvtldct_R1.5 M958549A_ch.fm 3/12/15 2:34 pm 4" x 8" (101 mm x 203 mm) Redundant reporting of ECGs for this select set of arrhythmias is managed as follows: ▪ The Wearable Sensor will report no more than two (2) ECGs for each of these arrhythmias each hour. ▪ The Wearable Sensor will wait ten (10) minutes before allowing a subsequent ECG to be reported for each of these arrhythmias.
Medtronic Confidential mdvtldct_R1.5 M958549A_ch.fm 3/12/15 2:34 pm 4" x 8" (101 mm x 203 mm) Exposure to radio frequency signals To maintain compliance with FCC RF exposure guidelines when you carry the Transmitter on your body, use only the Transmitter Case supplied by Medtronic. Be sure to insert the Transmitter in the case as instructed in “How to use the Transmitter”.
Medtronic Confidential mdvtldct_R1.5 M958549A_ch.fm 3/12/15 2:34 pm 4" x 8" (101 mm x 203 mm) Non-sterile Manufacturer’s name and address Temperature limitations Collection of electrical and electronic equipment The entire Wearable Sensor is a type BF applied part; Denotes device is not in direct contact with cardiac muscle Wireless transmission symbol Ingress Protection 3 means protection against objects >=2.
Medtronic Confidential mdvtldct_R1.5 M958549A_ch.fm 3/12/15 2:34 pm 4" x 8" (101 mm x 203 mm) What do I do when I feel symptoms? Whenever symptoms occur, trigger the Wearable Sensor to transmit a record of your heart activity by pushing the blue Patient Trigger Button located in the middle of the Wearable Sensor until you hear a beep. An ECG will be transmitted to the Transmitter and then transmitted to the Medtronic Monitoring Center for review and delivery to your physician.
Medtronic Confidential mdvtldct_R1.5 M958549A_ch.fm 3/12/15 2:34 pm 4" x 8" (101 mm x 203 mm) Can I wear a Wearable Sensor through an electronic antitheft system, such as in a store? Yes, the Wearable Sensor will not set off antitheft systems and will not be damaged by them. Can I use microwave ovens or TV remotes while wearing a Wearable Sensor? Yes, it is safe to operate these devices as they will not affect performance of the Wearable Sensor.
Medtronic Confidential mdvtldct_R1.5 M958549A_ch.fm 3/12/15 2:34 pm 4" x 8" (101 mm x 203 mm) 24 English M958549A001 Rev B SEEQ MCT Instructions for use Refer to doc # A73903 for Printing Instructions.
M958549AUS_bc.fm 3/12/15 2:34 pm 4" x 8" (101 mm x 203 mm) M958549A001 Rev C Medtronic Confidential mdvtldct_R1.5 Refer to doc # A73903 for Printing Instructions.
M958549AUS_bc.fm 3/12/15 2:34 pm 4" x 8" (101 mm x 203 mm) Medtronic, Inc. 710 Medtronic Parkway Minneapolis, MN 55432 USA www.medtronic.com +1 763 514 4000 Medtronic Confidential mdvtldct_R1.5 Europe/Middle East/Africa Medtronic International Trading Sàrl Route du Molliau 31 Case Postale 84 CH-1131 Tolochenaz Switzerland +41 21 802 7000 © Medtronic, Inc. 2015 M958549A001C 2015-03-12 *M958549A001* M958549A001 Rev C Refer to doc # A73903 for Printing Instructions.
