M957944A_fc.fm 4/11/14 10:30 am 5.5" x 7.0" (139.7 mm x 177.8 mm) Medtronic Confidential Starlight_Pat_R1.5 M957944A001.book Page 1 Friday, April 11, 2014 10:30 AM MyCareLink Smart™ Patient Reader 25000 Patient Manual Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. M957944A001 Rev A Refer to the doc #xxxxxx for Printing Instructions.
M957944A_fc.fm 4/11/14 10:30 am 5.5" x 7.0" (139.7 mm x 177.8 mm) Medtronic Confidential Starlight_Pat_R1.5 M957944A001.book Page 2 Friday, April 11, 2014 10:30 AM 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.
M957944A_fc.fm 4/11/14 10:30 am 5.5" x 7.0" (139.7 mm x 177.8 mm) Medtronic Confidential Starlight_Pat_R1.5 M957944A001.book Page 3 Friday, April 11, 2014 10:30 AM Follow instructions for use (blue) Package contents patient reader Product documentation Non-ionizing electromagnetic radiation Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. Do not dispose of this product in the unsorted municipal waste stream.
M957944A_fc.fm 4/11/14 10:31 am 5.5" x 7.0" (139.7 mm x 177.8 mm) Medtronic Confidential Starlight_Pat_R1.5 M957944A001.book Page 4 Friday, April 11, 2014 10:30 AM For US audiences only Manufacturer Date of manufacture Authorized representative in the European community System meets the applicable Canadian and U.S. electrical safety standards. M957944A001 Rev A Refer to the doc #xxxxxx for Printing Instructions.
M957944A001TOC.fm 4/11/14 10:31 am 5.5" x 7.0" (139.7 mm x 177.8 mm) Medtronic Confidential Starlight_Pat_R1.5 M957944A001.
M957944A001TOC.fm 4/11/14 10:31 am 5.5" x 7.0" (139.7 mm x 177.8 mm) Medtronic Confidential Starlight_Pat_R1.5 M957944A001.book Page 6 Friday, April 11, 2014 10:30 AM 6 M957944A001 Rev A Refer to the doc #xxxxxx for Printing Instructions.
M957944A001TOC.fm 4/11/14 10:31 am 5.5" x 7.0" (139.7 mm x 177.8 mm) Medtronic Confidential Starlight_Pat_R1.5 M957944A001.book Page 7 Friday, April 11, 2014 10:30 AM 7 M957944A001 Rev A Refer to the doc #xxxxxx for Printing Instructions.
M957944A001TOC.fm 4/11/14 10:31 am 5.5" x 7.0" (139.7 mm x 177.8 mm) Medtronic Confidential Starlight_Pat_R1.5 M957944A001.book Page 8 Friday, April 11, 2014 10:30 AM 8 M957944A001 Rev A Refer to the doc #xxxxxx for Printing Instructions.
M957944A_ch.fm 4/11/14 10:31 am 5.5" x 7.0" (139.7 mm x 177.8 mm) Medtronic Confidential Starlight_Pat_R1.5 M957944A001.book Page 9 Friday, April 11, 2014 10:30 AM Introduction This manual is intended to help you use the Medtronic MyCareLink Smart™ 25000 Patient Reader (patient reader). If you have any questions setting up or using the patient reader, or if you have problems with the patient reader, please contact Medtronic.
M957944A_ch.fm 4/11/14 10:31 am 5.5" x 7.0" (139.7 mm x 177.8 mm) Medtronic Confidential Starlight_Pat_R1.5 M957944A001.book Page 10 Friday, April 11, 2014 10:30 AM Figure 1: Patient reader Indications for use The patient reader is a portable electronic device that communicates with your Medtronic implanted heart device and transmits implanted heart device data to the CareLink Network via the Medtronic MyCareLink Heart™ application.
M957944A_ch.fm 4/11/14 10:31 am 5.5" x 7.0" (139.7 mm x 177.8 mm) Medtronic Confidential Starlight_Pat_R1.5 M957944A001.book Page 11 Friday, April 11, 2014 10:30 AM doctor has provided instructions, follow them. Waiting to seek medical attention could be dangerous to your health. Warning: To ensure the safe operation of the patient reader and your implanted heart device, follow these instructions: • Use the patient reader as described in this manual. Save this manual.
M957944A_ch.fm 4/11/14 10:31 am 5.5" x 7.0" (139.7 mm x 177.8 mm) Medtronic Confidential Starlight_Pat_R1.5 M957944A001.book Page 12 Friday, April 11, 2014 10:30 AM reduce the risk of electric shock, and injury to persons, including the following: • Do not use the patient reader near water, for example, near a bath tub, wash bowl, kitchen sink or laundry tub, in a wet basement, or near a swimming pool. Precautions Caution: Only install the recommended batteries in the patient reader.
M957944A_ch.fm 4/11/14 10:31 am 5.5" x 7.0" (139.7 mm x 177.8 mm) Medtronic Confidential Starlight_Pat_R1.5 M957944A001.book Page 13 Friday, April 11, 2014 10:30 AM fall out of the patient reader. If the batteries become dislodged or fall out of the patient reader, the patient reader will not operate. Caution: Verify that the batteries are installed with correct polarity by verifying that the batteries align with the polarity markings on the inside of the battery compartment.
M957944A_ch.fm 4/11/14 10:31 am 5.5" x 7.0" (139.7 mm x 177.8 mm) Medtronic Confidential Starlight_Pat_R1.5 M957944A001.book Page 14 Friday, April 11, 2014 10:30 AM Install the batteries before each use and remove them when the patient reader is not in use. Replace the batteries when the amber indicator on the patient reader is lit. Warning: Do not inhale or swallow the batteries. Inhaling or swallowing the batteries can cause serious physical harm.
M957944A_ch.fm 4/11/14 10:31 am 5.5" x 7.0" (139.7 mm x 177.8 mm) Medtronic Confidential Starlight_Pat_R1.5 M957944A001.book Page 15 Friday, April 11, 2014 10:30 AM patient reader requires proper battery polarity for operation. The patient reader will not turn on or operate if the batteries are installed with incorrect battery polarity. 4. Close the battery compartment door firmly. Note: Always operate the patient reader with the battery compartment door firmly closed.
M957944A_ch.fm 4/11/14 10:31 am 5.5" x 7.0" (139.7 mm x 177.8 mm) Medtronic Confidential Starlight_Pat_R1.5 M957944A001.book Page 16 Friday, April 11, 2014 10:30 AM . Table 1. Patient reader indicator lights and standby button Indicator light or button 1. Blue Icon Description The blue indicator light indicates if the patient reader is turned on and shows the connection between the patient reader and the smart phone or tablet.
M957944A_ch.fm 4/11/14 10:31 am 5.5" x 7.0" (139.7 mm x 177.8 mm) Medtronic Confidential Starlight_Pat_R1.5 M957944A001.book Page 17 Friday, April 11, 2014 10:30 AM Table 1. Patient reader indicator lights and standby button Indicator light or button 3. Amber 4. Standby button Icon Description The amber indicator light shows the battery status of the patient reader. If the amber indicator light is lit, the patient reader batteries are low. Replace the batteries when the amber indicator is lit.
M957944A_ch.fm 4/11/14 10:31 am 5.5" x 7.0" (139.7 mm x 177.8 mm) Medtronic Confidential Starlight_Pat_R1.5 M957944A001.book Page 18 Friday, April 11, 2014 10:30 AM 4. Install the application. 5. Open the application. Bluetooth enabling between the patient reader and the application Your patient reader is paired with the application using a Bluetooth connection. To enable the patient reader and the application with Bluetooth, perform the following steps: 1. 2. 3. 4. 5. 6.
M957944A_ch.fm 4/11/14 10:31 am 5.5" x 7.0" (139.7 mm x 177.8 mm) Medtronic Confidential Starlight_Pat_R1.5 M957944A001.book Page 19 Friday, April 11, 2014 10:30 AM 1. Locate the security key code on the device label on the bottom of the patient reader on the left side of the security key symbol. 1 1. Security key code Figure 3: patient reader device label including the security key code 2. Open the application. 3. Follow the prompts in the application and enter the security key code.
M957944A_ch.fm 4/11/14 10:31 am 5.5" x 7.0" (139.7 mm x 177.8 mm) Medtronic Confidential Starlight_Pat_R1.5 M957944A001.book Page 20 Friday, April 11, 2014 10:30 AM The patient reader is not intended to be operated while you are walking, mobile, or traveling in a vehicle. • Choose a location that receives an adequate cellular or wireless network signal. • Hold the smart phone or tablet in a location where you can see its screen and can sit comfortably.
M957944A_ch.fm 4/11/14 10:31 am 5.5" x 7.0" (139.7 mm x 177.8 mm) Medtronic Confidential Starlight_Pat_R1.5 M957944A001.book Page 21 Friday, April 11, 2014 10:30 AM Figure 4: Patient reader held over an implanted device 6. Watch the application to follow the status of the implanted device interrogation. 7. Remove the patient reader from over your implanted device when the application indicates that the interrogation is complete. 8.
M957944A_ch.fm 4/11/14 10:31 am 5.5" x 7.0" (139.7 mm x 177.8 mm) Medtronic Confidential Starlight_Pat_R1.5 M957944A001.book Page 22 Friday, April 11, 2014 10:30 AM Notes: • While the patient reader is communicating with your implanted device, remain still and make sure the patient reader is placed over your implanted device. This process typically takes less than 3 minutes.
M957944A_ch.fm 4/11/14 10:31 am 5.5" x 7.0" (139.7 mm x 177.8 mm) Medtronic Confidential Starlight_Pat_R1.5 M957944A001.book Page 23 Friday, April 11, 2014 10:30 AM For some errors, you will be instructed to contact Medtronic. See “How to contact Medtronic” on page 29, or use the information found on the back cover of this manual. Patient reader battery status The patient reader requires batteries with power to operate properly.
M957944A_ch.fm 4/11/14 10:31 am 5.5" x 7.0" (139.7 mm x 177.8 mm) Medtronic Confidential Starlight_Pat_R1.5 M957944A001.book Page 24 Friday, April 11, 2014 10:30 AM The green indicator light is not lit. Reposition the patient reader over your implanted device and verify that the green indicator light on the patient reader is fully lit. When the green indicator light is lit, the patient reader is communicating with the implanted device.
M957944A_ch.fm 4/11/14 10:31 am 5.5" x 7.0" (139.7 mm x 177.8 mm) Medtronic Confidential Starlight_Pat_R1.5 M957944A001.book Page 25 Friday, April 11, 2014 10:30 AM The blue indicator light flashes Verify that the blue indicator light on the patient reader is fully lit. When the blue indicator light is lit, the Bluetooth connection has been established between the patient reader and the application.
M957944A_ch.fm 4/11/14 10:31 am 5.5" x 7.0" (139.7 mm x 177.8 mm) Medtronic Confidential Starlight_Pat_R1.5 M957944A001.book Page 26 Friday, April 11, 2014 10:30 AM Patient reader does not function Error Action The amber, green, and blue If all of the indicator lights indicator lights flash flash simultaneously when the simultaneously. standby button is pressed, the patient reader is no longer functioning properly and must be replaced.
M957944A_ch.fm 4/11/14 10:31 am 5.5" x 7.0" (139.7 mm x 177.8 mm) Medtronic Confidential Starlight_Pat_R1.5 M957944A001.book Page 27 Friday, April 11, 2014 10:30 AM please contact Medtronic. See “How to contact Medtronic” on page 29, or use the information found on the back cover of this manual. You can clean the exterior of your patient reader by using a clean cloth and light application of water, hydrogen peroxide, alcohol (methyl, ethyl or isopropyl) or a mild detergent.
M957944A_ch.fm 4/11/14 10:31 am 5.5" x 7.0" (139.7 mm x 177.8 mm) Medtronic Confidential Starlight_Pat_R1.5 M957944A001.book Page 28 Friday, April 11, 2014 10:30 AM Battery removal and disposal Remove the three LR6-sized (AA) alkaline batteries from the patient reader when it is not in use. Store the batteries in the box the patient reader was shipped in when it is not being used.
M957944A_ch.fm 4/11/14 10:31 am 5.5" x 7.0" (139.7 mm x 177.8 mm) Medtronic Confidential Starlight_Pat_R1.5 M957944A001.book Page 29 Friday, April 11, 2014 10:30 AM How to contact Medtronic Patients in the United States To speak directly with a Patient Services Specialist, call 1-800-9294043. Our staff is available Monday through Friday from 8:00 AM to 5:00 PM (Central Standard Time). Medtronic is dedicated to providing you with the most up-todate information available about your patient reader.
M957944A_ch.fm 4/11/14 10:31 am 5.5" x 7.0" (139.7 mm x 177.8 mm) Medtronic Confidential Starlight_Pat_R1.5 M957944A001.
M957944A_ch.fm 4/11/14 10:31 am 5.5" x 7.0" (139.7 mm x 177.8 mm) Medtronic Confidential Starlight_Pat_R1.5 M957944A001.book Page 31 Friday, April 11, 2014 10:30 AM Maximum altitude usage Do not use the patient reader above an altitude of 3000 meters (9,842 feet). Expected service life The expected service life of a patient reader is 5 years. Electromagnetic interference Keep your smart phone or tablet in your hand and follow the instructions in the app while interrogating your implanted device.
M957944A_ch.fm 4/11/14 10:31 am 5.5" x 7.0" (139.7 mm x 177.8 mm) Medtronic Confidential Starlight_Pat_R1.5 M957944A001.book Page 32 Friday, April 11, 2014 10:30 AM This device complies with part 15 of the FCC Rules. Operation is subject to the following 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.
M957944AOUS_bc.fm 4/11/14 10:31 am 5.5" x 7.0" (139.7 mm x 177.8 mm) Medtronic Confidential Starlight_Pat_R1.5 M957944A001.book Page 1 Friday, April 11, 2014 10:30 AM M957944A001 Rev A Refer to the doc #xxxxxx for Printing Instructions.
M957944AOUS_bc.fm 4/11/14 10:31 am 5.5" x 7.0" (139.7 mm x 177.8 mm) Medtronic Confidential Starlight_Pat_R1.5 M957944A001.book Page 2 Friday, April 11, 2014 10:30 AM Medtronic, Inc. 710 Medtronic Parkway Minneapolis, MN 55432 USA www.medtronic.com +1 763 514 4000 Medtronic USA, Inc.
