MyCareLink™ Patient Monitor Model 24951 Patient Manual Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician.
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Keep dry Use only with provided power supply Type BF applied part Caution Consult instructions for use Package contents Home monitor Product documentation Accessories MyCareLink Patient Monitor 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. Dispose of this product according to local regulations. See http:// recycling.medtronic.com for instructions on proper disposal of this product.
Medical equipment with respect to electric shock, fire, and mechanical hazards, only in AAMI/ES 60601-1(2006) / A2 (2010) and CSA 22.2 NO 60601-1 CAN/CSA:2008 China RoHS USB port Direct current. 5V 0.
Contents Introduction 9 About your monitor 9 Indications for use 10 Contraindications 11 Warnings 11 Precautions 14 Contents of the monitor package 15 About the monitor 16 Choosing a place to set up the monitor 18 Setting up the monitor 19 Sending information using the monitor 20 Start-up screen information 26 Reader LED indicator lights 28 Troubleshooting error messages 29 Traveling with your monitor 37 Monitor care 38 How to contact Medtronic 39 Monitor specifications 40 Consumer information and Requireme
Introduction This manual is intended to help you use the MyCareLink Patient Monitor Model 24951. If you have any questions setting up or using the monitor, or if you have problems with the monitor, please contact Medtronic. See “How to contact Medtronic” on page 39, or use the information found on the back cover of this manual. If you have questions about your medical condition, talk to your doctor. Your doctor knows your medical history.
implanted devices could interrupt the prescribed operation of their device. Indications for use The monitor is an external electronic device that interfaces with Medtronic implanted heart devices and a telecommunications connection to transmit stored implanted heart device data to the physician or clinician. Sending information at the request of your doctor or clinic You will sometimes need to send information at times other than those scheduled by your doctor or clinic.
Contraindications There are no known contraindications for the monitor. Warnings Warning: If you are feeling ill, seek immediate medical attention. Do not use the monitor unless directed by your doctor. If there is an emergency, call your local emergency number. If your doctor has provided instructions, follow them. Waiting to seek medical attention could be dangerous to your health.
page 39, or use the information found on the back cover of this manual. Warning: Do not use the monitor if the monitor does not operate as described in “Sending information using the monitor” on page 20. To ensure proper operation of your implanted heart device, follow the instructions in this manual about positioning the reader over your implanted heart device. If you do not follow these instructions, the monitor may not be recording or sending information from your implanted heart device.
Warning: Important safety instructions. When using the monitor, basic safety precautions should always be followed to reduce the risk of fire, electric shock, and injury to persons, including the following: • Do not use the monitor near water, for example, near a bath tub, wash bowl, kitchen sink or laundry tub, in a wet basement, or near a swimming pool. • If you suspect a gas leak, do not use the monitor and do not use a telephone in the vicinity of the leak to report a gas leak.
Precautions • Use only the supplied power cord with this monitor. Using a different power cord could damage the monitor and adversely affect your safety. • Do not use the monitor within two meters (six feet) of a television, computer monitor or screen, or wireless communications equipment such as wireless home network devices, mobile phones, cordless telephones and their base stations, or ‘walkie-talkies.
Contents of the monitor package You should receive the following: • One Medtronic MyCareLink Patient Monitor Model 24951 base • One Medtronic MyCareLink Model 24955 removable reader • One Medtronic MyCareLink Model 24956 power cord • One Patient Manual • One Quick Start Guide • One set of ‘For Your Records’ labels • One Cellular Modem safety manual 15
About the monitor 1 5 4 2 3 1 Reader 2 Accept Button 3 Monitor screen 4 Power LED 5 Power port Figure 1: Monitor base and removable reader (front view) 16
The monitor (Figure 2) consists of three components: • A monitor base • A removable reader to gather information from your implanted heart device • A power cord 1 2 3 1 Power cord 2 Reader 3 Base Figure 2: Components 17
Figure 3: Monitor reader (front and back view, approximately 1/3 actual size) Choosing a place to set up the monitor Consider the following recommendations for choosing a place to set up the monitor: • Place the monitor where you can sit comfortably and see the front of the monitor. • Place the monitor in a location that receives an adequate cellular signal. • Place the monitor within reach of a power outlet, and position it so that it can be unplugged from the power outlet if necessary.
• Do not place the monitor anywhere it could get wet. Setting up the monitor Before you use the monitor you will need to plug the monitor into a power outlet. To plug in your monitor, locate the power cord port on the left side of the monitor base. Insert the power cord end into the monitor side port, then plug the wall plug into a wall outlet. Caution: Use only the supplied power cord with this monitor. Using a different power cord could damage the monitor and adversely affect your safety.
Figure 4: Plugging in the monitor Sending information using the monitor Use this procedure at these times: • When completing first-time set-up. • At the request of your doctor or clinic. Before using your monitor: • Turn off any television, computer monitor, or screen within two meters (six feet) of the monitor.
• Turn off or remove any cellular phone or other wireless device that is within two meters (six feet) of the monitor. When you send a transmission using this procedure, your monitor screen will also show step by step instructions for you to follow. You can use these on-screen instructions to guide you through this procedure. Note: If the monitor screen shows an error message icon during this procedure, refer to “Troubleshooting error messages” on page 29 of this manual.
3. Press the “Accept” button. The monitor screen will show an image instructing you to pick up the reader. 4. When the monitor screen shows an image of a reader being placed over a device, hold the reader over your implanted device. You may either hold the reader snugly against your clothing, or against your bare skin.
5. When the monitor begins reading data from your implanted device, the monitor screen will show a green progress bar, indicating that data is being sent from the reader to the monitor base.
– While the monitor is communicating with your implanted device, remain still and make sure the monitor reader is placed over your implanted device. This process typically takes less than 3 minutes, but may take up to 12 minutes. 6. When the monitor is finished communicating with your implanted device, the monitor will make two short tones, and the monitor screen will instruct you to return the reader to the monitor base. 7. The monitor will send your implanted device data to the CareLink Network.
120 s 8. Your transmission is complete when the monitor makes two short tones and the monitor screen shows a green check mark image.
Start-up screen information When your monitor is activated by pressing the “Accept” button, your monitor screen will show a system status image with the following information: 1 2 4 3 Table 1. Start screen information Image 1 Reader status icon 26 Description This area shows the status of the reader. The reader icon may show the reader is charging, missing, or has a low battery.
Table 1. Start screen information Image Description 2 Cellular signal icon This icon shows the status of the monitor’s connection to a cellular network 3 Last transmission This icon shows the date of your last successful transmission to the CareLink Network. Note: The date format shown on your monitor will depend on which country you are from. 4 Start transmission icon This icon means the monitor is ready to begin a transmission. Press the “Accept” button to begin a transmission.
Reader LED indicator lights The monitor’s reader has three LED indicator lights that indicate the status of a transmission, the connection between the reader and monitor base, and the reader’s battery status. 1 2 3 Table 2. reader LED indicator lights Indicator Light 1 Green indicator light 28 Description The green indicator light shows transmission of data between the reader and monitor base. When the green indicator light is lit, the reader is transmitting data to the monitor base.
Table 2. reader LED indicator lights Indicator Light 2 Blue indicator light Description The blue indicator light shows the connection between the reader and monitor base. • A flashing blue light means the reader is establishing a connection with the monitor base • A sold blue light means the reader and monitor base are connected. 3 Amber indicator light The amber indicator light shows the battery status of the reader. If the amber indicator light is lit, the reader battery is low.
You can find information about the following errors: • Error #3230 - “Reader not found by monitor base” on page 31 • Error #3248 - “Reader battery status” on page 32 • Error #5704 - “No cellular signal” on page 33 • “Reader position” on page 35 • “System errors” on page 36 If you receive an error message while using your monitor, your monitor screen will show an error icon with an orange background, and a 4 digit error number.
Reader not found by monitor base When you activate the monitor, if the monitor base is unable to communicate with the reader, the monitor screen will show Error #3230 - No reader found by monitor base. 1 2 Figure 5: No reader found by monitor base This can occur when: • The reader is off the monitor base, and has powered down. • The reader is off the base station and has no battery life remaining. • The reader is out of range of the monitor base.
correct the error, contact Medtronic for assistance. See “How to contact Medtronic” on page 39, or use the information found on the back cover of this manual. Reader battery status The monitor reader includes a rechargeable battery. If the reader battery needs to be recharged, the monitor’s screen will show Error #3248 Recharge Reader. In addition, the amber LED indicator light on the reader head may be lit. • To recharge the reader, place the reader on the monitor base.
20 Figure 6: Reader battery status Note: The monitor reader should be replaced when your reader battery no longer recharges, or only holds a charge for a brief period. If you are unable to complete a transmission without receiving the Recharge Reader error message, please contact Medtronic. See “How to contact Medtronic” on page 39, or use the information found on the back cover of this manual.
If your monitor does not have adequate cellular service connection, the monitor’s screen will show Error # 5704 - No cellular signal. See Figure 7 • Change the orientation of the monitor by rotating the monitor base. • Change the location of your monitor so it is near a window or outside wall. • If you are unable to find an adequate cellular signal for your monitor, please contact Medtronic. See “How to contact Medtronic” on page 39, or use the information found on the back cover of this manual.
Reader position The monitor reader must be properly positioned over your implanted device in order to communicate with it. If the monitor reader is moved out of position during a transmission, you will hear 3 short tones from your monitor, and see the Reader Placement Problem image on the monitor screen. See Figure 8 1 2 Figure 8: Reader placement problem • Reposition the reader over your implanted device. • When the reader is repositioned correctly a green progress bar will appear on the monitor screen.
System errors If your monitor encounters a system error, your monitor screen will show a system error icon and an error message code. This image indicates that your monitor has encountered an internal error, and does not mean that there is a problem with your implanted heart device. If this occurs, restart the monitor by disconnecting then reconnecting the monitor’s power supply. If restarting your monitor does not correct the error, please contact Medtronic.
Figure 9: System error Traveling with your monitor Note: Your monitor will work in most locations. However, in some locations, cellular service may not be available. If you are planning on traveling with your monitor, please contact Medtronic to confirm availability of coverage. Replacing your power supply or reader If your power supply or monitor reader is lost or damaged, you can contact Medtronic to receive information on ordering a replacement.
Monitor care Do not drop your monitor or reader on hard surfaces. Dropping the monitor or reader can damage them and prevent them from functioning properly. If your monitor or reader has been damaged, please contact Medtronic. See “How to contact Medtronic” on page 39, or use the information found on the back cover of this manual. You can clean the exterior of your monitor by using a clean cloth and light application of water, hydrogen peroxide, alcohol (methyl, ethyl or Isopropyl) or a mild detergent.
How to contact Medtronic Patients in the United States To speak directly with a Patient Services Specialist, call 1-800-929-4043. 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-to-date information available about your monitor. Website information is available 24 hours a day. • Medtronic website: www.medtronic.com • Medtronic CareLink Network information: www.medtronic.
Monitor specifications Open Source Software The operating system for this device includes open source software. Information on open source software licensing can be found at www.medtronic.
Recommended environmental conditions during storage and transport Temperature: -40 °C to 70 °C (-40 °F to 158 °F) Relative Humidity: 5% to 95% Safe when stored or transported in temperatures from -40 °C without relative humidity control to 70 °C at a relative humidity of 5% to 95%, including condensation. Recommended operating conditions Temperature: 5 °C to 40 °C (41 °F to 104 °F) Safe when operated at temperatures from 5 °C to 40 °C (41 °F to 104 °F) in relative humidity from 15% to 93%, non-condensing.
Current 0.5A Max. at 90 VAC input The power supply is to be used for mains disconnection. Expected service life The expected service life of a monitor is 5 years. Disposal Follow local regulations for proper disposal of this product. Do not dispose of this product in the unsorted municipal waste stream. This product contains materials that can harm the environment. See http://recycling.medtronic.com for instructions on proper disposal of this product.
impacted by other devices, the user is encouraged to try to correct the interference by one or more of the following measures: • Reorient or relocate the devices. • Increase the separation between the devices. • Consult Medtronic for help. If you experience performance issues with your 24951 MyCareLink Monitor, try using it at least two meters (6 feet) away from all wireless communication devices such as cellular phones, television monitors, or computer screens.
Telecommunications Terminal Equipment and Directive 90/385/EEC on Active Implantable Medical Devices. FCC Requirements The monitor has been tested for compliance to FCC regulations. Changes or modifications of any kind not expressly approved by Medtronic could void the user’s authority to operate the monitor. FCC ID LF524951 FCC ID LF524955 (contains FCC ID T7V1315) This device complies with part 15 of the FCC Rules.
Industry Canada Requirements IC ID 3408D-24951 IC ID 3408D-24955 (contains IC ID 216Q-1315) 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.
Manufacturer Medtronic, Inc. 710 Medtronic Parkway Minneapolis, MN 55432 USA www.medtronic.com Tel. +1 763 514 4000 Fax +1 763 514 4879 Medtronic USA, Inc. Information for patients: Toll-free +1 800 551 5544 (7 a.m. – 6 p.m., Monday–Friday, central time) Fax +1 763 514 1855 Medtronic E.C. Authorized Representative Medtronic B.V. Earl Bakkenstraat 10 6422 PJ Heerlen The Netherlands Tel.
