Medtronic 24950B 24950B User Manual

Medtronic, Inc. 24950B

User Manual

MyCareLink™ Patient MonitorModel 24950Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician.Patient Manual
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 and MyCareLinkExplanation of SymbolsConformité Européenne (European Conformity).This symbol means that the device fully complies with European Directives. This symbol means that the device fully complies with the AIMD Directive 90/385/EEC (as amended by 2007/47/EC)(NB 0123)(Reader) This product complies with international electrical safety rating IP22 with regard to ingress of dust, other foreign objects, and water as required by IEC 60601-11.
(Monitor base) This product complies with international electrical safety rating IP21 with regard to ingress of dust, other foreign objects, and water as required by IEC 60601-11.Keep dryUse only with provided power supply Type BF applied partCautionConsult instructions for usePackage contentsHome monitorProduct documentationAccessoriesMyCareLink Patient Monitor
Non-ionizing electromagnetic radiationCaution: 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.Reorder numberSerial numberTemperature limitationHumidity limitationFor US audiences onlyManufacturerDate of manufacture
Authorized representative in the European communityConforms To AAMI Std ES60601-1, IEC Stds 60601-1-6 & 60601-1-11 Certified To CSA Std C22.2 #60601-1China RoHSUSB portDirect current. 5V 3.0ARefer to instruction manual
7ContentsIntroduction 9About your monitor 9Indications for use 11Contraindications 12Warnings 12Precautions 15Contents of the monitor package 16About the monitor 17Choosing a place to set up the monitor 19Setting up the monitor 20Sending information using the monitor 21Start-up screen information 28Reader LED indicator lights 30Troubleshooting error messages 31Traveling with your monitor 38Monitor care 39How to contact Medtronic 40Monitor specifications 41
9IntroductionThis manual is intended to help you use the MyCareLink Patient Monitor Model 24950.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 40, 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.About your monitorThe monitor is an electronic device that provides an easy way for your doctor to obtain information about your heart device. The monitor gathers this information to allow your doctor to manage your care.How your monitor gathers information from your heart device is determined by the kind of heart device you have.
10Some heart devices communicate wirelessly with your monitor. Once you have set up your monitor and completed an initial manual transmission, the monitor is designed to automatically gather information from your implanted heart device. This automatic wireless communication between your heart device and the monitor takes place at times scheduled by your doctor or clinic. Sending heart device information to your clinic using wireless technology does not require you to interact with your monitor. The process is silent and invisible. Clinics typically schedule the automatic process to occur while you sleep. For this reason, the monitor must remain plugged in to a power outlet. The heart device information is sent to your clinic using the cellular phone network. Other heart devices require you to use your monitor’s reader to gather information from your heart device so your monitor can send the information to your clinic.To find out which kind of device you have, see your heart device patient manual, or talk to your doctor.
11The monitor is intended specifically for your use only. It will not work with other implanted devices and should only be used by you as directed by your doctor. Unauthorized use by others with implanted devices could interrupt the prescribed operation of their device.Sending information at the request of your doctor or clinicYou will sometimes need to send information at times other than those scheduled by your doctor or clinic. These times are:• When completing first-time setup, to allow automatic wireless communication between your monitor and your heart device • At the request of your doctor or clinicSee “Sending information using the monitor” on page 21 of this manual.Indications for useThe monitor is an external electronic device that interfaces with Medtronic implanted heart devices and a telecommunications connection to transmit
12stored implanted heart device data to the physician or clinician.ContraindicationsThere are no known contraindications for the monitor.WarningsWarning: 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.Warning: To ensure the safe operation of the monitor and your implanted heart device, follow these instructions:Use the monitor as described in this manual. Save this manual.Use the monitor only at the times prescribed by your doctor.
13If you need further assistance, please contact Medtronic. See “How to contact Medtronic” on page 40, 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 21. 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. If you need further assistance, please contact Medtronic. See “How to contact Medtronic” on page 40, or use the information found on the back cover of this manual. Warning: Do not modify this equipment. Modifications may impact monitor effectiveness, and adversely affect your safety.Warning: Do not touch open ports or plugs, or insert your finger or any objects into the open ports on the monitor. Inserting your finger or objects into an open port may result in electrical shock.
14Warning: 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.
15Precautions• 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.’ Using your monitor near these devices could interfere with communication between your implanted heart device and the monitor.
16Contents of the monitor packageYou should receive the following:• One Medtronic MyCareLink Patient Monitor Model 24950 base• One Medtronic MyCareLink Model 24955 removable reader•One power cord• One Patient Manual•One Quick Start Guide• One set of ‘For Your Records’ labels• One Cellular Modem safety manual
17About the monitorFigure 1: Monitor base and removable reader (front view) 1 Reader 4 Power LED2 Accept Button 5 Power port3 Monitor screen12345
18The monitor (Figure 2) consists of three components:•A monitor base• A removable reader to gather information from your implanted heart device•A power cordFigure 2: Components 1 Power cord 2 Reader 3 Base123
19Figure 3: Monitor reader (front and back view, approximately 1/3 actual size)Choosing a place to set up the monitorConsider the following recommendations for choosing a place to set up the monitor:• Place the monitor near where you sleep, preferably on a nightstand or a table. Your monitor is capable of receiving signals from your heart device up to 3 meters (10 feet) away, but you should consult your heart device manual for recommended distances specific to your device.
20• 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 monitorBefore 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.
21Figure 4: Plugging in the monitorSending information using the monitorUse 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.
22• 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 31 of this manual.To send information using your monitor, perform the following steps:1. If the monitor screen is dark, press the “Accept” button on the front of the monitor to wake up the screen.2. When monitor wake-up is complete, the monitor screen will show an image indicating that the monitor is ready to begin a transmission.
233. 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
24either 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.
25– 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.120 s
267. The monitor will send your implanted device data to the CareLink Network. The monitor screen will show a green progress bar indicating that data is being sent.120 s
278. Your transmission is complete when the monitor makes two short tones and the monitor screen shows a green check mark image.
28Start-up screen informationWhen your monitor is activated by pressing the “Accept” button, your monitor screen will show a system status image with the following information:Table 1. Start screen informationImage Description1 Reader status icon This area shows the status of the reader. The reader icon may show the reader is charging, missing, or has a low battery.1234
292 Cellular signal icon This icon shows the status of the monitor’s connection to a cellular network3 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 in.4 Start transmission iconThis icon means the monitor is ready to begin a transmission. Press the “Accept” button to begin a transmission.Table 1. Start screen informationImage Description
30Reader LED indicator lightsThe 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.Table 2. reader LED indicator lightsIndicator Light Description1 Green indicator light 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.123
31When you place the reader on the monitor base, all three indicator lights will flash briefly to indicate that the reader is properly docked with the monitor base.Troubleshooting error messagesUse the information in this section to troubleshoot the use of your monitor.2 Blue indicator light 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 solid 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. Place the reader on the monitor base to recharge the reader battery.Table 2. reader LED indicator lightsIndicator Light Description
32You can find information about the following errors:• Error #3230 - “Reader not found by monitor base” on page 33• Error #3248 - “Reader battery status” on page 34• Error #5704 - “No cellular signal” on page 35• “Reader position” on page 36• “System errors” on page 37If 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.Some error messages may include an animated demonstration to help you correct the problem. Follow these instructions to resolve the error.For some errors, you will be instructed to contact Medtronic. See “How to contact Medtronic” on page 40, or use the information found on the back cover of this manual.
33Reader not found by monitor baseIf the monitor base is unable to communicate with the reader, the monitor screen will show Error #3230 - No reader found by monitor base.Figure 5: No reader found by monitor baseThis 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.To restore communication between the reader and monitor base, return the reader to the monitor base cradle, and wait for the error message to disappear. If returning the reader to the monitor base does not correct the error, please contact Medtronic. See “How to contact Medtronic” on page 40, or use the 1 2
34information found on the back cover of this manual. Reader battery statusThe 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. Recharging the reader battery will take approximately 20 minutes.Figure 6: Reader battery status20
35Note: 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 40, or use the information found on the back cover of this manual. No cellular signalYour monitor uses a cellular telephone connection to transmit implanted device data to your doctor.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. Remember, your monitor should be placed within 3 meters (10 feet) of where you sleep.• If you are unable to find an adequate cellular signal for your monitor, please contact
36Medtronic. See “How to contact Medtronic” on page 40, or use the information found on the back cover of this manual. Figure 7: No cellular signalReader positionThe reader must be properly positioned over your implanted device in order to communicate with it.If the 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
37Figure 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. When the reader is positioned correctly, the monitor will resume data collection. Hold the reader in position until your transmission is completed.System errorsIf 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.1 2
38If 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. See “How to contact Medtronic” on page 40, or use the information found on the back cover of this manual. Refer to the error code shown on your monitor screen to help Medtronic identify the problem.Figure 9: System errorTraveling with your monitorNote: 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.
39Replacing your power supply or readerIf your power supply or monitor reader is lost or damaged, you can contact Medtronic to receive information on ordering a replacement. See “How to contact Medtronic” on page 40, or use the information found on the back cover of this manual.Monitor careDo 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 40, 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.The monitor does not require any preventative inspection or maintenance.
40Caution: Do not get your monitor wet. If you get your monitor wet, please contact Medtronic. See “How to contact Medtronic” on page 40, or use the information found on the back cover of this manual.How to contact MedtronicPatients in the United StatesTo 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.com/patients/carelink
41Patients outside the United StatesIf you have questions that are not covered in this manual or you want more in-depth information about your heart monitor, please contact Medtronic using the information on the back cover of this manual. Monitor specificationsOpen Source SoftwareThis product contains certain third party software that is subject to specific license terms. You may go to www.Medtronic.com/monitorsource to obtain the terms and warranty limitations applicable to the software and, in some cases, a free copy of the software (subject to nominal distribution charges).Standards (The monitor complies with the following:)EMC: CFR 47 Part 15
42Patient Safety: IP22 (monitor base); IP21 (reader); IEC 60601-1, ETL, Type BF applied part (reader), ordinary, continuous operation, Class II, not suitable for use in the presence of a flammable anaesthetic mixture with air or with oxygen or nitrous oxide.Recommended environmental conditions during storage and transportTemperature: -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 conditionsTemperature: 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.
43Power supplyTo assure compliance to the specified standards, use only the power supply that came with your monitor: MENB1020A0502-XXX. Rated Voltage AC 100 - 240VRated Line Frequency 50 - 60HzCurrent 0.5A Max. at 100 VAC inputThe power supply is to be used for mains disconnection.Expected service lifeThe expected service life of a monitor is 5 years.DisposalFollow 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.
44TestingElectromagnetic Compliance (EMC) testing shows that the monitor provides reasonable protection against harmful interference in a typical medical installation. However, there is no guarantee that interference will not occur in a particular installation. If the monitor does cause harmful interference to other devices or is negatively 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 Model 24950 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.Safety and technical inspectionAn annual safety and technical inspection of the monitor is not required.
45Consumer information and RequirementsDeclaration of conformityMedtronic declares that this product is in conformity with the essential requirements of Directive 1999/5/EC on Radio and Telecommunications Terminal Equipment and Directive 90/385/EEC on Active Implantable Medical Devices.FCC RequirementsThe 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 LF524950BFCC ID LF524955 (contains FCC ID T7V1315) 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. The monitor has been tested for compliance to FCC regulations.
46Changes or modifications of any kind not expressly approved by Medtronic could void the user’s authority to operate the monitorThis transmitter is authorized by rule under the Medical Device Radiocommunication Service (in part 95 of the FCC Rules) and may not interfere with stations operating in the 400.15-406 MHz band in the meteorological aids, meteorological satellite, and earth exploration satellite services (i.e. transmitter and receivers used to communicate weather data) and must accept any interference received, including interference that may cause undesired operation. This transmitter shall be used only in accordance with FCC Rules governing the Medical Device Radiocommunication Service. Analog and digital voice communications are prohibited. Although this transmitter has been approved by the Federal Communication Commission there is no guarantee that it will not receive interference or that any particular transmission from this transmitter will be free from interference.
47Industry Canada RequirementsIC: 3408D-24950B IC: 3408D-24955 (contains IC: 216Q-1315) This device complies with Industry Canada's licence-exempt RSSs.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.“This device may not interfere with stations operating in the 400.150-406.000 MHz band in the meteorological aids, meteorological-satellite, and earth exploration-satellite services and must accept any interference received, including interference that may cause undesired operation.”
*M953321A001*© Medtronic, Inc. 2013M953321A001C2013-07-15ManufacturerMedtronic, Inc.710 Medtronic ParkwayMinneapolis, MN 55432USAwww.medtronic.com+1 763 514 4000Authorized Representative in the European CommunityMedtronic B.V.Earl Bakkenstraat 106422 PJ HeerlenThe Netherlands+31 45 566 8000Europe/Middle East/Africa Medtronic International Trading SàrlRoute du Molliau 31Case Postale 84CH-1131 TolochenazSwitzerland+41218027000AustraliaMedtronic Australasia Pty Ltd97 Waterloo RoadNorth Ryde, NSW 2113AustraliaCanadaMedtronic of Canada Ltd99 Hereford StreetBrampton, Ontario L6Y 0R3Canada+1 905 460 3800Technical manualswww.medtronic.com/manuals

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