SEEQ Mobile Cardiac Telemetry (MCT) System Sistema externo de monitorización cardíaca Instructions for use Instrucciones de uso Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. Precaución: Según las leyes federales de los Estados Unidos este dispositivo puede venderse únicamente por prescripción facultativa.
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. La siguiente lista contiene marcas comerciales o marcas comerciales registradas de Medtronic en Estados Unidos y posiblemente en otros países. Todas las demás marcas comerciales son propiedad de sus respectivos propietarios. Medtronic, SEEQ
Table of Contents Getting started 4 Using the SEEQ MCT System during the monitoring period 9 What to do at the end of monitoring 12 Indications for use, contraindications, and precautions 13 Services for physicians 15 Specifications, compliance, and symbols 16 Frequently asked questions 20 Instructions for use FOLLOW THESE INSTRUCTIONS CAREFULLY AND WATCH YOUR INSTRUCTIONAL VIDEO BEFORE USING THE SEEQ MCT SYSTEM. Medtronic Customer Support USA: 1-877-247-7449 The SEEQ Mobile Cardiac Telemetry (MCT) System is a wearable, wireless arrhythmia detection system that is used to aid clinicians in diagnosing suspected cardiac arrhythmias. It consists primarily of the Wearable Sensor monitoring device and the Transmitter (portable data transmission device). The SEEQ MCT System, in combination with interpretation services provided by the Medtronic Monitoring Center, as well as secure online review of data (for prescribing physicians only), enables patient- and physician-friendly arrhythmia detection for up to 30 days at a time. How the SEEQ MCT System works Once activated, the Wearable Sensor continuously monitors the heart and automatically collects ECGs. When rhythm abnormalities are detected, data is automatically transmitted from the Wearable Sensor to the Transmitter, which then automatically transmits the data to the Medtronic Monitoring Center. Patients can also trigger transmission of ECGs when they experience cardiac symptoms by using the Patient Trigger Button. Certified cardiographic technicians at the Medtronic Monitoring Center review received data and document symptoms reported to the Medtronic Monitoring Center by patients. Reports prepared by the Medtronic Monitoring Center are delivered to the prescribing physician and made available to them at www.medtronic.com to provide them with data for their diagnosis and identification of various clinical conditions, events and/or trends. Prescribing physicians may also be contacted by the Medtronic Monitoring Center directly when arrhythmias that meet pre-defined criteria are detected. IMPORTANT: The SEEQ MCT System is not intended to be an alarm or to alert patients or physicians, and will not summon emergency response in the event help is needed. SEEQ MCT Instructions for use English 3
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. Patients should talk to their healthcare provider immediately if there are any concerns or if their condition changes. Getting started Step 1: Locate the components of the SEEQ MCT System The Wearable Sensor is a wearable device that collects and transmits physiological data. One or more Wearable Sensors may be included in the package (inside a foil pouch), depending on the length of the prescription. The Transmitter is a device that receives data from the Wearable Sensor and transmits it to Medtronic. The Transmitter Case is used to carry the Transmitter. 4 English SEEQ MCT Instructions for use
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. If the lights on the Transmitter do not turn on, briefly press the Power Button for less than 1 second to power-up the Transmitter. If LED indicators turn ON, the Transmitter has powered up. To fully charge the battery, it is important to keep the Transmitter connected to wall power for at least 6 hours. Connector Power Button SEEQ MCT Instructions for use English 5
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. Using the Prep Wipe provided, clean the skin where the Wearable Sensor will be applied and allow time to dry (clean an area slightly larger than the Wearable Sensor). Do not use any creams or lotions on your skin before application as this will impact monitoring. IMPORTANT: Monitoring will be affected if hair is not trimmed or if skin is not cleaned with the Prep Wipe. If this happens, you may be required to use another Wearable Sensor. Remove the Wearable Sensor from the foil pouch by tearing at the notch. If you see any illuminated lights on the Wearable Sensor before application, contact Medtronic Customer Support at 1-877- 247-7449. Grasp the top side of the Wearable Sensor as seen in the diagram and turn it over to view the underside. Carefully remove each tab from the underside of the Wearable Sensor to expose the adhesive gel. IMPORTANT: Take care not to touch the adhesive gel while you handle the Wearable Sensor. 6 English SEEQ MCT Instructions for use
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. To minimize skin irritation, do not place the Wearable Sensor over broken or damaged skin. Male Collarbone Sternum Female Collarbone Sternum SEEQ MCT Instructions for use English 7
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. Avoid strenuous motion, activity, or showering for 30 minutes after Wearable Sensor application. EXAMPLES OF INCORRECT WEARABLE SENSOR APPLICATION Horizontal Upside down Applied over the nipple Applied under the arm IMPORTANT: Monitoring will be affected if the Wearable Sensor is not applied correctly. If this happens, you may be required to use another Wearable Sensor. 8 English SEEQ MCT Instructions for use
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. They will be used to ship the components back to Medtronic at the end of monitoring. Wear the Wearable Sensor continuously until you see the following two symbols ( and ) appear on the Wearable Sensor display. (Refer to the section When to remove or replace the Wearable Sensor on page 11.) You can wear the Wearable Sensor while you shower (it is water resistant), but do NOT submerge the Wearable Sensor in water (for example, by swimming or sitting in a hot tub). Avoid excessive rubbing of the Wearable Sensor while showering. Once applied, do not remove and then reapply or reposition the Wearable Sensor. If this happens, you may be required to use another Wearable Sensor (that is, it is meant for one-time use). Keep the Transmitter close to you at all times (within 30 feet [9 meters]) and charge it daily (for example, each night while you sleep). Whenever you feel symptoms, push the blue Patient Trigger Button in the middle of the Wearable Sensor device until you hear a beep. Using the SEEQ MCT System during the monitoring period What to do when you feel cardiac symptoms Whenever you feel cardiac symptoms, push the blue Patient Trigger Button in the middle of the Wearable Sensor device until you hear a beep. This will direct the Wearable Sensor to transmit a record of your heart rhythm (that is, ECG) to your Transmitter, which will then automatically transmit the information to the Medtronic Monitoring Center for review by Medtronic technicians. This information will then be provided to your physician. SEEQ MCT Instructions for use English 9
IMPORTANT: You may be contacted by a technician from the Medtronic Monitoring Center to discuss symptoms when the Patient Trigger Button is used. When you experience any symptoms, please make note of the following to discuss with a technician: type of symptoms time of symptoms duration of symptoms what you were doing How to use the Transmitter The Transmitter should be kept within 30 feet (9 meters) of you at all times to allow transmission of data from the Wearable Sensor to the Transmitter: During the day, carry the Transmitter with you using the Transmitter Case. At night, keep the Transmitter close to you while you sleep (for example, on a nightstand). The Transmitter should be kept ON at all times to allow transmission of data from the Wearable Sensor to the Transmitter. The Transmitter may be manually turned OFF by pressing and holding the Power Button for more than 6 seconds. When a Transmitter is in an OFF state (no lights are on), it can be turned ON by briefly pressing the Power Button for less than 1 second. However, please keep the Transmitter turned ON at all times to allow data transmission. IMPORTANT: If you are out of range of the Transmitter or required to turn it off (for example, when on an airplane or if asked by Medtronic Customer Support), you can continue to wear the Wearable Sensor and use the Patient Trigger Button to document symptoms. All of your data will be stored on the Wearable Sensor and sent to the Transmitter when you are again within range or when the Transmitter is turned back on. 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. 10 English SEEQ MCT Instructions for use
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. Refer to these lights only if asked by a Medtronic Customer Support representative. Power light: Green on: Adequate charge Yellow on: Low charge Flashing: Charging required IMPORTANT: If the battery on the Transmitter runs out, you can continue to wear the Wearable Sensor and use the Patient Trigger Button to document symptoms. All of your data will be stored on the Wearable Sensor and transmitted once the Transmitter is charged. When to remove or replace the Wearable Sensor Each Wearable Sensor is designed to operate with normal wear and tear over the course of use for up to 7.5 days. The Wearable Sensor is also water resistant. You can keep wearing the Wearable Sensor while you shower, but do not submerge it in water (for example, in a bath or hot tub). Depending on the length of your prescription, you may need to wear more than one Wearable Sensor. As seen in the diagram below, the Wearable Sensor display will let you know when it should be removed. 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). SEEQ MCT Instructions for use English 11
IMPORTANT: Each Wearable Sensor should be worn continuously until the two red lights behind the circle with the crossed line are seen. This may take up to 7.5 days, but could be less. Once it has been removed, do not reapply the removed Wearable Sensor as this will affect monitoring (that is, it is meant for one-time use only). Please call Medtronic Customer Support at 1-877-247-7449 if you have any questions about when to remove the Wearable Sensor. How to remove the Wearable Sensor Grasp an edge of the Wearable Sensor with one hand and begin to peel it away from your skin. Using the other hand, slowly and gently push the skin away from the Wearable Sensor as it is removed. IMPORTANT: Rapid removal can cause skin irritation. If irritation persists after Wearable Sensor removal, consult your healthcare provider for topical treatment options. What to do with a used Wearable Sensor Do not dispose of used Wearable Sensors. See the following section for instructions. The Wearable Sensor has a Lithium battery and must not be disposed of in a fire. What to do at the end of monitoring When your prescription is complete, you must return all of your Wearable Sensors, the Transmitter, the Transmitter Charger, and the Transmitter Case, to avoid being billed for the value of the system. Follow the steps below to return the components to Medtronic: Remove the postal return label provided in the original box. 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. Call Medtronic Customer Support at 1-877-247-7449 if you need information about the status of your prescription. 12 English SEEQ MCT Instructions for use
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. The System is indicated for those patients who require monitoring for the detection of non-lethal cardiac arrhythmias such as, but not limited to, supraventricular tachycardias (for example, atrial fibrillation, atrial flutter, paroxysmal SVTs), ventricular ectopy, bradyarrhythmias, and conduction disorders. The SEEQ MCT System monitors, derives, and displays the following: ECG, and Heart Rate. Description of the system The SEEQ MCT System consists primarily of the Wearable Sensor monitoring device and the Transmitter data transmission device. Once activated, the Wearable Sensor continuously monitors the heart and automatically collects ECGs. When rhythm abnormalities are detected, data is automatically transmitted from the Wearable Sensor to the Transmitter, which then automatically transmits the data to the Medtronic Monitoring Center. Patients can also trigger transmission of ECGs when they experience cardiac symptoms by using the Patient Trigger Button. Certified cardiographic technicians at the Medtronic Monitoring Center review received data and document symptoms reported to the Medtronic Monitoring Center by patients. Reports prepared by the Medtronic Monitoring Center are delivered to the prescribing physician and made available to them at www.medtronic.com to provide them with data for their diagnosis and identification of various clinical conditions, events and/or trends. Based on the indications, the SEEQ MCT System may be used for the following: patients who require monitoring for suspected or known, nonlife threatening arrhythmias patients with symptoms such as chest pain, syncope, lightheadedness or near syncope, vertigo, dizziness, fall, palpitations, transient ischemic episodes, and dyspnea (shortness of breath) that might be due to cardiac arrhythmias patients with cardiac arrhythmias associated with co-morbid conditions obtaining correlation of rhythm with symptoms when symptoms have unknown etiology evaluating possible arrhythmias in a) patients recovering from cardiovascular or thoracic surgery; b) survivors of myocardial infarction; c) patients with diagnosed sleep disorder breathing evaluating benefits after initiating or discontinuing pharmacological therapy (for example, anti-arrhythmic, betablocker, anti-coagulation therapies). assessing the results of an ablation procedure for an arrhythmia SEEQ MCT Instructions for use English 13
providing data to guide treatment decisions (for example, pharmacological or procedural/device-based treatments) and assessing treatment results in patients with non-life threatening arrhythmias Contraindications patients with known allergies or hypersensitivities to adhesives or hydrogel patients with potentially life-threatening arrhythmias, or who require inpatient / hospital monitoring Precautions Minute ventilation sensing on implantable devices should be disabled for the duration of Wearable Sensor usage. The Wearable Sensor should be removed prior to external defibrillation or an MRI scan. The Wearable Sensor may cause mild discomfort, skin irritation, redness, itching, rash, or contact dermatitis in some individuals. The device should be removed if any pain or discomfort occurs. If skin irritation or redness persists after the device has been removed, a topical anti-inflammatory cream may be applied to the area (in consultation with your health care provider). The Wearable Sensor is intended for single patient use and should not be reapplied it if peels off or is removed (that is, it is meant for one-time use). The Wearable Sensor should not be applied to broken, damaged, or irritated skin. The Wearable Sensor is water resistant but not waterproof. It should not be submerged in water (showering is acceptable, but swimming and submersion bathing are prohibited). The Wearable Sensor should not be disassembled. Do not apply the Wearable Sensor if it appears damaged upon receipt. No creams or lotions should be applied to the skin immediately prior to the application of the Wearable Sensor. Store the Wearable Sensor in a cool, dry location. The device is designed to withstand environmental temperature fluctuations between -4 F to 149 F (-20 C to 65 C). The system has not been fully evaluated for use with infants weighing less than 22 pounds (9.9 kilograms). The system is not designed to detect pacemaker spikes. Warning No modification of this equipment is allowed. 14 English SEEQ MCT Instructions for use
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. Clinical reports: Clinicians can receive clinical reports, including Episode, Daily, and End of Use Reports, directly from the Medtronic Monitoring Center by fax and/or email. Clinical data can also be securely reviewed online at www.medtronic.com. Clinicians may download and/or print clinical reports, review collected ECGs, and also establish service preferences. For any questions about online use, please contact Medtronic Customer Support at 1-877-247-7449. Notifications: The Medtronic Monitoring Center may send Episode Reports and contact prescribing physicians directly when arrhythmias that meet pre-defined criteria are identified. Contact information and notification preferences will be established upon registration and can be updated. IMPORTANT: Patient data available for transmission during the monitoring period are updated for physician display upon detection of a clinical event OR every two hours when no events are detected, assuming a) the Wearable Sensor is within 30 feet (9 meters) of Transmitter, b) the Transmitter has been appropriately installed and has sufficient power and c) sufficient cellular coverage for data transmission exists. Analysis of ECGs by the Medtronic Monitoring Center may also affect the timing of ECG display. Additional patient data may be available after the end of monitoring. SEEQ MCT Instructions for use English 15
Specifications, compliance, and symbols Specifications The following performance specifications are at 68 F (20 C) unless otherwise stated. Shelf life Battery Charger power requirement Battery life Wearable Sensor Transmitter Refer to Wearable N/A Sensor pouch label N/A 7.5 days (180 hours), non-rechargeable Operating temperature 32 F to 113 F (0 C to 45 C) Maximum temperature of the applied part Storage temperature (power off) 111.2 F (44 C) N/A -4 F to 149 F (-20 C to 65 C) 100-240 VAC, 50/60 Hz Provides 12 hours of function before recharging 32 F to 113 F (0 C to 45 C) -4 F to 149 F (-20 C to 65 C) Operating humidity 10% to 95% 10% to 95% Storage humidity 5% to 95% 5% to 95% Operating atmospheric pressure ECG Sampling rate Digital resolution Input dynamic range Input offset dynamic range Impedance measurements Peak current injection RMS current injection 700 hpa to 1060 hpa 200 Hz (+/-5%) 16bits +/-5 mv +/-300 mv 40 ua 29 ua 700 hpa to 1060 hpa N/A N/A Measurement ranges Heart Rate 25 to 250 bpm N/A Data storage Capacity 7.5 days N/A Weight 1.8 oz / 50 g max 5.3 oz / 150 g max Communication means Bluetooth between Wearable Sensor and Transmitter Cellular Phone between Transmitter and Server 16 English SEEQ MCT Instructions for use
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. ECGs are automatically transmitted upon detection of the following conditions: Heart Rate >= 130 bpm Heart Rate <= 40 bpm Pause >= 3 seconds Atrial Fibrillation Ventricular Tachycardia/Ventricular Fibrillation For example, the detection algorithm of the SEEQ MCT System detects the peak of each R-wave and calculates the interval between successive R-waves. The RR intervals are then used to calculate beat-to-beat heart rate values. RR intervals are also aggregated into 5-minute and 24-hour averages to summarize patient heart rate over the monitoring period. For Pause detection, the algorithm monitors the time between successive R-wave peaks. A pause trigger is activated if an internal timer advances to 3 seconds without R-wave detection. In order to provide relevant, exception-based arrhythmia reporting, the SEEQ MCT System proprietary ECG analysis algorithms proactively manage redundant reporting of ECGs for a select set of arrhythmias when persistently detected: Tachycardias with heart rate >= 130 bpm and < 165 bpm Bradycardias with heart rate >= 30 bpm and < 40 bpm Atrial Fibrillation Ventricular Tachycardia < 165 bpm For these arrhythmias, the Wearable Sensor algorithm detection sensitivity and positive predictive value results, which are obtained from the respective databases in strict accordance with EC-57 a and with 0% downtime, are as follows: Test Rhythm Name QRS Detection (average) Including all Tachycardias with heart rate >= 130 bpm and < 165 bpm, Bradycardias with heart rate >=30 bpm and <40 bpm Sensitivity (%) a AHA: 98.95 MIT-BIH: 99.83 Positive Predictive Value (%) a AHA: 99.34 MIT-BIH: 99.84 AF Duration (gross) MIT-BIH: 90 MIT-BIH: 85 a as measured by EC-57 standards testing on 12NOV2013 SEEQ MCT Instructions for use English 17
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. Note: a) ECGs are reported for all Tachycardias with heart rate >= 165 bpm, all Bradycardias with heart rate < 30 bpm, and all Pauses >= 3 seconds; b) the Wearable Sensor keeps a complete count of all arrhythmias that are detected; c) supplemental ECGs are also reported i) every six (6) hours for prolonged Atrial Fibrillation episodes and ii) every twenty-four (24) hours, irrespective of the presence of an arrhythmia. Transmitter maintenance Please attempt to keep the Transmitter dust free. If necessary, gently wipe the Transmitter with a soft dry cloth to clean the surface. The Transmitter is not waterproof and should be kept dry. This device does not have user serviceable components inside. Do not disassemble, crush, puncture, short external contacts or circuits, dispose of in fire or water, or expose the battery pack to temperatures higher than 149 F (65 C). Electromagnetic interference This equipment complies with International Standard IEC 60601-1-2 for electromagnetic compatibility for medical electrical equipment. Medical electrical equipment needs special precautions regarding EMC, and all equipment must be installed and put into service according to the EMC information provided upon request by calling Medtronic Customer Support at 1-877-247-7449. Portable and mobile RF communication equipment can affect nearby medical electrical equipment. FCC Compliance Information Wearable Sensor and Transmitter devices comply with Part 15 of the Federal Communications Commission (FCC) Rules Radio Frequency Devices: Operation is subject to the condition that (1) this device does not cause harmful interference and (2) this device must accept any interference received, including interference that may cause undesired operation. Changes or modifications not expressly approved by Medtronic could void the user s authority to operate the equipment. Note: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a residential environment. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instruction manual, may cause harmful interference to radio communications. 18 English SEEQ MCT Instructions for use
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. Use of accessories that are not expressly approved by Medtronic might violate FCC RF exposure guidelines. Specific absorption rate data The Transmitter meets the U.S. Government requirements for exposure to radio waves when used as directed in this section. The Transmitter is a radio transmitter and receiver. It is designed and manufactured not to exceed the emission limits for exposure to radio frequency (RF) energy set by the Federal Communications Commission (FCC) of the U.S. Government when used as directed in the previous section. These limits are part of comprehensive guidelines and establish permitted levels of RF energy for the general population. The exposure standard for wireless devices employs a unit of measurement known as the Specific Absorption Rate, or SAR. The SAR limit set by the FCC is 1.6W/kg. Tests for SAR are conducted using standard operating positions specified by the FCC. Before a wireless device model is available for sale to the public, it must be tested and certified to the FCC that it does not exceed the limit established by the government-adopted requirement for safe exposure under the recommendations of the International Commission on Non-Ionizing Radiation Protection (ICNIRP). The FCC has granted an Equipment Authorization for this wireless device model with all reported SAR levels evaluated and is in compliance with the FCC RF emission guidelines when the Transmitter is used as directed in this section. Symbol definitions Consult instructions for use Follow instructions for use Do not reuse Use-by (year-month) or (year-month-date) Caution: consult accompanying documents Latex free Batch number Serial number Date of manufacture Catalogue number Non-sterile Manufacturer s name and address SEEQ MCT Instructions for use English 19
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 Ingress Protection 3 means protection against objects >=2.5 mm in diameter (tools) 5 means protection against water jets (shower) Class II equipment Wireless transmission symbol Federal (USA) law restricts this product to sale by or on the order of a physician. Keep dry Conformité Européenne (European Conformity). This symbol means that the device fully complies with European Union Acts. Frequently asked questions What is a Wearable Sensor? A Wearable Sensor is a patient-worn medical device designed to comfortably adhere to the skin. The device contains sensors that collect your ECG waveform (a tool for analyzing the activity of your heart). How long will my Wearable Sensor last? Each Wearable Sensor is designed to last up to 7.5 days. However, inappropriate Wearable Sensor application, or removal and reapplication of the Wearable Sensor during use, will affect monitoring. If this happens, you may be required to use another Wearable Sensor. What information is transmitted to my physician? Your heart activity is monitored 24 hours a day, 7 days a week by the Wearable Sensor. When unusual heart activity is detected or when you use the Patient Trigger Button, information is transmitted to the Medtronic Monitoring Center for review and delivery to your physician. 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. 20 English SEEQ MCT Instructions for use
How can I report my symptoms? Technicians from Medtronic may call you to discuss your symptoms. Please make note of the type of symptoms, the duration of symptoms, when they happened, and what you were doing so it can be discussed with a technician. You should contact your physician if you need medical care. Can I take a shower while wearing my Wearable Sensor? Yes, the Wearable Sensor is water resistant so you can shower while wearing it. However, do NOT submerge the Wearable Sensor in water by swimming or sitting in a hot tub. In addition, avoid excessive rubbing of the Wearable Sensor during showering. Will I need to change the battery in the Transmitter or the Wearable Sensor? Battery replacement is not required for the Wearable Sensor and the Transmitter. However, we recommend that you charge the Transmitter every night. How close must I be to the Transmitter to ensure that the data collected by my Wearable Sensor is transmitted? Remain within 30 feet (9 meters) of the Transmitter for successful data transmission. How often do I need to change the Wearable Sensor device? When both of the following two symbols ( and ) appear on the Wearable Sensor display, you should remove the Wearable Sensor. Please apply a new Wearable Sensor if your monitoring period has not ended. What if the Wearable Sensor causes my skin to itch? If you experience skin irritation while wearing the Wearable Sensor, speak with your physician. Should I carry the Transmitter with me when I travel? Yes, take the Transmitter with you at all times. The Transmitter will remain charged for up to 12 hours. If you plan to be away for longer than 12 hours, take the Transmitter Charger with you. Will I need to notify security screeners about my Wearable Sensor? Carry the SEEQ MCT System patient travel card provided as part of your SEEQ MCT System when traveling or entering high security areas. Wearable Sensor and Transmitter devices may trigger security systems, but the devices will not be damaged. If your Wearable Sensor or Transmitter triggers a security system, simply show the security personnel this card and tell them you are wearing a medical device. 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. SEEQ MCT Instructions for use English 21
Can I be close to wireless phones, WiFi, or other electromagnetic devices? Yes, although some sources of Electromagnetic Interference (EMI) may temporarily disrupt data transmission. Can I carry my cellphone while wearing the Wearable Sensor? Yes, cellphones will not interfere with the Wearable Sensor device. Will hot or cold environments affect the Wearable Sensor performance? The Wearable Sensor provides accurate and reliable performance in a temperature range of 32 F to 113 F (0 C to 45 C). Is my medical data protected during transmission? Your data is transmitted securely to the Medtronic Monitoring Center and securely stored. 22 English SEEQ MCT Instructions for use
Tabla de contenido Cómo comenzar 24 Uso del sistema SEEQ durante el periodo de monitorización 29 Qué hacer al final de la monitorización 32 Indicaciones de uso, contraindicaciones y medidas preventivas 33 Servicios para médicos 35 Especificaciones, cumplimiento y símbolos 36 Preguntas más frecuentes 40 Instrucciones de uso SIGA ESTAS INSTRUCCIONES ATENTAMENTE Y VEA EL VÍDEO DE INSTRUCCIONES ANTES DE USAR EL SISTEMA SEEQ. Servicio de atención al cliente de Medtronic EE. UU.: 1-877-247-7449 El sistema externo de monitorización cardíaca SEEQ es un sistema inalámbrico de detección de arritmias que se lleva puesto y que se utiliza para ayudar al médico en el diagnóstico de posibles arritmias cardíacas. Se compone principalmente del dispositivo de monitorización, el sensor personal y el transmisor (dispositivo portátil de transmisión de datos). El sistema SEEQ, junto con los servicios de interpretación proporcionados por el centro de monitorización de Medtronic, así como la revisión segura de datos en línea (solo para médicos), permite la detección sencilla y cómoda para el paciente y el médico de las arritmias, durante un máximo de 30 días seguidos, de manera sencilla y cómoda tanto para el paciente como para el médico. Funcionamiento del sistema SEEQ Una vez activado, el sensor personal monitoriza continuamente el corazón y graba automáticamente el ECG. Cuando se detecta alguna anomalía, los datos se transmiten automáticamente desde el sensor personal al transmisor, que a su vez los transmite automáticamente al Centro de monitorización de Medtronic. Los pacientes también pueden activar la transmisión del ECG cuando tienen síntomas cardíacos mediante el botón de Activación del paciente. Los técnicos cardiógrafos certificados del Centro de monitorización de Medtronic revisan los datos recibidos y documentan los síntomas que los pacientes notifican al Centro de monitorización de Medtronic. Los informes preparados por el centro de monitorización de Medtronic se entregan al médico responsable del paciente y se ponen a su disposición en www.medtronic.com para proporcionarles datos para el diagnóstico e identificación de diversas condiciones clínicas, episodios y/o tendencias. El centro de monitorización de Medtronic también puede ponerse en contacto directamente con el médico cuando se detectan arritmias que cumplen criterios predefinidos. Instrucciones de uso del sistema SEEQ Español 23
IMPORTANTE: El sistema SEEQ no está previsto para funcionar como un sistema de alarma, ni para alertar a los pacientes o médicos, y no genera una respuesta de los sistemas de emergencia en el caso de que se necesite ayuda. El sistema SEEQ no está previsto para reemplazar la comunicación directa con los profesionales sanitarios. Medtronic no proporciona asesoramiento médico a los pacientes. Los pacientes deben comunicarse con su médico para obtener asesoramiento médico. Los datos proporcionados por el sistema los debe emplear el médico junto a otros hallazgos clínicos y exploraciones para elaborar un diagnóstico. Los pacientes deben hablar inmediatamente con el profesional sanitario si tienen alguna duda o si cambia su estado clínico. Cómo comenzar Paso 1: Identificar los componentes del sistema SEEQ El sensor personal es un dispositivo que se lleva puesto con el fin de recoger y transmitir datos fisiológicos. El paquete puede contener uno o más sensores personales (dentro de una bolsa de aluminio), en función de la duración de la monitorización que haya prescrito el médico. El transmisor es un dispositivo que recibe los datos del sensor personal y los transmite a Medtronic. 24 Español Instrucciones de uso del sistema SEEQ
La funda del transmisor se utiliza para transportar el transmisor. El cargador del transmisor se utiliza para cargar el transmisor. Las toallitas de preparación se utilizan para limpiar la piel antes de colocar el sensor personal. Documentación En la documentación se incluyen estas instrucciones y otra información para los pacientes. Paso 2: Cargar el transmisor Conecte el cargador del transmisor al transmisor y enchúfelo a una toma de corriente eléctrica normal. Si las luces del transmisor no se encienden, presione brevemente el botón de encendido durante menos de 1 segundo para encenderlo. Si los indicadores LED se encienden, el transmisor se ha encendido. Para cargar por completo la batería, es importante mantener el transmisor conectado a una toma de pared durante al menos 6 horas. Conector Botón de encendido Instrucciones de uso del sistema SEEQ Español 25
Paso 3: Prepararse para la colocación del sensor personal Corte todo el pelo que sea posible (para los hombres) en el lugar deseado dentro del cuadrante superior izquierdo del pecho, como se puede ver en el diagrama. Puede utilizar por ejemplo una máquina de afeitar eléctrica o una máquina para cortar el pelo. Recorte una zona ligeramente mayor que la del sensor personal. Limpie la piel de la zona en la que colocará el sensor personal con la toallita de preparación y deje que se seque (limpie una zona ligeramente mayor que del sensor personal). No utilice cremas ni lociones en la piel antes de la colocación del sensor, ya que esto afecta a la monitorización. IMPORTANTE: La monitorización se verá afectada si no se recorta el pelo o si la piel no se limpia con la toallita de preparación. Si esto sucediera, es posible que necesite usar otro sensor personal. Saque el sensor personal de la bolsa de aluminio rasgándola por la muesca. Si ve alguna luz iluminada en el sensor personal antes de la colocación, póngase en contacto con el Servicio de atención al cliente de Medtronic en el 1-877-247-7449. Sujete la parte superior del sensor personal como se muestra en el diagrama y dele la vuelta para ver la parte inferior. Quite con cuidado cada lengüeta de la parte inferior del sensor personal para dejar expuesto el gel adhesivo. IMPORTANTE: Tenga cuidado para no tocar el gel adhesivo mientras manipula el sensor personal. 26 Español Instrucciones de uso del sistema SEEQ
Paso 4: Colocarse el sensor personal en el pecho Acerque el sensor personal al cuadrante superior izquierdo del pecho, con cuidado de sostenerlo solamente como se describe en el Paso 3. Tal y como se muestra en los diagramas a continuación, coloque el extremo del sensor personal con el logotipo de Medtronic orientado hacia arriba, justo debajo de la clavícula e inclínelo hacia el pezón. Para reducir la irritación cutánea, no coloque el sensor personal sobre piel dañada o con heridas. Hombre Clavícula Esternón Mujer Clavícula Esternón Instrucciones de uso del sistema SEEQ Español 27
Los pacientes de menor tamaño pueden inclinar ligeramente el sensor hacia el brazo izquierdo, para alejarlo del pezón y conseguir un ajuste cómodo, como se muestra a continuación. Clavícula Esternón Una vez colocado, presione firmemente con la palma de la mano toda la superficie del sensor personal. A continuación, presione con los dedos los bordes del sensor personal sobre la piel. Evite realizar movimientos bruscos, actividad intensa o ducharse hasta transcurridos 30 minutos de la colocación del sensor personal. EJEMPLOS DE COLOCACIÓN INCORRECTA DEL SENSOR PERSONAL Horizontal Invertido Colocado sobre el pezón Colocado debajo del brazo IMPORTANTE: La monitorización se verá afectada si el sensor personal no se coloca correctamente. Si esto sucediera, es posible que necesite usar otro sensor personal. 28 Español Instrucciones de uso del sistema SEEQ
Paso 5: Confirmar que el sensor personal se ha activado Si ve una luz verde parpadeante dentro del símbolo de círculo, significa que el sensor personal está funcionando correctamente. Si NO ve esta luz en un plazo máximo de 15 minutos desde la colocación del sensor, llame al Servicio de atención al cliente de Medtronic en el 1-877-247-7449. Aspectos importantes que deben recordarse No deseche la caja del sistema SEEQ ni la etiqueta de devolución por correo. Será necesario utilizarlas para devolver los componentes a Medtronic al final de la monitorización. Lleve puesto siempre el sensor personal hasta que vea que en la pantalla aparecen los dos símbolos que se muestran a continuación ( y ). (Consulte el apartado Cuándo retirar o cambiar el sensor personal en la página 31). Puede llevar puesto el sensor personal mientras se ducha (es resistente al agua), pero NO lo sumerja en agua (por ejemplo, dándose un baño en una piscina o metiéndose en un una bañera). Evite frotar en exceso el sensor personal mientras se ducha. Una vez colocado, no retire y después vuelva a colocar o cambie de posición el mismo sensor personal. Si esto sucediera, es posible que tenga que usar otro sensor personal (es decir, el sensor está previsto para un solo uso). Mantenga el transmisor cerca de usted en todo momento (a 30 pies [9 metros] como máximo) y cárguelo todos los días (por ejemplo, todas las noches mientras duerme). Siempre que tenga síntomas presione el botón azul de Activación del paciente en el centro del sensor personal hasta que oiga un pitido. Uso del sistema SEEQ durante el periodo de monitorización Qué hacer cuando tiene síntomas cardíacos Siempre que tenga síntomas cardíacos presione el botón azul de Activación del paciente en el centro del sensor personal hasta que oiga un pitido. Esto ordenará al sensor personal que transmita un registro de su ritmo cardíaco (un ECG) al transmisor, que enviará automáticamente los datos al Centro de monitorización de Medtronic, para que los técnicos de Medtronic los revisen. Esta información se le hará llegar a su médico. Instrucciones de uso del sistema SEEQ Español 29
IMPORTANTE: Es posible que un técnico del centro de monitorización de Medtronic se ponga en contacto con usted para hablar de los síntomas cuando utilice el botón de Activación del paciente. Cuando sienta síntomas, tome nota de lo siguiente para tratarlo con el técnico: tipo de síntomas hora de los síntomas duración de los síntomas qué estaba haciendo Cómo utilizar el transmisor El transmisor se debe mantener a menos de 30 pies (9 metros) para permitir la transmisión de datos desde el sensor personal al transmisor: Durante el día lleve el transmisor consigo en su funda. Por la noche mantenga el transmisor cerca de usted mientras duerme (por ejemplo, en la mesilla). El transmisor se debe mantener encendido en todo momento para permitir la transmisión de datos desde el sensor personal al transmisor. El transmisor se puede apagar manualmente manteniendo presionado el botón de encendido durante más de 6 segundos. Cuando un transmisor está apagado (no hay ninguna luz encendida), puede encenderse presionando brevemente el botón de encendido durante menos de 1 segundo. No obstante, mantenga encendido el transmisor en todo momento para permitir la transmisión de datos. IMPORTANTE: Si sale del alcance del transmisor o necesita apagarlo (por ejemplo, si está en un avión o se lo pide el Servicio de atención al cliente de Medtronic), puede seguir llevando el sensor personal y usar el botón de Activación del paciente para documentar los síntomas. Todos los datos se guardarán en el sensor personal y los enviará al transmisor cuando vuelva a estar dentro del rango o el transmisor vuelva a estar encendido. Cómo cargar el transmisor Cargue el transmisor a diario (por ejemplo, todas las noches mientras duerme). 30 Español Instrucciones de uso del sistema SEEQ
El transmisor puede tardar hasta 6 horas en cargarse. Con una carga adecuada, el transmisor se puede usar durante un máximo de 12 horas antes de tener que volver a cargarlo. Las luces Linked, Cell y Send del transmisor las utiliza el Servicio de atención al cliente de Medtronic para la resolución de problemas. Consulte estas luces solamente si así se lo pide el representante del Servicio de atención al cliente de Medtronic. Luz de alimentación Verde encendida: carga adecuada Amarilla encendida: carga baja Parpadeante: es necesario cargar IMPORTANTE: Si el transmisor se queda sin batería, puede seguir utilizando el sensor personal y usar el botón de Activación del paciente para documentar los síntomas. Todos los datos se almacenarán en el sensor personal y se transmitirán cuando se cargue el transmisor. Cuándo retirar o cambiar el sensor personal Cada sensor personal está diseñado para funcionar con un desgaste normal durante un periodo de 7,5 días como máximo. El sensor personal también es resistente al agua. Puede llevar puesto el sensor personal mientras se ducha, pero no lo sumerja (por ejemplo, dándose un baño en una piscina o metiéndose en un la bañera). En función del periodo de tiempo que le hayan prescrito la monitorización es posible que necesite usar más de un sensor personal. Como puede ver en el diagrama a continuación, la pantalla del sensor personal le indicará cuándo es necesario retirarlo. Si ve una luz verde parpadeante dentro del símbolo de círculo, significa que el sensor personal está funcionando correctamente. Debe seguir llevando puesto el dispositivo. Si también ve dos luces rojas dentro del círculo con el símbolo de línea cruzada, debe retirar y reemplazar el dispositivo por un sensor personal nuevo (excepto si ha finalizado el periodo de monitorización). Instrucciones de uso del sistema SEEQ Español 31
IMPORTANTE: Cada sensor personal se debe llevar puesto de forma continuada hasta que se vean las dos luces rojas detrás de un círculo con la línea atravesada. Esto puede suceder en 7,5 días o menos. Una vez lo haya retirado, no vuelva a colocarse el mismo sensor personal, ya que esto afectará a la monitorización (es decir, el sensor está previsto para un solo uso). Si tiene alguna pregunta sobre cómo retirar el sensor personal, llame al Servicio de atención al cliente de Medtronic en el 1-877-247-7449. Cómo retirar el sensor personal Sujete uno de los bordes del sensor personal con una mano y comience a despegarlo de la piel. Mientras tanto, con la otra mano, presione lenta y suavemente la piel para separarla del sensor personal mientras lo retira. IMPORTANTE: La retirada rápida puede causar irritación cutánea. Si la irritación persiste después de la retirada del sensor personal, consulte con un profesional sanitario las opciones de tratamiento tópico más adecuadas. Qué hacer con un sensor personal usado No se deshaga de los sensores personales usados. Consulte las instrucciones en el apartado siguiente. El sensor personal tiene una pila de litio y no se debe quemar. Qué hacer al final de la monitorización Cuando finalice el periodo de monitorización que le ha indicado el médico debe devolver todos los sensores personales, el transmisor, el cargador del transmisor y la funda del transmisor, para evitar que se le cobre el valor del sistema. Siga los pasos a continuación para devolver los componentes a Medtronic: Retire la etiqueta de devolución por correo de la caja original. Meta los sensores personales, el transmisor, el cargador del transmisor y la funda del transmisor en la caja original. Pegue la etiqueta de devolución por correo en la parte exterior de la caja. Envíe la caja por correo. No es necesario franqueo. IMPORTANTE: Solo debe devolver los componentes cuando haya finalizado el periodo de monitorización prescrito por el médico. Llame al Servicio de atención al cliente de Medtronic en el 1-877-247-7449 si necesita información sobre el estado de su prescripción. 32 Español Instrucciones de uso del sistema SEEQ
Indicaciones de uso, contraindicaciones y medidas preventivas Indicaciones de uso El sistema de telemetría cardíaca móvil SEEQ está diseñado para medir, registrar continuamente y transmitir periódicamente datos fisiológicos. El sistema está indicado para aquellos pacientes que necesitan monitorización para la detección de arritmias cardíacas no letales, como las taquicardias supraventriculares (por ejemplo, fibrilación auricular, flutter auricular, taquicardia supraventricular paroxística), ectopia ventricular, bradiarritmias y trastornos de conducción, entre otros. El sistema SEEQ monitoriza, obtiene y muestra lo siguiente: ECG y frecuencia cardíaca. Descripción del sistema El sistema SEEQ se compone principalmente del dispositivo de monitorización del sensor personal y del dispositivo de transmisión de datos (el transmisor). Una vez activado, el sensor personal monitoriza continuamente el corazón y graba automáticamente el ECG. Cuando se detecta alguna anomalía, los datos se transmiten automáticamente desde el sensor personal al transmisor, que a su vez los transmite automáticamente al Centro de monitorización de Medtronic. Los pacientes también pueden activar la transmisión del ECG cuando tienen síntomas cardíacos mediante el botón de Activación del paciente. Los técnicos cardiógrafos certificados del Centro de monitorización de Medtronic revisan los datos recibidos y documentan los síntomas que los pacientes notifican al Centro de monitorización de Medtronic. Los informes preparados por el Centro de monitorización de Medtronic se entregan al médico responsable del paciente y se ponen a su disposición en www.medtronic.com para proporcionarles datos para el diagnóstico e identificación de diversas condiciones clínicas, episodios y/o tendencias. Según las indicaciones, el sistema SEEQ se puede utilizar para: pacientes que necesiten monitorización de arritmias no letales sospechadas o conocidas pacientes con síntomas como dolor en el pecho, síncope, sensación de inestabilidad o casi síncope, vértigo, mareos, caídas, palpitaciones, episodios isquémicos transitorios y disnea (falta de aliento) que puedan estar causados por arritmias cardíacas pacientes con arritmias cardíacas asociadas a otras enfermedades obtener una correlación entre el ritmo y los síntomas, cuando estos tienen una etiología desconocida evaluar posibles arritmias en a) pacientes que se recuperan de una intervención quirúrgica cardiovascular o torácica, b) pacientes que han sufrido un infarto de miocardio, c) pacientes diagnosticados con trastornos respiratorios durante el sueño evaluar los beneficios tras el inicio o la interrupción del tratamiento farmacológico (por ejemplo tratamiento contra arritmias, betabloqueantes y anticoagulantes) Instrucciones de uso del sistema SEEQ Español 33