quick start 4 apply the wearable sensor to your left chest ... · (e.g., atrial fibrillation,...

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IMPORTANT: Refer to the “Instructions for Use” manual and the instructional video for complete instructions. Keep all components and packaging for returning SEEQ components after use. Horizontal Upside down Applied over the nipple Applied under the arm IMPORTANT: You may be required to use another Wearable Sensor if it is applied incorrectly (examples below) Position the end of the Wearable Sensor on your left chest with the Medtronic logo pointing upward just below the collarbone, and angle the device toward the nipple. Collarbone Sternum Petite patients can angle the Wearable Sensor slightly away from the nipple. Ensure the Wearable Sensor is completely adhered to your skin. Avoid strenuous motion, activity or showering for 30 minutes after Wearable Sensor application. Collarbone Sternum Apply the Wearable Sensor to your left chest Confirm that the Wearable Sensor is working Look for the blinking green light on the Wearable Sensor display after application. Now you are ready to move about freely. DURING MONITORING § Once applied, do not remove and then reapply or reposition the Wearable Sensor § You can wear the Wearable Sensor while you shower, but do not submerge it in water § Whenever you feel symptoms, press the blue Patient Trigger Button in the middle of the Wearable Sensor until you hear a beep § Charge the Transmitter daily (for example, each night while you sleep) § Carry the Transmitter with you and refer only to the Power light SEEQ REMOVAL AND RETURN Remove the Wearable Sensor when you see two red lights ( ) on the Wearable Sensor display. Do not dispose of any used SEEQ components or packaging. At the end of your prescription, return your SEEQ System as directed in your “Instructions for Use” manual. Customer Support USA: 1 (877) 247-7449 Brief Statement Medtronic SEEQ Mobile Cardiac Telemetry (MCT) System (Referred to as “SEEQ External Cardiac Monitor (ECM)” in markets outside of the United States) Indications The Medtronic 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 (e.g., atrial fibrillation, atrial flutter, paroxysmal SVTs), ventricular ectopy, bradyarrhythmias and conduction disorders. The SEEQ MCT System monitors, derives, and displays: ECG, Heart Rate. Contraindications § Patients with known allergies or hypersensitivities to adhesives or hydrogel § Patients with potentially life-threatening arrhythmias, or who require inpatient/hospital monitoring Warnings and Precautions § Do not reapply the Wearable Sensor (it is meant for one-time use) § For a complete list of precautions, please refer to the Instructions for Use document See the device manual for detailed information regarding the indications, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at 1 (800) 328-2518 and/or consult Medtronic’s website at www.medtronic.com. Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician. The SEEQ™ MCT System and the Medtronic Monitoring Center are provided by Medtronic Monitoring Inc., a wholly owned subsidiary of Medtronic. Wearable Sensor Transmitter QUICK START GUIDE SEEQ Mobile Cardiac Telemetry (MCT) System GETTING STARTED 1 Locate components of your SEEQ TM MCT System 2 Charge the Transmitter for at least 6 hours 3 Prepare your skin: § Trim as much hair as possible (for men) § Clean your skin with the Prep Wipe provided and allow your skin to dry § Do not use lotions or creams before application IMPORTANT: You may be required to use another Wearable Sensor if hair is not trimmed or skin is not cleaned with the Prep Wipe. 4 5 medtronic.com UC201406935a ML © Medtronic 2016. Minneapolis, MN. All Rights Reserved. Printed in USA. 02/2016 Medtronic 710 Medtronic Parkway Minneapolis, MN 55432-5604 USA Tel: (763) 514-4000 Fax: (763) 514-4879 Toll-free: 1 (800) 328-2518 (24-hour technical support for physicians and medical professionals)

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IMPORTANT: Refer to the “Instructions for Use” manual and the instructional video for complete instructions. Keep all components and packaging for returning SEEQ components after use.

Horizontal Upside down

Applied over the nipple Applied under the arm

IMPORTANT: You may be required to use another Wearable Sensor if it is applied incorrectly (examples below)

Position the end of the Wearable Sensor on your left chest with the Medtronic logo pointing upward just below the collarbone, and angle the device toward the nipple.

Collarbone

Sternum

Petite patients can angle the Wearable Sensor slightly away from the nipple.

Ensure the Wearable Sensor is completely adhered to your skin. Avoid strenuous motion, activity or showering for 30 minutes after Wearable Sensor application.

Collarbone

Sternum

Apply the Wearable Sensor to your left chest Confirm that the Wearable Sensor is workingLook for the blinking green light on the Wearable Sensor display after application. Now you are ready to move about freely.

DURING MONITORING§ Once applied, do not remove and

then reapply or reposition the Wearable Sensor

§ You can wear the Wearable Sensor while you shower, but do not submerge it in water

§ Whenever you feel symptoms, press the blue Patient Trigger Button in the middle of the Wearable Sensor until you hear a beep

§ Charge the Transmitter daily (for example, each night while you sleep)

§ Carry the Transmitter with you and refer only to the Power light

SEEQ REMOVAL AND RETURNRemove the Wearable Sensor when you see two red lights ( ) on the Wearable Sensor display.

Do not dispose of any used SEEQ components or packaging. At the end of your prescription, return your SEEQ System as directed in your “Instructions for Use” manual.

Customer Support USA: 1 (877) 247-7449

Brief Statement

Medtronic SEEQ™ Mobile Cardiac Telemetry (MCT) System (Referred to as “SEEQ™ External Cardiac Monitor (ECM)” in markets outside of the United States)

Indications The Medtronic 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 (e.g., atrial fibrillation, atrial flutter, paroxysmal SVTs), ventricular ectopy, bradyarrhythmias and conduction disorders. The SEEQ MCT System monitors, derives, and displays: ECG, Heart Rate.

Contraindications § Patients with known allergies or hypersensitivities to adhesives or

hydrogel§ Patients with potentially life-threatening arrhythmias, or who

require inpatient/hospital monitoring

Warnings and Precautions § Do not reapply the Wearable Sensor (it is meant for

one-time use)§ For a complete list of precautions, please refer to the Instructions

for Use document

See the device manual for detailed information regarding the indications, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at 1 (800) 328-2518 and/or consult Medtronic’s website at www.medtronic.com.

Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.

The SEEQ™ MCT System and the Medtronic Monitoring Center are provided by Medtronic Monitoring Inc., a wholly owned subsidiary of Medtronic.

Wearable Sensor

Transmitter

QUICK STARTGUIDESEEQ™ Mobile Cardiac Telemetry (MCT) System

GETTINGSTARTED

1 Locate components of your SEEQTM MCT System

2 Charge the Transmitter for at least 6 hours

3 Prepare your skin:

§ Trim as much hair as possible (for men)§ Clean your skin with the Prep Wipe provided and allow

your skin to dry§ Do not use lotions or creams before application

IMPORTANT: You may be required to use another Wearable Sensor if hair is not trimmed or skin is not cleaned with the Prep Wipe.

4 5

medtronic.com

UC201406935a ML © Medtronic 2016. Minneapolis, MN. All Rights Reserved. Printed in USA. 02/2016

Medtronic710 Medtronic Parkway Minneapolis, MN 55432-5604 USA Tel: (763) 514-4000 Fax: (763) 514-4879

Toll-free: 1 (800) 328-2518(24-hour technical support for physicians and medical professionals)

Horizontal Invertido

Colocado sobre el pezón Colocado debajo del brazo

IMPORTANTE: Si se coloca incorrectamente, es posible que sea necesario utilizar otro sensor personal (vea los ejemplos a continuación).

Coloque el sensor personal en el lado izquierdo del pecho, con el logotipo de Medtronic orientado hacia arriba, justo debajo de la clavícula, e incline el dispositivo hacia el pezón.

Clavícula

Esternón

Los pacientes de menor tamaño pueden inclinar el sensor personal ligeramente para alejarlo del pezón.

Asegúrese de que el sensor personal está completamente adherido a la piel. Evite los movimientos bruscos, la actvidad intensa y ducharse en los 30 minutos siguientes a la colocación del sensor personal.

Clavícula

Esternón

Coloque el sensor personal en el lado izquierdo del pecho

Confirme que el sensor personal funcionaVerifique que la luz verde parpadea en la pantalla del sensor personal después de la colocación. Ahora ya puede moverse con libertad.

DURANTE LAMONITORIZACIÓN§ Una vez colocado, no retire y después

vuelva a colocar o cambie de posición el mismo sensor personal

§ No es necesario quitarse el sensor personal al darse una ducha, pero no lo sumerja en agua

§ Siempre que perciba síntomas presione el botón azul de Activación, que se encuentra en el centro del sensor personal, hasta que oiga un pitido

§ Cargue el transmisor a diario (por ejemplo, todas las noches mientras duerme)

§ Lleve consigo el transmisor o manténgalo a menos de 9 metros (30 pies) de distancia de usted en todo momento. Consulte el manual “Instrucciones de uso” para conocer más detalles.

RETIRADA Y DEVOLUCIÓNDEL SEEQRetire el sensor personal cuando vea dos lucesrojas ( ) en la pantalla del mismo. Si así lo indicasu médico, colóquese un nuevo sensor personal.

No elimine los componentes usados ni el envasedel SEEQ. Una vez le indiquen que deje de utilizarel sistema, devuelva el sistema SEEQ tal y comose especifica en el manual “Instrucciones de uso”.

Servicio de atención al cliente EE. UU.: 1 (877) 247-7449

Declaración breve

Sistema de telemetría cardiaca móvil (MCT) Medtronic SEEQ™ (“SEEQ™ Monitor Cardiaco Externo (ECM)” en mercados fuera de los Estados Unidos)

Indicaciones El sistema de telemetría cardiaca móvil (MCT) Medtronic SEEQ está diseñado para medir y registrar continuamente y transmitir periódicamente datos fisiológicos. Está indicado para aquellos pacientes que necesitan monitorización para la detección de arritmias cardiacas no letales, como las taquicardias supraventriculares (p. ej., fibrilación auricular, aleteo auricular, taquicardia supraventricular paroxística), ectopia ventricular, bradiarritmias y trastornos de conducción, entre otros. El sistema SEEQ MCT monitoriza, obtiene y muestra lo siguiente: ECG y frecuencia cardiaca.

Contraindicaciones § Pacientes con alergias o hipersensibilidades conocidas a los

adhesivos o el hidrogel§ Pacientes con arritmias potencialmente mortales o que requieran

ingreso o monitorización hospitalaria

Advertencias y medidas preventivas § No vuelva a colocar el sensor personal (está previsto para un solo

uso)§ Para obtener una lista completa de precauciones, consulte el

documento de instrucciones de uso

Consulte el manual del dispositivo para obtener información detallada sobre las indicaciones, las contraindicaciones, las advertencias, las precauciones y los posibles efectos secundarios o complicaciones. Para obtener más información, póngase en contacto con Medtronic llamando al 1 (800) 328-2518 o consulte la página web de Medtronic en www.medtronic.com.

Precaución: Las leyes federales estadounidenses restringen la venta de estos dispositivos al personal médico o bajo prescripción facultativa.

El sistema SEEQ™ MCT y el Centro de Monitorización de Medtronic pertenecen a Medtronic Monitoring Inc., una filial propiedad absoluta de Medtronic.

IMPORTANTE: Consulte el manual “Instrucciones de uso” y el vídeo correspon-diente para obtener instrucciones completas. Conserve todos los componentes y el envase para devolver los componentes del sistema SEEQ después de utilizarlo.

Sensor Personal

Transmisor

INICIO1 Identifique los componentes del sistemar SEEQ™

2 Cargue el transmisor durante 6 horas como mínimo

3 Prepare la piel:

§ Corte todo el pelo que sea posible de la zona de colocación (para los hombres)§ Limpie la piel con la toallita de preparación y deje que la

piel se seque§ No utilice lociones o cremas antes de colocar el sensor

IMPORTANTE: Si no se corta el pelo o no se limpia la piel con la toallita de preparación es posible que sea necesario utilizar otro sensor personal.

GUÍA DE INICIO RÁPIDOSEEQ™ Sistema de telemetría cardíaca móvil

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UC201406935a ML © Medtronic 2016. Minneapolis, MN. All Rights Reserved. Printed in USA. 02/2016