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Bioventus EXOGEN Guia Del Usuario

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EXOGEN
User Guide
®
Read before using your device

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Resumen de contenidos para Bioventus EXOGEN

  • Página 1 EXOGEN User Guide ® Read before using your device...
  • Página 2 EU: Not for General Waste. This symbol indicates that EXOGEN should not be disposed of with ordinary household waste at the end of its life. For details on how to dispose of this device correctly, contact your local government waste disposal agency or your local Bioventus representative.
  • Página 3 Preparing to Treat Your Fracture Place the Strap EXOGEN Classifications If You Have a Cast Guidance and Add Gel and Place Transducer Manufacturer’s Declaration First Use – EXOGEN Setup Customer Service First Use Limited Warranty Hour Setting Treating Your Fracture Start Treatment...
  • Página 4 † use with conservatively-treated fresh fractures application or performance. The EXOGEN • The EXOGEN device has also been reported Ultrasound Bone Healing System consists of and non-unions, or surgically-treated non-unions. as effective as an adjunctive non-invasive...
  • Página 5 EXOGEN contains the internal electronics and EXOGEN as well as damage to the charger. The battery. It checks the ultrasound signal to make use of chargers, transducers or cables, other than sure EXOGEN works properly.
  • Página 6 The safety and effectiveness of the use of EXOGEN is approved for use by persons that are EXOGEN. The gel is to be placed on the trans- 18 years or older and skeletally mature. There is EXOGEN has not been established for: ducer every time you use EXOGEN.
  • Página 7 Automatically displays when count- Treatment Complete down timer reaches zero to show that treatment is complete. *EXOGEN should be used for only 20 minutes per day, or as prescribed by your doctor.
  • Página 8 It takes about 5 hours to fully charge a discharged EXOGEN battery. WARNING: To avoid the risk of electric shock, EXOGEN must only be connected to a supply mains with protective earth (a 3-prong electrical outlet). Do not use any adapters or extension cords to charge EXOGEN. Only plug the charger into an UL listed electrical outlet.
  • Página 9 Recharging EXOGEN As you use EXOGEN, the symbol will change to You may charge EXOGEN at any time, whether show the reduced battery level. See Figure 6. it is on or off. When the battery level is low, Check the charge level on EXOGEN you must charge EXOGEN before your next following treatment.
  • Página 10 Preparing to Treat Your Fracture Place the Strap To treat your fracture, you will need EXOGEN, the gel and strap. If you have a cast around your fracture, you will not need the strap. Your doctor may have marked your fracture site with an ‘X’, or told you where to treat your...
  • Página 11 If You Have a Cast 3. Pull out the round felt plug inside the open- 1. Your cast will have a plastic port with cap 2. Use 2 fingers to squeeze the cap tabs ing. built into it. together to open the cap. Add Gel and Place Transducer Note: Some patients have experienced mild skin irritation caused by skin sensitivity to the gel.
  • Página 12 EXOGEN has a calendar which tracks how often the system is used. The current hour needs to be set to make sure the calendar is accurate. The hour must be set once, the very first time EXOGEN is turned on. Hour Setting 1.
  • Página 13 Treating Your Fracture Start Treatment Hold EXOGEN in your hand to view the screen, or ® set EXOGEN down on a nearby flat surface. Perform the following steps to begin treatment: 1. Press the button on EXOGEN. EXOGEN beeps and the start-up screen appears for 2 seconds.
  • Página 14 EXOGEN to be serviced. 4. Remove the strap and clean any gel from your skin and strap with a soft cloth. 5. Place EXOGEN, the strap and gel back into the carrying case until you are ready to treat again.
  • Página 15 6. Snap the cap shut. and port with a soft cloth. port. This plug helps prevent swelling in the 7. Place EXOGEN and the gel back into the cast when you are not using EXOGEN. carrying case until you are ready...
  • Página 16 Treatment Calendar EXOGEN tracks how often you use it. A calendar The current month is shown when you turn on EXOGEN for a treatment. Today’s date will have a purple shows your usage on the screen. There are two box around it. EXOGEN will mark your calendar every day with one of the following symbols: X-mark, parts to the calendar screen.
  • Página 17 Usage Summary Data EXOGEN also displays you usage on the screen during your treatment. The Usage Summary Data screens show your overall usage as well as recent consecutive usage. 19:50 19:40 The goal screen will be displayed during your The adherence screen will also be displayed The day streak screen will also be displayed treatment for 10 seconds.
  • Página 18 After using EXOGEN over time, you may want ® to view your treatment history month by month. EXOGEN will store up to twelve months of recent treatment history. You can show your treatment history to your doctor. EXOGEN lets you view...
  • Página 19 Calendar Pause You can pause the calendar screen to August 2013 view your treatment history for longer than 5 seconds. Any calendar screen can be paused. To pause the calendar, perform the following steps: 12 13 14 15 16 17 1.
  • Página 20 • If any parts of EXOGEN or its accessories are After your fracture has healed or prior to long- portable and mobile communication units marked damaged, do not use EXOGEN.
  • Página 21 • With the battery charger cable stretched across a floor or other areas where people walk that would cause a tripping hazard • On floor or other area where EXOGEN or the cable may be damaged by people walking on them...
  • Página 22 Only remove the battery from EXOGEN for disposal. To remove the battery, follow these steps: 1. Make sure EXOGEN is not plugged in to an electrical outlet. 2. Turn EXOGEN screen side down and find 3. Use a screwdriver to remove the the battery door screw.
  • Página 23 Troubleshooting EXOGEN will alert you if something is not working properly. EXOGEN will beep and display an alert screen. See the table below for examples of alerts and what to do if you get an alert. Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the Competent Authority of the Member State in which the user and/or patient is established.
  • Página 24 Clinical Results study established the safety and effectiveness intensity pulsed ultrasound on two difficult cases of the EXOGEN bone healing system in treating EXOGEN treatment accelerated healing by 38% of Charcot non-unions with multiple prior failed non-unions. This includes cases that had long (61±3.4 days in the active group versus 98±5.2...
  • Página 25 Several studies were conducted to assess the treatment no effect was observed on fixation safety of EXOGEN as part of the FDA summary Clinical Results screws or the torques necessary for loosening of safety & effectiveness. Results from a placebo the screws in an in-vivo study.
  • Página 26 EXOGEN ultrasound signal stimulates cells Effects on chondrocytes—Chondrocytes have through an integrin pathway . Within this integrin been shown to respond to the EXOGEN signal pathway, cytoskeletal organization, transcription by an increase in proteoglycan synthesis factor activation, gene upregulation, protein...
  • Página 27 (cavitation). Complications No device-related adverse reactions or medical complications related to the use of EXOGEN were reported during the clinical studies. Some patients have experienced mild skin irritation caused by skin sensitivity to the gel. If you feel your skin is sensitive to the gel, you may change the gel to mineral oil lubricant for skin or glycerin.
  • Página 28 Table 1 Clinical Study results for the FDA reviewed non-union cases – stratification by category variables Categorical Variable Prior to Start Completed Cases Fisher’s Exact Probability† Displaced at the start of SAFHS Therapy of SAFHS Treatment Missing 1.00 Total Healed Failed %Healed p-value...
  • Página 29 Chenery D, Harrison AJ. Pulsed low intensity ultrasound 4. Duarte LR. University of Sao Paulo, Brazil, unpublished data ultrasound stimulation (Exogen). Ultrasonics. 2004;42(1-9): enhances mineralization in pre-osteoblast cells. Orthopaedic presented Societe Internationale de Chirurgie Orthopedique et de 915-917.
  • Página 30 Input Voltage (USB) 5.0 VDC, 2.6A max. Beam type Collimated The essential performance of EXOGEN includes the following: • Free from the display of incorrect numerical values (numbers) associated with the ultrasound therapy • Free from the production of unwanted ultrasound output •...
  • Página 31 EXOGEN has the following classifications: • Internally Powered Equipment EXOGEN is intended for use in the electromagnetic environment specified below. The customer or the user • Type BF Applied Part of EXOGEN should assure that it is used in such an environment.
  • Página 32 Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 1 V/m. Warning: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the EXOGEN device, including cables specified by the manufacturer.
  • Página 33 RF communications equipment and EXOGEN EXOGEN is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of EXOGEN can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and EXOGEN as recommended below, according to the maximum output power of the communications equipment.
  • Página 35 Customer Service is available to answer ques- Bioventus LLC (“Seller”) warrants to the 1. Call Customer Service at tions regarding EXOGEN and to handle servicing original purchaser (“Purchaser”) of its EXOGEN 1-800-836-4080 and request or disposal needs.
  • Página 36 Bioventus LLC 4721 Emperor Blvd Suite 100 Durham, NC 27703 1-800-836-4080 / 1-800-396-4325 (toll free) 1-919-474-6700 www.exogen.com © 2023 Bioventus LLC Bioventus, the Bioventus logo and EXOGEN are registered trademarks of Bioventus LLC. 81087030 Rev. G 2023-04...
  • Página 37 Guía del usuario de EXOGEN ® Léase antes de utilizar el dispositivo...
  • Página 38 La ley federal (EE. UU.) restringe el dispositivo a ventas, distribución o uso por parte de o bajo la orden de un médico o un profesional con licencia. EXOGEN está destinado únicamente para su uso por parte del individuo a quien se le prescribe. EXOGEN está previsto SOLAMENTE para su uso Monitoreo de su tratamiento 13 en un solo paciente.
  • Página 39 EXOGEN. Use este cargador Indicaciones de uso Descripción de EXOGEN Enchufe Mini USB USB. El cable y el transductor de EXOGEN no son proporcionado solamente con EXOGEN. Los pacientes administran el tratamiento en su El Sistema de Consolidación Ósea por Ultrasonido El Sistema de Consolidación Ósea por Ultrasonido...
  • Página 40 Treatment Complete tratamiento con EXOGEN *EXOGEN solamente se debe utilizar durante 20 minutos al día o según lo prescrito por su médico.
  • Página 41 ADVERTENCIA: Para evitar el riesgo de choque eléctrico, EXOGEN debe estar conectado solamente a fuentes de alimentación con conexión EXOGEN. a tierra (un tomacorriente con 3 espigas). No utilice ningún adaptador o cable de extensión para cargar EXOGEN. Solamente enchufe el cargador No conecte EXOGEN a ningún otro equipo en un tomacorriente con certificación UL.
  • Página 42 Antes de comenzar, verifique que el cable y el transductor no presenten grietas o signos de daños. Si está dañado, no use EXOGEN 2. Hale el extremo largo de la correa a través de la 1. Coloque la correa con la tapa hacia arriba.
  • Página 43 Sostenga EXOGEN en su mano para ver la ® EXOGEN tiene un calendario que hace seguimiento a la frecuencia en la que se usa el sistema. pantalla, o déjelo en una superficie plana cercana. La hora actual se debe establecer para asegurarse de que el calendario sea preciso.
  • Página 44 Este enchufe suave. No es necesario utilizar ningún 7. Vuelva a colocar EXOGEN y el gel en el con fuerza para sacar el transductor líquido de limpieza.
  • Página 45 El mes actual aparece cuando enciende EXOGEN para un tratamiento. La fecha del día tendrá un EXOGEN también visualiza el uso en la pantalla durante el tratamiento. La pantalla de Datos de resumen Un calendario muestra su uso de este en la cuadrado morado alrededor.
  • Página 46 Historial de tratamiento Pausa del calendario July Después de usar EXOGEN por un tiempo, puede Puede pausar la pantalla del calendario para August 2013 ® ver su historial de tratamiento mes por mes. visualizar su historial de tratamiento durante EXOGEN almacenará hasta doce meses de más de 5 segundos.
  • Página 47 0 °C (32 °F) o por sobre los 45 °C (113 °F) Vida útil prevista de EXOGEN • Si el área de la batería de EXOGEN o el cargador u orientar EXOGEN en relación con el equipo realización de mantenimiento •...
  • Página 48 EXOGEN está previsto solamente para uso en un EXOGEN lo alertará si algo no funciona de manera correcta. EXOGEN emitirá un pitido y visualizará una pantalla de alerta. Consulte la tabla a continuación para solo paciente. Para obtener más detalles sobre ver los ejemplos de alertas y qué...
  • Página 49 6% frente a grupo de control 36%). EXOGEN y se alcanzó una tasa de éxito del 85% establecieron la seguridad y efectividad del enmascarado). Donde 67 pacientes con fracturas Cook et al.
  • Página 50 La salida acústica de EXOGEN es de 20 a Efectos en condrocitos: se ha demostrado que los en alza de los genes, la síntesis de proteínas y el...
  • Página 51 Tipo de hueso largo: solo para casos Sexo: Femenino 4. Duarte LR. University of Sao Paulo, Brazil, unpublished data ultrasound stimulation (Exogen). Ultrasonics. 2004;42(1-9): Chenery D, Harrison AJ. Pulsed low intensity ultrasound de huesos largos 0,19 enhances mineralization in pre-osteoblast cells. Orthopaedic...
  • Página 52 EXOGEN tiene las siguientes clasificaciones: EXOGEN está previsto para el uso en los entornos electromagnéticos especificados a continuación. El cliente o el usuario de EXOGEN debe asegurarse de que se utilice en tales entornos. • Equipo alimentado internamente Frecuencia de ultrasonido...
  • Página 53 Entorno electromagnético: guía EXOGEN está previsto para su uso en un entorno electromagnético en el cual se controlan las interrupciones de RF radiadas. El cliente o el usuario de EXOGEN pueden ayudar a prevenir las interferencias electromagnéticas manteniendo una distancia mínima entre el equipo de comunicaciones de RF móvil y portátil (transmisores) y EXOGEN, según se recomienda a continuación y de Descarga electroestática...
  • Página 54 El servicio de atención al cliente está disponible Bioventus LLC (“Vendedor”) garantiza al de autorización de retorno (RA). para responder a las preguntas sobre EXOGEN comprador original (“Comprador”) de su Sistema y para manejar el mantenimiento o las de Consolidación Ósea por Ultrasonido EXOGEN 2.
  • Página 55 Bioventus LLC 4721 Emperor Blvd Suite 100 Durham, NC 27703 1-800-836-4080 / 1-800-396-4325 (gratuito) 1-919-474-6700 www.exogen.com © 2023 Bioventus LLC Bioventus, el logotipo de Bioventus y EXOGEN son marcas comerciales registradas de Bioventus LLC. 81087030 Rev. G 2023-04...