Bioventus EXOGEN Manual Del Usuario
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Ver también para EXOGEN:
- Guia del usuario (55 páginas) ,
- Manual de uso (2 páginas) ,
- Manual de uso rápido (2 páginas)
Manuales relacionados para Bioventus EXOGEN
Resumen de contenidos para Bioventus EXOGEN
- Página 1 EXOGEN User Guide ® Read before using your device Labeling LBL-000319 [D] RELEASED...
- 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.
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Página 3: Tabla De Contenido
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: Exogen Overview
† 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 Device (Exogen)
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: Ultrasound Gel
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: Display Symbols And Descriptions
Automatically displays when count- Treatment Complete down timer reaches zero to show that treatment is complete. Labeling LBL-000319 [D] RELEASED *EXOGEN should be used for only 20 minutes per day, or as prescribed by your doctor. -
Página 8: Getting Started
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
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
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: Add Gel And Place Transducer
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: First Use
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
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 Cleaning
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. Labeling LBL-000319 [D] RELEASED... - 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 to treat again.
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Página 16: Tracking Your Treatment
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: Treatment Summary Data
Treatment Summary Data For example, if you use EXOGEN every day for If you have EXOGEN for 60 days, but forgot to The treatment summary shows your overall use 60 days, you will have the following numbers: treat 10 of those days, your numbers will look like: of EXOGEN. -
Página 18: Treatment History
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
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: 1. When you see a calendar screen, press the 12 13 14 15 16 17 button to pause. -
Página 20: Exogen Care
• 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: Battery And Charging Safety
• 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 Labeling LBL-000319 [D] RELEASED... -
Página 22: Exogen Disposal
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
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. Alerts What does this mean? -
Página 24: Clinical Studies
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...
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Página 27: Adverse Events
(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 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...
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Página 29: References
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: Technical Information
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 Classifications
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: Guidance And Manufacturer's Declaration - Electromagnetic Immunity
TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which EXOGEN is used exceeds the applicable RF compliance level above, EXOGEN should be observed to verify normal operation. - 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 34 Labeling LBL-000319 [D] RELEASED...
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Página 35: Customer Service
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 © 2020 Bioventus LLC Labeling LBL-000319 [D] RELEASED Bioventus, the Bioventus logo and EXOGEN are registered trademarks of Bioventus LLC. 2020-03 81087030 Rev. D...
- Página 37 Manual del usuario de EXOGEN ® Léalo antes de utilizar el dispositivo Labeling LBL-000319 [D] RELEASED...
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Página 38: Descripciones De Los Símbolos Utilizados Y Clasificación Del Equipo Exogen
(Estados Unidos) restringen la venta, distribución o uso de este dispositivo a un médico o profesional autorizado. EXOGEN solo debe utilizarse por el individuo para el que se ha prescrito. La unidad EXOGEN es para uso EXCLUSIVO de un único paciente. -
Página 39: Introducción A Exogen
Botón Banda Cable en espiral Banda Figura 4 – Banda para EXOGEN (n.º de ref.: 71034622) Transductor Labeling LBL-000319 [D] RELEASED Figura 2 – Dispositivo EXOGEN (n.º de ref.: 71034401) Figura 1: sistema de consolidación ósea por ultrasonido EXOGEN... -
Página 40: Gel De Ultrasonido
EXOGEN. *EXOGEN debe utilizarse solo 20 minutos al día o el tiempo que determine su médico. -
Página 41: Puesta En Marcha
Utilice el cargador instrucciones de carga del dispositivo. suministrado con el sistema de consolidación ADVERTENCIA: para evitar riesgos de descarga eléctrica, EXOGEN solo debe conectarse a una red eléctrica con puesta a tierra de Carga completa ósea por ultrasonido EXOGEN. -
Página 42: Preparación Para Tratar La Fractura
Preparación para tratar la fractura Si lleva escayola Coloque la banda Para tratar la fractura, necesitará EXOGEN, el gel y la banda. Si lleva una escayola alrededor de la fractura, no necesitará la banda. Su médico puede haber marcado la zona de la fractura con una ‘X’, o puede haberle... -
Página 43: Configuración De Exogen
Realice los siguientes pasos para iniciar el tratamiento: La hora se debe configurar una sola vez. Esto se debe hacer la primera vez que se enciende el dispositivo EXOGEN. Configuración de la hora 1. Pulse el botón en EXOGEN. -
Página 44: Limpieza De Exogen
No 7. Vuelva a guardar EXOGEN y el gel en cable! Si tira fuerte del cable para paño suave. abertura. Este tapón previene hincha- necesita utilizar líquido limpiador. -
Página 45: Seguimiento Del Tratamiento
En la pantalla aparece un calendario olvidado tratarse en 10 de los 60 días, las El día actual aparecerá rodeado por un recuadro púrpura. EXOGEN pondrá cada día en su total que hace de EXOGEN. Los datos de día durante 60 días, tendrá las cifras del uso que usted hace del dispositivo. -
Página 46: Historial De Tratamiento
Cualquier pantalla de calendario puede del historial de tratamiento reciente. Puede pausarse. Para pausar el calendario, realice August 2013 mostrar dicho historial a su médico. EXOGEN 10 11 12 13 14 15 los siguientes pasos: le permite ver el historial sin tener que 16 17 18 19 20 21 22 comenzar un tratamiento. -
Página 47: Cuidado De Exogen
EXOGEN administrará ninguno más. menos 30 minutos a que vuelva a la • El suelo u otras áreas en las que EXOGEN o el cable - Está protegido contra la entrada dañina de agua corran riesgo de ser pisados temperatura ambiente. -
Página 48: Eliminación De Exogen
Eliminación de EXOGEN La unidad EXOGEN ha sido diseñada para EXOGEN le alertará si hay algo que no funciona correctamente. EXOGEN emitirá un pitido y aparecerá una pantalla de alerta. Consulte uso exclusivo de un único paciente. Para la tabla que aparece a continuación para conocer los ejemplos de alerta y los pasos que debe seguir si se emite una alerta. -
Página 49: Estudios Clínicos
1. (4 de 4 puntos de consolidación en el hueso señal de ultrasonido de EXOGEN y se obtuvo doble, aleatorizado y controlado con placebo, ósea por ultrasonido EXOGEN para el cortical según el juicio del investigador Nolte et al. -
Página 50: Acontecimientos Adversos
La Un análisis de los efectos de EXOGEN en el provoca movimiento a escala nanométrica, lo se vio inhibido por la presencia de un de MC3T3-E1. -
Página 51: Referencias
0,19 Hombre 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 Falta 0,05 Research Society Annual Meeting. Washington, 2005. -
Página 52: Información Técnica
EXOGEN está diseñado para utilizarse en el entorno electromagnético especificado a • Equipo con fuente de alimentación interna continuación. El cliente o el usuario de EXOGEN debe asegurarse de utilizar el dispositivo en el Frecuencia de ultrasonido 1,5 +/- 5% MHz •... - Página 53 AM y FM y televisivas no pueden predecirse teóricamente con exactitud. Para evaluar el entorno electromagnético causado por los transmisores de RF fijos, debe considerarse la posibilidad de un estudio entorno electromagnético in situ. Si la intensidad de campo medida en el lugar en el cual va a utilizarse EXOGEN supera el nivel de cumplimiento de RF aplicable que se ha indicado pre- viamente, EXOGEN debe ser sometido a observación para comprobar que funciona normalmente.
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Página 54: Atención Al Cliente
EXOGEN. tendrá vigencia durante un año a partir de la fecha de compra. Llame al 1-800-836-4080 (llamada gratuita) 3. Ponga EXOGEN en su embalaje original. Si no puede, empaquete EXOGEN Información general: 1-800-396-4325 (llamada En caso de incumplimiento sustancial de... - Página 55 4721 Emperor Blvd Suite 100 Durham, NC 27703 EE. UU. 1-800-836-4080 / 1-800-396-4325 (llamada gratis) 1-919-474-6700 www.exogen.com © 2020 Bioventus LLC Labeling LBL-000319 [D] RELEASED Bioventus, el logo de Bioventus y EXOGEN son marcas registradas de Bioventus LLC. 2020-03 81087030 Rev D...