Bioventus EXOGEN User Manual
Ultrasound bone healing system
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- User manual (55 pages) ,
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- Quick instruction manual (2 pages)
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Summary of Contents for Bioventus EXOGEN
- Page 1 EXOGEN User Guide ® Read before using your device EXOGEN Overview Getting Started EXOGEN Setup Tracking Your Treatment EXOGEN Care Troubleshooting Customer Service...
- Page 2 Federal Law (U.S.A.) restricts this device to sale, distribution, or use by or on the order of a physician or properly licensed practitioner. EXOGEN is only intended for use by the individual for whom it is prescribed. EXOGEN is for single patient use ONLY.
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Page 3: Table Of Contents
EXOGEN Overview EXOGEN Care Indications for Use Operating Conditions EXOGEN Description Storage EXOGEN Device (EXOGEN) EXOGEN Expected Service Life Charger (power supply) Battery and Charging Safety Strap EXOGEN Disposal Ultrasound Gel Removing the Battery for Disposal Important Things to Know... -
Page 5: Exogen Overview
† consists of one EXOGEN device, a charger, or surgically treated. EXOGEN transmits a gel bottle and strap. The EXOGEN device • Accelerating the time to heal of fresh a low-intensity ultrasound signal to the provides the treatment control circuitry, the... -
Page 6: Exogen Device (Exogen)
EXOGEN. Do not plug other from EXOGEN. chargers into EXOGEN. Other chargers may cause injury to you or others near EXOGEN EXOGEN contains the internal electronics as well as damage to the charger. The use and battery. It checks the ultrasound signal of chargers, transducers or cables, other to make sure EXOGEN works properly. -
Page 7: Strap
EXOGEN is approved for use by persons the transducer over your treatment site. use with EXOGEN. The gel is to be placed that are 18 years or older and skeletally The strap has a port in it to hold the on the transducer every time you use mature. -
Page 8: Contraindications
Precautions • The safety and effectiveness of EXOGEN when used for more than There are no known contraindications to the • EXOGEN will not correct or alter one daily 20-minute treatment period use of EXOGEN. post-reduction (when your fracture has not been studied. -
Page 9: Display Symbols And Descriptions
Counts down from 20 minutes to Countdown Timer show treatment time remaining. 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. -
Page 11: Getting Started
EXOGEN has a rechargeable lithium-ion battery. A fully-charged battery delivers approximately five 20-minute treatments. 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. -
Page 12: Recharging Exogen
Recharging EXOGEN As you use EXOGEN, the symbol will You may charge EXOGEN at any time, change to show the reduced battery level. whether it is on or off. When the battery Check the charge level on EXOGEN See Figure 6. -
Page 13: 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... -
Page 14: If You Have A Cast
If You Have a Cast 1. Your cast will have a plastic port with 2. Use 2 fingers to squeeze the cap tabs 3. Pull out the round felt plug inside the cap built into it. together to open the cap. opening. -
Page 15: Add Gel And Place Transducer
Add Gel and Place Transducer Note: 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. Add gel on the transducer every time you treat your fracture. -
Page 17: Exogen Setup
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 time must be set once, the very first time EXOGEN is used to treat your fracture. -
Page 18: Time Setting
(shown only when charging) 6. A treatment symbol flashes as the timer counts down. This means you are treating your fracture. (Note: To stop EXOGEN in the middle of the 20-minute treatment, press and hold the button until EXOGEN turns off.) Treatment symbol If your EXOGEN has an error during treatment, see “Troubleshooting”... -
Page 19: 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. -
Page 20: Exogen Cleaning
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. - Page 21 6. Snap the cap shut. skin and port with a soft cloth. the port. This plug helps prevent swell- 7. Place EXOGEN and the gel back into ing in the cast when you are not using the carrying case until you are ready EXOGEN.
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Page 23: Tracking Your Treatment
The current month is shown when you turn on EXOGEN for a treatment. Today’s date will have a purple box around it. EXOGEN will mark your calendar every day with one of the calendar shows your usage on the screen. -
Page 24: Treatment History
Treatment History August 2013 After using EXOGEN over time, you may want to view your treatment history month by month. EXOGEN will store up to three months of recent treatment history. You can ® show your treatment history to your doctor. -
Page 25: Calendar Pause
Calendar Pause You can pause the calendar screen to view your treatment history for longer than 5 seconds. Any calendar screen can be paused. To August 2013 pause the calendar, perform the following steps: 1. When you see a calendar screen, press the button to pause. -
Page 27: Exogen Care
EXOGEN is observed, attempt to long-term storage of EXOGEN, remove the relocate or reorient EXOGEN in • If any parts of EXOGEN or its battery to prevent leakage of the battery. relation to the interfering equipment accessories are damaged, do until the interference stops. -
Page 28: Battery And Charging Safety
• Within the reach of small children battery charger and/or the other device. • With the battery charger cable stretched • If the battery area on EXOGEN or the across a floor or other areas where battery charger becomes excessively... -
Page 29: Removing The Battery For 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 down and find 3. Use a screwdriver to remove the the battery door screw. -
Page 31: 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 when you get an alert. Alerts What does this mean? -
Page 32: Clinical Studies
. The ultrasound output 1-39 strated acceleration of fresh fracture by 38% intensity of EXOGEN is 30 mW/cm and is and a non-union heal rate of 86%. typically only 1% to 5% of the output intensity of conventional therapeutic ultrasound devices. -
Page 33: References
11. Gold SM, Wasserman R. Preliminary results of tibial bone lengthening. J Ultrasound Med. 1999;18:699-702. transports with pulsed low intensity ultrasound (Exogen). 32. Strauss E, Gonya G. Adjunct low intensity ultrasound in charcot J Orthop Trauma. 2005;19:10-16. -
Page 34: 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 •... -
Page 35: Exogen Classifications
• Internally Powered Equipment EXOGEN is intended for use in the electromagnetic environment specified below. The customer or the user of EXOGEN should assure that it is used in such an environment. • Type BF Applied Part Emissions Test Compliance Electromagnetic environment –... - Page 36 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.
- Page 37 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.
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Page 39: Customer Service
Customer Service Limited warranty Customer Service is available to answer Bioventus LLC (“Seller”) warrants to the questions regarding EXOGEN and to handle original purchaser (“Purchaser”) of its servicing or disposal needs. EXOGEN Ultrasound Bone Healing System (“System”) purchased by Purchaser directly... - Page 40 Authorized European Community (EC) Bioventus LLC © 2013 Bioventus LLC All rights reserved EXOGEN and the Bioventus logo are registered Representative 4721 Emperor Blvd Suite 100 trademarks of Bioventus LLC. EMERGO EUROPE Durham, NC 27703 USA Molenstraat 15 Customer Service:...
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