Table of Contents
A. Introduction .........................................................................1
B. Indications for use...............................................................1
C. Contraindications, General Warnings, and
Precautions .........................................................................2
D. Device Description..............................................................4
1. The EXOGEN 4000+™ Bone Healing System ......................4
2. Technical Specifications of the EXOGEN 4000+
Ultrasound Signal .................................................................5
3. The EXOGEN 4000+ System Components .........................5
a. The Main Operating Unit (MOU) .....................................5
b. The Transducer................................................................6
c. Snap-on Cap with Tether ................................................6
In-Cast Application
d. Retaining and Alignment Fixture (RAF) ............................7
e. Black Round Foam Disc ...................................................7
f. Round Felt Plug/with Tab .................................................7
On-Cast or Non-Cast Application
g. RAF/Snap-on Cap/Strap Assembly.................................7
h. Foam Pad .........................................................................7
Other Accessories
i. Coupling Gel....................................................................8
E. Adverse Effects ...................................................................8
F. Device Operating Instructions............................................9
1.
Starting your Daily Treatment Period .....................................9
2. Turning “On” the EXOGEN Model 4000+ for a Daily
Treatment Period .................................................................11
3. At the End of a Daily Treatment Period...............................12
G. Interruption of a Treatment Period....................................12
H. Special Instructions when No Cast Is Used or when the
Cast Is Removed and Treatment Is Continued..................13
1. Without Cast Treatment.......................................................13
a. Starting Your Treatment Period ......................................13
b. At the End of a Without Cast Treatment Period.............15
I. Treatment Schedule...........................................................16
J. Trouble Signals and Corrective Actions ............................16
1. Add Gel ...............................................................................17
2. Error or Problem Message...................................................17
K. Care and Handling of the EXOGEN 4000+ System ..........18
L. Return Shipping Instructions.............................................19
M.General Information...........................................................19
N. Guidance and Manufacturer’s Declaration —
Electromagnetic Emissions and Immunity Testing...........20
Appendix 1: Clinical Study Results for the Nonunion
Supplement Completed Cases—Stratification by
Categorical Variables.........................................................22
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