Smith & Nephew EXOGEN 4000+ Manual, Patient's Instructions For Use & Package Insert

28, 22 Appendix 1 Clinical Study Results for the Nonunion Supplement Completed Cases—Stratification by Categorical Variables † Two-sided exact p-value, Fisher’s exact test, testing homogeneity of strata. Categorical Variable Prior to Start of SAFHS Treatment 6 7 8 9 39 12 14 28 13 7 6 4 …

3, NOTE: The EXOGEN 4000+™ device has been tested and found to comply with the limits for Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against interference with radio or television reception or communication…

13, In-Cast Application d. Retaining and Alignment Fixture (RAF): If you are in a cast, the RAF is incorporated into the cast (In-Cast installation—see Figure 2). The RAF holds the transducer in the proper position during the daily 20-minute treatment period. e. Black Round Foam D…

15, F. Device Operating Instructions 1. Starting Your Daily Treatment Period The instructions shown below are to be followed when using the EXOGEN 4000+™ device with an ON-cast or IN- cast application. See Section H for instructions on device use when your physician does not use a cas…

24, Smith & Nephew EXOGEN 4000+ 18 Consult Manual icon there is a problem with the device, please call Patient Services at 1-800-836-4080 (select option #2). Treatment Stop symbol This symbol indicates that the current 20-minute treatment period has been completed. K. Care and Handling of the EXOGEN 4000+™ Sys…

18, 12 3. At the End of A Daily Treatment Period: The device will automatically stop treatment after 20 minutes. A two-tone beeping sound will indicate that treatment has been completed, and the LCD and system will then turn OFF automatically. a. Remove the transducer from the RAF. The transduce…