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Summary of Contents for Smith & Nephew EXOGEN 4000+
- Page 1 *smith&nephew Patient’s Instructions for Use & Package Insert EXOGEN 4000+ ™ Low-intensity Ultrasound Fracture Healing System for the Treatment of Nonunion and Fresh Fractures Caution: This device is intended for use only by the individual for whom it is prescribed.
- Page 3 NOTE: The EXOGEN 4000+™ device has been tested and This Class B digital apparatus meets all requirements found to comply with the limits for Class B digital device, of the Canadian Interference-Causing Equipment pursuant to Part 15 of the FCC Rules. These limits are Regulations.
- Page 4 DEFINITION OF SYMBOLS Attention, consult manual. Refer to Instructions for Use A blinking addition (+) symbol with an audio tone means you need to add gel to the transducer face. Pulsing Treating Symbol indicates device is operating properly Treatment Stop or Treatment Lockout Symbol Type B APPLIED PART CE Mark indicates conformity with European Council Directive of 14 June 1993 concerning Medical Devices (93/42/EEC).
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Page 5: Table Of Contents
Table of Contents F. Device Operating Instructions..........9 Starting your Daily Treatment Period ........9 2. Turning “On” the EXOGEN Model 4000+ for a Daily A. Introduction .................1 Treatment Period ..............11 B. Indications for use ...............1 3. At the End of a Daily Treatment Period.......12 C. -
Page 7: Introduction
A. Introduction B. Indications for Use Your physician has prescribed a device, the EXOGEN The EXOGEN 4000+, or any other EXOGEN Bone Healing 4000+™ Bone Healing System, which may heal your System is indicated for the non-invasive treatment of † nonunion or accelerate the healing of your fracture. -
Page 8: Contraindications, General Warnings And Precautions
C. Contraindications, General Warnings With active, implantable devices, such as cardiac • pacemakers, operation may be adversely affected by close and Precautions exposure to the EXOGEN™ device; therefore, evaluation during EXOGEN treatment by the attending cardiologist or Contraindications: physician is recommended. There are no known contraindications to the use of Patients in the clinical studies were instructed to apply the •... - Page 9 Fresh fracture indication: sensitivity (very sensitive skin), sensory paralysis (lack of sensation), alcoholism and/or nutritional deficiency. Warnings: Individuals receiving steroid, anti-coagulant, prescription • The safety and effectiveness of the use of this device has non-steroidal anti-inflammatory, calcium channel blocker not been established for the following: and/or diphosphonate therapy.
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Page 10: Device Description
D. Device Description Operation of implantable devices, such as cardiac • pacemakers, may be adversely affected by close exposure to the EXOGEN™ device. This applies to you or any other 1. The EXOGEN 4000+ Bone Healing System person in close proximity during treatment. You or the other person should be evaluated by the attending The EXOGEN 4000+ device provides a non-invasive cardiologist or physician before starting treatment with the... -
Page 11: Technical Specifications Of The Exogen 4000+ Ultrasound Signal
2. Technical Specifications of the EXOGEN 4000+™ during the 20-minute treatment period. During non- treatment periods in both the In-Cast and On-Cast Ultrasound Signal applications, the transducer is removed and replaced with a felt plug to maintain even pressure on the skin. Ultrasound frequency ....1.5 ±... -
Page 12: The Transducer
The MOU: automatically shuts off the device at the end of the • 20-minute treatment period, and alerts you with an monitors and controls system operation during treatment. • audio signal that treatment has ended. verifies operation of the transducer and the MOU and •... -
Page 13: In-Cast Application
In-Cast Application f. Round Felt Plug/With Tab: The round felt plug with tab is placed into the center hole of the RAF between d. Retaining and Alignment Fixture (RAF): If you are in treatment periods. The felt plug should be inserted a cast, the RAF is incorporated into the cast (In-Cast with the tab on top. -
Page 14: Other Accessories
E. Adverse Effects Other Accessories i. Coupling Gel: Two containers of hypoallergenic In laboratory, animal and clinical research, the EXOGEN ultrasound coupling gel, which is 96% water, are device intensity (power level) (See Section D — “Device provided with your EXOGEN™ device. You must apply Description”) was assessed for its potential for producing coupling gel to the transducer surface at the start of significant temperature increases in body tissue, the most... -
Page 15: Device Operating Instructions
F. Device Operating Instructions the fracture location (see Section D —”Device Description”). The instructions shown below are to be followed when using the device: 1. Starting Your Daily Treatment Period a. Remove the RAF Cap (Figure 3) by gently squeezing The instructions shown below are to be followed when the tabs on the Cap Assembly with an inward motion using the EXOGEN 4000+™... - Page 16 transducer. Do not spread the gel over the transducer surface. Replace the plastic top on the gel bottle. Note: The system is designed so that the gel spreads evenly when the transducer contacts the skin. You should use the recommended amount of gel.
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Page 17: Turning "On" The Exogen Model 4000+ For A Daily
2. Turning “On” the EXOGEN Model 4000+™ for a although this spacing may not always be possible to maintain. As an example, if the treatment started at Daily Treatment 10:00 PM on Monday, Tuesday’s treatment should be Press and release the orange “On/Off” button once on performed after 10:00 AM. -
Page 18: At The End Of A Daily Treatment Period
3. At the End of A Daily Treatment Period: Pulsing Treating Symbol indi- The device will automatically stop treatment after 20 cates device is operating minutes. A two-tone beeping sound will indicate that properly. treatment has been completed, and the LCD and system will then turn OFF automatically. -
Page 19: Special Instructions When No Cast Is Used Or When The Cast Is Removed And Treatment Is Continued
period of time (e.g., to answer a telephone or a doorbell), 4. Replace the transducer in the RAF. the device can be carried with you. In this instance, it is 5. Snap the RAF cap back on. not necessary to turn off the device. However, if you do not want to carry the device to attend to the interruption, you 6. - Page 20 a padded surface during “without-cast” treatment. The foam pad has a paper covered adhesive side with a tab for easy removal. The paper backing should be removed and the adhesive side of the foam placed on the underside of the RAF (Figures 10a, 10b) to provide a padded surface over the fracture site and to prevent movement of the RAF on the skin surface.
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Page 21: At The End Of A Without Cast Treatment Period
4. The strap should be tightened, utilizing the adjustable fastener to prevent the RAF from sliding out of place. It should not be so tight as to cause discomfort (Figure 12). 5. The strap assembly must be secured in place over the treatment site (Figure 11) BEFORE the transducer with gel applied is inserted into the RAF. -
Page 22: Treatment Schedule
I. Treatment Schedule from drying on the transducer surface and interfering with the subsequent treatments. Use a damp cloth or paper towel to remove any dried gel You should comply with the recommended daily 20-minute residue. treatment period that has been prescribed by your physician. 5. -
Page 23: Add Gel
system. During the entire treatment period, the MOU If the problem has been corrected within 30 seconds continues to monitor system operation. It detects whether: of the alarm, the blinking symbol will turn off and the treatment countdown will continue. If the problem is •... -
Page 24: Care And Handling Of The Exogen 4000+ System
Consult Manual icon there is a problem with the device, temperature conditions below 0° F (-18° C) or above 130° please call Patient Services at 1-800-836-4080 (select F (54° C) range, or damage may result to internal option #2). electronic components. The device shall operate in normal use under the following conditions: Treatment Stop symbol Ambient temperature range : 50°... -
Page 25: Return Shipping Instructions
local refuse laws. The EXOGEN™ unit is for single patient device during return shipment. Please label the side of use only. Dispose of batteries properly to prevent injury. Do the box with permanent marker. Return to: Smith & not throw into fire. Nephew, Inc., 1450 Brooks Rd., Memphis, TN 38116. -
Page 26: Guidance And Manufacturer's Declaration - Electromagnetic Emissions And Immunity Testing
3. If your RAF strap is installed on-cast over your treatment Interference with proper operation of the site, it is imperative that the unit remains exactly in EXOGEN 4000+ device may occur in the place as set by the physician or installer. Notify your vicinity of equipment marked with this symbol. - Page 27 Electromagnetic Test Description Published Test Level or Class Pass/Fail, Comments Compatibility Testing IEC 60601-1-2:2001 Summary: IEC 61000-4-2 ±6kV contact discharge Pass Electrostatic Discharge ±8kV air discharge Testing Report for: IEC 61000-4-3 1 kHz sine wave (80% AM) Pass RF Electromagnetic Field 80–2500 MHz , 3 V/m Smith &...
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Page 28: Appendix 1: Clinical Study Results For The Nonunion Supplement Completed Cases - Stratification By Categorical Variables
Appendix 1 † Completed Cases Fisher’s Exact Probability Categorical Variable Prior to Start of SAFHS Treatment Clinical Study Results for the Nonunion Supplement Total Healed Failed % Healed p-value Completed Cases—Stratification by Categorical Prior days without surgery (days Variables from last surgical procedure to SAFHS start): <... - Page 29 † † Completed Cases Fisher’s Exact Probability Completed Cases Fisher’s Exact Probability Categorical Variable Prior to Categorical Variable Prior to Start of SAFHS™ Treatment Total Healed Failed % Healed p-v v a a l l u u e e Start of SAFHS Treatment Total Healed Failed % Healed p-v v a a l l u u e e Other Bones Conservative...
- Page 31 Authorized European In the USA: Copyright © 2006 Smith & Community (EC) Smith & Nephew, Inc. Nephew, Inc. Representative: 1450 Brooks Rd. ™Trademark of Smith & Nephew, Reg. US Pat. & TM Off. Smith & Nephew Memphis, TN 38116 Orthopaedics GmbH Alemannenstrasse Telephone: 1-901-396-2121 Product No.
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