Smith & Nephew EXOGEN 4000+ Patient'S Instructions For Use & Package Insert Download Page 1

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EXOGEN 4000+

™

Low-intensity Ultrasound Fracture Healing

System for the Treatment of Nonunion

and Fresh Fractures

*smith&nephew

Patient’s

Instructions

for Use

& Package

Insert

Caution:

This device is intended for use only by

the individual for whom it is prescribed.

Summary of Contents for EXOGEN 4000+

Page 1: ...rasound Fracture Healing System for the Treatment of Nonunion and Fresh Fractures smith nephew Patient s Instructions for Use Package Insert Caution This device is intended for use only by the individ...

Page 2: ...ii...

Page 3: ...s interference to radio or television reception which can be determined by turn ing the EXOGEN 4000 device off and on the patient can attempt to correct the interference by one or more of the followin...

Page 4: ...symbol denotes that this device should not be disposed of with ordinary household waste at the end of it s life For details of how to dispose of this item correctly please contact your local governme...

Page 5: ...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 Speci...

Page 6: ...vi...

Page 7: ...he treatment of your fracture upon the prescription of your physician PLEASE BE SURE TO READ THE ENTIRE MANUAL BEFORE USING THE EXOGEN 4000 DEVICE B Indications for Use The EXOGEN 4000 or any other EX...

Page 8: ...reatments With active implantable devices such as cardiac pacemakers operation may be adversely affected by close exposure to the EXOGEN device therefore evaluation during EXOGEN treatment by the atte...

Page 9: ...r insufficiency poor blood supply abnormal skin sensitivity very sensitive skin sensory paralysis lack of sensation alcoholism and or nutritional deficiency Individuals receiving steroid anti coagulan...

Page 10: ...study one patient complained of pain during treatment but this resolved by the next follow up visit and one patient complaining of pain withdrew from the study D Device Description 1 The EXOGEN 4000 B...

Page 11: ...F strap is applied to the cast or skin over the fracture site and insures proper positioning during the 20 minute treatment period During non treatment periods in both the In Cast and On Cast applicat...

Page 12: ...wered by the MOU battery supply and is connected to the MOU by a permanently attached flexible coil cable capable of extending from 1 5 feet 45 cm to approximately 5 feet 1 5 m The round flat black tr...

Page 13: ...g maintains even pressure on the skin to prevent window edema swelling The spring force in the cap assembly will hold the felt plug in place against the skin On Cast or Non Cast Application g RAF Snap...

Page 14: ...if you need more coupling gel Manuals This manual describing how to use the EXOGEN 4000 System is included E Adverse Effects In laboratory animal and clinical research the EXOGEN device intensity pow...

Page 15: ...install the Retaining and Alignment Fixture RAF Strap Assembly on your cast or incorporate the separate RAF in the cast at the fracture location see Section D Device Description The instructions shown...

Page 16: ...er contacts the skin You should use the recommended amount of gel The EXOGEN 4000 device will alert you if insufficient gel is present see Section J Trouble Signals and Corrective Actions d Insert the...

Page 17: ...Symbol and the countdown clock will be shown on the display see Figure 6a The LCD display will provide a warning message if either insufficient gel has been applied or a fault or problem has been dete...

Page 18: ...surface of the RAF and remove any gel that may have accumulated on the transducer to prevent gel hardening on the device c Replace the round felt plug with tab into the RAF Figure 8 d Snap on the RAF...

Page 19: ...ur total response time for the above steps took less than 30 seconds the treatment will continue to completion However if the total time of response exceeds 30 seconds the device will turn off It will...

Page 20: ...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 3 For your daily treatment with the EXOGEN 4000 device use the RAF wit...

Page 21: ...2 for starting a treatment You should remain in a resting position as much as possible during a treatment period to minimize movement of the transducer and RAF Strap Cap assembly b At the End of a Wi...

Page 22: ...was shown in the device clinical trials Please note that ultrasound therapy is automatically shut off after each treatment period However the transducer should be removed from the RAF after each treat...

Page 23: ...properly snaps in place If the problem has been corrected within 30 seconds of the alarm the blinking symbol will turn off and the treatment countdown will continue If the problem is corrected after...

Page 24: ...n temperature conditions below 0 F 18 C or above 130 F 54 C range or damage may result to internal electronic components The device shall operate in normal use under the following conditions Ambient t...

Page 25: ...overed 1 Pack the device in the original packaging If original packaging is not available pack the device in a suitable box using packing material to prevent movement of the device during return shipm...

Page 26: ...atments N Guidance and Manufacturer s Declaration Electromagnetic Emissions and Immunity Testing Electromagnetic Environment Guidance The EXOGEN 4000 device uses radio frequency RF energy only for its...

Page 27: ...l and I O ports 0 15 80 MHz 3 or 10 V Not Applicable The EUT cable is less than 3 m long IEC 61000 4 8 Power frequency Magnetic Field 3A rms m 50 Hz and 60 Hz Pass IEC 61000 4 11 Voltage Dips Short In...

Page 28: ...es calcaneus Ankle Scaphoid Other Hand Bones metacarpal Other 4 clavicle 1 pelvis 1 rib Tibio talar arthrodesis Long Bone vs Other Bones Long Bones 28 tibia 13 femur 7 radius 6 humerus 4 metatarsal 1...

Page 29: ...50 24 50 9 10 2 50 12 3 6 45 2 34 21 1 6 38 16 43 21 46 8 5 3 6 1 2 2 1 2 6 1 1 0 5 0 7 3 4 1 67 89 92 75 98 85 95 50 100 88 100 86 88 92 89 1 00 0 05 0 16 0 31 1 00 0 58 Completed Cases Fisher s Exa...

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Page 31: ...n Germany Telephone 49 746 22080 Fax 49 746 2208135 In the USA Smith Nephew Inc 1450 Brooks Rd Memphis TN 38116 USA Telephone 1 901 396 2121 1 800 836 4080 In Other Countries Call USA Telephone 1 901...

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