DJO Global X4, Instructions For Use Manual

Page 1: ...X4TM Knee Brace Instructions for Use ...

Page 2: ......

Page 3: ...TIONS 2 WARNINGS AND CAUTIONS 2 SYMBOLS 3 ENVIRONMENTAL CONDITIONS 3 APPLICATION SET UP AND PAIRING 4 BRACE APPLICATION INFORMATION 4 CLEANING INSTRUCTIONS 7 MATERIAL CONTENTS 7 X4 SMART BRACE BATTERY REPLACEMENT 8 FCC AND IC STATEMENTS 10 ELECTROMAGNETIC COMPATIBILITY EMC 12 TECHNICAL SPECIFICATIONS 16 WARRANTY 17 DISPOSAL 17 ...

Page 4: ...vide post operative knee support during the rehabilitation process The Motion IntelligenceTM platform together with X4 is intended to be used to measure and evaluate knee joint range of motion during rehabilitation and exercise in the pre operative and post operative phases of reconstructive knee surgery C O N T R A I N D I C AT I O N S None WA R N I N G S A N D C A U T I O N S Brace is intended t...

Page 5: ... C TO 104 F 40 C Relative Humidity 15 to 90 non condensing Atmospheric Pressure 700hPa to 1060 hPa Altitude Maximum of 3000m Transport and Storage Conditions Temperatures 13 F 25 C without relative humidity control up to 158 F 70 C Relative Humidity 15 90 non condensing Atmospheric Pressure 500 hPa to 1060 hPa When operating after transporting or storage in Elevated or Low temperature conditions p...

Page 6: ... button on the front of the lateral outside hinge until the blue LED light blinks d Click Yes to pairing request prompt in app on your mobile phone or tablet e Screen will show Connected and provide battery life Note This step only needs to occur one time Brace will pair automatically while wearing the brace and standing in full extension B R A C E A P P L I C AT I O N I N F O R M AT I O N Note Pl...

Page 7: ... I O N S EN 2 Wrap on thigh strap and secure Clinician may trim excess material as needed Figure 2a and 2b Figure 2a Figure 2b 3 Wrap on calf strap and secure Clinician may trim excess material as needed Figure 3a and 3b Figure 3a Figure 3b ...

Page 8: ... knee joint After you have successfully paired the device to the app the first time subsequently when the brace is worn the MI 360TM sensor will automatically collect data on the exercises and steps 6 Follow the in app instructions and go through each exercise and answer the survey questions when prompted Figure 5 NOTE If needed a clinician may use a Goniometer to determine proper leg angle for th...

Page 9: ... R U C T I O N S Remove softgoods from the brace by sliding the straps off the top and bottom of the hinge bars Wash softgoods in water 86 F 30 C using soap Rinse thoroughly air dry Do not wash the hinge component containing the electronic sensor Brace Re assembly Place thigh bar with label in thigh wrap slot such that the LED light on the hinge is facing forward and text Thigh Front on wrap facin...

Page 10: ...R A C E B AT T E RY R E P L A C E M E N T 1 Fully Extend Brace and lay flat with Hinge facing upward Figure 6 Figure 6 2 Take 1 5 mm Hex Key Allen wrench and remove 2 hinge screws on the cover Figure 7 Figure 7 3 Remove cover by pulling up Figure 8 Figure 8 ...

Page 11: ...re 9 Figure 9 5 Remove used battery by pushing from back and pull out then insert new battery with the facing UP Ensure printed circuit board is nestled along entire edge within the silicone tray Figure 10a 10b Figure 10a Figure 10b 6 Re insert silicone tray back into hinge by aligning metal rods and screw holes Figure 11 Figure 11 ...

Page 12: ...t to Part 15 of the FCC Rules These limits are designed to provide reasonable protection against harmful interference in a residential installation This equipment generates uses and can radiate radio frequency energy and if not installed and used in accordance with the instructions may cause harmful interference to radio communications However there is no guarantee that interference will not occur...

Page 13: ...ference that may cause undesired operation IC Statements This device complies with Industry Canada licence exempt RSS standard s Operation is subject to the following two conditions 1 this device may not cause interference and 2 this device must accept any interference including interference that may cause undesired operation of the device Le présent appareil est conforme aux CNR d Industrie Canad...

Page 14: ...nment Guidance RF Emissions CISPR 11 Group 1 The X4 Knee Brace Sensor is equipment where there is intentionally generated or used conductively coupled Radio Frequency RF energy that is necessary for the internal functioning of the equipment RF Emissions CISPR 11 Class B The X4 Knee Brace Sensor is suitable for use in all establishments including domestic establishments and those directly connected...

Page 15: ...y should be that of a typical com mercial or hospital environment Surge IEC 61000 4 5 1 kV differential mode 2 kV common mode N A Battery Powered Mains power qual ity should be that of a typical com mercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 U 95 dip in TU for 0 5 cycle 40 U 60 dip in TU for 5 cycles 70 U 30 ...

Page 16: ...4 3 3 V m 80 MHz to 2 5 GHz 10 V m 0 35 P 80 MHZ TO 800 MHZ 0 7 P 800 MHZ TO 2 5 GHZ Where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each f...

Page 17: ...ronment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the X4TM Knee Brace Sensor is used exceeds the applicable RF compliance level above the X4 Knee Brace Sensor should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relo...

Page 18: ...ons equipment Rated maximum output power of transmitter Watts Separation distance according to frequency of transmitter Meters 150 KHz to 80 MHz d 1 2 P 80 MHz to 800 MHz d 0 35 P 800 MHz to 2 5 GHz d 0 7 P 0 01 0 12 0 03 0 07 0 1 0 38 0 11 0 22 1 1 2 0 35 0 7 10 3 8 1 1 2 2 100 12 3 5 7 For transmitters rated at a maximum output power not listed above the recommended separation distance d in mete...

Page 19: ...not dispose of the device in municipal waste Do not puncture Do not dispose in fire or incinerate Dispose of the unit according to national state and local regulations Expected life is six months Rx ONLY INTENDED FOR SINGLE PATIENT USE NOT MADE WITH NATURAL RUBBER LATEX NOTICE WHILE EVERY EFFORT HAS BEEN MADE IN STATE OF THE ART TECHNIQUES TO OBTAIN THE MAXIMUM COMPATIBILITY OF FUNCTION STRENGTH D...

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