DJO Donjoy X-ROM iQ Instructions For Use Manual Download Page 3 | Manualshive

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TABLE OF CONTENTS

INTENDED USER PROFILE ......................................................................2
INTENDED USE/INDICATIONS ...............................................................2
CONTRAINDICATIONS .............................................................................2
WARNINGS AND CAUTIONS ..................................................................2
SYMBOLS ......................................................................................................3
ENVIRONMENTAL CONDITIONS ..........................................................3
APPLICATION SET UP AND PAIRING ....................................................4
BRACE APPLICATION INFORMATION .................................................5
CLEANING INSTRUCTIONS .....................................................................9
MATERIAL CONTENTS .............................................................................9
BATTERY REPLACEMENT ........................................................................9
FCC AND IC STATEMENTS ..................................................................... 12
ELECTROMAGNETIC COMPATIBILITY (EMC) .................................. 14
TECHNICAL SPECIFICATIONS .............................................................. 18
WARRANTY ............................................................................................... 19
DISPOSAL ................................................................................................... 19

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Summary of Contents for Donjoy X-ROM iQ

Page 1: ...X ROM iQ Instructions For Use ...

Page 2: ......

Page 3: ...NGS AND CAUTIONS 2 SYMBOLS 3 ENVIRONMENTAL CONDITIONS 3 APPLICATION SET UP AND PAIRING 4 BRACE APPLICATION INFORMATION 5 CLEANING INSTRUCTIONS 9 MATERIAL CONTENTS 9 BATTERY REPLACEMENT 9 FCC AND IC STATEMENTS 12 ELECTROMAGNETIC COMPATIBILITY EMC 14 TECHNICAL SPECIFICATIONS 18 WARRANTY 19 DISPOSAL 19 ...

Page 4: ...urgeries and meniscal repairs This product was designed to help complement the variety of medical treatments common to the above afflictions The range of motion settings frequency and duration of use should be determined by your prescribing Healthcare professional The Motion iQ platform together with the X ROM iQ brace is intended to be used to measure and evaluate activity and knee joint range of...

Page 5: ...ity 15 90 non condensing Atmospheric Pressure 500 hPa to 1060 hPa When operating after transporting or storage in elevated or low temperature conditions please keep sensor at ambient temperature for 15 min prior to operation SYMBOLS WARNING Read and understand all warnings and Instructions for Use before using this device Temperature range Atmospheric pressure range Indication for protection again...

Page 6: ...ow the instructions in the application to pair with your mobile phone or tablet a When prompted by the app to choose a brace to pair select X ROM iQ b Watch the pairing instruction video in the application c On the brace hinge marked with iQ use a small object such as a pen or paper clip to press the button until the blue LED light blinks see image 1 below d Click Go when prompted in the app on yo...

Page 7: ...ace flat by pulling both uprights apart 2 Place leg on top of flat brace Shorter upright is applied to the thigh Adjust brace until each upright is aligned to centerline of the medial and lateral sides of the leg and the center of the hinge is aligned with the center of the knee joint 3 2 ...

Page 8: ...l sides of leg Lower tab and apply pressure to secure strap 3 Telescope sliders by depressing the slider button until the desired length is reached The top and bottom sliders should be adjusted first followed by the sliders closest to the knee note that inner sliders cannot be adjusted until the outer sliders are moved to provide sufficient clearance Ensure that both bars are equal in length and t...

Page 9: ...he button center Release stops and ensure they are fully inserted B Utilize the quick lock feature at 10 0 10 20 or 30 degrees by aligning red arrow with desired degree and sliding the red quick lock button inward until the lock is engaged Ensure uprights do not rotate If another lock setting is required see step 6 and ensure both Flexion and Extension buttons are set at the same angle setting 6A ...

Page 10: ...f possible STRAP REPLACEMENT Should straps require replacement carefully use scissors to cut away the strap where it connects to the slider Insert the new strap and secure Contact DJO for the X ROM iQ Replacement Straps Kit If you are having any medical issues or need an urgent response please call your doctor s office directly If assistance is needed with the brace or setting up or using the App ...

Page 11: ...not heat dry Do not wash the hinge component containing the electronic sensor MATERIAL CONTENTS Nylon 50 Aluminum 40 Polypropylene 5 Delrin 3 Stainless Steel 2 BATTERY REPLACEMENT 1 Locate the hinge with the iQ logo Using a Phillips head screw driver unscrew the two screws and remove the hinge cover CR 2032 10 30 10 0 1 0 20 9 0 1 0 0 1 1 0 12 0 60 50 40 30 2 0 1 0 0 1 0 70 0 10 20 10 30 4 0 5 0 6...

Page 12: ...uch as a ball point pen push the gold battery clip to the side and lift up the battery to remove 3 Place the new battery into the slot towards the gold clip then push the opposite side down until the battery clicks into place 12 CR 2032 14 11 13 ...

Page 13: ...slide the hinge cover back onto the brace and secure by replacing the screws Be careful to not over tighten the screws 30 10 0 1 0 20 9 0 1 0 0 1 1 0 12 0 60 50 40 30 2 0 1 0 0 1 0 70 0 10 20 10 30 4 0 5 0 60 70 80 90 15 ...

Page 14: ...ion which can be determined by turning the equipment off and on the user is encouraged to try to correct the interference by one or more of the following measures Reorient or relocate the receiving antenna Increase the separation between the equipment and receiver Connect the equipment into an outlet on a circuit different from that to which the receiver is connected Consult the dealer or an exper...

Page 15: ...s de licence L exploitation est autorisée aux deux conditions suivantes 1 l appareil ne doit pas produire de brouillage et 2 l utilisateur de l appareil doit accepter tout brouillage radioélectrique subi même si le brouillage est susceptible d en compromettre le fonctionnement Cet équipement est conforme aux limites d exposition aux radiations dans un environnement non contrôlé Cet équipement est ...

Page 16: ...oup 1 The X ROM iQ 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 X ROM iQ sensor is suitable for use in all establishments including domestic establishments and those directly connected to public low voltage power supply network that ...

Page 17: ...at of a typical commercial or hospital environment Surge IEC 61000 4 5 1 kV differential mode 2 kV common mode N A Battery Powered Main power quality should be that of a typical commercial 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 dip in TU for 25 c...

Page 18: ...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 surveya should be less than the compliance level in each frequency rangeb Inter...

Page 19: ... fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the X ROM iQ sensor is used exceeds the applicable RF compliance level above the X ROM iQ sensor should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the X ROM iQ sensor...

Page 20: ...ion 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 meters m can be estimated using the equation applicable to the frequency ...

Page 21: ...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 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 DURABILITY AND COMFORT THERE ...

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Page 24: ...DJO LLC 1430 Decision Street Vista CA 92081 8553 USA T 1 800 321 9549 T 1 800 336 6569 F 1 800 936 6569 DJOglobal com 2021 DJO LLC All rights reserved 14 4014 REV B 2021 02 16 ...

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