DJO Global X4 User manual

X4TM Knee Brace
Instructions for Use

1
TABLE OF CONTENT S
EN
TABLE OF CONTENT S
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..................................................................4
CLEANING INSTRUCTIONS......................................................................................7
MATERIAL CONTENTS ..............................................................................................7
X4SMART BRACE BATTERY REPLACEMENT......................................................8
FCC AND IC STATEMENTS........................................................................................10
ELECTROMAGNETIC COMPATIBILITY (EMC).....................................................12
TECHNICAL SPECIFICATIONS .................................................................................16
WARRANTY..................................................................................................................17
DISPOSAL......................................................................................................................17

2
INTENDED USER PROFILE
EN
BEFORE USING THE DEVICE, PLEASE READ THE FOLLOWING
INSTRUCTIONS COMPLETELY AND CAREFULLY. CORRECT APPLICATION
IS VITAL TO THE PROPER FUNCTIONING OF THE DEVICE.
INTENDED USER PROFILE
The intended user should be a licensed medical professional, the patient, the
patient’s caretaker, or a family member providing assistance. The user should
be able to read, understand and be physically able to perform and follow the
directions, warnings and cautions provided in the information for use. This
device is not intended for use by children.
INTENDED USE/INDICATIONS
The XTM brace is intended to provide post-operative knee support during the
rehabilitation process. The Motion IntelligenceTM platform together with X
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.
CONTRAINDICATIONS
None.
WARNINGS AND CAUTIONS
Brace is intended to be worn during waking hours in direct contact with skin
or as directed by a medical professional. If you experience any pain, swelling,
sensation changes, or any unusual reactions while using this product, consult
your medical professional immediately.
Do not wear brace while swimming, in the shower or bath or while sleeping.
Warning: Equipment contains CR lithium coin cell battery. There is
danger of explosion if lithium ion batteries are incorrectly replaced.

3
SYMBOLS
EN
SYMBOLS
WARNING! Read and
understand all warnings
and Instructions for Use
before using this device.
Manufacturer
Temperature range
Non-ionizing
electromagnetic
radiation
Atmospheric pressure
range Humidity range
Indication for protection
against water and
particular matter
Prescription only (USA)
ENVIRONMENTAL CONDITIONS
Operating
Conditions
Temperatures +°F °CTO +°F °C
Relative Humidity % to % non-condensing
Atmospheric Pressure hPa to  hPa
Altitude Maximum of m
Transport
and
Storage
Conditions
Temperatures
°F (°C ) without relative
humidity control, up to °F
(°C)
Relative Humidity % - % non-condensing
Atmospheric Pressure  hPa to  hPa
When operating after transporting or storage in Elevated or Low temperature
conditions, please keep sensor at ambient temperature for  min. prior to
operation.
Motion IntelligenceTM system consists of - regular hinge, hinge with sensor,
thigh strap, calf strap, software app for smart device.

4
APPLICATION SET UP AND PAIRIN G
EN
APPLICATION SET UP AND PAIRIN G
. Download Motion IntelligenceTM App from the App store.
. Follow in-app instructions to setup. Enter Application Key as provided by
the clinician.
. To pair the device with your mobile phone or tablet:
a. Ensure Bluetooth is enabled in your phone or tablet Settings.
Settings > Bluetooth > On.
b. In the Motion Intelligence App: Settings > Sensors > Connect.
c. On Brace device: With app open, press 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.
BRACE A PPLICATION INFORMATION
Note: Place brace straps on intact skin, over wound dressings, or over clothing
only. Do not place brace straps directly on broken skin.
. In a seated position bend leg at about  degrees, align the MI sensor
hinge on lateral or outside of the knee at the center of the knee joint.
(Figure 1)
Figure 1

5
ENVIRONMENTAL CONDITIONS
EN
. Wrap on thigh strap and secure. Clinician may trim excess material as
needed. (Figure 2aand 2b)
Figure 2a Figure 2b
. Wrap on calf strap and secure. Clinician may trim excess material as
needed. (Figure 3aand 3b)
Figure 3a Figure 3b

6
ENVIRONMENTAL CONDITIONS
EN
. Secure the opposite hinge on the medial or inside of the knee at the
center of the knee joint. (Figure 4aand 4b)
Figure 4a Figure 4b
. Stand and walk, make adjustments to straps as needed to ensure hinges
are centered on the knee joint.
After you have successfully paired the device to the app the first
time, subsequently when the brace is worn, the MI TM sensor will
automatically collect data on the exercises and steps.
. 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 thigh and calf uprights and custom bend uprights to proper
leg angle.
Figure 5

7
CLEANING INSTRUCTIONS
EN
If you are having any medical issues or need an urgent response, please call
your doctor’s oce directly.
If assistance is needed with the brace or setting up or using the App, please call
or email:
Phone: (/ 
Email: [email protected]om
Visit: www.djoglobal.com/MI
CLEANING INSTRUCTIONS
Remove softgoods from the brace by sliding the straps othe top and bottom
of the hinge bars.
Wash softgoods in water °F/°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 facing forward. Repeat
on calf portion.
MATERIAL CONTENT S
Hinge Bars: Aluminum, Steel, Nylon
Softgoods: Nylon, Styrene Butadiene Rubber, Neoprene, Polyester

8
X4SMART B RACE BATTERY R E PLACEMENT
EN
X4SMART BRACE BATTERY
REPLACEMENT
. Fully Extend Brace and lay flat with Hinge facing upward. (Figure 6)
Figure 6
. Take .mm Hex Key (Allen wrench) and remove hinge screws on the
cover. (Figure 7)
Figure 7
. Remove cover by pulling up. (Figure 8)
Figure 8

9
X4SMART B RACE BATTERY R E PLACEMENT
EN
. Lift silicone tray by pulling straight up (metal rod needs to align during
reassembly). (Figure 9)
Figure 9
. 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 10aFigure 10b
. Re-insert silicone tray back into hinge by aligning metal rods and screw
holes. (Figure 11)
Figure 11

10
FCC ANDICSTATEMENT S
EN
. Replace Hinge cover sliding it over silicone tray. (Figure 12)
Figure 12
. Secure the two screws into hinge cover. (Figure 13)
Figure 13
FCC AND IC S TAT E M ENT S
FCC Statements
Warning: Changes or modifications to this device not expressly
approved by (DJO LLC) could void the user’s authority to operate the
equipment.
NOTE: This equipment has been tested and found to comply with the limits
for a Class B digital device, pursuant to Part  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 in a particular
installation. If this equipment does cause harmful interference to radio or
television reception, which can be determined by turning the equipment o
and on, the user is encouraged to try to correct the interference by one or
more of the following measures:

11
FCC ANDICSTATEMENT S
EN
ɪ Reorient or relocate the receiving antenna.
ɪ Increase the separation between the equipment and receiver.
ɪ Connect the equipment into an outlet on a circuit dierent from that to
which the receiver is connected.
ɪ Consult the dealer or an experienced radio/TV technician for help.
This equipment complies with radiation exposure limits set forth for an
uncontrolled environment. This equipment is in direct contact with the body of
the user under normal operating conditions. This transmitter must not be co-
located or operating in conjunction with any other antenna or transmitter.
This device complies with Part  of the FCC Rules. Operation is subject to the
following two conditions: ( This device may not cause harmful interference,
and ( this device must accept any interference received, including
interference 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: () this device may not
cause interference, and () 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 Canada applicables
aux appareils radio exempts de licence. L'exploitation est autorisée aux deux
conditions suivantes :  l'appareil ne doit pas produire de brouillage, et ()
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 en contact direct avec le
corps de l'utilisateur dans des conditions de fonctionnement normales. Cet
émetteur ne doit pas être co-localisées ou opérant en conjonction avec tout
autre antenne ou transmetteur.

12
ELECTROMAGNETIC COMPATIBILITY (EMC)
EN
ELECTROMAGNETIC COMPATIBILITY
(EMC)
The XTM Knee Brace MI TM Sensor is intended for use in the electromagnetic
environment specified below. The customer or user of the XKnee Brace MI
 Sensor should assure that it is used in such an environment.
Guidance and Manufacturer’s Declaration – Electromagnetic Emissions
Emissions
Tests Compliance Electromagnetic Environment Guidance
RF Emissions
CISPR  Group 
The X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  Class B
The XKnee Brace Sensor is suitable
for use in all establishments, including
domestic establishments and those
directly connected to public low-voltage
power supply network that supplies
buildings used for domestic purposes.
Harmonic
Emissions
IEC
N/A. Battery
Powered. N/A
Voltage
Fluctuations/
emission
oscillations
IEC
N/A. Battery
Powered. N/A

13
ELECTROMAGNETIC COMPATIBILITY (EMC)
EN
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
Immunity
Test
IEC60601
Test Level
Compliance
Level
Electromagnetic
Environment
Guidance
Electrostatic
Discharge
(ESD)
IEC
±kV contact
±kV air
±8 kV
contact
± kV air
Floors should be
wood, concrete,
or ceramic tile. If
floors are covered
with synthetic
material, the
relative humidity
should be at least
%.
Electrical Fast
Transient/Burst
IEC
±kV for power
supply lines
±kV for input/
output lines
N/A. Battery
Powered.
Mains power qual-
ity should be that
of a typical com-
mercial or hospital
environment.
Surge
IEC
±kV dierential
mode
±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
<% U (>% dip in
TU ) for .cycle
% U % dip in
TU ) for cycles
% U (% dip in
TU ) for  cycles
<% U (>% dip in
TU) for sec
N/A. Battery
Powered.
Mains power qual-
ity should be that
of a typical com-
mercial or hospital
environment.
Power
Frequency
(/Hz)
Magnetic
Fields
IEC
A/m  A/m
Power frequency
magnetic fields
should be at levels
characteristic of
a typical location
in a typical com-
mercial or hospital
environment.

14
ELECTROMAGNETIC COMPATIBILITY (EMC)
EN
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
Portable and mobile RF communications equipment should be used no closer to
any part of the XTM Knee Brace Sensor, including cables, than the recommended
separation distance calculated from the equation applicable to the frequency of
the transmitter.
Immunity Test IEC60601
Test Level
Compliance
Level
Recommended Separation
Distance
Conducted RF
IEC
Vrms
KHz to
MHz
V .√P
Radiated RF
IEC
V/m
MHz to
.GHz
 V/m .√P  MHZ TO  MHZ
.√P  MHZ TO .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,ashould be less than
the compliance level in each
frequency rangeb.
Interference may occur in the
vicinity of equipment marked
with the following symbol:
NOTE 1: At MHz and MHz, the higher frequency range applies.
NOTE 2:These guidelines may not apply in all situations. Electromagnetic
propagation is aected by absorption and reflection from structures, objects and
people.

15
TECHNICAL SPECIFICATIONS
EN
aField strengths from fixed transmitters, such as base stations for radio (cellular/
cordless) telephones and land mobile radios, amateur radio, AM and FM radio
broadcast and TV broadcast cannot be predicted theoretically with accuracy.
To assess the electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the measured field strength
in the location in which the XTM Knee Brace Sensor is used exceeds the applicable
RF compliance level above, the XKnee Brace 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Knee Brace Sensor.
bOver the frequency range  kHz to  MHz, field strengths should be less than
V/m.

16
TECHNICAL SPECIFICATIONS
EN
TECHNICAL SPECIFICATIONS
Recommended Separation Distances between Portable and Mobile RF
Communications Equipment and the X4Knee Brace Sensor
The XTM Knee Brace Sensor is intended for use in an electromagnetic
environment in which radiated RF disturbances are controlled. The
customer or the user of the XKnee Brace Sensor can help prevent
electromagnetic interference by maintaining a minimum distance between
portable and mobile RF communications equipment (transmitters) and the
XKnee Brace Sensor as recommended below, according to the maximum
output power of the communications equipment.
Rated maximum
output power
of transmitter
(Watts)
Separation distance according to frequency of
transmitter (Meters)
KHz to
MHz
d = .√P
MHz to
MHz
d = . √P
MHz to
.GHz
d = .√P
. . . .
. . . .
. . .
 . . .
  . 
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 of the transmitter, where P is the
maximum output power rating of the transmitter in watts (W) according to
the transmitter manufacturer.
NOTE 1: At MHz and MHz, the separation distance for the higher
frequency range applies.
NOTE 2:These guidelines may not apply in all situations. Electromagnetic
propagation is aected by absorption and reflection from structures, objects
and people.

17
WARRANTY
EN
W A RRANTY
DJO, LLC will repair or replace all or part of the unit and its accessories for
material or workmanship defects for a period of six months from the date
of sale. To the extent the terms of this warranty are inconsistent with local
regulations. The provisions of such local regulations will apply.
DISPOSAL
Sensor is electronic equipment and may include substances that can damage
the environment. Do 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, DURABILITY AND COMFORT, THERE IS NO
GUARANTEE THAT INJURY WILL BE PREVENTED THROUGH THE USE OF
THIS PRODUCT. THIS DEVICE IS NOT INTENDED TO PREVENT INJURY,
BUT AS AN ADJUNCT TO POST-OPERATIVE THERAPY. USE CAUTION
AND FOLLOW YOUR DOCTOR’S ADVICE.

DJO, LLC
 Decision Street
Vista, CA՘ՑՏ՗Րɂ՗ՔՔՒɪ
T +...
T +...
F +...
DJOglobal.com
 DJO, LLC. All rights reserved.
 Rev C
//