DJO Donjoy X-ROM iQ User manual

X-ROM iQ
Instructions For Use

EN
1
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

EN
2
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
To aid in immobilization and protected range of motion associated
with ACL, PCL, LCL, MCL surgeries and meniscal repairs. This
product was designed to help complement the variety of medical
treatments common to the above aictions. 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 motion.
CONTRAINDICATIONS
None.
WARNINGS AND CAUTIONS
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. Do not
use this product outside of intended use.
Warning: Equipment contains CR lithium coin cell battery.
There is danger of explosion if lithium ion batteries are incorrectly
replaced.

EN
3
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.
SYMBOLS
WARNING! Read and
understand all warnings
and Instructions for Use
before using this device.
Temperature range
Atmospheric pressure
range
Indication for protection
against water and
particular matter.
Manufacturer
Non-ionizing
electromagnetic
radiation
Humidity Range
Prescription only (USA).

EN
4
APPLICATION SET UP AND PAIRING
. Download Motion iQTM App from the App store.
. Ensure Bluetooth is enabled on your phone or tablet Settings
a. For iPhone: Settings > Bluetooth > On
b. For Android: Settings > Connections. Bluetooth > On
. Follow the link in the welcome email from your clinician. This
will launch the Motion iQ application and start your account
setup. (Note: If you have not yet received a welcome email,
please contact your physician)
. Follow the instruction in the application to complete your
account setup.
. Follow 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  below)
d. Click “Go” when prompted in the app on your mobile
phone or tablet
e. Screen will show “Congratulations” when successfully
connected.
Note: This step only needs to occur one time. Brace will pair
automatically while wearing the brace and standing in full
extension.
30
10
0
-10
20
90
100
110
120
60
50
40
30
20
10
0
-10
70
80
0
-10
20
10
30
40
50
60
70
80
90
1

EN
5
BRACE APPLICATION INFORMATION
. Unfasten strap ends near black buckles and open brace flat by
pulling both uprights apart.
. 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

EN
6
4. Adjust the strap lengths:
– Ensure tab is lifted from the strap, allowing the strap to
move freely (see arrow position A in figure )
– By pulling strap away from the body, remove slack from the
backside of brace (see arrow position B in figure )
– Ensure uprights are aligned on medial and lateral sides of leg
– Lower tab and apply pressure to secure strap
. 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 sucient clearance). Ensure that both bars
are equal in length and that each strap slider is indexed to the
same position on each upright respectively.
4A 4B
5
A
B

EN
7
. Attach each of the black buckles. Tighten straps by pulling on
loose end. Remove excess strap and reposition alligator strap
end to new edge of the strap. Secure strap-end to strap.
. A) Adjust the hinge by pulling the Flexion and Extension stops
outward and rotating until the desired angle aligns with the
button center. Release stops and ensure they are fully
inserted.
B) Utilize the quick-lock feature at , , , , or  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  and ensure both Flexion and Extension
buttons are set at the same angle setting.
6A 6B
30
10
0
-10
20
90
100
110
120
60
50
40
30
20
10
0
-10
70
80
0
-10
20
10
30
40
50
60
70
80
90
7

EN
8
OTHER ADJUSTMENTS: The hinge bars may be bent to add varus
or valgus contouring. Bend each bar by holding thigh/calf bar firmly
against a solid surface and apply gentle and constant pressure
to the hinge in the direction desired. Bend each side bar an equal
amount above and below the hinge. For optimal ease of application
post-operatively, pre-fit the brace prior to surgery if 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 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]
Visit: DJOglobal.com
. To remove brace, release each buckle. Brace can then be re-
applied as a single unit.
8B8A

EN
9
CLEANING INSTRUCTIONS
Remove softgoods from the brace by sliding the straps o the top
and bottom of the hinge bars.
Hand wash foam liners in water (°C) with mild
detergent. Rinse thoroughly. AIR DRY only, do not heat
dry.
Do not wash the hinge component containing the
electronic sensor.
MATERIAL CONTENTS
Nylon %, Aluminum %, Polypropylene %, Delrin %, Stainless
Steel %.
BATTERY REPLACEMENT
. 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
-10
20
90
100
110
120
60
50
40
30
20
10
0
-10
70
0
-10
20
10
30
40
50
60
70
80
90
9

EN
10
. Using a fingernail or small object such as a ball point pen,
push the gold battery clip to the side and lift up the battery to
remove.
. 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

EN
11
. Carefully 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
-10
20
90
100
110
120
60
50
40
30
20
10
0
-10
70
0
-10
20
10
30
40
50
60
70
80
90
15

EN
12
FCC AND IC STATEMENTS
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:
• Reorient or relocate the receiving antenna.
• Increase the separation between the equipment and receiver.
• Connect the equipment into an outlet on a circuit dierent
from that to which the receiver is connected.
• 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.

EN
13
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.

EN
14
ELECTROMAGNETIC COMPATIBILITY (EMC)
The X-ROM iQ sensor is intended for use in the electromagnetic
environment specified below. The customer or user of the X-ROM
iQ 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-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  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 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

EN
15
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
± 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.
Main power
quality should be
that of a typical
commercial
or hospital
environment.
Surge
IEC 
± kV differential
mode
± 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 
<% 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.
Main power
quality should be
that of a typical
commercial
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
commercial
or hospital
environment.

EN
16
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
Portable and mobile RF communications equipment should be used
no closer to any part of the X-ROM iQ 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
a
, should be less than the
compliance level in each
frequency range
b
.
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 affected by absorption and reflection from structures,
objects and people

EN
17
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-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.
bOver the frequency range  kHz to  MHz, field strengths should be
less than V/m.

EN
18
Recommended Separation Distances between Portable and Mobile
RF Communications Equipment and the X-ROM iQ sensor
The X-ROM iQ sensor is intended for use in an electromagnetic
environment in which radiated RF disturbances are controlled. The
customer or the user of the X-ROM iQ sensor can help prevent
electromagnetic interference by maintaining a minimum distance
between portable and mobile RF communications equipment
(transmitters) and the X-ROM iQ 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 affected by absorption and reflection from structures, objects
and people.
TECHNICAL SPECIFICATIONS