DJO Global X4 Manuel utilisateur
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 XTM 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 °CTO +°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 oce directly.
If assistance is needed with the brace or setting up or using the App, please call
or email:
Phone: (/
Visit: www.djoglobal.com/MI
CLEANING INSTRUCTIONS
Remove softgoods from the brace by sliding the straps othe 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
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