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.