Chattanooga Intelect Mobile 2 Ultrasound User manual

COMBO, STIM, ULTRASOUND
Intelect®Mobile 2
QUICK START GUIDE
Guide de démarrage rapide • Guía de inicio rápido • Guida rapida d’avvio
Kurzanleitung • Snelle start gids • Hızlı başlama rehberi • Snabbstartsguide
Pikaopas • Hurtig start guide • Guia rápido • Rychlý návod
Skrócona instrukcja obsługi • Οδηγό γρήγορη εκκίνηση
   • Ghid de iniiere rapidă

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INTELECT® MOBILE 2 QUICK START GUIDE
Foreword.......................................................................................3
Intended User Profile...............................................................3
Intended Environment For Use...........................................3
Intended Use................................................................................3
Precautionary Instructions....................................................4
Electrotherapy Indications.....................................................9
Indications.....................................................................................9
Contraindications ......................................................................9
Ultrasound Indications..........................................................10
Indications...................................................................................10
Contraindications ....................................................................10
Additional Precautions..........................................................10
Product Description................................................................. 11
Components ...............................................................................11
Head ...............................................................................................11
Cart .................................................................................................11
Battery Module (Optional)...................................................11
Ultrasound Applicators ..........................................................11
Vacuum Module (Optional)................................................. 11
Operator Interface.................................................................. 12
Connecting Cables And Inserting Plugs ....................... 14
Initial Receipt.............................................................................14
If Unit Supplied With Optional Battery ..........................14
Powering Up The Device ......................................................14
IFU Download............................................................................ 15
Device Connected To The Mains.......................................16
Device Working On Battery.................................................16
Stop Treatment And Turn O The Device.....................16
Ultrasound Coupling...............................................................16
General Terminology............................................................... 17
System Software Symbols.................................................... 17
Description Of Device Markings........................................18
Vacuum Module Markings...................................................18
System Specifications And Dimensions..........................19
Power ............................................................................................19
Electro Stimulation
Specifications..............................................................................19
Vacuum Specifications...........................................................19
Ultrasound Specifications....................................................20
Output Power...........................................................................20
General System Operating And Storage
Temperature ............................................................................... 21
Waveforms ................................................................................. 22
CONTENTS


EN
This manual is intended for users of Intelect®Mobile
 . It contains general information on operation,
precautionary practices, and maintenance.
In order to maximize use, eciency, and the life of
the system, please read this manual thoroughly and
become familiar with the controls, as well as the
accessories before operating the system.
In addition to the above information, this manual
contains care and installation instructions for the
optional Cart and Vacuum module for the users of the
Intelect®Mobile .
Before administering any treatment to a patient, the
users of this equipment should read, understand,
and follow the information contained in this
manual for each mode of treatment available, as
well as the indications, contraindications, cautions,
warnings, and dangers. Consult other resources for
additional information regarding the application of
electrotherapy and ultrasound.
INTENDED USER PROFILE
The intended user of this device is a licensed medical
professional. The user should be able to:
• Read and understand the operator’s manual,
warnings, cautions and dangers.
• Sense auditory and visual signals.
• Read and understand indications and
contraindications of the device
FOREWORD INTENDED ENVIRONMENT FOR USE
The device is intended to be operated in the clinic
and remote treatment locations. The intended clinical
conditions for use are a typical clinic setting including
chiropractic clinics, physical therapist clinics, athletic
training rooms or other rehabilitation settings. The
patients home will also be a frequent use setting
where the clinician treats the patient in his/her own
home environment.
INTENDED USE
The Intelect Mobile  device will be used to deliver a
variety of modalities to the patient, Ultrasound and
electrical stimulation delivered either as stand alone
therapies or in combination.

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INTELECT® MOBILE 2 QUICK START GUIDE
NOTE: Throughout this manual, “NOTE”
indicators provide helpful information
regarding the particular area of function being
described.
CAUTION
Text with a “CAUTION” indicator explains possible
safety infractions that have potential to cause minor or
moderate injury or damage to the equipment.
Text with a “WARNING” indicator explains possible
safety infractions that will potentially cause serious
injury and equipment damage.
Text with a “DANGER” indicator will explain possible
safety infractions that are imminently hazardous
situations that would result in death or serious injury.
The precautionary instructions found in this section
and throughout this manual are indicated by specific
symbols. Understand these symbols and their
definitions before operating this equipment. The
definition of these symbols are as follows:
PRECAUTIONARY INSTRUCTIONS
WARNING
DANGER


EN
CAUTION
• This unit should be operated at +°C to +°C and % to % Relative Humidity. The unit should be
transported and stored at -°C to +°C and % to % Relative Humidity.
• Use of parts or materials other than DJO’s can degrade minimum safety.
• Connect to this unit only items and equipment that have been specified in this IFU as part of the ME
SYSTEM or that have been specified as being compatible with the ME SYSTEM.
• DO NOT disassemble, modify, or remodel the unit or accessories. This may cause unit damage, malfunction,
electrical shock, fire, or personal injury.
• DO NOT permit foreign materials, liquids or cleaning agents to enter the unit, including, but not limited to,
inflammables, water, and metallic objects, to prevent unit damage, malfunction, electrical shock, fire, or
personal injury.
• Before each use, inspect Ultrasound Applicator for cracks, which may allow the ingress of conductive fluid.
• Before each use, inspect Applicator cables, STIM cables and associated connectors.
• Before each use, inspect Vacuum Electrode Cups and Lead Hoses for cracks and damage which may not
allow the vacuum to properly secure the electrodes.
• Handle Ultrasound Applicator with care. Inappropriate handling may adversely aect its characteristics.
• Caution should always be exercised with current densities more than mA/cm².
• There are no user-serviceable parts inside the unit. If a malfunction occurs, discontinue use immediately
and consult dealer for repair service.
• In case of device unused with battery embedded, it is recommended to connect the device at least once
every  months to allow battery recharge.
• For waveforms with a DC component:
»Do not shave electrodes application area
»Warn the patient that tingling sensation under electrodes is normal and it is not linked to burn risk.
»Rinse thoroughly treatment area with tap water immediately after the treatment

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INTELECT® MOBILE 2 QUICK START GUIDE
WARNING
• This device should be used only under the continued supervision of a physician or licensed practitioner.
• Contaminated sponges, electrodes, leadwires, and gel can lead to infection.
• Use of electrode on multiple patients can lead to infection.
• Do not apply electro stimulation treatment during bath, shower, sauna,..
• DO NOT operate the Intelect® Mobile  within the vicinity or environment of an ultrasonic diathermy
system.
• DO NOT operate the Intelect® Mobile  within the vicinity or environment of any microware and RF
shortwave diathermy system.
• DO NOT operate this unit in an environment where other devices are being used that intentionally radiate
electromagnetic energy in an unshielded manner.
• Electronic monitoring equipment (such as ECG monitors and ECG alarms) may not operate properly when
electrical stimulation is in use.
• Simultaneous connection of a PATIENT to a high frequency surgical ME EQUIPMENT may result in burns at
the site of the STIMULATOR electrodes and possible damage to the STIMULATOR.
• Portable RF communications equipment should be used no closer than  cm ( inches) to any part
of the Intelect Mobile , including cables specified by the manufacturer. Otherwise, degradation of the
performance of this equipment could result.
• Use of accessories, transducers and cables other than those specified or provided by the manufacturer
of this equipment could result in increased electromagnetic emissions or decreased electromagnetic
immunity of this equipment and result in improper operation.
• Battery replacement by inadequately trained personnel could result in fire or explosion. Please read
carefully the battery replacement instructions in the Mobile  IFU before attempting to replace the battery.
• Device is designed to comply with electromagnetic safety standards. This equipment generates, uses, and
can radiate radio frequency energy and, if not installed and used in accordance with instructions for use,
may cause harmful interference to other devices in the vicinity. Harmful interference to other devices can
be determined by turning this equipment on and o. Try to correct the interference using one or more of
the following:
»Reorient or relocate the receiving device
»Increase the separation between the equipment
»Connect the equipment to an outlet on a dierent circuit from that to which the other device(s) are
connected
»Consult your authorized DJO dealer for help.
• Disconnect the system from the power source before attempting any maintenance, installation, removal,
or replacement procedures to prevent electrical shock and possible damage to system.


EN
• The Intelect® Mobile  may be susceptible to Electro-Static Discharge (ESD) at greater than ± kV when
first grasping the Ultrasound applicator. In the event of such a discharge, the Intelect® Mobile  may display
a permanent error. The Intelect® Mobile  will terminate all active outputs (stim, ultrasound,), automatically
place the unit in a safe state.
• To prevent Electro-Static Discharge (ESD) at greater than ± kV:
»Grasp and hold the Ultrasound prior to starting treatment. If the applicator must be put down prior to
completion of treatment, stop the current treatment first and then place the applicator in the holder.
»Maintain humidity in the use environment to at least % relative humidity.
»Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, DJO
recommends implementing additional controls to maintain relative humidity to at least %.
»Communicate these ESD-precautionary procedures to healthcare sta, contractors, visitors, and
patients.
WARNING

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INTELECT® MOBILE 2 QUICK START GUIDE
DANGER
• DO NOT connect the unit to an electrical supply without first verifying that the power supply is the correct
voltage. Incorrect voltage may cause unit damage, malfunction, electrical shock, fire, or personal injury.
Your unit was constructed to operate only on the electrical voltage specified on the Voltage Rating and
Serial Number Plate. Contact your DJO dealer if the unit is not properly rated.
• Device is not designed to be used in oxygen rich environment, Explosion hazard if the device is used in the
presence of flammable anesthetic mixture with air, oxygen, or nitrous oxide.


EN
INDICATIONS
TENS
• Symptomatic relief of chronic pain
• Management of post-operative pain
NMES
• Muscle re-education
• Increasing local blood supply
• Relaxation of muscle spasms
• Maintaining/Increasing range of motion
CONTRAINDICATIONS
The Intelect®Mobile  should NOT be used under the
following conditions:
• Do not use for symptomatic local pain relief
unless etiology is established or unless a pain
syndrome has been diagnosed.
• Do not use when cancerous lesions are
present in the treatment area.
• Do not apply stimulation over swollen,
infected, inflamed areas or skin eruptions
(e.g., phlebitis, thrombophlebitis, varicose
veins, etc.).
• Do not use when patient is suspected or
known to have infectious disease and/or
disease where it is advisable, for general
medical purposes, to suppress heat or fevers.
• Do not place electrode placements to
the carotid sinus region (anterior neck) or
transcerebrally (through the head).
• Do not use on pregnant women. Safety
has not been established for the use of
therapeutic electrical stimulation during
pregnancy.
• Do not use Intelect®Mobile  on patients
who have or have had implantable
neurostimulating cardiac demand
pacemakers, ICD, or other implantable
electronic devices.
• Do not use Intelect®Mobile  on patients
with body worn electro mechanical medical
devices, i.e. insulin pump.
• Do not use this system in an MRI or CT
environment. The Intelect®Mobile , its
components, and accessories are not to be
present in an MRI or CT environment.
• Do not apply stimulation transthoratically or
on the chest, the introduction of electrical
current into the heart may cause cardiac
arrhythmia
• Do not apply stimulation over the anterior
neck or mouth. Severe spasm of the laryngeal
and pharyngeal muscles may occur and the
contractions may be strong enough to close
the airway or cause diculty in breathing.
ELECTROTHERAPY INDICATIONS

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INTELECT® MOBILE 2 QUICK START GUIDE
INDICATIONS
• Relief of pain from muscle spasm
• Relief of pain from joint contracture
• Relief of pain associated with ligament
sprains, tendinitis and muscle sprain
CONTRAINDICATIONS
• Do not use for symptomatic local pain relief
unless etiology is established or unless a pain
syndrome has been diagnosed.
• Do not use when cancerous lesions are
present in the treatment area.
• Do not use when patient is suspected or
known to have infectious disease and/or
disease where it is advisable, for general
medical purposes, to suppress heat or fevers.
• Do not use over or near bone growth centers
until bone growth is complete.
• Do not use over the thoracic area if the
patient is using a cardiac pacemaker.
• Do not use over a healing fracture.
• Do not use over or applied to the eye.
• Do not use over a pregnant uterus.
• Tissue necrosis might result if the device is
used on ischemic tissues in individuals with
vascular disease, where the blood supply
would not keep up with the metabolic
demand.
• Do not use Intelect®Mobile  on patients
who have or have had implantable
neurostimulating cardiac demand
pacemakers, ICD, or other implantable
electronic devices.
• Do not use Intelect®Mobile  on patients
with body worn electro mechanical medical
devices, i.e. insulin pump.
• Do not use this system in an MRI or CT
environment. The Intelect®Mobile , its
components, and accessories are not to be
present in an MRI or CT environment.
ADDITIONAL PRECAUTIONS
Additional precautions should be used when
ultrasound is used on patients with the following
conditions:
• Over an area of the spinal cord following
a laminectomy, i.e., when major covering
tissues have been removed
• Over anesthetic areas
• On patients with hemorrhagic diatheses
ULTRASOUND INDICATIONS

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EN
PRODUCT DESCRIPTION
The Intelect®Mobile  COMBO is a two-channel
electrotherapy, ultrasound therapy and Combo system
used with or without an optional Cart, allowing for
the inclusion of a Vacuum module. This equipment is
to be used only under the prescription and supervision
of a licensed medical practitioner.
COMPONENTS
Throughout these instructions the terms “left”
and“right” referring to the machine sides are from the
perspective of a user standing in front of the unit.
The components of the Intelect®Mobile  COMBO are
shown below.
HEAD
CART
BATTERY MODULE (optional)
Battery is an 18V 3350mAh LiIon rechargeable battery
ULTRASOUND APPLICATORS
VACUUM MODULE OPTIONAL

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INTELECT® MOBILE 2 QUICK START GUIDE
OPERATOR INTERFACE
The Intelect®Mobile  COMBO Operator Interface
contains all the functions and controls necessary for
operator access to all operator utilities, modalities,
and parameters for modification and system set up.
Color Display and touch screen
Handle
Colour Touch Screen
Play / pause button
Adjustment dial
Ultrasound applicator
support
“On/O“ button
Ultrasound applicator
connectors
1. Adjustment dial
2. Play/pause button
3. “On/O“ button. Press and hold ( sec) the button
to switch OFF the device.
4. ON/OFF switch (only active when connected to
the mains)
5. Ultrasound Applicator holder, left and right sides
6. Mains power connector
7. Battery cover
8. USB Flash Drive Port
9. Magnetic fixation to the cart
10.Vacuum cover
11. Device handle

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EN
Ultrasound applicator
connectors
Lead wire connectors for
electro stimulation
ON / OFF switch only
active on mains power
USB port for
software upgrade
Mains power
connector
Battery cover Vacuum cover

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INTELECT® MOBILE 2 QUICK START GUIDE
CONNECTING CABLES AND INSERTING
PLUGS
When inserting the plugs, be sure to align the flat side
of the plug with the flat side of the slot and push in
gently. This is to avoid bending the pins in the plug.
Insert cable into the appropriate connector prior to
starting therapy.
INITIAL RECEIPT
Remove all packaging
IF UNIT SUPPLIED WITH OPTIONAL
BATTERY
After unpacking Intelect Mobile  to fit the battery
follow the following steps
. Unscrew the battery cover from the base of the
device by removing the  screws see below
. Remove the battery cover
. Plug the battery into the battery connector on the
device
. Insert the battery into its location
. Replace the  screws to close the battery cover
POWERING UP THE DEVICE
First time use always use mains power even if battery
connected. Insert the power cord into the back of
the unit, insert the plug into a power outlet, do not
position the Intelect Mobile  in such a way that
makes it dicult to disconnect from the mains power.
Switch device on with ON/OFF switch switch on the
back of the unit
. The Initialisation screen below will be shown for a
few seconds whilst the device starts.
. The first setup screen will be dispalyed after this
allowing the user to set language, device name,
time and choose patient pain scale as either NRS
(Numerical Rating Scale) or VAS (Visual Analogue
Scale).
. Click on "Continue" button to go to home screen


EN
IFU DOWNLOAD
. Go to the Chattanooga website
www.chattanoogarehab.com
. Go to Intelect Mobile  product tab
. Complete the registration form to be informed
about new product software version availability and
IFU updates.
. Go to documents tab
. Click on the latest version of your Intelect Mobile
 device (COMBO, US or STIM) User manual to
download
Nota: a pdf viewer is required to display IFU

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INTELECT® MOBILE 2 QUICK START GUIDE
DEVICE CONNECTED TO THE MAINS
. Plug the Power cord into the back of device. Plug the
other end of the cord into an electrical outlet.
NOTE: The Power Cord may be unplugged from the
back of the unit in an emergency situation.
. Turn on the ON/OFF switch located on the back of
the device.
3. Press ON/OFF button on LCD Front panel
. Select desired function on the Home Screen
DEVICE WORKING ON BATTERY
. Press the ON/OFF button on the LCD Front panel, as
shown below
. Select desired function on the Home Screen (shown
below).
ON/OFF Button
STOP TREATMENT AND TURN OFF THE
DEVICE
Press Play/pause button to pause treatment then press
stop on touch screen. If device is on mains power press
the on/o button on the front panel then turn o the
switch on the back of the unit.
If device is working on battery follow the above
procedure but to switch o only press the on/o
button on the front panel
PLAY/PAUSE button
ULTRASOUND COUPLING
To ensure correct operation of the Ultrasound coupling
detection, the start button must be pressed with the
applicator in air or on the holder (without gel). After
few seconds, it can be coupled and applied on skin
with gel. Missing this step will result in coupling failure
warning message.


EN
GENERAL TERMINOLOGY
The following are definitions for the terminology used throughout this manual . Study these terms to become
familiar with them for ease of system operation and control functionality of the Intelect® Mobile 2 .
SYSTEM SOFTWARE SYMBOLS
Home
Back to previous screen
Settings
Indicates a USB Flash Drive is Inserted
Indicates Battery Level
Indicates more content can be viewed by swiping
vertically
Indicates more content can be viewed by swiping
horizontally
Indicates more content can be viewed by scrolling
Close window / exit full screen
Confirm
Save Data
Edit
Guidelines / Assign to
Pain information
Run again
Exit
Export
Import
Delete
Delete all
Stop treatment
Stim
Ultrasound
Combo
Shortcut
SPS (Suggested Parameter Setup)
Custom Protocols
Treatment Data
Clinical Resources

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INTELECT® MOBILE 2 QUICK START GUIDE
DESCRIPTION OF DEVICE MARKINGS
The markings on the unit are assurance of its conformity to the highest applicable standards of medical equipment
safety and electromagnetic compatibility and conform to ISO  and ISO-- One or more of the following
markings may appear on the device:
Refer to Instructional Manual Booklet
Warning, Caution, or Danger
Electrical Type BF Equipment
Ultrasound
Stim
Combo
Play
Pause
ON/OFF
Manufacturer
Date of manufacture
Catalogue number
Serial number
Fragile, handle with care
This end up
Keep dry
Temperature Range
Relative Humidity Range
Atmospheric Pressure Range
Test agency
CE Mark of Conformity with notified body
number
Alternating current
Class II equipment
IP
Radio frequency equipment
WEEE Directive conformity
Shelf life
Batch number
US amplitude modulated
MD
VACUUM MODULE MARKINGS
Channel  device connection to vacuum
1 2
Channel  device connection to vacuum
1 2
+/- Channel  polarity
1 2
+/- Channel  Polarity
1 2

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EN
POWER
Input  -  V AC, . to . A, / Hz
Electrical Class CLASS II
Mode of Operation Continuous
Note: Mains isolation is achieved by use of the double
pole switch located on the rear panel.
Electrical Type (Degree of Protection)
Ultrasound .TYPE BF
Electrotherapy .TYPE BF
Electrotherapy Vacuum .TYPE BF
Ultrasound & Electrotherapy .TYPE BF
SYSTEM SPECIFICATIONS AND DIMENSIONS
Width Depth Height Weight (no battery)
Intelect Mobile  Head Unit
COMBO cm .cm cm .kg
UltraSound cm .cm cm .kg
STIM .cm .cm cm .kg
Cart configurations
Cart (Safe working load .kg) cm MAX cm MAX cm .kg
Cart with vacuum cm MAX cm MAX cm .kg
Device on cart - -  cm -
ELECTRO STIMULATION
SPECIFICATIONS
Output specifications are described for each
waveform from pages -.
Unless otherwise specified, electrotherapy controls
accuracy is: ±  %.
Load impedance: - Ohm
CC = constant current, eect of load impedance on
voltage
CV = constant voltage, eect of load impedance on
current
VACUUM SPECIFICATIONS
Power
Input - Vdc, maximum peak current A
Electrical Type TYPE BF

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INTELECT® MOBILE 2 QUICK START GUIDE
OUTPUT POWER
US applicator Frequency
cmcmcmcm
MHz MHz MHz MHz MHz MHz MHz MHz
Eective Radiating Area ERA INTL (cm2)
 . .  . .  .
Max Output power in Continuous mode
W .W W W W .W W.W
Max Output power in Pulsed mode
W .W
(*) .W W .W .W W.W
Max Amplitude in Continuous mode
W/
cm
W/
cm
W/
cm
W/
cm
W/
cm
W/
cm
W/
cm
W/
cm
Max Amplitude in Pulsed mode
W/
cm
W/
cm
W/
cm
W/
cm
W/
cm
W/
cm
W/
cm
W/
cm
(*) An error of + 0.25 W can be measured with 1cm2
US applicator, pulse mode 100Hz at 10% or 20% Duty
Cycle.
General characteristics
Vacuum Range . to  mbar maximum +/-
%
Vacuum Modes Continuous or Pulsed
Continuous.
 setting over vacuum range,
 mbar per setting,
+ mbar to  mbar per setting
Pulsed Mode
Maximum Vacuum settings  to , +mbar to
-mbar per setting
Minimum Vacuum settings in  to , +mbar to
-mbar per setting
Hold Time in minimum & maximum vacuum settings,
- seconds, in  second steps, +/-. seconds
ULTRASOUND SPECIFICATIONS
Frequency  MHz;  MHz
Duty Cycles %, %, %, Continuous
Pulse Repetition Rate , , or  Hz
Pulse duration:  -. ms
Max (ON): . ms
Min (OFF): ms