Chattanooga Intelect Mobile 2 Ultrasound User manual

COMBO, STIM, ULTRASOUND
Guide de démarrage rapide • Kurzanleitung • Guía de inicio rápido
Snelle start gids • Guida rapida d’avvio • Hızlı başlama rehberi


INTELECT® MOBILE 2 QUICK START GUIDE
Foreword.................................................... 
Intended User Profile .............................. 
Intended Environment for Use ............. 
Intended Use ............................................. 
Precautionary Instructions .................... 
Contraindications.....................................
Electrotherapy ..........................................
Ultrasound .................................................
Product Description............................... 
Components ............................................ 
Head........................................................... 
Cart ............................................................ 
Battery Module (Optional)................... 
Head to Cart Fixation............................ 
Ultrasound Applicators......................... 
Optional Vacuum Module.....................
Device Description...................................
Connecting Cables and
Inserting Plugs ......................................... 
Initial Receipt ........................................... 
If Unit Supplied with
Optional Battery...................................... 
IFU Download .......................................... 
System Start-Up...................................... 
Device Connected to the Mains .......... 
Device Working on Battery...................
To Stop Treatment ..................................
Home Screen Icon Descriptions .......... 
Appendix....................................................
CONTENTS


This guide is intended for users of Intelect®Mobile
 . It contains general information on operation,
precautionary practices, and maintenance.
Before administering any treatment to a patient, the
users of this equipment should read, understand, and
follow the information contained in this guide for each
mode of treatment available, as well as the indications,
contraindications, warnings, and precautions . 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 contraindications of
the device
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 clinical setting including
Chiropractic clinics, physical therapist clinics, athletic
training rooms or other rehabilitation settings. The
patient's home will also be a frequent use setting
where the clinician treats the patient in his/ her own
home environment.
FOREWORD
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
INTENDED USE
The intelect Mobile  device will be used to deliver
a variety of modalities to the patient, ultrasound,
electrical stimulation delivered either as stand alone
therapies or in combination.


INTELECT® MOBILE 2 QUICK START GUIDE
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 Intelect ME
SYSTEM or that have been specified as being compatible with the Intelect 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


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, this could result in fire or explosion. Please read carefully
the battery replacement instructions of 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.


INTELECT® MOBILE 2 QUICK START GUIDE
WARNING
• 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.


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.


INTELECT® MOBILE 2 QUICK START GUIDE
ELECTROTHERAPY
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 as 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.
CONTRAINDICATIONS


CONTRAINDICATIONS
ULTRASOUND
• 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.


INTELECT® MOBILE 2 QUICK START GUIDE
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  are shown
below.
HEAD
CART
COMPONENTS
See Intelect Mobile  Instructions for Use
ULTRASOUND APPLICATORS
OPTIONAL VACUUM MODULE
HEAD TO CART FIXATION
BATTERY MODULE optional
Battery is an V mAh LiIon rechargeable battery
PRODUCT DESCRIPTION
The Intelect®Mobile 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.
NOTE: This equipment is to be used only under the
prescription and supervision of a licensed medical
practitioner.
Ultrasound applicator
connectors


DEVICE DESCRIPTION
Handle
Colour Touch Screen
Play / pause button
Adjustment dial
Ultrasound applicator
support
ON/OFF button
Battery cover
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
Vacuum cover


INTELECT® MOBILE 2 QUICK START GUIDE
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
Battery cover screws
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.


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
Switch device on with switch on the back of the unit,
do not position the Intelect Mobile  in such a way
that makes it dicult to disconnect from the mains
power.
.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, date
and time in the device.
. Click the "Continue" button to go to home screen
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
Note: A pdf viewer is required to display IFU
A hard copy of the IFU can be requested from DJO
either by registration on the website or you local
DJO oce or dealer, the copy will be delivered to you
within  days
SYSTEM STARTUP
Complete the following steps for start-up of the
Intelect®Mobile :


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 Power switch located on the back of
the device.
. Select desired function on the Home Screen
(shown below)
DEVICE WORKING ON BATTERY
. Press the ON/OFF button on the LCD Front panel, as
shown below
. Select desired function on the Home Screen
ON/OFF Button
TO STOP TREATMENT AND STOP 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
Press and hold for
power o


HOME SCREEN ICON DESCRIPTIONS
Stim
Ultrasound
Combo
Shortcut
SPS (Suggested Parameter Setup)
Custom Protocols
Treatment Data
Clinical Resources
Home
Settings
Battery indicator
DESCRIPTION OF DEVICE MARKINGS
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


INTELECT® MOBILE 2 QUICK START GUIDE
This end up
Keep dry
Temperature Range
Relative Humidity Range
Atmospheric Pressure Range
Testing agency
CE Mark of Conformity with
notified body number
Alternating current
Class II equipment
IP21
Radio frequency equipment
WEEE Directive conformity
Shelf life
Batch number
US amplitude modulated


SYSTEM SPECIFICATIONS AND
DIMENSIONS
Width Depth Height
Weight
(no
battery)
Intelect Mobile 2 Head Unit
COMBO cm .cm cm .kg
UltraSound cm .cm cm .kg
STIM .cm .cm cm .kg
Cart configurations (Cart safe working load .kg)
Cart cm
MAX
cm
MAX cm .kg
Cart with
vacuum
cm
MAX
cm
MAX cm .kg
Device on
cart - -  cm -
POWER
Input  -  V AC, . to . A, / Hz
Electrical Class CLASS II
Mode of Operation Continuous
Electrical Type (Degree of Protection)
Ultrasound .TYPE BF
Electrotherapy .TYPE BF
Electrotherapy Vacuum .TYPE BF
Ultrasound & Electrotherapy .TYPE BF
ELECTRO STIMULATION
SPECIFICATIONS
Load impedance: - Ohm
CC = constant current, eect of load
impedance on voltage
CV = constant voltage, eect of load
impedance on current
Output specifications are described for each waveform
unless otherwise specified, electrotherapy controls
accuracy is +/- %
VACUUM SPECIFICATIONS
Power
Input - Vdc, maximum peak current A
Electrical Type TYPE BF
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
APPENDIX


INTELECT® MOBILE 2 QUICK START GUIDE
APPENDIX
ULTRASOUND SPECIFICATIONS
Frequency  MHz;  MHz
Duty Cycles %, %, %, Continuous
Pulse Repetition Rate , , or  Hz
Pulse duration:  -. ms
- Max (ON): . ms
- Min (OFF): ms
OUTPUT POWER
US applicator
Frequency
1 cm22cm25cm2
1MHz 3MHz 1MHz 3MHz 1MHz 3MHz
Eective
Radiating Area
ERA INTL (cm2)
1 0.9 1.5 12.5 2.7
Max Output
power in
Continuous mode
2W 1.8W 3W 2W 5W 5.4W
Max Output
power in Pulsed
mode
3W 2.7W
(*) 4.5W 3W 7.5W 8.1W
Max Amplitude
in Continuous
mode
2W/
cm2
2W/
cm2
2W/
cm2
2W/
cm2
2W/
cm2
2W/
cm2
Max Amplitude in
Pulsed mode
3W/
cm2
3W/
cm2
3W/
cm2
3W/
cm2
3W/
cm2
3W/
cm2
(*) An error of + 0.25 W can be measured with 1cm2
US applicator, pulse mode 100Hz at 10% or 20% Duty
Cycle.
Unless otherwise specified, ultrasound
controls accuracy is: ±  %.
Peak to Average Ratio: :, at % Duty Cycle
:, at % Duty Cycle
:, at % Duty Cycle
Beam Nonuniformity Ratio <:
Beam Type Collimating
Treatment Time  to  min
GENERAL SYSTEM OPERATING AND
STORAGE TEMPERATURE
Operating Conditions
The device will meet its requirement under the
following conditions:
Temperature: °C to °C
Relative Humidity: % to %
Atmospheric Pressure: kPa to kPa
Transport and Storage Conditions
The device will remain in proper condition under the
following conditions:
Temperature: -°C to °C
Relative Humidity: % to %
Atmospheric Pressure: kPa to kPa
Time required for the Intelect Mobile 2 to warm from
the minimum storage temperature between uses until
the Intelect Mobile 2 is ready for its INTENDED USE
when the ambient temperature is  °C: h


APPENDIX
Time required for the Intelect Mobile 2 to cool from
the maximum storage temperature between uses
until the Intelect Mobile 2 is ready for its INTENDED
USE when the ambient temperature is  °C: h
IPXX Rating for Unit
Rated to IP
IP* Protection against fingers or other object not
greater than mm in length and mm in diameter
* Protection from vertically dripping water
IPXX Rating for US applicator
Rated to IPX
IPX Protection from immersed in water (up to m
depth)
RED
RF transmitter/receiver characteristics:
- Frequency Band transmission: –. MHz
- Modulation type: GFSK
- Data rate: up to Mbps kHz deviation
at Mbps
- Eective radiated power: +dBm


INTELECT® MOBILE 2 QUICK START GUIDE
APPENDIX
WAVEFORMS
CC: Constant Current CV: Constant Voltage
IFC (Interferential) Traditional (4 Pole)
Advice on size and type of electrodes to be used is given in device GUI "treatment
guidelines" feature
Interferential Current is a medium frequency waveform. Current is
distributed through two channels (four electrodes). The currents
cross each other in the body at the area requiring treatment. The
two currents interfere with each other at this crossing point,
resulting in a modulation of the intensity (the current intensity
increases and decreases at a regular frequency).
Output Mode Electrodes
Available on Channel &,
Treatment Time - Minutes
Mode Selection CC
Output Intensity - mA (CC)
Beat Frequency - Hz
Carrier Frequency -, Hz
Cycle Time Continuous or User Defined
Sweep Time  sec
Sweep Low Beat Frequency - Hz
Sweep High Beat Frequency - Hz
Scan Percentage Static, %, %, Manual
IRMS -mA
DC component No
TENS- Asymmetrical Biphasic
Advice on size and type of electrodes to be used is given in device GUI "treatment
guidelines" feature
The Asymmetrical Biphasic waveform has a short pulse duration.
It is capable of strong stimulation of the nerve fibers in the skin
as well as of muscle tissue. This waveform is often used in TENS
devices.Because of its short pulse, the patient typically tolerates
the current well, even at relatively high intensities.
Output Mode Electrodes
Output Intensity - mA (CC) - V (CV)
Available on Channel ,
Treatment Time (Stim) - minutes
Treatment Time (Combo) - minutes
Mode Selection (Stim) CC or CV
Mode Selection (Combo) CV
Amplitude Modulation % (o) to % on % steps
Burst Frequency - bps
Cycle Time Continuous or User Defined
Frequency - pps
FrequencySweep On/O
Phase Duration - µsec
Sweep time  sec
Sweep Low Frequency - pps
Sweep High Frequency - pps
IRMS -mA
DC component No