Chattanooga Intelect Mobile 2 Ultrasound User manual

EN

CONTENTS EN
INTELECT®MOBILE 2 ULTRASOUND USER MANUAL
FOREWORD 
INTENDED USER PROFILE 
INTENDED ENVIRONMENT FOR USE 
INTENDED USE 
PRECAUTIONARY INSTRUCTIONS 
GENERAL TERMINOLOGY 
SYSTEM SOFTWARE SYMBOLS 
DESCRIPTION OF DEVICE MARKINGS 
VACUUM MODULE MARKINGS 
ULTRASOUND INDICATIONS 
INDICATIONS 
CONTRAINDICATIONS 
ADDITIONAL PRECAUTIONS 
PRODUCT DESCRIPTION 
COMPONENTS 
HEAD 
CART 
BATTERY MODULE OPTIONAL 
ULTRASOUND APPLICATORS 
VACUUM MODULE OPTIONAL 
OPERATOR INTERFACE 
VACUUM MODULE OPERATOR INTERFACE 
INTELECT MOBILE  SET COMPONENTS 
HEAD 
LEADWIRES 
POWERCORD 
STIM SET INCLUDES 
US SET INCLUDES 
ULTRASOUND APPLICATOR 
HEAD TO CART FIXATION 
CONNECTING CABLES AND INSERTING PLUGS 
INITIAL RECEIPT 
IF UNIT SUPPLIED WITH OPTIONAL BATTERY 
IFU DOWNLOAD 
DEVICE CONNECTED TO THE MAINS 
DEVICE WORKING ON BATTERY 
DEVICE LIGHT INDICATORS 
FRONT PANEL INDICATORS 
ON/OFF BUTTON BLUE INDICATOR: 
PLAY/PAUSE BUTTON BLUE INDICATOR: 
SYSTEM SPECIFICATIONS AND DIMENSIONS 
POWER 
ULTRASOUND SPECIFICATIONS 
OUTPUT POWER 
GENERAL SYSTEM OPERATING AND STORAGE
TEMPERATURE 
ULTRASOUND PATIENT PREPARATION 

CONTENTS EN
INTELECT®MOBILE 2 ULTRASOUND USER MANUAL
DEVICE USER INTERFACE 
SCREEN DESCRIPTION 
SETTINGS 
PRINT SCREEN FUNCTION 
HOME SCREEN 
TREATMENT REVIEW SCREEN 
GUIDELINES SCREEN 
ULTRASOUND OPERATION 
SPS SUGGESTED PARAMETER SETUP 
TREATMENT DATA 
CUSTOM PROTOCOLS 
SHORT CUTS 
UNASSIGN SHORT CUT 
CLINICAL RESOURCES 
MODALITY/WAVEFORM DESCRIPTIONS 
TROUBLESHOOTING 
GENERAL ACCESSORIES 
BATTERY 
ULTRASOUND APPLICATORS AND GEL 
CLEANING THE INTELECT®MOBILE  
CALIBRATION REQUIREMENTS 
DEVICE DISPOSAL 
INSTRUCTION FOR SOFTWARE UPGRADE 
IFU DOWNLOAD 
INSTALLATION OF BATTERY 
REPLACEMENT BATTERY 
WARRANTY REPAIR/OUT OF WARRANTY REPAIR 
WARRANTY 
ELECTROMAGNETIC COMPATIBILITY EMC 
ELECTROMAGNETIC COMPATIBILITY EMC TABLES 

INTRODUCTION EN
INTELECT®MOBILE 2 ULTRASOUND USER MANUAL
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
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.
FOREWORD
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
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.

INTRODUCTION EN
INTELECT®MOBILE 2 ULTRASOUND USER MANUAL
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  .
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
Ultrasound
Shortcut
SPS (Suggested Parameter Setup)
Custom Protocols
Treatment Data
Clinical Resources

INTRODUCTION EN
INTELECT®MOBILE 2 ULTRASOUND USER MANUAL
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
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

INDICATIONS FOR USE EN
INTELECT®MOBILE 2 ULTRASOUND USER MANUAL
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

DEVICE DESCRIPTION EN
INTELECT®MOBILE 2 ULTRASOUND USER MANUAL
PRODUCT DESCRIPTION
The Intelect®Mobile  ULTRASOUND is an ultrasound
therapy 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 
ELECTROTHERAPY are shown below.
HEAD
CART
BATTERY MODULE (optional)
Battery is an V mAh LiIon rechargeable battery
ULTRASOUND APPLICATORS

DEVICE DESCRIPTION EN
INTELECT®MOBILE 2 ULTRASOUND USER MANUAL
OPERATOR INTERFACE
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
The Intelect®Mobile  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
1. Adjustment dial
2. Play/pause button
3. “On/O“ button. Press and hold ( sec) the button to
switch OFF the device.
Handle
Colour Touch Screen
Play / pause button
Adjustment dial
Ultrasound applicator
support
“On/O“ button
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

 GENERAL WARNINGS AND PRECAUTIONS EN
INTELECT®MOBILE 2 ULTRASOUND USER MANUAL
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.
• Handle Ultrasound Applicator with care. Inappropriate handling may adversely aect its characteristics.
• 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.

 GENERAL WARNINGS AND PRECAUTIONS EN
INTELECT®MOBILE 2 ULTRASOUND USER MANUAL
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.
• 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.
• 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.
• 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.

 GENERAL WARNINGS AND PRECAUTIONS EN
INTELECT®MOBILE 2 ULTRASOUND USER MANUAL
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.

 DETAIL DEVICE DESCRIPTION EN
INTELECT®MOBILE 2 ULTRASOUND USER MANUAL
The components of the Intelect®Mobile  set are shown
below.
15-1200 Intelect Mobile  Ultrasound INTL Set EU Plug
15-1201 Intelect Mobile  Ultrasound INTL Set All Plug
15-1202 Intelect Mobile  Stim INTL Set EU Plug
15-1203 Intelect Mobile  Stim INTL Set All Plug
15-1204 Intelect Mobile  Combo INTL Set EU Plug
15-1205 Intelect Mobile  Combo INTL Set All Plug
HEAD
LEADWIRES
The available leadwires are shown below. If the user orders
a Mobile  Stim or Mobile  Combo, the box will include the
blue and green leadwires
POWERCORD
- Wall Power Cable m Black EU
- Wall Power Cable m Black UK
- Power Cable m Black AUS
INTELECT MOBILE  SET COMPONENTS COMBO SET INCLUDES:
- INTELECT MOBILE  COMBO
 Carbon electrodes
 STIM lead wires
 Chattanooga straps
 Electrodes gel
-// Power cord
- Printed Quick Start Guide
-  CMUltrasound Applicator
 Ultrasound Gel Bottle
- USB Drive
STIM SET INCLUDES:
- INTELECT MOBILE  STIM
 Carbon electrodes
 STIM lead wires
 Chattanooga straps
 Electrodes gel
-// Power cord
- Printed Quick Start Guide
- USB Drive
US SET INCLUDES:
- INTELECT MOBILE  ULTRASOUND
-// Power cord
- Printed Quick Start Guide
-  CM Ultrasound Applicator
 Ultrasound Gel Bottle
- USB Drive

 DETAIL DEVICE DESCRIPTION EN
INTELECT®MOBILE 2 ULTRASOUND USER MANUAL
. Applicator Head
The component of the applicator that makes
contact with the patient during Ultrasound or
Combination therapy.
. Applicator
The assembly that connects to the system and
incorporates the Applicator head.
. LED
The component of the applicator that indicates
if the Applicator is coupled or uncoupled on the
treatment area.
ULTRASOUND APPLICATOR

 SETUP INSTRUCTIONS EN
INTELECT®MOBILE 2 ULTRASOUND USER MANUAL
The optional Therapy System Cart, is designed for use with
the Intelect®Mobile  only and allows the user to easily
transport the System from patient to patient within the
clinic as well as store all necessary accessories, supplies, and
applicators used for the various modalities of the System.
The fixation of the head to the cart is magnetic.
Remove the Intelect®Mobile  device and cart from the
shipping carton. Visually inspect for damage. Report any
damage to the carrier immediately.
To assemble the Mobile  Head to the Cart, follow these
steps:
. Insert device front bottom on the cart lip
. Release device back gently on the cart. Magnets will help
to position the device correctly on the cart top.
HEAD TO CART FIXATION

 SETUP INSTRUCTIONS EN
INTELECT®MOBILE 2 ULTRASOUND USER MANUAL
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 and time.
. Click on "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
Nota: a pdf viewer is required to display IFU

 SETUP INSTRUCTIONS EN
INTELECT®MOBILE 2 ULTRASOUND USER MANUAL
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.
. 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

 SETUP INSTRUCTIONS EN
INTELECT®MOBILE 2 ULTRASOUND USER MANUAL
Intelect Mobile  ULTRASOUND has several light indicators:
FRONT PANEL INDICATORS:
. Colors:
• Light blue around Ultrasound therapy channel Left
and Right
. Behaviour:
• Steady when modality is selected and output is not
active
• Flashing when output is active
• Quickly flashing when treatment is interrupted and
user action is requested
ON/OFF BUTTON BLUE INDICATOR:
• steady ON from device connection to the mains
• Flashing while powering ON/OFF
PLAY/PAUSE BUTTON BLUE INDICATOR:
• It flashes when user can start/resume a treatment.
Otherwise, steady.
DEVICE LIGHT INDICATORS

 SYSTEM EN
INTELECT®MOBILE 2 ULTRASOUND USER MANUAL
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
SYSTEM SPECIFICATIONS AND DIMENSIONS
Width Depth Height Weight (no battery)
Intelect Mobile  Head Unit
UltraSound cm .cm cm .kg
Cart configurations
Cart (Safe working load .kg) cm MAX cm MAX cm .kg
Device on cart - -  cm -
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 (cm)  . .  . .
Max Output power
in Continuous mode W .W W W W .W
Max Output power
in Pulsed mode W .W (*) .W W .W .W
Max Amplitude in
Continuous mode
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
(*) An error of + 0.25 W can be measured with 1cm2 US applicator,
pulse mode 100Hz at 10% or 20% Duty Cycle.

 SYSTEM EN
INTELECT®MOBILE 2 ULTRASOUND USER MANUAL
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  to warm from the
minimum storage temperature between uses until the
Intelect Mobile  is ready for its INTENDED USE when the
ambient temperature is  °C: h
Time required for the Intelect Mobile  to cool from the
maximum storage temperature between uses until the
Intelect Mobile  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