Intelect Mobile 2 COMBO, STIM ULTRSOUND System Quick Start Guide Rev C June 2020

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FOREWORD

INTENDED ENVIRONMENT FOR USE

This manual is intended for users of Intelect® Mobile

The device is intended to be operated in the clinic

2 . It contains general information on operation,

and remote treatment locations. The intended clinical

precautionary practices, and maintenance.

conditions for use are a typical clinic setting including

In order to maximize use, efficiency, and the life of

chiropractic clinics, physical therapist clinics, athletic

the system, please read this manual thoroughly and

training rooms or other rehabilitation settings. The

become familiar with the controls, as well as the

patients home will also be a frequent use setting

accessories before operating the system.

where the clinician treats the patient in his/her own

In addition to the above information, this manual

home environment.

contains care and installation instructions for the optional Cart and Vacuum module for the users of the Intelect® Mobile 2.

INTENDED USE The Intelect Mobile 2 device will be used to deliver a

Before administering any treatment to a patient, the

variety of modalities to the patient, Ultrasound and

users of this equipment should read, understand,

electrical stimulation delivered either as stand alone

and follow the information contained in this

therapies or in combination.

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

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PRECAUTIONARY INSTRUCTIONS

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:

CAUTION Text with a “CAUTION” indicator explains possible safety infractions that have potential to cause minor or moderate injury or damage to the equipment.

WARNING Text with a “WARNING” indicator explains possible safety infractions that will potentially cause serious injury and equipment damage.

DANGER Text with a “DANGER” indicator will explain possible safety infractions that are imminently hazardous situations that would result in death or serious injury.

NOTE: Throughout this manual, “NOTE” indicators provide helpful information regarding the particular area of function being described.

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CAUTION • This unit should be operated at +5°C to +40°C and 15% to 90% Relative Humidity. The unit should be transported and stored at -20°C to +60°C and 10% to 90% 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 affect its characteristics. • Caution should always be exercised with current densities more than 2mA/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 4 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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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 2 within the vicinity or environment of an ultrasonic diathermy system. • DO NOT operate the Intelect® Mobile 2 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 30 cm (12 inches) to any part of the Intelect Mobile 2, 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 2 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 off. 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 different 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.

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WARNING • The Intelect® Mobile 2 may be susceptible to Electro-Static Discharge (ESD) at greater than ±6 kV when first grasping the Ultrasound applicator. In the event of such a discharge, the Intelect® Mobile 2 may display a permanent error. The Intelect® Mobile 2 will terminate all active outputs (stim, ultrasound,), automatically place the unit in a safe state. • To prevent Electro-Static Discharge (ESD) at greater than ±6 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 50% 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 50%. » Communicate these ESD-precautionary procedures to healthcare staff, contractors, visitors, and patients.

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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.

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ELECTROTHERAPY INDICATIONS INDICATIONS

• Do not use Intelect® Mobile 2 on patients who have or have had implantable

TENS • Symptomatic relief of chronic pain • Management of post-operative pain

neurostimulating cardiac demand pacemakers, ICD, or other implantable electronic devices. • Do not use Intelect® Mobile 2 on patients

NMES • Muscle re-education • Increasing local blood supply • Relaxation of muscle spasms • Maintaining/Increasing range of motion

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 2, its components, and accessories are not to be present in an MRI or CT environment.

CONTRAINDICATIONS The Intelect® Mobile 2 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,

• 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 difficulty in breathing.

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.

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ULTRASOUND INDICATIONS INDICATIONS • Relief of pain from muscle spasm • Relief of pain from joint contracture • Relief of pain associated with ligament sprains, tendinitis and muscle sprain

• Do not use Intelect® Mobile 2 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 2, its components, and accessories are not to be present in an MRI or CT environment.

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 2 on patients who have or have had implantable neurostimulating cardiac demand pacemakers, ICD, or other implantable electronic devices.

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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

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PRODUCT DESCRIPTION

BATTERY MODULE (optional)

The Intelect Mobile 2 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”

Battery is an 18V 3350mAh LiIon rechargeable battery

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 2 COMBO are

ULTRASOUND APPLICATORS

shown below.

HEAD

VACUUM MODULE (OPTIONAL)

CART

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OPERATOR INTERFACE The Intelect® Mobile 2 COMBO Operator Interface

1. Adjustment dial

contains all the functions and controls necessary for

2. Play/pause button

operator access to all operator utilities, modalities,

3. “On/Off“ button. Press and hold (2 sec) the button

and parameters for modification and system set up. Color Display and touch screen

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

Handle

Colour Touch Screen “On/Off“ button

Ultrasound applicator support Adjustment dial

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Play / pause button

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Battery cover

Ultrasound applicator connectors

Lead wire connectors for electro stimulation

Vacuum cover

ON / OFF switch only active on mains power

USB port for software upgrade Mains power connector

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CONNECTING CABLES AND INSERTING PLUGS

First time use always use mains power even if battery

When inserting the plugs, be sure to align the flat side

connected. Insert the power cord into the back of

of the plug with the flat side of the slot and push in

the unit, insert the plug into a power outlet, do not

gently. This is to avoid bending the pins in the plug.

position the Intelect Mobile 2 in such a way that

Insert cable into the appropriate connector prior to

makes it difficult to disconnect from the mains power.

starting therapy.

Switch device on with ON/OFF switch switch on the

POWERING UP THE DEVICE

back of the unit 1. The Initialisation screen below will be shown for a

INITIAL RECEIPT

few seconds whilst the device starts.

Remove all packaging

IF UNIT SUPPLIED WITH OPTIONAL BATTERY After unpacking Intelect Mobile 2 to fit the battery follow the following steps 1. Unscrew the battery cover from the base of the device by removing the 2 screws see below 2. Remove the battery cover 3. Plug the battery into the battery connector on the device 4. Insert the battery into its location 5. Replace the 2 screws to close the battery cover

2. 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).

3. Click on "Continue" button to go to home screen

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IFU DOWNLOAD 1. Go to the Chattanooga website www.chattanoogarehab.com 2. Go to Intelect Mobile 2 product tab 3. Complete the registration form to be informed about new product software version availability and IFU updates. 4. Go to documents tab 5. Click on the latest version of your Intelect Mobile 2 device (COMBO, US or STIM) User manual to download Nota: a pdf viewer is required to display IFU

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DEVICE CONNECTED TO THE MAINS 1. Plug the Power cord into the back of device. Plug the

STOP TREATMENT AND TURN OFF THE DEVICE

other end of the cord into an electrical outlet.

Press Play/pause button to pause treatment then press

NOTE: The Power Cord may be unplugged from the

stop on touch screen. If device is on mains power press

back of the unit in an emergency situation.

the on/off button on the front panel then turn off the

2. Turn on the ON/OFF switch located on the back of

switch on the back of the unit.

the device.

If device is working on battery follow the above

3. Press ON/OFF button on LCD Front panel

procedure but to switch off only press the on/off

4. Select desired function on the Home Screen

button on the front panel

PLAY/PAUSE button

DEVICE WORKING ON BATTERY 1. Press the ON/OFF button on the LCD Front panel, as shown below 2. Select desired function on the Home Screen (shown

ULTRASOUND COUPLING

below).

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.

ON/OFF Button

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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

Run again

Back to previous screen

Exit

Settings

Export

Indicates a USB Flash Drive is Inserted

Import

Indicates Battery Level

Delete

Indicates more content can be viewed by swiping vertically

Delete all

Indicates more content can be viewed by swiping horizontally

Stop treatment

Indicates more content can be viewed by scrolling

Stim

Close window / exit full screen

Ultrasound

Confirm

Combo

Save Data

Shortcut

Edit

SPS (Suggested Parameter Setup)

Guidelines / Assign to

Custom Protocols

Pain information

Treatment Data Clinical Resources

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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 7010 and ISO15-223-1 One or more of the following markings may appear on the device:

Refer to Instructional Manual Booklet

Atmospheric Pressure Range

Warning, Caution, or Danger

Test agency

Electrical Type BF Equipment

CE Mark of Conformity with notified body number

Ultrasound

Alternating current

Stim

Class II equipment

Combo

IP21

Play

Radio frequency equipment

Pause

WEEE Directive conformity

ON/OFF

Shelf life

Manufacturer

Batch number

Date of manufacture

US amplitude modulated

Catalogue number

MD

Serial number Fragile, handle with care This end up Keep dry Temperature Range Relative Humidity Range

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VACUUM MODULE MARKINGS 1

Channel 1 device connection to vacuum Channel 2 device connection to vacuum +/- Channel 1 polarity +/- Channel 2 Polarity

1

2

2

1 1

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SYSTEM SPECIFICATIONS AND DIMENSIONS Width

Depth

Height

Weight (no battery)

COMBO

34cm

35.5cm

15cm

3.1kg

UltraSound

34cm

35.5cm

15cm

2.8kg

STIM

25.5cm

35.5cm

15cm

2.9kg

Cart (Safe working load 6.5kg)

48cm (MAX)

52cm (MAX)

96cm

10.1kg

Cart with vacuum

48cm (MAX)

52cm (MAX)

96cm

11.5kg

Device on cart

-

-

111 cm

-

Intelect Mobile 2 Head Unit

Cart configurations

POWER Input

100 - 240 V AC, 1.0 to 0.42 A, 50/60 Hz

Electrical Class Mode of Operation

CLASS II Continuous

Note: Mains isolation is achieved by use of the double pole switch located on the rear panel. Electrical Type (Degree of Protection)

ELECTRO STIMULATION SPECIFICATIONS Output specifications are described for each waveform from pages 24-26. Unless otherwise specified, electrotherapy controls accuracy is: ± 20 %. Load impedance: 500-1000 Ohm CC = constant current, effect of load impedance on voltage

Ultrasound .TYPE BF

CV = constant voltage, effect of load impedance on

Electrotherapy .TYPE BF

current

Electrotherapy Vacuum .TYPE BF Ultrasound & Electrotherapy .TYPE BF

VACUUM SPECIFICATIONS Power Input Electrical Type

20-25 Vdc, maximum peak current 4A TYPE BF

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OUTPUT POWER

General characteristics

Continuous.

5cm2

10cm2

1MHz

3MHz

1MHz

3MHz

1MHz

3MHz

1MHz

3MHz

Effective Radiating Area ERA INTL (cm2)

Continuous or Pulsed

2cm2

1

0.9

1.5

1

2.5

2.7

6

6.8

Max Output power in Continuous mode

Vacuum Modes

1cm2

2W

1.8W

3W

2W

5W

5.4W

12W

6.8W

Max Output power in Pulsed mode

5%

US applicator Frequency

Vacuum Range .0 to 600 mbar maximum +/-

3W

(*)

4.5W

3W

7.5W

8.1W

18W

13.6W

2W/ cm2

2W/ cm2

2W/ cm2

2W/ cm2

2W/ cm2

2W/ cm2

2W/ cm2

1W/ cm2

3W/ cm2

3W/ cm2

3W/ cm2

3W/ cm2

3W/ cm2

3W/ cm2

3W/ cm2

2W/ cm2

10 setting over vacuum range, 60 mbar per setting, +10 mbar to 10 mbar per setting

Pulsed Mode Maximum Vacuum settings 2 to 10, +10mbar to -10mbar per setting Minimum Vacuum settings in 1 to 9, +10mbar to -10mbar per setting Hold Time in minimum & maximum vacuum settings,

ULTRASOUND SPECIFICATIONS Frequency

1 MHz; 3 MHz

Duty Cycles

10%, 20%, 50%, Continuous

Pulse Repetition Rate Pulse duration:

16, 48, or 100 Hz 1 -31.25 ms Max (ON): 31.25 ms Min (OFF): 5ms

Max Amplitude in Pulsed mode

Max Amplitude in Continuous mode

0-20 seconds, in 1 second steps, +/-0.5 seconds

(*) An error of + 0.25 W can be measured with 1cm2 US applicator, pulse mode 100Hz at 10% or 20% Duty Cycle.

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2.7W

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Unless otherwise specified, ultrasound

Time required for the Intelect Mobile 2 to cool from

controls accuracy is:

± 20 %.

the maximum storage temperature between uses until the Intelect Mobile 2 is ready for its INTENDED USE

Peak to Average Ratio:

1:1, at 50% Duty Cycle

when the ambient temperature is 20 °C: 5h

4:1, at 20% Duty Cycle 9:1, at 10% Duty Cycle Beam Nonuniformity Ratio

<5:1

IPXX Rating for Unit Rated to IP21

Beam Type

Collimating

IP2* Protection against fingers or other object not

Treatment Time

1 to 30 min

greater than 80mm in length and 12mm in diameter *1 Protection from vertically dripping water

GENERAL SYSTEM OPERATING AND STORAGE TEMPERATURE

IPXX Rating for US applicator Rated to IPX7 IPX7 Protection from immersed in water (up to 1m

Operating Conditions

depth)

The device will meet its requirement under the following conditions: Temperature:

5°C to 40°C

Relative Humidity: Atmospheric Pressure:

15% to 90% 70kPa to 106kPa

RED RF transmitter/receiver characteristics: - Frequency Band transmission: - Modulation type: - Data rate:

Transport and Storage Conditions

2400–2483.5 MHz GFSK

up to 2Mbps 500kHz deviation at 2Mbps

The device will remain in proper condition under the

- Effective radiated power:

+6dBm

following conditions: Temperature:

-20°C to 60°C

Relative Humidity:

10% to 90%

Atmospheric Pressure:

50kPa to 106kPa

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 20 °C: 5h

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