Roscoe Medical InTENSity IF Combo II User Manual User Manual

TENSPros

IF Combo II

INSTRUCTION MANUAL

www.roscoemedical.com

TENSPros

InTENSity IF Combo II Roscoe Medical

This manual is valid for the

IF Combo II

This instruction manual is published by Roscoe Medical Inc.

Roscoe Medical Inc. reserves the right to improve and amend it at any
time without prior notice. Amendments may however be published in
new editions of this manual.

All Rights Reserved.Rev.V1.0 © 2015, 20150119

United States Federal Law restricts this device to sale by or on the order
of a physician or licensed practitioner

Conformity to safety standards

Roscoe Medical Inc. declares that the

device complies with following normative documents:

IEC60601-1, IEC60601-1-2, I EC60601-2-10,

IEC62366, IEC60601-1-11, ISO10993-5, ISO10993-10,

ISO10993-1, ISO7010

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TENSPros

Roscoe Medical InTENSity IF Combo II

Table of Contents

1. Introduction ........................................4

1.1 General

1.2 Medical Background

1.3 Indication for use

2. Important Safety Precautions and Warnings............6

3. Package Contents .................................13

3.1 Front And Rear Panel

3.2 LCD Display

4. Specification ......................................16

4.1 Technical Information

4.2 Program Parameters

4.3 Waveform Information

5. Instruction For Use................................. 19

5.1 Battery

5.2 Connecting Electrodes

5.3 Connecting Lead Wires

5.4 Turn On The Device

5.5 Setting a New Program

5.6 Turn Off Device

5.7 Other Important Functions
Safety Lock Feature
Low Battery Indicator
Charging The Battery

5.8 Patient Compliance Meter

6. Cleaning And Storage ..............................32

6.1 Cleaning The Unit

6.2 Cleaning The Electrode Pads

6.3 Storing The Electrode Pads And Lead Wires

6.4 Storing The Unit

7. Troubleshooting ...................................34

8. Disposal ..........................................36

9. Glossary Of Symbols ...............................36

10. Electromagnetic Compatibility (EMC) Tables ..........37

11. Warranty .......................................... 43

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TENSPros

InTENSity IF Combo II Roscoe Medical

1. INTRODUCTION

1.1 General

The InTENsity IF Combo II is a portable electrotherapy device
featuring two therapeutic modes: Transcutaneous Electrical Nerve
Stimulator (TENS) and Interferential (IF), which are used for pain relief.
The stimulator sends gentle electrical current to underlying nerves via
electrodes applied on the skin. The parameters of device are controlled
by the buttons on the front panel. The intensity level is adjustable
according to the needs of patients.

1.2 Medical Background

Explanation of pain

Pain is an unpleasant sensation that can serve a useful purpose by
alerting us to a possible injury or disease. When the body is functioning
normally, pain serves as a warning system that something is not right.
Without pain a person would not know when to avoid danger or seek
medical help. Pain becomes a problem when it continues after treatment
has started or long after an injury is healed.

There are two types of pain:

Acute — Limited in duration. Examples include but are not limited to:

• Sprains • Incisional pain • Muscle strain

Chronic — Long-lasting, persistent pain that ceases to serve

• Low back pain • Pinched Nerves

• Bursitis • Joint Pain

The IF Combo II was developed to help relieve some types
of chronic and acute pain.

as a warning system and becomes a problem.
Examples include but are not limited to:

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Roscoe Medical InTENSity IF Combo II

How does TENS work?

There is nothing “magic” about Transcutaneous Electrical Nerve
Stimulation (TENS). TENS is intended to help relieve pain. The TENS unit
sends comfortable impulses through the skin to stimulate the nerve (or
nerves) in the treatment area. In many cases, this stimulation will greatly
reduce or eliminate the pain sensation the patient feels. Pain relief varies
by individual patients, mode selected for therapy, and the type of pain. In
many patients, the reduction or elimination of pain lasts longer than the
actual period of stimulation (sometimes as much as three to four times
longer). In others, pain is only modied while stimulation actually occurs.
You may discuss this with your physician or therapist.

How IF works

Interferential Stimulation (IF) is an anti-inammatory based
treatment modality. Interferential stimulation is characterized by
two alternating-current sine waves or square waves of differing
frequencies that “work” together to produce an interferential current
that is also known as a beat pulse or alternating modulation frequency.
One of the two currents is usually held at 5,000Hz,and the other can
be held constant or varied over a range of 5,001 – 5,150Hz. Because
of the frequency, the interferential wave meets low impedance when
crossing the skin to enter deep into soft tissues. The interferential
currents reportedly can stimulate sensory, motor, and pain bers.
These large impulse bers interfere with the transmission of pain
messages at the spinal cord level. This deep tissue penetration
stimulates parasympathetic nerve bers for increased blood ow
and edema reduction. It utilizes the low electric-current to stimulate
muscle nerves to achieve the symptomatic relief of chronic intractable
pain, post-traumatic pain, and post-surgical pain.

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InTENSity IF Combo II Roscoe Medical

1.3 Indication for use

IF Combo II Stimulator may be used for the following conditions:

1) Symptomatic relief of chronic intractable pain.

2) Post traumatic pain.

3) Post surgical pain.

2. IMPORTANT SAFETY PRECAUTIONS
AND WARNINGS

It is important that you read all the warning and

DANGER

WARNING

CAUTION

This stimulator must not be used in combination with the following medical
devices:

• Internally transplanted electronic medical devices,

• Electronic life support equipment, such as respirators.

• Electronic medical devices attached to the body,
such as electrocardiographs.
Using this stimulator with other electronic medical devices may cause errone­ous operation of those devices.

precautions included in this manual because they are
intended to keep you safe, prevent injury and avoid a
situation that could result in damage to the device.

SAFETY SYMBOLS USED IN THIS MANUAL

Indicates a potentially hazardous situation which, if not
avoided, could result in death or serious injury.

Indicates a potentially hazardous situation which, if not
avoided, could result in serious injury and equipment
damage.

Indicates a potentially hazardous situation which, if not
avoided, may result in minor or moderate injury to the user
or patient or damage to the device or other property.

DANGER

such as a pacemaker.

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Roscoe Medical InTENSity IF Combo II

WARNING

DO NOT USE THIS DEVICE UNDER THESE CONDITIONS

• Consult with your physician before using this device, because the device
may cause lethal rhythm disturbances in certain susceptible individuals.

• If you have a cardiac pacemaker, implanted debrillator, or other implanted
metallic or electronic device. Such use could cause electric shock, burns,
electrical interference, or death.

• Together with a life-supporting medical electronic device such as an articial
heart or lung or respirator.

• In the presence of electronic monitoring equipment (e.g., cardiac monitors,
ECG alarms), which may not operate properly when the electrical stimulation
device is in use.

• On open wounds or rashes, or over swollen, red, infected, or inamed areas
or skin eruptions (e.g., phlebitis, thrombophlebitis, varicose veins); or on top
of, or in proximity to, cancerous lesions.

• Over areas of skin that lack normal sensation.

• On the opposite sides of your head since the effects of stimulation
of the brain are unknown.

DO NOT USE ON THESE INDIVIDUALS

• Pregnant women, because the safety of electrical stimulation during
pregnancy has not been established.

• Children or infants, because the device has not been evaluated for
pediatric use.

• Persons incapable of expressing their thoughts or intentions.

DO NOT USE THIS DEVICE DURING THESE ACTIVITIES

• When in the bath or shower

• While sleeping

• While driving, operating machinery, or during any activity in which electrical
stimulation can put you at risk for injury.

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InTENSity IF Combo II Roscoe Medical

WARNING (CONTINUED)

PAIN MANAGEMENT WARNINGS

• If you have had medical or physical treatment for your pain, consult with your
physician before using this device.

• If your pain does not improve, becomes seriously chronic or severe, or
continues for more than ve days, stop using the device and consult with your
physician.

• The mere existence of pain functions as a very important warning telling us
that something is wrong. Therefore, if you suffer from any serious illness,
consult your physician in order to conrm that it is advisable for you to use
this TENS Stimulator.

WARNINGS AND PRECAUTIONS REGARDING THE PADS

• Apply pads to normal, healthy, dry, clean skin (of adult patients) because it
may otherwise disrupt the healing process.

• If you experience any skin irritation or redness after a session, do not continue
stimulation in that area of the skin.

NEVER APPLY THE PADS TO:

• The head or any area of the face.

• Any area of the throat because this could cause severe muscle
spasms resulting in closure of the airway, difculty in breathing,
or adverse effects on heart rhythm or blood pressure.

•

• Both sides of the thorax simultaneously (lateral or front and
back), or across your chest because the introduction of electrical
current may cause rhythm disturbances which could be lethal.

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CAUTION

WARNINGS AND PRECAUTIONS REGARDING THE PADS

• United States Federal Law restricts this device to sale by or on the order of a
physician or licensed practitioner

• Do not bend or fold because the pad may not function properly. Place the
pads onto the plastic lm and then store into the sealed package when not in
use.

• Do not apply ointment or any solvent to the pads or to your skin because it
will disrupt the pads from functioning properly.

• The pads are already pre-gelled and will adhere to your skin.

• To avoid damage to the adhesive surface of the pads, put the pads only on
the skin or on the plastic lm provided.

• Place the pads at least 1 inch apart on your skin. The pads should never
touch each other.

• Make sure the components are connected well and the pads are xed on the
part of the body you wish to treat or the therapy may not be effective.

DO NOT USE YOUR PADS THIS WAY

• Pads should not touch each other when placed onto your skin.

• Do not place on your spine or backbone.

• Pad should not touch any metal object, such as a belt buckle or necklace.

• Pads should not be placed simultaneously on the soles of both feet.

• Pads should not be placed simultaneously on the calves of both legs.

• Do not share pads with another person. This may cause a skin irritation or

infection. Pads are intended for use by one person.

• Do not place or relocate the pads while the device is on.

• Always turn the power off before removing or changing the pad location.

• Do not leave pads attached to the skin after treatment.

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TENSPros

InTENSity IF Combo II Roscoe Medical

CAUTION (CONTINUED)

CAUTION WHILE USING THE STIMULATOR

• If the stimulator is not functioning properly or you feel discomfort,
immediately stop using the device.

• Do not use for any other purpose except for what it is intended for.

• Do not insert the electrode plug into any place other than the jack
on the main unit.

• Do not mix Alkaline and Manganese batteries as this will shorten
the battery life.

• Do not pull on the electrode cord during treatment.

• Do not use the device while wearing electronic devices such as
watches as this may damage the device.

• Do not use near a cell phone as this may cause the stimulator to malfunction.

• Do not bend or pull the end of the cord.

• When pulling out the cord from the device, hold the plug and pull.

• Replace the cord when broken or damaged.

• Do not throw the batteries into a re. The batteries may explode.

• Dispose of the device, batteries, and components according to applicable
legal regulations. Unlawful disposal may cause environmental pollution.

• The size, shape and type of pads may affect the safety and effectiveness
of electrical stimulation.

• The electrical performance characteristics of pads may affect the safety
and effectiveness of electrical stimulation.

• Using pads that are too small or incorrectly applied, could result in
discomfort or skin burns.

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Roscoe Medical InTENSity IF Combo II

GENERAL PRECAUTIONS

• The long-term effects of electrical stimulation are unknown.

• Apply stimulation to only normal, intact, clean, dry, and healthy skin.

• TENS is not effective in treating the original source or cause of the pain,
including headache.

• TENS is not a substitute for pain medications and other
pain management therapies.

• TENS devices do not cure disease or injuries.

• TENS is a symptomatic treatment and, as such, suppresses the sensation
of pain that would otherwise serve as a protective mechanism.

• Effectiveness is highly dependent upon patient selection by a practitioner
qualied in the management of pain patients.

• You may experience skin irritation or hypersensitivity due to the electrical
stimulation or electrical conductive medium (gel).

• If you have suspected or diagnosed heart disease, you should follow
precautions recommended by your physician.

• If you have suspected or diagnosed epilepsy, you should follow precautions
recommended by your physician.

• Use caution if you have a tendency to bleed internally, such as following
an injury or fracture.

• Consult with your physician prior to using the device after a recent surgical
procedure, because stimulation may disrupt the healing process.

• Use caution if stimulation is applied over the menstruating or pregnant uterus.

• Use caution if stimulation is applied over areas of skin that lack
normal sensation.

• Keep unit away from young children. The unit contains small pieces
that may be swallowed. The electrode cord can cause strangulation.
Immediately contact your physician should any of these things occur.

• Use this device only with the leads, electrodes, and accessories
recommended by the manufacturer.

• Keep unit out of the reach of young children.

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InTENSity IF Combo II Roscoe Medical

POSSIBLE ADVERSE REACTIONS

• Do not use to treat one region for extended periods of time (more than 30
minutes a session, up to 2 times/day) or muscles in that region may become
exhausted and sore.

• You may experience skin irritation and burns beneath the stimulation
electrodes applied to your skin.

• You should stop using the device and consult with your physician if you
experience adverse reactions from the device.

Note: Always use electrodes that are legally marked and sold

in the United States under 510K guidelines.

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TENSPros

Roscoe Medical InTENSity IF Combo II

TM

3. PACKAGE CONTENTS

IF Combo II Unit 2 × Lead wires 4 × Electrode pads
(2" x 2")

IF Combo II

INSTRUCTION MANUAL

1 x Instruction Manual 1 × LI rechargeable 1 × USB Cable
Battery Pack and Wall Charger

QUICK REFERENCE GUIDE PAGE 1

The purpose of this guide is to assist you in correctly operating your Intensity™ 10 unit. This
device should only be used under the continued supervision of a licensed physician. This guide
is not intended to replace or substitute the Intensity™ 10 Instruction Manual. PLEASE READ
THE INSTRUCTION MANUAL COMPLETELY BEFORE USING THIS DEVICE. Read, understand
and practice the warnings, cautions and operating instructions. Always follow the operating
instructions prescribed by your healthcare provider.

INTENSITY™ 10 UNIT

Top

CH1 CH2

Channel 1 and 2 sockets

1

1

2

AC/DC adapter receptacle

Side Front Back

3

T (time) and S (therapeutic part)
selection buttons

Channel 1 intensity increase button

4

10

6

Channel 1 intensity decrease button

5

LCD display

6

3

Channel 2 intensity increase button

7

2

4

7

Channel 2 intensity decrease button

8

Power on/o button

9

8

5

9

Belt clip

10

Battery compartment cover

11

11

S

LCD DISPLAY

1

1

TENS therapeutic mode

2

6

Lock function indicator

2

3

ELECTRODES

Low-battery indicator

3

4

(2 SETS)

7

5

Treatment time

4

Timer symbol

5

Channel 1 intensity level

6

8

Channel 2 intensity level

7

LEAD WIRES

Body part selection

8

(2 SETS)

For more information about your Intensity™ 10 unit, please visit us online at roscoemedical.com or call 1-800-871-7858.

1 x Quick Start Guide

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InTENSity IF Combo II Roscoe Medical

3.1 Front and Rear Panel

9

12

CH1 CH2

8

1

2

7

3

4

1) LCD Display: Operating state of the device

2) Body Part Buttons: Select body part or treatment program

3) Channel 1 Intensity Buttons: Increase or decrease the output
intensity of channel 1.

4) Set button: Press this button to enter the setting status

5) Power Button: Press once to turn on. Press and hold for 3 seconds to
turn off.

6) Channel 2 Intensity Buttons: Increase or decrease the output
intensity of channel 2.

7) Pause/Mode Button: Press this button to change treatment modes
(TENS or IF). Press button again to pause active treatment status

8) LED: Charging indicator light.

9) Output Sockets: Lead wire output sockets

10) Battery compartment cover.

11) Belt Clip.

12) USB charging port.

S

5

6

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11

10

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Roscoe Medical InTENSity IF Combo II

3

12 11

3.2 LCD Display

1

2

4

5
6

7
8

9

1) Displays waveform mode.

2) Displays home screen

3) Displays set mode

4) Displays output state: start, pause, lock

5) Hour Indicator for compliance meter

6) Cycle Time

7) Displays output intensity of channel 1, pulse width and
pulse rate Beat L

8) Displays therapeutic body part: hand, foot, shoulder, arm,
leg and back

9) Displays therapeutic mode: TENS, IF

10) Low-battery indicator

11) Load indicator

12) Indicates compliance meter mode

13) Displays the treatment time

14) Display output intensity of channel 2, Beat H

10

13

14

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4. SPECIFICATION

4.1 Technical Information

Channel Dual, isolated between channels

Power Supply 3.7V LI rechargeable battery pack

Operating Conditions 5°C to 40°C (41°F to 104°F) with a relative

Storage and
Transport Conditions

Dimensions 11.7 × 6 × 2.1 cm (L*W*H)

Weight 3.5 oz. (Without battery)

Electrode Detection
Function

Technical Specifications

Waveform Symmetrical bi-phase rectangular wave

Pulse Amplitude Adjustable,

Pulse Width

Pulse Rate TENS: 1 ~ 150Hz

Treatment Time Time 5 ~ 90min

Cycle Time 1 ~ 20 sec.

charger output: 5.0V DC, 300mA (optional)

humidity of 30% – 75%,atmospheric pressure
from 700 to 1,060 Hpa

-10°C to 55°C (14°F to 131°F) with a relative
humidity of 10%-90%,atmospheric pressure
from 700 to 1,060 Hpa

The amplitude level will be reset to 0mA when the
amplitude level is 10mA or greater and an open
circuit at either channel is detected.

TENS: 0 ~ 100mA
IF: 3 ~ 35mA (@ 1,000ohm load), 1mA/Step

From 50 to 400µs microseconds

IF: Carrier F 2.5/5/10KHz,

Beat.L 1 ~ 149Hz
Beat.H 81 ~ 200Hz

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Neck

Shoulder

Hand

Low back

Knee

Foot

4.2 Program Parameters

TENS

Body

Part

Program

Treatment

Time

Pulse

Rate

Pulse
Width

Cycle

Time

Body Part Program

All

Therapeutic

Parts

P1 20 Min. 80 – 100Hz

P2 20 Min. 4Hz

P1 20 Min. 80 – 100Hz

P2 20 Min. 10Hz

P1 20 Min. 100Hz

P2 20 Min. 1 – 10Hz

P1 20 Min. 80 – 100Hz

P2 20 Min. 4Hz

P1 20 Min. 120Hz

P2 20 Min. 1 – 10Hz

P1 20 Min. 80 – 120Hz

P2 20 Min. 1 – 10Hz

Treatment

Time

U1

Adjustable

5 – 90 mins

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100 – 120µs

150 – 200µs

100µs

220 – 260µs

100µs

200µs

100µs

200 – 260µs

100 – 120µs

150 – 200µs

100 – 120µs

200µs

Pulse

Rate

Adjustable
1 – 150 Hz

10 Sec

20 Sec

10 Sec

20 Sec

Fixed

20 Sec

10 Sec

20 Sec

10 Sec

20 Sec

10 Sec

20 Sec

Pulse
Width

Adjustable
50 – 400µs

TENSPros

InTENSity IF Combo II Roscoe Medical

Neck

Shoulder

Hand

Low back

Knee

Foot

4.2 Program (Continued)

IF (Sweep) IF (Sweep)

Body Part Program

P1 20 Min. 10,000Hz

P2 20 Min. 5,000Hz

P1 20 Min. 10,000Hz

P2 20 Min. 5,000Hz

P1 20 Min. 10,000Hz

P2 20 Min. 5,000Hz

P1 20 Min. 10,000Hz

P2 20 Min. 5,000Hz

P1 20 Min. 10,000Hz

P2 20 Min. 5,000Hz

P1 20 Min. 10,000Hz

Treatment

Time

Carrier F

P2 20 Min. 5,000Hz

All Body
Parts

U1

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Min: 5 - 90,

Step is 5min

Default:

20Min

N/A

TENSPros

Roscoe Medical InTENSity IF Combo II

Pulse

Width

100µs

200µs

100µs

200µs

100µs

200µs

100µs

200µs

100µs

200µs

100µs

200µs

100µs, 200µs,
400µs change

in a cycle,

default: 100uS

Beat Low Beat High

1Hz 100Hz 10 Sec

1Hz 100Hz 20 Sec

50Hz 150Hz 10 Sec

50Hz 150Hz 20 Sec

1Hz 20Hz 10 Sec

1Hz 20Hz 20 Sec

1Hz 50Hz 10 Sec

1Hz 50Hz 20 Sec

60Hz 120Hz 10 Sec

60Hz 120Hz 20 Sec

1Hz 30Hz 10 Sec

1Hz 30Hz 20 Sec

1 – 149Hz

step is 1,

default: 1Hz

81 – 200Hz

Step is 1,

Default: 81Hz

Default: 20s

Cycle

Time

1 – 20s

Step is 1,

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InTENSity IF Combo II Roscoe Medical

Cycle time

Cycle time

Cycle time

4.3 Waveform Information — TENS

Continuous

Pulse Width Modulation

Pulse Rate Modulation

Modulation (Pulse rate and width modulation)

Waveform Information — IF

Interferential

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Roscoe Medical InTENSity IF Combo II

5. INSTRUCTION FOR USE

5.1 Battery

Installation of Battery

Push down on the belt clip to release it. Remove the battery cover and
insert the battery, as shown on the diagram. Replace the battery cover
and belt clip. For battery charging instructions, please see page 30.

Disposal of Battery

Depleted batteries do not belong in the household waste.
Dispose of the batteries according to the your federal,
state and local regulations. As a consumer, you are
obligated by law to return depleted batteries.

CAUTION

1) Keep the battery and the product out of the range of children.

2) Battery may not be dismantled, thrown into re or short-circuited.

3) Protect battery from excess heat; Take the battery out of the product if
the product is not used for a long period of time.

4) Always replace with the same type of battery.

5.2 Connecting Electrodes

Take the pads out of the sealed package; insert the pin of the lead wire
into the electrodes pigtail. Make sure there is no bare metal exposed.

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CAUTION

Always use electrodes with CE mark, or which are legally marketed
in the US under 510(K) procedure.

5.3 Connecting Lead Wires

1) Before proceeding to this step, be sure the device is completely
turned OFF.

2) Insert the lead wires into the output sockets located on the top
of the device.

3) Holding the insulated portion of the connector, push the plug end
of the wire into one of the sockets (see drawing); one or two sets
of wires may be used.

4) This device has two output receptacles controlled by Channel 1 and
Channel 2 at the top of the unit. You may choose to use one channel
with one pair of lead wires or both channels with two pairs of lead
wires. Using both channels gives the user the advantage of stimulat­ing two different areas at the same time.

Note: If you use only one Channel, only plug in 1 lead wire

at the top of the unit

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5.4 Turn on The Device

Press the [ ] button to turn on the device.

CAUTION

Before using the device for the rst time, you are strongly advised

to take careful note of the contraindications and safety measures

detailed at the beginning of this manual (Safety information),

as this powerful equipment is neither a toy nor a gadget!

5.5 Setting a New Program

There are 6 therapeutic body part buttons available — neck, shoulder,
hand, low back, knee and foot. Each therapeutic part has 3 programs –
P1, P2 and U1 for a total of 36 programs.

1. Press [ M/II ] button to select the treatment mode (TENS or IF).

2. Select a body part on the device and press it.

3. The body part will display on the LCD screen.

4. Press the same button again to select one of the 3 programs
(such as P1, P2 or U1).

4

2

1

M /

S

3

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Manual IF Program — U1

A. Select Body Part

Select the body part which you want to treat. Then press the body part
button until the LCD displays program "U1" like the following:

B. Set Treatment Time

Press [ S ] button to enter treatment time and the “min.” will ash.
Then press [ + ] or [ − ] button to adjust the treatment time.

C. Set Pulse Width

Press [ S ] button to enter the pulse width and the "µs" will ash. Then
press [ + ] or [ − ] button to adjust the pulse width.

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Roscoe Medical InTENSity IF Combo II

D. Set Pulse Beat (Low & High)

Press [ S ] button to enter the pulse rate and the “Hz” will ash.
Press [ + ] or [ − ] button to adjust pulse rate.

E. Set Cycle Time

Press [ S ] button to set the cycle time and the “sec.” will ash
and you will see the below image circled in red on the screen.
Then press [ + ] or [ − ] button to adjust the treatment time.

After you nished settings, press the [ ] or [ S ] button to conrm,
and the device will go back to standby status.

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Set Preset IF Program — P1 or P2

A. Select Body Part

Press the “M/II” button to choose IF mode. Then select the body part
which you want to treat. Press the body part button until the LCD
displays program "P1" or "P2"

B. Set Treatment Time

Press [ S ] button to enter the treatment time and the "Min" will ash.
Press [ + ] or [ − ] button to adjust treatment time. After you nished
settings, press the [ S ] or [ ]button to conrm, the device will go back
to the home screen.

C. Start Treatment

Press [CH1+] or [CH2+] to increase the output intensity of channel 1
and/or channel 2. Press [CH1−] or [CH2−] to decrease the output
intensity of channel 1 and/or channel 2.

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Roscoe Medical InTENSity IF Combo II

Manual TENS Program — U1

A. Select Body Part

Select the body part which you want to treat. Then press the body part
button until the LCD displays program "U1" like the following:

B. Set Pulse Rate

Press [ S ] button to enter the pulse rate and the "Hz" will ash.
Press [ + ] or [ − ] button to adjust pulse rate.

C. Set Pulse Width

Press [ S ] button to enter the pulse width and the "µs" will ash. Then
press [ + ] or [ − ] button to adjust the pulse width.

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InTENSity IF Combo II Roscoe Medical

D. Set Treatment Time

Press [ S ] button to enter treatment time and the "min." will ash.
Then press [ + ] or [ − ] button to adjust the treatment time.

Set Preset Programs — P1 and P2

A. Select Body Part

Select the body part which you want to treat. Press the body part button
until the LCD displays program "P1" or "P2"

B. Set Treatment Time

Press [ S ] button to enter the treatment time and the "Min" will ash.
Press [ + ] or [ − ] button to adjust treatment time. After you nished
settings, press the [ S ] or [ ]button to conrm, the device will go back
to the home screen.

C. Start Treatment

Press [CH1+] or [CH2+] to increase the output intensity of channel 1
and/or channel 2. Press [CH1−] or [CH2−] to decrease the output

intensity of channel 1 and/or channel 2.

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Roscoe Medical InTENSity IF Combo II

CAUTION

1) If the electrodes are not placed rmly on skin or the device has not

connected with the electrodes or lead wires securely, and the output
intensity level is equal to or greater than 10mA, the intensity will stop
automatically.

2) If the stimulation levels become uncomfortable, reduce the intensity

to a comfortable level. Contact your medical practitioner if the
problems persist.

D. Pause or Stop Treatment

If there is an immediate need to pause treatment, press the [ M/II ] button
and the “II” will display on the LCD. Press it again to continue treatment
or press [ ] button to stop treatment and the device will return to the
home screen.

5.6 Turn OFF Device

Press and hold [ ] button until the device turns off.

CAUTION

If there is no operation in the panel for 3 minutes in the

standby status, the device will shut off automatically and

5.7 Other Important Functions

Safety Lock Feature

The lock function automatically activates after there is no operation
in the panel for 20 seconds while in treatment status. The indicator " "
will display on the LCD .

you will hear a beep sound.

This is a safety feature to prevent accidental changes to your settings
and to prevent accidentally increasing the output intensity level. Press
[CH1−] or [CH2−] button to unlock.

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TENSPros

InTENSity IF Combo II Roscoe Medical

Low Battery Indicator

When the low power indicator " " displays on the LCD, stop the
device and charge the battery.

Charging the Battery

NOTE: Battery comes pre-charged.

Proceed as follows to recharge the battery:

• This device cannot be used while charging.

• Make sure that the device has been switched off.

• Make sure that the device is no longer connected to
the patient (the output cables and electrodes must be
disconnected).

• Connect the USB cable to the charging port on the top of device.

• Connect the USB cable to the wall outlet or USB port.

• When the device is charging, the indicator light will be red.

• It could take up to 6 hours to reach a full charge.

• When charging is completed, the indicator light will be green.

After the battery has been recharged, disconnect the cable from the wall
outlet or USB port and the device is ready to be used again.

The life of a rechargeable battery depends on the number of recharging/
rundown cycles it undergoes and how these cycles are performed.
The following suggestions will help prolong the life of the battery:

• Whenever the device is not used frequently, charge
the battery once a month.

• For longer battery life, discharge the battery as much
as possible during battery operation.

CAUTION

1) Please use the standard charger provided by the manufacturer or agent.

2) When you are using the device, never connect it to the charger. If you

do, the device will turn off automatically.

3) When charging is complete, you are strongly advised to disconnect
the charger

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TENSPros

Roscoe Medical InTENSity IF Combo II

5.8 Patient Compliance Meter

You can store 90 sets of treatment records and a total treatment time of
up to 100 hours on this device.

A. Check and Delete Individual Records

In standby, press [ M/II ] button and hold for 3 seconds to enter the
compliance meter records. The LCD will show the number of records
and treatment time (as shown in the below picture). Press [ + ] or [ − ]
buttons to check each record. To delete a record, press [ S ] button and
hold for 3 seconds.

B. Check and Delete Accumulative Records

Individual records menu, press [ II ] button to switch to accumulative
records menu. Press [ S ] button holding for 3 seconds and all of records
will be deleted followed by a beeping sound. press [ ] button to return
to the home screen.

CAUTION

The records will be permanently deleted and can be not restored if you

follow the delete records method mentioned above.

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TENSPros

InTENSity IF Combo II Roscoe Medical

6. CLEANING AND STORAGE

6.1 Cleaning the Unit

1) Turn unit off and disconnect the lead wires from the unit.

2) Clean the device after use with a soft, slightly moistened cloth
and wipe gently.

• Do not use chemicals (like thinner, benzene).

• Do not let water get into the internal area.

Note:

This device and accessories (including the electrodes) do not
require sterilization.

6.2 Cleaning the Electrode Pads

1) Turn the power off and remove the lead wires from the electrodes.

2) Wash the electrodes when the adhesive surface becomes dirty and/or
the electrodes are difcult to attach.

• To “wash” the pads, place a small drop of water on your clean

ngertip and rub the water across the entire gel part. Place the
adhesive part face up and let it air dry until the water is absorbed
and has been reconstituted. Do not wipe with a tissue paper or
cloth. If the electrode still does not stick properly, replace them
with new electrodes.

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TENSPros

Roscoe Medical InTENSity IF Combo II

CAUTION

1) The life of electrodes may vary by the frequency of washing,
skin condition, and storage state.

2) If the electrodes no longer stick to your skin or the electrodes are broken,
you should replace new electrodes.

3) Before applying the self-adhesive electrodes, it is recommended
to wash and degrease the skin, and then dry it.

4) Do not turn on the device when the electrodes are not positioned
on the body.

5) Never remove the self-adhesive electrodes from the skin while the
device is still turned on.

6) If replacement electrodes are necessary, use only electrodes that
are the same size (2" x 2") as the electrodes provided with the
IF Combo II.

7) Use of electrodes that are larger may reduce the effect of the
stimulation. Use of electrodes that are much smaller than the
electrodes provided with the IF Combo II may increase the chance
of skin irritation or electrode burns occurring under the electrodes.

8) Always use electrodes that have been cleared for marketing in the
USA by the FDA.

6.3 Storing The Electrode Pads and Lead Wires

1) Turn the device off and remove the lead wires from the unit.

2) Remove the electrodes from your body and disconnect the lead wires
from the electrodes.

3) Place the electrodes onto the plastic lm and then store into the
sealed package.

4) Wrap the lead wires and store into the sealed package.

6.4 Storing the Unit

1) Place the unit, electrodes, lead wires and manual back into
the carrying case. Store the box in a cool, dry place, -10ºC ~ 55ºC;
10% ~ 90% relative humidity.

2) Do not keep in places that can be easily reached by children

3) When not in use for a long period, remove the battery before storage.

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TENSPros

InTENSity IF Combo II Roscoe Medical

7. TROUBLESHOOTING

Problem Possible Causes Possible Solution

Are the batteries

The unit cannot
power on

Stimulation weak
or cannot feel any
stimulation

Stimulation is
uncomfortable

Intermittent output Lead wires

exhausted?

Are the batteries installed
correctly?

Electrodes dried out or
contaminated

Electrodes are not securely
attached to the skin.

Lead wires
Old/worn/damaged

Intensity is too high Decrease intensity.

Electrodes are too close
together

Electrode active area size
is too small.

May not be operating the
device according to the
manual.

- 34 -

Charge or replace the
batteries.

Insert the batteries
observing polarity.

Replace with new
electrodes

Reconnect the electrodes

Replace with new
lead wires

Reposition the electrodes
at least 1-1∕2" apart.

Replace electrodes with
ones that have an active
area no less than 25.0cm2
(5cm*5cm).

Please check the manual
before use

Verify connection is
secure.

Turn down the intensity.

Rotate lead wires in socket
90°. If still intermittent,
replace lead wire.

If still intermittent after
replacing lead wire, a
component may have
failed. Call the repair
department.

TENSPros

Roscoe Medical InTENSity IF Combo II

7. TROUBLESHOOTING (Continued)

Problem Possible Causes Possible Solution

Stimulation is
ineffective.

The skin becomes
red and/or you feel
a stabbing pain

Output current
stops during
therapy

Li rechargeable
battery pack
doesn’t last or life
is short

Improper electrode place­ment

Unknown Contact clinician.

Using the electrodes on the
same site every time.

The electrodes aren’t stuck
onto the skin properly

The electrodes are dirty.

The surface of the electrode
was scratched.

The electrodes come
off the skin.

The lead wires are
disconnected

The power of the batteries
has been exhausted.

Brand new or stored
batteries

Used Li rechargeable
battery has reached end
of life

Reposition the electrodes
at least 1-1∕2” apart.

Re-position the
electrodes. If at any time
you feel pain or discomfort
stop use immediately.

Ensure the electrodes
are stuck securely on
the skin.

Clean the electrodes
according to description
in this manual or replace
with new electrodes.

Replace with a new
electrode.

Turn off the device and
place the electrodes again.

Turn off the device and
reconnect the lead wires.

Charge or replace the
batteries.

This is normal operation.
Please charge and use in
device. You must do this
3 – 5 times before
full capacity is reached.

Charge the battery. If this
does not work, replace
the battery.

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TENSPros

InTENSity IF Combo II Roscoe Medical

8. DISPOSAL

Used fully discharged batteries must be disposed of in
a specially labeled collection container, at toxic waste
collection points or through an electrical retailer. You are
under legal obligation to dispose of batteries correctly.

Please dispose of the device in accordance with the
legal obligation.

9. GLOSSARY OF SYMBOLS

Electrical devices are recyclable material and should not

Type BF Applied Part

Please refer to instruction manual because of the higher

be disposed of with household waste after their useful life!
Help us to protect the environment and save resources
and take this device to the appropriate collection points.
Please contact the organization which is responsible for
waste disposal in your area if you have any questions.

levels of output.

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TENSPros

Roscoe Medical InTENSity IF Combo II

10. ELECTROMAGNETIC COMPATIBILITY
(EMC) TABLES

Information for accompanying documents in the scope of

Important information regarding Electro Magnetic Compatibility (EMC)

With the increased number of electronic devices such as PC’s and mobile
(cellular) telephones, medical devices in use may be susceptible to
electromagnetic interference from other devices. Electromagnetic
interference may result in incorrect operation of the medical device and
create a potentially unsafe situation. Medical devices should also not
interfere with other devices.
In order to regulate the requirements for EMC (Electro Magnetic
Compatibility) with the aim to prevent unsafe product situations,
the EN60601-1-2 standard has been implemented. This standard
denes the levels of immunity to electromagnetic interferences as well as
maximum levels of electromagnetic emissions for medical devices.

Medical devices manufactured for Roscoe Medical Inc. conform to this
EN60601-1-2:2007 standard for both immunity and emissions.
Nevertheless, special precautions need to be observed:

• The use of accessories and cables other than those specied by
Roscoe Medical, with the exception of cables sold by Roscoe Medical
as replacement parts for internal components, may result in increased
emission or decreased immunity of the device.

• The medical devices should not be used adjacent to or stacked with
other equipment. In case adjacent or stacked use is necessary, the
medical device should be observed to verify normal operation in the
conguration in which it will be used.

• Refer to further guidance below regarding the EMC environment in
which the device should be used.

IEC60601-1-2:2007

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TENSPros

InTENSity IF Combo II Roscoe Medical

Guidance and manufacturer’s declaration — electromagnetic emissions

The device is intended for use in the electromagnetic environment

specied below. The customer or the user should assure that it is used

Emissions Test Compliance

RF emissions
CISPR 11

RF emissions
CISPR11

Harmonic
emissions lEC
61000-3-2

Voltage uctuations
/ icker emissions
lEC 61000-3-3

in such an environment.

Group 1

Class B

Not applicable

Not applicable

Electromagnetic Environment

— Guidance

The device uses RF energy only for
its internal function. Therefore, its
RF emissions are very low and are
not likely to cause any interference
in nearby electronic equipment.

The device is suitable for use in all
establishments including domestic
and those directly connected to the
public low-voltage power supply
network that supplies buildings used
for domestic purposes.

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TENSPros

Roscoe Medical InTENSity IF Combo II

Guidance And Manufacturer’s Declaration — Electromagnetic Immunity

The device is intended for use in the electromagnetic environment

specied below. The customer or the user should assure that it is used

Immunity Test

Electrostatic
discharge (ESD)
lEC 61000-4-2

Electrical fast
transient/ burst
IEC 61000-4-4

Surge IEC
61000-4-5

Voltage dips,
short
interruptions and
voltage varia­tions on power
supply IEC
61000-4- 11

Power frequency
(50/ 60 Hz) mag­netic eld IEC
61000-4-8

in such an environment.

EC 60601

Test Level

±6 kV contact
±8 kV air

Not applicable Not applicable Not applicable

Not applicable Not applicable Not applicable

Not applicable Not applicable Not applicable

3 A/m 3 A/m

Compliance

Level

±6 kV contact
±8 kV air

Electromagnetic

Environment

— Guidance

Floors should be wood,
concrete or ceramic tile.
If oors are covered with
synthetic material, the
relative humidity should
be at least 30 %.

Power frequency
magnetic elds should
be at levels characteristic
of a typical location in
a typical commercial or
hospital environment.

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TENSPros

InTENSity IF Combo II Roscoe Medical

Guidance And Manufacturer’s Declaration — Electromagnetic Immunity

Immunity

Test

Conducted
RF IEC
61000-4-6

Radiated
RF IEC
61000-4-3

EC 60601

Test Level

Not applicable

3 V/m
80 MHz to

2.5 GHz

(Continued)

Compliance

Level

3 V/m

Electromagnetic

Environment

— Guidance

Portable and mobile RF
communications equipment
should be used no closer to any
part of the Electrical Stimulator
including cables, than the
recommended separation
distance calculated from the
equation appropriate to the
frequency of the transmitter.

Recommend separation
distance

d = 1.2 √P
d = 1.2 √P 80 MHz to 800 MHz
d = 2.3 √P 800 MHz to 2.5 GHz

Where P is the maximum output
power rating of the transmitter in
watts (W) according to he
transmitter manufacturer and
d is the recommended
separation distance in meters (m).
Field strengths from xed RF
transmitters as determined by an
electromagnetic site survey,
(a) should be less than the com-

pliance level in each frequency
range.

(b) Interference may occur in the

vicinity of equipment marked
with he following symbol:

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TENSPros

Roscoe Medical InTENSity IF Combo II

Guidance And Manufacturer’s Declaration — Electromagnetic Immunity

Note1: At 80 MHz and 800 MHz, the higher frequency range applies.
Note2: These guidelines may not apply in all situations. Electromagnetic
propagation is affected by absorption and reection from structures, objects,
and people.

a Field strengths from xed transmitters, such as base stations for radio

(cellular/ cordless) telephones and land mobile radio, AM and FM radio
broadcast, and TV broadcast cannot be predicted theoretically with
accuracy. To assess the electromagnetic environment due to xed RF
transmitters, an electromagnetic site survey should be considered. If the
measured eld strength in the location in which the Electrical Stimulator are
used exceeds the applicable RF compliance level above, the Electrical
Stimulator should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such as
reorienting or relocating the Electrical Stimulator.

b Over the frequency range 150 kHz to 80MHz, eld strengths should be

less than 3 V/m.

(Continued)

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TENSPros

InTENSity IF Combo II Roscoe Medical

Recommended separation distance between portable and mobile RF

communications equipment and the Electrical Stimulator

The Electrical Stimulator are intended for use in an electromagnetic
environment in which radiated RF disturbances are controlled. The
customers or the users of these Electrical Stimulator can help prevent
electromagnetic interference by maintaining a minimum distance between
portable and mobile RF communications equipment (transmitters) and the
Electrical Stimulator as recommended below, according to the maximum
output power of the communications equipment.

Separation distance according to frequency of

Output Power of

Transmitter in

Watt

0.01 0.12 0.12 0.23

0.1 0.38 0.38 0.78

1 1.2 1.2 2.3

10 3.8 3.8 7.3

100 12 12 23

For transmitters rated at a maximum output power not listed above, the
recommended separation distance d in meters (m) can be estimated using
the equation applicable to the frequency of the transmitter, where P is the
maximum output power rating of the transmitter in watts (W) according to the
transmitter manufacturer.
Note: At 80MHz and 800MHz, the separation distance for the higher pole

frequency range applies

Note: These guidelines may not apply in all situations. Electromagnetic

propagation is affected by absorption and reection from structures,
objects, and people.

150 kHz to

80 MHz

d = 1.2 √P

transmitter in meter

80 MHz to

800 MHz

d = 1.2 √P

800 MHz to

2.5GHz

d = 2.3 √P

Note: EMC tests conducted including attached electrode cord

of 1.5 m length.

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TENSPros

Roscoe Medical InTENSity IF Combo II

11. WARRANTY

Please contact your dealer or the device center in case of a claim
under the warranty. If you have to send in the unit, enclose a copy
of your receipt and state what the defect is. The following warranty
terms apply:

1) The warranty period for device is one years from date of purchase.
In case of a warranty claim, the date of purchase has to be proven
by means of the sales receipt or invoice.

2) Repairs under warranty do not extend the warranty period either
for the device or for the replacement parts.

3) The following is excluded under the warranty:

• All damage which has arisen due to improper treatment, e.g.

nonobservance of the user instruction.

• All damage which is due to repairs or tampering by the customer or

unauthorized third parties.

• Damage which has arisen during transport from the manufacturer to

the consumer or during transport to the service center.

• Accessories which are subject to normal wear and tear.

4) Liability for direct or indirect consequential losses caused by the
unit is excluded even if the damage to the unit is accepted as a
warranty claim.

Note:

Shelf life is most inuenced by several factors: exposure to light

and heat, transmission of gases (including humidity), and mechanical
stresses, this device and accessories does not require sterilization.
The device is supplied to be used under non-sterile conditions,
Material is not degraded phenomenon, also won’t produce volatile
phenomenon, this device has not restricted shelf-life.

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TENSPros

Manufactured for:

Roscoe Medical

21973 Commerce Parkway

Strongsville, Ohio 44149

Ph: (800) 3-ROSCOE (376-7263)

www.roscoemedical.com