TENSunits.com OMEGA TENS, OMEGA NMES Instruction manual

INSTRUCTION MANUAL

www.tensunits.com

ΩMEGA TENSunits.com

This manual is valid for the

Omega

This instruction manual is published by TENSunits.com

TENSunits.com 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, 20151015

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

Conformity to safety standards

TENSunits.com 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

- 2 -

TENSunits.com ΩMEGA

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. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

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 Start Treatment

5.7 Other Important Functions

Safety Lock Feature

Low Battery Indicator

Charging The Battery

5.8 Other Important Functions

5.9 Patient Compliance Meter

6. Cleaning And Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

8. Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

9. Glossary Of Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

10. Electromagnetic Compatibility (EMC) Tables . . . . . . . . . . 36

11. Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

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1. INTRODUCTION

1.1 General

The Omega is a portable electrotherapy device featuring two therapeutic modes: Transcutaneous Electrical Nerve Stimulator

(TENS) and Neuromuscular Electrical Stimulation (NMES), which are used for pain relief and electrical muscle stimulation. The stimulator sends gentle electrical current to underlying nerves and muscle group 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 as a warning system and becomes a problem.

Examples include but are not limited to:

• Low back pain

• Bursitis

• Pinched Nerves

• Joint Pain

The Omega was developed to help relieve some types of chronic and acute pain.

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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 modified while stimulation actually occurs.

You may discuss this with your physician or therapist.

How NMES works

Neuromuscular Electrical Stimulation (NMES) is an internationally accepted and proven way of treating muscular injuries. It works by sending electronic pulses to the muscle needing treatment; this causes the muscle to exercise passively. This device is low frequency and in conjunction with the square wave pattern allows the stimulation to work directly on the muscle groups. This is being widely used in hospitals and sports clinics for the treatment of muscular injuries and for the re-education of paralyzed muscles, to prevent atrophy in affected muscles and improving muscle tone and blood circulation.

The goal of electrical muscle stimulation is to achieve contractions or vibrations in the muscles. Normal muscular activity is controlled by the central and peripheral nervous systems, which transmit electrical signals to the muscles. NMES works similarly but uses an external source (the stimulator) with electrodes attached to the skin for transmitting electrical pulses into the body. The pulses stimulate the nerves to send signals to a specifically targeted muscle, which reacts by contracting, just as it does with normal muscular activity

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1.3 Indication for Use

Omega Stimulator may be used for the following conditions:

1) Symptomatic relief of chronic intractable pain.

2) Post traumatic pain.

3) Post surgical pain.

For Neuromuscular Electrical Stimulation Therapeutic Mode (NMES):

1) Relaxation of muscle spasm.

2) Increase of blood flow circulation.

3) Prevention of disuse atrophy.

4) Muscle re-education.

5) Maintaining or increasing range of motion.

6) Immediate post-surgical stimulation of lower leg muscles to prevent venous thrombosis.

2. IMPORTANT SAFETY PRECAUTIONS

AND WARNINGS

It is important that you read all the warning and 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

DANGER

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

WARNING

CAUTION

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.

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DANGER

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

• Internally transplanted electronic medical devices, such as a pacemaker.

• 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.

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 defibrillator, 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 artificial 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 inflamed 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.

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WARNING (CONTINUED)

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.

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 five 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 confirm 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, difficulty 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 film 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 film 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 fixed 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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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 fire. 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.


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 qualified 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.

- 10 - 11 -


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.

TENSunits.com

3. PACKAGE CONTENTS

ΩMEGA

Omega Unit 2 × Lead wires 4 × Electrode pads

(2 " x 2")

QUICK REFERENCE GUIDE – OMEGA

11

SET RAMP UP TIME

Set Ramp Up/Down Time

Press [ S ] button to set the ramp up and down time and the “sec.” will flash and you will see the below image circled in red on the screen.

Press [ + ] or [

−

] adjust the treatment time.

PAGE 5

QUICK REFERENCE GUIDE – OMEGA

12

SET CONTRACTION TIME

Set Contraction Time

Press [ S ] button to set the contraction time and the “sec.” will flash along with the symbol circled in red to the left. Then press [ + ] or [ button to adjust the time.

−

]

13 SET RELAXATION TIME

Set Relaxation Time

Press [ S ] button again to set the relaxation time and the “sec.” will flash along with the symbol circled in red to the left. Then press [ + ] or [ button to adjust the time.

−

]

After you finished settings, press [ S ] or [ ] button to confirm, the device will back to standby status.

To set your treatment time refer back to Step 5.

To start your treatment refer back to Step 7.

14 NMES — SET PRESET PROGRAMS — P1 & P2

Select Treatment Mode

Press [ M/II ] button to select the NMES treatment mode. Select the body part which you want to treat. Press the body part button until the LCD displays program “P1” or “P2” like the screen on the left.

To set your treatment time refer back to Step 5.

To start your treatment refer back to Step 7.

Manufactured for:

TENSunits.com

12399 S. Belcher Rd., Ste 160

Largo, FL 33773

Ph: 866-237-4013 www.tensunits.com

INSTRUCTION MANUAL

www.tensunits.com

1 x Instruction

Manual

PAGE 6

Model: DI2788

QUICK REFERENCE GUIDE

PAGE 1

The purpose of this guide is to assist you in correctly operating your Omega

TENS/NMES (DI2788) 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 Omega Instruction Manual.

PLEASE READ THE INSTRUCTION MANUAL COMPLETELY BEFORE USING

THIS DEVICE. Read, understand and practice the IMPORTANT SAFETY

PRECAUTIONS AND WARNINGS found on pages 6 – 12 of your user manual.

Always follow the operating instructions prescribed by your healthcare provider.

LEAD WIRES

(1 PAIR)

ELECTRODES

(4 PADS)

M /

S Li RECHARGEABLE

BATTERY

WALL CHARGER

& USB CABLE

1 x Quick Start

1

Side

Guide

2

3

CH2

9

2

4

1

Front

8

7

6

Back

11

10

7

M /

5 8

9

3

5

10

4

S

6

11

1

2

LCD Display

Body Part Selection

3

4

Channel 1 Intensity Buttons

Set Button

5

6

Power Button

Channel 2 intensity buttons

7

8

Pause Button

LED Charging Indicator Light

9

Lead Wire Output Sockets

10

Battery compartment cover

11

Belt Clip

12

USB Charging Port

1 × LI rechargeable

Battery Pack

1 × USB Cable and Wall Charger

- 12 - 13 -


3.1 Front and Rear Panel

9

12

CH1 CH2

8

1 11

2

3

4

M /

S

7

5

6

10

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 NMES). 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.

- 14 -

TENSunits.com

3.2 LCD Display

ΩMEGA

1

2

4

5

6

7

8

9

3 12 11

10

13

14

1. Displays waveform mode.

2. Displays home screen

3. Displays set mode

4. Displays output state: start, pause, lock

5. Hour Indicator

6. Contraction, Relaxation & Ramp

7. Displays output intensity of channel 1 , pulse width and pulse rate

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

9. Displays therapeutic mode: TENS, NMES

10. Low-battery indicator

11. Load indicator

12. Indicates compliance meter mode

13. Displays the treatment time

14. Display output intensity of channel 2

- 15 -


4. SPECIFICATIONS

4.1 Technical Information

Channel

Power Supply

Dual, isolated between channels

3.7V LI rechargeable battery pack

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

Operating Conditions 5°C to 40°C (41°F to 104°F) with a relative humidity of 30% – 75%,atmospheric pressure from 700 to 1,060 Hpa

Storage and

Transport Conditions

-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

Dimensions

Weight

Electrode Detection

Function

11.7 × 6 × 2.1 cm (L*W*H)

3.5 oz. (Without battery)

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.

Technical Specifications (TENS & NMES)

Waveform

Pulse Amplitude

Pulse Width

Pulse Rate

Treatment Time

TENS: Symmetrical bi-phase rectangular wave

NMES: Biphasic rectangular

TENS/NMES: Adjustable, 0 to 100mA at 1,000 ohm

Load each channel, 1mA/Step

TENS: From 50 to 400us microseconds

NMES: From 200 to 400us (microseconds)

TENS: From 1 to 150Hz

NMES: From 1 to 100Hz

5 to 90 minutes

Technical Specifications (NMES ONLY)

Contraction Time

Treatment Time

5 to 30 seconds

Relaxation Time 5 to 60 seconds

Ramp Up/Down Time 1 to 9 seconds

5 to 90 minutes

- 16 -

TENSunits.com

4.2 Program Parameters

Body

Part

Program

Treatment

Time

TENS

Pulse

Rate

P1 20 Min.

Pulse

Width

80 – 100Hz 100 – 120µs

ΩMEGA

Cycle

Time

10 Sec

Neck

P2 20 Min.

4Hz 150 – 200µs 20 Sec

P1 20 Min.

80 – 100Hz 10 Sec

Shoulder

P2 20 Min.

10Hz 220 – 260µs 20 Sec

Hand

Low back

Knee

Foot

P1

P2

P1

P2

P1

P2

P1

P2

Body Part Program

All

Therapeutic

Parts

U1

20 Min.

20 Min.

20 Min.

20 Min.

20 Min.

20 Min.

20 Min.

20 Min.

100Hz 100µs

1 – 10Hz 200µs

80 – 100Hz 100µs

4Hz

200 – 260µs

120Hz

1 – 10Hz

100 – 120µs

150 – 200µs

80 – 120Hz 100 – 120µs

1 – 10Hz 200µs

Treatment

Time

Adjustable

5 – 90 mins

Fixed

Pulse

Rate

Adjustable

1 – 150 Hz

Pulse Width

Adjustable

50 – 400µs

20 Sec

10 Sec

20 Sec

10 Sec

20 Sec

10 Sec

20 Sec

- 17 -

100µs


4.2 Program (Continued)

Body

Part

Program

Treatment

Time

NMES

Pulse

Rate

Pulse

Width

Contract

Time

Relax

Time

Ramp

Up/Down

P1 20 Min.

40Hz 300µs 12 Sec 20 Sec 2 Sec

Neck

P2

Shoulder

Hand

Low back

Knee

Foot

P1

P2

P1

P2

P1

P2

P1

P2

P1

P2

All

Body

Parts

U1

20 Min.


20 Min.


20 Min.


20 Min.


20 Min.


20 Min.

20 Min.

20 Min.

20 Min.

20 Min.

60Hz

70Hz

20Hz

25Hz

30Hz

300µs

300µs

300µs

300µs

300µs

12 Sec

12 Sec

12 Sec

12 Sec

12 Sec

20 Sec

30 Sec

30 Sec

50 Sec

20 Sec

20 Min.

Min:

5 - 90,

Step:

5min

Default:

20Min

5Hz 300µs

1 - 100Hz

Step:

1Hz

Default:

40Hz

200 - 400µs

Step: 5

Default:

300uS

12 Sec

5 - 30s

Step:1s

Default:

12s

30 Sec

5 - 60s

Step:

1s

Default:

20s

2 Sec

1 - 9s

Step: 1s

Default:

2s

2 Sec

2 Sec

2 Sec

2 Sec

2 Sec

- 18 -

TENSunits.com

4.3 Waveform Information — TENS

Continuous

Pulse Width Modulation

Pulse Rate Modulation

Cycle time

Cycle time

Modulation (Pulse rate and width modulation)

Cycle time

Waveform Information — NMES

Synchronous intensity

CH1

CH2

- 19 -

time

ΩMEGA


5. INSTRUCTIONS 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 29.

TENSunits.com

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 fire 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.

- 20 -

Note: If you use only one Channel, only plug in 1 lead wire at the top of the unit

- 21 -

ΩMEGA

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.


5.4 Turn on The Device

Press the [ ] button to turn on the device.

CAUTION

Before using the device for the first 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 NMES).

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).

Omega

4

3

2

1

M /

S

- 22 -


Manual TENS Program — U1

A. Select Body Part

Press the “M/II” button to choose TENS mode. Then select the body part which you want to treat. Press the body part button until the LCD displays program “U1”

B. Set Pulse Rate

Press [ S ] button to enter the pulse rate and the "Hz" will flash.

Press [

+

] or [

−

] button to adjust pulse rate.

C. Set Pulse Width

Press [ S ] button to enter the pulse width and the "µs" will flash. Then press [

+

] or [

−

] button to adjust the pulse width.

- 23 -


D. Set Treatment Time

Press [ S ] button to enter treatment time and the "min." will flash.

Then press [

+

] or [

−

] button to adjust the treatment time.


Manual NMES Program — U1


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

Set Preset TENS Programs — P1 and P2


Press the “M/II” button to choose TENS 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 treatment time and the “min.” will flash.

Then press [

+

] or [

−



Press [ S ] button to enter the treatment time and the "Min" will flash.

Press [

+

] or [

−

] button to adjust treatment time. After you finished settings, press the [ S ] or [ ]button to confirm, the device will go back to the home screen.

C. Set Pulse Rate

Press [ S ] button to enter the pulse rate and the “Hz” will flash.

Press [

+

] or [

−

] button to adjust pulse rate.

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.

- 24 -

D. Set Pulse Width

Press [ S ] button to enter the pulse width and the “µs” will flash. Then press [

+

] or [

−

] button to adjust the pulse width.

- 25 -


E. Set Ramp Up Time

Press [ S ] button to set the ramp up and down time and the “sec.” will flash and you will see the below image circled in red on the screen.

Then press [

+

] or [

−



After you have finished settings, press [ ] button to confirm, the device will go back to the home screen.

H. Start Treatment


Set Preset NMES Programs — P1 and P2


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

“P1” or “P2”

F. Set Contraction Time

Press [ S ] button to set the contraction time and the “sec.” will flash along with the symbol circled in red below. Then press [ button to adjust the time.

+

] or [

−

]


Press [ S ] button to enter the treatment time and the "Min" will flash.

Press [

+

] or [

−

] button to adjust treatment time. After you finished settings, press the [ S ] or [ ]button to confirm, the device will go back to the home screen.

G. Set Relaxation Time

Press [ S ] button again to set the relaxation time and the “sec.” will flash along with the picture circled in red below. Then press [

+

] or [

−

] button to adjust the time.

- 26 -

C. Start Treatment


- 27 -


CAUTION

1. If the electrodes are not placed firmly 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.

5.7 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 you will hear a beep sound.

5.10 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 .

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.

- 28 -


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.

CAUTION

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

2.

Do not use the device for treatment when in charging status as it will not work. When you are using the device, never connect it to the charger. If you do, the device will turn off automatically as a safety precaution and you will not be able to turn it back on until you disconnect the charger from the device.

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

- 29 -


5.9 Patient Compliance Meter

You can store 60 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.

TENSunits.com

6. CLEANING AND STORAGE

ΩMEGA

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 difficult to attach.

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

CAUTION

The records will be permanently deleted and can be not restored if you follow the delete records method mentioned above.

- 30 - 31 -


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 Omega.

7. Use of larger electrodes may reduce the effect of the stimulation.

Use of electrodes that are much smaller than the electrodes provided with the Omega 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 film 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.

- 32 -

TENSunits.com

7. TROUBLESHOOTING

ΩMEGA

Problem

The unit cannot power on

Stimulation weak or cannot feel any stimulation

Stimulation is uncomfortable

Intermittent output

Possible Causes

Are the batteries 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

Electrodes are too close together

Electrode active area size is too small.

May not be operating the device according to the manual.

Lead wires

Possible Solution

Charge or replace the batteries.

Insert the batteries observing polarity.

Replace with new electrodes

Reconnect the electrodes

Replace with new lead wires

Decrease intensity.

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

Replace electrodes with ones that have an active area no less than 25.0cm

2

(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.

- 33 -


7. TROUBLESHOOTING (Continued)

Problem

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

Possible Causes

Improper electrode placement

Unknown

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

Possible Solution

Reposition the electrodes at least 1½ " apart.

Contact clinician.

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.

- 34 -

TENSunits.com

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.

ΩMEGA

9. GLOSSARY OF SYMBOLS

Electrical devices are recyclable material and should not 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.

Type BF Applied Part

Please refer to instruction manual because of the higher levels of output.

- 35 -


10. ELECTROMAGNETIC COMPATIBILITY

(EMC) TABLES

Information for accompanying documents in the scope of

IEC60601-1-2:2007

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 defines the levels of immunity to electromagnetic interferences as well as maximum levels of electromagnetic emissions for medical devices.

Medical devices manufactured for TENSunits.com 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 specified by

TENSunits.com, with the exception of cables sold by TENSunits.com 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 configuration in which it will be used.

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


Guidance and manufacturer’s declaration — electromagnetic emissions

The device is intended for use in the electromagnetic environment specified below. The customer or the user should assure that it is used in such an environment.

Emissions Test

RF emissions

CISPR 11

Compliance

Group 1

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.

RF emissions

CISPR11

Harmonic emissions lEC

61000-3-2

Voltage fluctuations

/ flicker emissions lEC 61000-3-3

Class B

Not applicable

Not applicable

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.

- 36 - 37 -


Guidance And Manufacturer’s Declaration — Electromagnetic Immunity

The device is intended for use in the electromagnetic environment specified below. The customer or the user should assure that it is used in such an environment.

Immunity Test

Electrostatic discharge (ESD) lEC 61000-4-2

EC 60601

Test Level

±6 kV contact

±8 kV air

Compliance

Level

±6 kV contact

±8 kV air

Electromagnetic

Environment

— Guidance

Floors should be wood, concrete or ceramic tile.

If floors are covered with synthetic material, the relative humidity should be at least 30 %.

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

Not applicable Not applicable Not applicable



Power frequency

(50/ 60 Hz) magnetic field IEC

61000-4-8

3 A/m 3 A/m

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



(Continued)

Immunity

Test

Conducted

RF IEC

61000-4-6

EC 60601

Test Level

Not applicable

Compliance

Level

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.

Radiated

RF IEC

61000-4-3

3 V/m

80 MHz to

2.5 GHz

3 V/m

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 fixed RF transmitters as determined by an electromagnetic site survey,

(a) should be less than the compliance level in each frequency range.

(b) Interference may occur in the vicinity of equipment marked with he following symbol:

- 38 - 39 -



(Continued)

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 reflection from structures, objects, and people.

a Field strengths from fixed 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 fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field 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, field strengths should be less than 3 V/m.

- 40 -


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.

Output Power of

Transmitter in

Watt

0.01

0.1

1

10

100

Separation distance according to frequency of transmitter in meter

150 kHz to

80 MHz d = 1.2 √P

0.12

0.38

1.2

80 MHz to

800 MHz d = 1.2 √P

0.12

0.38

1.2

800 MHz to

2.5GHz

d = 2.3 √P

0.23

0.78

2.3

3.8

12

3.8

12

7.3

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 reflection from structures, objects, and people.

Note: EMC tests conducted including attached electrode cord of 1.5 m length.

- 41 -


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 year 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.

- 42 -

Distributed by:

TENSunits.com

12399 S. Belcher Rd., Ste 160

Largo, FL 33773

Ph: 866-237-4013 www.tensunits.com

42_DI2788_00 ©2015

Printed in China

TENSunits.com OMEGA TENS, OMEGA NMES Instruction manual

Assistant Bot

INSTRUCTION MANUAL

www.tensunits.com

This manual is valid for the

Omega

Table of Contents

1. INTRODUCTION

1.1 General

1.2 Medical Background

How does TENS work?

How NMES works

1.3 Indication for Use

2. IMPORTANT SAFETY PRECAUTIONS

AND WARNINGS

DO NOT USE THIS DEVICE UNDER THESE CONDITIONS

DO NOT USE ON THESE INDIVIDUALS

DO NOT USE THIS DEVICE DURING THESE ACTIVITIES

PAIN MANAGEMENT WARNINGS

WARNINGS AND PRECAUTIONS REGARDING THE PADS

NEVER APPLY THE PADS TO:

WARNINGS AND PRECAUTIONS REGARDING THE PADS

DO NOT USE YOUR PADS THIS WAY

CAUTION WHILE USING THE STIMULATOR

3. PACKAGE CONTENTS

3.1 Front and Rear Panel

3.2 LCD Display

4. SPECIFICATIONS

4.1 Technical Information

Technical Specifications (TENS & NMES)

Technical Specifications (NMES ONLY)

4.2 Program Parameters

4.3 Waveform Information — TENS

Waveform Information — NMES

5. INSTRUCTIONS FOR USE

5.1 Battery

5.2 Connecting Electrodes

5.3 Connecting Lead Wires

5.4 Turn on The Device

5.5 Setting a New Program

Manual TENS Program — U1

A. Select Body Part

B. Set Pulse Rate

C. Set Pulse Width

D. Set Treatment Time

Manual NMES Program — U1

A. Select Body Part

Set Preset TENS Programs — P1 and P2

A. Select Body Part

B. Set Treatment Time

B. Set Treatment Time

C. Set Pulse Rate

C. Start Treatment

D. Set Pulse Width

E. Set Ramp Up Time

H. Start Treatment

Set Preset NMES Programs — P1 and P2

A. Select Body Part

F. Set Contraction Time

B. Set Treatment Time

G. Set Relaxation Time

C. Start Treatment

D. Pause or Stop Treatment

5.7 Turn OFF Device

5.10 Other Important Functions

Safety Lock Feature

Low Battery Indicator

Charging the Battery

5.9 Patient Compliance Meter

A. Check and Delete Individual Records

B. Check and Delete Accumulative Records

6. CLEANING AND STORAGE

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

7. TROUBLESHOOTING (Continued)

8. DISPOSAL

9. GLOSSARY OF SYMBOLS