Electromed Wellnesspro + User manual

User Manual

Caution: Federal law restricts this device to sale by or on the order of a practitioner licensed by the law of the State in which he/she practices to use or

order the use of the device.

Inc. is strictly prohibited. This publication was written, illustrated and prepared for print by Electromedical Technologies, Inc

TABLE OF CONTENTS

Foreword.......................................................................................................................................................... 3

Precautionary Instructions / Definition of Symbols...................................................................................... 4

Indications, Contraindications & Adverse Effects:....................................................................................... 5

General information ....................................................................................................................................... 5

Cautions ........................................................................................................................................................ 5

Indications of use........................................................................................................................................... 5

Contraindications........................................................................................................................................... 5

Precautions.................................................................................................................................................... 5

Adverse Effects.............................................................................................................................................. 6

Storage/Usage/Transportation ....................................................................................................................... 7

Maintenance & Cleaning Method.................................................................................................................... 7

Radiofrequency interference with medical devices...................................................................................... 7

Waveform descriptions:.................................................................................................................................. 8

Type 1............................................................................................................................................................ 9

Type 2............................................................................................................................................................ 9

Type 3.......................................................................................................................................................... 10

Type 4.......................................................................................................................................................... 10

Type 5.......................................................................................................................................................... 10

Technical specifications............................................................................................................................... 11

Package components and assembly instructions:..................................................................................... 12

AC Adapter.................................................................................................................................................. 14

Voltage requirements................................................................................................................................... 14

How to connect wires................................................................................................................................... 15

Description of LCD display........................................................................................................................... 21

Keyboard functions...................................................................................................................................... 22

Intensity Level Controls................................................................................................................................ 23

Operating instructions:................................................................................................................................. 27

Turning unit ON ........................................................................................................................................... 27

Turning unit OFF.......................................................................................................................................... 27

Screen appearance...................................................................................................................................... 27

Auto Codes.................................................................................................................................................. 28

Single Code description............................................................................................................................... 29

Make your own Auto Code using single codes............................................................................................. 31

Make your own Auto Code using frequencies.............................................................................................. 34

Mistakes & Errors......................................................................................................................................... 37

Functions description:.................................................................................................................................. 38

Dual mode (On/Off)...................................................................................................................................... 38

Dual mode operation.................................................................................................................................... 39

FLUX mode (On/Off).................................................................................................................................... 42

Multi AUTO sequence (STANDARD READY MODE) .................................................................................. 44

Multi AUTO sequence (DUAL READY MODE) ............................................................................................ 47

Backup and Restore .................................................................................................................................... 51

Turning LED On/Off..................................................................................................................................... 54

Sound On/Off............................................................................................................................................... 55

Microcurrent On/Off ..................................................................................................................................... 55

Single Code description (continued) ............................................................................................................ 59

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Foreword

Thank you for purchasing the WellnessPro 2010 Plus Electrotherapy Unit. This manual contains general

safety, operating, maintenance and care instructions for the owners and operators of the WellnessPro 2010

Plus Unit.

At the time of publication the information contained herein was current and up to date. However, due to

continual technological improvements and increased clinical knowledge in the field of electrotherapy, as well as

our policy of continual improvement, Electromedical Technologies, Inc reserves the right to make periodic

changes and improvements to their equipment and documentation without any obligation on the part of

Electromedical Technologies, Inc.

Read, understand and follow the information contained in this manual. Stay current with the latest clinical

developments in the field of electrotherapy and observe all applicable precautionary measures for treatment.

Keep informed on appropriate indications and contraindications for the use of electrotherapy.

For the existing users of the WellnessPro®2010:

The WellnessPro®2010 was improved and the successor model is the WellnessPro 2010 Plus. The indications

of use and applications have not been changed. The same programming principles apply. The user interface

has been improved in order to simplify programming and use of the device. This manual will explain those

improvements.

Please send all Company Correspondence to:

Electromedical Technologies, LLC

3104 E. Camelback Rd. #528

Phoenix, AZ 85016

Manufacturer Location:

Electromedical Technologies, LLC

16561 N. 92nd Street, #101

Scottsdale, AZ 85260

Tel: (888) 880-7888

Fax: (480) 452-1518

Visit our website:

http://www.electromedtech.com

Customer Service email: info@electromedtech.com

Technical Support email: support@electromedtech.com

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Precautionary Instructions / Definition of Symbols

Read, understand and practice the precautionary and operating instruction found in this manual. Know the limitations and

hazards associated with using any electrical stimulation device. Observe the precautionary and operational decals placed

on the unit.

DO NOT operate the unit when connected to any unit other than the WellnessPro 2010 Plus. Do not operate the unit in an

environment of short-wave diathermy use.

Inspect treatment electrodes for cracks or damage before each use. Replace with new electrodes should any damage be

found.

Inspect treatment electrode leads and associated connectors before each use for signs of damage. Replace with new

leads upon notice of damage.

Simultaneous connection of a patient to a h.f. surgical equipment may result in burns at the site of the stimulator

electrodes and possible damage to the stimulator.

Operation in close proximity (3 feet) to shortwave or microwave therapy equipment may produce instability in the

stimulator outputs.

Care must be taken when operating this equipment around the other equipment. Potential electromagnetic or other

interference could occur to this or to the other equipment. Try to minimize this interference by not using other equipment in

conjunction with it.

The precautionary instructions found in this section and throughout this manual are indicated by specific symbols.

Understand these symbols and their definitions before operating this equipment. The definitions of these symbols are as

follows:

Caution

Indicates the need for the user to consult the instructions for use for important cautionary information such as warnings

and precautions that cannot, for a variety of reasons, be presented on the medical device itself.

Warning: electricity.

This symbol alerts you to a potentially hazardous condition such as the presence of dangerous voltage that Reduce the

Risk of Fire or Electrical Shock. Do not Expose This Apparatus to Rain or Moisture. Refer to the accompanying Warning

Label or Tag, and exercise extreme caution.

Class II equipment.

A product without a protective earth (PE) and where double or reinforced insulation is relied upon to provide the protection

against electric shock. The Class II symbol is a double walled square, indicating the product’s double insulation. To

identify equipment meetings the safety requirements specified for Class II equipment according to IEC 61140.

Type BF equipment

(Non-cardiac floating, Applied Part)

It is only intended for connection to patient’s skin but has floating input circuits. No connections between patient and earth.

Applied Part: any part of the product under test that intentionally comes in contact with the patient.

Refer to instruction manual/booklet

To signify that the instruction manual/booklet must be read.

NOTE

Throughout this manual “NOTE” may be found. This is helpful information to aid in the particular area or

function being described.

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Indications, Contraindications & Adverse Effects

General information:

This TENS is a lightweight and portable medical device which can help to reduce pain and discomfort. It

utilizes low electric-current to stimulate nerves to achieve the symptomatic relief of chronic-intractable, post-

traumatic and post-surgical pain.

Cautions:

Federal law (USA) restricts this device to sale by or on the order of practitioners licensed by the State in which

they practice to use or order the use of the device.

Indications of use:

This device is used for symptomatic relief of chronic-intractable, post-traumatic and post-surgical pain.

Contraindications:

Do not use this device on patients who have a cardiac pacemaker, implanted defibrillator, or other

implanted metallic or electronic device, because this may cause electric shock, burns, electrical

interference, or death.

Do not use this device on patients whose pain syndromes are undiagnosed.

Warnings

Do not apply stimulation over the patient’s neck 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;

Stimulation should not be applied over the carotid sinus nerves (anterior neck), particularly in

patients with a known sensitivity to the carotid sinus reflex or transcereberally (through the head).

Stimulation should not be applied over the neck or mouth. Severe spasm of the laryngeal and

pharyngeal muscles may occur and the contractions may be strong enough to close the airway or

cause difficulty in breathing.

Do not apply stimulation over head, or in proximity to eyes;

Do not apply stimulation across the patient’s chest, because the introduction of electrical current into

the chest may cause rhythm disturbances to the patient’s heart, which could be lethal; Consult your

physician before using this device, because the device may cause lethal rhythm disturbances to the

heart in susceptible individuals;

Do not apply stimulation over open wounds, rashes, swollen, red, infected, inflamed or eruptions of

the skin (e.g., phlebitis, thrombophlebitis, varicose veins);

Do not apply stimulation over, or in proximity to, cancerous lesions;

Do not apply stimulation 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;

Do not apply stimulation when the patient is in the bath or shower;

Do not apply stimulation while the patient is sleeping;

Do not apply stimulation while the patient is driving, operating machinery, or during any activity in

which electrical stimulation can put the patient at risk of injury.

Apply stimulation only to normal, intact, clean, healthy skin.

Precautions:

Effectiveness of TENS devices is highly dependent upon patient selection by a practitioner qualified

in the management of pain patients;

The long-term effects of electrical stimulation are unknown;

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Since the effects of stimulation of the brain are unknown, stimulation should not be applied across

the head, and electrodes should not be placed on opposite sides of the head;

The safety of electrical stimulation during pregnancy has not been established;

Some patients may experience skin irritation or hypersensitivity due to the electrical stimulation or

electrical conductive medium (gel);

Patients with suspected or diagnosed heart disease should follow precautions recommended by

their physician;

Patients with suspected or diagnosed epilepsy should follow precautions recommended by their

physician;

Use caution if the patient has a tendency to bleed internally, such as following an injury or fracture;

Use caution following recent surgical procedures when stimulation may disrupt the patient’s 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 this device out of the reach of children;

Use this device only with the leads, electrodes, and accessories recommended by the manufacturer;

Use this device only under the continued supervision of a licensed practitioner;

Keep electrodes separate during treatment. Electrodes in contact with each other could result in

improper stimulation or skin burns.

For external use only.

Adverse Effects:

Patients should stop using the device and should consult with their physicians if they experience

adverse reactions from the device.

Isolated cases of skin irritation may occur at the site of the electrode placement following long-term

application.

Possible allergic skin reaction to tape or gel may occur.

If the stimulation levels are uncomfortable or become uncomfortable, reduce the stimulation

amplitude to a comfortable level and contact your physician if problems persist.

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Storage/Usage/Transportation:

Storage/Transportation temperature: -10° C ~ +65° C (avoid direct sun exposure)

Operating temperature: 0° C ~ +55° C (avoid direct sun exposure)

Maintenance & Cleaning Method:

Lead Wires and Carbon Rubber Electrodes: Clean with a damp cloth and wipe dry with cloth or towel. Do

not use bleach or harsh cleaners.

Unit: Use moist cloth and avoid any abrasive chemicals.

Radiofrequency interference with medical devices:

The past few years have seen increased reports that medical devices, such as pacemakers, apnea monitors,

electrically powered wheelchairs, etc., have failed to operate correctly because of interference from various

emitters of radiofrequency energy. This condition is called radiofrequency interference (RFI). The

consequences of these failures range from inconvenience to serious injuries and death. Reasons for this

problem are twofold: 1) increasing numbers of electronically controlled medical devices with inadequate

electronic protection against RFI, and 2) a significant increase in the number of RF sources in the environment.

Medical devices are widely used outside the hospital and may be attached to, or implanted in, patients.

Portable wireless communications equipment, including cellular phones, handheld transceivers, and vehicle-

mounted transceivers, comprise one of the largest sources of RFI. Some medical devices are especially

sensitive to the type of digital modulation that some of the wireless communications devices utilize.

NOTE:

The WellnessPro 2010 Plus is designed to fully comply with these requirements and is safe for usage in hospitals

among other medical devices.

NOTE:

No serviceable components inside.

Any attempt to open the device will result in all the unit functions being instantly disabled and the following

screen:

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Waveform descriptions:

WellnessPro 2010 Plus has 2 Modes of waveforms:

Continuous and Pre-modulated

Continuous mode produces a continuous train of impulses. The stimulation parameters are not automatically

interrupted nor varied in any way. The continuous mode is quite versatile because it may be applied with a

variety of rate settings.

Variation of continuous mode looks like this:

3 - 3.5 sec 3 - 3.5 sec0.5-1 sec 0.5-1 sec

This variation shows the same continuous mode with a continuous train of impulses (3-3.5 sec) with a small

pause (0.5-1 sec) in between.

Pre-modulated mode produces an amplitude-modulated impulse (Output power is modulated while the

frequency remains the same).

Variation amplitude-modulated mode looks like this:

3 sec 3 sec1 sec 1 sec

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Another variation is a combination of the previously described modes

3 sec 1 sec 3 sec 1 sec

These modes and variations are labeled as Wave type 1, 2, 3, 4 and 5.

Detailed waveform descriptions:

Type 1

Wave type 1is a continuous symmetrical biphasic pulse, where amplitude depends on the selected intensity

level (Max. voltage AC ~ 35 V; 12 V Peak into 1000-Ohm Load, Max. current 12 mA). Sampling depends on

selected frequency (up to 10000 Hz).

The hertz (symbol Hz) is the SI* unit of frequency. Frequency is the measurement of the number of times that

a repeated event occurs per unit time.

One hertz simply means "one per second" (1 / s); 100 Hz means "one hundred per second", and so on.

*(International System of Units - abbreviated SI from the French phrase, Système International d'Unités)

Type 2

3 sec 3 sec1 sec 1 sec

Wave type 2 is a ramp up (amplitude modulated) symmetrical biphasic pulse with duration of 3 seconds and

pause of 1 second in between. Amplitude and sampling depends on selected intensity level and selected

frequency. (Max. voltage AC ~ 35 V; 12 V Peak into 1000-Ohm Load, Max. current 12 mA). Max frequency

10000 Hz.

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Type 3

3 - 3.5 sec 3 - 3.5 sec0.5-1 sec 0.5-1 sec

Wave type 3is a continuous symmetrical biphasic pulse. This wave type is also known as a “Burst” type with

duration of 3 –3.5 seconds and pause of 0.5 –1 second in between. Amplitude and sampling depends on

selected intensity level and selected frequency. (Max. voltage AC ~ 35 V; 12 V Peak into 1000-Ohm Load,

Max. current 12 mA). Max frequency 10000 Hz.

Type 4

4 sec 4 sec

Wave type 4 is a ramp up –ramp down, also known as “Amplitude Modulated”which is a symmetrical

biphasic pulse with duration of 4 seconds. Amplitude and sampling depends on selected intensity level and

selected frequency. (Max. voltage AC ~ 35 V; 12 V Peak into 1000-Ohm Load, Max. current 12 mA). Max

frequency 10000 Hz.

Type 5

3 sec 1 sec 3 sec 1 sec

Wave type 5 is a combination of wave types 2 and 3. It is a ramp up –pause –continuous symmetrical

biphasic pulse with segment durations of 3 seconds and pause of 1 second.

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Technical specifications:

Number of output channels:

2 (A and B)

Output (both channels)

Waveform 1

“Continuous

mode”

Continuous symmetrical biphasic pulse.

Waveform 2

“Spectrum mode”

Amplitude modulated (ramp up) symmetrical biphasic pulse

with duration of 3 seconds and pause of 1 second in between.

Waveform 3

“Burst mode”

Continuous symmetrical biphasic pulse with duration of 3 –3.5

seconds and pause of 0.5 –1 second in between. “Burst”

wave type.

Waveform 4

“Sweep mode”

Amplitude modulated (ramp up –ramp down) symmetrical

biphasic pulse with duration of 4 seconds.

Waveform 5

“Duplex mode”

Combination of wave types 2 and 3.

Continuous symmetrical biphasic pulse with segment durations

of 3 seconds and pause of 1 second.

Voltage

max. voltage AC ~ 35 V;

12 V Peak into 1000-Ohm Load, Max. current 12 mA

Frequency range

0.1 –10000 Hz

Modes of Operation (both channels)

Continuous

1-10000 pps

Burst

1-10000 pps

Amplitude

modulated

1-10000 pps

Duration (Variable)

1 to 60 minutes per frequency

Treatment Timer

Fully customizable. Increments of 1 minute

Power Requirements

Medical power adapter ONLY

Input:

100-240 V~, 50-60Hz, 0.2A

Output:

7.5 V DC, 2500 mA

Physical Dimensions

Size

11 7/8”W (29 cm) x 3” H (7.7cm) x 7” D (17.7cm)

Weight

2.5 lbs (1.1 kg)

Shipping Weight

(unit only)

3.0 lbs (1.3 kg)

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Package components and assembly instructions:

Your pack contains:

WellnessPro 2010 Plus Unit

7.5 Volt universal power adapter

Two (2) input cables

Eight (8) lead wires

Two (2) rectangular carbon-rubber electrodes

Two (2) round carbon-rubber electrodes

Four (4) self adhesive electrodes 2'' x 2'' Pro Pulse HD

Four (4) self adhesive electrodes 2'' x 4'' Pro Pulse HD

Four (4) snap-on wire adapters

One (1) large WellnessWrapTM

Two (2) small WellnessWrapsTM

Salt free hypoallergenic conductivity gel

Instruction manual and warranty info

Figure 1: Keyboard layout

6.2 “

Color

LCD Display

Intensity level controls

On/Off button

Frequency

selection button

Function buttons

group

Microcurrent controls

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Figures 2 and 3: Back and side view of the unit

Output channel A

Power adapter plug

Custom programs

Backup and restore

STIM card

Output channel B

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AC Adapter:

Plug the WellnessPro+®AC adapter into the back of the unit,

Then into a wall outlet.

Figure 4: AC Power adapter

Voltage requirements:

The AC adapter included with your WellnessPro+®unit is a universal adapter and can be used in any country

all over the world.

NOTE: The WellnessPro+®unit MUST ONLY be powered with the medical adapter that has the WellnessPro+®

logo on it. (Input: 100-240 V~, 50-60Hz, 400mA Output: 7.5 V DC, 2.5 A)

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How to connect wires:

WellnessPro+®comes with cables and receptacles that are equipped with LEMO QUICK-LOK™ Push-Pull

Self-Latching System. LEMO’s Original QUICK-LOK push-pull, self-latching system is renowned worldwide for

its easy and quick connect and disconnect features. It provides absolute security against vibration, shock or

pulling of the cable, and facilitates operation in a very limited space offering unique advantages for all

applications:

Speed –Engage connectors simply and quickly by pushing plugs axially into mating receptacles.

Pull on outer shell to remove plug easily.

Space Savings –Just one finger clearance on two sides is needed to engage/disengage connectors, so

there’s no need to twist or turn a locking ring.

Reliability –Connections are reliable and assured when locking mechanism is engaged.

Ruggedness –Sturdy design, with sealed models to various IP levels.

Figure 5: Input cable

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How QUICK-LOK™Works

To connect/disconnect LEMO connectors (plugs) to/from WellnessPro+, please follow these steps in order to

avoid bending or breaking the connector contacts.

NOTE: Red dot on the connector shell will need to align with the indentation on the receptacle.

WARNING: Do not attempt to disconnect the plug by pulling on the cable or twisting the connector in

any way. Doing so will damage or break the contacts and void the warranty.

Engaging

QUICK-LOK allows the connector to be mated by

simply pushing the plug straight into the receptacle.

Latched

Once firmly latched, connection cannot be broken by

pulling on the cable or any other component part

other than the outer release sleeve.

Disengaging

When required, the connector is disengaged by a

single straight pull on the outer release sleeve.

This first disengages the latches and then withdraws

the plug from the receptacle.

red dot

Indentation

Receptacle

(Side of the WellnessPro+)

Release sleeve (connector shell)

Cable

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Connecting the Input Cable with the WellnessPro+

Connect the steel end of the input cable (image below) into the yellow socket of either “Channel A”or “Channel

B”of the unit. Yellow sockets are located on both sides of the unit and are closer to the front of the unit.

Make sure the red dot is aligned on the connector and receptacle (see page 16 for quick reference).

Figure 6: LEMO connector

Figure 7: Left side of the unit

Output channel A

(Yellow)

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Connecting the Lead Wires with the Input Cable

Figure 8: Lead wires

Connect at least two lead wires into the plastic mold on input cable containing four holes.

Figures 9 and 10: Proper color-coded connections shown

If only two wires are being used, they will have to be connected to the left or right two holes (see

images above). The ends of the wires are color coordinated as well as the holes on the plastic mold.

The shielded end of the lead wires are going into the plastic mold.

The exposed end of the cable is meant for the accessories.

Figure 11: Four wires connected to the input cable

NOTE: If you are using four lead wires at

the same time, do not remove any wires

from your body while a program is

running. Removing lead wires while

running a program will result in change of

the electrical resistance and significant

increase of the intensity will be detected in

the remaining wires.

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Connecting the Lead Wires with Accessories

Plug the exposed end of the cable into the hole of the electrode (left) or into the Snap-on wire adapter if you

are using the self-adhesive electrodes (right).

Our electrodes are made with highly durable yet soft silicone material. Their conductive rubber pads feel

comfortable on the skin while the low resistance design gives an effective treatment every time.

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Certificates:

* EN ISO13485, FDA 510K, COFEPRIS.

Electrode Specifications:

Resistance Under 200 Ohms

Highly durable and flexible

Conductive Gel can be applied on the conductive surface for uniform conductivity

Negative

- Cytoxicity

- Skin Sensitization

- Acute Cutaneous Irritation

Electrical Dispersion Test

Below: These pictures exhibit the electrical current dispersion of the WellnessPro+®Electrodes compared to a

competitor's. Notice the full, uniform color of the WellnessPro+®electrodes compared to the "Hot Spot" that is

created from the competitor's electrode. The competitor's electrodes are not dispersing electrical current

evenly which may cause major skin irritation and burns.

WellnessPro+®Electrode (RCR-210)

WellnessPro+®Electrode Competitor Brand

(RCR-55)

NOTE: Many accessories for electrotherapy are available on the market. We covered the connection for some

of the accessories. Same principles apply for compatible accessories. Only use accessories provided by

Electromedical Technologies.

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