Current Solutions Intensity 10 User Manual

INSTRUCTION MANUAL

This manual is valid for the

InTENSity 10 TENS Stimulator

This user manual is published by Current Solutions™, LLC

Current Solutions™, LLC does not guarantee its contents and 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.

United States Federal Law restricts this device to sale by

or on the order of a physician or licensed practitioner

Conformity to safety standards

Current Solutions™, LLC declares that the device complies

with following normative documents:

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

ISO10993-5,

ISO10993-10, ISO10993-1

10, IEC60601-1-4,

TABLE OF CONTENTS

1. SAFETY INFORMATION…..…………………………............…….4

1.1 General

1.2 Medical background

1.3 Indication for use

1.4 Contraindications

1.5 Warnings, Cautions, Adverse Reactions

2. PRESENTATION…………………………….........……............…

2.1 Front and Rear panel

2.2 LCD display

3. SPECIFICATION………………………………………............…..

3.1 Accessories

3.2 Technical information

3.3 The waveforms of the stimulation programs

4. INSTRUCTION FOR USE …………………………………...........15

4.1 Battery

4.2 Connect electrodes to lead wires

4.3 Connect lead wires to device

4.4 Electrode

4.5 Turn ON

4.6 Select the Therapeutic Program

4.7Adjust Channel Intensity

4.8 Safety Lock Feature

4.9 Turn OFF

4.10 Low battery indicator

5. PROGRAM……………………………………………................… 21

6. CLEANING AND CARE……………………………...............….…22

6.1 Tips for skin care

6.2 Cleaning the device

6.3 Electrodes

6.4 Cleaning the Electrodes cords

6.5 Maintenance

7. TROUBLESHOOTING…………………………………...........…..

8. STORAGE…………………………………………....................….

9. DISPOSAL……………………………………………................….

10. ELECTROMAGNETIC COMPATIBILITY (EMC) TABLES…....

11. ………………………….….............34

GLOSSARY OF SYMBOLS

12. WARRANTY………………………………………..….................

26 28 28 28

1. SAFETY INFORMATIO N

1.1 General

InTENSity 10 TENS stimulator is a portable electrotherapy

device featuring Transcutaneous Electrical Nerve Stimulation (TENS) therapeutic device, which is used for pain relief. The stimulator sends a gentle electrical current to underlying nerves and muscle group via electrodes applied on the skin. The parameters of device are controlled by the buttons. Its intensity level is adjustable according to the needs of patients.

1.2 Medical background

EXPLANATION OF PAIN

Pain is a warning system and the body's method of telling us that something is wrong. Pain is important; without it abnormal conditions may go undetected, causing damage or injury to vital parts of our bodies. Even though pain is a necessary warning signal of trauma or malfunction in the body, nature may have gone too far in its design.

Aside from its value in diagnosis, long-lasting persistent pain serves no useful purpose. Pain does not begin until coded message travels to the brain where it is decoded, analyzed, and then reacted to. The pain message travels from the injured area along the small nerves leading to the spinal cord. Here the message is switched to different nerves that travel up the spinal cord to the brain. The pain message is then interpreted, referred back and the pain is felt.

EXPLANATION OF TENS

Transcutaneous Electrical Nerve Stimulation (TENS) is a noninvasive, drug free method of controlling pain. TENS uses tiny electrical impulses sent through the skin to nerves to modify your

pain perception. TENS does not cure any physiological problem; it only helps control the pain. TENS does not work for everyone;

however, in most patients it is effective in reducing or eliminating the pain, allowing for a return to normal activity.

HOW TENS WORKS

There is nothing "magic" about Transcutaneous Electrical Nerve Stimulations

(TENS). TENS is intended to be used to relieve pain. The TENS unit sends comfortable impulses through the skin that 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.

1.3 Indication for use

InTENSity 10 TENS Stimulator should be used for the

Symptomatic relief of chronic intractable pain, acute post traumatic pain, acute post surgical pain and arthritis pain.

MPORTANT SAFETY INFORMATION!

Read instruction manual before operation. Be sure to comply with all “Contraindications”, Warnings”, “Cautions” and “Adverse reactions” in the manual. Failure to follow instructions can cause harm to user or device.

1.4 Contraindications

This device should not be used for symptomatic local pain relief unless etiology is established or unless a pain syndrome has been diagnosed.

2) This device should not be used when cancerous lesions are

present in the treatment area.

3) Stimulation should not be applied over swollen, infected, inflamed areas or skin eruptions (e.g. phlebitis, thrombophlebitis, varicose veins, etc.).

4) Electrodes must not be applied to sites that might cause current/stimulation to flow through the carotid sinus region (anterior neck) or transcerebrally (through the head).

5) Do not use this device if the patient has a demand-type cardiac pacemaker or any implanted defibrillator.

6) This device should not be used over poorly enervated areas.

7) Epilepsy

8) Serious arterial circulatory problems in the lower limbs

9) Abdominal or inguinal hernia

10) Do not use this device if you have heart disease without consulting your physician.

1.5 Warnings, Cautions and Adverse Reactions

WARNINGS:

1) This device should be used only under the continued supervision of a licensed physician.

2) The long-term effects of chronic electrical stimulation are unknown. Electrical stimulation devices do not have any curative value.

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

4) Safety has not been established for the use of therapeutic electrical stimulation during pregnancy. Do not use during pregnancy unless directed by your physician.

5) Electrical stimulation is not effective for pain of central origin.

6) Electronic monitoring equipment (such as ECG monitors and ECG alarms) may not operate properly when electrical stimulation is in use.

7) Stimulation should not be applied over the carotid sinus nerves, particularly in patients with a known sensitivity to the

carotid sinus reflex.

8) Stimulation should not be applied over the anterior neck or mouth. Severe spasm of the laryngeal and pharyngeal muscles may occur and the contractions may be strong enough to close the airway or cause difficulty in breathing.

9) Stimulation should not be applied transthoracically in that the introduction of electrical current into the heart may cause cardiac arrhythmias.

10) Stimulation should not take place while the user is connected to high-frequency surgical equipment, it may cause burn injuries on the skin under the electrodes, as well as problems with the stimulator.

11) Do not use the stimulator in the vicinity of shortwave or microwave therapy equipment, since this may affect the output power of the stimulator.

12) Never use in environments with high humidity such as in the bathroom or when having a bath or shower.

13) Caution should be used in applying electrical stimulation to patients suspected of having heart disease. Further clinical data is needed to show there are no adverse results.

14) Never use near the heart. Stimulation electrodes should never be placed anywhere on the front of the thorax (marked by ribs and breastbone), but above all not on the two large pectoral muscles. Here it can increase the risk of ventricular fibrillation and lead to cardiac arrest.

15) Electrodes should not be placed over the eyes, in the mouth, near the genitals or internally.

16) Never use on the areas of the skin which lack normal sensation.

17) Apply the electrodes to clean, dry, and unbroken skin only.

18) Keep electrodes separate during treatment, electrodes in contact with other could result in improper stimulation or skin burns.

19) Keep the stimulator out of reach of children.

20) Consult your doctor if you are in any doubt whatsoever.

CAUTIONS:

1) Federal law (USA) restricts this device to sale by or on the order of a physician.

2) For single patient use only.

3) Keep yourself informed of the contraindications.

4) This stimulator not intended for unattended, personal use by patients who have noncompliant, emotionally disturbed, dementia, or low IQ.

5) Read, understand, and practice the warnings, cautions and operating instructions. Know the limitations and hazards associated with using any device. Observe the precautionary and operational decals placed on the unit. Always follow the operating instructions prescribed by your healthcare practitioner.

6) The instruction of use was listed; any improper use may be dangerous.

7) Do not use this device for undiagnosed pain syndromes until consulting a physician.

8) Patients with an implanted electronic device, such as a cardiac pacemaker, implanted defibrillator, or any other metallic or electronic device should not use this device without first consulting a doctor.

9) Stimulation delivered by this device may be sufficient to cause electrocution. Electrical current of this magnitude must not flow through the thorax or across the chest because it may cause a cardiac arrhythmia.

10) Do not place electrodes on the front of the throat as spasm of the Laryngeal and Pharyngeal muscle may occur. Stimulation over the carotid sinus (neck region) may close the airways, make breathing difficult, and may have adverse effects on the heart rhythm or blood pressure.

11) Do not place electrodes on your head or at any sites that may cause the electrical current to flow transcerebrally (through the head).

12) Patients with heart disease, epilepsy, cancer or any other health condition should not use this device without first consulting a physician.

13) Some patients may experience skin irritation or

hypersensitivity due to the electrical stimulation or silicone rubber. If rash develops or pain persists, discontinue use and consult a doctor.

14) Electrode placement and stimulation settings should be based on the guidance of prescribing practitioner.

15) Effectiveness is highly dependent upon patient selection by a person qualified in the management of pain afflicted patients.

16) Isolated cases of skin irritation may occur at the site of the electrode placement following long-term application. If this occurs, discontinue use and consult your physician.

17) The electrodes are only to be placed on healthy skin. Avoid skin irritation by ensuring that good contact is achieved between electrodes and skin.

18) If the stimulation levels are uncomfortable or become uncomfortable, reduce the stimulation Intensity to a comfortable level and contact your physician if problems persist.

19) This device should not be used while driving, operating machinery, close to water, or during any activity in which involuntary muscle contractions may put the user at undue risk of injury.

20) Never use the device in rooms where aerosols (sprays) are used or pure oxygen is being administered.

21) Do not use it near any highly flammable substances, gases or explosives.

22) Do not use this device at the same time as other equipment which sends electrical pulses to your body.

23) Do not confuse the electrode cables and contacts with your headphones or other devices, and do not connect the electrodes to other devices.

24) Do not use sharp objects such as pencil point or ballpoint pen to operate the buttons on the control panel.

25) Inspect Applicator cables and associated connectors before each use.

26) Turn the device off before applying or removing electrodes.

27) Electrical stimulators should be used only with the leads and electrodes recommended for use by the manufacturer.

28) This device has no AP/APG protection. Do not use it in the

presence of explosive atmosphere and flammable mixture.

ADVERSE REACTIONS:

1) Skin irritation from the electrode gel and electrode burns are potential adverse reactions. If skin irritation occurs, discontinue use and consult your physician.

2) If the stimulation levels are uncomfortable, reduce the stimulation Intensity to a comfortable level and contact your physician if problems persist.

2. PRESENTATION

2.1 Front and Rear Panel

DC9V/0.8 A

1) Output socket.

2) Adapter Receptacle.

3) Therapeutic part program selection

4) Increasing the output intensity of channel 1.

5) Decreasing the output intensity of channel 1.

6) LCD display: Shows the operating state of the device.

7) Increasing the output intensity of channel 2.

8) Decreasing the output intensity of channel 2.

9) Press [ ] button to turn on or turn off the device.

10) Belt Clip.

11) The battery compartment cover.

2.2 LCD Display

1) Display TENS therapeutic mode.

2) Lock function indicator.

3) Low-battery indicator.

4) Display numbers of the treatment time.

5) Timer symbol.

6) Display numbers of the output intensity for channel 1.

7) Display numbers of the output intensity for channel 2.

8) Display therapeutic program by body part.

3. SPECIFICATION

3.1 Accessories

No DESCRIPTION Q’TY 1 TENS stimulator device 1 piece 2 Electrodes Leads 2 pieces 3 40mm x 40mm adhesive electrodes 4 pieces 4 9V Alkaline Battery, type 6LR61 1 piece 5 Instruction Manual 1 piece 6 Carrying case 1 piece

3.2 Technical Information

Channel Dual, isolated between channels

Power supply

Operating conditions

Storage conditions

Dimensions

Weight

Tolerance

Electrode Detection Function

Timer

9.0 V Alkaline battery, type: 6LR61 Adapter output:9.0Vdc, 800mA (optional)

5°C to 40°C （41℉H to 104℉H）with a relative humidity of 30%-75%,atmospheric pressure from 700 to 1060 Hpa

-10°C to 50°C （14℉H to 122℉H）with a relative humidity of 10%-90%,atmospheric pressure from 700 to 1060 Hpa

4.5×2.55×0.9 inches(L*W*H)

0.28 lbs(With battery)

There may be a ±5% tolerance of all setting and ±10% tolerance of output of intensity.

The amplitude level will be reset to 0mA when the amplitude level is 12mA or greater and an open circuit at either channel is detected.

15,30,60 minutes and continuous

Technical specifications

Waveform Mono-phase square pulse wave Pulse

amplitude

Pulse Width

Pulse Rate

Adjustable, 0~105mA peak at 1000 ohm Load each channel, 1mA/Step.

From 100 to 260us microseconds

From 50 to 150 Hz

3.3 The waveforms of the stimulation programs

Normal

Pulse Width Modulation

Cyc le time

Pulse Rate Modulation

Cyc le time

Modulation(Pulse width and Pulse rate)

Cyc le time

4. INSTRUCTION FOR USE

4 .1 Battery

4.1.1 Check/Replace the battery

Over time, in order to ensure the functional safety of device, changing the battery is necessary.

1) Slide the battery compartment cover and open.

2) Insert the 9V battery into the battery compartment.

3) Make sure you are installing the battery properly. Be sure to match the positive and negative ends of the battery to the marking in the battery compartment of the device.

4) Press and pull down following the direction of the arrow indicated on the photo.

5) Replace the battery compartment cover and press to close

6) If replace the battery, you should slide the battery compartment cover and open. Pull up the battery following the direction of the arrow indicated on the photo. And insert the 9V battery according to the above step 2) to 5).

4.1.2 Disposal of battery

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

CAUTION:

1) Battery may be fatal if swallowed. Therefore, keep the battery and the product out of the range of children, if a battery was swallowed, consult a physician immediately.

2) If a battery has leaked, avoid contact with skin, eyes and mucus membranes, Rinse the affected spots with lots of clear water immediately and contact a physician right away.

3) Battery may not be charged, dismantled, thrown into fire or short-circuited.

4) Protect battery from excess heat; Take the battery out of the product if they are spent or in case you no longer use the article. This prevents damage caused by leaking battery.

5) Always replace the same type battery.

4.2 Connect electrodes to lead wires

Insert the lead wire connector into electrodes connector (standard 0.08 inch female connection). Make sure no bare metal of the pins is exposed.

Connection Cables

CAUTION:

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

Transparent Film

4.3 Connect lead wires to device

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

2) The wires provided with the system insert into the jack sockets located on top of the device.

3) Holding the insulated portion

of the connector, push the plug end of the wire into one of the jacks (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.

CAUTION:

Do not insert the plug of the patient lead wire into any AC power supply socket.

4.4 Electrode

4.4.1 Electrode options

The electrodes are disposable and should be routinely replaced when they start to lose their adhesive nature. If you are unsure of your electrode adhesive properties, order new replacement electrodes. Replacement electrodes should be re-ordered through or on the advice of your physician to ensure proper quality. Follow application procedures outlined in electrode packing, to maintain optimal stimulation and to prevent skin irritation.

4.4.2 Place electrodes on skin

Apply electrodes to the exact site indicated by your physician or therapist, before applying electrodes, be sure the skin surface over which electrodes are placed is thoroughly cleaned and dried. Make sure the electrodes are placed firmly to the skin and make good contact between the skin and the electrodes. Place the electrodes over the skin; attach them properly, firmly, and evenly.

CAUTION:

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

2) Do not turns on the device when the self-adhesive electrodes are not positioned on the body.

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

4) It is recommended that, at minimum, 40mm x 40mm self-adhering based, square electrodes are used at the treatment area

4.4.3 Electrode placement

The placement of electrodes can be one of the most important parameters in achieving success with therapy. Of utmost importance is the willingness of the physician to try the various styles of electrode placement to find which method best fits the needs of the individual patient. Every patient responds to electrical stimulation differently and their needs may vary from the conventional settings suggested here. If the initial results are not positive, speak to your physician about alternative stimulation settings and/or electrode placements. Once an acceptable placement has been achieved, mark down the electrodes sites and the settings, so the patient can easily continue treatment at home.

4.5 Turn on

Before using the device for the first time, you are strongly advised to take careful note of the counter-indications and safety measures detailed at the beginning of this manual (Safety information), as this powerful equipment is neither a toy nor a gadget! In order to turn on the device, press the [ ] button and then the operation page appears on the screen.

4.6 Select the therapeutic part program

InTENSity™ TENS Stimulator with 10 pre-set programs, the details please refer to Page 21 <Programs>. The therapeutic part program can be selected by pressing the [ S ] button control. The therapeutic part program indicator will flash after you selected. Apply electrodes to the exact site indicated by your physician or therapist.

4.7 Select the treatment time

There are 4 choices available for the treatment time-15 min, 30min, 60min and continuous. The treatment time can be selected by press [ T ] button.

4.8 Adjust channel intensity

Press the intensity control button ([▲] and [▼]) to control the intensity output. Slowly press the intensity button control until you reach the setting recommended by your physician or therapist. Repeat for the other channel, if both channels are to be used.

CAUTION:

1) If the stimulation levels are uncomfortable or become uncomfortable, reduce the stimulation intensity to a comfortable level and contact your medical practitioner if problems persist.

2) If the electrodes no placed firmly on skin or the device has not connected on the electrodes, the stimulator's output intensity surpasses 12mA, the intensity will enulls automatically.

4.9. Safety Lock Feature

The Safety Lock Feature automatically activates after there is no operation in the panel for 30 seconds by locking out the ability to press the buttons. This is a safety feature to prevent accidental changes to your settings and to prevent accidental increases to the intensity levels. You can press either one of the [▼] button to unlock the device.

4.10. Turn OFF

If you want to turn off the device, Press [ ] button is OK.

CAUTION:

If there is no operation in the panel for 2 minutes in the waiting state, the device will be turns off automatically.

4.11. Low battery indicator

A battery symbol is shown on the display when the battery is almost empty. As long as the stimulator is working normally you can continue the treatment. When stimulation feels weaker than usual or the stimulator turns off, it is time to replace the new battery.

5. PROGRAMS

Therapeutic part program

NECK

SHOULDER

MID BACK

LOW BACK

ELBOW

Waveform

Modulation

Pulse rate

modulation

Pulse rate modulation

Frequency modulation

Continuous

WRIST Continuous

HIP

KNEE

ANKLE

FOOT

Pulse rate modulation

Pulse width modulation

Continuous

Modulation

Frequency

(Hz)

Pulse Wide

60-100 100-150

800-100 260

100-150 100

50-80 260

100 100

100 260

100-150 200

120 100-150

100 100

60-100 100-160

(us)

Treatment time (Min)

default

6. CLEANING AND C AR E

6.1 Tips for skin care

To avoid skin irritation, especially if you have sensitive skin, follow these suggestions:

1) Wash the area of skin where you will be placing the electrodes, using mild soap and water before applying electrodes, and after taking them off. Be sure to rinse soap off thoroughly and dry skin well.

2) Excess hair may be clipped with scissors; do not shave stimulation area.

3) Wipe the area with the skin preparation your clinician has recommended. Let this dry. Apply electrodes as directed.

4) Many skin problems arise from the “pulling stress” from adhesive patches that are excessively stretched across the skin during application. To prevent this, apply electrodes from centre outward; avoid stretching over the skin.

5) To minimize “pulling stress”, tape extra lengths of lead wires to the skin in a loop to prevent tugging on electrodes.

6) When removing electrodes, always remove by pulling in the direction of hair growth.

7) It may be helpful to rub skin lotion on electrode placement area when not wearing electrodes.

8) Never apply electrodes over irritated or broken skin.

6.2 Cleaning the device

1) Remove the battery from the device every time when you clean.

2) Clean the device after use with a soft, slight moistened cloth. In case of more extreme soiling you can also moisten the cloth with mild soapy water.

3) Do not use any chemical cleaners or abrasive agents for cleaning.

6.3 Electrodes

1) Use the device only with the leads and electrodes provided by the manufacturer. Use only the electrode placements and stimulation settings prescribed by your physician or therapist.

2) It is recommended that, at minimum, 40mm*40mm self-adhering based, square electrodes are used at the treatment area.

3) Inspect your electrodes before every use. Replace electrodes as needed. Reusable electrodes may cause slight skin irritation, lose adhesion and deliver less stimulation if overused.

Adhesive Pad

Connector for inserting Lead wire Pin

Reusable, Self-adhering electrodes

To use these electrodes:

1) Attach the electrode to the lead wire.

2) Remove the protective backing from the electrode surface. Do not throw away the protective backing because it is reused after the treatment session has been completed.

3) Place the tacky surface to the prescribed skin area by pressing the electrode firmly against the skin.

To remove your electrodes:

1) Lift the corner of the electrode and gently remove it from the skin.

2) Apply the protective backing to the tacky side of the electrode. Place the electrode on the side of the protective backing that is labeled with the word on.

3) It may be helpful to improve repeated application by spreading a few drops of cold water over the adhesive and turn the surface up to air dry. Over Saturation with water will reduce the adhesive properties.

4) Between uses, store the electrodes in the resealable bag in a cool dry place.

CAUTION:

Do not pull on the electrode wire. Doing so may damage the wire and electrode. Do not apply to broken skin. The electrodes should be discarded when they are no longer adhering. The electrodes are intended for single patient use only. If irritation occurs, discontinue use and consult your clinician. Read the instructions for use of self-adhesive electrodes before application. Always use the electrodes with CE mark, or are legally marketed in the US under 510(K) procedure.

6.4 Cleaning the Electrodes cords

Clean the electrode cords by wiping them with damp cloth. Coating them lightly with talcum powder will reduce tangles and prolong the life.

6.5 Maintenance

1) Maintenance and all repairs should only be carried out by an authorized agency. The manufacturer will not be held

responsible for the results of maintenance or repairs by unauthorized persons.

2) The user must not attempt any repairs to the device or any of its accessories. Please contact the retailer for repair.

3) Opening of the equipment by unauthorized agencies is not allowed and will terminate any claim to warranty.

4) Check the unit before each use for signs of wear and/or damage. Replace wear items as required.

7. TROUBLESHOOTING

If your device does not seem to be operating cor re ct ly, refer to the chart below to determine what may be wr on g. S ho ul d none of these measures correct the probl em , th e de vi ce should be serviced.

Problem

Displays fail to light up

Stimulation weak or cannot feel any stimulation

Stimulation is uncomfortable

Intermittent output

Possible Cause

Battery contact failure

Electrodes

1. Dried out or contaminated

2. Placement

Lead wires Old/worn/damaged

Intensity is too high

Electrodes are too close together

Damaged or worn electrodes or lead wires

Electrode active area size is too small.

Mayn't operate the device according to the manual.

Lead wires

Solution

1. Try fresh batteries.

2. Ensure batteries are inserted correctly. Check the following contacts:

• All contacts are in place.

• All contacts are not broken.

Replace and re-connect

Replace

Decrease intensity.

Reposition the electrodes.

Replace.

Replace electrodes with ones that have an active area no less than 16.0cm (4cm*4cm).

Please check the manual before use.

1. Verify connection is secure. Insure firmly.

2. Turn down the intensity. Rotate lead wires in socket 90°. If still intermittent, replace lead wire.

Stimulation

is ineffective.

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

Output current stops during therapy

Program option in use

Improper electrode and applicator placement Unknown Use 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 electrode pads come off the skin.

The cable is disconnected

The power of the batteries has been exhausted.

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

Some programs will seem intermittent. This is expected. Refer to the Program Option Controls in the Operation section for a description of the program

option.

Reposition electrode and applicator Contact clinician.

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

Ensure the electrode is stuck securely on the skin.

Clean the electrode pads with a damp, lint free cloth or replace new electrode pads. Clean the electrode belt according the description in user manual.

Replace new electrode.

Turn off the device and stick the electrode pad firmly to the skin.

Turn off the device and connect the cable

Please replace them with new batteries.

8. STORAGE

1) For a prolonged pause in treatment, store the device in a dry room and protect it against heat, sunshine and moisture.

2) Store the device in a cool, well-ventilated place

3) Never place any heavy objects on the device.

9. 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.

10. ELECTROMAGNETIC COMPATIBILITY (EMC) TABLES

Guidance and manufacturer's declaration

- electromagnetic emissions

The device is intended for use in the electromagnetic

environment specified below. The customer or the user

assures 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

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) IEC 61000-4-2

Class B

The device is suitable for use in all establishments other than domestic and those directly connected to the public low-

Not applicable

Guidance and manufacturer's declaration —

IEC 60601 test level

±6 kV contact

±8 kV air

voltage power supply network that supplies buildings used for domestic purposes.

electromagnetic immunity

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, therelative 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 input lines IEC 61000-4-11

±2kV for power supply lines ±1kV for input/output lines

±1kV differential mode ±2kV common mode

<5% UT (>95% dip in UT) for 0.5 cycle

40% UT (60% dip in UT) for 5 Cycles

70% UT (30% dip in UT) for 25 Cycles

<5% UT (>95% dip in UT) for 5 sec

Not applicable

Not applicable Mains power quality

Mains power quality should be that of a typical commercial or hospital environment.

should be that of a typical commercial or hospital environment.

Power frequency (50/60Hz) 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.

NOTE UT is the a.c mains voltage prior to application of the test level.

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

Conducted RF lEC 61000-4-6

Radiated RF lEC 61000-4-3

IEC 60501 test level

3 Vrms 150 kHz to 80 MHz

3 V/m80 MHz to

2.5 GHz

Compliance level

3 Vrms

3 V/m

Electromagnetic environment guidance

Portable and mobile RF Communications equipment should be used no closer to any part of the device, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance

, 80MHz to 800MHz

, 800MHz to 2,5MHz

Where P i s the maxim um o utput power r at in g of th e trans mi tter In w at ts (W) acc or ding to t he . Tra nsmit te r manuf ac turer a nd d i s the rec om mende d separ at io n dis ta nc e in meter s (m ). Field s tr ength s fr om fixed R F tr ansmi tt er s, as dete rm ined by a n elect ro ma gne ti c si te surve y,a shou ld b e less th an t he compl ia nc e lev el i n each fr eq ue ncy range .b

NOTE I At 80 M Hz e nds 800 M Hz . th e highe r fr equen cy range a pp li es. NOTE 2 Th ese gui de li nes may n ot a pply in a ll s ituat io ns . Elect ro magne ti c pr opaga ti on is aff ected b y ab so rptio n and ref le ction f ro m st ructu re s, obje ct s an d peo pl e.

a Field s tr ength s fr om f ixed tr an smitt er s, such a s ba se stati on s for rad io ( ce llula r/ cordl es s) t ele ph on es and la nd mobil e ra dios, a ma te ur radi o, AM a nd FM rad io b ro adc as t and TV br oadca st c an not be pr ed icted t he oreti ca ll y with accur ac y. To asse ss t he el ec tr omagn et ic envi ro nm ent due to fixe d RF t ransm it te rs, an el ec troma gn etic si te s ur vey shoul d be c onsid er ed . If the me as ured fi el d st ren gt h in t he locat io n in whic h th e de vice is u se d excee ds t he a ppl ic ab le RF comp li ance le ve l ab ove, sh ou ld be obs er ve d to ve ri fy norma l op erati on . If a bnorm al p erfor ma nc e is ob se rv ed, addit io nal mea su re s may be ne ce ssary, s uch as re or ie nting or relo ca ting th e de vi ce. b Over th e fr equen cy r an ge 150 kH z to 8 0 MHz, fi el d st ren gt hs shoul d be l ess tha n [V i] V/m

Recom me nded se pa ra tion di st ances b et ween

porta bl e and mob il e RF c ommun ic ation s eq uipme nt a nd

The dev ic e is inte nd ed f or use in a n el ectro ma gneti c envir on ment in w hi ch r adiat ed R F distu rb ances a re contr ol led. Th e cu st omer or t he u ser of th e de vice ca n help pr ev ent ele ct ro magne ti c inter fe rence b y maint ai ning a mi ni mu m dista nc e betwe en p ortab le a nd mobil e RF c ommun ic at ions eq ui pment ( tr ansmi tt er s) and the a s re comme nd ed b elow, acco rd ing to th e maxim um o utput p ow er o f the com mu nicat io ns equip me nt.

Separ at io n dis ta nc e accor di ng to fre qu en cy of

Rated

maxim um

outpu t

power o f

trans mi tter

150 kHz t o 80 MHz

the dev ic e

trans mi tter

80 MHz to 800 MH z

800 MHz to 2,5 GH z

0.01 0.12 0.12

0.1

100

For t ran smi tters rated at a maximum output po wer n ot li ste d abo ve, t he re com mended separation distance d i n met ers ( m) can b e est ima ted u sing the equation applicable t o the f req uen cy of th e tra nsm itter, whe re P is t he ma ximum output power rating of th e tra nsm itter in watts (W) accordable to t he tr ans mit ter man ufa ctu rer. NOT E I At 80 MHz and 800 MHz. the s epa rat ion d ist anc e for t he hig her f req uen cy range applies. NOT E 2 These gui del ine s may n ot ap ply i n all s itu ati ons . Ele ctr oma gne tic propagation is aff ect ed by a bso rpt ion and ref lec tio n from structures, objects and p eop le.

0.38 0.38 0.73

1.2 1. 2 2.3

3.8 3. 8 7.3

12 12 23

0.23

1 1 .2 1.2

100

For tra ns mitte rs r at ed at a max im um outp ut p ow er no t li st ed above , th e recom me nd ed sepa ra tion di st an ce d in met er s (m) can be es ti mated u si ng t he equa ti on appl ic ab le to the f re quenc y of the tr an smitt er, w he re P is t he m aximu m ou tput po we r ra ting of the tr an smitt er i n wa tts (W) a cc ordab le t o the tra ns mi tter manuf ac turer. NOTE I At 80 M Hz a nd 800 MH z. t he s epara ti on dist an ce f or th e highe r fr eq uen cy r an ge appl ie s. NOTE 2 Th ese gui de li nes may n ot a pply in a ll s ituat io ns . Elect ro magne ti c pr opaga ti on is aff ected b y ab so rptio n an d refle ct ion fro m st ru cture s, o bject s an d pe opl e.

3.8 3. 8 7.3

12 12

2.3

11. GLOSSARY OF SYMBOLS

Batch c od e

Seria l nu mb er

Elect ri cal dev ic es a re recy cl able ma te ri al and shoul d no t be d isp os ed o f with ho us ehold waste a ft er thei r us ef ul life ! He lp us to pr ot ec t the env ir on men t an d sa ve reso ur ces and t ak e this de vi ce to the a pp ro priat e co llect io n po ints. Pleas e co nt act t he o rg aniza ti on whic h is respo ns ib le fo r wa st e dispo sa l in your a re a if you ha ve a ny q ues ti on s.

Atten ti on: Rea d th e op erati ng i nstru ct io n for use !

Type BF App li ed P art

Type of pr ot ectio n ag ai nst ele ct ric sho ck : Class I I Eq uipme nt

12. WARRANTY

Please contact your dealer 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 parities. Damage which has arisen during transport from the manufacturer to the consumer or during transport to the service centre. 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.

Manufactured for: Current Solutions LLC 3814 Woodbury Drive

Ph:(800)871-7858

www.currentsolutionsnow.com

Austin,TX 78704

Current Solutions Intensity 10 User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual