INTENSITY 10 Instruction Manual Rev V1.0

This manual is valid for the InTENSity TM 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.

All Rights Reserved.Rev.V1.0 © 2011

: 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 EC60601-2-10, IEC60601-1-4, ISO10993-5, ISO10993-10, ISO10993-1

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……………………………...……...… 10 2.1 Front and Rear panel 2.2 LCD display 3. SPECIFICATION………………………………………...….. 13 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…………………………………...…..26 8. STORAGE…………………………………………...….28 9. DISPOSAL……………………………………………...….28 10. ELECTROMAGNETIC COMPATIBILITY (EMC) TABLES…... 28 11. GLOSSARY OF SYMBOLS………………………….…...34 12. WARRANTY………………………………………..…... 35

3

1. SAFETY INFORMATION 1.1 General InTENSityTM 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;

4

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 InTENSityTM 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 1)

2)

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

5

present in the treatment area. 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. 3)

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

6

carotid sinus reflex. 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.

8)

7

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

8

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

9

presence of explosive atmosphere and flammable mixture. ADVERSE REACTIONS: 1)

2)

Skin irritation from the electrode gel and electrode burns are potential adverse reactions. If skin irritation occurs, discontinue use and consult your physician. If the stimulation levels are uncomfortable, reduce the stimulation Intensity to a comfortable level and contact your physician if problems persist.

10

2. PRESENTATION 2.1 Front and Rear Panel

DC9V/0.8A

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.

11

2.2 LCD Display

1) 2) 3) 4) 5) 6) 7) 8)

Display TENS therapeutic mode. Lock function indicator. Low-battery indicator. Display numbers of the treatment time. Timer symbol. Display numbers of the output intensity for channel 1. Display numbers of the output intensity for channel 2. Display therapeutic program by body part.

12

3. SPECIFICATION 3.1 Accessories No DESCRIPTION 1 TENS stimulator device 2 Electrodes Leads 3 40mm x 40mm adhesive electrodes 4 9V Alkaline Battery, type 6LR61 5 Instruction Manual 6 Carrying case

Q’TY 1 piece 2 pieces 4 pieces 1 piece 1 piece 1 piece

3.2 Technical Information Channel

Dual, isolated between channels

Power supply

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

Operating conditions

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

Storage conditions

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

Dimensions

4.5×2.55×0.9 inches(L*W*H)

Weight

0.28 lbs(With battery)

Tolerance

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

Electrode Detection Function

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.

Timer

15,30,60 minutes and continuous

13

Technical specifications Waveform Pulse amplitude Pulse Width

Mono-phase square pulse wave Adjustable, 0~105mA peak at 1000 ohm Load each channel, 1mA/Step. From 100 to 260us microseconds

Pulse Rate

From 50 to 150 Hz

3.3 The waveforms of the stimulation programs Normal

Pulse Width Modulation

Cycle time

Pulse Rate Modulation

Cycle time

Modulation(Pulse width and Pulse rate)

Cycle time

14

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) 2) 3)

4) 5) 6)

Slide the battery compartment cover and open. Insert the 9V battery into the battery compartment. 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. Press and pull down following the direction of the arrow indicated on the photo. Replace the battery compartment cover and press to close 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.

15

2)

3) 4)

5)

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

Transparent Film

Connection Cables CAUTION:

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

16

4.3 Connect lead wires to device 1)

2)

Before proceeding to this step, be sure the device is completely turns OFF. The wires provided with the system insert into the jack sockets located on top of the device. 10 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. 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. TM

3)

4)

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.

17

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)

2) 3) 4)

Before applying the self-adhesive electrodes, it is recommended to wash and degrease the skin, and then dry it. Do not turns on the device when the self-adhesive electrodes are not positioned on the body. Never remove the self-adhesive electrodes from the skin while the device is still turns on. 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.

18

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.

19

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.

20