01 Intensity Micro Combo Instruction Manual

**01 Intensity Micro Combo Instruction Manual

**

This manual is valid for the INTENSity™ Micro Combo TENS/MIC 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 © 2010

United States Fedoral Law restrcts 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 document:

Safety information

General
INTENSity™ Micro Combo is a portable electrotherapy device featuring four therapeutic modes : Transcutaneous Electrical Nerve Stimulation (TENS) and Microcurrent (MIC), which are used for pain relief and electrical muscle stimulation. The stimulator sends gentle electrical current to underlying nerves and muscle groups via electrodes applied on the skin. The parameters of the device are controlled by the buttons on the front panel. The intensity level is adjustable according to the needs of patients.

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 detected, 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 t0o far in its design. Aside from its value i diagnosis, long-lasting persistent pain serves no useful purpose. Pain does not begin until the 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 s felt.

EXPLANATION OF TENS

Transcutaneous Electrical Nerve Stimulation (TENS) is a non- invasive, 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 Stimulation (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 patient, 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. fonger). In others, pain is only modified while stimulation actually Occurs. You may discuss this with your physician or therapist.

WHAT IS MICROCURRENT?

currentis sent into the cells of the body. Microcurrent is a very faint current that is so small it is measured in millionths of an amp (Microamps). Human cells generate a current that is in the micro amp range which is why you can’t feel it – the current is so low it doesn’t stimulate the sensory nerves. Microcurrent is a physiological electric modality that increases ATP (energy) production in the cells of your body. This dramatically increases the tissue’s healing rate. The immediate response to the correct microcurrent frequency suggests that other mechanisms are involved as well. The exact effects or changes in the tissue are unmistakable; scars will often suddenly soften; trigger points often become less painful within minutes when the “correct” frequency is applied. In many situations the changes seen seem to be long lasting and in many cases permanent

Indication for use
InTENSity™ Micro Combo TENS/MIC Stimulator may be used for the following conditions:

1. Symptomatic relief of chronic pain
2. Post traumatic pain.
3. Post surgical pain.

IMPORTANT SAFETY INFORMATION!
Read the 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:

Contraindications

1. This device should not be used for symptomatic local pain relief unless etiology is established or nless 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. phiebitis, thrombophlebitis, varicose veins, etc.). 4) Electrodes must not be applied 10 sites that might cause current/stimulation to flow through the carotid. sinus region (anterior neck) or transcerebrally (through the head).
4. Do not use this device if the patient has a demand-type cardiac pacemaker or any implanted defibrillator.
5. This device should not be used over poorly enervated areas.
6. This device should not be used on patients with epilepsy.
7. This device should not be used on patients with serious arterial circulatory problems in the lower limbs.
8. This device should not be used on patients with abdominal or inguinal hernia.
9. Do ot use this device if you have heart disease without consulting your physician.

Warnings, Cautions and Adverse Reactions

1. WARNINGS:

2. This device should be used only under the continued supervision of licensed physician or practitioner.

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

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

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

6. Electrical stimulation is not effective for pain of central origin, such as headache.

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

8. Stimulation should not be applied over the carotid sinus nerves, particularly in patients with a known sensitivity to the carotid sinus reflex.

9. 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

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

14. Further dlinical data is needed to show there are no adverse results.

15. Never use near the heart. Stimulation electrodes should never be placed anywhere on the front of the thorax (marked by ribs and breastbone), take extreme caution not to place near or on the two large pectoral muscles.

16. Here it can increase the risk of ventricular fibrillation and lead to cardiac
    arrest. Electrodes should not be placed over the eyes, in the mouth, near the genitals or internally.

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

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

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

20. Keep the stimulator out of reach of children 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 cautionary 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.
15. The electrodes are only to be placed on healthy skin. Avoid skin irritation by ensuring that good contact is achieved between electrodes and skin.
16. If the stimulation levels are uncomfortable or become uncomfortable, reduce the stimulation Intensity to a comfortable level and contact your physician if problems persist.
17. 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.
18. Never use the device in rooms where aerosols (sprays) are used or pure oxygen is being administered.
19. Do not use it near any highly flammable substances, gases or explosives.
20. Do not use this device at the same time as other equipment which sends electrical pulses to your body.
21. Do not confuse the electrode cables and contacts with your headphones or other devices, and do not connect the electrodes to other devices.
22. 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.
23. 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.
24. This device has no AP/APG protection. Do not use it in the presence of explosive atmosphere and flammable mixture.

Adverse Reac ns:

1. Skin iritation from the electrode gel and electrode burns are potential adverse reactions. If skin irritation occurs, discontinue use and consult your physician. Note: Always use electrodes that are legally marketed and sold in the United States under 510K guidelines.
2. If the stimulation levels are uncomfortable, reduce the stimulation Intensity to a comfortable level and contact your physician if any problems persist.

Presentation

_Front and Rear Panel

_

1. Output socket: electric signal output after connection of the cable with adhesive electrodes on channel 1.

2. Output socket: electric signal output after connection of the cable with adhesive electrodes on channel 2.

3. Increasing the output intensity of channel 1 [▲]. Use to set the application program and the parameter of the waveform in the setting state.

4. Decreasing the output intensity of channel 1 [▼]. Use to set the application program and the parameter of the waveform in the setting state and to unlock the current treatment program.

5. Therapeutic mode selection. Stop the treatment. Exit setting mode to return to the user interface.

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

7. Increasing the output intensity of channel 2 [▲]. Use to set the application program and the parameter of the waveform in the setting state.

8. Decreasing the output intensity of channel 2 [▼]. Use to set the application program and the parameter of the waveform in the setting state. Use to unlock the current treatment program. 9) Parameter Selection: press the button to enter setting state; you can select the different parameters in conjunction with [▲] and [▼].

9. Press [] to turn ON.

10. Press [ ] button and hold for approximately 3 seconds to turn off the device.

11. Belt Clip.

12. The battery compartment cover for user access.

13. Adapter Receptacle. LCD display

14. Displays therapeutic mode.

15. Displays therapeutic program.

16. Displays the cycle time for TENS and MIC therapeutic mode in setting state.

17. Timer symbol 5) Display of waveform pulse width.

18. Displays channel 1.

19. Display of the output intensity for channel 1 (CH1); Display of waveform pulse width

20. The device is locked indicator.

21. Display of waveform pulse rate.

22. Display of the outputintensity for channel 2 (CH2);

23. Display of waveform pulse rate.

24. Displays channel 2

25. Displays the treatment time.

26. Low-battery indicator,

Specification

Accessories

Technical information

9.0VDC, 400mA (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 1060 hPa
Storage Conditions| -10°C to 50°C (14°F to 122°F) with a relative humidity of 10%-90%, atmospheric pressure from 700 to 1060 hPa
Dimensions| 4.5 (L) x 2.55 (W) x 0.9(H) inches.
Weight| 0.28 lbs. (with battery)
Tolerance| There may be a ±5% tolerance of all settings and ±10% tolerance of output intensity.
Timer| Adjustable from 1 to 60 minutes or continuous. Adjusts in 1 minute steps. Treatment time countdown is automatic.
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.

Technical specifications for Transcutaneous Electrical Nerve Stimulator (TENS) mode

1mA/step
Pulse Width| Adjustable from 50 to 300µs, 10µs/step
Pulse Rate| Adjustable, from 1 to 150 Hz, 1 Hz/step
Burst (B)| Burst rate: Adjustable, 0.5 ~ 5Hz Pulse width adjustable, 50~300µS Frequency fixed = 100 Hz
Normal (N)| The pulse rate and pulse width are adjustable. It generates continuous stimulation based on the setting value.
Pulse Width Modulation (M)| The pulse width is automatically varied in a cycle time. The pulse width is decreased from its original setting to 60% in setting cycle time, and then increased from 60% to its original setting in the next setting cycle time. In this program, pulse rate (1 to 150Hz), pulse width (50 to 300µS) and cycle time (5 to 30 sec) are fully adjustable.
**** Pulse Rate Modulation (M1)| The pulse rate is automatically carried in a cycle time. The pulse rate is decrease from its original setting to 60% in setting cycle time, and then increased from 60% to its original setting in the nest setting cycle time. In this program, pulse rate (1 to 150Hz), pulse width (50 to 300µS) and cycle time (5 to 30 sec) are fully adjustable.

Technical Specifications for Microcurrent (MIC) Mode

0.01mA/step
**** Pulse Rate (P.R.)| Adjustable from 0.1Hz to 150Hz; there into, 0.1Hz/step in the range of 0.1Hz~2Hz, 1Hz/step in the range of 2Hz ~150Hz.

Pulse Width (P.W.)| Adjustable (in correlation to the Pulse Rate), from 2 to 200ms, 1ms/step
Constant (N)| Constant stimulation based on setting value. Only pulse width, pulse rate and timer are adjustable in this program. “Constant” is equal to the “Normal” mode of a TENS therapeutic mode.
Pulse Width Modulation (M)| The pulse width is automatically varied in a cycle time. The pulse width is decreased from its original setting to 60% in the setting cycle time, and then increased from 60% to its original setting in the next setting cycle time. In this program, pulse rate (0.1 to 150Hz), pulse width (2 to 200ms) and cycle time (5 to 30 sec) are fully adjustable.
**** Pulse Rate Modulation (M1)| The pulse rate is automatically varied in a cycle time. The pulse rate is decreased from its original setting to 60% in setting cycle time, and then increased from 60% to its original setting in the next setting cycle time. In this program, pulse rate (0.1 to 150 Hz), pulse width (2 to 200ms) and cycle time (5 to 30 sec) are fully adjustable.

The Waveforms of the Stimulation Programs

**TENS – Burst (B)

TENS – Normal (N)

TENS – Pulse Width Modulation (M)

TENS – Pulse Rate Modulation (M1)

Microcurrent – Constant

**

INSTRUCTIONS FOR USE

Battery

Check/Replace the battery

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

1. Slide the battery compartment cover to 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 push down the battery following the directionof the arrow indicated on the photo.

5. Replace the battery compartment cover and press to close.

6. If battery requires replacement, slide the battery compartment cover to open. Pull up the battery following thedirections of the arrow indicated on the photo and insert a new 9V battery according to the above steps 2 to 5.

Disposal of battery

Dispose of used batteries according to the current federal, state and local regulations. As a consumer, you are obligated by law to discard spent batteries appropriately.

CAUTION:

1. Swallowing a battery may be fatal. Keep the battery and the device out of the reach of children. If a battery is swallowed, consult a physician immediately.
2. If a battery has leaked, avoid contact with skin, eyes and mucus membranes. Rinse the affected areas with clear water immediately and contact a physician immediately.
3. Battery should not be charged, dismantled, thrown into fire or short-circuited.
4. Protect battery from excess heat.
5. Remove batteries from the unit if they are spent or if you arenot using the unit for prolonged periods of time. This prevents damage caused by leaking battery.
6. Always replace with the same type battery.

Connect Electrode to Lead Wires
Insert the lead wire connector into electrode connector (standard 0.08 inch female connection). Make sure the connectors are completely pushed together showing no exposed metal of the pins.

CAUTION:
Always use the electrodes with CE mark, or which are legally marketed in the U.S. under 510(K) procedure.
Connect Lead Wires to Device

1. Before proceeding to this step, be sure the device is completely turned OFF.
2. Insert the wires provided with the system into the jack sockets located on topof 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.

Electrode
Electrode Options**
The electrodes are disposable and should be routinely replaced before they start to lose their adhesive nature. Replacement electrodes should be re- ordered through or on the advice of your physician to ensure proper quality. Follow application procedures outlined in electrode package to maintain optimal stimulation and to prevent skin irritation.

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 dry.
Make sure the electrodes are pressed 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 that you wash, degrease and dry the skin first.
2. Do not turn 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 turned on. You will feel an uncomfortable electrical shock.
4. It is recommended that, at a minimum, 1.5” x 1.5” self-adhering, square electrodes are used at the treatment area.

Electrode Placement
The placement of electrodes can be one of the most important parameters in achieving success with this 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 location has been achieved, mark down the electrode sites and the device settings, so the patient can easily continue treatment on their own.

Turning On the Device
Before using the device for the first time, you are strongly advised to take careful note of the contraindications and safety measuresdetailed at the beginning of this manual (Safety information), as this powerful equipment is neither a toy nor a gadget!
To turn on the device, PRESS and RELEASE the ON/OFF button. The operation page will appear on the LCD screen.

Select the Therapeutic Mode
There are two therapeutic modes available – TENS and MIC. The therapeutic mode can be selected by pressing the [M] button control.

CAUTION:
Consult your physician for your suitable therapeutic mode.

Steps to Set a New Program

TENS Setting
Press the [S] button to cycle and enter the setting state. The settings can be adjusted according to the following steps:

Step 1: Set the Therapeutic Program
There are 4 programs available in TENS B N therapeutic mode – Burst (B), Normal (N), Pulse Width Modulation (M), and Pulse Rate Modulation (M1). The therapeutic program can be selected by 150- 80Hz pressing the up [▲] and down [V] button. For example, when you choose the “M” program, “M” will be outlined by a flashing box.

Step 2: Set Cycle Time (optional)
Cycle time is adjustable from 5 to 30 seconds. Only the modulation program has this parameter setting. Press the [S] button to cycle and to enter this menu, and then press the up [▲] and down [▼] buttons to adjust the cycle setting.
Step 3: Set Timer
Press [S] button to cycle and to enter this setting. The treatment time is adjustable from 1 to 60 minutes or Continuous. Press the up [V] or down [▲] button controls to adjust the setting. You can set the timer to “Continuous” mode by pressing the up [▲] control when it shows 60 minutes. The output will shut off when time is up. When in Continuous mode, you will need to manually turn off the device.
Step 4: Set Pulse Width
Pulse Width is adjustable from 50 μS to 300 μS. Press the [S] button to enter this menu, then press the up [▲] or down 7] button to adjust the setting.

Step 5: Set Pulse Rate
Pulse Rate is adjustable from 1 Hz to 150 Hz (0.5 Hz to 5 Hz for Burst). Press the [S] button to cycle and to enter this menu, and then press the up [▲]or down [▼] button to adjust the setting.

Microcurrent Setting
Press the [S] button cycle to enter the setting state. The settings can be adjusted according to the follow steps:
Step 1: Set the Therapeutic Program There are 3 available programs in MIC therapeutic program: Constant (N), Pulse Width Modulation (M), and Pulse Rate Modulation (M1). The therapeutic program can be selected by pressing the up [▲] and down [▼] button. The mode you selected will show up on the top of LCD display. TENS MIC N M MI 30 PA min. PW 20-
Step 2: Set Timer
Press the [S] button to cycle and to enter this setting. The treatment time is adjustable from 1 to 60 minutes or Continuous. Press the up [▲] or down [V] button to adjust the setting. You can set the time to “Continuous” mode by pressing the up [▲] button when it shows 60 minutes. The output will shut off when time is up. When in Continuous mode, you will need to manually turn off the device.
Step 3: Set Pulse Width
Pulse Width is adjustable from 2ms to 200ms. Press the [S] button to cycle and to enter this menu, then press the up [▲] or down [▼] button to adjust the setting.
Step 4: Set Pulse Rate
Pulse rate is adjustable from 1Hz to 150Hz. Press the [S] button again to enter this menu, and then press the up [▲] or down [▼] button to adjust the setting.
Step 5: Set Cycle Time (Optional – For Modulation Mode only)
Cycle time is adjustable from 5 to 30 seconds. Only modulation mode has this parameter setting. Press the [S] button to cycle and to enter this menu, and then press the up [▲] and down [▼] button to adjusting the setting.

Adjust Channel Intensity
Press the intensity control buttons up [▲] and down [▼] 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. When using TENS therapeutic mode, if the electrodes are not placed firmly on the skin or the device is not connected to the electrodes and the stimulator’s output intensity surpasses 12mA, the intensity will automatically reset to 0mA.

Safety Lock Feature
The Safety Lock Feature automatically activates by locking out your ability to operate the buttons when you have stopped setting the program or adjusting the intensity for 30 seconds. 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 two down [] buttons to unlock the device.

Stop the Treatment
When you have activated the treatment timer, you can press the [M] button or either of the two down [] buttons to control or stop the treatment.

CAUTION:

1. Default state, if the button is locked, you can press only one of the down [V] buttons to unlock, and then press the [M] button or the down [] button to control stop the treatment. 4.11 Turn Off Press and HOLD the button and for approximately 3 seconds to turn OFF the device. CAUTION: 1. If there is no operation in the panel for 2 minutes in the waiting state, the device will turn off automatically.
2. In shutdown state, keep pressing the channel 2 down [▼] button first, and then press the button at the same time to restore factory parameter settings. 4.12 Low

Battery Indicator
A battery symbol is shown flashing on the display when the battery is almost empty. The battery should be replaced with a new battery as soon as possible. However, the unit may continue to operate for an extended period of time depending on the setting and intensity level.

PROGRAM

Mode| Program| Modulation Method| Frequency| Pulse Width| Treatment Time
---|---|---|---|---|---
**** TENS| B| Burst| 0.5-5Hz| 50-300µs| 1-60 min; continuous
N| Continuous| 1-150Hz| 50-300µs| 1-60 min;continuous
M| Pulse Width Modulation| 1-150Hz| 50-300µs| 1-60 min; continuous
M1| Frequency Modulation| 1-150Hz| 50-300µs| 1-60 min; continuous
**** MIC| N| Continuous| 0.1-150Hz| 2-200ms| 1-60 min; continuous
M| Pulse WidthModulation| 0.1-150Hz| 2-200ms| 1-60 min;continuous
M1| Frequency Modulation| 0.1-150Hz| 2-200ms| 1-60 min; continuous

CLEANING AND CARE

Tips for Skin Care
Follow these suggestions to avoid skin irritation, especially if you have sensitive skin:

1. Wash the area of skin you will be placing the electrodes on with soap. Rinse thoroughly and dry the area completely before and after placing electrodes.
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 center 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 during treatment down time when you are not wearing electrodes.
8. Never apply electrodes over irritated or broken skin.

Cleaning the Device

1. Remove the battery from the device before you clean the device.

2. Clean the device after use with a soft, slightly moistened cloth.
   For hard to clean situations, you can also moisten the cloth with mild soapy water.

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

Electrodes

1. Use this 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, at minimum, 1.5” x 1.5” self-adhering electrodes be used at the treatment area.
3. Inspect your electrodes before every use. Replace electrodes as needed. Reusable electrodes can cause slight skin irritation, lose adhesion properties and deliver less stimulation if overused.

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 no throw away the protective backing because it can be 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. It may be helpful to improve repeated electrode application by spreading a few drops of cold water over the adhesive side and turn the surface up to air dry. Over saturation with water will reduce the adhesive properties.
3. Between uses, place the electrodes back onto the protective sleeve and insert them into the re-sealable bag and store in a cool dry place.

CAUTION:

1. Do not pull on the electrode wire. Doing so may damage the wire and electrode.
2. Do not apply to broken skin.
3. The electrodes should be discarded when they are nolonger adhering to the skin.
4. The electrodes are intended for single patient use only.
5. If irritation occurs, discontinue use and consult your clinician.
6. Read the instructions for use of self-adhesive electrodes before application.
7. Always use the electrodes with the requirements of the IEC/EN60601-1, ISO10993-1/-5/-10 and IEC/EN60601-1-2, such as with CE mark, or are legally marketed in the U.S. under 510(K) procedures.

Cleaning the Electrode’s Cords
Clean the electrode cords by wiping them with a damp cloth. Coating then lightly with talcum powder will reduce tangles and prolong their life.

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 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 worn items as required.

TROUBLESHOOTING

If your device does not seem to be operating correctly, refer to the chart below to determine what may be wrong. Should none of these measures correct the problem, the device should be serviced.

1. Try fresh batteries.
2. Ensure batteries are inserted correctly.Check the following:·  
   • All contacts are in place·
   • All contacts are not broken

Stimulation weak| Electrodes / Lead Wires

1. Dried out or contaminated
2. Placement of lead wires
   Old/worn/damaged lead wires or electrodes

| Replace and re-connect Follow instruction manual Follow instruction manual Replace
Stimulation is uncomfortable| Intensity is too high Electrodes are too close together Damaged or worn electrodes or lead wires Electrode active area size is too small.| Decrease intensity. Reposition the electrodes. Replace. Replace electrodes with ones that have an active area no less than
Intermittent output| Lead wires Program option in use|

1. Verify connection is secure & firmly seated2.   Turn down the intensity. Rotate lead wires in socket 90°. If still intermittent, replace lead wire.
2. 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.

Stimulation is ineffective.| Improper electrode and applicator placement Unknown| Reposition electrode and applicator Contact clinician.

STORAGE

1. For prolonged pauses in treatment, store the device in a cool dry room and protect it against heat, sunshine and moisture and remove the battery to avoid battery leaking.
2. Store the device in a cool, well-ventilated place.
3. Never place any heavy objects on the device.

DISPOSAL

Used fully discharged batteries must be disposed of in a specially labeled collection container, at a toxic waste collection point or through an electrical retailer. Please dispose of the device in accordance with the laws in your area.

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| Compliance| Electromagnetic environment- guidance
**** RFemissions CISPR 11| **** Group 1| 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 electronicequipment.
RFemissions CISPR11| **** Class B| **** 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.
Harmonic emissions lEC 61000-3-2| Not applicable
Voltage fluctuations/flicker emissions lEC 61000-3-3| **** Not applicable
Immunity test| IEC 60601test level| Compliance level| Electromagnetic environment – guidance
**** Electrostatic discharge (ESD) IEC 61000-4-2| **** ±6 kVcontact ±8 kV air| **** ±6 kVcontact ** ±8 kV air| 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| ±2kV for power supply lines±1kV for input/outputlines| Not applicable| Main power quality should be that of a typical commercial or hospital environment.
Surge IEC 61000-4-5| ±1kVdifferential mode±2kV commonmode| Not applicable| Main power quality should be that of a typical commercial or hospital environment.
Voltage dips,| <5% UT(>95% dip inUT) for 0.5cycle40% UT(60% dip inUT) for 5 Cycles70% UT(30% dip inUT) for 25Cycles<5% UT(>95% dip inUT) for 5 sec| Not applicable| Main power qualityshould be that of atypical commercial orhospital 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.
Guidance and manufacturer’s declaration electromagnetic immunity –
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| IEC 60501test level| Compliance level| 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
Conducted RF lEC 61000-4-6| 3 Vrms150 kHzto 80 MHz| 3 Vrms| Where P is the maximum output power rating of the transmitter In watts (W) according to the. 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, should be less than the compliance level in each frequency range. Interference may occur In the vicinity of equipment marked with the following symbol:

Radiated RF lEC 61000-4-3| 3 V/m80 MHz to2.5 GHz| 3 V/m| , 80MHzto 800MHz, 800MHzto 2,5MHz
| | |
** NOTE I. At 80 MHz and 800 MHz. the separation distance for the higher frequency range applies. NOTE 2. 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 basestations for radio (cellular/cordless) telephones and land mobile radios, amateur 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 thelocation in which the device is used exceeds the applicable RF compliance level above, should be observed to verify normal operation. If abnormal performance is observed,additional measures may be necessary, such as reorienting or relocating the device.b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [Vi] V/m
Recommended separation distances between portable and mobile RF communications equipment and thedevice
The device is intended for use in an electromagnetic environment in which radiated RF disturbances arecontrolled. The customer or the user of the device can help prevent electromagnetic interference bymaintaining a minimum distance between portable and mobile RF   communications   equipment   (transmitters) as recommended below, according to the maximumoutput power of the communications equipment.
**** Rated maximumoutput power oftransmitter W| Separation distance according to frequency of transmitterm
150 kHz to 80 MHz | 80 MHzto 800 MHz | 800 MHzto 2,5 GHz
0.01| 0.12| 0.12| 0.23
0.1| 0.38| 0.38| 0.73
1| 1.2| 1.2| 2.3
10| 3.8| 3.8| 7.3
100| 12| 12| 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) accordable to the transmitter manufacturer. NOTE I. At 80 MHz and 800 MHz. the separation distance for the higher frequency range applies.NOTE 2. These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

Glossary of Symbols

of with householdwaste 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 isresponsible for waste disposal in your areaif you have any questions.
****| Degree of Electrical Protection BF

12. Warranty

Please contact your dealer in case of a claim under the warranty. If you have to send the unit back to your provider, 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 retailer.
   • 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.

3814 Woodbury Drive, Austin, TX 78704 512-600-7080 ⚫ 800-871-7858 www.currentsolutionsnow.com Current Solutions LLC © 2010 Manufactured for https://manual-hub.com/

References

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