North Coast Eco-Stim TENS and EMS Machine USER MANUAL

Page 1
Eco-Stim
TENS + EMS
Instruction Manual
NC89481
Be sure to read this instruction manual before operating device.
Keep manual in a safe place.
Page 2
North Coast Medical does not guarantee its content and reserves the right to improve and amend it at any time without prior notice. However, Amendments will be published in a new edition of this manual.
TABLE OF CONTENTS
QUICK REFERENCE GUIDE 4
All Rights Reserved. © 2021, North Coast Medical, inc.
North Coast Medical declares that the device complies with the following normative documents: IEC60601-1, IEC60601-1-2, IEC60601-1-11, IEC60601-2-10, IEC62304, ISO10993-5, ISO10993-10, ISO10993-1, ISO14971
1. FOREWORD 6
2. SAFETY INFORMATION 8
3. GETTING TO KNOW YOUR DEVICE 13
4. SPECIFICATION 16
5. OPERATING INSTRUCTION 17
6. INSTRUCTIONS FOR USE 24
7. CLEANING AND MAINTENANCE 31
8. TROUBLESHOOTING 32
9. STORAGE 34
10. DISPOSAL 34
11. ELECTROMAGNETIC COMPATIBILITY (EMC) TABLES 35
12. NORMALIZED SYMBOLS 40
13. WARRANTY 41
Page 3
QUICK REFERENCE GUIDE
Please read the instruction manual completely before attempting to use this device. Steps 1-3 should be completed with the device turned o.
1) Open the battery cover, insert four batteries (type AAA) into the battery compartment. Make sure you are installing the batteries properly. Place the batteries according to the markings of positive terminal (+) and negative terminal (-) in the battery compartment of device. (More info on pg.17-18)
4) Press the [ON/OFF/M] button to turn on the device. The LCD will light up, and then go into standby mode. Based on your needs, press [O N/O FF/ M ] button to select the treatment mode:
2) Insert the electrode wire connector into the electrode connector. Make sure the two components are properly connected to ensure optimal performance. Select one of the two available channels and insert the lead wire rmly into the device port.
3) Place the electrode on the location where you feel pain. Refer to section 5.4.3 for correct electrode placement for dierent body parts after reading 2.2.1 Contraindications and 2.2.3 Precautions.
5) Select treatment program. Based on your needs, press [P] button to select the treatment program.
6) Set program parameter. Press and hold [P] button to enter the setting mode. In programs p1 to p6 of the TENS mode, and programs p1 to p5 of the EMS mode, Press [+] /[- ] button to adjust treatment time. (More info on pg. 25)
7) In programs U1 to U3 of the TENS mode, and programs U1 to U3 of the EMS mode, press [P] button to adjust pulse rate -> pulse width -> treatment time by setting the parameters. Press [+]/[-] button to adjust.
8) Start treatment. Press the [+] /[- ] button of CH1 or CH2 to increase or decrease intensity.
9) Stop treatment. Press [ON/OFF/M] button to stop treatment and return to the standby mode.
54
Page 4
1. FOREWARD
Introduction
The Norco® Eco-Stim™ TENS + EMS is a dual channel output TENS, EMS and MASSAGE stimulator. Before using, please read all the instructions in this user manual carefully and keep it in a safe place for future use.
The Eco-Stim™ TENS + EMS belongs to the group of electrical stimulation systems. It has three basic functions: TENS (Transcutaneous Electrical Nerve Stimulation), EMS (Electronic Muscle Stimulation) and MASSAGE.
Function of the Eco-Stim™ TENS + EMS: The device has 22 programs (9 TENS programs, 8 EMS programs and 5 MASSAGE programs) and applies electric currents in the low-frequency range for therapy. Each program controls the generated electric impulses, intensity, frequency and pulse width.
Based on simulating the body’s natural pulses, the mechanism of electrical stimulation equipment is to create electric impulses that are transcutaneous transmitted to nerves or muscle bers through the electrode. The intensity of the dual channel can be adjusted independently and applied individually to one body part. This dual channel device can be used with four electrodes, which allow you to stimulate one muscle group simultaneously with a wide selection of standard programs. The electrical pulse is rst transmitted to the tissue, and then aects the transmission of stimulation in nerves as well as muscle tissues in the body parts.
1.2 Medical background
1.2.1 ABOUT PAIN
Pain is an important signal in the human body warning system. It reminds us that something is wrong, without which, abnormal conditions may go undetected, causing damage or injury to vital parts of our bodies.
Pain does not occur until encoded messages travel to the brain where they are decoded, analyzed, and reacted to. The message is transmitted via dierent nerves that travel up the spinal cord to the brain. Pain is felt when the brain interprets the message.
1.2.2 WHAT IS TENS?
TENS (Transcutaneous Electrical Nerve Stimulation) is often eective for pain relief. It is used daily and clinically proven by physiotherapists, caregivers and top athletes around the world. High-frequency TENS activates the pain-inhibiting mechanisms of the nervous system. Electrical impulses from electrodes, placed on the skin over or near the pain area stimulate the nerves to block the pain signals to the brain, causing the pain to go un perceived. Low-frequency TENS facilitate the release of endor­phins, the body’s natural painkillers.
1.2.3 WHAT IS EMS?
Electrical Muscle Stimulation is an internationally accepted and proven way of treating muscular injuries. It works by sending electronic pulses to the muscle being treated and causes the muscle to exercise passively. It is a product derived from the square waveform, originally invented by John Faraday in 1831. Through the square wave pattern, it is able to work directly on muscle motor neurons. The EMS System uses low frequency and in conjunction with the square wave pattern allows direct work on muscle groups.
1.2.4 WHAT IS MASSAGE?
The massage function is a non-medical function. The Massage stimulation program provides relaxing muscle vibration to loosen tight muscles.
-
76
Page 5
2. SAFETY INFORMATION
2.1 Intended Use
TENS mode
TENS mode is used for temporary relief of pain associated with sore and aching muscles in the neck, shoulder, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household activities.
EMS mode
EMS mode is designed to stimulate healthy muscles in order to improve and facilitate muscle performance.
Users must be 18 years or older.
2.2 Important Safety Precautions and Warnings
It is important to read all warnings and precautions in this manual because they are intended to keep you safe, prevent injury and avoid a situation that could result in damage to the device.
SAFETY SYMBOLS USED IN THIS MANUAL
2.2.1 Contraindication
1) Do not use this device if you are using a cardiac pacemaker, implanted debrillator, or other implanted metallic or electronic devices. Such use could cause electric shock, burns, electrical interference, or death.
2) The device should not be used when cancerous lesions or
other lesions are present in the treatment area.
3) Stimulation should not be applied over swollen, infected,
inamed areas or skin eruptions (e.g. phlebitis, thrombo­ phlebitis, varicose veins, etc.).
4) Electrode placements must be avoided in the carotid sinus area (anterior neck) or transcerebrally (through the head).
5) This device should not be used in overly enervated areas.
6) Inguinal hernia.
7) Do not use on scarred areas following a surgery for at least 10 months after the operation.
8) Do not use with severe arterial circulatory problems in the lower limbs.
2.2.2 Warning
1) If you have had medical or physical treatment for your pain, consult with your physician before use.
2) If your pain has not subdued, becomes more than mild, or lasts for more than ve days, stop using the device and consult with your physician.
3) Do not apply stimulation over your neck because this could cause severe muscle spasms resulting in closure of your airway, diculty in breathing, or adverse eects on heart rhythm or blood pressure.
4) Do not apply stimulation across your chest because the introduction of electrical current into the chest may cause rhythm disturbances to your heart, which could be lethal.
5) Do not apply stimulation over, or in proximity to cancerous lesions.
6) Do not apply stimulation in the presence of electronic monitoring equipment (e.g. cardiac monitors, ECG alarms), which may not operate properly when electrical stimulation device is in use.
7) Do not apply stimulation while bathing or showering.
98
Page 6
8) Do not apply stimulation while sleeping.
9) Do not apply stimulation while driving, operating machinery,
or during any activity when electrical stimulation can put you at risk of injury.
10) Apply stimulation only to normal, intact, clean, healthy skin.
11) The long-term eects of electrical stimulation are unknown.
This electrical stimulation device cannot replace drugs.
12) Stimulation should not take place while the user is
connected to high-frequency surgical equipment, which may cause burn injuries on the skin under the electrodes, as well as problems with the stimulator.
13) Do not use the stimulator in the vicinity of shortwave or
microwave therapy equipment, since this may aect the output power of the stimulator.
14) Never use in the thoracic area. Stimulation electrodes should
never be placed anywhere on the front of the thorax
(marked by ribs and breastbone), and not on the two large pectoral muscles. Placing electrodes in these areas can increase the risk of ventricular brillation and lead to cardiac arrest.
15) Never place electrodes on eyes, head or face.
16) Never place electrodes near genitals.
17) Never place electrodes on skin that lacks normal sensation.
18) Keep electrodes separated during treatment. It could result
in improper stimulation or skin burns if electrodes are in contact with each other.
19) Keep the stimulator out of reach of children.
20) Consult your doctor if you have any questions.
21) Discontinue use and do not increase the intensity level if you
feel discomfort during use.
2.2.3 Precautions
1) TENS is not eective for pain of central origin including headache.
2) TENS is not a substitute for pain medications and other pain management therapies.
3) TENS is a symptomatic treatment and, as such, suppresses the sensation of pain that would otherwise serve as a protective mechanism.
4) Eectiveness is dependent upon patient selection by a practitioner qualied in the management of pain.
5) Since the eects of stimulating the brain are unknown, stimulation should not be applied across your head, and electrodes should not be placed on opposite sides of your head.
6) The safety of electrical stimulation during pregnancy has not been established.
7) You may experience skin irritation or hypersensitivity due to the electrical stimulation or electrical conductive medium (silica gel).
8) If you have suspected or diagnosed heart disease or epilepsy, you should follow precautions recommended by your physician.
9) Do not use if you have a tendency to bleed internally, e.g. following an injury or fracture.
10) Consult with your physician prior to using the device after a recent surgical procedure, because stimulation may disrupt the healing process.
11) Use caution if stimulation is intended to be applied over the menstruating or pregnant uterus.
12) For single patient use only.
1110
Page 7
13) This stimulator should not be used by patients who are
noncompliant, emotionally disturbed or suer from dementia.
14) The instruction for use is listed and should be obeyed; any
improper use may be dangerous.
15) Rare cases of skin irritation may occur at the site of the
electrode placement following long-term application.
16) Do not use this device in the presence of other equipment
which sends electrical pulses to your body.
17) Do not use sharp objects such as a pencil or ballpoint tip
pen to operate the buttons on the control panel.
18) Check the electrode connections before each use.
19) Electrical stimulators should only be used with the electrodes
recommended for use by the manufacturer.
2.2.4 Adverse Reactions
1) Possible skin irritation or electrode burn under the electrodes
may occur.
2) On very rare occasions, rst-time users of TENS report feeling
light-headed or faint. We recommend that you use the product while seated until you become accustomed to the sensation.
3) If the stimulation makes you uncomfortable, reduce the
stimulation intensity to a comfortable level and contact your physician if problems continue.
3. GETTING TO KNOW YOUR DEVICE
3.1 Accessories
No. Description QTY
1 Eco-Stim™ TENS + EMS 1 pc
2 Electrode pad (2 in x 2 in) 4 pcs
3 Electrode wires 2 pcs
4 Batteries (1.5V, AAA) 3 pcs
5 Instruction manual 1 pc
3.2 LCD display
15
1 2
3 4
5
6 7 8
No. Function Description No. Function Description
1 Timer Sign 8 Intensity for Channel 2
2 Treatment mode 8 Symbol of pulse width (μs)
3 Key locking symbol 10 Symbol of pulse rate (Hz)
4 Symbol of Channel 1 11 Symbol of Channel 2
5 Intensity for Channel 1 12 Symbol of treatment time (min)
6 Symbol of SET 13 Program number and Treatment time
14 Symbol of Program
7 Indicator of no load
(Channel 1 and Channel 2)
15 Low battery indicator
1312
14
13
12
11
10 9
Page 8
3.3 Device Illustration 3.3 Device Illustration
No.
Description
1 LCD display
[ON/OFF/M] button:
In power saving mode, press the [ON/OFF/M] button to turn on the device;
2
1
In standby mode, press the [ON/OFF/M] button to select treatment mode; In standby mode, press and hold the [ON/OFF/M] button to turn off the device; In treatment mode, press the [ON/OFF/M] button to stop the treatment.
[+] button:
2 3
4
5
6
7
8
In standby or treatment mode, press the [+] button to increase the intensity
3
of the CH1; In setting mode, press the [+] button to increase the corresponding data for the pulse rate, pulse width or treatment time.
[-] button:
In treatment mode, press the [-] button to decrease the intensity of the CH1
4
At the key locking mode, press the [-] button to unlock the keys. In setting mode, press the [-] button to decrease the corresponding data for the pulse rate, pulse width or treatment time.
[+] button:
In standby or treatment mode, press the [+] button to increase the CH1 or CH2;
5
At setting mode, press the [+] button to increase the corresponding data for the pulse rate, pulse width or treatment time.
[-] button:
In treatment mode, press the [-] button to decrease the intensity of CH2;
6
In the key locking mode, press the [-] button to unlock the keys. In setting mode, press the [-] button to decrease the corresponding data for the pulse rate, pulse width or treatment time.
[P] button:
7
In standby mode, press the [P] button to select the treatment program.
9
In standby mode, press and hold [P] button to enter the setting mode.
8 Battery cover
9 Output socket
1514
Page 9
4. SPECIFICATION
4.1 Technical information
Device Name Norco® Eco-Stim™ TENS + EMS
Model/type NC89481
Power sources 4.5V D.C., 3x AAA batteries
Output channel Dual channel
Waveform Bi-phase square-wave pulse
Output current Max. 120mA (at 500ohm load)
Output intensity 0 to 40 levels, adjustable
Treatment mode: TENS, EMS and MASSAGE mode
Operating condition
Storage condition
Dimension 109 x 54.5 x 23mm (L x W x H)
Weight About 70g (without batteries)
Automatic shuto 1 minute
Classification BF type applied part, internal power equipment, IP22
Size of electrodes pad 50 x 50mm, square
Output precision ±20% error is allowed for all the output parameters
TENS mode
Number of programs 9 programs
P.W. (Pulse Width) 100-300μs
P.R. (Pulse Rate) 2-100Hz (Hz=vibration per second)
Treatment time 5-90 minutes
5° C to 40° C with a relative humidity of 15%-93%, atmospheric pressure from 700 hPa to 1060 hPa
-10° C to 55° C with a relative humidity of 10%-95%, atmospheric pressure from 700 hPa to 1060 hPa
EMS mode
Number of programs 8 programs
P.W. (Pulse Width) 100-300μs
P.R. (Pulse Rate) 2-100Hz (Hz=vibration per second)
Treatment time 5-90 minutes
MASSAGE mode
Number of programs 5 programs
P.W. (Pulse Width) 100-250μs
P.R. (Pulse Rate) 2-100Hz (Hz=vibration per second)
Treatment time 5-90 minutes
5. OPERATING INSTRUCTION
5.1 Battery
5.1.1 Check / replace batteries
Open the battery cover, insert four batteries (type AAA) into the battery compartment. Make sure you are installing the batteries properly. Be sure to place the batteries according to the positive terminal (+) and negative terminal (-) markings in the battery compartment of device.
5.1.2 Disposal of battery
Spent batteries should not be placed in household garbage. Dispose of the batteries following your local regulations. As a consumer, you have a legal obligation
to dispose of spent batteries properly.
1716
Page 10
1) If a battery was swallowed accidentally, please seek medical
assistance immediately!
2) In case of battery leakage, please avoid contact with the
battery through skin, eyes and mucus membranes. If contact occurs, please wash the contacted body part with plenty of clean water and contact your doctor immediately.
3) Batteries should not be dismantled, thrown into re or
short-circuited.
4) Protect batteries from excess heat; take the batteries out of the
product if they are spent or you don't use it for a long time. This can prevent device from damage due to battery leakage.
5) Replace all of the batteries simultaneously.
6) Always use the same type of battery when replacing.
5.2 Connect electrode pads to electrode wires
Insert the electrode wire connector into electrode connector. Make sure the two components are properly connected to ensure optimal performance. Please refer to the picture below.
Caution
Always use electrode pads which comply with the requirements of the IEC/EN60601-1, ISO10993-1/-5/-10 and IEC/ EN60601-1-2, as well as CE and FDA 510(K) regulation.
5.3 Connect electrode wires to device
Before proceeding to this step, ensure that the device is completely switched OFF.
Hold the insulated portion of the electrode wire connector and insert the connector into the port on the top of the device.
Ensure the electrode wires are inserted correctly. The device has two output ports controlled by Channel A and Channel B at the top of the unit. You may choose to use one channel with one pair of electrode wires or both channels with two pairs of electrode wires. Using both channels gives the user the advantage of stimulating two dierent areas at the same time.
Caution
Do not insert the plug of the electrode wires into any AC power supply socket.
5.4 Electrode
5.4.1 Electrode options
The electrodes should be routinely replaced when they start to lose their adhesiveness. If you are unsure of your electrode adhesive properties, please order new replacement electrodes. Follow application procedures outlined on electrode packaging when using the new replacement electrodes to maintain optimal stimulation and to prevent skin irritation.
5.4.2 Place electrodes on skin
Place the electrode on the body part in need of treatment according to the instructions provided in this user manual. Cleaning the skin before use will help ensure the skin and electrode connect well.
1918
Page 11
Caution
1) Remove the electrodes from the skin with a light to moderate
slow pull in order to avoid injury in the event of highly sensitive skin.
2) Before applying the self-adhesive electrodes, it is
recommended that the skin be washed and degreased, and then dried.
3) Do not turn on the device when the self-adhesive electrodes
are not positioned on the body.
4) Prior to removing or moving the electrodes, switch o the
device or the appropriate channel rst in order to avoid unwanted irritation.
5) It is recommended that, at minimum, 1.97”x 1.97” self-
adhesive square electrodes are used at the treatment area.
6) Never remove the self-adhesive electrodes from the skin
while the device is still on.
5.4.3 Electrode placement
The Norco® Eco-Stim™ TENS + EMS is an OTC stimulator, suitable for home or clinic use. It should be used in accordance with the user manual. Place the electrode on the position where you feel pain, conduct treatment and adjust based on how it feels.
Shoulder
Arm
Hand
Back
Abdomen
Hip
1
1
2
2
Position of electrode placement under TENS programs
Neck
Leg
2
1
2120
Page 12
Foot
Arm
Joint
(knee)
Joint
(elbow)
Joint
(ankle)
Joint
(wrist)
Position of electrode placement under EMS programs
Neck
1 2
1
Shoulder
2
2
1
2
1
Hand
Back
Abdomen
Hip
Leg
Foot
1
2
1 2
2322
Page 13
6. INSTRUCTIONS FOR USE
6.1 Turn on
When using device for the rst time, open the battery cover and load three new batteries (Please kindly review Section 5.1.1 for the operating steps and schematic diagram).
Press the [ON/OFF/M] button to turn on the device, the LCD will light up and then enter standby mode as shown below.
6.2 Select treatment mode
Based on your needs, press [ON/OFF/M] button to select the treatment mode. The LCD displays as follows:
6.4 Set program parameter
Press and hold [P] button to enter the setting mode.
1) In the program p1 to p6 of the TENS mode, and the program p1 to p5 of the EMS mode, Press [+ ] / [- ] button to adjust treatment time.
The LCD displays as follows:
6.3 Select treatment program
Based on your needs, press [P] button to select the treatment program. The LCD displays as follows:
2) In the program U1 to U3 of the TENS mode, and the program U1 to U3 of the EMS mode, press [P] button to adjust pulse rate -> pulse width -> treatment time by setting the parameter.
3) Press [+] / [- ] button to adjust corresponding data.
2524
Page 14
Treatment
Program
mode
TENS
EMS
NO.
PU1
PU2
PU3
PU1
PU2
PU3
Treatment time
(min)
Default: 30 Adjustable:
(5-90)
Default: 30 Adjustable:
(5-90)
Default: 30 Adjustable:
(5-90)
Default: 30 Adjustable:
(5-90)
Default: 30 Adjustable:
(5-90)
Default: 30 Adjustable:
(5-90)
Frequency
(Hz)
Default: 50
Adjustable:
(2-100)
Default: 60
Adjustable:
(2-100)
Default: 60
Adjustable:
(2-100)
Default: 5
Adjustable:
(2-100)
Default: 60
Adjustable:
(20-100)
Default: 70
Adjustable:
(20-100)
Pulse width
(us)
Default: 180
Adjustable:
(100-300)
Default: 160-260
Adjustable:
(100-300)
Default: 260
Adjustable:
(100-300)
Default: 300
Adjustable:
(100-300)
Default: 200
Adjustable:
(100-300)
Default: 200
Adjustable:
(100-300)
PWM
4) Press [ON /OFF/M] button to return to the standby mode.
Type
Con.
IM
Con.
SY
AL
6.6 Adjust the output intensity
Place the electrodes on the body parts, press the [+] button to increase output intensity. Intensity will be increased to a higher level after each press. The device has 40 levels of output intensity. Adjust the intensity to a level you feel comfortable. The level of output intensity will be shown on the LCD:
If the intensity is too strong, you can press [-] button to decrease intensity to a lower level. When the output intensity of both channels decreases to zero, the stimulator will return to the standby mode. The LCD displays as follows:
6.5 Start treatment
Press the [+] button of CH1 to increase the channel 1 intensity, press the [+] button of CH2 to increase the channel 2 intensity. The LCD displays as follows:
Caution
If you feel or become uncomfortable, reduce the stimulation intensity to a more comfortable level and consult with your medical practitioner if problems persist.
2726
Page 15
6.7 Stop the treatment and turn o the device
Press the [ON/O FF/M] button to stop treatment during the treating mode. Press the [ON/OFF/M] button again to turn o the stimulator, and the LCD will be blank.
6.8 Load detection
Automatic detection of the load occurs when the intensity is above level 5. If there is no load detection or the electrode contacts has poor contact with the skin, the intensity will automatically return to level 0 and the symbol ashes. The stimulator will return to standby mode.
6.9 Low battery detection
When the batteries are low, the icon will ash. Stop the device and change the batteries.
Caution
1) Batteries may be fatal if swallowed. Keep the batteries and the product out of children's reach. If a battery is swallowed, go to a hospital immediately.
2) If there is battery leakage, avoid contact with skin, eyes and mucus membranes. Rinse the aected spots with plenty of clear water immediately and contact a physician right away.
3) Batteries must not be charged, dismantled, or short-circuited.
4) Protect batteries from excess heat. Take the batteries out of the device if they are spent or you will no longer use them. This prevents damage caused by leaking batteries.
6.10 Use of electrode pads
1) The electrode may only be connected with the Eco-Stim™ TENS + EMS device. Make sure the device is turned o when attaching or removing the electrode pads.
2) If you want to reposition the electrode during the application, turn the device o rst.
3) Electrode use may lead to skin irritations. If you experience such skin irritations, e.g. redness, blistering or itching, discontinue using them. Do not use the Eco-Stim™ TENS + EMS permanently on the same body part, as this may also lead to skin irritations.
4) Electrode pads are intended for single patient use and not for use with more than one person.
5) The electrode must connect entirely to the skin surface to prevent hot spots, which may lead to skin burns.
6) Do not use the electrode pads longer than suggested by electrode manufacturer as the connection between electrodes and skin deteriorates over time.
2928
Page 16
7) The adhesive force of the electrodes depends on skin
properties, storage condition, and the number of applications. If your electrode pads no longer fully stick to the skin surface, replace them with new ones. Stick the electrode pads back onto the protective foil after use and store them in the storage bag to prevent them from drying out. This retains the adhesiveness for a longer period.
Caution
1) Before applying the electrode, it is recommended that the
user’s skin be washed and degreased, and then dried.
2) Never remove the electrode from the skin while the device
is still on.
3) Only use the electrode pads recommended by the
manufacturer. Use of inferior electrode products could result in injuries to the user.
6.11 Where do I attach electrode pads?
1) Each person reacts dierently to electric nerve stimulation.
Therefore, the placement of the electrodes may deviate from one person to another. If the application is not successful, contact your healthcare provider to nd out which placement techniques are best for you.
2) Do not use smaller sized adhesive electrodes than what
was provided by the original manufacturer, otherwise the current density may be too high and cause injuries.
3) The size of the adhesive pads may not be customized,
e.g. by clipping o parts of them.
4) Make sure that the region radiating the pain is enclosed by
the electrodes. In case of painful muscle groups, attach the electrodes in such a way that the aected muscles are also enclosed by the electrodes.
Usage advice for TENS:
If you feel the output intensity too strong, you can press [-] button to decrease it.
If you don’t feel any discomfort during the treatment, we advise you to use the device until the session ends. Normally, the pain relief occurs after 5-10 min of treatment; Normally, we advise 1-2 treatments per day and one week as a treatment period.
After a treatment period, if pain relief is not achieved or the pain gets worse, please consult your doctor.
Usage advice for EMS:
Place the electrodes on the body part you want to treat referring to the picture on Section 5.3.3.
1-2 treatments per day, about one week as a treatment period.
We advise that you use the device for one session per time. If you feel discomfort during treatment, you can either pause the session or decrease the intensity of the output.
7. CLEANING AND MAINTENANCE
Fully comply with the following necessary daily maintenance requirements to make sure the device is intact and guarantee long-term performance and safety.
7.1 Cleaning and care for the device
1) Disconnect the electrodes from the stimulator. Clean the device with a soft, slightly damp cloth. In case of heavier dirt build-up, you may also apply a mild detergent.
2) Do not expose the device to moisture or dampness. Do not hold the device under running water, nor submerge it in water or any liquid.
3) The device is sensitive to heat and should not be exposed to direct sunlight. Do not place device on hot surfaces.
3130
Page 17
4) Clean the surface of the electrode pads carefully with a
damp cloth after making sure the device is turned o.
5) For best hygiene, each user should use his/her own set
of electrodes.
6) Do not use any chemical cleaners or abrasive agents
for cleaning.
7) Ensure that no water penetrates into the device. Should this
happen, use the device again only when it is completely dry.
8) Do not clean the device during treatment. Be sure that the
device is turned o before cleaning.
7.2 Maintenance
1) The manufacturer has not authorized any maintenance
agencies. If your device has any problems, please contact the distributor. The manufacturer will not be 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.
Each product in manufacturing has been inspected through systematic validation. Calibration and validation is not required for this device.
If your product does not reach the expected performance and the basic function has changed in normal use, please contact the retailer.
8. TROUBLESHOOTING
Should a malfunction occur while using the device, check whether the parameters are set appropriately for therapy, and adjust the control correctly. Please see the following table:
Malfunction Common reasons Countermeasure
1. There’s foreign matter in the battery compartment.
2. The batteries are dead or
No display
after
replacing
the
batteries
No
sensation
of
stimulation
Automatic
halt in the treatment
Rash or tickle
on the
skin occurs
in the
treatment
installed incorrectly.
3. There’s foreign matter in the battery interface.
4. The batteries are not the right model or something is wrong with the battery interface.
5. Exception reset
1. The electrode is not connected to the skin well.
2. The electrode wire is not plugged into the unit.
3. The batteries are dead.
4. The skin is too dry.
1. The electrode loses connection with the skin.
2. The batteries are dead.
1. The treatment time lasts too long.
2. The electrode is not in good contact with the skin.
3. The interface of the electrode is dirty or dry.
4. The skin is sensitive to the electrode.
1. Check and clean the compartment.
2. Replace with new batteries or install the batteries correctly.
3. Check and clean the interface.
4. Replace the batteries with the right model.
1. Check and re-apply to skin.
2. Check the connection.
3. Replace the batteries.
4. Wipe the electrode and the skin with a wet cotton cloth.
1. Check and place the electrode properly on the skin.
2. Replace the batteries.
1. Do the treatment once a day and shorten the treatment time.
2. Stick the electrode to the skin better
3. Wipe the electrode with a wet cotton cloth before use.
4. Check your allergic history. Change the electrode location or shorten the treatment time. If your skin is over-sensitive, stop the treatment or see a doctor.
3332
Page 18
9. STORAGE 11. ELECTROMAGNETIC COMPATIBILITY
9.1 Storing the Electrode Pads and Lead Wires
1) Turn the device o and remove the lead wires from the unit.
2) Remove the electrodes from your body and disconnect the lead wires from the electrodes.
3) Place the electrodes onto the plastic lm and store in the sealed package.
4) Wrap the lead wires and store in the sealed package.
9.2 Storing the Unit
1) Place the unit, electrodes, lead wires and manual back into the box. Store the box in a cool, dry place, -10° C ~ 55° C; 10% ~ 90% relative humidity.
2) Do not keep in places that can be easily reached by children.
3) When not in use for a long period, remove the batteries before storage.
10. DISPOSAL
Spent batteries should not be placed in the household garbage. Dispose of the batteries according to local regulations. As a consumer, you have the obligation to dispose of batteries properly.
Consult your municipal authority or your dealer for information about disposal.
At the end of the product lifecycle, do not throw this product into the normal household garbage. Bring it to a collection point for the recycling of electronic equipment. Obsolete electrical and electronic equipment may have potentially harmful eects on the environment. Incorrect disposal can cause toxins to build up in the air, water and soil and jeopardize human health.
(EMC) TABLES
Guidance and manufacturer’s declaration — electromagnetic emissions
The device is intended for use in the electromagnetic environment specied below. The user of the device should assure it is used in such environment.
Emissions test Compliance 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.
The device is suitable for use in all establishments, including those directly connected to the public low-voltage power supply network that supplies building power used or domestic purposes.
RF emissions CISPR11
RF emissions CISPR11
Harmonic emissions IEC 61000-3-2
Voltage uctuations / Flicker emissions IEC 61000-3-3
Group 1
Class B
Not applicable
Not applicable
3534
Page 19
Guidance and manufacturer’s declaration — electromagnetic immunity
The device is intended for use in the electromagnetic environment specied below. The user of the device should assure it is used in such environment.
Immunity test
Electrostatic discharge (ESD) IEC 61000-4-2
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
Power frequency (50Hz/60Hz) magnetic eld IEC 61000-4-8
NOTE:
IEC 60601 Test level
±8kV direct & indirect contact; ±15kV air discharge
±2 kV for power supply lines
± 1 kV line(s) to line(s)
<5% U (>95% dip in UT) for 0.5 cycle
40% U
T
(60% dip in UT) for 5 cycles
70% U
T
(30% dip in UT) for 25 cycles
<5% U (>95% dip in UT) for 5 sec
10V/m 10V/m
UT is the a.c. mains voltage prior to application of the test level.
Compliance level
±8kV direct & indirect contact; ±15kV air discharge
not applicable
not applicable
T
Electromagnetic environment - guidance
Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.
not applicable (for internally powered equipment)
not applicable (for internally powered equipment)
not applicable
T
(for internally powered equipment)
Power frequency magnetic elds should be at levels characteristic of a typical location in typical commercial or hospital environment.
not applicable
Guidance and manufacturer’s declaration — electromagnetic immunity
The device is intended for use in the electromagnetic environment specied below. The user of the device should assure it is used in such environment.
IEC 60601
Compliance level
10V/m & table 9
Immunity test
Radiated RF IEC 61000-4-3
Test level
10V/m & table 9
Electromagnetic environment - guidance
Portable and mobile RF communications equipment should be used not 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
80 MHz to 800 MHz
800 MHz to 2.5 GHz
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 strength from xed RF transmitters, as determined by an electromagnetic site surveya, should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol:
b
.
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations.
Electromagnetic propagation is aected by absorption and reection from structures, objects and people.
3736
Page 20
a
Field strengths from xed transmitters, such as base stations 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 xed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the device is used exceeds the applicable RF compliance level above, the device 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, eld strengths should be
less than [Vi] V/m.
Test specications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment (Table 9)
Test
frequency
(MHz)
385
450
710 745 780
810
870
930
1720
1845
1970
2450
5240
5785
NOTE: If it is necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting antenna and the ME EQUIPMENT or ME SYSTEM may be reduced to 1 m. The 1 m test distance is permitted by IEC 61000-4-3.
Band
(MHz)
380­390
430­470
704­787
800­960
1700­1990
2400­2570
5100­5800
a)
Service
TETRA 400
GMRS 460,
FRS 460
LTE Band
GSM800/900,
TETRA 800,
iDEN 820, CDMA 850, LTE Band 5
GSM1800;
CDMA 1900;
GSM 1900;
DECT; LTE
Band 1, 3, 4,
25; UMTS Bluetooth,
WLAN,
802.11 b/g/n, RFID 2450, LTE Band 7
WLAN
802.11
13,17
a/n
a)
Modulation
modulationb)
FM
deviation 1kHz sine
modulationb)
modulationb)
modulationb)
modulationb)
modulationb)
Pulse
18Hz
c)
±5kHz
Pulse
217Hz
Pulse
18Hz
Pulse
217Hz
Pulse
217Hz
Pulse
217Hz
Maximum
b)
Power
(W)
1.8 0.3 27
2 0.3 28
0.2 0.3 9
2 0.3 28
2 0.3 28
2 0.3 28
0.2 0.3 95500
Distance
(m)
Immunity Test Level
(V/m)
a) For some services, only the uplink frequencies are included.
b) The carrier shall be modulated using a 50% duty cycle square wave signal.
c) As an alternative to FM modulation, 50% pulse modulation at 18Hz may
be used because it does not represents actual modulation.
3938
Page 21
12. NORMALIZED SYMBOLS 13. WARRANTY
IP22
Electrical devices are recyclable material and should not be disposed of with household waste after use! Help us protect the environment and save resources by taking this device to the appropriate collection points. Please contact the organization which is responsible for waste disposal in your area if any questions.
Applied part of type BF
Refer to instruction manual
The rst number 2: Protect against solid foreign objects of 12,5 mm Ф and greater. The second number: Protect against vertically falling water drops when enclosure tilted up to 15°. Vertically falling drops shall have no harmful eects when the enclosure is tilted at any angle up to 15°, vertically on either side.
R Year Month Numerical Order R: Product Model
Please contact your dealer or North Coast Medical in case of a claim under the warranty. If you have to return the unit, enclose a copy of your receipt with clear statement of defect description.
Warranty terms:
1) The warranty period for this device is 1 year from the 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 should be in the warranty period for the device.
3) The following cases are excluded under the warranty:
• All damages that arise due to improper operation, e.g. nonobservance of the user instructions.
• All damages due to repairs or tampering by the customer or unauthorized third-parties.
• Accessories which are subject to normal wear and tear.
• Device damages due to disassembling device.
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: North Coast Medical, Inc.
Manufacture date
4140
Page 22
USER NOTES
4342
Page 23
Eco-Stim
TENS + EMS
Instruction Manual
North Coast Medical, Inc. www.ncmedical.com
Manufactured for:
North Coast Medical, Inc. 780 Jarvis Drive, Suite 100 Morgan Hill, CA 95037 – U.S.A.
Made in China
REV89481i_0521
Loading...