easy home PL-009 Device Stimulation Device User Manual

easy home PL-009 Device Stimulation Device

Easy@Home PL-009(TENS) Overview

PL-009(TENS), a TENS (Transcutaneous Electrical Nerve Stimulation) device, is proven effective and safe for drug-free pain relief on many parts of the body including the waist, back, shoulders, joints, hands, legs and feet. TENS delivers small impulses to the electrode pads, in a way that stimulates the nerves to trigger the body’s natural painkillers, endorphins. As a result, the pain and tightness of muscles are relieved.
The PL-009(TENS) Pain Relief Device is a model of the Easy@Home TENS Unit product line that is perfect for those with any generalized pain. It comes with two independent output channels, which is part of the unique­ness of this model. It is easy to use in two different spots on the body at the same time with different intensity levels. The unit features 10 adjustable intensity levels, three massage types: massage, beat, and knead, and 5 automatic procedure modes (mixtures of the massage types and speeds) to target a specific area best. This device is portable, very safe, and perfect for pain relief, relaxation, and sore and tired muscles. The LCD display is very convenient showing you the mode type, impulse frequency/speed, body target area, and time remaining through easy-to-understand visual representations. This portable and convenient unit is FDA Cleared for OTC (over-the-counter) use without a prescription.

What’s in the Box

How to Operate PL-009(TENS)

NOTE: Each channel has its own individual knob to turn the channel on or off and adjust the intensity.

Let’s Get Started with PL-009(TENS) (Setup)

Setup/start guide

Unpack the product, adapter/accessories.

• Step 1: Make sure the PL-009(TENS) Pain Relief Device has working batteries installed
• Step 2: Connect the pads to the leads; connect the top of the leads to the device
• Step 3: Put the PL-009(TENS) Pain Relief Device pads on the body area that requires treatment Step 4: Turn the Device ON and Choose Modes/Intensity/Speed

Batteries

Place the 4 AAA batteries in the device (included). Make sure the polarity is correct and the batteries fit snugly in the compartment in the back of the device before the first use

Connect pads to leads and leads to device

Connect the 4 electrode pads to the 2 lead wires (2 connected to each lead), and the other end of the lead wires to the left and right output of top of the device (channel A and channel B). You can use one or both channels; just make sure you have the correct channel on to match up with the pads you are using.

Pad placemat

Attach one or two pairs of electrode pads to the treatment area, such as the shoulder and/or leg. Make sure to press down so the electrode pads adhere well to the skin. Make sure that the pads do not touch each other.

Turn on device

• Turn one of the two-channel knobs to 1 to turn on PL-009(TENS). This turns on your device.
• You will see a letter P on the screen indicating your device is ready for use.
• You can turn on only A or B channels or both channels.
• If you want to turn on both channels, make sure both channel knobs are turned to one.

Select an auto procedure mode or manual mode

One of the features of the Easy@Home PL-009(TENS) is auto procedure modes. Each muscle group responds differently to various electronic pulses, and we’ve created a mixture of the massage types and speeds to form S preset auto procedure modes to target the best suitable area for your convenience. These areas are represent­ ed dots on the body image ” “on the display. But if you prefer to customize the massage sensation by yourself, you can choose one of the massage types such as massage, beat, or knead and adjust the speed to get the best massage sensation that you feel most comfortable on a given area.

Adjust the intensity as needed

Once you’ve selected a massage program, adjust the intensity to find the setting that feels best. You have control over the intensity of the pulses to ensure that you’re getting the desired results. NOTE: adjust gradual­ ly from low to high. Remember, each channel has its own knob to adjust the intensity for the corresponding lead.

Operation

How to operate the product

Turn on the device by spinning one or two spin dials on the side of the unit and click on 1. Turn on both dials if you want to use both channels for two separate areas. The screen will show a Pon the screen display. This means the EHE009 device is ready to use.
You can choose between auto procedure modes or manual customized modes

1. If you prefer one of the auto procedure modes (mixture of message types and speed), press the button that matches your treatment area best such as SHOULDER or WAIST.
2. if you prefer to customize the massage sensation by yourself, you can choose one of the manual massage types: MASSAGE, BEAT, or KNEAD. This will override the auto procedure mode. Then increase or decrease the SPEED by pressing “SPEED+” or “SPEED-“.

Scrolling the channel knobs will increase the intensity (strength) for channel A and channel B. Each channel has its own individual intensity knob. The intensity will have a max level of 10. Stay at a level that is comfortable for you. THEN simple enjoy the therapy.
There is a 15-minute countdown timer on the screen. The device will timeout and turn off after the session. If you want to continue a certain massage mode in an auto procedure program (mixture of 3 mode types), PRESS repeat and the symbol ” “will appear on the display screen. Press the symbol again to turn off the repetition of the chosen mode. If you want to conclude the treatment before the timer is up, spin either dial or both dials on each side of the unit to the “OFF” label until you hear “click” sound.
NOTE: It is recommended to begin treatment from the lowest intensity (1) and then gradually adjust to a comfortable level on a scale from level 1 to 10 with 10 being the highest intensity.
NOTE : You may choose to use either the left side or the right side of the unit, or both, but the electrode pads must be used in pairs to work. Meaning you cannot use one electrode from each side of the unit.

Reference Chart

BUTTON

| ****

OUTPUT RESPONSE

---|---

Scroll Left or Right Knob to 1/Off Label

| ****

ON/OFF

Scroll Left Knob

| ****

Change Intensity Channel A

Scroll Right Knob

| ****

Change Intensity Channel B

MASSAGE

| ****

Massage Type-Manual Mode

BEAT

|

Massage Type-Manual Mode

---|---

KNEAD

|

Massage Type- Manual Mode

BACK (Automatic Mode)

| COMBINATION:

BEAT output for 30 seconds, KNEAD output for 30 seconds,

the MASSAGE output for 30 seconds,

the BEAT plus KNEAD outputs for 30 seconds, and the MASSAGE output for 30 seconds

SHOULDER (Automatic Mode)

|

BEAT output

JOINT (Automatic Mode)

|

COMBINATION:

MASSAGE output for 30 seconds,

MASSAGE plus BEAT outputs for 30 seconds, BEAT output for 30 seconds,

KNEAD output for 30 seconds, BEAT output for 30 seconds,

and KNEAD output for 30 seconds

HAND-FOOT (Automatic Mode)

| COMBINATION:

BEAT output for 60 seconds, KNEAD output for 30 seconds,

MASSAGE plus BEAT outputs for 30 seconds, MASSAGE output for 30 seconds,

and BEAT output for 30 seconds

SOLE (Automatic Mode)

| COMBINATION:

MASSAGE plus BEAT outputs for 30 seconds, BEAT output for 30 seconds,

MASSAGE output for 30 seconds, BEAT output for 60 seconds,

and KNEAD output for 30 seconds

REPEAT

|

repeat of the last output for the remainder of the session for any automatic mode-turn repeat off by pressing REPEAT again (for any auto mode)

SPEED+

|

increase of the output frequency for manual mode

SPEED-

|

decrease of the output frequency for the manual mode

Attach Electrode Pads to the Desired Area

Once you decide the desired muscles or joints you wish to treat, plug the electrode pads into the lead wires and press the pads to stick to the desired skin area. Our high-quality electrode pads attach easily to the treatment area, so there is no need to press down too hard. The pads were designed to remain attached during the treatment. The pads are covered with a gel that facilitates the transfer of the micro-currents to your skin. Overtime, these pads will wear out and should be replaced. Contact the seller for replacement nforma­tion.

JOINTS

Athletes and arthritis sufferers really feel the painful effects of tight joints. Use electrotherapy to massage these areas to bring comfort and relief. Experiment with the placement of the pads to find the position that brings the most relief to you. Place pads around the painful area and not directly on it.
FOREARMS/ HANDS

Carpal tunnel can be extremely painful and can greatly limit your ability to use your hands and arms. TENS therapy can help alleviate the pain from this and similar ailments. This can be a sensitive area for some individuals; we recommend starting out treatment at the lowest setting and increase gradually as needed.
SHOULDERS

Improper posture, book bags, sports injuries, and natural wear and tear can create stress on our shoulders. To relieve yourself of discomfort and pain, use the Easy@Home EHE009 TENS Pain Relief Device on your shoulders. Start with the electrode pads on either side of the center of the painful area and adjust the distance of the pads to the centre of the source of the pain for the best results.
WAIST

Sitting for too long, having weak hip flexors, or exercising can aggravate pain in our hips and waist. To alleviate tension or pain, attach the electrode pads around your waist and lower back. Space the pads from 2 inches to 6 inches apart for the best results.

THIGHS/ LEGS

Bicyclists know the incredible stress and strain that your thigh muscles can experience. Since these large muscles are so crucial to our mobility, it is important to take care of them and help them relax. Placing the electrode pads on the top and back side of your thighs is an uncomplicated way to relax and de-stress this area.

FEET

Wearing high heels, running, walking, or unexpected trauma can cause muscle spasms, and pain in our feet. These muscles are some of the smallest in our body, but also, some of the most important. To relieve your feet of the daily stress they endure, attach the electrode pads to the soles of your feet. The pads can also be used on your ankles and the tops of your feet.

Best Practices

• To enhance and ensure the desired results, each treatment should last approximately 15 minutes.
  This ensures that the muscles and deep tissue are stimulated enough to elicit positive results. Using the massager for anything shorter than 10 minutes won’t allow your system to adapt to positive changes.

• To maximize results, use the unit twice a day.

• Think of TENS as a type of massage. You will want to use the PL-009 TENS Pain Relief Device twice a day for 30 minutes to see consistent results in relieving your pain. Using your TENS occasionally, does not allow you to take full advantage of its benefits.

• Intensity and speed are up to you.

• Your level of comfort will determine the intensity and speed used. The Easy@Home PL-009 should never be uncomfortable-it is in fact for pain therapy. If you might wonder if higher speeds and intensities mean better results, the truth is consistent use and application produce the best results.

• Clean the device consistently for your safety.

• Bacteria from your skin and sweat can grow on the electrode pads. They will need to be replaced after some time. To ensure cleanliness and extend the life of the pads, wipe the device or pads or both with a moistened cloth from time to time. This will prevent the growth of unwanted germs and dirt.

• You can extend the life of the pads by following these practices:

• Always cleanse the skin with soap and water before attaching the electrode pads. (The skin should be completely dry before treatment.) Place the pads on the plastic sheet they came on when not in use. The life of the pads can be reduced significantly if they are exposed to air between uses or touched by any other surface such as; clothing, fingertips, carpet, etc. When the pads begin to lose their adhesion, they will need to be replaced.

• Purchase electrode pad replacements as needed.

• The electrode pads are not permanent. They are disposable and will lose their stickiness over time. It is recommended to purchase pad replacements when the pads lose adhesion. To ensure the best experience possible, always use genuine Easy@Home compatible accessories.

FAQ

• Why I can only feel a massage sensation from one channel?
  Since your PL-009 Unit has two independent channels and each channel has its own individual knob that turns the channel on or off and adjusts the intensity, you want to make sure:

  • Leads are connected properly on both channels
  • TENS pads are applied to the two areas on the body firmly before turning on the device
  • Make sure 2 pads are attached to each lead you are using
  • You turn on the both knobs that control the separate channels
  • You turn both knobs to the proper intensity shown in the round “intensity window” for either side

• Why am I not experiencing any results?
  While you might feel refreshed after your first treatment, it takes time for long lasting benefits to occur. Those who stay with a regular treatment routine experience the best results with TENS. For many centuries, many people have experienced the benefits of TENS. Now you can do too from the comfort of your home or even on the go (such as at work or traveling). The Easy@Home PL-009(TENS) is a comprehensive electronic therapy device for those just starting out with TENS or those who prefer a helpful overall experience in relieving pain.

• Why is the stimulation weak or nonexistent?
  Since the Easy@Home PL-009(TENS) is a unique electronic device, the lack of stimulation means that it probably is not properly connected somewhere. First, make sure both leads are plugged into the device and the pads are connected to the leads securely. Also, ensure that all the electrode pads are connected closely to the skin and you are using the electrode pads in pairs of two or four. Each pair should be connected to one lead wire.
  THINGS TO TRY:

  • Disconnect the cables and try reconnecting to ensure that the electrode pads do not touch each other.
  • Replace the batteries; weak batteries are the main cause of weak or non-existent pulses.
    

• Why is my skin red or feeling numb?
  If your skin is feeling numb, then either the treatment is too strong, or you may be overusing the device. Reduce usage or lower the intensity and/or speed of the treatment. If your skin becomes red or a rash develops, you may be having a reaction to the gel on the pads. However, particularly sensitive people may experience redness or rash.
  PLEASE NOTE : If you notice a reaction of redness or a rash, discontinue use immediately and consult a medical professional.

• Why won’t my pads stick to my skin?
  Over time, the pads will lose adhesion and must be replaced. This is normal. Our pads are specifically designed to be long-lasting and are made using solid-core carbon and American-sourced gel, certified latex-free, for maximum sessions. Not only does this provide a hygienic experience, it also ensures that the electrode pads are always working to the best ability for your convenience. You can extend the life of the pads by following our best practice instructions on page 8.

• Why won’t my device turn on?
  Check if the battery is out of power. If so, replace the batteries. The device requires 4AAA batteries DC 6V. The unit is “ON” when the letter “P” appears on the LCD display but DOES NOT begin treatment until you choose a treatment type and increase the intensity.
  PLEASE NOTE: Make sure to press/connect the pads to the skin BEFORE increasing the intensity and choosing mode.

Specifications

1. Liquid crystal display (LCD) screen
2. Power: DC 6V, 4 AAA batteries
3. Size : 19.9×5.7×2.2cm
4. Weight : 137g
5. Two output channels
6. Adjustable speed and intensity
7. Accessories included: 4 electrode pads, 2 electrode wires and 4 AAA batteries

Safety Warnings

Contraindications

• Do not use this device on patients who have a cardiac pacemaker, implanted defibrillator, or other implanted metallic or electronic device, because this may cause electric shock, burns, electrical interference, or death.
• Do not use this device on patients whose pain syndromes are undiagnosed.

Warnings

• Do not apply stimulation over the patient’s neck because this could cause severe muscle spasms resulting in closure of the airway, difficulty in breathing, or adverse effects on heart rhythm or blood pressure.
• Do not apply stimulation across the patient’s chest, because the introduction of electrical current into the chest may cause rhythm disturbances to the patient’s heart, which could be lethal.
• Do not apply stimulation over or in proximity to, cancerous lesions.
• Do not apply stimulation when the patient is in the bath or shower.
• If you have one of the following conditions, please consult with your physician before purchasing or using this device:  Acute disease, malignant tumour, infective disease, pregnant, heart disease, high fever, abnormal blood pressure, lack of skin sensation or an abnormal skin condition, any condition requiring the active supervision of a physician.

Precautions

• Do not use this device while driving.
• Do not use this device while sleeping.
• Do not use this device in high-humidity areas such as a bathroom.
• Keep the device away from wet, high temperatures and direct sunlight places.
• Keep this device out of reach of children.
• Stop using this device at once if you feel pain, discomfort, dizziness or nausea and consult your physician.
• Do not attempt to move the electrode pads while the device is operating.
• Do not use the device around the heart, on the head, mouth, genitals or blemished skin areas.
• Do not apply stimulation of this device in the following conditions

1. across the chest because the introduction of electrical current into the chest may cause rhythm disturbances to the heart, which could be lethal;
2. over painful areas. Please consult with your physician before using this device if you have painful areas;
3. over open wounds or rashes, or over swollen, red, infected, or inflamed areas or skin eruptions (e.g., phlebitis, thrombophlebitis, varicose veins). Apply stimulation only to normal, intact, clean, healthy skin;
4. in the presence of electronic monitoring equipment (e.g., cardiac monitors, ECG alarms). The electronic stimulator may not operate properly when the electrical stimulation device is in use;
5. while operating machinery, or during any activity in which electrical stimulation can put you at risk of injury;
6. on children

Be aware of the following:

1. to consult with your physician before using this device. The simulation with the device may:
2. cause lethal rhythm disturbances to the heart in susceptible individuals;
3. disrupt the healing process after a recent surgical procedure;
4. that the device is not effective for pain of central origin, including headache;
5. that the device is not a substitute for pain medications and other pain management therapies;
6. that the device has no curative value;
7. that the device is a symptomatic treatment and, as such, suppresses the sensation of pain that would otherwise serve as a protective mechanism;
8. that the long-term effects of electrical stimulation are unknown;
9. that the user may experience skin irritation, burns or hypersensitivity due to the electrical stimulation or electrical conductive medium (gel);
10. if the user has suspected or diagnosed epilepsy, the user should follow precautions recommended by his or her physician;
11. to use caution if the user has a tendency to bleed internally, such as following an injury or fracture;
12. use caution if stimulation is applied over the menstruating uterus;
13. use caution if stimulation is applied over areas of skin that lack normal sensation;
14. stop using the device if the device does not provide pain relief;
15. use this device only with the leads, electrodes, and accessories that the manufacturer recommends;
16. Do not share the use of the electrode pads with others;
17. Do not use the device while it’s charging;
18. Dispose of the battery-containing device according to local, state, or federal laws.

The long-term effects of electrical stimulation are unknown. Since the effects of stimulation of the brain are unknown, stimulation should not be applied across the head, and electrodes should not be placed on opposite sides of the head. The safety of electrical stimulation during pregnancy has not been established. Some patients may experience skin irritation or hypersensitivity due to the electrical stimulation or electrical conductive medium (gel). Patients with suspected or diagnosed heart disease should follow precautions recommended by their physicians. Patients with suspected or diagnosed epilepsy should follow precautions recommended by their physicians. Use caution if stimulation is applied over the menstruating or pregnant uterus.

Adverse reactions

• Patients may experience skin irritation and burns beneath the stimulation electrodes applied to the skin;
• Patients may experience headaches and other painful sensations during or following the application of electrical stimulation near the eyes and to the head and face.
• Patients should stop using the device and should consult with their physicians if they experience adverse reactions from the device.

Environmental condition for normal working, transport and storage

• Normal working ambient temperature: 5°C~40°C (41°F~104° F)
• Normal working ambient humidity: 15%-90% RH
• Transport and storage ambient temperature: -25°C~ 70°C (-13° F~ 158° F) T
• transport and storage ambient humidity: 0%-90% RH
• Atmospheric pressure: 70kPa~ 106kPa

Symbols Interpretation

Safety test standards:

• Medical Devices Directive 93/42/EEC
• IEC60601-1:2005+A 1 :2012/EN 60601-1 :2006Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
• IEC 60601-1-2:2007/EN 60601-1-2:2007 Medical electrical equipment – Part 1-2: General requirements for safety – Collateral standard: Electromagnetic compatibility – Requirements and tests
• IEC 60601-2-10:2012/EN 60601-2-10:2000+A 1:2001 Medical electrical equipment – Part 2-10: Particular requirements for the safety of nerve and muscle stimulators
• IEC 60601-1-11:2010 Medical electrical equipment — Part 1-11: General requirements for basic safety and essential performance — Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
• ISO 15223-1:2016 Medical devices – Symbols to be used with medical device labels, labelling and informa­tion to be supplied – Part 1: General requirements
• EN 1041 Information supplied by the manufacturer with medical devices
• IEC/60601-1-6/ EN 60601-1-6 Medical electrical equipment- Part1 -6: General requirements for basic safety and essential performance – Collateral standard: Usability
• IEC 60601-1-11/ EN 60601-1-11 Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance – Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
• IEC 62304/ EN 62304 Medical device software – Software life-cycle processes
• IEC 62366/ EN 62366 Medical devices -Application of usability engineering to medical devices
• ISO 10993-1 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk manage- ment process

FCC Statement

Electromagnetic Compatibility and FCC Compliance Statement

1. This product needs special precautions regarding electromagnetic compatibility (EMC) and needs to be installed and put into service according to the EMC information provided, and this unit can be affected by portable and mobile radio frequency (RF) communications equipment.
2. Do not use a mobile phone or other devices that emit electromagnetic fields, near the unit. This may result in incorrect operation of the unit.
3. Caution : This unit has been thoroughly tested and inspected to ensure proper performance and operation!
4. Caution: This machine should not be used adjacent to or stacked with other equipment and if adjacent or stacked use is necessary, this machine should be observed to verify normal operation in the configuration in which it will be used.

Guidance and manufacture’s declaration – electromagnetic emission

The PL-009(TENS) is intended for use in the electromagnetic environment specified below.

The customer or the user of the PL-009(TENS) should assure that it is used in such an environment.

EMISSION TEST

|

COMPLIANCE

| ELECTROMAGNETIC ENVIRONMENT –

GUIDANCE

RF emissions CISPR 11

| Group 1|

The PL-009(TENS) use RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF emission CISPR 11| Class B|

The PL-009(TENS) is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Harmonic emissions

IEC 61000-3-2

| Not applicable (internal battery powered)
Voltage fluctuations/ flicker emissions

IEC 61000-3-3

| Not applicable (internal battery powered)
Guidance and manufacture’s declaration – electromagnetic immunity

The PL-009(TENS) is intended for use in the electromagnetic environment specified below. The customer or the user of PL-009(TENS) should assure that it is used in such an environment.
IMMUNllY TEST| IEC 60601 TEST LEVEL| COMPLIANCE LEVEL| ELECTROMAGNETIC ENVIRONMENT –

GUIDANCE

Electrostatic discharge (ESD) IEC 61000-4-2|

±6 kV contact

±8 kV air

|

±6 kV contact

±8 kV air

| Floors should be wood, concrete or ceramic tile. If the floor is covered with synthetic material, the relative humidity should be at least 30%.
|

±2 kV for power supply lines

±1 kV for input/ output lines

|

Not applicable (internal battery powered)

|

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

---|---|---|---

Surge

IEC 61000-4-5

| ± 1 kV line(s) to line(s)

± 2 kV line(s) to earth

|

Not applicable (internal battery powered)

|

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

|

<5%UT

(>95%dip in UT)

for 0.5 cycle

| |

Voltage dips, short interruptions and voltage variations on power supply input lines

IEC 61000-4-11

|

40%UT

(60%dip in UT)

for 5 cycles

70%UT

(30%dip in UT)

for 25 cycles

|

Not applicable (internal battery powered)

|

Mains power quality should be that of a typical commercial or hospital environment. If the user of the PL-009 requires continued operation during power mains interruptions, it is recommended that the PL-009 be powered from an uninterruptible power supply or a battery.

|

<5%UT

(>95%dip in UT)

for 5 sec

| |

Power frequency (50Hz/60Hz)

magnetic field IEC 61000-4-8

|

3A/m

|

3A/m

|

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

NOTE : UT is the a.c. mains voltage prior to application of the test level.
Guidance and manufacturer’s declaration – electromagnetic immunity

The PL-009(TENS) is intended for use in the electromagnetic environment specified below.

The customer or the user of the PL-009(TENS) should assure that it is used in such an environment.

IMMUNITY TEST| IEC60601 TEST LEVEL| COMPLIANCE LEVEL| ELECTROMAGNETIC ENVIRONMENT –

GUIDANCE

Conducted RF

|

3Vrms

|

3 Vrms

|

Portable and mobile RF communications equipment should be used no closer to any part of the PL-009(TENS), including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance

d-1,2fp

d -1,2fp 80 MHz to 800 MHz d -2,3!P 800 MHz to 2,5 GHz

Where Pis is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and dis the recommended separation distance in

metres (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:

I

IEC 61000-4-6| 150 kHz to|
| 80 MHz|

Radiated RF

|

3V/m

|

3V/m

IEC 61000-4-3| 80 MHz to|
| 2.5 GHz|
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 affected by absorption and reflection from structures, objects and people.

a: Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcasts and TV broadcasts 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 the location in which the PL-009(TENS) is used exceeds the applicable RF compliance level above, the PL-009(TENS)

should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the PL-009(TENS).

b: Over the frequency range of 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Recommended separation distances between portable and mobile RF communications equipment and the PL-009(TENS) .

The PL-009(TENS) is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the PL-009(TENS) can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications

equipment (transmitters) and the PL-009(TENS) as recommended below, according to the maximum output power of the communications equipment.

Rated maximum output power of transmitter (W)| Separation distance according to frequency of the transmitter (m)
150 KHz to 80 MHz| 80 MHz to 800 MHz| 800 MHz to 2.5 GHz
0.01| 0.12| 0.12| 0.23
0.1| 0.38| 0.38| 0.73
| 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 din metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where Pis the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

NOTE 1 : 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.

The subject device has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. The product generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that the interference will not occur in a particular installation. If the product does cause harmful interference to radio or television reception, which can be determined by turning the product on or off, the user is encouraged to try to correct the interference by one or more of the following:

• Reorient or relocate the receiving antenna;
• Increase the separation between the product and the receiver;
• Consult the dealer or an experienced radio /TV technician for help.
• Connect the equipment to an outlet on a circuit different from that to which the receiver is connected.

Changes or modifications to this product not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment.

Warranty

Warranty Information PL-009(TENS)

We are so confident that you will love this product that we offer a 1-Year PRODUCT Quality Guarantee.

Contents

• 1x TENS Unit
• 2 x Output Wire
• 4 x Gel Pads
• 1 x Manual
• 4 x AAA Batteries

Technical Information

Single wave pulse

| Degree of protection against electric shock| ****

Type BF applied part

Pulse duration

| ****

100-500us

(Microseconds)

| Type of protection against electric shock| Internally powered equipment

(Not applicable)

Pulse frequency

| 1-62.SHz (Hz=vibration per second)| ****

Output Voltage

| Max. 140Vpp ±20%

(at S0Oohm load)

Lifetime for electrode

| Storage for 2 years (no use), Times of reusable: 30 times| ****

Treatment time

| ****

1 Sminutes

Output intensity

| 0 to 10 levels, adjustable| ****

Mode of operation

| ****

Continuous operation

Modes| 3 auto modes| Software version| AO
NOTE: Not intended to be sterilized.
Not for use in an OXYGEN RICH ENVIRONMENT

Product Programs

Cleaning and Maintenance

Please use a wet cloth to clean the device first, and then use a dry cloth to wipe it again. The electrode pads coming with the device are disposable and should be replaced when their adhesiveness becomes worse. Contact the seller for replacements. Do not let the sticky side of the pads touch anything, including greasy fingertips.

Troubleshooting

The intensity is not felt or a very weak intensity level

| Pads are not attached to the body firmly| ****

Attach both pads firmly to the skin

The transparent films are still stuck to the pads| Peel off film on the adhesive surface of pads
The pads stack together or overlap| Do not stack pads together or overlap pads
The intensity setting is getting weak| ****

Increase the intensity level

The battery capacity is low

| ****

Change the battery

The skin turns red or the skin feels irritated

| ****

The adhesive surface of the pads is dirty or dry

| Wash the adhesive surface of the pads gently

with your fingertips for about 3 seconds under slow-running water

The therapy time is too long, or the intensity is set too high| Reduce the application time or reduce the intensity
The electrode pad surface if worm out| ****

Replace electrode pad

It is difficult to attach the pad to the skin

| Have you removed the transparent film from the pad?| Peel off the film on the adhesive surface of the pads
Was the pad applied immediately after washing?| ****

Dry the pad

Is the adhesive surface of the pad damaged?| ****

Replace the pad

The adhesive surface of the pads is not sticky

| Pads get deteriorative| Contact the vendor for replacements
Were the pads stored in high temperature, humidity, or direct

sunlight?

| ****

Replace the pads

If your device is not operating properly, please check for common problems and suggested solutions. If the recommended action does not solve the problem, please contact the seller.

contact

• Shanghai International  Holding Corp GbmH (Europe)
• Address: Eifferstrasse 80, 20537 Hamburg, Germany
• JKH Health Co.,Ltd.
• Add: 4-SF, Building 12, Hengmingzhu Industrial Park,
• Xinqiao Tongfuyu Industrial Area, Shajing, Baoan,
• Shenzhen, China

Questions or Comments?

• E-mail: service@healthcare-manager.com
• Distributed by/ Vertrieb durch/ Distribuito da/
• Distribué par/ distribuido por
• Easy Healthcare Corporation
• 360 Shore Dr. Burr Ridge, IL USA 60527
• Made in China

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