iReliev ET-5050, PlayMakar Instruction Manual

Therapeutic Wearable System™
TENS + EMS Wireless Muscle Stimulator
Instruction ManualMODEL NO. ET-5050
INDICATIONS FOR USE
Your PlayMakar
®
-Temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities. (Choose TENS Modes P1 through P7)
-Temporary relief of pain associated with sore and/or aching muscles in the upper and lower extremi­ ties (arm and/or leg) due to strain from exercise or normal household and work activities. (Choose TENS Modes P1 through P7)
-Symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis. (Choose TENS Mode P8)
-Use by healthy adults for the stimulation of healthy muscles in order to improve or facilitate muscle performance. (Choose EMS Modes P1 through P6)
WHAT YOUR SYSTEM INCLUDES:
1. Wireless Hand Remote x 1
2. Wireless Receiver Pods (CH1 & CH2) x 2
3. Self-Adhesive Electrode Pads x 2
4. Dual USB Charging Cable x 1
5. AC Adaptor x 1
6. Carry Case x 1
Visit www.iReliev.com or your authorized reseller to purchase additional CH3 and CH4 wireless receiver pods, accessories, and replacement electrode pads.
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TABLE OF CONTENTS
INDICATIONS AND CONTRAINDICATIONS.................................................................................................................................................................................................................................. 4
WARNINGS AND PRECAUTIONS………………………………………………............................................................................................................................................................................................................ 5
GENERAL INFORMATION ………………………....……………………………......................................................................................................................................................................................................................... 12
ABOUT RECHARGEABLE BATTERY ……………….……..………………….................................................................................................................................................................................................... 13
Charging the Remote Using the AC Adaptor……………..…………………....................................................................................................................................................
Charging the Receiver Pod…………………………………………………………………..............................................................................................................................................................................
Charging the System via USB Port…………………………….........................................................................................................................................................................................
STEP BY STEP OPERATION GUIDE FOR TRAINING ……..…………………....................................................................................................................................................................... 17
Preparing the Skin……………………………………………………........................................................................................................................................................................................................................
Placement of Electrode Pads …………………………………………………………………....................................................................................................................................................................
Operation of Remote Control…………………………………………………………...............................................................................................................................................................................
Operation of Wireless Receiver Pod(s)…………………………….………………………………..............................................................................................................................................
Communication between Remote and Receiver Pod(s) ……………………………………........................................................................................................
Selecting a Program.……………………………………………………………………................................................................................................................................................................................................
Selecting Therapy Time….…………………………………………………....................................................................................................................................................................................................
Selecting the Therapy Intensity Level……………………………………………………………….............................................................................................................................................
CARE AND MAINTENANCE…………………………………………………............................................................................................................................................................................................................................ 26
TROUBLESHOOTING.………..……………………………………………….….................................................................................................................................................................................................................................. 28
TECHNICAL SPECIFICATIONS……………………………………………………................................................................................................................................................................................................................ 29
RADIO FREQUENCY WIRELESS INFORMATION ……………………………….......................................................................................................................................................................... 32
CONFORMITY OF STANDARDS …………………………………………………............................................................................................................................................................................................................. 33
INFORMATION ABOUT ELECTROMAGNETIC COMPATIBILITY ………...................................................................................................................................................... 34
FCC INFORMATION ………………………………………………………………..................................................................................................................................................................................................................................... 38
WARRANTY………………………………………….................................................................................................................................................................................................................................................................................. 39
REGISTER YOUR DEVICE …………………............................................................................................................................................................................................................................................................... 40
REGISTRATION.................................................................................................................................................................................................................................................................................................................... 41
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INDICATIONS AND CONTRAINDICATIONS
Read instruction manual before operation. Be sure to comply with all “CAUTIONS” and “WARNINGS” in the manu­al. Failure to follow instructions can cause harm to the user or device.
The device is intended for over-the-counter use. However, you may consult your physician and observe your physician’s precise instructions and let them show you where to apply the electrodes pads.
What is TENS
TENS stands for transcutaneous electrical nerve stimulator and is used to apply an electrical current to elec­trode pads on a patient’s skin to relieve pain associated with sore or aching muscles.
What is EMS
EMS, which stands for electrical muscle stimulation and also known as powered muscle stimulator, is used to stimulate healthy muscle in order to improve muscle strength and performance.
Indications for Use
The Therapeutic Wearable System™ is a digital electrical stimulator for active treatment as per the following intended use:
-for temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities. (Choose TENS Modes P1 through P7)
-for temporary relief of pain associated with sore and aching muscles in the upper and lower extremi- ties (arm and/or leg) due to strain from exercise or normal household and work activities. (Choose TENS Modes P1 through P7)
-for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis. (Choose TENS Mode P8)
-for use by healthy adults for the stimulation of healthy muscles in order to improve or facilitate muscle performance. (Choose EMS Modes P1 through P6)
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Contraindications
Do not use this device if you have a cardiac pacemaker, implanted defibrillator or any other implanted metallic or electronic device. Such use could cause electric shock, burns, electrical interference or death.
Do not use this device if you have undiagnosed chronic pain.
Do not use this device if you are pregnant. The safety of TENS or Electronic Muscle Stimulation (EMS) over a pregnant uterus has not been determined or established.
Do not use this device if you have cancer. The effects of electronic stimulation on cancerous tissue is unknown.
Do not use this device if you are under medical supervision for cognitive dysfunction as you may not be able to comply with safety and operating instructions.
Do not use this device if it is in close proximity to shortwave or microwave diathermy equipment.
Do not wear the device or place electrode pads over areas where drugs/medicines are administered (short-term or long-term) by injection (e.g. hormone treatment).
Do not use if you have epilepsy.
Do not use if you have recently undergone a surgical procedure.
Do not use following acute trauma or fracture in case of critical ischemia of the limbs.
WARNINGS AND PRECAUTIONS
Warnings
If you are under the care of a Physician, consult with your Physician before using this system.
The long-term effects of this system are not known.
Do not place the electrode pads on or close to your heart.
Do not place the electrode pads around or close to your neck. Do not apply stimulation over the neck. Severe spasm of the muscles may occur and the contractions may be strong enough to close the airway or cause difficulty in breathing. Stimulation over the neck could also have an adverse effect on hearing or blood pressure.
Do not apply stimulation across the chest because the introduction of electrical current into the chest may cause rhythm disturbances to the heart.
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Do not place electrode pads on or around your head. The effects of stimulation of the brain are unknown.
Do not use the electrode pads over or close to sores on the skin.
Do not place the electrode pads on the front or sides of the neck, or across the heart (one electrode pad on the front of the chest and one on the back). Do not place on the genital region or on the head as such risk is considered inappropriate muscles, organs or areas of the body.
Do not place the electrode pads over any recent scars, broken or inflamed areas of infection or suscepti- bility to acne, thrombosis or other vascular problems (e.g. varicose veins), or any part of the body where feeling is limited.
Do not place the electrode pads over areas of injury or restricted movement (e.g. fractures or sprains).
Do not use this system while sleeping.
Do not use if you feel numbness.
Do not use this system in or close to water.
Do not apply stimulation across the chest because the introduction of electrical current into the chest may cause rhythm disturbances to the heart, which could be lethal.
Do not use electrode pads over or close to cancerous lesions.
Use the electrode pads only on normal, healthy, clean and dry skin. Do not use the electrode pads on open wounds, rashes or over swollen, red, infected or inflamed skin.
If you have ever had back surgery, consult your Physician before using this system.
Electronic monitoring equipment (such as ECG and ECG alarms) may not operate properly when electri- cal stimulation is in use.
Avoid areas of injury or restricted movement (e.g. fractures or sprains).
Avoid placing the electrode pads over metal implants.
Do not use in the bath/shower or in an environment of elevated humidity (e.g. sauna, hydrotherapy, etc).
Do not use the device in an environment where flammable or explosive fumes may exist.
User should never operate potentially dangerous machinery such as power saws, automobiles, etc. during electrical stimulation. It might result in burs at the site of the stimulator electrode pads and possi­ ble damage to the stimulator if you connect to high frequency equipment.
Application of electrodes pads near the thorax may increase the risk of cardiac fibrillation.
The system is internally powered (power from battery pack), IP 22, continuous operation. (Please refer to
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technical specification section more about the battery information and explanation of the symbol).
Wait Before Using the Unit:
At least 6 weeks after the birth of your baby (you must consult your doctor before use).
One month after an IUD contraceptive device (e.g. coil) has been fitted (you must consult your doctor before use).
At least 3 months after having a cesarean section (you must consult your doctor before use).
Until the heavy days of your period have finished. Vigorous abdominal exercise or muscle stimulation is not recommended during this time.
Precautions
Read user manual before using this system for the first time.
Keep this manual available whenever you use this system.
The system is intended for personal use on healthy adults only.
The safety of using the system during pregnancy or birth has not been established.
The effectiveness of the system depends greatly on a person’s individual physical condition. It may not always be effective for every user.
The safety of neuromuscular stimulation during pregnancy has not been established.
Use caution when and/or if:
- Sensory nerve damage is present by a loss of normal skin sensation.
- Use caution prior to using this device on patients suspected of having heart disease.
- Use caution for patients with suspected or diagnosed with epilepsy when using this device.
- Use caution following recent surgical procedures when muscle contraction may disrupt the heal­ ing process.
- Use caution when there is a tendency to hemorrhage, such as following acute trauma or fracture.
- Over a menstruating or pregnant uterus.
- User experiences skin irritation due to electrical stimulation or the electrical conductive medium used to remove the electrode pads. Discontinue stimulation and consult a clinician. Irritation may be reduced by an alternative conductive medium or an alternative electrode pad
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placement. Isolated cases of skin irritation may occur at the site of electrode pad placement following long-term application.
Place electrode pads in accordance with illustrations on page 18 in this instruction manual.
This unit should not be used while driving, operating machinery or during any activity in which involun­ tary muscle contractions may place the user at undue risk of injury.
Some users may experience skin irritation or hypersensitivity due to the electrical stimulation or the conduc tive medium.
Keep this device out of reach of children. If the user is a child, make sure he/she is properly supervised during electrical stimulation.
Application of moderate heat (thermal wrap) to muscles as well as moistening skin prior to treatment improves treatment efficacy and the use of cold packs on treated muscles after treatment is likewise recommended.
This unit should only be used with iReliev
®
brand electrode pads and accessories.
The device is not intended for medical use, for the treatment of any medical condition or for any per­ manent physical changes.
Contact ExcelHealth Inc. or an authorized reseller if your unit is not working correctly. Do not use in the meantime.
An effective session should not cause discomfort.
For first time users, muscle stimulation can be an unusual sensation. We recommend that you begin in a seated position with low stimulation intensity settings to familiarize yourself with the sensation before progressing to higher intensity settings.
The electrode pads must not be connected to other objects.
Do not overexert yourself while using muscle stimulation. Any workout should be at a comfortable level for you.
Do not place electrode pads over jewelry or body piercings.
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Use Caution and consult your Physician before using this system if any of the following conditions apply to you:
You have any serious illness, diagnosis or injury not mentioned in this guide.
You have recently undergone a surgical procedure.
You take insulin for diabetes.
You use the unit as part of a rehabilitation program.
If you suspect or have been diagnosed with a heart problem.
If you suspect or have been diagnosed with epilepsy.
If you have a tendency to bleed internally following an injury.
If you recently have had surgery or have ever had surgery on your back.
If areas of skin lack normal sensations, such as skin that tingles or is numb.
During menstruation or during pregnancy.
Some people may feel skin irritation or experience a very sensitive feeling in the skin due to electrical stimulation. If this occurs, stop using your system and consult your Physician.
If skin under one or more electrode pads feels irritated after using the stimulator for a long period of time, use the stimulator for a shorter period of time.
Minor redness at stimulation placement is a normal skin reaction. It is not considered as skin irritation, and it will normally disappear within 30 minutes after the electrode pads are removed. If the redness does not disappear after 30 minutes from the removal of electrode pads, do not use the stimulator again until excessive redness has disappeared.
Turn off the stimulator if the stimulation feels unpleasant or does not provide pain relief.
Keep your system out of the reach of children.
Use your stimulator only with iReliev
®
brand electrode pads and accessories.
Do not use this system when driving, operating machinery, or when swimming.
Before removing the electrode pads, be sure to power off device to avoid unpleasant stimulation.
After Strenuous Exercises or Exertion:
Always use lower intensity to avoid muscle fatigue.
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Important:
Effectiveness is highly dependent upon user's selection of therapy program. Please refer to a clinician qualified in the management of pain or rehabilitation.
Do not use this system at the same time as any other device which transfers an electrical current into the body (e.g. another muscle stimulator).
Stop using your unit if you are feeling light-headed or faint. Consult a doctor if this happens.
Do not touch the electrode pads or metal studs while the unit is switched on.
Do not use this system if you are wearing a belly button ring. Remove ring before session.
Use the device with only the leads and electrode pads provided for use by iReliev
®
with your device. Any others may not be compatible with your unit and could degrade the minimum safety levels. Use only the electrode pad placements and stimulation settings prescribed by your practitioner.
This device is for external use only.
Choking may result from a child swallowing a small part that has become detached from the device.
Note: If you have any doubt or have medical questions about using this system, please consult your doctor.
Electrode Pad Precautions
To reposition the electrode pads during a session, always pause the program currently running, reposi­ tion the electrode pads, and then restart the program.
The electrode pads are for single person use only.
Do not plunge the electrode pads into water.
Do not apply solvents of any kind to the electrode pads.
Always ensure the unit is OFF before removing the electrode pads.
Apply the whole surface of the electrode pads firmly to the skin. Do not use electrode pads that do not adhere properly to the skin.
If your skin is red under the electrode pad after a session, do not start another session in the same area until your redness has completely disappeared.
Do not snap electrode pads onto receiver pods while they are charging.
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Adverse Reactions
You may experience skin irritation and/or minor burns due to prolonged exposure of the stimulation electrode pads applied to your skin.
You may experience potential allergic reactions to accessible materials used in the electrode pads.
Do not apply electrode pads to your head or face. You may experience headaches and other painful sensations during or following the application of electrical stimulation near your eyes, head, and face.
You should stop using the device and should consult with your physician if you experience adverse re­ actions from the device.
Conditions That May Affect Your System
Since the stimulator is a battery-operated electronic system, its output performance and safety may be affect­ed greatly in extreme humidity. Therefore, it is very important to keep the system device(s) dry to ensure the safety and performance of the stimulator.
User of this system must be at least 16 years old.
This system is for indoor home-use.
This system may be used daily with no operation time limit but it is recommended to not exceed 60
minutes per day.
If there is any other problem, please consult ExcelHealth or return the device to an authorized iReliev
®
reseller . Do not try to repair a defective device.
For plug-in equipment, the power outlet socket must be located near the equipment and must be
easily accessible.
WARNING: No modification of this system is allowed.
WARNING: Use of non-iReliev
®
brand accessories may negatively affect the system's performance.
WARNING: Do not stack and store this system close to other equipment.
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GENERAL INFORMATION
Package Content
1. Wireless Hand Remote x 1
2. Wireless Receiver Pods (CH1 & CH2) x 2
3. Self-Adhesive Electrode Pads x 2 Size: 3 in. x 5 in.
4. Dual USB Charging Cable x 1 Length: 23.5 in.
5. AC Adaptor x 1
6. Carry Case x 1
About Remote Control
1. Power ON key
2. SET key
3. Power OFF key
4. CH key
5. ON/+ key: increase
6. OFF/- key: decrease
7. USB Charger Socket
About Receiver Pods
8. CH1 Receiver Pod: Power ON/OFF key
9. CH2 Receiver Pod: Power ON/OFF key
10. Snaps for Electrode Pad
11. USB Charger Socket
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ABOUT RECHARGEABLE BATTERIES
Please fully charge the batteries in both the remote unit and the receiver pods before using this device.
Charging the Remote Using the AC Adaptor
1. Connect the small end of the USB cable to the remote and the larger end to the AC adaptor.
2. Plug the adaptor into any standard wall outlet.
When charging, the battery symbol lights on and lasts until fully charged. When fully charged, the battery sym­bol will disappear.
Charging the Receiver Pod Using the AC Adaptor
1. Connect the small end of the USB cable to the receiver pod and the other end into the AC adaptor.
2. Plug the adaptor into any standard wall outlet.
An orange light indicates the receiver pod is now in charge mode; once fully charged the orange light will turn off.
Note: You may not use the handheld remote while it's charging. When charging, the handheld remote will turn off automatically. Note: Do not charge receiver pods with electrode pads snapped on to the receiver pods as it will reduce lon- gevity of the electrode pads due to excessive heat from charging.
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Remote Battery Status
Remote ON Remote Low Battery Remote Battery Drained
Battery Symbol Showing
Remote Charging Remote Done Charging
Battery Symbol Showing NO Battery Symbol Showing
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