PlayMakar PRO-500 User Manual

Model # PRO-500

Instruction Manual

INDICATIONS

Read this instruction manual before operation. Be sure to comply with all “CAUTIONS” and “WARNINGS” in this manual. Failure to follow and implement according to the use and operating instructions can cause harm to the user or device.

The device is intended for over-the-counter use however if you have medical questions we strongly encourage you to consult with your physician regarding indications for use of this device.

What is EMS?

EMS stands for electrical muscle stimulation. This electric muscle stimulator is used to stimulate healthy muscles to improve muscle strength and performance.

What is TENS?

TENS stands for transcutaneous electrical nerve stimulation. This TENS unit is intended to deliver electrical current to electrode pads applied to your skin to relieve pain associated with sore or aching muscles.

PlayMakar® Sport Muscle Stimulator, Model PRO-500 Indications for Use

The PlayMakar® Sport Muscle Stimulator is a muscle stimulator for active treatment as per intended use:

• For use by healthy adults for the stimulation of healthy muscles in order to improve or facilitate muscle performance and therefore may be considered a technique of muscle training. (Choose EMS Modes P1 through P6) The PRO-500 is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind.

• 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 P3)

• For temporary relief of pain associated with sore and aching muscles in the upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities. (Choose TENS Modes P1 through P3)

• For symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis. (Choose TENS Mode P4)

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TABLE OF CONTENTS

INDICATIONS......................................................................................................................................................................................................................................................................................................................... 2

CONTRAINDICATIONS, WARNINGS, AND PRECAUTIONS……………………………………………....................................................................................................................................... 4-7

WHAT'S INCLUDED………….……………....……………………………............................................................................................................................................................................................................................................. 8

DEVICE FEATURES…….…………………....…………………………….............................................................................................................................................................................................................................................. 9

ABOUT RECHARGEABLE BATTERIES……….……….……..…………………....................................................................................................................................................................................................... 10

USING THE AC ADAPTER TO CHARGE DEVICE.................................................................................................................................................................................................................... 10-11

STEP BY STEP OPERATION GUIDE FOR TREATMENT……...………………….................................................................................................................................................................... 12-14

• Preparing the Skin…………….………………………………………........................................................................................................................................................................................................................................ 12

• Connect Lead Wires to Channel 1 and to Channel 2…………….……………………………………………………...................................................................................................................... 12

• Connect Electrode Pads to Lead Wire(s)………….………………………………………………………........................................................................................................................................................ 12

• Remove Electrode Pads from Plastic Film…………………………………………………………............................................................................................................................................................ 13

• Place Electrode Pads on Skin…………………………….…………………………….................................................................................................................................................................................................. 13

• Turning On & Off the Device……………………………………………………………………............................................................................................................................................................................................ 13

• Select EMS or TENS….………….…………………………………….................................................................................................................................................................................................................................... 13

• Select Therapy Program….……………….………………………………........................................................................................................................................................................................................................ 14

• Select Treatment Minutes.…….………………………………………………………………............................................................................................................................................................................................... 14

• Adjust Intensity………….………….................…………………………….................................................................................................................................................................................................................................. 14

SPECIAL FEATURES…….…………….................……………………………................................................................................................................................................................................................................................... 15

PAD PLACEMENT BY MUSCLE GROUP……………………………………....................................................................................................................................................................................................... 16-17

EMS PROGRAMS……….……………………………....................................................................................................................................................................................................................................................................... 18

TENS PROGRAMS…….……………………………….................................................................................................................................................................................................................................................................... 19

CARE & MAINTENANCE …………………………………….................................................................................................................................................................................................................................................. 20

TROUBLESHOOTING.………..……………………………………………….….................................................................................................................................................................................................................................... 21

TECHNICAL SPECIFICATIONS….…………………………………………………............................................................................................................................................................................................................... 22-24

INFORMATION ABOUT ELECTROMAGNETIC COMPATIBILITY.………............................................................................................................................................................. 25-28

FCC INFORMATION………………………………………………………………...................................................................................................................................................................................................................................... 29

WARRANTY…………………………………………................................................................................................................................................................................................................................................................................... 30

REGISTER YOUR DEVICE.…………………................................................................................................................................................................................................................................................................... 31-32

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EMS CONTRAINDICATIONS

Powered muscle stimulators should not be used on people with cardiac demand pacemakers.

WARNINGS

• The long-term effects of chronic electrical stimulation are unknown.

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

• Stimulation should not be applied over the neck or mouth. Severe spasm of the laryngeal and pharyngeal muscles may

occur and the contractions may be strong enough to close the airway or cause difculty in breathing.

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

• Stimulation should not be applied transcerebrally.

• Stimulation should not be applied over swollen, infected, or inflamed areas or skin eruptions, e.g., phlebitis, thrombophlebitis, varicose veins, etc.

• Stimulation should not be applied over, or in proximity to, cancerous lesions.

PRECAUTIONS

• Safety of powered muscle stimulators for use during pregnancy has not been established.

• Caution should be used for people with suspected or diagnosed heart problems.

• Caution should be used for people with suspected or diagnosed epilepsy.

• Caution should be used in the presence of the following:

• When there is a tendency to hemorrhage following acute trauma or fracture.

• Following recent surgical procedures when muscle contraction may disrupt the healing process.

• Over the menstruating or pregnant uterus.

• Over areas of the skin which lack normal sensation.

• Some people may experience skin irritation or hypersensitivity due to electrical stimulation or electrical conductive medium. The irritation can usually be reduced by using an alternate conductive medium, or alternate pad placement.

• Electrode placement and stimulation settings should be based on the guidance of the prescribing practitioner.

• Powered muscle stimulators should be kept out of the reach of children.

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• Powered muscle stimulators should only be used with the leads and electrodes provided for use by the manufacturer.

• Do not apply stimulation while driving, operating machinery, or during any activity in which electrical stimulation can put you at risk of injury.

• Muscle contractions may put the user at undue risk of injury which may include use while driving, operating machinery, or during any activity in which involuntary muscle contractions may put the user at undue risk of injury.

ADVERSE REACTIONS

Skin irritation and burns beneath the electrodes have been reported with the use of powered muscle stimulators.

TENS CONTRAINDICATIONS

• TENS should not be used if you have a cardiac pacemaker, implanted debrillator, or other implanted metallic electronic device. Such use could cause electric shock, burns, electrical interference, or death.

WARNINGS

• If you are in the care of a physician consult with your physician before using this device.

• If you have had medical or physical treatment for your pain, consult with your physician before using this device.

• If your pain does not improve, becomes more than mild, or continues for more than ve days, stop using the device and consult with your physician.

• Do not apply stimulation over your neck because this could cause severe muscle spasms resulting in closure of your

airway, difculty in breathing, or adverse effects on heart rhythm or blood pressure.

• 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.

• Do not apply stimulation over open wounds or rashes, or over swollen, red, infected, or inflamed areas or skin eruptions (e.g. phlebitis, thrombophlebitis, varicose veins).

• Do not apply stimulation over, or in proximity to, cancerous lesions.

• Do not apply stimulation in the presence of electronic monitoring equipment (e.g., cardiac monitors, ECG alarms), which may not operate properly when the electrical stimulation device is in use.

• Do not apply stimulation when in the bath or shower.

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• Do not apply stimulation while sleeping.

• Do not apply stimulation while driving, operating machinery, or during any activity in which electrical stimulation can put you at risk of injury.

• Do not use the device on children, if it has not been evaluated for pediatric use.

We also recommend the following:

• Consult with your physician before using this device, because the device may cause lethal rhythm disturbances to the heart in susceptible individuals.

• Apply stimulation only to normal, intact, clean, healthy skin.

PRECAUTIONS

• TENS is not effective for pain of central origin, including headache.

• TENS is not a substitute for pain medications and other pain management therapies.

• TENS devices have no curative value.

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

• Effectiveness is highly dependent upon the individual using. Results may vary.

• 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 your head, and electrodes should not be placed on opposite sides of your head.

• The safety of electrical stimulation during pregnancy has not been established.

• You may experience skin irritation or hypersensitivity due to the electrical stimulation or electrical conductive medium (gel).

• If you have suspected or diagnosed heart disease, you should follow precautions recommended by your physician.

• If you have suspected or diagnosed epilepsy, you should follow precautions recommended by your physician.

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We also recommend the following:

• Use caution if you have a tendency to bleed internally, such as following an injury or fracture. Consult with your physician prior to using the device after a recent surgical procedure, because stimulation may disrupt the healing process.

• Use caution if stimulation is applied over the menstruating or pregnant uterus.

• Use caution if stimulation is applied over areas of skin that lack normal sensation.

• Keep this device out of the reach of children.

• Use this device only with the leads, electrodes, and accessories recommended by the manufacturer to avoid adverse reactions.

• Electrode pads are intended for single person use only.

Please be aware of adverse reactions and precautions below:

• You may experience skin irritation and burns beneath the stimulation electrodes applied to your skin.

• You may experience headaches and other painful sensations during or following the application of electric stimulation near your eyes and to your head and face.

• You should stop using the device and should consult with your physician if you experience adverse reactions from the device.

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WHAT'S INCLUDED

Package Content

1. Wired Muscle Stimulator (1)

2. Electrode Pads

2" x 2" (4) 2" x 4" (2)

3. AC Adapter (1)

4. USB Charging Wire (1)

5. Lead Wires (2)

6. Belt Clip Holster (1)

7. Tote Bag (1)

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DEVICE FEATURES DESCRIPTION

Indicators and Buttons:

1 Power ON/Increase Button

2 Power OFF/Decrease Button

3 Mode (Setting Select/Set)

4 Therapy Program

5 Therapy Mode (EMS or TENS)

6 Battery Status/Lock Function Indicator

7 Channel Indicator

8 Treatment Minutes Remaining

9 Intensity Level

10 CH1 (Channel 1) Button

11 CH2 (Channel 2) Button

12 Therapy Program Description

1. LED backlight will display for 10 seconds upon turning on.

2. When charging, the device will shut off automatically.

3. If symbol is displayed, battery power is low.

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ABOUT RECHARGEABLE BATTERIES

Please fully charge the battery in the device. To prevent the risk of electric shock, make sure power cord is unplugged from wall socket. To fully disengage the power to the unit, please disconnect the power cord from the AC outlet. Do not remove cover (or back). The AC outlet shall be readily available and accessible.

Note: The unit has a built-in rechargeable battery that cannot be exchanged by the user.

USING THE AC ADAPTER TO CHARGE DEVICE

Charging the Device Using the AC Adapter

1. Connect the small end of the USB cable to the device

and the large end to the AC adapter.

When charging the remote, the battery symbol will flash until fully charged; When fully charged, the battery symbol will be displayed and will not be flashing.

Note: You may not use the device while it’s charging. When charging, the device will turn off automatically.

2. Plug the adapter into any standard wall outlet.

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Device Charging

Device Charging Complete

1. When battery is charging, the symbol will show on LCD screen.

2. The battery symbol will not change as the voltage increases; it only serves as an indication.

3. Battery symbol will be flashing, 1 flash/sec.

Low Battery Status Indicator on Display

The low battery status indicator will be visible whenever the battery is low. This indicates that you will soon have to recharge the battery.

The need to recharge the device is dependent on Treatment Minutes, Therapy Program, Intensity Level, and use of single or dual channels while receiving treatment.

Note: When voltage is lower or equal to 3.3v the symbol will show on the LCD screen.

1. When the device is done charging, the full battery symbol will show on the LCD screen and will not be flashing.

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