Introduction

Therapy is a unique wireless remote controlled pain relief device incorporating TENS technology to specifically target back pain. The thin and flexible design perfectly contours the back for maximum surface contact. The advanced electronics design maximizes energy use, providing over 120 30-minute treatment sessions per battery life.

This innovative device is safe, drug-free, easy to use, discreet and comfortable to wear, and most importantly allows you to control your pain to maintain an active lifestyle. Indications for 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.

The Aleve TENS Device is priced at approximately $79.99.

Syncing the Remote Control and the ALEVE Direct Therapy Device

Note: Your remote control has been pre-synced to your ALEVE Direct Therapy Device prior to its first use. You may need to re-sync your remote control and ALEVE Direct Therapy device when you replace the battery in the remote control. This will ensure communication between your remote control and ALEVE Direct Therapy device. If your remote control and ALEVE Direct Therapy device ever lose communication, please repeat these syncing instructions.

Using the provided screwdriver, remove the back cover from the ALEVE Direct Therapy device.
Remove the clear plastic tab from the remote control.
On the remote control, press and hold the(+) and(-) buttons simultaneously until the LED appears solid green (~ 10 seconds).
Quickly insert the batteries into the ALEVE Direct Therapy device.
Note: The LED on the remote control will flash several times indicating syncing is complete.
Replace the back cover on the device.

Safety

CONTRAINDICATIONS
Do not use this device if you have a cardiac pacemaker, implanted defibrillator, or other implanted metallic or electronic device, or are connected to high frequency surgical equipment. Such use could cause electric shock, burns, electrical interference, or death. It may also damage the stimulator.

WARNING!

Do not allow children to swallow or ingest accessories or detachable parts (e.g., screwdriver, lithium coin battery, alkaline batteries).
Do not use this device across or through your chest because the electrical currents introduced into the chest may cause rhythm disturbances to your heart, which may be lethal.
Do not use this device if you are susceptible to rhythm disturbances to the heart unless under the direction of your physician.
Do not use this device over your eyes, mouth, face, front of neck (especially in the carotid sinus), head, upper back, or across your heart because this could cause severe muscle spasms resulting in closure of your airway, difficulty in breathing, or adverse effects on heart rhythm or blood pressure.
Consult with your physician before using this device 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.
Stop using this device and consult your physician if your pain does not improve, becomes more than mild, or continues for more than five days.
Do not use this device while driving, operating machinery, or during any activity in which electrical stimulation can put you at risk of injury.
Do not use this device over open wounds or rashes, or over swollen, red, infected, or inflamed areas or skin eruptions (e.g., phlebitis, thrombophlebitis, varicose veins).
Do not use this device over, or in proximity to, cancerous lesions.
Do not use this device on children because it has not been evaluated for pediatric use.
Do not use this device 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 use this device when in the bath, shower or other sources of moisture.
Do not use this device while sleeping.
Do not use this device on abnormal skin, or skin that is not intact, clean, or healthy.
Do not operate in close proximity (e.g. 1 m) to shortwave or microwave therapy equipment as it may produce instability in the stimulator output.

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Technical Specifications

Channels: Single channel
Waveform: Asymmetric biphasic square pulse
Pulse Amplitude: 0 ~110 mA = 0 ~ 55 volts, adjustable (at 500 ohm load)
Pulse Frequency: (Hz) 5-120

Mode	Stage 1	Stage 2	Stage 3
Pulse Duration (sec) Measured positive* phase	120µs	240µs	120µs
Pulse repetition frequency (Hz)	80 to 120Hz (Variable)	5 to10Hz (Variable)	80 to 120Hz (Variable)
Output voltage (V)	55V	55V	55V
Load Range that is valid for these parameters (Q)	5000
Effect of load impedance on these parameters	External load resistance can be up to1OkO. If this load resistance is exceeded, the nominalcurrent flowing to the patient may be less than the set target stimulation current.

Timer Control: (mins) 30
Power Supply: Device: Two (2) AAA batteries (Internally Powered)
Remote Control: One (1) CR2032 lithium battery (Internally Powered)
Size (D x W x H): 0.7" x 7.5" x 3.5" (18 mm x 191 mm x 90 mm)
Weight (including battery): 4.8 oz (136 g)
The Aleve Direct Therapy use life is 120 uses based on battery life.
The expected service life for Aleve Direct Therapy is three years.
Shelf life of gel pads is two years (see "Use By" date printed on pouch).
Safety Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-10
Made in Malaysia

Low battery - device	Yellow Yellow	One (1) flash every two (2) seconds when the device is ON. Rapid flashing during the stimulation treatment.
Low battery - remote control	Yellow	One (1) flash every time the START/STOP button is pressed.
Device transition from OFF to ON	Green	One (1) flash every two (2) seconds.
Device transition from ON to OFF	None	Green flashing stops.
Device transition from ON to START STIMULATION mode	Green	Rapid flashing during treatment.
On remote control, press of START/STOP TREATMENT button to either START or STOP treatment	Green	One (1) flash when START/STOP button is pressed.
Device at maximum intensity and + button pressed on remote	Green	Two (2) flashes each time button is pressed.
Remote control communication error	Green/ Yellow	One (1) Green flash, followed by two (2) Yellow flashes

Features and Functions

Electrode Area: Surface where the gel pads are placed
On/Off Button: Press to turn the device On/Off
Start/Stop Button: Press to start or stop treatment
+/- Buttons: Press to increase or decrease stimulation intensity

Description

The Aleve Bayer Direct Therapy Tens Device 1613538 is designed to be a comprehensive pain relief solution. It uses TENS technology to send electrical impulses to the nerves, interrupting pain signals to the brain. The device is equipped with pre-set programs tailored for different types of pain, ensuring that users can find the most effective setting for their specific needs.

The adjustable intensity settings allow users to customize their therapy sessions according to their comfort level. The device is powered by batteries, making it convenient for use at home, in the office, or while traveling.

Preparation for Use

Before using your ALEVE Direct Therapy you will need to apply the gel pads to the device and prepare the device for a treatment.

Applying the Gel Pads to the ALEVE Direct Therapy Device
The gel pads are intended for single person use. They will last, depending on skin type, oils, and pH levels, approximately two to five applications. Replace the gel pads when they no longer adhere completely. Follow these steps to apply the gel pads:

Separate two gel pads.
Remove the blue liner from the side being applied to the electrode area. Do not remove the green protective liner.
Align the shape of the first gel pad with the electrode area. Apply the gel pad onto the electrode area and firmly press across the entire surface to ensure good adhesion.
Repeat steps 1 - 3 for the second gel pad.

Skin Preparation

Trim, not shave, excessive hair on the treatment area.
Wash the skin and dry completely. Treatment area should be void of oils and/or lotions.

Setup Guide

To operate the Aleve Bayer Direct Therapy Tens Device 1613538, follow these steps:

Ensure the device is fully charged or replace the batteries if necessary.
Clean and prepare the skin area where the electrodes will be placed.
Attach the reusable electrodes to the device leads and position them on the affected area according to the user manual.
Turn on the device and select the appropriate pre-set program based on your type of pain.
Adjust the intensity setting as needed for comfort and effectiveness.
Start the therapy session and let the device work for the recommended duration.

Use

The ALEVE Direct Therapy exclusive, patent-pending 3-stage waveform incorporates both clinical theories of TENS to provide pain relief. The 30-minute stimulation treatment is delivered as follows:

Stage 1: 5 minutes of high frequency stimulation that initiates a feeling of pain relief by suppressing the transmission of pain signals in nerves. This stage provides a high sensory sensation and allows you to establish a comfortable intensity setting for the entire treatment.
Stage 2: 20 minutes of low frequency stimulation that initiates an increased endorphin release in the body to reduce the sensitivity to pain for an extended period of time following the 30-minute treatment. This stage provides a low sensory sensation often described as a gentle tapping sensation.
Stage 3: 5 minutes of high frequency stimulation, providing the same high sensory sensation experienced in Stage 1. This stage allows you to maintain the feeling of pain relief and complete the overall treatment with a comfortable high sensory sensation.

Treatment Recommendations

You can leave the device in position for multiple treatments during the day. It will automatically turn off after two (2) hours of inactivity.
It is recommended you wait a minimum of 30 minutes between treatments.

Conducting a Treatment

Always read the safety warnings before conducting a treatment. Follow these steps to conduct a treatment:

Do NOT activate stimulation of the device prior to application of the device to the back.

Remove the green liners from the gel pads by slowly peeling the liner diagonally from an inside corner to the opposite outside corner. Important! Avoid contact of the gel pad with other objects. Contact with other objects may affect the pads' adhesion properties. Save the green liners for storage of the device.
Press, and hold, the On/Off button on the ALEVE Direct Therapy device for one (1) second. The LED will begin flashing indicating the device is ready for use.
Note: The ALEVE Direct Therapy device must always be ON prior to application.
Align the center of the device over the spine and place the device on your back in the area of pain. If you cannot place the device properly, ask another person for assistance.
Important! Do not apply the gel pads/electrodes directly over the spine.
Press the Start/Stop button on the remote control to begin the treatment.
Note: The LED on the ALEVE Direct Therapy device will flash rapidly during treatment.
Press the(+/-) buttons to increase or decrease the intensity of the stimulation until it is at a comfortable level.
Press the Start/Stop button on the remote control to stop the treatment at any time. Treatment will automatically stop after 30 minutes. Note: If a treatment is stopped and restarted the treatment will c ) restart at the first stage. Care should be taken to not inadvertently depress the ON/OFF button on the device when being worn. If the ON/OFF button is depressed during use, the treatment will stop.

Removing the ALEVE Direct Therapy

Important! Do not remove the device until the treatment has stopped.

After treatment, or when you want to remove the device, grasp the edge of the device and gel pad to ensure the gel pad does not stay on the skin. Slowly peel the device away from the skin.
Align and place the green protective liners back on the gel pads. Ensure the pads are completely covered.

Battery Replacement
When battery replacement is needed the LED will flash as follows:

ALEVE LED flashes yellow every two (2) seconds when Direct Therapy the unit is On device LED flashes yellow rapidly during treatment	(2) AAA alkaline batteries
Remote Control LED flashes yellow once when the Start/Stop button is pressed.	(1) CR2032 lithium battery

Note: Fully depleted batteries will have no flashing LED.

To replace the AL EVE Direct Therapy Device Batteries:

Using the included #0 Phillips head screwdriver remove the cover.
Remove the old batteries, and place the new batteries in the correct polarity.
Replace the battery compartment cover.

To replace the remote control battery:

Place the provided screwdriver, coin or flat tool in the groove on the side of the remote control. Turn the coin and lift the cover off.
Slide the old battery out, and slide a new CR2032 battery into the slot.
Note: The (+) is facing upward.
Align the cover with the remote control base. Holding the handle portion of the remote control, snap the cover down into place.

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Note: Consult your local authorities for proper disposal of batteries, device, and accessories

Maintenance and Storage

Use a damp cloth and mild soap to gently wipe clean after each use, when the is device is soiled, or to remove buildup of gel-pad residue. Remove any soap residue from cleaning. Damage to the device and/or remote control will occur if submerged in water or other liquids. Aleve Direct Therapy is manufactured with water detection technology to detect exposure to water that may cause damage to the electronics and void the product warranty.
The unit should be routinely checked before each use to determine all controls function normally.
The device should be operated, transported and stored at temperatures between 50° F and 104 ° F (10° C and 40° C), with relative humidity between 30% - 85%. All values have +/-10% tolerance.
Store the device, remote control and gel pads in the original packaging when not in use.
Remove batteries before extended storage to reduce likelihood of battery corrosion or leakage.
If the device is not working properly, stop using immediately. Do not disassemble or modify the device.

Manufacturer's Warranty

Bayer Health Care warrants the original purchaser that the Aleve Direct Therapy Device is free from defects in materials and workmanship for one year from the date of original purchase, except as noted below. During the stated one-year penod, Bayer Health Care shall, at no charge, replace a unit found to be detective with an equivalent or current version of the owner's model. For warranty service, contact Consumer Relations at 1-800-395-0689.

Pros & Cons

Pros

Effective in managing chronic and acute pain
User-friendly interface with pre-set programs
Adjustable intensity settings for personalized comfort
Portable and easy to use on-the-go
Affordable compared to other TENS devices on the market

Cons

May not be suitable for all types of pain or medical conditions
Requires regular battery replacements or charging
Some users may experience skin irritation from electrodes
Limited customization options beyond pre-set programs

Customer Reviews

Customers have generally praised the Aleve Bayer Direct Therapy Tens Device 1613538 for its effectiveness in reducing pain. Many users appreciate its ease of use and portability. However, some have noted occasional issues with electrode placement and skin irritation.

A common complaint is that the device may not be as effective for severe pain conditions, but it works well for mild to moderate pain relief.

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