Check out the where it works page also for video instructions and proper placement.

Painaway Pro users manual

Chapter 1 Introduction

INTENDED USE

The PAIN AWAY PRO is intended for the symptomatic relief and management of chronic intractable pain and adjunctive treatment of post surgical or post traumatic acute pain. This device must be used in strict accordance with these instructions.

THE PAIN AWAY PRO SYSTEM

The PAIN AWAY PRO pain relief system incorporates a revolutionary enhance thermal delivery pad and a Transcutaneous Electrical Nerve Stimulator or TENS unit combined synergistically. The PAIN AWAY PRO provides a unique combination of soothing cold and electrical pulses are sent through the skin and along the nerve fibers. The cold controls and eliminates swelling and inflammation while the pulsed stimulation suppresses pain signals to the brain. The Pain Away Pro also stimulates the body to produce higher levels of its own natural pain killing chemicals known as beta – endorphins (natural morphine) to ensure longer, deeper and more complete relief. The PAIN AWAY PRO does not work for work for everyone: however, in most people it is very effective in reducing or eliminating the pain. In many cases the Pain Away Pro will promote the bodies own ability to heal.

CHAPTER 2: EXPLANATION OF TENS

1. FOREWARD

Transcutaneous Electrical Nerve Stimulation is a non-invasive, drug free pain control device. TENS uses small electrical impulses sent through the skin to nerves to modify your pain perception.

Read this User manual carefully before you start using the TENS unit provided in the PAIN AWAY PRO pain relief system. Before use, please read the following cautions, warnings, contraindications, precaution and adverse reactions. If you are still in doubt about the use or suitability of the TENS unit, please contact Innovative Medical Modalities at 602 428-8722.

2. PRECAUTIONS

1. TENS is not effective for pain of central origin. (This includes headache)

2. TENS has nor curative value

3. Keep the device out of reach of children.

4. Long term stimulation with traditional electrodes at the same site may cause skin irritation. (This is not a problem if the PAIN AWAY PRO pad is used properly).

1. CONTRAINDICATIONS

1. If you have a demand-type cardiac pacemaker, do not use a TENS unit.

2. Do not use TENS on the carotid sinus (front of neck) region.

3. Do not use TENS for people with known myocardial disease or arrhythmias without consultation and evaluation of a physician.

4. Do not apply TENS for undiagnosed pain syndromes until etiology is established.

5. Do not place The PAIN AWAY PRO pad on any site that may cause current to flow transcerebrally (through the head).

2. WARNINGS

1. The safety of TENS devices for use during pregnancy or birth has not been established. Do not use TENS during pregnancy.

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

3. Electronic monitoring equipment (such as ECG monitors and ECG alarms) may not operate properly when TENS is in use.

4. If you have epilepsy, myocardial disease or arrhythmias always consult with your doctor before using TENS.

5. Don’t attempt to use TENS in any other way than described in this user’s guide.

6. Do not use the PAIN AWAY PRO pain relief system while operating potentially dangerous machinery.

7. Do not use TENS or the PAIN AWAY PRO pad over the eyelids, in the mouth or internally. Do not use on the chest, over the heart or the abdomen.

8. Never apply TENS or the PAIN AWAY PRO pad over irritated or broken skin.

9. Never apply TENS over surgically implanted metal or devices.

10. Never operate TENS in close proximity (1Meter) to shortwave or microwave devices as it may produce instability in the stimulator output.

11. Remove battery if the unit is store for an extended period of time.

3. ADVERSE REACTIONS

Allergic reactions are rare. However an allergic reaction to the pad or conductive gel may occur in the form of skin irritation. Rarely an electrode burn on the electrode site may occur. If skin irritation persists, discontinue use and consult a physician.

CHAPTER 3: EMC WARNINGS

This equipment has been tested and found to comply with the limits for medical devices in IEC 60601-1-2:2002. These limits are designed to provide reasonable protection against harmful interference in a typical medical installation.

The equipment generates, uses and can radiate radio frequency and if not installed and used in accordance with the instructions may cause harmful interference to other devices in the vicinity. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to other devices, which can be determined by turning the equipment off and on, the user is encouraged to try and correct the interference by one or more of the following measures:

• Reorient or relocate the receiving device.

• Increase the separation between the equipment.

• Consult the manufacture for help.

CHAPTER 4: GENERAL DISCRIPTION

The PAIN AWAY PRO TENS is a battery operated pulse generator that sends electrical impulses to the body which reach the nerves causing pain. The device is provided with two controllable output channels, each independent of each other. An electrode pair can be connected to each output channel.

The electronics of the PAIN AWAY PRO TENS create electrical impulses whose intensity, duration, number per second and modulation may be altered with the controls or switches.

PLEASE NOTE: THE PAIN AWAY PRO TENS UNIT HAS BEEN PRESET

FOR OPTIMUM PREFORMANCE! IF ANY OF THE SETTINGS ARE

CHANGED IT WILL EFFECT THE PAIN RELEAVING CAPABILITIES OF

THE UNIT!

he side cover will prevent accidental changer to the preset control settings. The side cover should be left in the full up position at all times except when changing the battery.

The dial controls on the top of the unit control the intensity of the electrical pulse and are very easy to use.

T

CHAPTER 5 PAIN AWAY PRO PAD

GENERAL DISCRIPTION

The PAIN AWAY PRO PAD is made of platinum grade silicone and high thermal fillers. The construction of the pad will allow for very frequent use for years to come. Imbedded in the silicone are two black carbon electrodes. The pad and electrodes are designed to maintain maximum flexibility and will couture to the shape of the body part to which it is applied. Opposite the front side (the electrode side) are two wires used to attach the lead wires from the TENS unit to the PAIN AWAY PRO PAD.

PROPER USE

The PAIN AWAY PRO PAD is uniquely designed to provide instant soothing cooling and reduction of any unpleasant electrical feeling associated with tens. The cold supplied by the PAIN AWAY PRO PAD has a markedly stronger and longer lasting analgesic effect than conventional electrical therapies.

Before applying the PAIN AWAY PRO PAD it must be cooled in any household freezer for at least 30 minutes. To maximize the analgesic effect the pad should be cooled to substantially below freezing. (In a professional setting the pad is cooled to below zero and applied directly to the skin without harmful effect). The pad will remain flexible and retain contouring capabilities to minus 50 degrees F.

Remove the cold pad from the freeze and apply a liberal amount of conductive gel over the black carbon electrode pads. The electrodes are slightly recessed to provide a shallow reservoir for the gel. The gel must cover and extend ¼ inch away front the electrode on every side. Warning: an inadequate amount of conductive gel will result in reduced pain relieving effects and may result in electrical burns.

Insure safe and proper function by applying a liberal amount of conductive gel to the electrode.

After the conductive gel has been properly applied to the PAIN AWAY PRO PAD place the pad over the area of pain. (The pad must never be placed over the heart, the carotid sinus in the front of the neck, so as the electric pulse will pass through the head, over any broken skin, metal implants or used by a pregnant individual. Please review the contraindications, precautions and warnings sections of this manual before use.)

After the PAIN AWAY PRO PAD has been placed over the area of pain (NOTE: the black electrode side is applied directly to the skin over the area of pain) attach the lead wire of the TENS to the pad by plugging the pin connectors to the electrode receptacles on the side opposite the imbedded electrodes. To insure proper connection grasp the electrode wire by the insulated receptacle and slide the TENS pin in until securely attached. Repeat this process for the second lead wire. The TENS wire pins are color coded black and red it makes no difference which pin is placed in the right or left pad receptacle.

Once the PAIN AWAY PRO PAD has been placed over the area of pain and the lead wires attached, locate the intensity dial on the top of the TENS unit and turn on the unit by moving the dial in a clockwise fashion. The wire from the TENS to the PAIN AWAY PRO PAD must be on the same side as the intensity dial. Once the dial is turned a LED will light up on the same side that the TENS wire is plugged into the TENS unit. If the LED is does not light up on the same side as the TENS wire, then turn off the unit by turning the intensity dial counterclockwise until in stops. Then turn on the intensity dial on the same side as the attached TENS wire.

If when the intensity dial is turned and the LED lights up on the same side as the TENS wire, then slowly advance the dial until the electrical pulse is felt. Once the electrical pulse is felt continue to increase the intensity of the pulse until the pulse strength is substantial (NOT UNCOMFORTALE OR PAINFUL). Once desired pulse strength is achieved secure the TENS unit and allow the PAIN AWAY PRO SYSTEM to work for 15 minutes. The TENS unit will automatically shut off, If a longer treatment is desired the turn the intensity dial to the off position and then restart the 15 minute cycle by turning dial clockwise and to the desired intensity setting. When the electrical pulses of the TENS unit have shut off, immediately reset the TENS intensity dial to off by turning it counter clockwise until it stops.

When you have finished with the treatment cycle detach the TENS wire from the pad by grasping both the pin and receptacle and gently unplug the pin from the receptacle.

JERKING THE WIRE INSTEAD OF THE INSULATED CONNECTOR BODY WILL RESULT IN WIRE BREAKAGE AND DAMAGE TO THE PAD!

Once the wires have been safely unplugged remove the PAIN AWAY PRO PAD and wipe away any excess conductive gel that may be on the skin.