Paingone Plus Manual

Intended purpose

TENS device for the symptomatic temporary relief of acute and chronic musculoskeletal pain (excluding pain resulting from bone fractures).
Indications The device may be used at any site or joint in the body that is not included in the warnings or cautions for the following indications:

• Pain following normal daily/occupational/sporting activities communicated as pain arising from a particular part of the musculoskeletal system (for example, knee pain, neck pain, back pain, elbow pain or shoulder pain).
• Chronic musculoskeletal pain that may or may not have a diagnosed cause

Target population
The device can be used by adults. Typical users include anyone suffering from acute or chronic pain primarily of a musculoskeletal origin.

What is Paingone Plus?
Paingone Plus is a low frequency TENS (Transcutaneous Electrical Nerve Stimulation) therapy device powered by battery. This therapy relieves pain by sending mild electrical impulses through the skin into the nerve fibres.

Mechanism of Action
Paingone Plus is placed directly on the area you wish to use it. Holding the activating button results in the generation of electrical impulses that are transferred to the skin via the contact electrode. Pain relief is achieved via TENS therapy.

Paingone Plus Overview

Inserting the battery

Your Paingone Plus comes supplied with 1 × AAA battery. The battery is found in the foam layer underneath the device.
Locate the removable battery cover (2).
This is the orange section of the device immediately below the Power Button.
Remove the battery cover by gently twisting it anticlockwise. It will gradually unscrew from its fixture.

Insert the battery with the positive (+) tip going in first.
If the battery is inserted incorrectly the device will not work.
Replace the battery cover by twisting it gently in a clockwise direction until it is secured. Be careful not to damage the mechanism through excessive force.
Your Paingone Plus is now ready to use.

Applying Paingone Plus

Hold Paingone Plus in your hand and firmly wrap your fingers around the metal contact plate (3)
Now place the tip (4) of the device directly on the point you wish to use it. Press and hold the Power Button (1) for 30 seconds.
Paingone Plus will emit controlled electrical pulses. You will probably feel the pulses against your skin, although the sensation varies by user.
After 30 seconds, simply release the Power Button (1). This will deactivate the device and the electrical pulses will stop.
You can treat larger areas by moving the device along the line of pain as it delivers the pulses. Note that Paingone Plus can also be applied over light clothing.
Re-apply Paingone Plus when necessary, up to 4-5 times a day on each desired area

Maintenance

To clean, simply wipe with a soft, slightly damp cloth and allow to dry before re-use.
Do not immerse the device in water. If you require to disinfect the device you can use an alcohol wipe.
Replace the battery when the device ceases to emit electrical pulses. One AAA battery can provide approximately 800 applications. This represents about 8 months' use, based on 3 applications per day (performance may vary depending on battery used).
Remove the battery if you are not going to use the device for more than one month.

Verifying functionality

The device is working correctly if you apply it to your skin and you feel it emitting electrical pulses. If you don't feel the electrical pulses even after applying the device to your fingertip then check the battery.

Conditions for transportation and storage

Conditions for Use

Operating life: 24 months
Shelf life: 5 years

Symbols

	Manufacturer's name and address
	Attention, consult accompanying documents
	Protection against electric shock. Type BF applied part according to European Norm EN 60601-1.
	Protected against solid foreign objects of 12.5mm diameter and greater Protected against vertically falling water drops when enclosure tilted up to 15°
	The battery should not be disposed of in normal household waste but returned via battery collection point. The equipment should not be disposed in the normal waste stream.
	The LOT number includes the year of manufacture.
	CE marking of conformity to the European Medical Device Directive 93/42/EEC under the supervision of Notified Body Number 1282
	ON/OFF
	Battery direction
	Read instruction
	Indicates the item is a medical device
	Single-patient multiple use device
	Model/catalogue number
	Unique device identifier
	Date of manufacture

Do not use Paingone Plus

• If you use a pacemaker or any other electrical implanted device
• During pregnancy
• If you suffer from epilepsy
• If you have malignant tumour, cancer or suspected cancer in the area being treated
• If you have previously suffered from skin irritation, itching or severe reddening of the skin, or have experienced any other adverse reaction from using TENS or Paingone Plus
• On injured or irritated skin or open wounds
• On the carotid sinus nerves, laryngeal or pharyngeal muscles in the front/side of your neck or on your head
• Over the heart or directly over metal implants
• If you suffer from severe heart rhythm problems or atrial fibrillation
• While driving or using heavy machinery
• In and around your eyes or on mucous membranes
• On wet or unclean skin or in damp surroundings
• In the presence of gas, flammable liquids or surroundings rich in oxygen
• On skin where you have applied creams, oils or any other flammable alcoholic products
• If taking anticoagulant or steroid treatments, or, in case of special clinical conditions without first consulting a doctor
• If the device is damaged and internal parts are exposed.
• Using Paingone Plus in close proximity to other medical electronic or electromagnetic equipment may result in incorrect functioning of the medical equipment, medical intervention and/or a risk of burns.

Failure to follow these warnings could result in serious injury.

Precautions:

• Read the instructions and keep them dry and in a safe place
• Keep out of reach of children
• No product or advice is solely intended to replace current medication, diagnose or cure any condition
• Please consult your doctor if you are concerned about the applicability of the product in relation to your condition
• If you experience new, unexpected or worsening pain, seek medical advice
• Always hold the Paingone Plus in the correct manner. Firmly grip the metal ring encircling the device.
• Possible side effects from using this device are: burns, local skin reaction including discolouration or bruising, electric shock, pain or discomfort
• In the unlikely event that you experience a serious incident as a result of using this device please report it to the manufacturer and to the competent authority of the Member State where you are established.

Please visit www.paingone.com/warranty to register your extended Paingone Plus warranty and for full terms and conditions and return address details.