Chattanooga Primera User Manual

PRIMERA™

for Temporary Pain Relief and to Facilitate and Improve Muscle Performance

USER’S MANUAL

PRIMERA™ User’s Manual	Page 2
	© 2013 STW, Inc.

Contents

	Page
Important Notes	3
Warnings, Safety and Indications	4
Contraindications and Precautions	7
Electrode Guidelines	10
What is Pain?	12
What is TENS?	12
What is NMES?	13
How to Use the PRIMERA™	14
General Quick Start Instructions	19
Programs	20
Description of Kit Components	23
Suggested General Electrode Placement	25
Commonly Asked Questions	33
Care and Maintenance	34
Specifications	36
Issues and Solutions	38
PRIMERA™ Warranty	41
Symbols Appearing on the Back of the Device	42
Special Notes and Reorder	Back Cover

PRIMERA™ User’s Manual	Page 3
Important Notes	© 2013 STW, Inc.

The PRIMERA™ is equipped with a mA LOCKOUT. Forty-five seconds after the stimulator is turned “ON,” the intensity setting will lock. To make any adjustment to the level of intensity (mA), you must first press the negative first to increase the mA.

Please carefully read the Warnings, Safety and Indications sections of this user’s manual and be fully aware of the contents of this user’s manual before using your PRIMERA™. The device should not be used for any indication other than the intended use!

Indications for use:

Programs 01 to 07, and HAN are to be used for TENS. The device is intended to be used for the temporary relief of pain associated with sore and aching muscles in the lower back, upper extremities (arms) and lower extremities (legs) due to strain from and/or normal non-commercial household work activities.

Programs 08 to 13 are for NMES and are intended to be used to stimulate healthy muscles in order to facilitate and improve muscle performance.

CAUTION: FEDERAL LAW (U.S.A.) RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A LICENSED HEALTH CARE PROFESSIONAL.

PRIMERA™ User’s Manual	Page 4
Warnings	© 2013 STW, Inc.

*The PRIMERA™ is a Class II Medical device for use by adults only.

*Keep out of reach of children.

*Always use this device in accordance with the manual.

*Do not insert lead wires into a mains power supply.

*Do not immerse unit into water or any other substance.

*Do not use the PRIMERA™ unit in the presence of a flammable anaesthesia gas mixture and air or with oxygen or nitrous oxide.

*Never connect the PRIMERA™ unit directly to a battery charger or any other mains powered equipment.

*Electrodes are for single patient use only - do not share electrodes with another person.

*Operation in close proximity (e.g., one meter, three feet two inches) to a shortwave or microwave therapy equipment may produce instability in the stimulator output.

*Simultaneous connection to a patient to high frequency surgical equipment may result in burns at the site of the stimulator electrodes and possible damage to the stimulator.

* No modification of this equipment is allowed!

*Only use leads, electrodes and accessories provided by the manufacturer.

*Safety of electrical stimulation during pregnancy has not been established.

*Think about what you are doing and use common sense.

PRIMERA™ User’s Manual	Page 5
	© 2013 STW, Inc.

NEVER DO the following with the PRIMERA™:

*Never use it in ways other than those recommended by the user’s manual.

*Never operate without full understanding of the user’s manual.

*Never use it while driving or operating machinery.

*Never use it in a humid/wet atmosphere (e.g., sauna, bathroom, bath, shower or swimming pool).

*Never use on people with diminished abilities.

*Never use the unit if it is not functioning properly or you feel discomfort.

*Stop using the unit if you feel nausea or dizziness.

Warnings:

*Always place electrodes in accordance with this user’s manual.

*Do not place electrodes across the chest or heart as doing so may create rhythmic disturbances to the heart.

*The PRIMERA™ is not effective in treating pain of central origin, including headache.

*The PRIMERA™ provides symptomatic relief only and has no curative value.

*The PRIMERA™ in TENS mode provides symptomatic treatment and as such suppresses the sensation of pain, which would otherwise serve as a protective mechanism.

*The user must keep the PRIMERA™ away from children.

*Electronic monitoring equipment (such as ECG monitors and ECG alarms) may not operate properly when PRIMERA™ stimulation is in use.

PRIMERA™ User’s Manual	Page 6
	© 2013 STW, Inc.

*The long-term effects of chronic electrical stimulation are unknown. 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 over swollen, infected, or inflamed areas or skin eruptions: e.g., phlebitis, thrombophlebitis, varicose veins, etc.

*The effects of stimulation on the brain are unknown. Therefore do not apply stimulation to or across the head.

*Stimulation should not be applied to the neck. Spasm of the laryngeal and pharyngeal muscles may occur and cause contractions which may close the airway.

*Stimulation applied to the neck may have adverse effects on heart rhythm and blood flow.

*Do not remove electrodes while the unit is being used.

*Do not use on people with diminished capacity or capabilities.

*Do not use while sleeping.

*Do not use the unit for any purpose except what it is intended for.

*Do not place electrodes over the abdominal region during menstruation periods.

*Do not let electrodes come into contact with metal of any type during the session.

*Do not use the unit for extended periods of time in case muscles become exhausted or painful.

If in doubt about the use of the PRIMERA™ unit contact your distributor or ask an experienced licensed health care professional for advice.

PRIMERA™ User’s Manual	Page 7
Contraindications and Precautions	© 2013 STW, Inc.

Remember, pain is a signal your body creates as a very important warning function.

Contraindications:

*Never use your PRIMERA™ on:

-atrophied muscles.

-muscles with spasms.

-muscles associated with an impaired joint or limb.

-muscles with undiagnosed pain.

*Never use the PRIMERA™ when pregnant or if you think you are pregnant.

*Do not use your PRIMERA™:

-with demand-type cardiac pacemakers, defibrillators, or other implanted metallic or electronic devices.

-over the carotid sinus (neck) region.

-over the neck or mouth.

-over the carotid sinus nerves.

-trans cerebrally (over the head).

-over the eyes.

-over the heart or chest.

-when there is a tendency to haemorrhage following acute trauma or fracture.

- following surgical procedures when muscle contraction may disrupt the healing process. - over areas of skin which lack normal sensation.

PRIMERA™ User’s Manual	Page 8
	© 2013 STW, Inc.

-over swollen, infected, or inflamed areas or skin eruptions: e.g., phlebitis, thrombophlebitis, varicose veins, etc.

*Do not use your PRIMERA™ if you have one or more of the following medical conditions:

-epilepsy.

-cancerous lesions.

-abdominal or inguinal hernia.

-critical ischemia of lower limbs.

-blood flow deficiencies/venous thrombosis.

-heart problems/condition.

Precautions:

*Isolated cases of skin irritation may occur at the site of the electrode placement following long-term application. Consult your physician if skin irritation develops.

*The effectiveness of PRIMERA™ in TENS mode is highly dependent upon program selection and electrode placement determined by user response. If in doubt, consult a person qualified in pain management.

*Caution should be used for patients with suspected or diagnosed heart problems.

*Caution should be used for patients with suspected or diagnosed epilepsy.

*Some patients may experience skin irritation or hypersensitivity due to the electrical stimulation or electrical conductive medium. The irritation can usually be reduced by using an alternate conductive medium or an alternate electrode placement.

PRIMERA™ User’s Manual	Page 9
	© 2013 STW, Inc.

*Electrode placement and stimulation settings should be in accord with the instructions in this manual or based on the advice of an experienced licensed health care professional.

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

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

*Powered muscle stimulators should not be used while driving, operating machinery, or during any activity in which involuntary muscle contractions may put the user at undue risk of injury.

*Do not immerse the unit in water or any other liquid.

*Before using the PRIMERA™ please consult your physician if you are experiencing or have any of the following conditions:

-an acute disease.

-malignant tumor.

-infectious disease.

-heart disease.

-high fever.

-abnormal blood pressure.

-skin sensory disorders or skin problems.

-hernia (abdominal or inguinal).

-any serious illness.

-prone to impulsive, foolish or stupid decisions.

PRIMERA™ User’s Manual	Page 10
Electrode Guidelines	© 2013 STW, Inc.

Please note that the correct selection of the skin electrodes for a TENS device is a significant concern. The electrodes for this TENS device are FDA cleared 2 inch skin electrodes from Chattanooga. To ensure you obtain the proper type of skin electrode please re-order from Chattanooga, DJO Global or your PRIMERA™ authorized dealer.

Never Apply Electrodes to:

-the head or any area of the face.

-the neck.

-the chest.

-across the heart.

-on both sides of the thorax simultaneously (laterally or front and back).

Caution with Electrodes:

-Always turn the power to the PRIMERA™ off when applying or moving electrodes.

-Ensure the entire surface of the electrode is stuck to the skin.

-If skin irritation occurs, move the electrodes to a different position.

-Do not apply solvents or cleaning agents to electrodes.

-Electrodes are for single patient use only - do not share electrodes with another person.

-Users should discontinue use immediately if there is any dermal discomfort.

PRIMERA™ User’s Manual	Page 11
	© 2013 STW, Inc.

Adverse Reactions:

*Please note that this equipment is capable of delivering current densities for any electrodes exceeding 2mA r.m.s/cm2. Skin irritation and electrode burns are potential adverse reactions. Users should discontinue use immediately if there is any dermal discomfort.

A Few Good Tips (Self-Adhesive Electrodes):

*If you find the electrodes will not stick due to oily skin, cleanse the skin with soap and water, then rinse and dry the area around the electrode site. If this does not work, try cleansing the skin with a swab impregnated with alcohol.

*Clip away hair on skin using scissors; don’t use a razor to remove hairs.

*The electrode’s conductive material is water-based. If it becomes saturated (e.g., from perspiration), it will lose its adhesive qualities. After use, leave the electrodes face up overnight to dry out (replace on plastic film in the morning).

*At some point the electrodes will become dry. Moisten the adhesive surface with a few drops of water, and apply onto the plastic film overnight. This procedure will give you a few more days of electrode life.

PRIMERA™ User’s Manual	Page 12
What is Pain?	© 2013 STW, Inc.

When we feel pain it is the body’s process of informing us that something is wrong. To feel pain is important, without this feeling abnormal conditions may go undetected, creating damage or injury to critical parts of the body. Although pain is essential in warning our body of trauma or malfunction, nature may have gone too far in its design. Continued long-term chronic pain has no useful value apart from its importance in

diagnosis. Pain only begins when a coded signal travels to the brain where it is decoded, and analysed. The pain message travels from the injured area of the body along small diameter nerves leading to the spinal cord. At this point the message is switched to a different kind of nerve that travels up the spinal cord to the brain area. The brain then analyses the pain message, refers it back and the pain is felt.

What is TENS?

Transcutaneous Electrical Nerve Stimulation (TENS) uses a small battery-operated unit to provide a noninvasive method of controlling acute and principally long-term intractable pain. It can also be used as an adjunctive treatment in the management of post-surgical traumatic pain problems. In TENS mild electrical impulses are transmuted through the skin via surface electrodes to modify the body’s pain perception. TENS does not cure problematic physiological conditions; it only helps to control the pain perception. TENS will not work for every user. However, physical therapists and

PRIMERA™ User’s Manual	Page 13
	© 2013 STW, Inc.

physicians throughout the world prescribe TENS extensively and it is generally seen to work for the majority of users. There are millions of small nerve fibers throughout the body and it only requires a few impulses to produce chronic pain. In addition to small fibers, which allow the sensation of pain to be felt, the body is also made up of larger diameter nerve fibers. These larger nerve fibers transmit less unpleasant sensations such as touch or warmth, assisting us to form an impression of our environment. Stimulating the larger nerve fibers using TENS may have the effect of inhibiting the transmission of pain along the smaller nerve fibers to the spinal cord [known as the ‘Pain Gate Theory’].

What is NMES?

Neuro Muscular Electrical Stimulation has been used for many years to stimulate muscle to treat a number of muscle and nerve related conditions. The PRIMERA™ is a dual channel device combining several treatment programs into one unit. Neuromuscular Stimulation is increasingly understood by therapists and physicians. There is a better understanding of the mechanisms that exist between nerves and muscles that makes

it possible to stimulate the neuromuscular system with precise electrical signals. The PRIMERA™ offers precision, giving full controls of Pulse Widths, Rates, Rampup Times, Work/Rest cycles as well as alternating or synchronous application if two channels are used.

PRIMERA™ User’s Manual	Page 14
How to Use the PRIMERA™	© 2013 STW, Inc.

In order to use the PRIMERA™ effectively, you must consider the following points:

-Planning of stimulation sessions

-Choice of appropriate treatment mode

-Stimulation intensity level

-Electrode placement

Planning:

The PRIMERA™ is a portable device so no special planning is required for use of temporary pain relief. The unit should not be used while operating a vehicle or machinery.

When using the PRIMERA™ to improve muscle performance it is recommended that you only stimulate the muscle groups for sessions of 30 minutes three times per week.

Appropriate Treatment Mode:

There are five treatment modes available on the PRIMERA™:

1.Continuous TENS or Normal: This is the most frequently used mode for pain relief. For general TENS use, the most common selection is program 01.

2.Burst Mode: This mode is comparable to the low rate TENS technique except that each low rate pulse is substituted by a short BURST of 9 pulses [200 µS] at 150 Hz. It is a combination of conventional and low rate TENS. Use program 06 or 07.