managing your pain with empi active - djo...

Managing Your Pain with

Empi Active™

360372A.indd 1 6/7/11 8:26:5

EMPI Active User Guide

Dear Patient,

Welcome to Empi, the leader in home rehabilitation devices.

Your healthcare professional has prescribed an Empi device to aid in your reha-bilitation and/or pain management program. It is our goal, in partnership with your healthcare provider, to help you achieve the best possible outcome in the shortest amount of time.

In the next several days, an Empi Patient Care Specialist will attempt to contact you to:

1) Assess your overall satisfaction with the Empi device;

2) Address questions you may have regarding the device; and

3) Provide you with information regarding your insurance company’s coverage policy.

If your health insurance policy provides coverage for the device, we will submit a claim to them on your behalf. In the unlikely event the device is not a covered benefit, Empi will contact you to discuss available payment options. If you decline the self-pay option, you will be asked to return the device within 10 days of notification. A conve-nient, pre-paid postage return envelope is provided with the Empi device kit.

For immediate assistance or for answers to questions regarding your Empi device, please contact Empi at 800.328.2536 and an Empi Patient Care Specialist will be avail-able to help you. Operating hours are 7:30AM to 5:30PM CST, Monday through Friday.

As a partner with your healthcare provider, Empi is committed to helping you improve your health and quality of life. Thank you for the opportunity to serve you and help you “rediscover living”.

Sincerely,

Your Empi Team

CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician (or licensed practitioner).

The following symbols may be located on the back of the Empi Active device:

Type BF Applied Part

Lead wires comply with the Performance Standard for electrode lead wires (21 CFR part 898)

Attention, consult accompanying documents

Electronic Testing Lab, indicates product meets US and Canadian product safety standards. This device complies with UL Std. 60601-1 and is certified to CAN/CSA Std. C22.2 No. 601.1.

Council Directive 2002/96/EC concerning Waste Electrical and Electronic Equipment (WEEE). Indicates a requirement not to dispose of WEEE as municipal waste. Contact your local distributor for information regarding disposal of the unit and accessories.

Federal Law (USA) restricts this device to sale by or on the order of a physician (or licensed practitioner).

C

ETL

CLASSIFIED

9900900

13051_360372A.indd 2 6/7/11 8:27:00 PM


Dear Patient,

Welcome to Empi, the leader in home rehabilitation devices.

Your healthcare professional has prescribed an Empi device to aid in your reha-bilitation and/or pain management program. It is our goal, in partnership with your healthcare provider, to help you achieve the best possible outcome in the shortest amount of time.

In the next several days, an Empi Patient Care Specialist will attempt to contact you to:

1) Assess your overall satisfaction with the Empi device;

2) Address questions you may have regarding the device; and

3) Provide you with information regarding your insurance company’s coverage policy.

If your health insurance policy provides coverage for the device, we will submit a claim to them on your behalf. In the unlikely event the device is not a covered benefit, Empi will contact you to discuss available payment options. If you decline the self-pay option, you will be asked to return the device within 10 days of notification. A conve-nient, pre-paid postage return envelope is provided with the Empi device kit.

For immediate assistance or for answers to questions regarding your Empi device, please contact Empi at 800.328.2536 and an Empi Patient Care Specialist will be avail-able to help you. Operating hours are 7:30AM to 5:30PM CST, Monday through Friday.

As a partner with your healthcare provider, Empi is committed to helping you improve your health and quality of life. Thank you for the opportunity to serve you and help you “rediscover living”.

Sincerely,

Your Empi Team

CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician (or licensed practitioner).

The following symbols may be located on the back of the Empi Active device:


Lead wires comply with the Performance Standard for electrode lead wires (21 CFR part 898)

Attention, consult accompanying documents

Electronic Testing Lab, indicates product meets US and Canadian product safety standards. This device complies with UL Std. 60601-1 and is certified to CAN/CSA Std. C22.2 No. 601.1.

Council Directive 2002/96/EC concerning Waste Electrical and Electronic Equipment (WEEE). Indicates a requirement not to dispose of WEEE as municipal waste. Contact your local distributor for information regarding disposal of the unit and accessories.

Federal Law (USA) restricts this device to sale by or on the order of a physician (or licensed practitioner).

C

ETL

CLASSIFIED

9900900

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EMPI Active User GuideEMPI Active User Guide

ContentsImportant Notice . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

How does Empi Active work? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 What is pain? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 What is TENS? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 How does TENS control pain? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

Frequently Asked Questions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 How long can I wear my Empi Active? . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Can I wear my Empi Active to bed? . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Can I wear my Empi Active while driving? . . . . . . . . . . . . . . . . . . . . . . . 3 How should I clean the electrodes or specialized wrap? . . . . . . . . . . . . 3

Prescribing Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Indications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Dangers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Adverse Effects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

What You Should Have Received . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Quick Reference . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Start a Therapy Session . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Change Intensity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 End a Therapy Session . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Detailed Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Your Empi Active Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Using Your Empi Active Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 Charge the Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 Connect the Device to an Electrode or Specialized Wrap . . . . . . . . . . 12 Place the Electrode or Specialized Wrap on Your Skin . . . . . . . . . . . . 13 Begin Therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 Change the Intensity: the Automatic Lock Feature . . . . . . . . . . . . . . . 13 End the Therapy Session . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 Device Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 Replacement Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Contents continued

Technical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 Simple Modulated Pulse Waveform . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 Standard Measurement Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 Standard Measurement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 Pulse Duration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 Maximum Current . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 Modulation Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 Physical Dimensions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 Approximate Weight . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 Environmental Requirements. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 Transport and Storage Requirements . . . . . . . . . . . . . . . . . . . . . . . . . 17 Specifications - Guidance and Manufacturer’s Declaration . . . . . . . . . 18 Specifications – Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the Empi Active Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 1. Warning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 2. Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 3. Limitation of Liabilities and Disclaimer of Warranties . . . . . . . . . . . . 21

Important NoticeConsult a healthcare professional if you have specific questions or problems regard-ing the use of your Empi Active device. He or she is most familiar with your situation and is the best source of additional guidance. Use your Empi Active device only under proper medical supervision and only as described in this user guide.

Before using your Empi Active device, read this entire user guide, giving special at-tention to the Indications, Contraindications, Warnings, Precautions, Dangers, and Adverse Effects sections.

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1EMPI Active User GuideEMPI Active User Guide

ContentsImportant Notice . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

How does Empi Active work? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 What is pain? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 What is TENS? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 How does TENS control pain? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

Frequently Asked Questions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 How long can I wear my Empi Active? . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Can I wear my Empi Active to bed? . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Can I wear my Empi Active while driving? . . . . . . . . . . . . . . . . . . . . . . . 3 How should I clean the electrodes or specialized wrap? . . . . . . . . . . . . 3

Prescribing Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Indications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Dangers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Adverse Effects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

What You Should Have Received . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Quick Reference . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Start a Therapy Session . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Change Intensity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 End a Therapy Session . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Detailed Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Your Empi Active Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Using Your Empi Active Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 Charge the Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 Connect the Device to an Electrode or Specialized Wrap . . . . . . . . . . 12 Place the Electrode or Specialized Wrap on Your Skin . . . . . . . . . . . . 13 Begin Therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 Change the Intensity: the Automatic Lock Feature . . . . . . . . . . . . . . . 13 End the Therapy Session . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 Device Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 Replacement Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Contents continued

Technical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 Simple Modulated Pulse Waveform . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 Standard Measurement Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 Standard Measurement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 Pulse Duration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 Maximum Current . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 Modulation Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 Physical Dimensions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 Approximate Weight . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 Environmental Requirements. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 Transport and Storage Requirements . . . . . . . . . . . . . . . . . . . . . . . . . 17 Specifications - Guidance and Manufacturer’s Declaration . . . . . . . . . 18 Specifications – Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the Empi Active Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 1. Warning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 2. Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 3. Limitation of Liabilities and Disclaimer of Warranties . . . . . . . . . . . . 21

Important NoticeConsult a healthcare professional if you have specific questions or problems regard-ing the use of your Empi Active device. He or she is most familiar with your situation and is the best source of additional guidance. Use your Empi Active device only under proper medical supervision and only as described in this user guide.

Before using your Empi Active device, read this entire user guide, giving special at-tention to the Indications, Contraindications, Warnings, Precautions, Dangers, and Adverse Effects sections.

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EMPI Active User Guide2 EMPI Active User Guide

How does Empi Active work?What is pain?

Pain is an unpleasant sensation that can serve a useful purpose by alerting us to a possible or actual injury or disease. When the body is functioning normally, pain serves as a warning device that something is not right. Without pain a person would not know when to get away from danger or seek medical help. But pain becomes a problem when it continues after treatment has started or long after an injury is healed. There are two types of pain: acute and chronic. Acute pain is limited in dura-tion. Typical examples are sprains, incisional pain, and muscle strain. This type of pain is typically associated with workplace or recreational injuries. Chronic pain, on the other hand, is a long-lasting, persistent pain that ceases to serve as a warn-ing device and becomes a problem. The Empi Active device was developed to help relieve some types of both acute and chronic pain.

What is TENS?

TENS stands for Transcutaneous Electrical Nerve Stimulation. Pain, whether chronic (long-term) or acute (short-term), can be relieved through a variety of methods, including drugs, topical ointments, surgery, and electrical stimulation. TENS devices deliver electrical pulses through the skin to the cutaneous (surface) and afferent (deep) nerves to control pain. Unlike drugs and topical ointments, TENS does not have any systemic side effects.

How does TENS control pain?

Empi Active pain control uses a patented SMP (simple modulated pulse) waveform designed to maximize pain relief in two ways. One is the gate control mechanism. When the body is injured, both pain and non-pain impulses are sent to the brain from the nervous system. These pulses travel through nerves in your skin to deeper nerves, and then to the spinal cord and brain. Along the path are many areas referred to as “gates”. These gates determine which impulses are allowed to continue on to the brain. The gates prevent the brain from receiving too much information too quickly. Since the same nerve cannot carry a pain and a non-pain impulse at the same time, the stronger, non-pain impulse from the Empi Active device “controls the gate”.

The other mechanism of pain control is endorphin release. The Empi Active device can trigger the body’s natural pain killers, called endorphins. These chemicals interact with receptors, blocking the perception of pain. This is similar to the way the pharmaceutical drug, morphine works, but without morphine’s side effects.

No matter which pain control mechanism is employed, Empi Active has been proven useful in pain management. By reading this manual and carefully following the treat-ment instructions provided by your clinician, you can receive maximum benefit from your Empi Active device.

Frequently Asked Questions How long can I wear my Empi Active?

Please follow directions provided by your clinician.

Can I wear my Empi Active to bed? No. Do not wear your Empi Active while sleeping. There is a danger that the electrode or specialized wrap may become disconnected from the device.

Can I wear my Empi Active while driving? No. See the “Precautions” section of this user guide.

How should I care for electrodes/specialized wrap? Follow the instructions provided on the packaging for these products as well as on the box that your Empi Active came in.

Prescribing InformationIntroduction

You should use electrical stimulation only under medical supervision to manage specific conditions. Read, understand, and practice the precautionary and operating instructions in this user guide. Know the limitations and hazards associated with the Empi Active pain control device. Observe all precautions and warnings on the device and in this manual.

Indications

TENS devices are indicated for:

Symptomatic relief and management of chronic, intractable pain.•

Adjunctive treatment for post-surgical and post-trauma acute pain.•

Relief of pain associated with arthritis.•

Contraindications

TENS treatments should not be used in any of the following situations:

Cardiac pacemakers: Do not use this device if the patient has a demand type cardiac pacemaker or any implanted defibrillator.

Transcerebral stimulation: Do not apply electrical stimulation transcerebrally (through the head).

Carotid sinus: Do not use electrical stimulation over the carotid sinus nerves (throat).

Unknown etiology: Do not use this device when pain syndromes are undiagnosed. Use only after origin of pain has been diagnosed.

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EMPI Active User Guide EMPI Active User Guide 3

How does Empi Active work?What is pain?

Pain is an unpleasant sensation that can serve a useful purpose by alerting us to a possible or actual injury or disease. When the body is functioning normally, pain serves as a warning device that something is not right. Without pain a person would not know when to get away from danger or seek medical help. But pain becomes a problem when it continues after treatment has started or long after an injury is healed. There are two types of pain: acute and chronic. Acute pain is limited in dura-tion. Typical examples are sprains, incisional pain, and muscle strain. This type of pain is typically associated with workplace or recreational injuries. Chronic pain, on the other hand, is a long-lasting, persistent pain that ceases to serve as a warn-ing device and becomes a problem. The Empi Active device was developed to help relieve some types of both acute and chronic pain.

What is TENS?

TENS stands for Transcutaneous Electrical Nerve Stimulation. Pain, whether chronic (long-term) or acute (short-term), can be relieved through a variety of methods, including drugs, topical ointments, surgery, and electrical stimulation. TENS devices deliver electrical pulses through the skin to the cutaneous (surface) and afferent (deep) nerves to control pain. Unlike drugs and topical ointments, TENS does not have any systemic side effects.

How does TENS control pain?

Empi Active pain control uses a patented SMP (simple modulated pulse) waveform designed to maximize pain relief in two ways. One is the gate control mechanism. When the body is injured, both pain and non-pain impulses are sent to the brain from the nervous system. These pulses travel through nerves in your skin to deeper nerves, and then to the spinal cord and brain. Along the path are many areas referred to as “gates”. These gates determine which impulses are allowed to continue on to the brain. The gates prevent the brain from receiving too much information too quickly. Since the same nerve cannot carry a pain and a non-pain impulse at the same time, the stronger, non-pain impulse from the Empi Active device “controls the gate”.

The other mechanism of pain control is endorphin release. The Empi Active device can trigger the body’s natural pain killers, called endorphins. These chemicals interact with receptors, blocking the perception of pain. This is similar to the way the pharmaceutical drug, morphine works, but without morphine’s side effects.

No matter which pain control mechanism is employed, Empi Active has been proven useful in pain management. By reading this manual and carefully following the treat-ment instructions provided by your clinician, you can receive maximum benefit from your Empi Active device.

Frequently Asked Questions How long can I wear my Empi Active?

Please follow directions provided by your clinician.

Can I wear my Empi Active to bed? No. Do not wear your Empi Active while sleeping. There is a danger that the electrode or specialized wrap may become disconnected from the device.

Can I wear my Empi Active while driving? No. See the “Precautions” section of this user guide.

How should I care for electrodes/specialized wrap? Follow the instructions provided on the packaging for these products as well as on the box that your Empi Active came in.

Prescribing InformationIntroduction

You should use electrical stimulation only under medical supervision to manage specific conditions. Read, understand, and practice the precautionary and operating instructions in this user guide. Know the limitations and hazards associated with the Empi Active pain control device. Observe all precautions and warnings on the device and in this manual.

Indications

TENS devices are indicated for:

Symptomatic relief and management of chronic, intractable pain.•

Adjunctive treatment for post-surgical and post-trauma acute pain.•

Relief of pain associated with arthritis.•

Contraindications

TENS treatments should not be used in any of the following situations:

Cardiac pacemakers: Do not use this device if the patient has a demand type cardiac pacemaker or any implanted defibrillator.

Transcerebral stimulation: Do not apply electrical stimulation transcerebrally (through the head).

Carotid sinus: Do not use electrical stimulation over the carotid sinus nerves (throat).

Unknown etiology: Do not use this device when pain syndromes are undiagnosed. Use only after origin of pain has been diagnosed.

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Prescribing Information continued

Warnings

Supervised use: This device should only be operated under the prescription and supervision of a physician (or licensed practitioner) who is familiar with the precau-tionary measures and operational functions associated with the unit being used.

Long-term effects: The long-term effects of chronic use of electrical stimulation are unknown. Electrical stimulation devices do not have any curative value.

Symptomatic treatment: This device is a symptomatic treatment and, as such, suppresses the sensation of pain, which would otherwise serve as a protective mechanism.

Central origin pain: Electrical stimulation is not effective for central origin pain such as headache.

Pregnancy: The safety of using electrical stimulation during pregnancy or birth has not been established.

Throat stimulation: Severe spasm of the laryngeal and pharyngeal muscles may occur when the electrodes are placed across the throat or mouth. This may be strong enough to close off the airway or cause breathing difficulty.

Transthoracic stimulation: Do not apply electrical stimulation transthoracically (through the chest area) because the introduction of electrical current into the heart may cause cardiac arrhythmias.

Skin and vascular problems: Do not use this device over infected areas, skin erup-tions, or areas of decreased sensation.

Heart disease: Precaution should be taken prior to using electrical stimulation on patients suspected of having heart disease.

High frequency surgical devices: Simultaneous connection of a patient to a high frequency surgical device may result in burns at the site of the electrode or possible damage to the device.

Damage from liquids: Do not immerse the device in water or other liquids. Water or liquids could cause malfunction of internal components of the system, causing a risk of injury to the patient.

Electrical shock: To prevent electrical shock, disconnect the unit from the power source before attempting any maintenance procedures.

Uncomfortable stimulation: If the stimulation levels are uncomfortable or become uncomfortable, reduce the intensity to a comfortable level. Contact your healthcare professional if this does not resolve the problem or if the problem persists.


Skin reactions: On rare occasions, therapy can result in transient skin reactions such as rash, inflammation, irritation, or burns. These skin reactions may be the result of individual sensitivity or the condition of the skin at the onset of treatment, reaction to the materials in the electrodes, or a poor connection between the electrode and your skin. If a visible skin reaction does occur, discontinue the treatment and consult your healthcare professional.

Electromagnetic compatibility: Care must be taken when operating this device adjacent to other equipment. Potential electromagnetic or other interference could occur to this or other equipment. Try to minimize this interference by not using other equipment in conjunction with this device (i.e. cell phones, etc.).

Lead connection: Do not connect the lead wires or specialized wrap to an AC power source or other equipment not specified as safe for the lead wire or special-ized wrap. Doing so could result in severe shock or burns whether or not the lead wires or specialized wrap is attached to the stimulator.

Accessories: Use only accessories that are specially designed for this device. Do not use accessories manufactured by other companies on this device. Empi is not responsible for any consequence resulting from using products manufactured by other companies. The use of other accessories may result in increased emissions or decreased immunity of this device.

Defibrillation signals: Remove the TENS electrode before defibrillation signals are applied. Defibrillation of a person wearing a TENS device can damage the device whether it is turned on or off. Under some circumstances there can be risk of burns under the electrode site during the defibrillation.

Safety: The safety and efficacy of the Empi Active system depend on the proper use and handling of the device and accessories. If used improperly, the Empi Active system has a potentially hazardous electrical output. It must be used only as prescribed. Electrode burns may result from misuse. Electrodes should be securely fastened to prevent inadvertent disconnection. Electrodes will eventually wear out. Check accessories regularly for signs of wear, and replace if needed.

Proper electrode size: Output current density is related to electrode size or conductive zones. Improper application may result in patient injury. If any question arises as to the proper electrode size, consult a healthcare professional prior to therapy session.

Precautions

Epilepsy: Use caution for patients with suspected or diagnosed epilepsy when using this device.

Hemorrhages: Use caution when there is a tendency to hemorrhage, such as following acute trauma or fracture.

Post-surgical use: Use caution following recent surgical procedures when muscle contraction may disrupt the healing process.

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Warnings

Supervised use: This device should only be operated under the prescription and supervision of a physician (or licensed practitioner) who is familiar with the precau-tionary measures and operational functions associated with the unit being used.

Long-term effects: The long-term effects of chronic use of electrical stimulation are unknown. Electrical stimulation devices do not have any curative value.

Symptomatic treatment: This device is a symptomatic treatment and, as such, suppresses the sensation of pain, which would otherwise serve as a protective mechanism.

Central origin pain: Electrical stimulation is not effective for central origin pain such as headache.

Pregnancy: The safety of using electrical stimulation during pregnancy or birth has not been established.

Throat stimulation: Severe spasm of the laryngeal and pharyngeal muscles may occur when the electrodes are placed across the throat or mouth. This may be strong enough to close off the airway or cause breathing difficulty.

Transthoracic stimulation: Do not apply electrical stimulation transthoracically (through the chest area) because the introduction of electrical current into the heart may cause cardiac arrhythmias.

Skin and vascular problems: Do not use this device over infected areas, skin erup-tions, or areas of decreased sensation.

Heart disease: Precaution should be taken prior to using electrical stimulation on patients suspected of having heart disease.

High frequency surgical devices: Simultaneous connection of a patient to a high frequency surgical device may result in burns at the site of the electrode or possible damage to the device.

Damage from liquids: Do not immerse the device in water or other liquids. Water or liquids could cause malfunction of internal components of the system, causing a risk of injury to the patient.

Electrical shock: To prevent electrical shock, disconnect the unit from the power source before attempting any maintenance procedures.

Uncomfortable stimulation: If the stimulation levels are uncomfortable or become uncomfortable, reduce the intensity to a comfortable level. Contact your healthcare professional if this does not resolve the problem or if the problem persists.


Skin reactions: On rare occasions, therapy can result in transient skin reactions such as rash, inflammation, irritation, or burns. These skin reactions may be the result of individual sensitivity or the condition of the skin at the onset of treatment, reaction to the materials in the electrodes, or a poor connection between the electrode and your skin. If a visible skin reaction does occur, discontinue the treatment and consult your healthcare professional.

Electromagnetic compatibility: Care must be taken when operating this device adjacent to other equipment. Potential electromagnetic or other interference could occur to this or other equipment. Try to minimize this interference by not using other equipment in conjunction with this device (i.e. cell phones, etc.).

Lead connection: Do not connect the lead wires or specialized wrap to an AC power source or other equipment not specified as safe for the lead wire or special-ized wrap. Doing so could result in severe shock or burns whether or not the lead wires or specialized wrap is attached to the stimulator.

Accessories: Use only accessories that are specially designed for this device. Do not use accessories manufactured by other companies on this device. Empi is not responsible for any consequence resulting from using products manufactured by other companies. The use of other accessories may result in increased emissions or decreased immunity of this device.

Defibrillation signals: Remove the TENS electrode before defibrillation signals are applied. Defibrillation of a person wearing a TENS device can damage the device whether it is turned on or off. Under some circumstances there can be risk of burns under the electrode site during the defibrillation.

Safety: The safety and efficacy of the Empi Active system depend on the proper use and handling of the device and accessories. If used improperly, the Empi Active system has a potentially hazardous electrical output. It must be used only as prescribed. Electrode burns may result from misuse. Electrodes should be securely fastened to prevent inadvertent disconnection. Electrodes will eventually wear out. Check accessories regularly for signs of wear, and replace if needed.

Proper electrode size: Output current density is related to electrode size or conductive zones. Improper application may result in patient injury. If any question arises as to the proper electrode size, consult a healthcare professional prior to therapy session.

Precautions

Epilepsy: Use caution for patients with suspected or diagnosed epilepsy when using this device.

Hemorrhages: Use caution when there is a tendency to hemorrhage, such as following acute trauma or fracture.

Post-surgical use: Use caution following recent surgical procedures when muscle contraction may disrupt the healing process.

13051_360372A.indd 5 6/7/11 8:27:00 PM



Uterus: Do not use electrical stimulation over a menstruating or pregnant uterus.

Sensory loss: Do not use electrical stimulation where sensory nerve damage is present, causing a loss of normal skin sensation.

Prescription: Use electrical stimulation only in the prescribed manner and for the prescribed diagnosis. If there are any changes in an existing condition, or if a new condition develops, the patient should consult a healthcare professional.

Effectiveness: Effectiveness is highly dependent upon patient selection by a healthcare professional qualified in the management of pain or rehabilitation.

Keep out of reach of children: Keep this device out of the reach of children. If the patient is a child, make sure he/she is properly supervised during electrical stimulation.

Leads and Electrodes: Use the device only with the electrodes or specialized wrap provided for use by the manufacturer. The safety of other products has not been established, and their use could result in injury to the patient. Use only the electrode placements and stimulation settings prescribed by your practitioner.

NOTE: An electrode active area of no less than 1.2 in2 (7.9 cm2) is recommended for the Empi Active.

Electronic equipment: Electronic monitoring equipment (such as ECG and ECG alarms) may not operate properly when electrical stimulation is in use.

Microwave or radio frequency sources: Operation in close proximity, such as 3 feet (1 meter), to shortwave or microwave therapy equipment may produce instability in the device output and may shut the device off.

Machinery operation: Patient should never operate potentially dangerous machinery such as power saws, automobiles, etc. during electrical stimulation.

Flammable: Do not use the device in an environment where flammable or explosive fumes may exist.

External use: This device is for external use only.

Electromagnetic energy: Do not operate this unit in an environment where other devices are being used that intentionally radiate electromagnetic energy in an unshielded manner. Portable and mobile RF communications equipment can affect medical electrical equipment.

Sharp objects: Do not use sharp objects such as a pencil point or ballpoint pen to operate the buttons on the device.

Connectors: Inspect connectors before each use.

Treatment outcome: Treatment outcome will be influenced by the patient’s psychological state and use of drugs.


Negative reaction to stimulation: Patients who react negatively to the stimulation sensation after an adequate trial period or who find stimulation intolerable should not undergo further treatment.

Operation conditions: This unit should be operated in temperatures between 50° F and 104° F (10° C and 40° C), atmospheric pressures between 50 kPa and 106 kPa, and relative humidity between 30% and 75%.

Transportation and storage conditions: This unit should be transported and stored in temperatures between -40° F and 158° F (-40° C and 70° C), atmospheric pressures between 50 kPa and 106 kPa, and relative humidity between 10% and 90%.

Using device while sleeping: Do not use while sleeping because the electrode or specialized wrap may become disconnected.

Heat and cold products: The use of heat or cold producing devices, such as electric heating blankets, heating pads or ice packs, may impair the performance of the electrode or alter the patient’s circulation/sensitivity and increase the risk of injury to the patient.

Battery charger: Only the Empi battery charger should be used to charge the battery in the device.

Radio frequency generation: This equipment generates, uses, and can radiate radio frequency energy 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. Harmful interference to other devices can be determined by turning the unit on and off. Try to correct the interference using one or more of the following: reorient or relocate the receiving device, increase the separation between the equipment, or consult the Empi Service Department (800.328.2536) for help.

Dangers

Dangerous voltage: Stimulus delivered by the TENS waveform of this device, in certain configurations, will deliver a charge of up to 20 microcoulombs (μC) or greater per pulse and may be sufficient to cause electrocution. Electrical current of this magnitude must not flow through the thorax (chest) because it may cause a cardiac arrhythmia.

Biohazardous materials: Handle, clean, and dispose of components and accessories that have come in contact with bodily fluids according to national, local, and facility rules, regulations, and procedures.

Adverse Effects

Skin irritation, inflammation, and burns beneath the electrode are potential adverse reactions.

BIOHAZARD

13051_360372A.indd 6 6/7/11 8:59:09 PM



Uterus: Do not use electrical stimulation over a menstruating or pregnant uterus.

Sensory loss: Do not use electrical stimulation where sensory nerve damage is present, causing a loss of normal skin sensation.

Prescription: Use electrical stimulation only in the prescribed manner and for the prescribed diagnosis. If there are any changes in an existing condition, or if a new condition develops, the patient should consult a healthcare professional.

Effectiveness: Effectiveness is highly dependent upon patient selection by a healthcare professional qualified in the management of pain or rehabilitation.

Keep out of reach of children: Keep this device out of the reach of children. If the patient is a child, make sure he/she is properly supervised during electrical stimulation.

Leads and Electrodes: Use the device only with the electrodes or conductive garment provided for use by the manufacturer. The safety of other products has not been established, and their use could result in injury to the patient. Use only the electrode placements and stimulation settings prescribed by your practitioner.

NOTE: An electrode active area of no less than 1.2 in2 (7.9 cm2) is recommended for the Empi Active.

Electronic equipment: Electronic monitoring equipment (such as ECG and ECG alarms) may not operate properly when electrical stimulation is in use.

Microwave or radio frequency sources: Operation in close proximity, such as 3 feet (1 meter), to shortwave or microwave therapy equipment may produce instability in the device output and may shut the device off.

Machinery operation: Patient should never operate potentially dangerous machinery such as power saws, automobiles, etc. during electrical stimulation.

Flammable: Do not use the device in an environment where flammable or explosive fumes may exist.

External use: This device is for external use only.

Electromagnetic energy: Do not operate this unit in an environment where other devices are being used that intentionally radiate electromagnetic energy in an unshielded manner. Portable and mobile RF communications equipment can affect medical electrical equipment.

Sharp objects: Do not use sharp objects such as a pencil point or ballpoint pen to operate the buttons on the device.

Connectors: Inspect connectors before each use.

Treatment outcome: Treatment outcome will be influenced by the patient’s psychological state and use of drugs.


Negative reaction to stimulation: Patients who react negatively to the stimulation sensation after an adequate trial period or who find stimulation intolerable should not undergo further treatment.

Operation conditions: This unit should be operated in temperatures between 50° F and 104° F (10° C and 40° C), atmospheric pressures between 50 kPa and 106 kPa, and relative humidity between 30% and 75%.

Transportation and storage conditions: This unit should be transported and stored in temperatures between -40° F and 158° F (-40° C and 70° C), atmospheric pressures between 50 kPa and 106 kPa, and relative humidity between 10% and 90%.

Using device while sleeping: Do not use while sleeping because the electrode or specialized wrap may become disconnected.

Heat and cold products: The use of heat or cold producing devices, such as electric heating blankets, heating pads or ice packs, may impair the performance of the electrode or alter the patient’s circulation/sensitivity and increase the risk of injury to the patient.

Battery charger: Only the Empi battery charger should be used to charge the battery in the device.

Radio frequency generation: This equipment generates, uses, and can radiate radio frequency energy 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. Harmful interference to other devices can be determined by turning the unit on and off. Try to correct the interference using one or more of the following: reorient or relocate the receiving device, increase the separation between the equipment, or consult the Empi Service Department (800.328.2536) for help.

Dangers

Dangerous voltage: Stimulus delivered by the TENS waveform of this device, in certain configurations, will deliver a charge of up to 20 microcoulombs (μC) or greater per pulse and may be sufficient to cause electrocution. Electrical current of this magnitude must not flow through the thorax (chest) because it may cause a cardiac arrhythmia.

Biohazardous materials: Handle, clean, and dispose of components and accessories that have come in contact with bodily fluids according to national, local, and facility rules, regulations, and procedures.

Adverse Effects

Skin irritation, inflammation, and burns beneath the electrode are potential adverse reactions.

BIOHAZARD

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What You Should Have ReceivedYou should have received everything shown below in Figure 1. If anything is missing, contact your clinician or call Empi at 800.328.2536:

Figure 1:

Included:

1. Empi® Active™ Device

2. Package containing electrodes and/or specialized wrap

3. Battery charger

4. Carrying bag

5. This user guide: Managing Your Pain with Empi Active

5

4

32

1


1. Wash and dry the skin area where you will apply the electrode or specialized wrap.

2. Connect a charged Empi Active device to an electrode or specialized wrap. Figure 2

3. Apply the electrode or specialized wrap (with electrodes applied) to your skin.

4. Press . Figure 3 The light will glow blue steadily for about five seconds.

5. Press until you feel the desired intensity. Figure 4 The light will flash blue every 5 seconds to indicate that the device is operating and therapy is being delivered.

Quick Reference continued

When you are familiar with your Empi Active device, the following quick reference will be helpful. For complete information, see “Detailed Instructions,” beginning on page 11.

Start a Therapy Session

Important: Be sure your Empi Active device is turned off (in this condition, the light is off for more than 5 seconds) before connecting it to an electrode or specialized wrap.

13051_360372A.indd 8 6/8/11 2:06:48 PM


What You Should Have ReceivedYou should have received everything shown below in Figure 1. If anything is missing, contact your clinician or call Empi at 800.328.2536:

Included:

1. Empi® Active™ Device

2. Package containing electrodes and/or specialized wrap

3. Battery charger

4. Carrying bag

5. This user guide: Managing Your Pain with Empi Active

5

4

32

1



2. Connect a charged Empi Active device to an electrode or specialized wrap. Figure 2


4. Press . Figure 3 The light will glow blue steadily for about five seconds.

5. Press until you feel the desired intensity. Figure 4 The light will flash blue every 5 seconds to indicate that the device is operating and therapy is being delivered.


When you are familiar with your Empi Active device, the following quick reference will be helpful. For complete information, see “Detailed Instructions,” beginning on page 11.

Figure 2:Connect Device to Electrode or Specialized Wrap

Figure 3:Turn Device ON/Off

Figure 4: Increase Intensity

Start a Therapy Session

Important: Be sure your Empi Active device is turned off (in this condition, the light is off for more than 5 seconds) before connecting it to an electrode or specialized wrap.

13051_360372A.indd 9 6/7/11 9:00:16 PM



Change Intensity

When your Empi Active device has been on for 20 seconds and no buttons have been pressed, the unit automatically becomes “locked” at the set intensity. Press to unlock the unit. Figure 5 Then press either or to adjust the intensity of your therapy.

If you press when the unit is already at its lowest possible setting — or press when the unit is already at its highest possible setting — the blue light will flash quickly.

End a Therapy Session

To end a therapy session, press and hold1. for at least 1 second. The light will first glow steady blue for a few seconds and will then flash four times This is the “goodbye” signal. Your Empi Active device is now turned off.

Carefully remove the electrode or specialized wrap from your skin. (Leave the 2. device attached to the specialized wrap unless you need to recharge the device.)

Follow the instructions on the electrode or specialized wrap package 3. for storage.

If needed, use adhesive remover to remove gel/adhesive from your skin. 4.

Use skin cream to moisturize your skin after removing the electrode or 5. specialized wrap.

Store the components in your carrying bag.6.

Detailed InstructionsIntroduction

This section gives you complete details on how to use your Empi Active device. Before operating the device, read the previous sections of this user guide that describe the device and its features, including the “Prescribing Information” section beginning on page 3. To get the most from your therapy, follow the instructions received from your healthcare professional. Use the device only for the symptoms your healthcare professional has discussed with you. Contact your healthcare professional if you have questions or problems — or if you have new symptoms or painful areas. Your healthcare professional is most familiar with your situation and can give you the best advice. You may also contact Empi Customer Service at 800.328.2536.

Your Empi Active Device

Figure 6 shows your Empi Active device and its main parts:

• — Turns the device on and off

• — Increases stimulation

• — Decreases stimulation

Connector Slot• — Attaches the device to an electrode, specialized wrap or to the battery charger Status Light• — Shows the device’s current status

Figure 5:Decrease Intensity

13051_360372A.indd 10 6/7/11 8:27:01 PM


Connector Slot:Attaches the device to an electrode, specialized wrap or to the battery charger

On/OffTurns the deviceon and off

Status LightShows the device’scurrent status

Increase:IncreasesstimulationDecrease:

Decreasesstimulation


Change Intensity

When your Empi Active device has been on for 20 seconds and no buttons have been pressed, the unit automatically becomes “locked” at the set intensity. Press to unlock the unit. Figure 5 Then press either or to adjust the intensity of your therapy.

If you press when the unit is already at its lowest possible setting — or press when the unit is already at its highest possible setting — the blue light will flash quickly.


To end a therapy session, press and hold1. for at least 1 second. The light will first glow steady blue for a few seconds and will then flash four times This is the “goodbye” signal. Your Empi Active device is now turned off.

Carefully remove the electrode or specialized wrap from your skin. (Leave the 2. device attached to the specialized wrap unless you need to recharge the device.)


If needed, use adhesive remover to remove gel/adhesive from your skin. 4.



Detailed InstructionsIntroduction

This section gives you complete details on how to use your Empi Active device. Before operating the device, read the previous sections of this user guide that describe the device and its features, including the “Prescribing Information” section beginning on page 3. To get the most from your therapy, follow the instructions received from your healthcare professional. Use the device only for the symptoms your healthcare professional has discussed with you. Contact your healthcare professional if you have questions or problems — or if you have new symptoms or painful areas. Your healthcare professional is most familiar with your situation and can give you the best advice. You may also contact Empi Customer Service at 800.328.2536.

Your Empi Active Device

Figure 6 shows your Empi Active device and its main parts:

• — Turns the device on and off

• — Increases stimulation

• — Decreases stimulation

Connector Slot• — Attaches the device to an electrode, specialized wrap or to the battery charger Status Light• — Shows the device’s current status

Figure 6:

Figure 5:Decrease Intensity

13051_360372A.indd 11 6/7/11 8:27:02 PM


Detailed Instructions continued

Using Your Empi Active Device

Caution: United States federal law restricts this device to sale by or on the order of a healthcare professional.

Charge the Battery

The rechargeable battery in your Empi Active device cannot be removed. A fully charged battery will provide about 12 hours of therapy when the device is set at full intensity. You should charge the battery as needed to maintain your therapy schedule.

If the battery does not have enough charge to power the device, the blue light will flash for five seconds, and the unit will turn itself off.

To charge the battery:

As shown in 1. Figure 7, align the device connector slot with the charger connector and gently slide the device onto the charging unit until you hear and feel a click.

Plug the charging unit into a standard power 2. outlet. The light on the device will glow amber while the unit is charging. The light will glow green when the battery has been fully charged.

When the battery is fully charged, unplug the 3. charging unit from the power outlet and remove the device from the charging unit by pressing the “Press” button.

Connect the Device to an Electrode or Specialized Wrap

Important: Be sure your Empi Active device is turned off before connecting it to an electrode or specialized wrap. The light is off when the device is not powered on. If the light is on — either steady or blinking — press for at least 1 second to turn the device off. Figure 8

For application of electrodes or specialized wrap, follow instructions provided with the electrodes or specialized wrap.

Figure 7:Connect

the Device to the

Battery Charger

Figure 8:Connect Device to Electrode or Specialized Wrap


Place the Electrode or Specialized Wrap on Your Skin

Place the electrode or specialized wrap exactly where instructed by a healthcare professional. The most common problems with Empi Active therapy are caused by failing to use the device as directed.

Note: Keep electrodes or specialized wrap away from heat sources.

Begin Therapy

To begin your therapy session:

Press and hold down1. for at least one second. If the battery has enough charge, the blue light will come on steadily for about five seconds, and the therapy level will automatically be zero. In other words, there will be no stimulation until you set the level.

If the battery does not have enough charge when you turn the unit on, the blue light will flash for five seconds, and the unit will turn itself off. If this happens, charge the battery.

Press2. to increase stimulation to a comfortable level, as directed by your healthcare professional. The blue light will come on while you hold down .

If you set the intensity too high, press3. . During therapy, the blue light will flash every few seconds.

Note: You can operate either or by holding the button down to steadily change the intensity or by pressing it quickly several times to change the intensity in small amounts.

Note: If the unit is left on at zero intensity for five minutes, it will turn off.

Change the Intensity: the Automatic Lock Feature

When your Empi Active has been on for 20 seconds and no buttons have been pressed, the unit automatically becomes “locked” at the set intensity. This protects you from accidentally changing the setting. Press to unlock the unit. Then press and/or as needed.

Note: If you press when the unit is at its lowest possible setting — or press when the unit is at its highest possible setting — the blue light will flash quickly.

13051_360372A.indd 12 6/7/11 9:15:25 PM



Using Your Empi Active Device

Caution: United States federal law restricts this device to sale by or on the order of a healthcare professional.

Charge the Battery

The rechargeable battery in your Empi Active device cannot be removed. A fully charged battery will provide about 12 hours of therapy when the device is set at full intensity. You should charge the battery as needed to maintain your therapy schedule.

If the battery does not have enough charge to power the device, the blue light will flash for five seconds, and the unit will turn itself off.

To charge the battery:

As shown in 1. Figure 7, align the device connector slot with the charger connector and gently slide the device onto the charging unit until you hear and feel a click.

Plug the charging unit into a standard power 2. outlet. The light on the device will glow amber while the unit is charging. The light will glow green when the battery has been fully charged.

When the battery is fully charged, unplug the 3. charging unit from the power outlet and remove the device from the charging unit by pressing the “Press” button.

Connect the Device to an Electrode or Specialized Wrap

Important: Be sure your Empi Active device is turned off before connecting it to an electrode or specialized wrap. The light is off when the device is not powered on. If the light is on — either steady or blinking — press for at least 1 second to turn the device off. Figure 8

For application of electrodes or specialized wrap, follow instructions provided with the electrodes or specialized wrap.

Figure 7:Connect

the Device to the

Battery Charger


Place the Electrode or Specialized Wrap on Your Skin

Place the electrode or specialized wrap exactly where instructed by a healthcare professional. The most common problems with Empi Active therapy are caused by failing to use the device as directed.

Note: Keep electrodes or specialized wrap away from heat sources.

Begin Therapy

To begin your therapy session:

Press and hold down1. for at least one second. If the battery has enough charge, the blue light will come on steadily for about five seconds, and the therapy level will automatically be zero. In other words, there will be no stimulation until you set the level.

If the battery does not have enough charge when you turn the unit on, the blue light will flash for five seconds, and the unit will turn itself off. If this happens, charge the battery.

Press2. to increase stimulation to a comfortable level, as directed by your healthcare professional. The blue light will come on while you hold down .

If you set the intensity too high, press3. . During therapy, the blue light will flash every few seconds.

Note: You can operate either or by holding the button down to steadily change the intensity or by pressing it quickly several times to change the intensity in small amounts.

Note: If the unit is left on at zero intensity for five minutes, it will turn off.

Change the Intensity: the Automatic Lock Feature

When your Empi Active has been on for 20 seconds and no buttons have been pressed, the unit automatically becomes “locked” at the set intensity. This protects you from accidentally changing the setting. Press to unlock the unit. Then press and/or as needed.

Note: If you press when the unit is at its lowest possible setting — or press when the unit is at its highest possible setting — the blue light will flash quickly.

13051_360372A.indd 13 6/7/11 9:01:03 PM



End the Therapy Session

To end a therapy session, press and hold1. for at least 1 second. The blue light will first glow steadily for a few seconds and will then flash four times. This is the “goodbye” signal; while it is flashing, you cannot change the set-tings. Your Empi Active device is now turned off.

Carefully remove the electrode or specialized wrap from your skin. 2. (Leave the device connected to the specialized wrap unless you need to recharge the device.)


Clean your skin with mild soap. If needed, use adhesive remover to remove 4. gel/adhesive from your skin.



Maintenance

Check the unit before each use for signs of wear and damage. Replace electrodes or specialized wrap as required. Send damaged units back to Empi for repair, as explained in the “Warranty,” section beginning on page 21 of this user guide.

Cleaning

Use a damp cloth moistened with mild soap and water to clean the exterior of the device. Use of other cleaning solutions may damage the case. Never immerse the de-vice in water or other liquids. Do not use cleaning fluids or solvents to remove stains or dirt. These liquids may damage the plastic case and the connector. Note: Refer to electrode or specialized wrap package for care instructions.

Device Storage

If you will not be using your Empi Active device for two weeks or more, place it in its carrying bag and store it in a dry location. The non-removable battery in your Empi Active device will slowly lose its charge in storage. You should recharge the battery at least every six months. The battery can lose its capacity to hold a charge when it is stored for a long time. You can renew its capacity to hold a charge by charging and discharging it several times. If your battery does not retain a charge during standard operation, contact Empi Customer Service at 800.328.2536.

Disposal

Dispose of the unit according to national, state, and local regulations. If needed, ship the used device, postage prepaid, to the Empi Service Center for proper disposal or recycling, as explained in the “Warranty,” section beginning on page 21 of this user guide. Please enclose a note indicating that the item is being returned for disposal or recycling. Outside of North America, contact your authorized Empi distributor, or contact Empi directly at 651.415.9000.


Troubleshooting

If you cannot solve your problem using this troubleshooting section, call Empi Customer Service at 800.862.2343.

Problem Possible Cause Solution

Device is on, but nostimulation is experienced

Device not properlyconnected to electrode or special-ized wrap

Confirm connection between device and electrode or specialized wrap is secure (see page 9 or 12)

During stimulation, blue light begins flashing and then unit turns itself off

Low battery Charge battery

When device is turned on, blue light flashes and unit won’t turn on


Stimulation weak eventhough battery is charged

Dried out, contaminated, or incor-rectly placed electrode or specialized wrap

Verify correct electrode or specialized wrap position with a healthcare pro-fessional – OR – replace electrode or specialized wrap

Stimulation stops eventhough battery is charged

Poor electrode or specialized wrap contact – OR – damaged or worn electrode or specialized wrap

Reapply electrode or specialized wrap, securing it firmly – OR – replace electrode or specialized wrap

Though battery is charged, stimula-tion weakens within minutes of starting treatment

This is a normal adaptation of your body

Increase intensity

Stimulation is uncomfortable

Intensity is too high – OR – damaged or worn electrode or specialized wrap

Decrease intensity – OR –replace electrode orspecialized wrap

Stimulation is ineffective Improper electrode or specialized wrap placement

Reposition electrode orspecialized wrap

Intermittent stimulationoutput

Electrode or specialized wrap life has been exceeded

Replace electrode orspecialized wrap

Replacement Parts

The following replacement parts can be ordered from Empi at 800.328.2536.

Part Part Number

Empi Active Kit 199611-001

Empi Active device 199609-001

Carrying Bag 096533

Battery Charger 200049

User Guide 360372-001

Note: For replacement of electrodes or specialized wraps, contact Empi at 800.328.2536.

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End the Therapy Session

To end a therapy session, press and hold1. for at least 1 second. The blue light will first glow steadily for a few seconds and will then flash four times. This is the “goodbye” signal; while it is flashing, you cannot change the set-tings. Your Empi Active device is now turned off.

Carefully remove the electrode or specialized wrap from your skin. 2. (Leave the device connected to the specialized wrap unless you need to recharge the device.)


Clean your skin with mild soap. If needed, use adhesive remover to remove 4. gel/adhesive from your skin.



Maintenance

Check the unit before each use for signs of wear and damage. Replace electrodes or specialized wrap as required. Send damaged units back to Empi for repair, as explained in the “Warranty,” section beginning on page 21 of this user guide.

Cleaning

Use a damp cloth moistened with mild soap and water to clean the exterior of the device. Use of other cleaning solutions may damage the case. Never immerse the de-vice in water or other liquids. Do not use cleaning fluids or solvents to remove stains or dirt. These liquids may damage the plastic case and the connector. Note: Refer to electrode or specialized wrap package for care instructions.

Device Storage

If you will not be using your Empi Active device for two weeks or more, place it in its carrying bag and store it in a dry location. The non-removable battery in your Empi Active device will slowly lose its charge in storage. You should recharge the battery at least every six months. The battery can lose its capacity to hold a charge when it is stored for a long time. You can renew its capacity to hold a charge by charging and discharging it several times. If your battery does not retain a charge during standard operation, contact Empi Customer Service at 800.328.2536.

Disposal

Dispose of the unit according to national, state, and local regulations. If needed, ship the used device, postage prepaid, to the Empi Service Center for proper disposal or recycling, as explained in the “Warranty,” section beginning on page 21 of this user guide. Please enclose a note indicating that the item is being returned for disposal or recycling. Outside of North America, contact your authorized Empi distributor, or contact Empi directly at 651.415.9000.


Troubleshooting

If you cannot solve your problem using this troubleshooting section, call Empi Customer Service at 800.862.2343.

Problem Possible Cause Solution

Device is on, but nostimulation is experienced

Device not properly connected to electrode or specialized wrap

Confirm connection between device and electrode or specialized wrap is secure (see page 9 or 12)

During stimulation, blue light begins flashing and then unit turns itself off


When device is turned on, blue light flashes and unit won’t turn on


Stimulation weak eventhough battery is charged

Dried out, contaminated, or incorrectly placed electrode or specialized wrap

Verify correct electrode or specialized wrap position with a healthcare pro-fessional – OR – replace electrode or specialized wrap

Stimulation stops eventhough battery is charged

Poor electrode or specialized wrap contact – OR – damaged or worn electrode or specialized wrap

Reapply electrode or specialized wrap, securing it firmly – OR – replace electrode or specialized wrap

Though battery is charged, stimula-tion weakens within minutes of starting treatment

This is a normal adaptation of your body

Increase intensity

Stimulation is uncomfortable

Intensity is too high – OR – damaged or worn electrode or specialized wrap

Decrease intensity – OR –replace electrode orspecialized wrap

Stimulation is ineffective Improper electrode or specialized wrap placement

Reposition electrode orspecialized wrap

Intermittent stimulationoutput

Electrode or specialized wrap life has been exceeded

Replace electrode orspecialized wrap

Replacement Parts

The following replacement parts can be ordered from Empi at 800.328.2536.

Part Part Number

Empi Active Kit 199611-001

Empi Active device 199609-001

Carrying Bag 096533

Battery Charger 200049

User Guide 360372-001

Note: For replacement of electrodes or specialized wrap, contact Empi at 800.328.2536.

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Technical SpecificationsSimple Modulated Pulse (SMP) Waveform

As shown in Figure 9, the output of the Empi Active device is a patented asymmetrical Simple Modulated Pulse (SMP) waveform designed to maximize pain relief. SMP delivers a group of pulses as a repeating 12-second cycle. Within each cycle, the rate and duration of the pulses vary.

Standard Measurement Conditions

23°C, 1 k ohm resistive load, 4.2V d.c. supply voltage.

Standard Measurement

Pulse Duration

Pulse duration is adjustable and determined by the intensity setting. Range is 48 to 400μs at 50% peak amplitude.

Maximum Current

Absolute average value: 10 mA into 500 ohms Root Mean Square: 10 mA into 1k ohm Electrode surface area: 1.2 in2 (7.9 cm2) minimum area recommended.


Internally powered only. Ordinary protection against entry of liquids. Continuous operation.

Asymmetrical Waveform

Empi Patented WaveformFigure 9:


Output

Both Phases (Vpp)* 0 to 60V

1 k ohm resistance (lpp) ** 0 to 60mA

* Vpp = Volts peak to peak ** Ipp = mA peak to peak

Technical Specifications continued

Modulation Characteristics

As illustrated in Figures 10 and 11, the output of Empi Active is a balanced asymmetrical biphasic waveform that has nominally constant voltage in the positive phase and nominally constant current in the negative phase over the AAMI load range of 200 to 1k ohms with a 20% tolerance.

Physical Dimensions

Approximate Weight

0.99 oz. (28.3 grams)

Environmental Requirements

Operating Temperature Range: 50° F to 104° F (10° C to 40° C) Atmospheric Pressure Range: 50 kPa to 106 kPa Relative Humidity Range: 30% to 75%

Transport and Storage Requirements

Temperature Range: -40° F to 158° F (-40° C to 70° C) Atmospheric Pressure Range: 50 kPa to 106 kPa Relative Humidity Range: 10% to 90%

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Technical SpecificationsSimple Modulated Pulse (SMP) Waveform

As shown in Figure 9, the output of the Empi Active device is a patented asymmetrical Simple Modulated Pulse (SMP) waveform designed to maximize pain relief. SMP delivers a group of pulses as a repeating 12-second cycle. Within each cycle, the rate and duration of the pulses vary.

Standard Measurement Conditions

23°C, 1 k ohm resistive load, 4.2V d.c. supply voltage.

Standard Measurement

Pulse Duration

Pulse duration is adjustable and determined by the intensity setting. Range is 48 to 400μs at 50% peak amplitude.

Maximum Current

Absolute average value: 10 mA into 500 ohms Root Mean Square: 10 mA into 1k ohm Electrode surface area: 1.2 in2 (7.9 cm2) minimum area recommended.


Internally powered only. Ordinary protection against entry of liquids. Continuous operation.


Empi Patented WaveformFigure 9:


* Vpp = Volts peak to peak ** Ipp = mA peak to peak


Modulation Characteristics

As illustrated in Figures 10 and 11, the output of Empi Active is a balanced asymmetrical biphasic waveform that has nominally constant voltage in the positive phase and nominally constant current in the negative phase over the AAMI load range of 200 to 1k ohms with a 20% tolerance.

Physical Dimensions

Approximate Weight

0.99 oz. (28.3 grams)

Environmental Requirements

Operating Temperature Range: 50° F to 104° F (10° C to 40° C) Atmospheric Pressure Range: 50 kPa to 106 kPa Relative Humidity Range: 30% to 75%

Transport and Storage Requirements

Temperature Range: -40° F to 158° F (-40° C to 70° C) Atmospheric Pressure Range: 50 kPa to 106 kPa Relative Humidity Range: 10% to 90%

Figure 10:Rate Modulation

125pps

2pps

12sec 12sec

Rate Modulation(pulses per sec)

Figure 11:Duration Modulation

Duration Modulation

100%4sec 4sec

60%

12sec 12sec

Inches Centimeters

Height 1.94 4.92

Length 2.54 6.45

Width 0.57 1.44

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Specifications – Guidance and Manufacturer’s Declaration

The Empi Active is intended for use in the electromagnetic environment specified below. The customer or user of the Empi Active should assure that it is used in such an environment.

Electromagnetic Emissions

Emission Tests Compliance Guidance Regarding Electromagnetic Environment

RF emissions CISPR 11 Group 1The Empi Active uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment

RF emissions CISPR 11 Class B

The Empi Active is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Harmonic emissionsIEC 61000-3-2

N/A - Battery Operated Device

Voltage fluctuations/Flicker Emissions IEC 61000-3-3


Electromagnetic Immunity

Immunity TestIEC 60601Test Level

Compliance LevelElectromagnetic

Environment - Guidance

Electrostatic discharge (ESD)

IEC 61000-4-2

±6 kV contact±8 kV air


Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

Electrical fast transient/burst

IEC 61000-4-4

±2 kV for power supply lines

±1 kV for input/output lines


Mains power quality should be that of a typical commercial or hospital environment.

SurgeIEC 61000-4-5

±1 kV differential mode

±2 kV common mode



Voltage dips, short interruptions and voltage

variations on power supply input linesIEC 61000-4-11

<5% UT(>95% dip in

UT) for 0.5 cycle

40% UT(60% dip in

UT) for 5 cycles

70% UT(30% dip in

UT) for 25 cycles

<5% UT(>95% dip in

UT) for 5 sec



Power frequency (50/60Hz) magnetic field

IEC 61000-4-8

3 A/m 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical com-mercial or hospital environment.

NOTE: UT is the a.c. mains voltage prior to application of the test level.



Electromagnetic Immunity continued

Immunity Test

IEC 60601Test Level

Compliance Level

Electromagnetic Environment - Guidance

Portable and mobile RF communications equipment should be used no closer to any part of the Empi Active device, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance:

Conducted RFIEC 61000-4-6

3 Vrms150 kHz to

80 MHz

3 V d = [3.5]√P

V1

Radiated RFIEC 61000-4-3

3 V/m80 MHz to 2.5 GHz

3 V/m d = [3.5]√P 80 MHz to 800 MHz

E1

d = [7]√P 800 MHz to 2.5 GHz

E1

Where P is the maximum output power rating of the transmit-ter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).Field strengths from fixed RF transmitters, as determined by an electromagnetic site surveya, should be less than the compliance level in each frequency rangeb.Interference may occur in the vicinity of equipment marked with the following symbol:

NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones

and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be

predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF

transmitters, an electromagnetic site survey should be considered. If the measured field strength

in the location in which the Empi Active device is used exceeds the applicable RF compliance

level above, the Empi Active device should be observed to verify normal operation. If abnormal

performance is observed, additional measures may be necessary, such as reorienting or relocating

the Empi Active device.

b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m.

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The Empi Active is intended for use in the electromagnetic environment specified below. The customer or user of the Empi Active should assure that it is used in such an environment.

Electromagnetic Emissions

Emission Tests Compliance Guidance Regarding Electromagnetic Environment

RF emissions CISPR 11 Group 1The Empi Active uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment

RF emissions CISPR 11 Class B

The Empi Active is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Harmonic emissionsIEC 61000-3-2


Voltage fluctuations/Flicker Emissions IEC 61000-3-3


Electromagnetic Immunity

Immunity TestIEC 60601Test Level

Compliance LevelElectromagnetic

Environment - Guidance

Electrostatic discharge (ESD)

IEC 61000-4-2



Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

Electrical fast transient/burst

IEC 61000-4-4

±2 kV for power supply lines

±1 kV for input/output lines



SurgeIEC 61000-4-5

±1 kV differential mode

±2 kV common mode



Voltage dips, short interruptions and voltage

variations on power supply input linesIEC 61000-4-11

<5% UT(>95% dip in

UT) for 0.5 cycle

40% UT(60% dip in

UT) for 5 cycles

70% UT(30% dip in

UT) for 25 cycles

<5% UT(>95% dip in

UT) for 5 sec



Power frequency (50/60Hz) magnetic field

IEC 61000-4-8

3 A/m 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical com-mercial or hospital environment.

NOTE: UT is the a.c. mains voltage prior to application of the test level.



Electromagnetic Immunity continued

Immunity Test

IEC 60601Test Level

Compliance Level

Electromagnetic Environment - Guidance

Portable and mobile RF communications equipment should be used no closer to any part of the Empi Active device, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance:

Conducted RFIEC 61000-4-6

3 Vrms150 kHz to

80 MHz

3 V d = [3.5]√P

V1

Radiated RFIEC 61000-4-3

3 V/m80 MHz to 2.5 GHz

3 V/m d = [3.5]√P 80 MHz to 800 MHz

E1

d = [7]√P 800 MHz to 2.5 GHz

E1

Where P is the maximum output power rating of the transmit-ter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).Field strengths from fixed RF transmitters, as determined by an electromagnetic site surveya, should be less than the compliance level in each frequency rangeb.Interference may occur in the vicinity of equipment marked with the following symbol:

NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones

and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be

predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF

transmitters, an electromagnetic site survey should be considered. If the measured field strength

in the location in which the Empi Active device is used exceeds the applicable RF compliance

level above, the Empi Active device should be observed to verify normal operation. If abnormal

performance is observed, additional measures may be necessary, such as reorienting or relocating

the Empi Active device.

b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m.

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Specifications – Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the Empi Active Device

The Empi Active device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Empi Active device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Empi Active device as recommended below, according to the maximum output power of the communications equipment.

Rated Maximum Output Power of Transmitter

(watts)

Separation Distance According to Frequency of Transmitter (meters)

150 kHz to 80 MHz

d = [3.5]√P

V1

80 MHz to 800 MHz

d = [3.5]√P

V1

800 MHz to 2.5 GHz

d = [7]√P

V1

0.01 0.12 0.12 0.23

0.1 0.38 0.38 0.73

1 1.2 1.2 2.3

10 3.8 3.8 7.3

100 12 12 23

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.

Warranty1. Warning

While, in the opinion of Empi Inc. (hereinafter “ Empi” ), the use of the Empi Active Transcutaneous Electrical Nerve Device (TENS) (hereinafter “the Product”) has met with some success in the treatment of pain, Empi makes no warranties to the pur-chaser as to the effectiveness of the product.

2. Warranty

2A. Empi warrants all of its manufactured product to be free from defects in workmanship and materials for three years from the initial date of purchase from Empi (the “Warranty Period”).

2B. Carrying bag, electrodes or specialized wrap, and other accessories are warranted to be free from defects in workmanship and materials at the time of delivery.

2C. Empi will repair or replace, at its facility, any product found to be defective. This warranty does not apply to any product damaged by misuse, or repaired or altered by anyone other than Empi in Clear Lake, South Dakota.

2D. This warranty is in lieu of any or all other warranties, expressed or implied. No person is authorized to bind Empi to any representation of warranty other than those specifically set forth herein.

Note: Warranty period begins with the date of purchase from manufacturer.

3. Limitation of Liabilities and Disclaimer of Warranties

3A. Empi’s sole obligation in the case of any breach of its warranties set forth in paragraph 2A or 2B above, shall be, at Empi’s option, to repair or replace the Product with a new or factory reconditioned product without charge to Purchaser or to refund the purchase price of the Product. In order to recover under this Warranty, Purchaser must send Empi written notice of the defect (setting forth the problem in reasonable detail) prior to expiration of the Warranty Period, and within 30 days of discovery of the defect. Upon Empi’s written request and authorization, Purchaser shall return the Product to Empi, freight and insurance prepaid, for inspection. Notice and return shipment shall be sent to Empi at 47492 Highway 22 East, Clear Lake, South Dakota 57226. Purchaser may request shipment approval by calling Empi Warranty Repair Department on its toll free number 800.862.2343. In the case of repairs or returns outside of North America, notification and return shipment shall be sent to an Empi Authorized Service Center. To locate the appropriate service center outside of North America, contact your Authorized Empi Distributor, or contact Empi directly at 800.328.2536. Empi will not be responsible for damage due

13051_360372A.indd 20 6/7/11 8:27:03 PM



Specifications – Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the Empi Active Device

The Empi Active device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Empi Active device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Empi Active device as recommended below, according to the maximum output power of the communications equipment.

Rated Maximum Output Power of Transmitter

(watts)

Separation Distance According to Frequency of Transmitter (meters)

150 kHz to 80 MHz

d = [3.5]√P

V1

80 MHz to 800 MHz

d = [3.5]√P

V1

800 MHz to 2.5 GHz

d = [7]√P

V1

0.01 0.12 0.12 0.23

0.1 0.38 0.38 0.73

1 1.2 1.2 2.3

10 3.8 3.8 7.3

100 12 12 23

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.

Warranty1. Warning

While, in the opinion of Empi Inc. (hereinafter “ Empi” ), the use of the Empi Active Transcutaneous Electrical Nerve Device (TENS) (hereinafter “the Product”) has met with some success in the treatment of pain, Empi makes no warranties to the pur-chaser as to the effectiveness of the product.

2. Warranty

2A. Empi warrants all of its manufactured product to be free from defects in workmanship and materials for three years from the initial date of purchase from Empi (the “Warranty Period”).

2B. Carrying bag, electrodes or specialized wrap, and other accessories are warranted to be free from defects in workmanship and materials at the time of delivery.

2C. Empi will repair or replace, at its facility, any product found to be defective. This warranty does not apply to any product damaged by misuse, or repaired or altered by anyone other than Empi in Clear Lake, South Dakota.

2D. This warranty is in lieu of any or all other warranties, expressed or implied. No person is authorized to bind Empi to any representation of warranty other than those specifically set forth herein.

Note: Warranty period begins with the date of purchase from manufacturer.

3. Limitation of Liabilities and Disclaimer of Warranties

3A. Empi’s sole obligation in the case of any breach of its warranties set forth in paragraph 2A or 2B above, shall be, at Empi’s option, to repair or replace the Product with a new or factory reconditioned product without charge to Purchaser or to refund the purchase price of the Product. In order to recover under this Warranty, Purchaser must send Empi written notice of the defect (setting forth the problem in reasonable detail) prior to expiration of the Warranty Period, and within 30 days of discovery of the defect. Upon Empi’s written request and authorization, Purchaser shall return the Product to Empi, freight and insurance prepaid, for inspection. Notice and return shipment shall be sent to Empi at 47492 Highway 22 East, Clear Lake, South Dakota 57226. Purchaser may request shipment approval by calling Empi Warranty Repair Department on its toll free number 800.862.2343. In the case of repairs or returns outside of North America, notification and return shipment shall be sent to an Empi Authorized Service Center. To locate the appropriate service center outside of North America, contact your Authorized Empi Distributor, or contact Empi directly at 800.328.2536. Empi will not be responsible for damage due

13051_360372A.indd 21 6/7/11 8:27:03 PM

EMPI Active User Guide22

Warranty continued

to improper packaging or shipment. If Empi determines in its sole reasonable discretion that the Product contains defective workmanship or materials, Empi will refund to the Purchaser the purchase price for the defective product, or return the repaired Product or a replacement thereof to Purchaser, freight and insurance billed to the Purchaser, as soon as reasonably possible following receipt of the Product by Empi. If Empi determines in its sole reasonable discretion that the Product does not contain defective workmanship or materials, Empi will return the Product to the Purchaser, freight and insurance billed to the Purchaser.

3B. This Warranty is voided immediately as to any Product which has been repaired or modified by any person other than authorized employees or agents of Empi or which has been subjected to misuse, abuse, neglect, damage in transit, accident, or negligence.

3C. Except as provided in paragraph 2A, the product is being sold on an “as is” basis, all accessories are sold “as is”, and the entire risk as to the quality and performance of the product is with Purchaser. The warranty provided in paragraph 2A is intended solely for the benefit of the initial Purchaser and Empi disclaims all other warranties, express or implied including, but not limited to, any implied warranties of merchantability and fitness for a particular purpose; provided, however, that notwithstanding the foregoing sentence, in the event an implied warranty is determined to exist, the period for performance by Empi thereunder shall be limited to three years from the initial date of purchase from Empi. No employee, representative, or agent of Empi has any authority to bind Empi to any affirmation, representation, or warranty except as stated in this written warranty policy. (This Warranty gives Purchaser specific legal rights and Purchaser may also have other rights which vary from state to state. Some states do not allow limitations of how long an implied warranty lasts, so the above limitation may not apply to the Purchaser.)

3D. Empi shall not be liable to any person for any direct, indirect, special, incidental, or consequential damages, lost profits or medical expenses caused by any defect, failure, malfunction or otherwise of the product, regardless of the form in which any legal or equitable action may be brought against Empi (e.g. contract, negligence or otherwise). The remedy provided in paragraph 3A above shall constitute Purchaser’s sole remedy. In no event shall Empi’s liability under any cause of action relating to the product exceed the purchase price of the product. (This Warranty gives Purchaser specific legal rights and Purchaser may also have other rights which vary from state to state. Some states do not allow the exclusion or limitation of incidental or consequential damages, so the above limitation may not apply to the Purchaser.)

13051_360372A.indd 22 6/7/11 8:27:03 PM


Warranty continued

to improper packaging or shipment. If Empi determines in its sole reasonable discretion that the Product contains defective workmanship or materials, Empi will refund to the Purchaser the purchase price for the defective product, or return the repaired Product or a replacement thereof to Purchaser, freight and insurance billed to the Purchaser, as soon as reasonably possible following receipt of the Product by Empi. If Empi determines in its sole reasonable discretion that the Product does not contain defective workmanship or materials, Empi will return the Product to the Purchaser, freight and insurance billed to the Purchaser.

3B. This Warranty is voided immediately as to any Product which has been repaired or modified by any person other than authorized employees or agents of Empi or which has been subjected to misuse, abuse, neglect, damage in transit, accident, or negligence.

3C. Except as provided in paragraph 2A, the product is being sold on an “as is” basis, all accessories are sold “as is”, and the entire risk as to the quality and performance of the product is with Purchaser. The warranty provided in paragraph 2A is intended solely for the benefit of the initial Purchaser and Empi disclaims all other warranties, express or implied including, but not limited to, any implied warranties of merchantability and fitness for a particular purpose; provided, however, that notwithstanding the foregoing sentence, in the event an implied warranty is determined to exist, the period for performance by Empi thereunder shall be limited to three years from the initial date of purchase from Empi. No employee, representative, or agent of Empi has any authority to bind Empi to any affirmation, representation, or warranty except as stated in this written warranty policy. (This Warranty gives Purchaser specific legal rights and Purchaser may also have other rights which vary from state to state. Some states do not allow limitations of how long an implied warranty lasts, so the above limitation may not apply to the Purchaser.)

3D. Empi shall not be liable to any person for any direct, indirect, special, incidental, or consequential damages, lost profits or medical expenses caused by any defect, failure, malfunction or otherwise of the product, regardless of the form in which any legal or equitable action may be brought against Empi (e.g. contract, negligence or otherwise). The remedy provided in paragraph 3A above shall constitute Purchaser’s sole remedy. In no event shall Empi’s liability under any cause of action relating to the product exceed the purchase price of the product. (This Warranty gives Purchaser specific legal rights and Purchaser may also have other rights which vary from state to state. Some states do not allow the exclusion or limitation of incidental or consequential damages, so the above limitation may not apply to the Purchaser.)

13051_360372A.indd 23 6/7/11 8:27:03 PM

Quick Start InstructionsImportant: Be sure your Empi Active device is turned off (in this condition, the light is off for more than 5 seconds) before connecting it to an electrode or specialized wrap.


2. Connect a charged Empi Active device to an electrode or specialized wrap.


4. Press The light will glow blue steadily for about five seconds.

5. Press until you feel the desired intensity. The light will flash blue every 5 seconds to indicate that the device is operating.

Change Intensity

When your Empi Active device has been on for 20 seconds and no buttons have been pressed, the unit automatically becomes “locked” at the set intensity. Press

to unlock the unit. Then press either or to adjust the intensity of your therapy.

If you press when the unit is already at its lowest possible setting — or presswhen the unit is already at its highest possible setting — the blue light will flash

quickly.


1. To end a therapy session, press and hold for at least 1 second. The light will first glow steady blue for a few seconds and will then flash four times. This is the “goodbye” signal. Your Empi Active device is now turned off.

2. Carefully remove the electrode or specialized wrap from your skin. (Leave the device attached to the specialized wrap unless you need to recharge the device.)

3. Follow the instructions on the electrode or specialized wrap package for storage.

Empi, Inc.205 Highway 22 EastClear Lake, SD 57226

800.328.2536www.empi.com

360372-001 Rev. B; © 2009, 2011 Empi 05/11 DJOglobal.com

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