Empi Active User manual

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
E
T
L
C
L
A
S
S
I
F
I
E
D
9900900
13051_360372A.indd 2 6/7/11 8:27:00 PM

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
E
T
L
C
L
A
S
S
I
F
I
E
D
9900900
13051_360372A.indd 3 6/7/11 8:27:00 PM

EMPI Active User GuideEMPI Active User Guide
Contents
Important 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 Notice
Consult 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.
13051_360372A.indd 4 6/7/11 8:27:00 PM

1
EMPI Active User GuideEMPI Active User Guide
Contents
Important 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 Notice
Consult 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.
13051_360372A.indd 1 6/7/11 8:27:00 PM

EMPI Active User Guide
2
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 Information
Introduction
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.
13051_360372A.indd 2 6/7/11 8:27:00 PM

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 Information
Introduction
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
4
EMPI Active User Guide
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.
Prescribing Information continued
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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EMPI Active User Guide
EMPI Active User Guide 5
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.
Prescribing Information continued
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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EMPI Active User Guide
6
EMPI Active User Guide
Prescribing Information continued
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.
Prescribing Information continued
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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EMPI Active User Guide
EMPI Active User Guide 7
Prescribing Information continued
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.
Prescribing Information continued
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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EMPI Active User Guide
8
EMPI Active User Guide
What You Should Have Received
You 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
3
2
1
Managing Your Pain with
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.
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EMPI Active User Guide
EMPI Active User Guide 9
What You Should Have Received
You 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
3
2
1
Managing Your Pain with
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.
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.
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EMPI Active User Guide
10
EMPI Active User Guide
Quick Reference continued
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 the2.
device attached to the specialized wrap unless you need to recharge the device.)
Follow the instructions on the electrode or specialized wrap package3.
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 or5.
specialized wrap.
Store the components in your carrying bag.6.
Detailed Instructions
Introduction
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
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EMPI Active User Guide
EMPI Active User Guide 11
Connector Slot:
Attaches the device to an electrode,
specialized wrap or to the battery charger
On/Off
Turns the device
on and off
Status Light
Shows the device’s
current status
Increase:
Increases
stimulation
Decrease:
Decreases
stimulation
Quick Reference continued
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 the2.
device attached to the specialized wrap unless you need to recharge the device.)
Follow the instructions on the electrode or specialized wrap package3.
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 or5.
specialized wrap.
Store the components in your carrying bag.6.
Detailed Instructions
Introduction
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
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EMPI Active User Guide
12
EMPI Active User Guide
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 in1. 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 power2.
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 the3.
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
Detailed Instructions continued
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

EMPI Active User Guide
EMPI Active User Guide 13
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 in1. 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 power2.
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 the3.
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
Detailed Instructions continued
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

EMPI Active User Guide
14
EMPI Active User Guide
Detailed Instructions continued
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.)
Follow the instructions on the electrode or specialized wrap package3.
for storage.
Clean your skin with mild soap. If needed, use adhesive remover to remove4.
gel/adhesive from your skin.
Use skin cream to moisturize your skin after removing the electrode or5.
specialized wrap.
Store the components in your carrying bag.6.
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.
Detailed Instructions continued
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 no
stimulation is experienced
Device not properly
connected 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
Low battery Charge battery
Stimulation weak even
though 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 even
though 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 or
specialized wrap
Stimulation is ineffective Improper electrode or specialized
wrap placement
Reposition electrode or
specialized wrap
Intermittent stimulation
output
Electrode or specialized wrap life has
been exceeded
Replace electrode or
specialized 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.
13051_360372A.indd 14 6/7/11 8:27:02 PM

EMPI Active User Guide
EMPI Active User Guide 15
Detailed Instructions continued
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.)
Follow the instructions on the electrode or specialized wrap package3.
for storage.
Clean your skin with mild soap. If needed, use adhesive remover to remove4.
gel/adhesive from your skin.
Use skin cream to moisturize your skin after removing the electrode or5.
specialized wrap.
Store the components in your carrying bag.6.
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.
Detailed Instructions continued
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 no
stimulation 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
Low battery Charge battery
When device is turned on, blue light
flashes and unit won’t turn on
Low battery Charge battery
Stimulation weak even
though 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 even
though 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 or
specialized wrap
Stimulation is ineffective Improper electrode or specialized
wrap placement
Reposition electrode or
specialized wrap
Intermittent stimulation
output
Electrode or specialized wrap life has
been exceeded
Replace electrode or
specialized 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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EMPI Active User Guide
16
EMPI Active User Guide
Technical Specifications
Simple 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.
Type BF Applied Part
Internally powered only. Ordinary protection against entry of liquids.
Continuous operation.
Asymmetrical Waveform
Empi Patented Waveform
Figure 9:
Asymmetrical Waveform
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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