EMPI Active User Guide

Transcription

Managing Your Pain with
Empi Active™
Dear Patient,
Welcome to Empi, the leader in home rehabilitation devices.
Your healthcare professional has prescribed an Empi device to aid in your rehabilitation 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 convenient, 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 available 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
CL
A S SI F
D
ET
IE
L
C
9900900
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).
Contents
Important Notice. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
How does Empi Active work? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
What is pain? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
What is TENS? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
How does TENS control pain? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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Frequently Asked Questions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
How long can I wear my Empi Active?. . . . . . . . . . . . . . . . . . . . . . . . . . .
Can I wear my Empi Active to bed?. . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Can I wear my Empi Active while driving?. . . . . . . . . . . . . . . . . . . . . . . .
How should I clean the electrodes or specialized wrap?. . . . . . . . . . . . .
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Prescribing Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Indications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Warnings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Precautions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Dangers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Adverse Effects. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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What You Should Have Received . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Quick Reference. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Start a Therapy Session . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Change Intensity. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
End a Therapy Session. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Detailed Instructions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Your Empi Active Device. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Using Your Empi Active Device. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Charge the Battery. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Connect the Device to an Electrode or Specialized Wrap. . . . . . . . . . .
Place the Electrode or Specialized Wrap on Your Skin . . . . . . . . . . . . .
Begin Therapy. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Change the Intensity: the Automatic Lock Feature . . . . . . . . . . . . . . . .
End the Therapy Session . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Cleaning. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Device Storage. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Replacement Parts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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Contents continued
Technical Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Simple Modulated Pulse Waveform. . . . . . . . . . . . . . . . . . . . . . . . . . . .
Standard Measurement Conditions. . . . . . . . . . . . . . . . . . . . . . . . . . . .
Standard Measurement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Pulse Duration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Maximum Current. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Modulation Characteristics. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Physical Dimensions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Approximate Weight. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Environmental Requirements. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Transport and Storage Requirements. . . . . . . . . . . . . . . . . . . . . . . . . .
Specifications - Guidance and Manufacturer’s Declaration. . . . . . . . . .
Specifications – Recommended Separation Distances between
Portable and Mobile RF Communications Equipment and
the Empi Active Device. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
20
Warranty. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1. Warning. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2. Warranty. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3. Limitation of Liabilities and Disclaimer of Warranties. . . . . . . . . . . . .
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Important Notice
Consult a healthcare professional if you have specific questions or problems regarding 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 attention to the Indications, Contraindications, Warnings, Precautions, Dangers, and
Adverse Effects sections.
1
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 duration. 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 warning 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 treatment instructions provided by your clinician, you can receive maximum benefit from
your Empi Active device.
2
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.
3
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 precautionary 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 eruptions, 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.
4
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 specialized 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.
5
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.
6
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.
BIOHAZARD
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.
7
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:
ith
ain w
ur P
g Yo
agin
Man
4
5
1
3
2
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
8
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
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.
Figure 3:
Turn Device ON/Off
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.
Figure 4: Increase Intensity
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.
9
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.
Figure 5:
Decrease
Intensity
when the unit is already at its
If you press
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
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.
4. If needed, use adhesive remover to remove gel/adhesive from your skin.
5. Use skin cream to moisturize your skin after removing the electrode or
specialized wrap.
6. Store the components in your carrying bag.
10
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:
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
Decrease:
Decreases
stimulation
•
— Turns the device on and off
•
— Increases stimulation
•
— Decreases stimulation
Increase:
Increases
stimulation
Figure 6:
• Connector Slot — Attaches the device to an electrode, specialized wrap or to the
battery charger
• Status Light — Shows the device’s current status
11
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:
1. As shown in 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.
2. Plug the charging unit into a standard power
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.
Figure 7:
3.When the battery is fully charged, unplug the
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
Connect
the Device
to the
Battery Charger
Figure 8:
Connect Device to
Electrode or
Specialized
Wrap
For application of electrodes or specialized wrap,
follow instructions provided with the electrodes or
specialized wrap.
12
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:
1. Press and hold down
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.
2. Press
to increase stimulation to a comfortable level, as directed by your
healthcare professional.
The blue light will come on while you hold down
.
.
3.If you set the intensity too high, press
During therapy, the blue light will flash every few seconds.
or
by holding the button down to steadily
Note: You can operate either
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.
when the unit is at its lowest possible setting — or
Note: If you press
press
when the unit is at its highest possible setting — the blue light
will flash quickly.
13
End the Therapy Session
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 settings. Your Empi Active device is now turned off.
2. Carefully remove the electrode or specialized wrap from your skin.
(Leave the device connected to the specialized wrap unless you need
to recharge the device.)
for storage.
4. Clean your skin with mild soap. If needed, use adhesive remover to remove
gel/adhesive from your skin.
5. Use skin cream to moisturize your skin after removing the electrode or
specialized wrap.
6. Store the components in your carrying bag.
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 device 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.
14
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 professional – 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, stimulation 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.
15
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.
Asymmetrical Waveform
Figure 9:
Empi Patented Waveform
Asymmetrical Waveform
Standard Measurement Conditions
23°C, 1 k ohm resistive load, 4.2V d.c. supply voltage.
Standard Measurement
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
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.
16
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.
125pps
Rate Modulation
(pulses per sec)
2pps
Figure 10:
Rate Modulation
12sec
12sec
4sec
4sec
12sec
12sec
100%
Duration Modulation
60%
Figure 11:
Duration Modulation
Physical Dimensions
Inches
Centimeters
Height
1.94
4.92
Length
2.54
6.45
Width
0.57
1.44
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%
17
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
RF emissions CISPR 11
Compliance
Guidance Regarding Electromagnetic Environment
Group 1
The 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
Harmonic emissions
IEC 61000-3-2
N/A - Battery
Operated Device
Voltage fluctuations/
Flicker Emissions
IEC 61000-3-3
N/A - Battery
Operated Device
Immunity Test
IEC 60601
Test Level
Compliance Level
Electrostatic discharge
(ESD)
IEC 61000-4-2
±6 kV contact
±8 kV air
±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
N/A - Battery
Operated Device
Mains power quality should be that
of a typical commercial or hospital
environment.
Surge
IEC 61000-4-5
±1 kV differential
mode
±2 kV common
mode
N/A - Battery
Operated Device
environment.
Voltage dips, short
interruptions and voltage
variations on power
supply input lines
IEC 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
N/A - Battery
Operated Device
environment.
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 commercial or hospital environment.
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.
Electromagnetic Immunity
Electromagnetic
Environment - Guidance
NOTE: U T is the a.c. mains voltage prior to application of the test level.
18
Specifications – Guidance and Manufacturer’s Declaration
Electromagnetic Immunity continued
Immunity Test
IEC
60601
Test
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 RF
IEC 61000-4-6
3 Vrms
150 kHz to
80 MHz
3V
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to
2.5 GHz
3 V/m
d = [3.5] P
V1 √
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 transmitter 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.
19
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.
Separation Distance According to Frequency of
Transmitter (meters)
Rated Maximum Output
Power of Transmitter
(watts)
150 kHz to 80 MHz
80 MHz to 800 MHz
800 MHz to 2.5 GHz
d = [3.5]
V1 √P
d = [3.5]
V1 √P
d = [7]
V1√P
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.
20
Warranty
1. 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 purchaser 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
21
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.)
22
Quick Start Instructions
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.
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.
3. Apply the electrode or specialized wrap (with electrodes applied) to your skin.
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.
when the unit is already at its lowest possible setting — or press
If you press
when the unit is already at its highest possible setting — the blue light will flash
quickly.
End a Therapy Session
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.)
for storage.
Empi, Inc.
205 Highway 22 East
Clear Lake, SD 57226
800.328.2536
www.empi.com
360372-001 Rev. B; © 2009, 2011 Empi 05/11
DJOglobal.com

EMPI Active User Guide

Transcription

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