Select
User’s Manual
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 Select stimulator:
Type BF Applied Part
Attention, consult accompanying documents
Lead wires comply with the Performance Standard for
electrode lead wires (21 CFR part 898)
Electronic Testing Lab, indicates product meets US and Canadian product safety
standards. This device complies with UL 60601-1 and CSA C22.2 No. 601-1-M90.
9900900
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.
Empi
© 2008 Empi All rights reserved.
Table of Contents
Introduction
How Select Works .................................................................... 6
Main Operating Components ........................................................... 7
Prescribing Information
Indications
Contraindications
Warnings
Precautions .................................................................................
Dangers ....................................................................................
Adverse Effects
Quick Reference
Starting a Therapy Session ............................................................. 14
Changing a Therapy Session ........................................................... 14
Ending a Therapy Session .............................................................. 15
System Components
Device ............................................................................. 16
Device Physical Features .............................................................. 17
LCD Screen ....................................................................... 17
Operating Buttons .................................................................. 18
Intensity Lockout Feature ............................................................. 18
Output Jacks ...................................................................... 18
On/Off Indicator Lights ............................................................... 19
Battery Compartment ................................................................ 19
Belt Clip ......................................................................... 19
Carrying Case ..................................................................... 19
Documentation .................................................................... 19
Lead Wires ....................................................................... 20
Electrodes ........................................................................ 20
Operation
Overview ........................................................................... 21
Installing the Batteries .................................................................22
Connecting the Lead Wires to the Electrodes .............................................. 23
Connecting the Lead Wires to the Device ................................................. 24
Preparing the Skin for a Therapy Session .................................................. 24
Applying the Electrodes to the Skin ...................................................... 25
Turning on the Device ................................................................. 26
Choosing the Treatment Settings ........................................................ 26
Intensity Lockout Feature .............................................................. 26
.......................................................... 6
................................................ 8
.............................................................. 8
......................................................... 8
............................................................. 9
11
13
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Table of Contents
Quick Select Feature ..................................................................26
Program Option Controls ..............................................................27
Beginning Treatment .................................................................. 30
Recording Treatment ..................................................................30
Ending Treatment .................................................................... 30
Using the Timer ...................................................................... 30
Data Retrieval .......................................................................31
Changing the Batteries ................................................................32
Charging the Batteries ................................................................ 33
Maintenance ........................................................................ 33
Cleaning ........................................................................... 34
Storage ............................................................................34
Disposal ............................................................................ 34
Specifications
Physical Characteristics ............................................................... 35
Standard Measurement Conditions ....................................................... 35
Waveform ........................................................................ 35
Standard Measurement ............................................................... 35
Pulse Duration ..................................................................... 35
Maximum Current .................................................................... 35
Absolute Average Value ............................................................... 35
Root Mean Square .................................................................. 35
Electrode Surface Area ............................................................... 35
Physical Dimensions .................................................................. 35
Environmental Conditions .............................................................. 35
Program Options and Default Parameters ................................................. 36
Program Options and Adjustable Parameters ..............................................37
To Select Parameters for Programs ...................................................... 38
Data Retrieval Codes .................................................................. 38
Battery Information ................................................................... 38
Waveforms ......................................................................... 38
Electromagnetic Compatibility (EMC) Tables ............................................... 40
Troubleshooting
Replacement Parts
Warranty
........................................................ 35
....................................................... 44
.................................................... 47
............................................................48
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Congratulations! Your physician has prescribed Empi’s Select Pain Control system to help
you with pain management. Empi is dedicated to helping you regain your active lifestyle
– from our field sales representatives training you on how to use the system, to our patient
coordinators following up with you. We make your success our goal.
How Select Works
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
system 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 or muscle strain. This type of pain is typically
associated with workplace or recreational injuries. Chronic pain, however, is a long-lasting,
persistent pain that ceases to serve as a warning system and becomes a problem.
The Select was developed to help relieve some types of both chronic and acute 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?
The Select provides pain relief in two ways. The first is the gate control method. When the
body is injured, both pain and non-pain impulses are sent to the brain from the nervous
system. These pulses travel through the cutaneous nerves to the deeper, afferent nerves,
and then to the spinal cord and brain. Along the path are many areas referred to as “gates,”
which 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 Select device “controls the gate.”
The second method of pain control is the endorphin release method. The Select device
can be set to trigger the body’s natural pain killers, called endoprhins. These chemicals
interact with recpetors, blocking the perception of pain. This is similar to the way the
pharmaceutical drug morphine works, but without the side effect associated with morphine.
No matter which pain control method is employed, the Select has been proven useful in
pain management. By reading this manual and carefully following the treatment instructions
provided by your clinician, you can attain maximum benefit from your Select device.
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IntroductionIntroduction
Main Operating Components
Consult a health care professional (clinician) if you have specific questions or
problems regarding the use of the device. They are most familiar with your situation
and are the best source of additional guidance. This system should be used only
under proper medical supervision and only as described by this manual.
Before using your Select Pain Control system, please read all of the indications,
contraindications, warnings, and precautions in the Prescribing Information section
(on page 8).
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In general, stimulation should be used under medical supervision in the management of
specific conditions.
Read, understand, and practice the precautionary and operating instructions found in this
manual. Know the limitations and hazards associated with the Select Pain Control system.
Observe any and all precautionary and operational decals placed on the unit.
Indications
TENS devices are indicated for:
• Symptomatic relief and management of chronic, intractable pain
• Adjunctive treatment for post-surgical and post-trauma acute pain
• For the relief of pain associated with arthritis
Contraindications
TENS treatments should not be used if you have any of the following:
Cardiac pacemakers
cardiac pacemaker or any implanted defibrillator.
Transcerebral stimulation
(through the head).
Carotid sinus
Unknown etiology
Use only after origin of pain has been diagnosed.
– Do not use this device if the patient has a demand-type
– Do not apply electrical stimulation transcerebrally
– Do not use electrical stimulation over the carotid sinus nerves (throat).
– Do not use this device when pain syndromes are undiagnosed.
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Prescribing InformationPrescribing Information
Warnings
Supervised use
supervision of a physician (or licensed practitioner) that is familiar with the precautionary
measures and operational functions associated with the unit being used.
Long-term effects
unknown. Electrical stimulation devices do not have any curative value.
Symptomatic treatment
suppresses the sensation of pain, which would otherwise serve as a protective mechanism.
Central origin pain
as headache.
Pregnancy
been established.
Throat stimulation
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
(through the chest area) in that the introduction of electrical current into the heart may
cause cardiac arrhythmias.
Skin and vascular problems
or areas of decreased sensation.
Heart disease
patients suspected
High frequency surgical devices
frequency surgical device may result in burns at the site of the electrodes and possible
damage to the device.
Damage from liquids
liquids could cause malfunction of internal components of the system, causing a risk of
injury to the patient.
Electrical shock
before attempting any maintenance procedures.
Uncomfortable stimulation
uncomfortable, reduce the intensity to a comfortable level. Contact your clinician if this
does not resolve the problem or if the problem persists.
– This device should only be operated under the prescription and
– The long-term effects of chronic use of electrical stimulation are
– This device is a symptomatic treatment and, as such,
– Electrical stimulation is not effective for central origin pain such
– The safety of using electrical stimulation during pregnancy or birth has not
– Severe spasm of the laryngeal and pharyngeal muscles may occur
– Do not apply electrical stimulation transthoracically
– Do not use this device over infected areas, skin eruptions,
– Precaution should be taken prior to using electrical stimulation on
having heart disease.
of
– Simultaneous connection of a patient to a high
– Do not immerse the device in water or other liquids. Water or
– To prevent electrical shock, disconnect the unit from the power source
– If the stimulation levels are uncomfortable or become
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Skin reactions
as rash, inflammation, irritation, or burns. These skin reactions may be the result of
individual sensitivity to 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 the prescribing
physician or licensed practitioner.
Lead connection
equipment not specified as safe for the lead wires. Doing so could result in severe shock
or burns whether or not the lead wires are attached to the stimulator.
Electromagnetic compatibility
adjacent to or stacked with 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 it. (i.e. cell phones, etc.)
Accessories
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 or cables may result in increased emissions or decreased immunity of
this device.
Defibrillation signals
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 sites during the defibrillation.
Safety
– The safety and efficacy of the Select system depends on the proper use and
handling of the device and accessories. If used improperly, the Select system has a
potentially hazardous electrical output. It must be used only as prescribed. Electrode
or lead wire burns may result from misuse. Electrodes and lead wires should be securely
fastened to prevent inadvertent disconnection. The length of lead wires could result in
injury. Electrodes and lead wires will eventually wear out. Check accessories regularly
for signs of wear, and replace if needed.
– On rare occasions, therapy can result in transient skin reactions such
– Do not connect the lead wires to an AC power source or other
– Care must be taken when operating this device
– Use only accessories that are specially designed for this device. Do not use
– Remove the TENS electrodes before defibrillation signals are
Proper electrode size
application may result in patient injury. If any question arises as to the proper electrode
size, consult a licensed practitioner prior to therapy session.
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– Output current density is related to electrode size. Improper
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Prescribing InformationPrescribing Information
Precautions
Epilepsy
this device.
Hemorrhages
acute trauma or fracture.
Post-surgical use
contraction may disrupt the healing process.
Uterus
Sensory loss
causing a loss of normal skin sensation.
Unequal electrode size
or increased stimulation intensity under the smaller electrode. Some programs may require
the use of different sized electrodes for treatment.
Prescription
prescribed diagnosis. If there are any changes in an existing condition, or if a new condition
develops, the patient should consult a physician.
Effectiveness
qualified in the management of pain or rehabilitation.
Keep out of reach of children
patient is a child, make sure he/she is properly supervised during electrical stimulation.
Leads and electrodes
use by
use could result in injury to the patient. Use only the electrode placements and stimulation
settings prescribed by your practitioner.
NOTE:
the Select system.
NOTE:
connection as pictured.
– Use caution for patients with suspected or diagnosed epilepsy when using
– Use caution when there is a tendency to hemorrhage, such as following
– Use caution following recent surgical procedures when muscle
– Do not use electrical stimulation over a menstruating or pregnant uterus.
– Do not use electrical stimulation where sensory nerve damage is present,
– Using different size electrodes together can cause skin irritation
– Use electrical stimulation only in the prescribed manner and for the
– Effectiveness is highly dependent upon patient selection by a clinician
– Keep this device out of the reach of children. If the
– Use the device with only the leads and electrodes provided for
manufacturer. The safety of other products has not been established, and their
the
An electrode active area of no less than 1.227 in2 (7.917 cm2) is recommended for
The Select system requires the use of Empi lead wires with the custom safety
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Electronic equipment
may not operate properly when electrical stimulation is in use.
Microwave or radio frequency sources
(1 meter), to shortwave or microwave therapy equipment may produce instability in the
device output and may shut the device off.
Machinery operation
such as power saws, automobiles, etc. during electrical stimulation.
Flammable
fumes may exist.
External use
– Do not use the device in an environment where flammable or explosive
– This device is for external use only.
Electromagnetic energy
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
operate the buttons on the control panel.
Cables and connectors
Treatment outcome
psychological state and use of drugs.
Negative reaction to stimulation
sensation after an adequate trial period or who find stimulation intolerable should not
undergo
further treatment.
Operation conditions
50° F and 104° F (10° C and 40° C), atmospheric pressures between 50 and 106 kPa,
and relative humidity between 30% and 75%.
Transportation and storage conditions
in temperatures between -40° F and 158° F (-40° C and 70° C), atmospheric pressures
between 50 and 106 kPa, and relative humidity between 10% - 90%.
Batteries
period of time, i.e. 2 weeks or more.
– Remove the Select system batteries if the unit is to be unused for an extended
Transportation of batteries
place where the terminals could become short-circuited, e.g. by way of a coin or paper clip.
Intense heat could be generated and injury may result.
Using device while sleeping
electrodes may become disconnected.
– Electronic monitoring equipment (such as ECG and ECG alarms)
– Operation in close proximity, such as 3 feet
– Patient should never operate potentially dangerous machinery
– Do not operate this unit in an environment where other
– Do not use sharp objects such as a pencil point or ballpoint pen to
– Inspect cables and connectors before each use.
– Treatment outcome will be influenced by the patient’s
– Patients who react negatively to the stimulation
– This unit should be operated in temperatures between
– This unit should be transported and stored
– Do not carry batteries in a pocket, purse or any other
– Do not use while sleeping because the lead wires or the
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Prescribing InformationPrescribing Information
Heat and cold products
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
batteries. Do not attempt to recharge any battery other than the rechargeable battery
supplied by Empi for this device. Attempts to charge alkaline or other non-rechargeable
batteries could cause the battery to overheat, burst, or be permanently damaged.
– Only the Empi battery charger should be used with Empi rechargeable
Radio frequency generation
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 orrelocate the receiving device,
increase the separation between the equipment and consult the Empi Service Department
for help.
– The use of heat or cold producing devices, such as electric
– This equipment generates, uses, and can radiate
Dangers
Dangerous voltage
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 because it may cause a
cardiac arrhythmia.
Biohazardous materials
accessories that have come in contact with bodily fluids according to national,
local, and facility rules, regulations, and procedures.
– Stimulus delivered by the TENS waveforms of this device,
– Handle, clean, and dispose of components and
Adverse Effects
Skin irritation, inflammation, and electrode burns beneath the electrodes are potential
adverse reactions.
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When you are very familiar with the operation of the Select system, use the following steps
as a quick reference to operate the device. For more information, refer to the Operation
section in this manual.
Starting a Therapy Session
1. Connect the lead wire(s) to the electrodes and the device.
NOTE:
Make sure the device is turned off before connecting the lead wires to the device.
CORRECT NOT CORRECT
2. Wash and dry the skin areas where you will be applying the electrodes.
Use skin prep if necessary.
3. Apply the electrodes to your skin.
4. On the device, press the button to display the Program screen. The
software version will flash, then the entire LCD display will be displayed for 1/2
second. The last program used will display.
5. U se the Ch1 and Ch2 buttons (fig. ch) to set the intensity for each
channel,as directed by your clinician. The program will begin to operate.
6. On the device, press the button to shut the device off.
fig. ch
Changing a Therapy Session
1. Follow steps 1 through 4 in Starting a Therapy Session, above.
2. Select offers nine (9) program options. Selecting a specific program option
is done by pressing the button or one of the five Quick Select Program
buttons.
3. Use the Ch1 and Ch 2 buttons (fig. ch) to set the intensity for each
channel, as directed by your clinician.
4. On the device, press the button to shut the device off.
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fig. ch
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Quick ReferenceQuick Reference
Ending a Therapy Session
1. On the device, press the button to shut the device off.
2. Unclip the belt clip from your clothing.
3. Disconnect the lead wire(s) from the device.
4. Disconnect the lead wire(s) from the electrodes.
5. Remove the electrodes from your skin. Follow the instructions on the electrode
package for storing electrodes. If necessary, use adhesive remover to remove
any remaining adhesive (or gel) from your skin.
6. Use skin cream or lotion to moisturize your skin after removing the electrodes.
7. Remove the batteries from the device prior to storing.
8. Store the components in the carrying case.
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Device
The Select system is a battery-operated electrical stimulator. The device has five Quick
Select programs and four program options that can be customized by a clinician.
Program Option
Control
Intensity
Controls
(Channel 1)
ON/OFF
Button
Quick
Select
Buttons
Session Parameter
Control
Intensity
Controls
(Channel 2)
Quick
Select
Buttons
ON/OFF Indicator Lights
Device
Front View
Device
Side View
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Channel Output Jacks
Device
Back View
Belt Clip and
Battery
Compartment
Cover
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