Empi Continuum User manual

Read this manual carefully before
operating the Continuum™
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USER’S MANUAL
Complete Electrotherapy System

© 2012 Empi, Inc. All rights reserved. Designed and assembled in the USA.

Continuum User’s Manual i
Table of Contents
PRODUCT DESCRIPTION.............................................. 1
How Electrotherapy Works............................................ 1
Empi Continuum Features ............................................ 1
Indications for Use ................................................... 2
Contraindications .................................................... 3
Warnings ............................................................ 3
Precautions .......................................................... 5
Dangers ............................................................. 8
Adverse Effects....................................................... 8
Glossary of Terms..................................................... 9
DIRECTIONS FOR USE PATIENT .................................... 10
Electrode Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Re-Application and Storage of Electrodes ............................ 12
Getting Started ..................................................... 13
Using the Front Panel................................................ 13
Programming & Adjusting Stimulation ............................... 16
Other Features ...................................................... 17
Changing the Batteries ......................................... 17
Using the Belt Clip .............................................. 17
Using the Kick Stand............................................ 17
Troubleshooting and Repair..................................... 18
Maintenance, Cleaning & Storage ............................... 19
PRODUCT INFORMATION CLINICIAN .............................. 20
Hardware and Labeling ............................................ 21
External Remote Switch Port .................................... 21
Front Panel ..................................................... 21
Backside Labeling .............................................. 21
Pre-programmed & Custom Regimens............................. 22
NMES Regimens ................................................ 22
TENS Regimens................................................. 28
Pulsed DC Current Regimens.................................... 31
Programming the Device .......................................... 32
Setting Treatment Parameters................................... 32
Locking the Device ............................................. 33
Unlocking the Device ........................................... 34
View & Reset Compliance Data .................................. 34
Resetting Parameter Defaults ................................... 35
Choosing a Language........................................... 35
Changing the Contrast.......................................... 36
Changing the Switch Working Mode .............................36
Using the Foot Switch .......................................... 37
Using the Hand Switch.......................................... 37

ii Continuum User’s Manual
Table of Contents
Accessories......................................................... 38
Technical Data ..................................................... 38
Standard Measurement Conditions.............................. 38
Typical Waveforms.............................................. 38
Output Waveforms ............................................. 39
Timer .......................................................... 42
Remote Control Switch ......................................... 42
Low Voltage Indication ......................................... 42
Physical Characteristics ......................................... 42
EN 60601-1 Classification ....................................... 42
Electromagnetic Compatibility Tables ........................... 43
TROUBLESHOOTING................................................. 47
LIMITED WARRANTY................................................. 50
Warning ....................................................... 50
Warranty ....................................................... 50
Limitation of Liabilities and Disclaimer of Warranties............. 50

Continuum User’s Manual 1
The Empi Continuum is a state-of-the-art, multifunction electrotherapy device.
It has the ability to provide two channels of conventional neuromuscular
electrical nerve stimulation (NMES), conventional transcutaneous electrical
nerve stimulation (TENS) and Pulsed DC Current (Pulsed Galvanic Stimulation)
electrotherapy. This wide-ranging capability allows the clinician to
employ electrotherapy throughout the healing cycle with a single device.
Furthermore, programmability of the device allows the clinician to customize
the treatment to meet the individual needs of each patient.
The Continuum (NMES) feature produces an electrical stimulus that, when
properly applied, activates specific muscles or muscle groups. The waveforms
are fully programmable for maximum treatment flexibility.
The Empi Continuum has a Pulsed DC Current feature that can be used for
increasing the local blood circulation.
The Empi Continuum has thirteen pre-programmed and three custom
regimens for NMES, TENS, and Pulsed DC Current therapies. In addition to
being able to control the treatment duration time, the device can modify
waveform type (Symmetrical or Asymmetrical), pulse rates and durations
(widths), cycling type, off times, channel ramp times, and on time.
The device produces a mild electrical current transmitted via lead wires to
electrodes placed on the skin over the motor point of the targeted muscle.
Stimulation of motor end plates causes nerve depolarization and activation
of muscle fibers, resulting in a muscle contraction.
When applied as a TENS device, electrical stimulation may directly block
transmission of pain signals along nerves. In addition, electrical stimulation
has been shown to promote the release of endorphins, which are natural
painkillers produced by the body.
The Empi Continuum provides many features that permit a range of
treatment options:
•Two independent digital intensity controls
•Timed therapy sessions
•Continuous or cycled stimulation
•Adjustable pulse rates and durations
•13 pre-programmed with three custom regimens for NMES, TENS, and
Pulsed DC Current therapies
•Adjustable ON and OFF time controls
Empi Continuum Features
How Electrotherapy Works
Product Description

2 Continuum User’s Manual
Empi Continuum Features (continued)
•Adjustable Ramp Up and Ramp Down time controls
•Dual channel stimulation
•Balanced asymmetrical and symmetrical waveforms
•An accessory output channel allowing use of a remote hand or foot
switch for gait training
Indications for Use
As an NMES device, indications are for the following conditions:
•Retarding or preventing disuse atrophy
•Maintaining or increasing range of motion
•Re-educating muscles
•Relaxation of muscle spasms
•Increasing local blood circulation
•Prevention of venous thrombosis of the calf muscles immediately after
surgery
As a TENS device, indications are for the following conditions:
•Symptomatic relief and management of chronic, intractable pain
•Adjunctive treatment for post-surgical and post-trauma acute pain
•Relief of pain associated with arthritis
As a Pulsed Current device, indications are for the following conditions:
•Reduction of edema (under negative electrode)
•Reduction of muscle spasm
•Influencing local blood circulation (under negative electrode)
•Retardation or prevention of disuse atrophy
•Facilitation of voluntary motor function
•Maintenance of increase of range of motion
As a functional electrical stimulation (FES) device, the indications for the
following condition:
•Stimulation of the leg and ankle muscles of partially paralyzed patients
to provide flexation of the foot, thus improving the patient’s gait
Product Description

Continuum User’s Manual 3
Contraindications
Empi Continuum should not be used for the following situations or patients with:
•Demand type implanted pacemaker of defibrillator
•Any transcerebral electrode placement
•Any electrode placement that applies current to the carotid sinus region
Specific to use of Empi Continuum as a TENS device:
•Whenever pain syndromes are undiagnosed, until etiology is established
Specific to use of Empi Continuum as an FES device:
•Assisting paraplegic patients into the standing position
Warnings
Supervised Use – This device should only be operated under the
prescription and 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 – 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 headaches.
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) in that the introduction of electrical
current into the heart may cause cardiac arrhythmias.
Skin & Vascular Problems – Do not use this device over swollen, inflamed or
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.
MRI Scans – Do not wear electrode or controller during Magnetic Resonance
Imaging (MRI) scans as this may result in metal overheating and causing skin
burns in the area of the patch.
CAUTION: Federal Law (USA) restricts this device to sale by or on the
order of a physician (or licensed practitioner).
Product Description

4 Continuum User’s Manual
Warnings (continued)
Tripping – Care should be used to avoid tripping on lead wires, especially
when the foot switch is utilized.
High Frequency Surgical Devices – Simultaneous connection of a patient
to a high frequency surgical device may result in burns at the site of the
electrodes and 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 clinician if the problem persists.
Skin Reactions – On rare occasions, therapy can result in transient skin
reactions such as rash, inflammation, irritation, or burns. These skin reactions
may be the result of individual sensitivity to the condition of the skin at the
onset of treatment, reaction to the materials in the electrodes, or a poor
connection between the electrodes and the patient’s skin. Advise the patient
of this possibility before starting treatment. If a visible skin reaction does
occur, instruct the patient to discontinue the treatment and consult the
prescribing physician or licensed practitioner.
Lead Connection – Do not connect the lead wires to an AC power source
or other 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 – Care must be taken when operating
this device 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 phone, etc.). The Empi Continuum should not be
used adjacent to or stacked with other equipment and if adjacent or stacked
use is necessary, the Empi Continuum should be observed to verify normal
operation in the configuration in which it will be used.
Accessories – Use only accessories that are specifically designed for this
device. Do not use the 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 Accessories,
transducers, or cables other than those specified by the manufacturer, may
result in increased emissions or decreased immunity of the Empi Continuum.
Product Description

Continuum User’s Manual 5
Warnings (continued)
Defibrillation Signals – Remove the electrodes before defibrillation signals
are applied. Defibrillation of a person wearing a 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 Empi Continuum system depends
on the proper use and handling of the device and accessories. If used
improperly, the Empi Continuum 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 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.
Proper Electrode Size – Output current density is related to electrode size.
Improper application may result in patient injury. If any question arises as
to the proper electrode size, consult a licensed practitioner prior to therapy
session.
DC Component - The Empi Continuum waveforms may contain a DC
component. Always use Empi electrodes with a minimum active area of 16
cm2(including Empi square (2”x 2”) StimCare electrodes). Use of an electrode
with an area less than 16 cm2can cause burns when the unit is used at higher
intensities. Consult your clinician prior to using any electrode less than 16
cm2.
To calculate this DC component, use the following equation:
Measured V (peak) x DC Component Percentage
Heart Problems – Use caution for patients with suspected or diagnosed heart
problems.
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.
Uterus – Do not use electrical stimulation over menstruating or pregnant
uterus.
Sensory Loss – Do not use electrical stimulation where sensory nerve damage
is present, causing a loss of normal skin sensation.
Precautions
Product Description

6 Continuum User’s Manual
Unequal Electrode Size – Use precaution and follow clinician instructions
when using different size electrodes together. Improper use can cause skin
irritation or increased stimulation intensity under the smaller electrode.
Prescription – Use electrical stimulation only in the prescribed manner and for
the prescribed diagnosis. If there are any changes in the existing condition, or if
a new condition develops, the patient should consult a physician.
Effectiveness – Effectiveness is highly dependent upon patient selection by a
clinician 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 the child is properly supervised
during electrical stimulation.
Leads and Electrodes – Use the device with only the leads and electrodes
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.
Electronic Equipment – Electronic monitoring equipment (such as ECG and
ECG alarms) may not operate properly when electrical stimulation is in use.
Microwave or 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 device in an environment
where other devices are being used that intentionally radiates 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 control panel.
Cables and Connectors – Inspect cables and connectors before each use.
Treatment Outcome – Treatment outcome will be influenced by the patient’s
psychological state and use of drugs.
Precautions (continued)
Product Description

Continuum User’s Manual 7
Precautions (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
and 106 kPa, and relative humidity between 30% and 75%.
Transportation & 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 and 106 kPa and relative humidity between
10% and 90%.
Batteries – Remove the Empi Continuum system batteries if the unit is to be
unused for an extended period of time, i.e. 2 weeks or more.
Transportation of Batteries – Do not carry batteries in a pocket, purse or any
other place where the terminals could become short-circuited, e.g. by way of
paper clip. Intense heat could be generated and injury may result.
Using Device While Sleeping – Do not use while sleeping because the lead
wires or the electrodes 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 performance of
the electrode or alter the patient’s circulation/sensitivity and increase the risk of
injury to the patient.
Battery Charger – Only the prescribed Empi battery charger should be used
with the Empi rechargeable 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.
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 interferences to other devices in the
vicinity. However, there is no guarantee that the 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 and consult the Empi Service Department
for help.
EMC Information - Medical Electrical Equipment needs special precautions
regarding EMC and needs to be installed and put into service according to the
EMC information provided in this manual.
Product Description

8 Continuum User’s Manual
Adverse Eects
Skin irritation, inflammation, and electrode burns beneath the electrodes are
potential adverse reactions.
Dangers
Electrodes - Any Empi Electrode with a minimum active area of 16
cm2may be used with this device. This includes Empi square (2” x 2”),
and StimCare Carbon FM. Use of an electrode with an area less than
16 cm2can cause burns when the unit is used at higher intensities.
Consult your clinician prior to using any electrode less than 16 cm2.
Dangerous voltage – Stimulus delivered by the TENS waveforms 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 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.
Product Description

Continuum User’s Manual 9
Product Description
Glossary of Terms
The following symbols may be located on the Continuum stimulator or
packaging:
Dangerous voltage – Stimulus delivered by the TENS waveforms 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 because it may cause a cardiac arrhythmia.
Refer to Instruction Manual/Booklet.
Keep Dry
Type BF Applied Part
Manufacturer
Reference Number
Lead wires comply with the Performance Standard for electrode lead
wires (21 CFR part 898)
ETL Classied C US, 9900900, Electronic Testing Lab, indicates
product meets US and Canadian product safety standards. This
device complies with UL Std. 60601-1 and is certied 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.
ON/OFF

10 Continuum User’s Manual
Directions for Use (Patient)
Electrode Setup
1. Make sure unit is turned off and lead wires are
disconnected before and after treatment.
2. Clean electrode application area with soap and
water. Rinse and dry. Electrode should only be
applied to intact, clean skin (e.g., not over open
wounds, lesions, infected, or inflamed areas).
3. With electrodes still on liner, connect lead wire
from unit electrode connector. No bare metal
should be visible.
4. Remove electrode from liner by grasping the
edge of the electrode and peeling it off the
liner. Retain liner for storage.
5. Place the electrode on exact skin location by
applying the center of the electrode first and
smoothing down to electrode edges.
6. Attach lead wire to unit and begin treatment.
7. After treatment, turn unit off.
8. Remove electrode from skin by peeling
electrode edge.

Continuum User’s Manual 11
Directions for Use (Patient)
Electrode Setup (continued)
9. DO NOT place electrodes on broken skin. If skin
irritation develops, discontinue use. Consult
physician. Replace electrodes when they do not
adhere or when treatment becomes uncomfortable.
10. DO NOT use unit while driving or operating
machinery.
11. For single patient use only. These electrodes may be
repositioned up to several times on the same patient.
12. Stimulation should not be applied to transcerebrally
or over the anterior neck region.
13. Keep electrodes separated during treatment.
14. DO NOT remove electrode by pulling on the lead
wire.
15. DO NOT exceed 0.1 Watts/cm2.
16. Using stimulation electrodes that are too small or
incorrectly applied could result in discomfort or
skin burns.
Precautions

12 Continuum User’s Manual
Re-Application and Storage of Electrodes
Directions for Use (Patient)
• If adhesive becomes over-saturated, allow electrode to air dry in a
refrigerator with adhesive side up until gel regains tack.
• If the electrode gel appears dry, add a few drops of water to the
electrode gel. Let rest to regain tack and apply to skin.
• If electrode accumulates dirt/dust in the adhesive, the impedance
increases, usually leading to increased heat dissipation at the electrode
which can lead to skin burns. Inspect the electrode for dust and dirt
accumulation before reuse. Feel the electrode to make sure it is still
tacky. If the adhesive has accumulates too much dirt/dust, it will no
longer adhere. Replace electrode when it does not adhere.
• Between uses (on the same patient), return electrode to liner and store
in resealable bag in a cool place out of direct sunlight.
NOTE: The life of the electrode varies depending on skin conditions skin
preparation, type of stimulation, storage,and climate.

Continuum User’s Manual 13
Directions for Use (Patient)
Getting Started
Your kit may include:
•AA Batteries
•Belt Clip
•Carrying Case
•Electrodes and Touch proof Lead Wires Note: Your electrodes have been
specified by your clinician as part of the prescription.
•Empi Continuum Device
•Battery charger and instructions for use
•Instruction Manual
Using the Front Panel
Before you use the device, you should be familiar with the location of the
Soft Key control buttons, ON/OFF ( ) button, OK button and the Home
button.
Simple Operational Procedure Steps
The front panel should appear as shown below.
On/OHome OK
Soft
Keys
Soft
Keys

14 Continuum User’s Manual
Directions for Use (Patient)
1. Press the ON/ OFF button ( ) located on the bottom row, middle button.
You should first see the Empi logo along with software version number
displayed on the LCD for four seconds before displaying a therapy options
menu as seen below. The device is now ready to function.
Using the Front Panel (continued)

Continuum User’s Manual 15
Directions for Use (Patient)
Using the Front Panel (continued)
2. If your unit has previously been configured for operation by a clinician,
selecting one of the options (NMES, TENS or Edema) will display the
“In-Progress” screen on the LCD as shown below. For instructions on
programming your unit, see “Product Information (Clinician)” on page 20.
For specific therapy settings, contact your clinician.
3. Press the soft key next to the Channel 1 UP arrow. This will ramp up
the level of stimulation for Channel 1. You should see a dot next to the
channel output on the LCD screen when output is active.
4. Repeat this procedure for channel 2 on the right if using two channels.
You can only ramp intensity on an active channel and can only ramp one
channel at a time.
5. If the device has operated as expected, turn it off by pressing the ON/OFF
() button located on the bottom row, middle button.
6. If the LCD does not display any information at startup, check the battery
compartment. If the batteries have not been inserted, see the “Changing
the Batteries” on page 17. If the batteries have been inserted, change
batteries.
7. If after changing batteries, the device still does not respond, refer to the
Troubleshooting guide on page 47.

16 Continuum User’s Manual
Directions for Use (Patient)
Programming & Adjusting Stimulation
NOTE: The following steps assume that your clinician has set up the
device for you. If you are unsure, call your clinician before
proceeding. The instructions below describe all of the buttons
you should press to work the device. Please note the config
button is intended for clinician use.
1. Connect the lead wires to the device. If only one lead wire will be
used, plug it into the Channel 1 output channel.
CAUTION: Ensure the device is OFF before connecting the lead
wires.
2. Power on the device by pressing the ON/OFF ( ) button
3. Press the type of treatment option desired from the main options
menu.
4. Select the desired localized treatment type.
5. Select and/or modify the related parameter values for the treatment
type and then press OK to lock them in.
6. Begin the treatment by pressing the intensity buttons found to
both the left and right of the screen. Press the Up arrows to increase
intensity on channel 1 or 2 and press the Down arrows to decrease
intensity on channel 1 or 2.
7. Treatment can be ended by pressing the OFF button for at least 1sec.
8. Store electrodes for future use. See instructions on page 12 for
electrode storage and maintenance.
9. The Continuum device locks the intensity increase buttons to prevent
accidental increases in intensity. This safety feature is activated after
20 seconds of unchanged intensity.
10. To unlock the device, press either intensity Down button. You can
now increase the intensity.