Empi Continuum User Manual
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Empi Continuum User Manual

Complete electrotherapy system
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Complete Electrotherapy System
U S E R ' S M A N U A L
Read this manual carefully before
operating the Continuum™
Visit us at www.empi.com

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Summary of Contents for Empi Continuum

  • Page 1 Complete Electrotherapy System U S E R ’ S M A N U A L Read this manual carefully before operating the Continuum™ Visit us at www.empi.com...
  • Page 2 © 2012 Empi, Inc. All rights reserved. Designed and assembled in the USA.

  • Page 3: Table Of Contents

    Empi Continuum Features ........
  • Page 4 Warranty ............50 Limitation of Liabilities and Disclaimer of Warranties... . . 50 Continuum User’s Manual...

  • Page 5: Product Description

    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.

  • Page 6: Indications For Use

    Product Description 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...

  • Page 7: Contraindications

    CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician (or licensed practitioner). Contraindications Empi Continuum should not be used for the following situations or patients with: • Demand type implanted pacemaker of defibrillator •...
  • Page 8 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.

  • Page 9: Precautions

    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.
  • Page 10 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. Continuum User’s Manual...
  • Page 11 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.

  • Page 12: Dangers

    Dangers Electrodes - Any Empi Electrode with a minimum active area of 16 may 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 cm can cause burns when the unit is used at higher intensities.

  • Page 13: Glossary Of Terms

    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...

  • Page 14: Directions For Use (Patient)

    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...
  • Page 15 13. Keep electrodes separated during treatment. 14. DO NOT remove electrode by pulling on the lead wire. 15. DO NOT exceed 0.1 Watts/cm 16. Using stimulation electrodes that are too small or incorrectly applied could result in discomfort or skin burns. Continuum User’s Manual...

  • Page 16: Re-Application And Storage Of Electrodes

    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...

  • Page 17: Getting Started

    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...
  • Page 18 Using the Front Panel (continued) 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.
  • Page 19 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. Continuum User’s Manual...

  • Page 20: Programming & Adjusting Stimulation

    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.

  • Page 21: Other Features

    2. Insert the top of the cover and press until it clicks securely in place. Using the Belt Clip Empi Continuum has a simple belt clip that fits comfortably over a belt or waistband. To attach the belt clip, simply...

  • Page 22: Troubleshooting And Repair

    If the message continues to show after all electrodes and wires have been checked, remove the electrodes, clean and dry the skin area under the electrodes, and replace the electrodes.  If the error message persists, call Empi Customer Service. Continuum User’s Manual...

  • Page 23: Maintenance, Cleaning & Storage

    For more detailed Troubleshooting information, see “Troubleshooting” on page 47. Repair There are no user serviceable parts inside the device. If the device appears to be non-functional, contact your clinician, or contact Empi directly at (800) 862-2343. Maintenance, Cleaning, and Storage Maintenance Under normal conditions, the device does not require periodic maintenance, calibration or testing.

  • Page 24: Product Information (Clinician)

    The numerous NMES regimens are available for muscle re-education when the patient is ready for the post- surgical rehabilitation program. The Empi Continuum may also be used as a TENS for the symptomatic relief and management of chronic, intractable pain and as an adjunctive treatment for post-surgical and post-trauma acute pain.

  • Page 25: Hardware And Labeling

    The labeling, found on the back of the device, details the standards to which this device has been tested (i.e., ETL approval). Federal law (USA) restricts this device to sale by or on the order of a physician. Continuum User’s Manual...

  • Page 26: Pre-Programmed & Custom Regimens

    Pre-Programmed & Custom Regimens The Empi Continuum has thirteen pre-programmed and three custom regimens. Regimens are the centerpiece of the Empi Continuum. They are designed for very specific clinical applications and are intended to simplify the use of the device by allowing the clinician to educate the patient on the use of the device with very little effort.
  • Page 27 Treatment Time, Off Time and Pulse Rate are listed in the table below Adjustable Parameters Range Default Setting Treatment Time 5-60 min or Continuous 30 min Off Time 0-60 sec 10 sec Pulse Rate 2 Hz-150 Hz 50 Hz Continuum User’s Manual...
  • Page 28 The intensity of each channel is independently adjustable. Waveform, pulse width, and pulse rate parameters have default settings and are the adjustable parameters (within range). Depending on the cycle selected, all parameters may not be adjustable. Continuum User’s Manual...
  • Page 29 Treatment Time, Off Time and Pulse Rate are listed in the table below. Adjustable Parameters Range Default Setting Treatment Time 5-60 min or Continuous 30 min Off Time 0-60 sec 10 sec Pulse Rate 2 Hz-150 Hz 80 Hz Continuum User’s Manual...
  • Page 30 0 sec CH 1 Up Time 3 sec CH 1 On Time 10 sec CH 1 Down Time 2 sec CH 2 Up Time 3 sec CH 2 On Time 10 sec CH 2 Down Time 2 sec Continuum User’s Manual...

  • Page 31: Tens Regimens

    Adjustable Parameters Range Default Treatment Time 5-60 min or Continuous 30 min Pulse Rate 2 Hz-150 Hz 100 Hz Preset Parameters Settings Cycling Time 12 sec Attenuated Span Pulse Width 300 µs Mode Continuum User’s Manual...
  • Page 32 Adjustable Parameters Range Default Setting Treatment Time 5-60 min or Continuous 30 min Pulse Rate 2 Hz-150 Hz 100 Hz Preset Parameters Settings Cycling Time 12 sec Span Pulse Width 300 µs Mode Continuum User’s Manual...
  • Page 33 Pulse Rate , which can be adjusted by the clinician. Adjustable Parameters Range Default Setting Treatment Time 5-60 min or Continuous 30 min Pulse Rate 2 Hz-150 Hz 100 Hz Preset Parameters Settings Cycling Time 12 sec Pulse Width 300 µs Mode Continuum User’s Manual...
  • Page 34 All parameters are preset with the exception of Treatment time, which can be adjusted by the clinician. Adjustable Parameters Range Default Setting Treatment Time 5-60 min or Continuous 30 min Continuum User’s Manual...

  • Page 35: Pulsed Dc Current Regimens

    Amplitude at 500 ohm is 50 V (DC component 3.1%) peak Chronic Bi-Phasic: • Amplitude at 1000 ohm is 100 V (DC component 2%) peak • Amplitude at 500 ohm is 50 V (DC component 3.7%) peak Continuum User’s Manual...

  • Page 36: Programming The Device

    Product Information (Clinician) Programming the Device Setting Treatment Parameters Programming the Empi Continuum is designed to be intuitive. The Empi Continuum has been engineered to guide the clinician through the programming process. The clinician will first set up the parameters for treatment and then proceed to restrict the user’s ability to reprogram the...

  • Page 37: Locking The Device

    12. Set up patient with electrodes and ramp up the intensity. Locking the Device The Empi Continuum has been designed with a feature that allows the clinician to set up a treatment regimen for each of the three different stimulation therapy type programs. This feature allows the clinician to be confident that the treatment instructions are more likely to be followed by the patient during the course of treatment.

  • Page 38: Unlocking The Device

    Unlocking the Device When the Empi Continuum is locked, it allows the clinician to control the patient’s use of the device to assure access to only the pre-selected protocol. “Unlocking” the device gives the clinician the ability to set up a new treatment protocol.

  • Page 39: Resetting Parameter Defaults

    5. Press the Home button. Resetting Parameter Defaults The Empi Continuum has the ability to modify treatment parameters prior to treatment application. This allows the clinician to tailor treatment to the individual patient. When the clinician needs to reset this data due to a new patient, the following steps are to be applied: 1.

  • Page 40: Changing The Contrast

    Product Information (Clinician) Changing the Contrast The Empi Continuum has the ability to modify the contrast setting of the LCD screen to immediately fit the needs of the patient or the clinician. When the clinician needs to alter the contrast of the unit, the following steps are to be applied: 1.

  • Page 41: Using The Foot Switch

    Product Information (Clinician) Using the Foot Switch The Empi Continuum unit has the ability to use a foot switch for gait training. The Foot Switch must be plugged in so that the unit recognizes that a gait treatment is wanted. Otherwise, a normal Large Muscle, Custom treatment is performed.

  • Page 42: Accessories

    Consult your clinician prior to using any electrode less than 16 cm Lead Wires Any Empi TENS/NMES Lead Wire (100 cm – 40”) with the touch proof device connection (part number 193057-100). Remote Switches •...

  • Page 43: Output Waveforms

    Product Information (Clinician) Typical Waveforms (continued) Output Waveforms NMES Symmetrical Waveform NMES Asymmetrical Waveform Continuum User’s Manual...
  • Page 44 Product Information (Clinician) TENS Shoulder High / Low Cycle SMP Waveform TENS Knee Modulated Amplitude Full / Partial Waveform Pulsed DC Current Acute Tri-Phasic Waveform Pulse Rate 208 Hz Continuum User’s Manual...
  • Page 45 Product Information (Clinician) Pulsed DC Current Acute Bi-Phasic Waveform Pulse Rate 270 Hz Pulsed DC Current Chronic Tri-Phasic Waveform Pulse Rate 208 Hz Pulsed DC Current Chronic Bi-Phasic Waveform Pulse Rate 270 Hz Continuum User’s Manual...

  • Page 46: Timer

    Type BF Applied Part • Internally powered only • Ordinary protection ingress of liquids • Continuous operation • Not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide. Continuum User’s Manual...

  • Page 47: Electromagnetic Compatibility Tables

    Guidance and Manufacturer’s Declaration–Electromagnetic Emissions The Empi Continuum is intended for use in the electromagnetic environment specified in the table below. The user of the Empi Continuum should assure that it is used in such an environment. Emission Tests Compliance Electromagnetic Environment - Guidance The Empi Continuum uses RF energy only for its internal function.
  • Page 48 Guidance and Manufacturer’s Declaration–Electromagnetic Immunity The Empi Continuum is intended for use in the electromagnetic environment specified in the table below. The user of the Empi Continuum should assure that it is used in such an environment. IEC 60601 Electromagnetic...
  • Page 49 RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Empi Continuum is used exceeds the applicable RF compliance level above, the Empi Continuum should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Empi Continuum.
  • Page 50 Mobile RF Communications Equipment and the Empi Continuum The Empi Continuum is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Empi Continuum can help prevent electromagnetic interference...

  • Page 51: Troubleshooting

    C. If still intermittent after replacing lead wire, a component may have Intermittent Output failed. Call the repair department. Preprogrammed Regimen in use. Some programs will seem intermittent. This is expected. Refer to "Preprogrammed & Custom Regimens" on page 22 for descriptions. Continuum User’s Manual...
  • Page 52 Open Load Detection: If the intensity of either channel is above 4.5, the Continuum checks to make sure that there is good contact between the device and the patient.  If bad contact is detected, the text “OPEN” will be displayed instead of the intensity, and the intensity on both channels will go to zero. The treatment...
  • Page 53 9. If there is no sensation, call the repair department. 10. If sensation is felt - even if weak, = device is working properly. You may need to reposition the electrodes or contact your clinician. 11. Repeat Steps 1 through 10 for Channel 2. Continuum User’s Manual...

  • Page 54: Limited Warranty

    Limited Warranty Warning While, in the opinion of Empi (“Empi”), the use of the Empi Continuum (“the Product”) has met with some success, Empi makes no warranties to the purchaser as to the effectiveness of the product. Warranty A. Empi warrants to the initial Purchaser (“Purchaser”) (and to no other...
  • Page 55 Empi has any authority to bind empi to any affirmation, representation or warranty except as stated in this written warranty policy. D. Empi shall not be liable to any person for any direct, indirect, special, incidental or consequential damages, lost profits or medical expenses...
  • Page 56 199610-001 Continuum Kit Empi, Inc. 205 Hwy 22 East Clear Lake, SD 57226 USA 651.415.9000; 800.328.2536 360411 Rev. B, © 2012 Empi, Inc.

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