Empi Continuum User Manual
Contents
1. Empi will not be responsible for damage due 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 the purchase price for the defective product or return the repaired Product or a replacement 50 Continuum User s Manual Limited Warrant Limitation of Liabilities and Disclaimer of Warranties thereof to Purchaser freight and insurance prepaid as soon as reasonably possible following receipt of the Product by Empi 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 B 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 C Except as provided in paragraph A the product is being sold on an as is basis all accessories are sold as is and the entire risk as to the guality and performance of the product is with purchaser The warranty provided in paragraph A is intended solely for the benefit of the initial purchaser and Empi disclaims all other2. 100 V eax DC component 2 Amplitude at 500 ohm is 50 V eax DC component 3 7 Continuum User s Manual 31 ation 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 unit In essence the clinician will set up the device such that the user has only to press one button before starting the treatment NMES Parameters 1 Cv ON AU AWN 11 12 13 14 15 Power ON the device by depressing the ON OFF D button Press the top soft key on the left to select NMES programming Select the Muscle Type either Large or Small Muscle Select Treatment type Atrophy Spasm Point or Custom Using left side soft key scroll to the desired parameter item Using right side soft keys scroll parameter value up or down Press the Home button to get back to the Option menu Press the soft key labeled CONFIG Press right side soft key labeled LOCKS Using left soft keys scroll to desired item NMES L MUSCLES or NMES S MUSCLES Press the upper right soft key until a locked icon displays Press Home button to accept the change Press the NMES button a lock must be visible beside the pre
3. 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 46 Continuum User s Manual Troubleshootinc Problem Possible Cause attery Contact Failure Display does not come on Weak Stimulation with fresh batteries Electrode Placement A Lead Wires are Old Worn or Damaged Stimulation stops with B Bad electro fresh batteries le Contact Damaged Worn Wires Stimulation weakens within minutes of start of treatment with fresh batteries This is a Normal body adaptive process Stimulation Uncomfortable lectrodes too close Ensure the proper regimen is Stimulation Ineffective being used Improper Electrode placement Stimulation only felt on one electrode improper Placement of Electrode A Worn or Damaged Electrode B Improper Electrode placement Stimulation on one channel side only Lead Wire Component Failure Lead Wires Intermittent Output Preprogrammed Regimen in use Continuum User s Manual Solution A Try fresh batteries B Try 2 AA Energizer or Eveready alkaline batteries C Ensure batteries are inserted correctly See instructions for proper placement A Check contacts are in place B Check contacts are not broken C Check contacts are not pushed in Th
4. Continuum User s Manual 33 Product Informatio Additional Lockout Feature There is an additional lockout feature that the clinician can use to remove the option of a treatment from the screen so that the patient does not have the option of selecting a particular treatment type It can be accomplished as follows 1 On the main options page press CONFIG to get to the CONFIG menu 2 Press LOCKS Lower Right Soft Key 3 Using the Left Soft Keys scroll down to one of the four lock items NMES L MUSCLES NMES S MUSCLES TENS and EDEMA Then using the upper right hand soft key scroll until a forbidden icon is shown 4 Press the Home button to get back to the main menu Notice that the therapy option has been removed from the display 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 To unlock the device perform the following steps 1 Press the ON button to turn on the device or press the Home button 2 Once the main Options menu is displayed choose CONFIG option 3 Choose the LOCKS option 4 Using the Left Soft Keys scroll down to a lock items NMES L MUSCLES NMES S MUSCLES TENS and EDEMA 5 Use the lower right side soft key to scroll the item s value until an un
5. 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 cm including Empi square 2 x 2 StimCare electrodes Use of an electrode with an area less than 16 cm can cause burns when the unit is used at higher intensities Consult your clinician prior to using any electrode less than 16 cm To calculate this DC component use the following equation Measured V x DC Component Percentage peak YAN Precautions 00 OO 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 Continuum User s Manual 5 Product Descriptio AN Precautions continued Unequal Electrode Size Use precaution and follow clinician instructions w
6. RF emissions CISPR 11 ASE N A Harmonic emissions Battery IEC 61000 3 2 Operated evice N A attery Operated evice Voltage fluctuations Flicker Emissions IEC 61000 3 3 Continuum User s Manual The Empi Continuumt 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 43 Product Informatii 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 Immunity Test Electrostatic discharge ESD EC 61000 4 2 IEC 60601 Test Level 6 kV contact 8 KV air Compliance Level 6 kV contact 8 kV air Electromagnetic Environment Guidance 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 EC 61000 4 4 2 kV for power supply lines 1 KV for input output lines Not Applicable Battery Operated Device Mains power quality should be that of a typical commercial or hospital environment Surge EC 61000 4 5 1 KV differential mode 2 kV common mode Not Applicable Battery Operated Device Mains
7. 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 6 Continuum User s Manual oduct Description AN 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 amp 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 relat
8. intensity of the device the device s intensity lock safety feature has likely engaged To disengage decrease the channel s intensity You should then be able to increase the intensity 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 Cleaning Use a damp cloth with mild soap to clean the exterior of the device and lead wires Use of other cleaning solutions may damage these items Never immerse the device in liquids Storage To store the stimulator for an extended time more than 30 days remove the batteries and store the device in a cool dry place Continuum User s Manual 19 Product Informatio The Empi Continuum is a state of the art NMES system that incorporates three widely used clinical modalities TENS NMES and Pulsed DC Current Low Volt The device is designed to allow the clinician to introduce electrotherapy into the rehabilitation cycle earlier than with conventional NMES devices The NMES component can be used pre surgically to treat disuse atrophy The Pulsed DC Current feature can be used pre or post surgically to increase local circulation The nu
9. of locking in parameter selections and item selections Backside 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 21 Product Informati Pre Programmed amp 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 The Empi Continuum device categorizes NMES Pre set and Custom programs by Large Muscle and Small Muscle An example of Large muscles would be the guadriceps hamstrings gluteus maximus and medius adductor magnus latissimus dorsi and abdominal musculature Small muscle examples would be anterior tib bicep deltoid supraspinatus teres minor subscapularis and the intrinsic foot and hand muscles NMES Regimens Large Muscle Atrophy Summary This is a sequenced 2 channel program for strengthening and re educating large atrophied muscles All parameters are preset with the exception of Treatment Time Off Time and the Pulse Rate which can be adjusted by the clinician The range of adjustments for Treatment Time Off Time and Pulse Rate ar
10. 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 i
11. 5 Product Informati Small Muscle Spasm Summary continued Preset Parameters Settings Waveform Type Cycling Type Pulse Width Lag Delay CH 1 Up Time CH 1 OnTime CH 1 Down Time CH 2 Up Time CH 2 On Time CH 2 Down Time Small Muscle Trigger Point Summary This treatment option is a 2 channel program for relaxation of muscles in a localized area All parameters are preset with the exception of Treatment Time Off Time and Pulse Rate which can be adjusted by the clinician The range of adjustments for Treatment Time Off Time and Pulse Rate are listed in the table below Adjustable Parameters Range Default Setting 26 Preset Parameters Setting CH1 OnTime CH 1 Down Time CH 2 UpTime CH2 OnTime CH 2 Down Time Continuum User s Manual ation Clinician Small Muscle Custom Remote Summary This option offers similar stimulation as Small Muscle Spasm and Trigger Point if no external Hand Switch is detected Adjustable Parameters Range Default Setting If used with an external Switch continuous stimulation is available for gait training protocol 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 TENS Regimens TENS Knee Summary This treatment option is a 2 channel Modulated Ampl
12. 57226 USA 651 415 9000 800 328 2536 360411 Rev B 2012 Empi Inc
13. C 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 How Electrotherapy Works 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 Empi Continuum Features 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 Continuum User s Manual 1 Product Descriptio 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 u
14. Empi Continuum Complete Electrotherapy System USER S MANUAL SEmpi b Read this manual carefully before operating the Continuum P Visit us at www empi com 2012 Empi Inc All rights reserved Designed and assembled in the USA Table of Contents PRODUCT DESCRIPTION se eee eee cece III 1 How Electrotherapy Works 0 cece cece cence m 1 Empi Continuum Features 22 260 eda wates E Ara XUI ER aka 1 Indications for USE 02 obati benahi eka ears ahad ken RS 2 ContraindicatiONS ea iore corti rete e eh eee saree kk ae t dee 3 Watnlhgs coda toch wide IN EN Ra EN M SEE RU DK dare Saga 3 PIECAUTIONS coo soeur nog ken aa baka UNE EPIO EPOD UD ea anunya 5 Drs m 8 Adverse Effects s2 sesama nakas mek lsm eas acnd asa 8 Glossary Of Terms 00 H 0 nama i ern APN meade 9 DIRECTIONS FOR USE PATIENT on 10 Electrode Setup cis p Ken iba Bea BN RN Ea 10 Re Application and Storage of Electrodes JJ 12 Getting Startedia s nna bsa NB 13 Using the Front Panels rrt Dee na maa eee 13 Programming amp Adjusting Stimulation kk 16 Other Features oo oo Komatsu an eka emas 17 Changing the Batteries Jah 17 Using the Belt Clip cessere t etr e Re p vee seein 17 Using th Kick Stand erre rre emm tx 17 Troubleshooting and Repair Jk 18 Maintenance Cleaning amp Storage Jk 19 PRODUCT INFORMATION CLINICIAN eeeeeeeeee 20
15. Hardware and Labeling Li 21 External Remote Switch Port css ee ee eee eee eee eee 21 Front Pariel i iieec corre mena basa an bata RE Rie ed EE 21 Backside Labeling oi 24 enr rh xr teh kata 21 Pre programmed amp Custom Regimens 22 NMES REGIMENS 6 3 1 eT x Re mr th CURIE Od E ME YS 22 TENS REGIMENS oon enam ERR ee RR ER E e ES 28 Pulsed DC Current Regimens cece cece tent eeeeee 31 Programming the Device c cece ee cence een teen ees 32 Setting Treatment Parameters cee eee eee eee eee eens 32 Locking the Device irs ere erre rer RR I eere 33 Unlocking the Device ce cece cece eee cence eine 34 View amp Reset Compliance Data Jk 34 Resetting Parameter Defaults Jk 35 Choosing a Language Ji 35 Changing the Contrast veas antes Ex EU UR Td 36 Changing the Switch Working Mode Jk 36 Using the Foot SWiteh 2 pu IE ERE RE EI STRA 37 Using the Hand Switch aa 37 Continuum User s Manual i Table of Contents Accessories enakan RISK IE Ree EN EU 38 Technical Data an 38 Standard Measurement Conditions JJ 38 Typical WaVetor MS eerte rep e ER RI REEL P RRE RR 38 Output Waveforms ia 39 BIST IERI 42 Remote Control Switch moon pb Re p Da E E E ETC EE 42 Low Voltage Indication 5 rcr RR rete 42 Physical Characteristics
16. MMETRICAL NMES OUTPUT WAVEFORM isi abon Lono AMPLITUDE IN VOLTS 4 am TIME iN SECONDS Output Waveforms NMES Symmetrical Waveform Tek Run Trig d SH 30V M 200gs A Chi 7 2 00V 11 Mar 2008 Ws Has Oo0ps 10 49 55 NMES Asymmetrical Waveform Tek Run 10 0 V M 200gs AL Chi J 9 40 V 11 Mar 2008 i H48 000ps 5 Continuum User s Manual 39 Product Information TENS Shoulder High Low Cycle SMP Waveform Tek Run ET Trig a Tek Run nga 7 aan CMUPo usl A Chi 7 20V 11 Mar 2008 11 Mar 2008 tie 448 000ps 10 56 47 tie 1448 0005 1 09 55 TENS Knee Modulated Mu Full Partial Waveform maa ma T ma C ol Las A CD ex Tv EE Oe AI Pulsed DC Current Acute Tri Phasic Waveform Pulse Rate 208 Hz Tekstop Eh u an iov Mi 0 ms A Chi 7 20V 11 Mar 2008 dr 548 0005 12 23 02 40 Continuum User s Manual Pulsed DC Current Acute Bi Phasic Waveform Pulse Rate 270 Hz janni EPI PEURPPEPE TURPE TUNES 8 20 V Mi 00ms A Chl Pulsed DC Current Chronic Tri Phasic Waveform Pulse Rate 208 Hz 10 0V Mi 00ms A Chi 4 8 20 V Pulsed DC Current Chronic Bi Phasic Waveform Pulse Rate 270 Hz TekRun i Continuum User s Manual 41 Product Informatioi Timer The timer is adjustable 5 to 60 minutes
17. Once the main Options menu is displayed choose CONFIG option 3 Choose the SETTINGS option 4 Use the right side soft keys to scroll to the Contrast setting to where it needs to be Changing the Switch Working Mode The EMPI Continuum has the ability to modify the working mode of an attached Hand or Foot switch Available options are Simultaneous or Alternated In Simutaneous mode both channel 1 and 2 will work simultaneously e In Alternated mode channel 1 and 2 will work alternately To access this setting the following steps are to be applied Press the ON button to turn on the device Once the main Options menu is displayed choose CONFIG option Choose the SETTINGS option Use the lower left soft key to scroll to the SWITCH option Use the right side soft keys to select the switch working mode Press the home screen button OS MP WON S Notice that if a switch is plugged in an icon will be shown in the upper right corner of the display 36 Continuum User s Manual yrmation 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 To do this the following steps are to be applied 1 Press the ON button to turn on the device Once the main
18. Options menu is displayed choose the NMES option Choose the LARGE MUSCLE option Choose the CUSTOM option Modify adjustable regimen parameters as needed and then press the OK button Plug the Foot Switch into the remote jack in the unit 7 Increase intensity For Channel 1 the unit will output a waveform as the foot is lifted up and stop its output as the foot is down For Channel 2 the output will behave according to the selected switch working mode mom Ww 9 Using the Hand Switch The Empi Continuum unit has the ability to use a hand switch for user activated stimulation The Hand Switch must be plugged in so that the unit recognizes that gait treatment is wanted Otherwise a normal Small Muscle Custom treatment is performed To do this the following steps are to be applied Press the ON button to turn on the device Once the main Options menu is displayed choose the NMES option Choose the SMALL MUSCLE option Choose the CUSTOM option Modify regimen parameters as needed and then press the OK button Plug the Hand Switch into the remote jack in the unit Increase intensity For Channel 1 the unit will output a waveform as the hand switch is pressed and stop its output as the hand switch is depressed For Channel 2 the output will behave according to the selected switch working mode en E E Both switches should be used with the custom programs not with the pre set therapies Continu
19. Treatment time which can be adjusted by the clinician Adjustable Parameters Range Default Setting Treatment Time 5 60 min or Continuous Pulsed DC Current Edema Chronic Summary This treatment option is a sequenced positively DC unbalanced 2 channel program for edema reduction and increased circulation 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 Continuum User s Manual Product Informatio NMES Regimens NMES large muscle Amplitude at 1000 ohm is 100 V eax DC component 2 2 Amplitude at 500 ohm is 50 V eax DC component 3 4 NMES small muscle Amplitude at 1000 ohm is 100 V eax DC component 2 1 Amplitude at 500 ohm is 50 V peak DC component 4 3 TENS Regimens TENS SMP Amplitude at 1000 ohm is 100 V eax DC component 2 Amplitude at 500 ohm is 50 V eax DC component 3 4 TENS MOD Amplitude at 1000 ohm is 100 V eax DC component 2 3 Amplitude at 500 ohm is 50 V peak DC component 3 4 Pulsed DC Current Regimens Acute Bi Phasic Amplitude at 1000 ohm is 100 V seak DC component 1 6 Amplitude at 500 ohm is 50 V eax DC component 2 7 Acute Tri Phasic Amplitude at 1000 ohm is 100 V seak DC component 2 3 Amplitude at 500 ohm is 50 V eax DC component 3 1 Chronic Bi Phasic Amplitude at 1000 ohm is
20. adhesive patches and electrode cream and the component parts thereof distributed or manufactured by Empi shall be free from defects in the workmanship and materials for three years from the initial date of purchase from Empi the Warranty Period Accessories including but not limited to chargers rechargeable batteries electrodes lead wires tape adhesive patches and electrode cream are excluded from the Warranty and sold AS IS because their structure is such that they may be easily damaged before or during use Limitation of Liabilities and Disclaimer of Warranties A Empi s sole obligation in the case of any breach of its warranties set forth in Paragraph A above shall be at Empi s option to repair or replace the 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 reguest 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 Hwy 22 Clear Lake South Dakota 57226 USA or to an Empi Authorized Service Center To locate the appropriate Service Center outside of North America or to request shipment approval contact Empi directly
21. 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 16 Continuum User s Manual Is for Use Patient Changing the Batteries Change BOTH of the AA batteries when The low battery indicator is visible on the LCD The Low Battery message displays f the device will not turn on Turn off the device to replace batteries Open the battery door by placing your thumb on the notch and the bottom back side of the unit and pushing up while pulling out When replacing the batteries be sure the battery polarity and markings match the markings on the device Use AA alkaline or rechargeable NiMH batteries The life of the battery is dependent on the program and amplitude intensity being used The battery use indicater may not show 10096 power when a fully charged rechargable battery is used but the battery life is still full NOTE Do not overcharge batteries Batteries should remain in t
22. ation inflammation and electrode burns beneath the electrodes are potential adverse reactions Continuum User s Manual oduct Description Glossary of Terms The following symbols may be located on the Continuum stimulator or packaging gt CHES QUASI Sutera E 3 d My 9900900 oe C X Dangerous voltage Stimulus delivered by the TENS waveforms of this device in certain configurations will deliver a charge of up to 20 microcoulombs uC 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 Classified 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 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 ON OFF Continuum User s Manual 9 Directions for Use Electrode Setup 10 Make sure unit is turned off and lead wires a
23. ccr rtp re REP 42 EN 60601 1 Classification Wi 42 Electromagnetic Compatibility Tables JJ 43 TROUBLESHOOTING 0 cece cece enhn 47 LIMITED WARRANTY ceret he eR IER EE ban dea EY n 50 WaltA ciuem iinbbrehte ra ERE dea RU ERE Pon Ee 50 Waltanty cc eh 50 Limitation of Liabilities and Disclaimer of Warranties 50 ii Continuum User s Manual oduct Description 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 D
24. e listed in the table below Adjustable Parameters Range Default Setting Preset Parameters Settings Waveform Type Cycling Type 22 Continuum User s Manual nation Clinician Large Muscle Spasm Summary This is a 2 channel program for relaxing and reducing spasmodic tightness in large muscles All parameters are preset with the exception of Treatment Time Off Time and the Pulse Rate which can be adjusted by the clinician The range of adjustments for Treatment Time Off Time and Pulse Rate are listed in the table below Adjustable Parameters Range Default Setting Preset Parameters Settings Large Muscle Trigger Point Summary This treatment option is a 2 channel program for relaxation of muscles in a localized area All parameters are preset with the exception of Treatment Time Off Time and Pulse Rate which can be adjusted by the clinician The range of adjustments for 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 Pulse Rate 2Hz150 Hz Continuum User s Manual 23 Product Informati Large Muscle Trigger Point Summary continued Preset Parameters Settings Waveform Type Cycling Type Pulse Width Lag Delay CH 1 Up Time CH 1 On Time CH 1 Down Time CH 2 Up Time CH 2 On Time CH 2 Down Time Large Muscle Custom Switch Summary This option offers simi
25. ey should make contact when inserted lectrodes Dried Out Replace electrodes Make certain Electrodes are at least 2 apart A Replace B Reapply electrodes securely amp firmly C Make certain Electrodes are at least 2 apart id il ncrease the intensity position electrodes to be a minimum of 2 inches apart amaged Worn Electrodes or Lead eplace Wires A A Refer to Preprogrammed amp Custom Regimens on page 22 for egimen descriptions B Contact clinician if discomfort persists C Reposition electrodes ce or Recharge Batteries A Reposition electro B Replace Electrodes A Reposition electro B Replace Electrodes les to be a minimum of 2 inches apart les to be a minimum of 2 inches apart Try each lead wire independently in each channel If there is no output on either channel the lead wire is defective and should be replaced If there is an output on one channel a component may have failed Call the repair department A Verify connection is secure B Turn down the intensity Rotate the Lead Wires 90 intermittent replace lead wire C If still intermittent after replacing lead wire a component may have failed Call the repair department eg If still Some programs will seem intermittent This is expected Refer to Preprogrammed amp Custom Regimens on page 22 for descriptions 47 Troubleshooting Intensity Auto Lock Once you have started therapy and
26. ful 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 Continuum User s Manual 7 Product Descri AC Electrodes Any Empi Electrode with a minimum active area of 16 cm 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 Consult your clinician prior to using any electrode less than 16 cm Dangerous voltage Stimulus delivered by the TENS waveforms of this device in certain configurations will deliver a charge of up to 20 microcoulombs uC 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 BIOHAZARD procedu res Adverse Effects Skin irrit
27. he charger for the recommended time Remove the batteries from the charger once charge is complete See the Instruction for Use for the battery charger for recommended charging time To Replace the Battery Cover 1 Insert the small lip at the base of the cover 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 face the back of the device toward you and slide the device with a gentle pull of the clip tab When in place you should feel a slight tension holding it in place Using the Kick Stand Empi Continuum has a simple pull out Kick Stand for use in patient monitoring To use the kick stand turn the device to the back side Placing your finger on the recessed tab pull the stand out for use Continuum User s Manual 17 Directions for Use Language To switch the language of the device 1 Select CONFIG on the Home screen by pressing the lower right hand soft key 2 Select SETTINGS by pressing the upper right hand soft key 3 Press the lower left hand soft key once to toggle to the Language option 4 Use the right hand soft keys to select your preferred language 5 Press OK on the bottom right Contrast To adjust the contrast of the screen 6 Select CONFIG on the Home screen by pressing the lower right hand soft ke
28. hen 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
29. 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 Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3V m Continuum User s Manual 45 Product Informati Recommended Separation Distances between Portable and Mobile RF Communications Eguipment 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 by maintaining a minimum distance between portable and mobile RF communications eguipment transmitters and the Empi Continuum as recommended below according to the maximum output power of the communications eguipment Separation Distance According to Freguency of Rated Maximum Transmitter Output Power of Transmitter m 80 MHz to 800 MHz 800 MHz to 2 5 GHz 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
30. ing 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 amp 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 Continuum User s Manual 3 Product Descriptio AN 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
31. itude program for the management of acute or chronic pain control in the knee All parameters are preset with the exception of Treatment Time and the Pulse Rate which can be adjusted by the clinician Adjustable Parameters Range Default 5 60 min or Continuous 2 He 150 Ha Too Preset Parameters Settings Continuum User s Manual 27 Product Informati TENS Shoulder Summary This treatment option is a 2 channel Simple Modulated Pulse SMP program for the management of acute or chronic pain control in the shoulder This treatment option modulates the pulse rate and the pulse width at the same time All parameters are preset with the exception of Treatment time and the Pulse Rate which can be adjusted by the clinician Adjustable Parameters Range Default Setting Preset Parameters Settings Pulse Width 300 us TENS Back Summary This treatment option is a 2 channel Modulated Amplitude program for the management of acute or chronic pain control in the Back All parameters are preset with the exception of Treatment time and the Pulse Rate which can be adjusted by the clinician Adjustable Parameters Range Default Setting Preset Parameters Settings 28 Continuum User s Manual nation Clinician TENS Hand Summary This treatment option is a 2 channel Simple Modulated Pulse SMP program for the management of acute or chronic pain control in the hand This treatment option modulate
32. ive 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 Harm
33. lar stimulation as Large Muscle Spasm and Trigger Point if no external Foot Switch is detected Adjustable Parameters Range Default Setting If used with an external Switch continuous stimulation is available for gait training protocol 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 24 Continuum User s Manual ation Clinician Small Muscle Atrophy Summary This is a 2 channel program for strengthening and re educating small atrophied muscles All parameters are preset with the exception of Treatment Time Off Time and the Pulse Rate which can be adjusted by the clinician The range of adjustments for Treatment Time Off Time and Pulse Rate are listed in the table below Adjustable Parameters Range Default Setting Preset Parameters Settings Small Muscle Spasm Summary This is a 2 channel program for relaxing and reducing spasmodic tightness in small muscles All parameters are preset with the exception of Treatment Time Off Time and the Pulse Rate which can be adjusted by the clinician The range of adjustments for 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 Continuum User s Manual 2
34. left the intensity level constant for 20 seconds the device will lock to prevent accidental increases to intensity You will see a lock symbol appear in the middle of the screen to indicate that this safety feature is in effect To unlock and increase intensity press the button to decrease the intensity first at which point the device will unlock and allow you to turn the intensity up 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 timer will stop To resume treatment assure that the leadwire is fully connected to the device and to the electrodes and that there is good contact between the electrodes and the skin Then increase the intensity to the desired level If the problem persists replace the leadwires and electrodes or contact the Empi Repair Department for assistance 800 862 2343 Battery Display The battery icon on the top left corner of the display shows the charged state of the battery This icon will show full for new alkaline batteries but less than full for fully charged rechargeable batteries Low battery voltage is indicated by a flashing battery indicator The device will display a low voltage message and power down if the battery voltage is too
35. lock icon is shown 6 Press the Home button to return to the main menu View amp Reset Compliance Data The Empi Continuum monitors patient usage of the device This feature helps determine patient compliance with the selected protocol s The following information is collected Number of total sessions Total session time hours Average session time minutes Average Channel 1 Intensity Average Channel 2 Intensity 34 Continuum User s Manual prmation Clinician To View the aforementioned Compliance Data the following steps are to be applied 1 Press the ON button to turn on the device 2 Once the main Options menu is displayed choose CONFIG option 3 Choose the data option upper right soft key 4 Use the left side soft keys to scroll through the data After scrolling through the data the clinician can choose to erase reset the data for future collection of compliance data Compliance Data is captured in 5 minute increments when the unit is producing output waveforms When the Clinician needs to reset this compliance data due to a new patient follow the following steps 1 Press the ON button to turn on the device Once the main Options menu is displayed choose CONFIG option Choose the CLEAR option To clear Compliance data select DATA option Press the Home button awn Resetting Parameter Defaults The Empi Continuum has the ability to modify treatment parame
36. low For more information see Changing the Batteries on page 17 48 Continuum User s Manual Troubleshootinc To self test for any of the above perform the following steps 1 Place new batteries in the device 2 Verify the device is off 3 Insert one new lead wire into two new electrodes 4 Place the new electrodes on your forearm as shown in the figure below Insert the lead wire in Channel 1 Turn your device on Select a TENS knee program This is a continuous treatment program Slowly increase the amplitude intensity until you can feel it If you do not get any sensation lower the amplitude intensity to zero and rotate the lead wire 90 degrees Slowly increase the amplitude intensity 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 NO Continuum User s Manual 49 Limited Warrant 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 gt Empi warrants to the initial Purchaser Purchaser and to no other person that the Product with the exclusion of accessories such as chargers rechargeable batteries electrodes lead wires tape
37. merous 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 The Empi Continuum has thirteen pre programmed and three custom regimens for NMES TENS and Pulsed DC Current each with Empi recommended default settings All the clinician needs to do is choose the appropriate therapy for the intended clinical application see Pre programmed amp Custom Regimens on page 22 and the device is ready for use The clinician can control the patient s access to the treatment parameters by either locking out treatment options altogether or by simply locking out parameter changes For treatment flexibility multiple stimulation parameters are adjustable including 2 Independent Intensity Controls Discrete adjustable rate settings Adjustable ON and OFF time controls Adjustable Ramp Up and Down controls Adjustable Treatment duration time Stimulation may be synchronous simultaneous or asynchronous alternating Symmetric or Asymmetric Biphasic waveforms or Pulsed DC waveforms The device also has the ability for Modifiable LCD Contrast settings Four different possible Languages English French Spanish and German Display of unit statistics Clearing of Non V
38. n only ramp one channel at a time 5 If the device has operated as expected turn it off by pressing the ON OFF Cb 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 Continuum User s Manual 15 Directions for Use Programming amp 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 WM 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
39. n 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 4 Continuum User s Manual oduct Description AN 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
40. 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 AE NN 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 breath
41. olatile memory to default Clearing of Unit Statistics 20 Continuum User s Manual ation Clinician Hardware and Labeling External Remote Switch Port The remote switch acts as a trigger for the selected regimen There are two available External Remote Switches Remote Hand Switch and Remote Foot Switch The remote switches should be used with the custom program For information on using a remote switch in conjunction with a gait Training Protocol see page 37 Switches are optional accessories and may not be included Front Panel Soft Key Control The Soft Keys on the left and right side of the unit serve multiple purposes for this device The left side soft keys have the ability to scroll modifiable items into or out of view Additionally the left side soft keys will act to increase or decrease the intensity of channel 1 output Similarly the right side soft keys act as a means of scrolling an item s value up or down Additionally the right side soft keys will increase or decrease the intensity of channel 2 output The stimulation level for each channel can be seen on the LCD screen coincident with the associated soft keys ON OFF Key The dedicated button with the international ON OFF D symbol both powers up and powers down the device Home Key The dedicated button with the picture of a Home on it will serve to transition the unit to the Options menu page OK Key The OK key is used as a means of putting the stamp
42. or unlimited Remote Control Hand Switch Active regimen starts with closed contact Low Voltage Indication Indicator Threshold 2 07 Volts typical Shutdown Voltage 1 77 Volts typical 1 5 Volt Minimum These voltages may be tested under NO load condition Physical Characteristics Size 1 26 3 2cm x 3 3 8 4cm c 4 5 11 4 Weight with batteries 226 8 grams Environmental Conditions Operational Temperature 10 C to 40 C Humidity Maximum 1096 9096 RH Transport amp Storage Store in Dry Cool Place 40 C to 70 C Pressure 50 106 kPA EN 60601 1 Classification Type BF Applied Part 2 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 42 Continuum User s Manual ation Clinician 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 RF emissions CISPR 11 group Electromagnetic Environment Guidance The Empi Continuum 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
43. part of the Empi Continuum including Cables than the recommended separation distance calculated from the eguation applicable to the freguency of the transmitter Recommended separation distance Conducted RF 3 Vrms d 3 5 IEC 61000 4 6 150 kHz to 3 P 80 MHz Radiated RF 3V m d 3 5 p 80MHz to 800 MHz IEC 61000 4 3 80 MHz to 3 P 2 5 GHz da 800 MHz to 2 5 GHz Zip 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 survey should be less than the compliance level in each frequency range erference may occur in the vicinity of equipment marked ith the following symbol FY 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
44. power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 596 U 59596 dip i for 0 5 cy 40 U 60 dip in 5 cycles 70 U 30 dip in U 25 cycles NU 29596 dip in U for 5 sec T Not Applicable Battery Operated Device Mains power quality should be that of a typical commercial or hospital environment If the user of the Empi Continuum requires continued operation during power mains interruptions it is recommended that the Empi Continuum be powered from an uninterrupted power supply or a battery Power frequency 50 60Hz magnetic field IEC 61000 4 8 3 A m Power frequency magnetic fields should be at levels characteristic of a typical location ina typical commercial or hospital environment NOTE U is the a c mains voltage prior to application of the test level 44 Continuum User s Manual ation Clinician Guidance and Manufacturer s Declaration Electromagnetic Immunity continued 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 Immunity 60601 Compliance Test Test Level Level Electromagnetic Environment Guidance Portable and mobile RF communications eguipment should be used no closer to any
45. re disconnected before and after treatment 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 With electrodes still on liner connect lead wire from unit electrode connector No bare metal should be visible Remove electrode from liner by grasping the edge of the electrode and peeling it off the liner Retain liner for storage Place the electrode on exact skin location by applying the center of the electrode first and smoothing down to electrode edges Attach lead wire to unit and begin treatment After treatment turn unit off Remove electrode from skin by peeling electrode edge Continuum User s Manual 1s for Use Patient Electrode Setup continued AN Precautions 9 EN NN YAN 11 12 13 14 15 16 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 DO NOT use unit while driving or operating machinery For single patient use only These electrodes may be repositioned up to several times on the same patient Stimulation should not be applied to transcerebrally or over the anterior neck region Keep electrodes separated during treatment DO NOT remove electrode by pulling on the lead
46. ruction 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 D button OK button and the Home button Simple Operational Procedure Steps The front panel should appear as shown below Continuum User s Manual 13 Directions for Use Using the Front Panel continued 1 Press the ON OFF button D 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 14 Continuum User s Manual 1s 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 ca
47. s the pulse rate and the pulse width at the same time All parameters are preset with the exception of Treatment Time and the Pulse Rate which can be adjusted by the clinician Adjustable Parameters Range Default Setting Preset Parameters Settings Pulse Width 300 us TENS Foot Summary This treatment option is a 2 channel Simple Modulated Pulse SMP program for the management of acute or chronic pain control in the foot This treatment option modulates the pulse rate and the pulse width at the same time All parameters are preset with the exception of Treatment Time and the Pulse Rate which can be adjusted by the clinician Adjustable Parameters Range Default Setting Preset Parameters Settings Continuum User s Manual 29 Product Informai TENS Custom Summary This treatment option is a sequenced 2 channel Modulated Amplitude MOD or a Simple Modulated Pulse SMP program for the management of acute or chronic pain All parameters have default settings and are adjustable by the clinician within the range described in the table below Adjustable Parameters Range Default Setting 20 95 Preset Parameters Settings Pulse Width 300 us Pulsed DC Current Regimens Pulsed DC Current Edema Acute Summary This treatment option is a sequenced positively DC unbalanced 2 channel program for edema reduction and increased circulation All parameters are preset with the exception of
48. se 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 2 Continuum User s Manual oduct Description CAUTION Federal Law USA restricts this device to sale by or on the R order of a physician or licensed practitioner AN Contraindications Empi Continuum should
49. ters 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 Press the ON button to turn on the device 2 Once the main Options menu is displayed choose CONFIG option 3 Choose the CLEAR option 4 To reset the waveform data to parameter default values select the PARAMETER option Choosing a Language The Empi Continuum has the ability to modify the language displayed upon the LCD screen The options are English Default French Spanish and German When the clinician needs to alter the currently displayed language the following steps are to be applied Press the ON button to turn on the device Once the main Options menu is displayed choose CONFIG option Choose the SETTINGS option Use the lower left soft key to scroll to the Languages option Use the right side soft keys to scroll to the proper language Press the OK button to select the language Press the Home button NOUO n p oM Continuum User s Manual 35 Product Informatio 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 Press the ON button to turn on the device 2
50. um User s Manual 37 Product Informati Accessories Battery Two AA rechargeable NiMH Batteries Part Number 200034 001 Electrodes Any Empi Electrode with a minimum active area of 16 cm may be used with this device This includes Empi square 2 x 2 StimCare electrodes DANGER Use of an electrode with an area less than 16 cm can cause burns when the unit is used at higher intensities 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 Use either Empi Foot Switch Part Number 198887 001 Empi Hand Switch Part Number 57202241 Bifurcated Lead wire for Edema Part Number 700211 001 Dispersive Pad for Edema Part Number 199501 001 Technical Data Standard Measurement Conditions Temperature 25 C 5 C Load 1 kohm Power Supply 3 0V DC 10 Typical Waveforms The following are theoretical standard measurement output voltage across purely resistive loads at maximum intensity setting Pulse Width and Vpp measured as shown across 500 ohm and 1k ohm loads Your output may vary depending on parameter settings ASYMMETRIC NMES OUTPUT WAVEFORM MU 0 90100 200EDt A20E4 amp 00EO4 amp 00EO4 1 00E 03 1 206 03 1 46 03 150623 120603 TEM SECONDS 38 Continuum User s Manual Typical Waveforms continued SY
51. viously selected item LARGE MUSCLE or SMALL MUSCLE Select the locked treatment to go to the In Progress screen Set up patient with electrodes and ramp up intensity TENS Parameters 1 Press bottom soft key on the left to select TENS programming Cv ON AU AWN Power ON the device by pressing the ON OFF C button Select the body part by scrolling thru options and press OK Using left side soft key scroll to the desired parameter item Using right side soft keys scroll parameter value up or down Press the Home button to get back to the Option menu Press soft key labeled CONFIG Press right side soft key labeled LOCKS Using lower left soft key scroll to item TENS Press the upper right soft key until a locked icon displays 32 Continuum User s Manual Product Informat 11 Press Home button to accept the change 12 Press the TENS button a lock must be visible beside it to go to the In Progress screen 13 Set up patient with electrodes and ramp up the intensity Pulsed DC Current Edema Parameters 1 Power ON the device by pressing the ON OFF WM button 2 Press top soft key on right to select EDEMA programming 3 Select Treatment type Acute or Chronic 4 Using right side soft keys scroll parameter value up or down 5 Press the Home button to get back to the Option menu 6 Press soft key labeled CONFIG 7 Press right side soft ke
52. 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 the lifetime of the initial purchaser 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 D 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 A 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 the 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 Continuum User s Manual 51 199610 001 Continuum Kit Empi Empi Inc 205 Hwy 22 East Clear Lake SD
53. wire DO NOT exceed 0 1 Watts cm Using stimulation electrodes that are too small or incorrectly applied could result in discomfort or skin burns Continuum User s Manual 11 Directions for Use e f adhesive becomes over saturated allow electrode to air dry in a refrigerator with adhesive side up until gel regains tack e 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 e f 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 e 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 12 Continuum User s Manual is for Use Patient 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 Inst
54. y 7 Select SETTINGS by pressing the upper right hand soft key 8 The screen will default to the Contrast option 9 Use the right hand soft keys to adjust the contrast as desired 10 Press OK on the bottom right Troubleshooting and Repair Troubleshooting If the device does not function Make sure the batteries are properly installed check polarity markings Make sure the battery contacts are clean If the device is ON but does not respond to pressing the key pad buttons Detach all patient lead wires from the device Remove batteries from the device Wait 10 seconds Re insert batteries and resume treatment If the Low Battery Indicator is visible replace both batteries If the device is on the indicator lights are illuminated over the intensity controls and you feel no stimulation check and verify the connection of lead wires and electrodes If the device appears to be functioning and there is no stimulation replace the lead wires and or electrodes If the channel shows an OPEN error message check to make sure that all electrodes and lead wires are properly attached 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 18 Continuum User s Manual ins for Use Patient If you are unable to increase the
55. y labeled LOCKS 8 Using lower left soft key scroll to item EDEMA 9 Press the upper right soft key until a locked icon displays 10 Press Home button to accept the change 11 Press the EDEMA button a lock must be visible beside it to go to the In Progress screen 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 After having set up a treatment s parameters the clinician can do as follows 1 On the main options page press CONFIG to get to the CONFIG menu 2 Press LOCKS Lower Right Soft Key 3 Using the Left Soft Keys scroll through available items NMES L MUSCLES NMES S MUSCLES TENS and EDEMA Initially these items will show an unlock icon to the right on the LCD screen 4 For each item press the upper right hand soft key once This will show the lock icon an image of a closed pad lock 5 Press the Home key 6 Notice the small lock beside the treatment option that was previously locked Notice also that when the corresponding soft key is pressed user transitions directly to the In Progress screen This can be done for all treatment types
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