Empi Select User`s Manual
Contents
1. Prescribing Information 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 a menstruating or pregnant uterus Sensory loss Do not use electrical stimulation where sensory nerve damage is present causing a loss of normal skin sensation Unequal electrode size Using different size electrodes together can cause skin irritation or increased stimulation intensity under the smaller electrode Some programs may require the use of different sized electrodes for treatment Prescription Use electrical stimulation only in the prescribed manner and for the prescribed diagnosis If there are any changes in an existing condition or if a new condition develops the patient should consult a 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 he she is properly supervised during electrical stimulation Leads and electrodes Use the device with only the leads and electrodes provided for use by2. Check the unit before each use for signs of wear and or damage Replace wear items as required Send damaged units back to factory for repair Wear items are 1 Electrodes 2 Lead wires 3 Batteries Cleaning Cleaning the device Use a damp cloth moistened with mild soap and water to clean the exterior of the device Use of other cleaning solutions may damage the case Never immerse the device in water or other liquids Do not use cleaning fluids or solvents to remove stains or dirt These liquids may damage the plastic case and lead wires Cleaning the battery contacts Gently clean the battery contacts using a cotton tipped swab soaked in rubbing alcohol Do not use sandpaper or other abrasive material Cleaning the lead wires Periodically wipe the lead wires clean with a cloth dampened in a mild soap solution then gently wipe them dry Use of rubbing alcohol on the lead wires will damage the insulation and dramatically shorten their life Storage To properly store the device for an extended period of time i e two weeks or more remove the batteries and store the device in a dry location Store all the operating components in the carrying case Batteries should be stored in the carrying case in a dry location at 50 F to 86 F 10 C to 30 C and away from direct sunlight Rechargeable batteries slowly lose their charge in storage so they should be recharged every six months The batteries can lose their capacity to hold a
3. than Empi in St Paul Minnesota This warranty is in lieu of any or all other warranties expressed or implied No person is authorized to bind Empi to any representation of warranty other than those specifically set forth herein NOTE warranty period begins with the date of purchase from manufacturer Ill 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 IIA above shall be at Empi s option to repair or replace the Product with a new or factory reconditioned product without charge to Purchaser or to refund the purchase price of the Product In order to recover under this Warranty Purchaser must send Empi written notice of the defect setting forth the problem in reasonable detail prior to expiration of the Warranty Period and within 30 days of discovery of the defect Upon Empi s written request and authorization Purchaser shall return the Product to Empi freight and insurance prepaid for inspection Notice and return shipment shall be sent to Empi at Clear Lake Industrial Park Clear Lake South Dakota 57226 Purchaser may request shipment approval by calling Empi Warranty Repair Department on its toll free number 1 800 862 2343 In the case of repairs or returns outside of North America notification and return shipment shall be sent to an Empi Authorized Service Center To locate the appropriate service center outside of North America
4. RR Ru dr Bana BR x 14 Changing a Therapy Session sssssieeeeee hh hh hrs 14 Ending a Therapy ESSI curd a aac KAE eq i oe a ac uoo i cand o eu rad DO M eiut EE 15 System Components sseuuueeeeee nnn hh 16 DOVICS X IQ 16 Device Physical EE ue toe sacas xdi RE E RS EE KERERE EUR Paar Vas 17 LCD Screen 17 Op rating BUNONS sae ara nerds eee Reena IBERIA PETERS PIE MORE qu e I DuC Ts 18 Intensity Lockout Feature 2i ved ce a py ess REERRERPG GCL ETRTRRRRERERPEDACERRWERERIPQSRA 18 CUD dhs ENEE adja E EE KA eae eae IPSE Eua E oe eke 18 On Off Indicator EE 19 Battery Oman saa aa an a ag ga a a Bang Ba EEEE EEEE EREE ese nae esu e 19 2 7 107 TET 19 Canine e MTM 19 Documentation EE 19 Lead Wiese anara aaa a aki E tea sae tons tease ELCHE E aa UE PAESE IURE UNES 20 Electrode S arana inaa ia anara aa he eae eee dee ee d Aa a na eae BN eee lat a aaa 20 ODCIAUON EE 21 B eg 21 SLANG ING DANG NGE CT a a aa a A an aa aa a Sak een Ba an BB a a an aa aa a 22 Connecting the Lead Wires to the Electrodes rre rh Rr were gan yw dx 23 Connecting the Lead Wires to the Device 1 1 k aa cette te hh hh hh rh 24 Preparing the Skin Tora Therapy Session ged re uva dr eas 3d REA XXe ka dnd 24 Appiving the Electrodes To TDe EE 25 ANI OR NGING e Mee PCI 26 Choosing the Treatment SeningS ere rr a aes ea ce rc eae d p C
5. device controls the gate The second method of pain control is the endorphin release method The Select device can be set to trigger the body s natural pain killers called endoprhins These chemicals interact with recpetors blocking the perception of pain This is similar to the way the pharmaceutical drug morphine works but without the side effect associated with morphine No matter which pain control method is employed the Select has been proven useful in pain management By reading this manual and carefully following the treatment instructions provided by your clinician you can attain maximum benefit from your Select device 6 Select User s Manual Introduction 1 Channel 1 Bah Bi vers e D e Main Operating Components Consult a health care professional clinician if you have specific questions or problems regarding the use of the device They are most familiar with your situation and are the best source of additional guidance This system should be used only under proper medical supervision and only as described by this manual Before using your Select Pain Control system please read all of the indications contraindications warnings and precautions in the Prescribing Information section on page 8 Select User s Manual 7 Prescribing Information In general stimulation should be used under medical supervision in the management of specific conditions Read understand and practice the precautiona
6. examples are sprains incisional pain or muscle strain This type of pain is typically associated with workplace or recreational injuries Chronic pain however is a long lasting persistent pain that ceases to serve as a warning system and becomes a problem The Select was developed to help relieve some types of both chronic and acute pain What is TENS TENS stands for Transcutaneous Electrical Nerve Stimulation Pain whether chronic long term or acute short term can be relieved through a variety of methods including drugs topical ointments surgery and electrical stimulation TENS devices deliver electrical pulses through the skin to the cutaneous surface and afferent deep nerves to control pain Unlike drugs and topical ointments TENS does not have any systemic side effects How Does TENS Control Pain The Select provides pain relief in two ways The first is the gate control method When the body is injured both pain and non pain impulses are sent to the brain from the nervous system These pulses travel through the cutaneous nerves to the deeper afferent nerves and then to the spinal cord and brain Along the path are many areas referred to as gates which determine which impulses are allowed to continue on to the brain The gates prevent the brain from receiving too much information too quickly Since the same nerve cannot carry a pain and a non pain impulse at the same time the stronger non pain impulse from the Select
7. of this manual NOTE Most therapy sessions are for 30 to 120 minutes with 30 to 60 minutes between sessions Follow your clinician s instructions 1 Press the Channel 1 and Channel 2 intensity controls until the stimulation is strong but comfortable It is important that you can feel the stimulation 2 The On Off indicator lights should be on The LCD display will show a low battery icon to indicate low battery status CAUTION Always turn the Select device off when changing the battery 3 The output of the device may decrease slightly during stimulation as the batteries wear down If this happens you may need to increase the intensity slightly to maintain adequate stimulation Recording Treatment Before turning off the TENS device you may want to record the location of the electrodes the settings of all controls and any progress achieved Good record keeping will help when resuming treatment or reviewing progress with your clinician If after several treatments you do not achieve pain relief consult your clinician for new electrode placement or stimulation program alternatives Ending freatment 1 Turn the device off Disconnect the lead wires grasping them by the insulated connector not the lead wire NOTE Turning the unit off will end the treatment and save the following information for data retrieval number of sessions total time of all sessions average session length and the average intensity used for each ch
8. options when the default parameters have been changed and saved the Custom text will denote that the buttons have been customized e Program options four program options Continuous Burst SMP and Modulation can be selected with the Mode button e Lock icon when treatment intensity is set at greater than zero and no activity has occurred within 15 seconds the Lock icon appears to tell the user that the unit is locked and intensity program cannot be changed until it is unlocked ep Pad contact icons two icons one for each channel icons will display a and flash indicating bad contact s e Battery icon displays the battery life e Quick Select programs five pre set programs for particular body areas Knee Shoulder Low Back Hip Hand Wrist and Back Select User s Manual System Components Operating Buttons These are the buttons you use to program your therapy settings such as selecting the treatment program and intensity e On Off used to turn the stimulator on and off e Quick Select programs used to select the most commonly used programs for a particular body area Knee Shoulder Low Back Hip Hand Wrist and Back e Mode used to select one of four program options Continuous Burst SMP and Modulation e Set used to change the therapy session parameters Rate Cycle Time and or Span Percentage based on which program option is selected Also used to access the Timer function e Ch 1 Increase
9. the batteries in backwards Check the and markers 2 Plug the charger into any standard 110V 60Hz outlet 3 If the batteries are new or have been stored for a long period of time full capacity will not be reached until the batteries have been through 3 5 charge use cycles 4 Rechargeable batteries have a natural life of approximately 500 charge use cycles Once this is reached it is not possible to achieve full capacity At this point batteries should be disposed of and replacement ones can be ordered through Empi at 1 800 328 2536 NOTE Batteries have a natural property to release the stored energy in small amounts this phenomenon is called self discharge This property is particularly noticeable in rechargeable batteries such as Nickel Metal Hydride batteries etc as compared to dry cell alkaline batteries For this reason rechargeable batteries cannot be used unless charged after purchase Regardless of the type of battery this natural self discharge phenomenon occurs In order to get the NiMH batteries to activate back to its full capacity you must charge use or discharge from 3 to 5 times All NiMH batteries must be activated when they are brand new or if they have been stored unused Once NiMH batteries reach their end of life approx 500 cycles they should be disposed of as continuing to re charge them will not do any good Select User s Manual 33 Operation Maintenance
10. toggle the screen between the treatment screen and the timer screen 4 To unlock the keypad press either Channel 1 or Channel 2 down button To return to the timer screen press the Set button as in step 1 To cancel the treatment program at any time simply turn the device Off 5 When timed treatment is complete the device will automatically turn Off remove and store electrodes Data Retrieval When the unit is in Data Retrieval mode the user can cycle through several codes that contain information saved from treatments With the unit off pressing the On Off button while holding down the Mode button will take you to the Data Retrieval screen The Data text icon will appear Pressing the Mode button will cycle through the data saved on the unit e SES The number of sessions maximum 255 Sessions are counted only when intensity is 3 0 SES will be displayed on the left side of the screen while the number of sessions will be displayed to the right of it e HrS The total time of all sessions hours maximum 999 HrS will be displayed on the left side of the screen while the time will be displayed to the right of it in the format hours e ASL The average session length hours and tenths of hours ASL will be displayed on the left side of the screen while the session length will be displayed to the right of it in the format hours tenth of hours e Channel 1 The Channel 1 text icon will be displayed
11. used to increase the intensity of the electrical current sent through the channel 1 output jack e Ch 1 Decrease used to decrease the intensity of the electrical current sent through the channel 1 output jack e Ch 2 Increase used to increase the intensity of the electrical current sent through the channel 2 output jack e Ch 2 Decrease used to decrease the intensity of the electrical current sent through the channel 2 output jack NOTE Pressing the Up or Down intensity controls increases or decreases the intensity in 0 5 increments Intensity range is 0 0 to 60 0 The Up or Down intensity controls can be held down to increase or decrease the intensity faster Intensity Lockout Feature Once the intensity is raised above zero with no activity for greater than 15 seconds the unit will initiate lockout of the increase intensity buttons A lock symbol will appear on the display to signify that this has occurred This feature prevents any unintended key presses to increase intensity or change the program option E To unlock press the Ch 1 or Ch 2 decrease button Output Jacks The output jacks are where you connect the lead wires to the device The output jacks are labeled on the LCD display Channels 1 and 2 operate independently There are two 2 LED indicator lights one for each channel NOTE At a high rate the LED indicator light will flash looking like it is constantly on At a low rate the LED indicator light will fl
12. D 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 This Warranty gives Purchaser specific legal rights and Purchaser may also have other rights which vary from state to state Some states do not allow limitations of how long an implied warranty lasts so the above limitation may not apply to the Purchaser 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 IIIA ABOVE SHALL CONSTITUTE PURCHASER S SOLE REMEDY IN NO EVENT SHALL EMPI S LIABILITY UNDER ANY CAUSE OF ACTION RELATING TO THE PRODUCT EXCEED THE PURCHASE PRICE OF THE PRODUCT This Warranty gives Purchaser specific legal rights and Purchaser may also have other rights which vary from state to state Some states do not allow the exclusion or limitation
13. Empi User s Manual T CAUTION Federal Law USA restricts this device to sale by or on the order of a physician or licensed practitioner gt The following symbols may be located on the back of the Select stimulator Type BF Applied Part Attention consult accompanying documents Lead wires comply with the Performance Standard for electrode lead wires 21 CFR part 898 Qe ve Pe ri Electronic Testing Lab indicates product meets US and Canadian product safety w standards This device complies with UL 60601 1 and CSA C22 2 No 601 1 M90 9900900 m WEEE Indicates a requirement not to dispose of WEEE as municipal waste Contact T Council Directive 2002 96 EC concerning Waste Electrical and Electronic Equipment your local distributor for information regarding disposal of the unit and accessories Empi 2008 Empi All rights reserved Table of Contents ligni EE 6 HOW Select WONG PRT 6 Main Operating Components 00 ccc ence hh hh ahhh as 7 Prescribing Information sesa aaa aaa aaa aa aaa aa aaa aaa 8 PG BAEN P r 8 CODI BINGAH aco dice E dete e Rec cd s dee cu rro Rae cacao o aapa OUR aa a d a 8 UY UTILE sve seca vu E CR TCR TETTE TTE EE TTC TETTE 9 EE 11 Dangel EE IU TTE 13 EE e Seto os ws Se a ey Bet Darah Se BG Gok ee Gdn Yd e es oo eo 13 QUICK er 14 saning a Therapy SESSION oi mira aa aaa es da rod cu Qa REOR ace c ru
14. Program d Program a Option 4 M 1 Option 5 hand wrist back 26 Select User s Manual Operation Quick Select Button Reset Mode With the unit off pressing the On Off button while holding down the Set button will take you to the Quick Select Button Reset Screen The Data text icon will appear The body part icons will be displayed along with the Custom text icon associated with the body part icon CP appears on the screen to clear all five programs saved on the unit Pressing both Down arrow buttons on each intensity channel will confirm the clearing of programs and reset the Quick Select buttons to the default parameters See the default parameters for each program in the Specifications section The Custom text icon will no longer be displayed Pressing the On Off button will cancel the clearing of the programs and will reset the programs to default parameters Pressing the On Off button will exit the Quick Select button reset screen or after one 1 minute has passed and no buttons have been pressed the unit will automatically exit the Quick Select button screen and turn off Program Option Controls Select offers nine 9 program options To select a specific program option depress the Mode button or one of the Quick Select buttons 1 Quick Select Knee Program Alternating Ramped Burst ARB 2 Quick Select Shoulder Program Simple Modulated Pulse SMP 3 Quick Select Low Back Hip Program Modulated Amplitude MA 4
15. Quick Select Hand Wrist Program Simple Modulated Pulse SMP 5 Quick Select Back Program Modulated Amplitude MA 6 Continuous C 7 Burst 8 Simple Modulated Pulse SMP 9 Modulation Quick Select Knee Program Alternating Ramped Burst ARB Cycla Time D s CycleTime e D s The Alternating Ramped Burst program is the same as the Burst but Channel 2 starts after Channel 1 has completed a cycle Channel 1 gradually increases intensity from O to the set level over 0 5 seconds holds at the set intensity for 5 0 seconds and then decreases intensity over 0 5 seconds After decreasing intensity to zero Channel 1 stays off while Channel 2 increases holds and decreases via the same pattern as Channel 1 Select User s Manual 27 Operation Quick Select Shoulder Hand Wrist Programs Simple Modulated Pulse SMP Set Duration Rate Modulation Duration Modulation fin microseconds in pulses per second 10 ppa 40 of Set Duration Time in seconds Time in seconds The Simple Modulated Pulse SMP program delivers a group of pulses as a repeating 12 second cycle Within each cycle the rate and duration of the pulses vary while the intensity remains constant This mode is unique because the rate stays in the 2 to 10 pps range for 1 3 of the cycle time 4 seconds as the rate modulates down to 2 pulses per second pps and then back up again Quick Select Back Low Back Hip Programs Modulation Amplitu
16. a DIMENS s yrii retinere 35 Enmviionmenal erer EE 35 Program Options and Default Parameter 36 Program Options and Adjustable Parameters 00s cece ccc tne han 37 To Select Parameters for Programs ias se eR ER AE Ee AE EE 38 Data AENCV 180 Mem 38 cuu TMPP 38 WAVCONNS ege EE ENEE 38 Electromagnetic Compatibility EMC Tables isse IH m 40 Troubleshooting Li lllluulellllrr rmn 44 Replacement Rate 47 dl el EE 48 4 Select User s Manual Select User s Manual Introduction Congratulations Your physician has prescribed Empi s Select Pain Control system to help you with pain management Empi is dedicated to helping you regain your active lifestyle from our field sales representatives training you on how to use the system to our patient coordinators following up with you We make your success our goal How Select Works What is Pain Pain is an unpleasant sensation that can serve a useful purpose by alerting us to a possible or actual injury or disease When the body is functioning normally pain serves as a warning system that something is not right Without pain a person would not know when to get away from danger or seek medical help But pain becomes a problem when it continues after treatment has started or long after an injury is healed There are two types of pain acute and chronic Acute pain is limited in duration Typical
17. a ep vds iq eebe 26 MONS Be 26 Select User s Manual 3 Table of Contents Quick Select Feature ENEE ee EE RO a aa aa aaa aaa EUR do Ron ACER EUER A E e obf na 26 Fogam ee e 27 Beginning LEET 30 Recording Teamen DD 30 Ecc MPMPEE 30 ee Wie M 30 Data Hemevdl M E 31 Chang Ne a EES 32 Soc Ne Te BaT ES T 33 NIN NDE Para oe ga KB a TETTE C TO CIT CET DOT TOLLIT 33 c FE PR eds 34 ve MEET C RS 34 Uer 34 ines Le eoo on ober dada orb awe sort ardt pd rad acquam 35 Physical Eoi T NEGEN Ar RR ror BK TEE 35 Standard Measurement Conditions asume aav e eaa wxqr Rr RE terse XR RQIREFE YE EXE eee ees 35 WEEDS c RS RE PRRURDRER PIT ERI TEIL seek EP Rd Sem SICH CES S EE 35 Standard Measurement s 2 22 ane seq eas doe E Saco PERDER E UE SACRE ERA wae eye ara dpi qd 35 Pulse DUrallon lt nrk mi a ain Be ee ee ae ee ee bius aly Sic Dedit a ga ag aan aa aa 35 Een sasen a anaa E a a 35 Absolute Average Value sisse ehh hh hh hr hrs 35 Root Mean Square 0 i2m cadens ea aor arte nnn or ranan den he o on Dr UR te O8 c e UE RR d 35 Electrode Surface Wed eese cau corti rit oren E REECE CER EEEE TEETE CE EERDE EE E EEDE D i 35 PVC
18. along with the average intensity for Channel 1 Select User s Manual 31 Operation e Channel 2 The Channel 2 text icon will be displayed along with the average intensity for Channel 2 Pressing the On Off button will exit the Data Retrieval screen or after one 1 minute has passed and no buttons have been pressed the unit will automatically exit the Data Retrieval screen and turn off Resetting to Default Parameters While in Data Retrieval mode press the Set button CL appears on the screen to clear the memory saved on the unit Pressing both Down arrows on each channel will confirm that memory is cleared and reset all options to factory defaults See the default parameters for each program in the Specifications section pages 35 43 Pressing the On Off button will cancel clearing the memory and resetting all options to factory defaults Changing the Batteries The Select device is powered by two 2 AA batteries For best results use Empi alkaline or rechargeable batteries The Select device can assess battery condition at start up When the ON button is held down for two seconds the battery icon will appear on the screen by itself If no bar or only one bar appears the device will not turn on until the batteries are replaced Change or replace the batteries when the low battery icon flashes on the LCD display or if the device will not turn on Full Battery Icon Low Battery Icon CAUTION Turn device off an
19. annel 2 Remove the electrodes carefully from your skin peeling them off gently in the direction that body hair lies The electrodes may be left in place if treatment will be resumed shortly 3 After the electrodes are removed clean the skin thoroughly with mild soap and water For electrode storage and care refer to electrode packaging for instructions NOTE The Select will automatically shut off when both channels are at a zero intensity for one 1 minute or if the batteries are low 30 Select User s Manual Operation Using the Timer Your Select device has a timer that can be set from one to 60 minutes 1 With the device turned on press the Set button until the screen displays dur to the left and Off to the right The number of times Set button needs to be pressed to reach this screen will vary depending on the mode selected 2 When this screen is displayed press the Channel 2 up button to set the number of minutes you want the Select to run The timer can be set in one minute increments up to 60 minutes To decrease the number of minutes press the Channel 2 down button until the desired timing for your treatment is reached 3 Once the desired time is set or the timer is turned Off press the Mode button to return the device to the normal treatment screen After the treatment session has started the keypad will lock in 15 seconds Pressing either the Channel 1 or Channel 2 up button after the keypad locks will
20. ash slowly 18 Select User s Manual System Components On Off Indicator Lights The On Off Indicator Lights indicate that the device is operational The brightness of flash changes with the output intensity As the intensity of the stimulation increases the brightness of the light also increases Above 40 pps the light will appear to be on continuously Battery Compartment The device is supplied with two packs of two AA rechargeable batteries The battery compartment is located on the back of the device Refer to pages 22 23 for battery installation Battery Compartment Belt Clip The belt clip is flexible so you can clip the device to your clothing allowing you to receive your treatment while going about your daily activities Carrying Case A carrying case is included to help protect the Select system and keep it clean Store your device and its components in the case when they are not in use Documentation Read and understand this user s manual carefully before operating the Select device The user manual is provided in English and Spanish If you have questions or cannot read these languages contact your clinician Select User s Manual 19 System Components Lead wires connect the device to the electrodes They carry the electrical pulses from the device to the electrodes on your skin You must have an electrode on both the pins for the device to work properly eM se n cm Plug er
21. at the top of the device They are labeled Channel 1 and Channel 2 on the LCD display 3 Insert one lead wire plug into each output jack If using only one lead Wire you can use either of the output jacks NOTE Use care when you connect and disconnect the lead wires from the electrodes and the device Pulling on the lead wire instead of its insulated connector may cause lead wire breakage ON OFF Indicator Lights Channel Output Jacks Preparing the Skin for a Therapy Session Proper preparation of the skin covered by the electrodes allows more stimulation to reach targeted tissues prolongs electrode life and reduces the risk of skin irritation To prepare your skin at the electrode placement sites 1 Identify those areas where your clinician has recommended electrode placement 2 Wash the area gently with mild soap and water then rinse and dry the area thoroughly The use of rubbing alcohol is discouraged except where necessary to decrease excessive oils on the skin 3 It may be necessary to trim excess body hair with scissors prior to applying the electrodes Do not shave the area immediately before beginning treatment Wait 24 hours after shaving an area before initiating treatment at that site Failure to adequately prepare the skin may cause improper adhesion or skin irritation and provide less than ideal stimulation 24 Select User s Manual Operation NOTE Skin is not accustomed to exposure to the elec
22. ations equipment transmitters and the Empi Select as recommended below mma rs oe Separation distance according to frequency of transmitter power of transmitter Ww m 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz d 3 5 VP d 3 5 VP d 7 NP For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the 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 Select User s Manual 43 Troubleshooting For repair of device call 1 800 862 2343 Mon Fri For supplies call 1 800 328 2536 Mon Fri For optimal use 1 Replace lead wires annually 2 Please follow the directions on the electrode packaging for the care of electrodes The life of the electrodes varies depending on skin conditions skin preparation storage and climate Replace electrodes that no longer stick 3 Ensure batteries are charged before each use Unplug the battery charger from the wall once charge is complete NOTE If the following measures fail to alleviate the problem please call the repair depart
23. c treatment This device is a symptomatic treatment and as such suppresses the sensation of pain which would otherwise serve as a protective mechanism Central origin pain Electrical stimulation is not effective for central origin pain such as headache Pregnancy The safety of using electrical stimulation during pregnancy or birth has not been established Throat stimulation Severe spasm of the laryngeal and pharyngeal muscles may occur when the electrodes are placed across the throat or mouth This may be strong enough to close off the airway or cause breathing difficulty Transthoracic stimulation Do not apply electrical stimulation transthoracically through the chest area in that the introduction of electrical current into the heart may cause cardiac arrhythmias Skin and vascular problems Do not use this device over infected areas skin eruptions or areas of decreased sensation Heart disease Precaution should be taken prior to using electrical stimulation on patients suspected of having heart disease High frequency surgical devices Simultaneous connection of a patient to a high frequency surgical device may result in burns at the site of the 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 preve
24. charge when they are stored for long periods of time You can renew their capacity by charging and discharging them several times If your batteries do not retain a charge during standard operation contact Empi Customer Service at 1 800 328 2536 Disposal Dispose the unit in accordance with national state or local regulations If needed ship the used device postage prepaid to the Empi Service Center for proper disposal or recycling Please enclose a note indicating that the item is being returned for disposal or recycling Outside of North America contact your Authorized Empi Distributor or contact Empi directly at 1 651 415 9000 34 Select User s Manual Specifications Physical Characteristics Standard Measurement Conditions 23 C 10 Resistive load 4 2V d c supply voltage Waveform Balanced asymmetrical biphasic nominally constant voltage positive phase and constant current negative phase over the AAMI load range of 200 to 1ko 2096 tolerance unless stated otherwise See Figures B and C Standard Measurement Output See Figure Both Phases Vpp 0 to 60V A 1kW resistive lpp 0 to 60mA A Vpp Volts peak to peak Ipp mA peak to peak Pulse duration Adjustable 0 to 400 us at 5096 peak amplitude See Figure A on Page 38 Determined by the intensity setting Maximum Current Absolute Average Value 10 mA into 5000 Root Mean Square 10 mA into 1ko Electrode Surface Area 1 227 in 7 917 cm minimum area re
25. charging the batteries refer to Charging the Batteries in this Operation section CAUTIONS e Do not connect the stimulator to any electrical outlet e Do not mix battery types Use either two alkaline or two nickel metal hydride NiMH rechargeable batteries e Remove the batteries from the stimulator during storage to prevent battery leakage Failure to do so may damage the stimulator e Replace batteries immersed in water or liquid Failure to do so may damage the stimulator e Never recharge alkaline batteries An explosion may result e f using rechargeable batteries carefully read and follow all instructions provided with the batteries and the battery charger e Dispose of batteries according to current federal state and local regulations Failure to observe these precautions can result in injury damage to the device and batteries or the environment To install the batteries into the device 1 Turn off Select device 2 Twist belt clip 90 degrees to either the right or left two clicks Fig 1 3 Gently press down and slide the battery compartment toward you Fig 2 4 At this point you have the option to remove the belt clip by sliding it to the left If you want to keep the belt clip on the device simply leave it turned at a 90 degree angle Fig 3 5 Insert batteries making sure positive and negative ends match the label inside the battery compartment 6 Line up all four tabs on the side of the batter
26. cold products The use of heat or cold producing devices such as electric heating blankets heating pads or ice packs may impair the performance of the electrode or alter the patient s circulation sensitivity and increase the risk of injury to the patient Battery charger Only the Empi battery charger should be used with 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 interference to other devices in the vicinity However there is no guarantee that interference will not occur in a particular installation Harmful interference to other devices can be determined by turning the unit on and off Try to correct the interference using one or more of the following reorient orrelocate the receiving device increase the separation between the equipment and consult the Empi Service Department for help AN 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 thi
27. commended e Type BF Applied Part Internally powered only Ordinary protection against entry of liquids Continuous operation Physical Dimensions Size H x W x D 4 31 in x 2 38 in x 1 38 in 10 95 cm x 6 03 cm x 3 49 cm Approx Weight with batteries 4 9 oz 138 9 grams without batteries 3 7 oz 104 9 grams Environmental Conditions Operating Temperature 50 F to 104 F 10 C to 40 C RH 30 to 75 50kPa to 106kPa Transport and Storage Temperature 40 F to 158 F 40 C to 70 C RH 10 to 90 50kPa to 106kPa Select User s Manual 35 Specifications Program Options 1 Alternate Ramped Burst ARB Quick Select Knee Program 2 Simple Modulated Pulse SMP Quick Select Shoulder Program 3 Modulated Amplitude MA Quick Select Low Back Hip Program 4 Simple Modulated Pulse SMP Quick Select Hand Wrist Program 5 Modulated Amplitude MA Quick Select Back Program 6 Continuous C 7 Burst 8 Simple Modulated Pulse SMP 9 Modulation 36 Default Parameters Rate 100 pps Ramp Up Time 0 55 On Time 5s Off Time 6s Channel 2 follows Channel 1 Channel 2 Ramp Up starts at the end of Channel 1 Ramp Down Ramp Up starts from O Rate 125 pps Cycle Time 12s Span Percentage 4096 Rate stays in the 2 10 pps range for 1 3 of the cycle time 4 seconds as the rate modulates down to 2 pulses per second pps and then back up again Rate 125 pps Cycle Time 1s Span Pe
28. contact your Authorized Empi Distributor or contact Empi directly at 1 800 328 2536 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 freight and insurance billed to the Purchaser as soon as reasonably possible following receipt of the Product by Empi If Empi determines in its sole reasonable discretion that the Product does not contain 48 Select User s Manual Warranty 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 IIA THE PRODUCT IS BEING SOLD ON AN AS IS BASIS ALL ACCESSORIES ARE SOLD AS IS AND THE ENTIRE RISK AS TO THE QUALITY AND PERFORMANCE OF THE PRODUCT IS WITH PURCHASER THE WARRANTY PROVIDED IN PARAGRAPH IIA IS INTENDED SOLELY FOR THE BENEFIT OF THE INITIAL PURCHASER AND EMPI DISCLAIMS ALL OTHER WARRANTIES EXPRESS OR IMPLIED INCLUDING BUT NOT LIMITED TO ANY IMPLIE
29. cts 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 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 3096 and 7596 Transportation and storage conditions This unit should be transported and stored in temperatures between 40 F and 158 F 40 C and 70 C atmospheric pressures between 50 and 106 kPa and relative humidity between 10 90 Batteries Remove the Select 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 a coin or 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 12 Select User s Manual Prescribing Information Heat and
30. d disconnect the electrode lead wires before inserting fresh batteries 1 Pull the belt clip and battery compartment off the unit to access the batteries 2 Remove the discharged batteries Dispose of the batteries in accordance with national state or local regulations 3 Place the new battery into the space provided Be sure the terminals are correctly aligned The of the battery should be lined with the terminal of the device and the of the battery should be lined with the terminal Do not force the battery If force is required you may be putting the battery in backwards Check the and markers 32 Select User s Manual Operation AN CAUTION Inserting the batteries incorrectly may cause the batteries to rupture or generate intense heat if allowed to remain in the incorrect position This may cause irreversible damage to the batteries If there are signs of this type of damage discard or recycle the batteries and order replacements Charging the Batteries If you purchased the optional rechargeable battery system you will typically charge one set of batteries while using the other If the low battery icon flashes recharge the batteries as soon as possible A CAUTION Do not attempt to charge alkaline batteries or any battery other than an Empi rechargeable battery 1 Place the batteries in the charger The batteries should slide in easily If force is required you may be putting
31. de MA In the Modulation Amplitude program for 0 5 seconds the intensity is at 10096 of the set level and for the next 0 5 seconds the intensity is at the set span percentage 6096 of the preset level The cycle is then repeated There is no off time Continuous C This setting produces a continuous stimulation at the set intensity Channel 1 pulses alternate with Channel 2 pulses 28 Select User s Manual Operation Burst Cycle Time Ds IL CyclsTime 3y2y jj 0 58 1 CyeleTimeet l2 The Burst program gradually increases the intensity from O to the set level over 0 4 seconds maintains it at the set level for 1 0 seconds and then gradually decreases the intensity over 0 5 seconds The device then sends no stimulation for 3 0 seconds Channel 1 pulses alternate with pulses of Channel 2 Modulation Rate is selected pseudo randomly from 8 rates 2 10 20 40 60 80 100 or 150 pps Span percentage for pulse duration is selected pseudo randomly from 7 values between 5096 of set pulse duration and the set pulse duration Each combination is on for the selected cycle time Select User s Manual 29 Operation Beginning Treatment After inserting the batteries connecting the electrodes connecting the lead wires preparing the skin and applying the electrodes you are ready to begin your therapy session For button identification information refer to Device Physical Features in the System Components section
32. ent Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment 41 Specifications Guidance and manufacturer s declaration electromagnetic immunity The Empi Select is intended for use in the electromagnetic environment specified below The customer or the user of the Empi Select should assure that it is used in such an environment IEC 60601 Electromagnetic environment I ity test li level mmunity tes testlevel Compliance leve edane Portable and mobile RF communications equipment should be used no closer to any part of the Empi Select including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Conducted RF 3 Vrms 3V d 3 5 VP VI IEC 61000 4 6 150 kHz to 80 MHz Radiated RF 3 V m 3 V m d 3 5 VP 80 MHz to 800 MHz E IEC 61000 4 3 80 MHz to 2 5 GHz d 7 NP 800 MHz to 2 5 GHz E 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 Interference may occur in the vicinity of equipment marked with the
33. essories that are specially designed for this device Do not use accessories manufactured by other companies on this device Empi is not responsible for any consequence resulting from using products manufactured by other companies The use of other accessories or cables may result in increased emissions or decreased immunity of this device Defibrillation signals Remove the TENS electrodes before defibrillation signals are applied Defibrillation of a person wearing a TENS device can damage the device whether it is turned on or off Under some circumstances there can be risk of burns under the electrode sites during the defibrillation Safety The safety and efficacy of the Select system depends on the proper use and handling of the device and accessories If used improperly the Select system has a potentially hazardous electrical output It must be used only as prescribed Electrode or lead wire burns may result from misuse Electrodes and lead wires should be securely fastened to prevent inadvertent disconnection The length of lead wires could result in injury Electrodes and lead wires will eventually wear out Check accessories regularly for signs of wear and replace if needed 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 10 Select User s Manual
34. following symbol 2 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 Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the Empi Select is used exceeds the applicable RF compliance level above the Empi Select should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the Empi Select gt Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m 42 Select User s Manual Specifications Recommended separation distances between portable and mobile RF communications equipment and the Empi Select The Empi Select is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the Empi Select can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communic
35. i uo Electrodes There are several types and sizes of electrodes and each type has different characteristics The Select usually includes two 2 packs of four 4 2 inch round or 2 inch square reusable self adhering electrodes as shown below Each electrode has a connector for inserting a lead wire pin and an electrical conductive adhesive pad that attaches to your skin These electrodes are flexible and conform to the skin very well They can be reused 10 to 15 times depending on skin type and electrode care Inspect your electrodes before every use Replace electrodes as needed If you need additional electrodes contact Customer Service at 800 328 2536 To use these electrodes Adhesive Te Connector pad for inserting NE aii lead wire pin 1 Attach the lead wire to the electrode 2 Remove the liner from the electrode and store in plastic bag 3 Apply the electrode to the prescribed skin area 4 Replace electrodes that do not adhere properly to the skin or that fail to deliver proper stimulation CAUTION Do not pull on the electrode wire Doing so may damage the wire and electrode 20 Select User s Manual Operation Overview A CAUTION United States Federal Law restricts this device to sale by or on the order of a physician or licensed practitioner This section includes the following instructions for performing a therapy session Perform these instructions in the order they are presented e Install
36. ing the Batteries e Connecting the Lead Wires to the Electrodes e Connecting the Lead Wires to the Device e Preparing the Skin for a Therapy Session e Applying the Electrodes to the Skin e Turn on the Device e Timer Function e Select the Treatment Settings e Intensity Lockout Feature e Quick Select Feature e Program Option Control e Begin Treatment e Record Treatment e End Treatment e Data Retrieval This section also includes the following instructions e Changing the Batteries e Charging the Batteries e Maintenance e Cleaning e Storage e Disposal Before operating the Select system read the previous sections of this manual that describe the system and its features To gain the maximum benefit from your Select system carefully follow your clinician s instructions and use the system for only the specific symptoms detailed by your clinician If you have any questions or problems or experience any new symptoms or painful areas contact your physician therapist or clinician for appropriate diagnosis and treatment They are most familiar with your specific situation and are the best source of additional guidance Select User s Manual 21 Operation Installing the Batteries The Select operates with two AA rechargeable or alkaline batteries Install the batteries before using the Select In addition install new batteries whenever the Low Battery icon flashes in the LCD display For information about
37. le Time 1 20s in 1s intervals Span 2096 9596 in 596 intervals Intensity Ch1 and Ch2 0 60 in 0 5 intervals Duration 0 400 us Cycle Time 1 20s in 1s intervals 37 Specifications To Select Parameters for Programs To Initiate Press Set button while device is on in the appropriate program option Display will show what Program is currently selected To Toggle Press the Set button again to toggle through the parameters To change Use the Channel 1 or Channel 2 Intensity buttons to change the parameters To Exit Press Mode button Automatic exit will happen after 10 seconds and display the Treatment Screen Data Retrieval Codes of sessions maximum 255 Average session length hours and tenths of hours Total hours in use Channel 1 Actual average intensity Channel 2 Actual average intensity Battery Information Supply Voltage Range 2 26V d c minimum to 3 3V d c maximum Low Voltage Indicator Threshold 2 26V d c Waveforms shown are typical Voltage V Figure A Standard measurement output voltage across purely resistive loads at maximum High Output Intensity setting Pulse duration and Vpp measured as shown across a 1 KQ load 38 Select User s Manual Specifications Voltage V Figure B Output voltage across AAMI loads at 5096 of maximum High Output Intensity setting Output is nominally constant voltage for intensity settings of 20 80us or greater Current mA Figure C Ou
38. lectrode Stimulation on one channel side only Intermittent output Rechargeable batteries don t last or life is short Electrode icon error This is a safety feature See pages 23 25 for operation Select User s Manual Troubleshooting Possible Cause Improper electrode placement Unknown Improper electrode placement Electrode life exceeded Electrodes 1 Worn or damaged 2 Improper placement 3 Electrode life exceeded Lead wires 1 Worn or damaged Component failure Lead wires Program option in use Electrode life exceeded Brand new or stored batteries Used NiMH batteries have reached end of life Lead wires Electrodes Solution Reposition electrodes Electrodes must be a minimum of 2 inches apart Contact clinician 1 Reposition electrodes Electrodes must be a minimum of 2 inches apart 2 Replace electrodes Replace Reposition electrode Electrodes must be a minimum of 2 inches apart N 1 Replace 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 output on one channel only a component may have failed Call the repair department 1 Verify connection is secure 2 Turn down the intensity Rotate lead wires in socket 90 If still intermittent replace lead wire 3 If still intermittent after replacing lead wire a component may have fai
39. led Call the repair department Some programs will seem intermittent This is expected Refer to the Program Option Controls in the Operation section for a description of the program option Replace electrodes 1 This is normal operation Please charge and use in device You must do this 3 5 times before full capacity is reached 2 Try step 1 If this does not work replace batteries 1 Make sure the lead wires are completely pushed into the lead wire socket 2 Check lead wire and electrodes to make sure that they are still good 45 Troubleshooting To self test for any of the mentioned problems perform the following steps 1 Place new batteries in the device 2 Verify the device is off 3 Insert the lead wire into Channel 1 of the unit CORRECT NOT CORRECT 4 Insert one new lead wire into two new electrodes 5 Place the new electrodes on your forearm as shown in the figure below 6 Turn your device on 7 Select Continuous Mode This is a continuous treatment program The lights on the device should be steady 8 Slowly increase the intensity until you can feel it If you do not feel any sensation lower the intensity to zero and rotate the lead wire 90 degrees Slowly increase the intensity No sensation Call the repair department Sensation is felt even if weak Device is working properly You may need to reposition the electrodes or contact your clinician 9 Repeat steps 1 thro
40. ment at 1 800 862 2343 Problem Display does not come on Stimulation weak with fresh batteries Stimulation stops with fresh batteries Stimulation weakens within minutes of starting treatment with fresh batteries Stimulation is uncomfortable 44 Possible Cause Battery Battery contact failure Electrodes 1 Dried out or contaminated 2 Placement Lead wires 1 Old worn damaged Poor electrode contact Damaged or worn electrodes or lead wires This is a normal body adaptive process Intensity is too high Electrodes are too close together Damaged or worn electrodes or lead wires Electrode active area size is too small Solution 1 Try fresh batteries 2 Ensure batteries are inserted correctly Check the following on the battery contacts e All contacts are in place e All contacts are not broken e All contacts are not pushed in They should make contact with the battery when it is inserted 1 Replace 2 Electrodes must be a minimum of 2 inches apart 1 Replace Reapply electrodes secure firmly Electrodes must be a minimum of 2 inches apart Replace Increase the intensity Decrease intensity Reposition the electrodes Electrodes must be a minimum of 2 inches apart Replace Replace electrodes with ones that have an active area no less than 1 227 in 7 917 em Select User s Manual Problem Stimulation is ineffective Stimulation only felt on one e
41. mized by a clinician Program Option Control pmr raya 3 Session Parameter Control Device Front View Intensity AN 3 Intensity Controls eme Controls Channel 1 uem Channel 2 NV ON OFF A Button Quick Select Quick Geer yg Buttons Buttons M f Device Side View Channel Output Jacks Device Back View Belt Clip and Battery Compartment Cover 16 Select User s Manual System Components LCD Screen This is the area that displays the therapy settings as you program and use the stimulator Channel 1 Data Channel 2 Rate Si 1 D Span GA Custom Jo version Sonn om LI pps sec SR Burs 09 SMP k H 006009 e Channel icons denotes the channel being used Channel 1 and or Channel 2 e Intensity displayed under the Channel icons and ranges from 0 0 to 60 0 in 0 5 increments e Software version displays for a few seconds when the Select is turned on e Data denotes that the unit is in Data Retrieval Mode or in Quick Select Button Reset Mode e Rate when adjusting the pulses per second Rate will be displayed next to the value along with ops e Cycle when adjusting the cycle time Cycle will be displayed next to the cycle time value along with sec e Span when adjusting the span percentage Span will be displayed next to the span percentage value along with 96 e Custom text for each of the Quick Select Program
42. n the electromagnetic environment specified below The customer or the user of the Empi Select should assure that it is used in such an environment IEC 60601 Electrostatic discharge ESD IEC 61000 4 2 Electrical fast transient burst IEC 61000 4 4 Surge IEC 61000 4 5 Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 Power frequency 50 60Hz magnetic field IEC 61000 4 8 6kV contact 8kV air 2kV for power supply lines 1kV for input output lines 1kV differential mode 2kV common mode lt 5 Ur gt 95 dip in Ur for 0 5 cycle 40 Ur 60 dip in Ur for 5 cycles 70 Ur 30 dip in Ur for 25 cycles lt 5 Ur gt 95 dip in Ur for 5 sec 6kV contact 8kV air Not Applicable Battery Operated Device Not Applicable Battery Operated Device Not Applicable Battery Operated Device NOTE Ur is the a c mains voltage prior to application of the test level Select User s Manual 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 Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environm
43. nt 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 this does not resolve the problem or if the problem persists Select User s Manual 9 Prescribing Information 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 electrode and your skin If a visible skin reaction does occur 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 phones etc Accessories Use only acc
44. of incidental or consequential damages so the above limitation may not apply to the Purchaser Select User s Manual 49 Empi 599 Cardigan Road St Paul Minnesota 55126 4099 USA 1 651 415 9000 1 800 328 2536 www empi com 360357 001 2008 Empi 02 08
45. rcentage 6096 amplitude modulation is done through pulse duration modulation 0 5s intensity is at 100 of set level and next 0 5s intensity is at 6096 set span percentage of preset level Rate 125 pps Cycle Time 12s Span Percentage 4096 Rate stays in the 2 10 pps range for 1 3 of the cycle time 4 seconds as the rate modulates down to 2 pulses per second pps and then back up again Rate 125 pps Cycle Time 1s Span Percentage 6096 amplitude modulation is done through pulse duration modulation 0 5s intensity is at 100 of set level and next 0 5s intensity is at 6096 set span percentage of preset level Rate 125 pps Adjustable 2 150 pps in 5 pps intervals continuous at set intensity Rate 15 pps Ramp Up Time 0 45 On Time 1s Ramp Down Time 0 5s 3s of no stimulation Rate 125 pps Cycle Time 12s Span Percentage 4096 Rate stays in the 2 10 pps range for 1 3 of the cycle time 4 seconds as the rate modulates down to 2 pulses per second pps and then back up again Rate is pseudo random between 2 10 20 40 60 80 100 and 150 pps Cycle Time 1s Span percentage 50 58 66 75 83 91 and 100 duration is modulated between 7 values between 5096 of set pulse duration and the set pulse duration Select User s Manual Program Options 1 Alternate Ramped Burst ARB Quick Select Knee Program 2 Simple Modulated Pulse SMP Quick Select Shoulder Program 3 Modula
46. ry and operating instructions found in this manual Know the limitations and hazards associated with the Select Pain Control system Observe any and all precautionary and operational decals placed on the unit Indications TENS devices are indicated for e Symptomatic relief and management of chronic intractable pain e Adjunctive treatment for post surgical and post trauma acute pain e For the relief of pain associated with arthritis Contraindications TENS treatments should not be used if you have any of the following Cardiac pacemakers Do not use this device if the patient has a demand type cardiac pacemaker or any implanted defibrillator Transcerebral stimulation Do not apply electrical stimulation transcerebrally through the head Carotid sinus Do not use electrical stimulation over the carotid sinus nerves throat Unknown etiology Do not use this device when pain syndromes are undiagnosed Use only after origin of pain has been diagnosed Select User s Manual CO Prescribing Information 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 Symptomati
47. s 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 mionazano local and facility rules regulations and procedures Adverse Effects Skin irritation inflammation and electrode burns beneath the electrodes are potential adverse reactions Select User s Manual 13 Quick Reference When you are very familiar with the operation of the Select system use the following steps as a quick reference to operate the device For more information refer to the Operation section in this manual Starting a Therapy Session 1 On the device press the Use the Ch1 and Ch2 buttons fig ch to set the intensity for each fig ch channel as directed by your clinician The program will begin to operate amp A On the device press the Conor button to shut the device off vj v Connect the lead wire s to the electrodes and the device NOTE Make sure the device is turned off before connecting the lead wires to the device CORRECT Wash and dry the skin areas where you will be applying the electrodes Use skin prep if necessary Apply the electrodes to your skin NOT CORRECT en of button to display the Program screen The software version will flash then the entire LCD display will be displayed for 1 2 second The last program
48. ted Amplitude MA Quick Select Low Back Hip Program 4 Simple Modulated Pulse SMP Quick Select Hand Wrist Program 5 Modulated Amplitude MA Quick Select Back Program 6 Continuous C 7 Burst 8 Simple Modulated Pulse SMP 9 Modulation Select User s Manual Specifications Adjustable Parameters Intensity Ch1 and Ch2 0 60 in 0 5 intervals Duration 0 400 us Rate 2 150 pps in 5 pps intervals Cycle Time 2 20s in 1s intervals Intensity 0 60 in 0 5 intervals Duration 0 400 us Rate 20 150 pps in 5 pps intervals Cycle Time 1 20s in 1s intervals Span 2096 9596 in 596 intervals Intensity 0 60 in 0 5 intervals Duration 0 400 us Rate 2 150 pps in 5 pps intervals Cycle Time 1 20s in 1s intervals Span 2096 9596 in 596 intervals Intensity 0 60 in 0 5 intervals Duration 0 400 us Rate 20 150 pps in 5 pps intervals Cycle Time 1 20s in 1s intervals Span 2096 9596 in 596 intervals Intensity 0 60 in 0 5 intervals Duration 0 400 us Rate 2 150 pps in 5 pps intervals Cycle Time 1 20s in 1s intervals Span 2096 9596 in 596 intervals Intensity Ch1 and Ch2 0 60 in 0 5 intervals Duration 0 400 us Rate 2 150 pps in 5 pps intervals Intensity Ch1 and Ch2 0 60 in 0 5 intervals Duration 0 400 us Rate 2 150 pps in 5 pps intervals Cycle Time 5 20s in 1s intervals Intensity 0 60 in 0 5 intervals Duration 0 400 us Rate 20 150 pps in 5 pps intervals Cyc
49. the intensity will drop to 6 0 If good contact has been reestablished within 30 seconds the intensity will ramp back up to the original setting If there has been more than 30 seconds of bad contact the intensity will drop to zero Intensity can be increased once good contact has been established e Do not place electrodes on cut broken or irritated skin If skin irritation develops immediately discontinue device use remove the electrodes and contact your clinician e For long term stimulation change electrode sites whenever possible Contact your clinician for new placement sites e Replace self adhesive electrodes that do not adhere well or fail to deliver proper stimulation e Do not refrigerate electrodes Keep them from heat sources Refer to the electrode packaging for information about electrode use and care Select User s Manual 25 Operation Turning On the Device Turn on the Select by pressing the On Off button Turning the unit on will default to the last treatment used The intensity of both channels will be 0 0 when the unit is turned on Choosing the Treatment Settings Your clinician has recommended one of the program options explained in the Quick Select Feature or Program Option Controls sections in the Operation section of this manual Set the device to the recommended setting if different from the one shown on the display NOTE Follow your clinician s instructions about changing the recommended set
50. the manufacturer The safety of other products has not been established and their use could result in injury to the patient Use only the electrode placements and stimulation settings prescribed by your practitioner NOTE An electrode active area of no less than 1 227 in 7 917 cm is recommended for the Select system NOTE The Select system requires the use of Empi lead wires with the custom safety connection as pictured gm Select User s Manual 11 Prescribing Information Electronic equipment Electronic monitoring equipment such as ECG and ECG alarms may not operate properly when electrical stimulation is in use Microwave or radio frequency sources Operation in close proximity such as 3 feet 1 meter to shortwave or microwave therapy equipment may produce instability in the device output and may shut the device off Machinery operation Patient should never operate potentially dangerous machinery such as power saws automobiles etc during electrical stimulation Flammable Do not use the device in an environment where flammable or explosive fumes may exist External use This device is for external use only Electromagnetic energy Do not operate this unit in an environment where other devices are being used that intentionally radiate electromagnetic energy in an unshielded manner Portable and mobile RF communications equipment can affect medical electrical equipment Sharp objects Do not use sharp obje
51. tings to achieve optimum comfort level Intensity Lockout Feature To unlock the unit simply press the intensity decrease button for the channel you wish to change and the unit will unlock This allows the intensity to be adjusted either up or down The program can also be changed when the intensity is above zero As soon as the program is selected the unit will automatically decrease the intensity of the current program to zero on both channels and change to the new program selected Intensity can then be increased on that program Quick Select Feature The Select has five buttons that allow you to quickly choose the most commonly used programs for a particular body part Choices include Low Back Hip Knee Hand Wrist Shoulder and Back By pressing one of the Quick Select buttons the unit is automatically set up for a particular program option Intensity is still adjusted by pressing the intensity control buttons and will start at zero NOTE Holding a Quick Select body part button for five b seconds after adjusting the parameters will save the parameters and the Custom text icon appears The Custom text icon will flash if any parameters are adjusted and saved NOTE See the Intensity Lockout Feature section above to change the program parameters Knee 7 Shoulde Zo Low Back Program i Ih Program H HipProgram J Option 1 X Option 2 M Option 3 knee shoulder low back hip Hand Wrist Ze Back
52. tput current into AAMI loads at 5096 of maximum High Output Intensity setting Negative phase undershoot is nominally constant current gt Oo i o gt Figure D Output voltage across a 1MQ resistive load at 50 of maximum High Output Intensity setting Select User s Manual 39 Specifications Guidance and manufacturer s declaration electromagnetic emissions The Empi Select is intended for use in the electromagnetic environment specified below The customer or the user of the Empi Select should assure that it is used in such an environment Emission tests RF emissions CISPR 11 Compliance Electromagnetic environment guidance The Empi Select uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Harmonic emissions IEC 61000 3 2 Voltage fluctuations flicker emissions IEC 61000 3 3 40 Not Applicable Battery Operated Device Not Applicable Battery Operated Device The Empi Select 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 Select User s Manual Specifications Guidance and manufacturer s declaration electromagnetic immunity The Empi Select is intended for use i
53. trode gel and adhesives used with the Select While Empi takes great care and tests all electrode materials to avoid problems irritation may appear as redness small pimple like lesions or blisters If your skin develops any persistent redness or irritation do not continue to apply the electrodes to the same area Discuss this with your clinician or call an Empi representative Applying the Electrodes to the Skin To apply the electrodes to the skin 1 Make sure the device is off 2 Remove the protective backing from the electrode and save the backing for reuse 3 Place the adhesive gel surface of the electrode on the skin placement site prescribed by your clinician 4 Press the entire surface of the electrode into place making sure it is secure 5 Repeat steps 2 through 4 for all electrodes NOTES e Inspect the electrodes before each use e Place the electrodes on the skin as recommended by your clinician Position the electrodes with a minimum of two 2 inches apart between them Do not let them touch each other Do not reposition the electrodes while the device is turned on The electrodes should be comfortable to wear and should be placed exactly where you have been shown The most common problems with TENS therapy are caused by failure to wear the electrodes as directed e he pad contact icon will display and flash if there is bad contact between the electrode and the skin e After three 3 seconds of bad contact
54. ugh 8 for Channel 2 46 Select User s Manual Replacement Parts The following replacement parts can be ordered from Empi at 1 800 328 2536 Part Part Number Select Kit 199584 001 Select Device 199580 001 Carrying Case 199551 001 Premium Electrodes 2 Round 198622 001 Lead Wire Safety Socket TENS Black 193068 100 40 in 100 cm in cable length unshielded Lead Wire Safety Socket TENS Black 193057 150 60 in 150 cm in cable length unshielded Battery Charger AA NiMH Battery Rechargeable AA NiMH 4 pack User Manual 360357 There are several types and sizes of electrodes that can be used with the Select Select User s Manual 47 Warranty I Warning While in the opinion of Empi Empi the use of the Select Transcutaneous Electrical Nerve Stimulator TENS the Product has met with some success in the treatment of pain Empi makes no warranties to the purchaser as to the effectiveness of the product Il Warranty Empi warrants all of their manufactured product to be free from defects in workmanship and materials for life Battery charger rechargeable batteries carrying cases lead wires electrodes and other accessories are warranted to be free from defects in workmanship and materials at the time of delivery Empi will repair or replace at its facility any product found to be defective This warranty does not apply to any product damaged by misuse or repaired or altered by anyone other
55. used will display Changing a Therapy Session Follow steps 1 through 4 in Starting a Therapy Session above Select offers nine 9 program options Selecting a specific program option On the device press the is done by pressing the madal button or one of the five Quick Select Program buttons d e Th T a A knot souder iow back nip n t nne Use the Ch1 and Ch 2 buttons fig ch to set the intensity for each EEN channel as directed by your clinician a G v uu an of button to shut the device off Select User s Manual Quick Reference Ending a Therapy Session On the device press the an of button to shut the device off Unclip the belt clip from your clothing Disconnect the lead wire s from the device Disconnect the lead wire s from the electrodes Remove the electrodes from your skin Follow the instructions on the electrode package for storing electrodes If necessary use adhesive remover to remove any remaining adhesive or gel from your skin Use skin cream or lotion to moisturize your skin after removing the electrodes Remove the batteries from the device prior to storing 8 Store the components in the carrying case 0O A O N N O Select User s Manual 15 System Components DIA The Select system is a battery operated electrical stimulator The device has five Quick Select programs and four program options that can be custo
56. y cover so they slide into slots in body of device Cover should be flush with back of device Slide up until cover clicks Return belt clip to original position if using Fig 4 22 Select User s Manual Operation Figure 2 Figure 3 Figure 4 Connecting the Lead Wires to the Electrodes To connect the lead wire s to the electrodes 1 Decide if you are using one lead wire two electrodes or two lead wires four electrodes Follow clinician s instructions 2 Locate the pins at the ends of the lead wire s If necessary refer to the image in the System Components section 3 Locate the pin insertion points on two or four electrodes as necessary NOTE Refer to the electrode package for complete instructions 4 With the electrodes still attached to the protective backing insert one lead wire pin into each electrode s insertion point Insert the pins entirely so that no metal shows NOTE Connect only one lead wire to each electrode 5 Connect the lead wires to the electrodes before applying the electrodes to the skin This will reduce the possibility of dislodging the electrodes Select User s Manual 23 Operation Connecting the Lead Wires to the Device A CAUTION The device must be off before connecting the lead wires to the device 1 Locate the plug s at the end of the lead wire s If necessary refer to the illustration in the System Components section page 20 2 Locate the output jacks
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