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Empi Phoenix User manual

1. 4 4 16 7 Operating Instructions e 17 7 1 Description of the Device 1 epasta steag se 17 7 2 Kit Composition and Accessories Description o a aoa a a ee 18 TPORTAL he he eG Oe ee e 19 7 3 1 Insertion replacement of the batteries 2 ee 19 7 3 2 Connection of the lead wires to the device 0004 19 7 3 3 Placement and care of the electrodes a ee 0 20 7 3 4 Connection of the lead wires to the electrodes aoa a a a a a a 20 7 3 5 Use of the Empi Phoenix Thigh Garment optional a a a a a aa 20 7 4 Operation of the Device e 21 4 5 LOD Display ae e as oh he PREG BAR RRS DS ee d RE 21 PAZ OPSratlo INIONMANON sei a ae a N sas AE s 21 7 4 3 Operating InstructionS s eaa s r esmi 4 0 0 e 4 WE 21 rad Fause FUNCION AREA PA Lec enor eae 4 hs Be eek ee eee eR EAE KHS DI 22 7 4 6 Use of the Hand Switch optional a a a a a a a a a Ze 2 Phoenix User s Manual TS Meaning Of INGICAIONS es rado ARA A 23 72 1 IMBASIV LOCK oa oe we eee ee dara a 23 7 5 2 Sequence Indicator o 29 15 0 WOK Rest INdiCaAtOr eosa e a ae e ee eS a ra 23 1D 4 Timer ICAO ema sr bee eee eee eee ee A 23 TO LOW Battery INACSIOP ER OPEREER ERA EEE HER Ae Gs 23 ROD OpPpenORCUITICON ss ERA che eke ES AAA 23 8 Troubleshooting a 24 9 Device Maintenance a 26 COITO EE
2. 5 You should position the electrodes so they surround the area of pain 6 To use on a portion of the body other than the knee consult a clinician EDEMA Program P4 Pulsed Direct 1 To use the Edema program you will need the bifurcated lead and il dispersive electrode If you did not receive these items contact Empi Customer Service 2 Plug the bifurcated lead into the red leadwire on Channel 1 0 9 Y 3 Place the electrodes on the bifurcated lead on the inside and j outside of the affected joint l 4 Attach the large dispersive electrode to the black lead on Channel l 1 and place over the upper thigh 5 To use on a portion of the body other than the knee consult a Clinician 38 Phoenix User s Manual 16 Quick Start Guide Read full instructions before using the device 1 Insert batteries into the device and replace the battery cover Place electrodes or garment following healthcare provider s instructions Insert the wire from the garment if using the garment or electrode leadwire if not using the garment by pressing the attachment into the port on the device Turn the device on by pressing the O button Select the therapy P1 Endurance P2 Strength P3 TENS or P4 Edema prescribed by your clinician by pressing the P or P button Adjust intensity to desired level by pressing the A and V buttons for channels 1 and 2 You must select your program before turning up the intensity
3. Empi PHOENIX COMPLETE ELECTROTHERAPY SYSTEM USER S MANUAL e Read this manual carefully before operating the Phoenix e Visit us at www djoglobal com EmDI Table of Contents l Foreword s so errar DEERE ea ER ee EE DU 4 2 Intended Use huaa aaa a SS SE SE SS se 5 2 1 Indications for USS s se Me RE HE we ee eA ee BOE we a HR MR N 5 Poe Lee ENVrOnMENT saa d sop oa a DARA A aa N a 5 3 Explanation of Symbols a 6 4 Safety Information a 7 AT GonaindiEsUGS aa s ed oe bm Goa oe a ee ara RE EE Ee Boe ee AE a 7 EL e eth eee Ga Se ee ee EA EDE eee oe Beets eae T 4 POCU s va a ee a Eea 8 SA DNG a a saw SR twee HEK MA a ER aage oe eR ee 10 ZO Adverse Reactions 4 s ea dira RA OSES la e 10 5 How Does Electrotherapy Work aaa a a 11 6 Usage Guidelines e E 61 FO basaar Bio AE Vi ERA ERA IRA 12 01 1 ERANANEE S P amp se Ee aa GE Be AR EE eR ARH a HER A GN 12 ops ie P sa as oe he EE ae Be EE HE SA N eS 13 6 13 Modulated TENSSPA cs sestara nin Re AE RE REE ES 14 6 1 4 Edema P4 ao oras KOR de HD a 14 6 2 Choice of the Appropriate Program SES SS SS 14 6 3 Planning of Stimulation Sessions oa oaoa a a e a e a SS SS SS 15 6 4 Electrode POSITIONS s ss ius a oa bag de dea as 16 6 4 1 Use of the Empi Phoenix Thigh Garment 15 6 5 olIMUlaton POSIMONS s s s y mea a aa A N 16 6 6 Adjusting Stimulation Energies
4. e Symptomatic relief and management of chronic intractable pain e Adjunctive treatment for post surgical and post trauma acute pain e 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 soasm Influencing local blood circulation under negative electrode Retardation or prevention of disuse atrophy Facilitation of voluntary motor function e Maintenance of increase of range of motion 2 2 Use Environment The Empi Phoenix device is a prescription device in the USA and is intended to be used following the directions of a healthcare provider The device should be used indoors and may be used in a healthcare facility setting or by a patient or lay operator in a home environment Phoenix User s Manual 5 3 Explanation of Symbols The following symbols are used either in this user manual on the device packaging or on the device label They may also appear on an accessory Symbol Explanation Reference number part number LOT Lot number O Follow instruction for use Type BF applied parts T Keep the device dry AN Keep the device away from sunlight IP22 Protected against solid foreign objects of 12 5 mm 0 5 in diameter and greater Protected against vertically falling water drops when enclosure tilted up to 15 70C Yi Minimum and maximum temperature indications to respect R Only Prescri
5. E E assess 26 9 2 Cleaning and Calibration e es ss a s a nr s BEE BEE EE SE ga 26 SiS oe LERE ERA DRR a EEEE E E ei ase er 9 4 Operating CONCIIONS s ss aus darias ss al 9 5 Transportation and Storage Conditions 0 ee 27 9 6 Expected Life and Disposal a oa ao a a a a 27 10 Ordering Information a 28 11 Clinician Only Section a 28 11 1 Compliance MONIOMAG e se ai eee a sa eoi as ai a 28 122P aM boek a e e a ee A A N OE 29 11 3 Ordering Information for Clinicians s s s ss ararsa t reias ia 29 12 Limited Warranty a 29 13 Technical Specifications aaa a a a 32 14 Guidance and Manufacturer s Declaration Electromagnetic Emissions 34 15 Additional Information on Electrode Placement for Knee Treatment 38 16 Quick Start Guide e 39 Phoenix User s Manual 3 1 Foreword The Empi Phoenix is a multifunctional electrotherapy device that provides two channels of neuromuscular electrical stimulation NMES transcutaneous electrical stimulation TENS or pulsed DC Edema treatment This wide ranging capability allows the patient to receive electrotherapy throughout the recovery cycle using a single device Its simplified programming makes the device convenient for home use after placing the electrodes and selecting the program as prescribed by a healthcare professional the patient only needs to incr
6. Once the intensity is increased the program will be locked NOTE P1 and P2 begin with a two minute Warm Up phase which will count down on the screen The Warm Up phase will cause your muscles to twitch but not contract Set the device intensity to a comfortable level during Warm Up Pia A k Once the Work Phase begins you can adjust the intensity further P1 and P2 finish with a Cool Down phase Refer to the Section 6 1 of this manual for a full explanation of these programs Phoenix User s Manual 39 199696 Phoenix Kit SEmpi Empl Inc 205 Hwy 22 East Clear Lake SD 57226 USA 651 415 9000 800 328 2536 360413 Rev A 2013 Empi Inc 04 13
7. Your clinician may request different electrodes 18 Phoenix User s Manual 7 3 Preparation 7 3 1 Insertion replacement of the batteries 1 Remove the belt clip by disengaging one of the arms on the side of the device 4 Close the battery door by sliding it upward until it clicks into place as shown Make sure the battery door is fully engaged before switching on the device 2 Remove the battery door by sliding it downward along the device 5 You may or may not use the belt clip as you prefer 6 Dispose of the old batteries in accordance with local and national regulations 3 Place the batteries as indicated on the bottom of the battery compartment Note the polarity and the battery type Use only IEC LRO6 AA 1 5 V Alkaline or rechargeable AA NiMH 1 2 V batteries Remove the batteries from the Empi Phoenix device if it is not used for a prolonged period of time e g more than 3 months 7 3 2 Connection of the lead wires to the device Always inspect the lead wires connection before using them If any connection is damaged do not use the lead wire and replace it 1 Connect Channel 1 and Channel 2 lead wires into their respective socket as shown 3 You may not need to insert Channel 2 lead wire depending on the program and electrode configuration you are using Consult your clinician for instruction on how to use the appropriate program and proper placement of the electrode s
8. are clean If the device is ON but does not respond to pressing the key pad buttons Device not A Detach all patient lead wires from the device answering B Remove batteries from the device C Wait 10 seconds D Re insert batteries and resume treatment Low batteries If the Low Battery Indicator is visible replace both batteries If the device is on the intensity bar graphs and controls are on Bad l l and you feel no stimulation check and verify the connection of lead connection wires and electrodes The stimulator is not working Lead wire or electrode defective If the device appears to be functioning and there is no stimulation replace the lead wires and or electrodes A Try fresh batteries B Ensure batteries are inserted correctly See instructions for proper placement Display does not come on A Check contacts are in place Battery B Check contacts are not broken contact failure C Check contacts are not pushed in They should make contact when battery is inserted Electrodes dried out Replace electrodes Weak stimulation with fresh batteries Electrode placement Poor electrode Reapply electrodes secure firmly Electrodes must be a minimum contact of 2 apart Stimulation stops with fresh Damaged batteries or worn Replace electrodes or lead wires Make the electrodes at least 2 apart Stimulation weakens This is a within minutes normal body of starting adapt
9. component Maximum charge per pulse 2 x 8 UC L leCroy 50 ps me 50 mA P4 Edema Program Maximum Intensity 100 mA DC component 266 yA independent of the set intensity as long as the set intensity is above 4 MA Maximum charge per pulse 7 2 UC for the positive pulse and 6 uC for the negative pulse 7 LeCroy 5 ms ma 50 mA ie Phoenix User s Manual Low Voltage Indication e Indicator Threshold 2 3 Volts typical e Shutdown Voltage 1 95 Volts typical e These voltages may be tested under NO load condition Fuse Characteristics 6V 1 5 A Resettable breaking capacity SA Physical Characteristics e Size without belt clip 5 4 x 2 6 x 1 2 e Weight with batteries and belt clip 6 ounces e Operational Temperature 10 C to 40 C e Humidity maximum 75 RH EN 60601 1 Classification e Type BF Applied Part e Internally powered only e Protection against ingress of particles and liquids IP22 e Continuous operation e Not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide Phoenix User s Manual 33 14 Guidance and Manufacturers Declaration Electromagnetic Emissions The Empi Phoenix device needs special EMC precautions and must be installed and started according to the EMC information supplied in this manu
10. is equipped with a Liquid Crystal Display LCD to make the User Interface easy to use and understand and to provide clear information about the on going treatment The following picture depicts the complete LCD with all its symbols Intensity Display Intensity Bar Graph and Open Circuit Icon are on the left for Channel 1 and on the right for Channel 2 Sequence Indicator Low Battery Symbol Open Circuit Icon N 7 Work Rest Symbol Intensity Bar Graph Program Locked Program Seguence Timer BBB e B88 T N Display Locked Symbol 7 4 2 Operation information e You can interrupt therapy at any time with the ON OFF switch If the stimulator is not used it switches off automatically after approximately 5 minutes e When the therapy timer is activated the device switches off automatically at the end of the programmed interval The remaining therapy time is always indicated on the display e The program can only be changed when the intensity in both channels is O 7 4 3 Operating instructions 1 Turn on the device by pressing the ON OFF button The software version will be displayed briefly mm am m nm T LIE 2 The LCD will then automatically switch to the Program Selection 2 gt OA TR Screen CE ELLU JD 3 Use the Program Selection Increase P and Decrease P buttons to select the program prescribed by your healthcare provider Change of program is possible only when bo
11. is still visible Don t scratch the redness area Heart disease Patients with suspected or diagnosed heart disease should follow precautions recommended by their physicians Epilepsy Patients with suspected or diagnosed epilepsy should follow precautions recommended by their physicians Internal bleeding Use caution when the patient has a tendency to bleed internally such as following an injury or fracture After surgery Use caution following recent surgical procedures when stimulation may disrupt the patient s healing process Over uterus Use caution if stimulation is applied over the menstruating or pregnant uterus 8 Phoenix User s Manual Lack of sensation Use caution if stimulation is applied over areas of skin that lack normal sensation Don t apply stimulation on patient unable to express themselves Hot casing or batteries Under extreme use conditions some parts of the casing might reach up to 109 F 43 C Use caution when manipulating the batteries right after device use or when holding the device There is no particular health risk associated with this temperature besides your comfort Children Keep this device out of the reach of children Electrode size Do not use electrodes with an active area less than 16 cm as there will be a risk of suffering a burn injury Caution should always be exercised with current densities more than 2mA crr Strangulation Do not wrap leadwires around your neck and keep t
12. mains supply which powers residential buildings Not applicable Harmonic emissions battery IEC 61000 3 2 powered Not applicable battery powered Voltage fluctuations emission oscillations IEC 61000 3 3 34 Phoenix User s Manual GUIDANCE AND MANUFACTURER S DECLARATION ELECTROMAGNETIC IMMUNITY Empi Phoenix is intended for use in the electromagnetic environment specified below The customer or user of the Empi Phoenix should assure that it is used in such an environment Immunity test Test level IEC Compliance Electromagnetic environment 60601 level recommendations Electrostatic discharge DES CEI 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 60 Hz magnetic field IEC 61000 4 8 6 kV contact 8 kV air 2 kV for power supply lines 1 kV for input output lines 1 kV differential mode 2 kV common mode lt 5 U gt 95 dip in U for 0 5 cycle 40 U 60 dip in U_ for 5 cycles 70 U 30 dip in U for 25 cycles 9 jol gt 95 dip in U for 5 sec 6 kV contact 8 kV air Not Applicable Battery powered Not Applicable signal lines less then 3 meters Not Applicable Battery powered Not Applicable Battery powered Floors should be wood concrete or ceramic
13. muscle group you want to stimulate Therefore always use the size of electrodes your clinician instructs you to use When using the garment always use the provided electrodes and electrode placements unless you have explicit instructions otherwise from your clinician Use the Empi Phoenix Thigh Garment only with P1 and P2 not with P3 or P4 6 4 1 Use of the Phoenix Thigh Garment The Empi Phoenix Thigh Garment can be used as an accessory to help you position and hold the electrodes in place for the Endurance P1 and Strength P2 programs Please refer to the Empi Phoenix Garment User Manual for proper use of the Empi Phoenix Thigh Garment with the Empi Phoenix device Phoenix User s Manual 15 6 5 Stimulation Positions Your body position during therapy will vary depending on the position of the electrodes the muscle group you wish to stimulate and the program you are using Follow your clinician s instructions for body positioning One commonly recommended position for Endurance and Strength P1 and P2 programs for knee treatments is to be seated with your foot flat on the floor and your knee at a 90 degree angle to allow for isometric contractions For P1 Endurance and P2 Strength programs you should normally stimulate isometrically this means that the extremities of the limb in which a muscle is being stimulated must be firmly fixed to prevent the movement that results from the muscle contraction Consult your clinician for use
14. of batteries in compliance with relevant national or state regulatory requirements Do not puncture Do not dispose in fire or incinerate When the electrodes no longer stick well to your skin dispose of them in a receptacle out of reach of children and pets 10 Ordering Information To order replacement electrodes leadwires or other accessories for your Empi Phoenix device contact Empi Patient Care at 800 328 2536 ext 8455 See Section 7 2 for Empi Phoenix Kit components Phoenix User s Manual 27 11 Clinician Only Section This section is only intended for clinicians and the functions described in this section should not be operated by the patient 11 1 Compliance Monitoring The Empi Phoenix device is equipped with a compliance monitoring system This allows you to monitor the usage of the device by your patient between visits To access the compliance screen simultaneously and continuously push on the Program Decrease P Left Decrease Intensity Y and Right Decrease Intensity Y buttons while you are in the Program Selection mode In the compliance screen you will see the total time spent in each of the programs by switching between the different programs for this use the P and P keys 17 aD A gt am amp eam HOURS MINUTES Note Timer indicates hours and minutes instead of minutes and seconds when you are in the Compliance screen Compliance counters reset To res
15. of the device together with movements For TENS and Edema programs P3 and P4 position yourself as comfortably as possible Precaution Never carry out an initial stimulation session on a person who is A N standing The first five minutes of stimulation must always be performed on a person who is sitting or lying down In rare instances people of a nervous disposition may experience a vasovagal reaction This reaction is connected with fear of the muscle stimulation as well as surprise at seeing one of their muscles contract without having intentionally contracted it themselves A vasovagal reaction causes heart to slow down and blood pressure to drop which can make you feel weak and faint If this does occur stop the stimulation and lie down with the legs raised until the feeling of weakness disappears 5 to 10 minutes 6 6 Adjusting Stimulation Energies When using the Endurance and Strength programs the benefits of therapy are improved as the electrical intensity increases Unless you have instructions from your clinician otherwise you should increase the intensity of the Endurance P1 and Strength P2 programs until you get a strong muscle contraction Please follow the Safety Information advice in Section 4 to avoid injury 16 Phoenix User s Manual 7 Operating Instructions You are strongly advised to carefully read the Safety Information in Section 4 at the beginning of this manual prior to using your stimulator Precauti
16. or shower Do not apply stimulation in humid atmosphere exceeding 75 of relative humidity Phoenix User s Manual 7 Sleeping Do not apply stimulation while the patient is sleeping Driving or operating machinery Do not apply stimulation while the patient is driving operating machinery or during any activity in which electrical stimulation or involuntary muscle contraction can put the patient at risk of injury Electrosurgical equipment or defibrillators Disconnect the Empi Phoenix stimulation electrodes before using electrosurgical equipment or defibrillators Otherwise skin burns may be caused below the electrodes and the Empi Phoenix device might be destroyed Magnetic Resonance Imaging Do not wear electrode or the Empi Phoenix device during Magnetic Resonance Imaging MRI scans as this may result in metal overheating and causing skin burns in the area of the electrode Flammable or explosive environment Do not use the Empi Phoenix device in areas where there is a risk of fire or explosion such as oxygen rich environments in the vicinity of flammable anaesthetics etc Power supply Never connect stimulation cables to an external power supply as there is a risk of electric shock Near other equipment Do not use the Empi Phoenix device beside or stacked on top of any other equipment If you must use it side by side or on top of another system you should check that the Empi Phoenix device works properly in the chosen configurat
17. the intensities for 10 seconds the intensities are automatically locked to avoid accidental intensity modification When the intensity lock is on the lock symbol appears next to the intensity displays To unlock the intensities press either of the Intensity Decrease V buttons You can then re adjust the intensity 7 5 2 Sequence indicator The sequence indicator is the set of three chevron symbols on the upper middle of the screen These symbols indicate when the program is in warm up first chevron treatment second chevron and cool down third chevron modes Each chevron is filled as that portion of therapy occurs For TENS P3 and Edema P4 treatments there is only one sequence 7 5 3 Work rest indicator The work rest indicator is the curved line on the upper right of the screen When the treatment is active this indicator will show whether the therapy is in work mode contraction or rest mode low frequency stimulation During the work mode the upper line of the symbol will blink During the rest mode the lower part of the symbol will blink TENS P3 and Edema P4 treatments do not have a rest mode 7 5 4 Timer indication The timer indicates the remaining time of the active sequence For the TENS program P3 the timer indicator displays as the program duration is unlimited n does not automatically shut off after a set time To end a TENS program press the ON OFF button twice 7
18. 5 5 Low battery indicator 5 rE When the battery voltage drops below a predefined limit the battery ma symbol appears It If you are in the middle of a treatment you may complete your a O treatment and change the batteries before starting a new treatment Su OIE Don t start a new treatment without changing the batteries if the low battery symbol is present Please refer to section 7 3 1 for proper battery replacement a a am am A 7 5 6 Open circuit icon The Open Circuit icon appears when the resistance between the r device and the skin is too high The symbol appears next to the Pr DE Sn channel bar graph where the open circuit has been detected RE Jaa E i The Open Circuit icon might appear due to a poor electrode f attachment or an interrupted electric circuit When the electric circuit mni Z 4 is interrupted the intensity drops to O and the program is paused In this case check whether the electrode lead wire is correctly connected to the device and whether the electrodes are properly connected Phoenix User s Manual 23 8 Troubleshooting If an error screen appears while you are using the device write down the error code displayed and contact Empi s Repair Department at 800 862 2343 co Li Solution Possible cause Problem A Make sure the batteries are properly installed Check polarity Batteries markings B Make sure the battery contacts
19. al Portable and mobile RF communications equipment could affect the Empi Phoenix device For example mobile phones can affect the Empi Phoenix device Avoid placing a mobile phone is direct proximity to the Empi Phoenix device Warning The use of accessories other than those recommended by the manufacturer may result in stronger emissions or reduce the immunity of the Empi Phoenix device Warning The Empi Phoenix device should not be used beside or stacked on top of any other equipment If you must use it side by side or on top of another system you should check that the Empi Phoenix device works properly in the chosen configuration Meeting the emissions levels shown in the first table is considered to be essential performance of the Empi Phoenix device GUIDANCE AND MANUFACTURER S DECLARATION ELECTROMAGNETIC EMISSIONS Empi Phoenix is intended for use in the electromagnetic environment specified below The customer or user of the Empi Phoenix should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guide The Empi Phoenix uses RF energy only for its o internal function Therefore its RF RF emissions ee emissions are very low and are not likely to CISPR 11 cause any interference in nearby electronic equipment Empi Phoenix is suitable for use in any RF emissions establishment other than a private dwelling or CISPR 11 a place connected directly to the low voltage
20. bsorption and reflection from structures objects and people Phoenix User s Manual 37 15 Additional information on Electrode Placement for Knee Rehabilitation In the absence of direction from a clinician on electrode placement use the following electrode placement guidelines for knee rehabilitation if using the Empi Phoenix device with direct leadwires and not with the Empi Phoenix Thigh Garment NMES Programs P1 Endurance and P2 Strength 1 Place the Channel 1 black lead over the Vastus Medialis Oblique VMO The VMO is a muscle in your quadriceps that typically sits just above and inside your kneecap 9 o 2 Place the Channel 2 black lead over the Vastus Lateralis VL The we VL is the muscle in your quadriceps that sits about two inches l further up the leg from the VMO but on the outside of the leg l 3 Place the Channel 1 red lead in the middle of your quadriceps thigh 4 Place the Channel 2 red lead in the middle of the upper part of your quadriceps thigh 5 To use on a portion of the body other than the knee quadriceps consult a clinician TENS Program P3 High Frequency TENS 1 Place the Channel 1 black lead over the upper inside portion of your knee 2 Place the Channel 2 black lead over the upper outside portion of your knee 2 o 3 Place the Channel 1 red lead over the lower outside portion of 2 h your knee o 4 Place the Channel 2 red lead in the lower inside portion of your knee
21. d with immediate atrophy after injury or and surgery P2 begins with a two minute Warm Up phase which will count down on the screen The Warm Up phase will cause your muscles to twitch but not contract Set the device intensity to a comfortable level during Warm Up Once the Work phase begins the intensity will automatically decrease by half You can then adjust the intensity to provide a comfortable but strong muscle contraction The program finishes with a Cool Down phase similar to the Warm Up phase STRENGTH P2 Symmetrical square biphasic asynchronous WARM UP SETTING Treatment time 2 min Pulse duration 300us Frequency warm up 6 Hz WORK PHASE SETTING Treatment time 15 min COOL DOWN SETTING Treatment time 3 MIN Pulse duration 300us Phoenix User s Manual 13 6 1 3 Modulated TENS P3 This treatment is a modulated TENS program for the treatment of post surgical or chronic pain Use this program with direct lead wires and electrodes included in the device box not with the garment Place the electrodes around the site of the pain TENS PARAMETER SETTING Waveform Symmetrical square biphasic asynchronous frequency modulated Treatment time Unlimited Unlimited means that the timer does not automatically stop the treatment after a set time 6 1 4 Edema P4 This treatment option is a sequenced net positive DC 2 channel program for edema reduction and increased circulation For acut
22. desired level This will automatically resume the timer When you are in the Pause mode you can also switch off the unit by pressing the ON OFF O button a second time 7 4 5 End of treatment For all treatments except P3 TENS the timer will automatically finish the treatment When the treatment is finished intensities are automatically reduced to O and the timer indicator will flash with 00 00 For the TENS P3 program the timer is unlimited meaning that it does not automatically shut off after a set time Stop the treatment after the time recommended by your healthcare provider by pressing the ON OFF 1 button e Turn off the device by pressing the ON OFF button Disconnect the electrodes and the lead wires as indicated in section 7 3 Electrodes no longer fit for use can be disposed of with the normal domestic waste 7 4 6 Use of the hand switch optional The hand switch connects to the unit on the dedicated port The hand switch can be used to manually change the cycles of contractions active rest or turn the stimulation On and OFF e Ina constant mode P3 P4 warm up and cool down of P1 and P2 pushing the button will activate the stimulation while releasing it will bring all intensities to O e In Work mode pushing and releasing the button respectively will toggle between contraction and active rest phases 22 Phoenix User s Manual 7 5 Meaning of Indicators 7 5 1 Intensity lock If you do not adjust
23. e Edema less than 48 hours post injury or post op place the positive electrodes over the treatment site and attach the negative leadwire pins to the dispersive pad For chronic Edema no immediate prior injury Surgery or more than 48 hours post injury or post op place the negative electrodes over the treatment site and attach the positive leadwire pins to the dispersive pad EDEMA PARAMETER SETTING Waveform Net positive pulsed DC Treatment time Pulse duration 6 2 Choice of the Appropriate Program The choice of a program is determined by your clinician based on the affected body part s The appropriate muscle stimulation program s e g Strength Endurance TENS or Edema and frequency of the program s are determined by your clinician Consult your Clinician or therapist if you are unsure which program to use 14 Phoenix User s Manual 6 3 Planning of Stimulation Sessions Your clinician will instruct you on a protocol intensity electrode placement number of times per day and per week to follow in order to use the Empi Phoenix device most effectively 6 4 Electrode Positions For optimal results use the electrode positions recommended by your medical professional Please also refer to the pictures and pictograms shown at the bottom of this section For best results wash and clean the skin and dry it before attaching the electrodes Each stimulation cable has two pins A positive pin red connection A nega
24. eadwire is defective and should be replaced If there is output on one channel only a component may have failed Call the Repair Department A Verify connection is secure B Turn down the intensity Rotate leadwires in socket 90 degrees If still intermittent replace leadwire If still intermittent after replacing the leadwire a component may have failed Call the Repair Department Some programs will seem intermittent This is expected Refer to section 6 1 for a description of the Programs A Check that all the settings are correct and ensure the electrodes are positioned properly B Change the positioning of the electrodes slightly 25 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 Figure A 5 Insert the lead wire in Channel 1 6 Turn your device on 7 Select program P3 TENS This is a Figure A continuous treatment program 8 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 the device is working properly You may need to reposition the electrodes or con
25. ease the intensity to begin therapy The Phoenix device s NMES Endurance and Strength programs utilize an electrical stimulus that when properly applied activates specific muscles or muscle groups to help treat disuse atrophy and re educate muscles The pre set programs are designed to provide therapeutic benefit while minimizing complexity for the patient and clinician The device can be paired with the Empi Phoenix Conductive Garment for the thigh which is designed to make treatment of the knee quadriceps with NMES easier for the patient and clinician The Phoenix device also includes a traditional TENS program for pain management and a pulsed DC Edema program to increase local blood circulation and reduce edema swelling Read this User Manual carefully before using the Phoenix device Pay particular attention to the Safety Information in Section 4 and additional warnings throughout the manual O R Caution Federal law restricts this device to sale by or on the order of a practitioner Only licensed by the law of the State in which he she practices to use or order the use of the device 4 Phoenix User s Manual 2 Intended Use As an NMES device indications are for the following conditions e Retarding or preventing disuse atrophy Maintaining or increasing range of motion Re educating muscles Relaxation of muscle spasms Increasing local blood circulation As a TENS device indications are for the following conditions
26. ee also Section 6 4 of this manual 4 To disconnect the 2 Make sure the lead lead wire pull the wire is fully engaged by lead wire connector pressing the leadwire head away from the connector head firmly connector Never into the socket pull on the lead wire i directly to remove it from the device as this may damage the lead wire Correct Incorrect Phoenix User s Manual 19 7 3 3 Placement and care of the electrodes NOTE This section applies to electrodes used with conventional leadwires If you are using the Phoenix Thigh Garment please follow the Garment and Garment Electrode instructions 1 Peel off the electrodes from the plastic film and apply them on the appropriate body area Follow your Clinician s recommendation and Section 6 4 for proper electrode placement Always ensure the electrodes are fully in contact with the skin If the adhesion of the electrodes is not good use new electrodes 2 Atthe end of the treatment first disconnect the lead wires from the electrodes Next peel off the electrodes from the skin and place them back on the plastic film Put them back into the plastic bag and reseal it 3 Electrodes will eventually wear out Check accessories regularly for signs of wear and replace as needed Stop using electrodes if their bonding power becomes poor Contact Empi to order additional electrodes To maximize service life for electrodes Clean the skin application sites with mild s
27. et the compliance counters press continuously and simultaneously for more than 3 seconds the Program Decrease P Left and right Decrease intensity Y same key combination as to access the compliance screen To exit the compliance screen switch Off the device by pressing the ON OFF switch 28 Phoenix User s Manual 11 2 Program Lock You can lock the Empi Phoenix into a specific program This will limit the use of the device in this specific program without the possibility for the patient to access any other program To lock the device 1 Select the program you want to lock the device into when you are in the Program Selection screen 2 Push continuously and simultaneously on the Program Increase P Program Decrease P and Right Decrease y buttons 3 The Program Lock symbol will appear The lock setting is kept in memory when you turn off the device To unlock the device Push continuously and simultaneously on the Program Increase P Program Decrease P and Right Decrease Y buttons until the Program Lock symbol disappears 11 3 Ordering Information for Clinicians To order the Empi Phoenix device for your patients contact either your local Empi DJO Global representative or Empi Clinic Services at 800 325 5663 Phoenix User s Manual 29 12 Limited Warranty Warning While in the opinion of Empi Inc the use of the Empi Phoenix the Product has met with some success Empi Inc makes no warranties to
28. hem out of the reach of children Strangulation may result from entanglement in the leadwires Tripping Care should be used to avoid tripping on lead wires Damaged device or accessories Never use the Empi Phoenix device or any of its accessories if it is damaged case cables etc or if the battery compartment is open as there is a risk of electric shock Carefully inspect the lead wires and connectors prior to each use Inspect electrodes Inspect electrodes before each use Replace electrodes when they begin to deteriorate or lose adhesion Poor contact between the electrodes and the patient s skin increases the risk of skin irritation or burns Electrodes will last longer if used and stored according to instructions on electrode packaging Attach the electrodes in such a way that their entire surface is in contact with the skin Foreign bodies Do not allow any foreign bodies soil water metal etc to penetrate the Empi Phoenix device and the battery compartment Garment Do not use the Empi Phoenix Thigh Garment in proximity of fire or excessive heat sources due to the risk of fire Make sure that the electrodes cover the metal connectors on the Phoenix garment before use to avoid shocking skin irritation and burns 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 Heat and co
29. ially the carotid sinus or the patient s mouth because this could cause severe muscle spasms resulting in closure of the airway difficulty in breathing or adverse effects on heart rhythm or blood pressure Stimulation across chest Do not apply stimulation across the patient s chest because the introduction of electrical current into the chest may cause rhythm disturbances to the patient s heart which could be lethal Across the head Since the effects of stimulation of the brain are unknown stimulation should not be applied across the head and electrodes should not be placed on opposite sides of the head Stimulation over compromised skin Do not apply stimulation over open wounds or rashes or over swollen red infected or inflamed areas or skin eruptions e g phlebitis thrombophlebitis varicose veins Stimulation near cancerous lesions Do not apply stimulation over or in proximity to cancerous lesions Stimulation over metallic implants Do not apply stimulation directly over implanted metallic devices because this may cause shock or burns Stimulation over eyes Do not apply stimulation directly on the eyes Environment Electronic monitoring equipment Do not apply stimulation in the presence of electronic monitoring equipment e g cardiac monitors ECG alarms which may not operate properly when the electrical stimulation device is in use Bath or shower Do not apply stimulation when the patient is in the bath
30. ion Miscellaneous Garment and electrodes for single patient Do not share electrodes or garments with other persons All users should have individual set of electrodes to prevent undesirable skin reactions or disease transmission Accessories Use this device only with the leads electrodes and accessories recommended by Empi Use of other accessories may adversely affect the performance of the device or may result in stronger electromagnetic emissions or reduce the electromagnetic immunity of the Empi Phoenix device No Modification No modification of the equipment is allowed A N 4 3 Precautions Supervision Use this device only under the continued supervision of a licensed practitioner Electrode placement and stimulation settings should be based on the guidance of the prescribing practitioner Pregnancy The safety of electrical stimulation during pregnancy has not been established Skin irritation Some patients may experience skin irritation or hypersensitivity due to the electrical stimulation or electrical conductive medium gel The irritation may be reduced by using an alternate conductive medium or alternate electrode placement Some patients may experience redness under the electrodes after a session This redness usually disappears within a few hours Advise the patient to consult the clinician if the skin redness does not disappear after a few hours Do not start another stimulation session in the same area if the redness
31. ive treatment with process fresh batteries Increase the amplitude intensity 24 Phoenix User s Manual Problem Stimulation is uncomfortable Stimulation is ineffective Stimulation only felt on one electrode Stimulation on one channel side only Intermittent Output Stimulation is not producing the usual sensation Possible cause Amplitude intensity is too high Electrodes are too close together Damaged or worn electrodes or leadwires Ensure proper program is being used Improper electrode placement Unknown Improper electrode placement Electrodes A Worn or damaged B Improper placement Leadwires worn or damaged Component failure Leadwires Intermittent program in use Settings and Electrodes positioning Phoenix User s Manual Solution Decrease amplitude intensity Reposition the electrodes Electrodes must be a minimum of 2 inches apart Replace A Refer to section 6 1 for a description of the Programs B Contact clinician if discomfort persists Reposition electrodes Electrodes must be a minimum of 2 inches apart Contact clinician A Reposition electrodes Electrodes must be a minimum of 2 inches apart B Replace electrodes A Replace B Reposition electrode Electrodes must be a minimum of 2 inches apart Replace Try each leadwire independently in each channel If there is no output on either channel the l
32. ld products The use of heat or cold producing devices e g 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 Pulled muscles Do not apply electrodes over pulled muscles Using the stimulator on a previously extended muscle might further pull such muscle The higher the stimulation intensity the higher the risk to further overextend such muscle DC Component The Empi Phoenix waveforms may contain a DC component only for Edema program P4 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 This DC component for the Edema program P4 is equivalent to 266 UA DC for all intensities above 4 mA Additional Precautions for TENS P3 e TENS is not effective for pain of central origin including headache e TENS is not a substitute for pain medications and other pain management therapies e TENS devices have no curative value e TENS is a symptomatic treatment and as such suppresses the sensation of pain that would otherwise serve as a protective mechanism e Effectiveness of TENS is highly dependent upon patient selection by a practitioner qualified in the ma
33. m of the fibers during the stimulation session The purpose is to increase the time for the muscle to maintain a medium contraction or the average power level for extended periods of time This program is recommended for use before and after the surgery as prescribed by your medical professionals P1 begins with a two minute Warm Up phase which will count down on the screen The Warm Up phase will cause your muscles to twitch but not contract Set the device intensity to a comfortable level during Warm Up Once the Work phase begins the intensity will automatically decrease by half You can then adjust the intensity to provide a comfortable but strong muscle contraction The program finishes with a Cool Down phase similar to the Warm Up phase ENDURANCE P1 Waveform Symmetrical square biphasic asynchronous WARM UP SETTING Treatment time 2 min Pulse duration 300us Frequency warm up 6 Hz WORK PHASE SETTING Treatment time 15 min 12 Phoenix User s Manual COOL DOWN SETTING Treatment time 3 min Pulse duration 300us 6 1 2 Strength P2 The Empi Phoenix Strength program imposes a high and instantaneous power working level on muscle fibers These contractions are separated by long periods of rest The result is an average medium power working level 20 minutes This program is intended to increase the maximum strength of muscle isometric contraction This program targets the muscle fibers that are typically afflicte
34. mber of pulses per second contraction time rest time total program time subject the muscles to different types of work In fact different tyoes of muscular fibers may be distinguished according to their respective contraction speed slow intermediate and fast fibers Fast fibers would predominate in a sprinter while a marathon runner would likely have more slow fibers With a good knowledge of human physiology and well designed stimulation programs muscular work can be directed very precisely towards the desired goal muscular re education relaxation of muscle spasm pain management increased blood flow maintaining or increasing range of motion etc Electrical pulse Excitation Transmission of the excitation Motor nerve Stimulated muscle Elementary Mechanical Response Twitch Phoenix User s Manual 11 6 Usage Guidelines 6 1 Program Descriptions The choice of a program is determined by the injured body parts or joints The appropriate stimulation programs e g Endurance Strength TENS or Edema and frequency of the program s are determined by the medical professional Consult your medical professional to be sure to understand the Empi Phoenix device 6 1 1 Endurance P1 The Empi Phoenix Endurance program focuses on generating a medium muscle contraction This working level is maintained over a long time period 20 minutes per session The Endurance program specifically activates the aerobic metabolis
35. n 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 A is intended solely for the benefit of the initial purchaser and Empi Inc disclaims all other 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 Inc thereunder shall be limited to the lifetime of the initial purchaser No employee representative or agent of Empi Inc has any authority to bind Empi Inc to any affirmation representation or warranty except as stated in this written warranty policy D Empi Inc 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 Inc e g contract negligence or otherwise the remedy provided in paragraph A above shall constitute purchaser s sole remedy In no event shall Empi Inc 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 als
36. nagement of pain patients Phoenix User s Manual 9 4 4 Dangers Electrodes Any Empi Electrode with a minimum active area of 16 cm may be used with this device This includes Empi 2 round and 2 square 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 Dangerous voltage Stimulus delivered by the waveforms of the Phoenix 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 4 5 Adverse Reactions e Patients may experience skin irritation and burns beneath the stimulation electrodes applied to the skin e Patients may experience headache and other painful sensations during or following the application of electrical stimulation near the eyes and to the head and face e Patients should stop using the device and should consult with their physicians if they experience adverse reactions from the device 10 Phoenix User s Manual 5 How Does Electrotherapy Work The principle of electrotherapy is to stimulate nerve fibers by means of electrical impulses transmitted by electrodes The NMES electrical pulses generated by the Empi Phoenix stimulators are high quality pul
37. o 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 Phoenix User s Manual 31 13 Technical Specifications Standard Measurement Conditions e Temperature 25 C 5 C e Load Range 500 Ohms 1 KONms e Power Supply 3 0V DC 10 Output Waveforms The following are theoretical standard measurement output current across purely resistive loads at maximum intensity setting Pulse Width and current measured as shown across 1kOhm loads These measurements are also valid on a 500 Ohm load as the Phoenix is a current controlled device Any load between 500 Ohms and 1 kOhm will not affect the output measurements Your output may vary depending on parameter settings P1 Endurance Program Maximum Intensity 520 Energy levels corresponding to 100 mA intensity and 300 us pulse width Zero net DC component Maximum charge per pulse 2 x 30 uC i LeCroy 1 ms 50 mA i BE T 4 P2 Strength Program Maximum Intensity 520 Energy levels corresponding to 100 mA intensity and 300 us pulse width Zero net DC component Maximum charge per pulse 2 x 30 uC i LeCroy 1 ms 50 mA SE gt E 1 32 P3 Modulated TENS Program Maximum Intensity 100 mA Zero net DC
38. oap water before attaching the electrodes After cleaning thoroughly rinse with water and dry the skin carefully Dry electrodes with poor adhesion can be reconditioned See electrode packaging for complete instructions If you encounter contact with the skin or repeated open lead detection replace the electrodes Remove electrodes by pulling on their edges Do not pull on the lead wire After use reattach the electrodes to their protective plastic film Store the electrodes in their bags Store the electrodes in a cool place We recommend clipping excess hair from sites where electrodes will be applied Trim the hair with scissors do not shave Do not leave the electrodes attached to your skin for a prolonged period of time Remove the electrodes after each use To avoid skin irritations apply the electrodes to different areas and clean the skin thoroughly after treatment lf you observe skin irritations consult your Clinician and discontinue therapy until the irritation subsides 7 3 4 Connection of the lead wires to the electrodes Connect the pin end of the lead wire to the chosen electrode Pay attention to the polarity shown in Section 6 4 and the indications given in Section 2 1 7 3 5 Use of the Empi Phoenix Thigh Garment Device optional Please refer to the Empi Phoenix Thigh Garment User Manual for proper use 20 Phoenix User s Manual 7 4 Operation of the Device 7 4 1 LCD display The Empi Phoenix device
39. on Sudden temperature changes can cause condensation to build up inside the stimulator To prevent this allow it to reach room temperature before use 7 1 Description of the Device gt U MO PHOENIX User Interface LCD ON OFF Pause button Program Selection Increase button P Program Selection Decrease button P Channel 1 Intensity Increase Decrease button A V Channel 2 Intensity Increase Decrease button A V Channel 1 output connector Channel 2 output connector Remote switch input connector hand switch is an optional accessory Belt Clip removable ACHAIO0ommouon gt gt Battery door to access the battery compartment A label describing the programs is affixed to the battery door Phoenix User s Manual 17 7 2 Kit Composition and Accessories 802425 235694 199696 235684 199321001 193057 100 199695 Accessory Part Number Quantity Description STANDARD INCLUSIONS PHOENIX DEVICE eses 193057 100 5 Package of one leadwire 40 long assembly with red and black pins Standard electrodes 199327 001 2 3 geel OURDAN COIN 2 x 2 StimCare electrodes Batteries 200045 y Package of four rechargeable AA batteries OPTIONAL PHOENIX THIGH GARMENT ney OPTIONAL INCLUSIONS AVAILABLE UPON REQUEST 60 long assembly with red and black pins Bifurcated lead 700211 001 Split lead for Edema use Hand switch 235693 Switch for manual stim activation
40. ption only USA ETL Classified C US 9900900 Electronic Testing Lab indicates product meets Ep US and Canadian product safety standards This device Conforms to AAMI Std d ES60601 1 Certified to CAN CSA Std C22 2 60601 1 Manufacturing year ual Manufacturer name and address Power Pause Dangerous voltage Lead wires comply with the Performance Standard for electrode lead wires 21 CFR part 898 Phoenix User s Manual 4 Safety Information This section includes Contraindications Warnings Precautions Dangers and Adverse Reactions N 4 1 Contraindications Implanted electronic devices Do not use the Empi Phoenix device on patients who have a cardiac pacemaker implanted defibrillator or other implanted electronic device because this may cause electric shock burns electrical interference or death TENS for undiagnosed pain Do not use the Empi Phoenix device as a TENS device P3 on patients whose pain syndromes are undiagnosed A Er Consult with physician Consult with the patient s physician before using the Empi Phoenix device because the device may cause lethal rhythm disturbances to the heart in susceptible individuals Skin condition Apply stimulation only to normal intact clean healthy skin Long term effects The long term effects of chronic electrical stimulation are unknown Stimulation location Stimulation over neck or mouth Do not apply stimulation over the patient s neck espec
41. res may be necessary such as re orienting or relocating the Empi Phoenix device Over the frequency range 150 kHz to 80 MHz field strengths should be less than 1 V m 36 Phoenix User s Manual RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT AND THE EMPI PHOENIX The Empi Phoenix is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the Empi Phoenix can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Empi Phoenix as recommended below according to the maximum output power of the communications equipment Rated Separation distances according to frequency of the transmitter maximum output power of transmitter From 150 kHz to From 80 kHz to From 800 MHz to 80 MHz 800 MHz 2 5 GHz d 12NP d 12NP d 23NP 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 separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is modified by a
42. ses that have been clinically tested and offer safety comfort and efficiency These electrical pulses can e Stimulate motor points of target muscles causing a muscle contraction This can help re educate and strengthen your muscles following an injury or surgery This is called neuromuscular electrical stimulation NMES The Empi Phoenix programs P1 and P2 are NMES programs e Manage pain The electrical pulses block the pain signal sent from the affected area on your nerve pathways This is called the Gate Theory of pain control and this form of electrotherapy is called transcutaneous electrical nerve stimulations TENS The Empi Phoenix program P3 is a TENS program e Increase local blood circulation helping to reduce swelling or edema The electrical current can affect the movement of fluid through tissue and increasing blood flow can help increase healing This therapy can be achieved using a pulsed direct current The Empi Phoenix program P4 is a pulsed direct current program During voluntary activity the brain sends a command to the nerve fibers in the form of an electrical signal to give the order to move This signal is then transmitted to the muscular fibers which contract The principle of electrotherapy emulates the process observed during a voluntary contraction In other words the muscle cannot distinguish whether the command comes from the brain or from the stimulator The parameters of the Empi Phoenix programs nu
43. tact your clinician 11 Repeat Steps 1 through 10 for Channel 2 9 Device Maintenance Please contact Empi at the numbers below if you need assistance setting up using or maintaining the Phoenix System or to report any unexpected operation or events For clinical questions contact the Professional Services Department at 800 328 2536 or 651 415 9000 If any component of the Phoenix System is not functioning properly or requires servicing contact the Empi Repair Department at 800 862 2343 or 605 874 6965 When returning any products please include your name address phone number and a description of the problem Return to Empi Attn Repair Department 47492 SD Hwy 22 Clear Lake SD 57226 USA 9 2 Cleaning and Calibration Clean using a damp cloth or soft cloth and an alcohol based solvent free cleaning product Use only a minimum amount of liquid when cleaning the Empi Phoenix device Allow the Empi Phoenix device to completely dry before use Do not sterilize the stimulator Do not immerse in liquids Your stimulator does not require calibration Each Empi Phoenix stimulator is tested prior to distribution Its characteristics do not vary under normal conditions 26 Phoenix User s Manual 9 3 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 Do not attempt to repair the stimulator or any of i
44. ter Recommended separation distances d 1 2 P 3 V m d 1 2 VP 80 MHz to 800 MHz 80 MHz to 2 5 GHz d 2 3 VP 800 MHz to 2 5 GHz Radiated RF IEC 61000 4 3 where P is the maximum output power of the transmitter in watts W according to the transmitter manufacturer and where d is the recommended separation distance in metres m The field strength from fixed RF transmitters as determined by an electromagnetic survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol fe i GO NOTE 1 At 80 MHz and at 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by ab sorption 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 in which the Empi Phoenix device is used exceeds the applicable RF compliance level above the Empi Phoenix device should be observed to verify normal operation If abnormal performance is observed additional measu
45. th PROGR LOCKED channel intensities are O The available programs are P1 it i Endurance P2 Strength P3 TENS and P4 Edema The IL i J list of programs is also mentioned on the battery door label The device might be locked into a pre defined program selected by your Clinician In this case you cannot change the program selection and the Program Selection buttons are inactive A corresponding text will appear below the program number Phoenix User s Manual 21 4 The sequence indicator will indicate the number of sequences for each program The program timer indicates the total duration of the program Once you have selected the desired program simply increase the intensities of the channels you want using the Increase Intensity buttons For intensity strength information refer to 6 6 5 The intensity of each channel will be displayed both numerically lt gt gt 7 N and with a bar graph Note that intensities of Endurance P1 and Strength P2 programs are expressed in Energy levels max N SEA 520 while intensities of TENS P3 and Edema P4 programs are TT N IT expressed in mA max 100 mA L II A IE NS 7 4 4 Pause function During a treatment you can pause the treatment at any time by pressing the ON OFF button once In this case both intensities will drop to 0 the timer will stop and the timer indicator will blink To resume the treatment increase the intensities to the
46. the purchaser as to the effectiveness of the product Warranty A Empi Inc 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 adhesive patches and electrode cream and the component parts thereof distributed or manufactured by Empi Inc shall be free from defects in the workmanship and materials for three years from the initial date of purchase from Empi Inc 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 or Warranties A 30 Empi Inc s sole obligation in the case of any breach of its warranties set forth in Paragraph A in the Warranty section above shall be at Empi Inc 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 Inc 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 Inc s written request and authorization P
47. 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 environment If the user of the Phoenix requires continued operation during power mains interruptions it is recommended that the Empi Phoenix be powered from an uninterruptible power supply or a battery Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment NOTE U is the a c mains voltage prior to application of the test level Phoenix User s Manual 35 GUIDANCE AND MANUFACTURER S DECLARATION ELECTROMAGNETIC IMMUNITY The Empi Phoenix is intended for use in the electromagnetic environment specified below The customer or the user of the Empi Phoenix should assure that it is used in such an environment Immunity test IEC 60601 test Compliance Electromagnetic environment level level recommendations Portable and mobile RF communication equipment should be used no closer to any part of the Empi Phoenix device Conducted RF 3 Vrms including cables than recommended IEC 61000 4 6 150 kHz to 80 separation distance calculated from the MHz equation applicable to the frequency of the transmit
48. tive pin black connection An electrode should be connected to each pin Always follow your clinician s instructions about electrode connection and application Attach the electrodes in such a way that their entire surface is in contact with the skin stimulator is switched on Switch the stimulator off first Always turn off the stimulator Precaution Do not disconnect any stimulation cables during a session while the N before moving or removing any electrodes during a session be a risk of suffering a burn injury Caution should always be exercised with current Precaution Do not use electrodes with an active area less than 16 cm as there will densities more than 2mA cm piercings buckles or any other removable metallic product or device in the area of stimulation Never use the electrodes contra laterally i e do not use two pins connected to the same channel on opposite segments of the body f Precaution Do not apply stimulation in the vicinity of metal Remove jewelry body Depending on the characteristics of the current efficacy can be optimized in certain programs When working with a muscle stimulation program program involving muscle contractions P1 or P2 it is important to place the negative electrode connected to the black connector on the motor point of the muscle To ensure the efficacy of the program it is crucial to choose the right size electrodes large or small and correctly position these on the
49. ts accessories Never dismantle the Empi Phoenix device because of risk of electric shock Empi Inc declines all responsibilities for any damages or consequences resulting from unauthorized attempts to open modify or repair the stimulator This may only be done by persons or repair services authorized by Empi Inc 9 4 Operating Conditions The Empi Phoenix device 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 9 5 Transportation and Storage Conditions The Empi Phoenix device should be transported and stored in temperatures between 40 F and 158 F 40 C and 70 C atmospheric pressures between 50 and 106 kPa and relative humidity between 10 and 90 9 6 Expected Life and Disposal The Empi Phoenix device is expected to provide at least seven years of normal use If you are renting the Empi Phoenix device please return it to Empi when you no longer need it for therapy The Empi Phoenix device is electronic equipment and may include substances that can damage the environment DO NOT dispose of the device in municipal waste Please deliver the device to a suitable collection point for recycling of electronic equipment or contact the Empi Repair Department see Service section to return it for recycling By doing so you will be contributing to the safeguarding of natural resources and health Please dispose
50. urchaser shall return the Product to Empi Inc freight and insurance prepaid for inspection Notice and return shipment shall be sent to Empi Inc at 47492 Hwy 22 Clear Lake South Dakota 57226 USA or to an Empi Inc Authorized Service Center To locate the appropriate Service Center outside of North America or to request shipment approval contact Empi Inc directly Empi Inc will not be responsible for damage due to improper packaging or shipment If Empi Inc determines in its sole reasonable discretion that the Product contains defective workmanship or materials Empi Inc 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 insurance prepaid as soon as reasonably possible following receipt of the Product by Empi Inc Empi Inc determines in its sole reasonable discretion that the Product does not contain defective workmanship or materials Empi Inc will return the Product to the Purchaser freight and insurance billed to the Purchaser 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 Inc or which has been subjected to misuse abuse neglect damage in transit accident or negligence Phoenix User s Manual C Except as provided in paragraph A the product is being sold on a

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