throbber
Petition for Inter Partes Review
`Patent No. 9,526,892 B2
`
`
`
`
`
`SALPETER
`EXHIBIT 1008
`
`
`
`
`
`

`

`in Energy eaee
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`ProcedureManual
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`A Breakt,
`A Breakthifgjigh
`in Energy tigerapy
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`

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`Ta b l e O f C o n t e n t s
`Introduction
`
`Terminology
`Specifications
`F e a t u r e s & B e n e fi t s
`
`Operation
`Care, Maintenance & Technical Support
`Troubleshooting
`Warranty
`
`T r e a t m e n t P r o t o c o l s
`3 H e a d
`4 Cervical Spine
`5 Thoracic Spine
`6 Lumbar Spine
`7 S h o u l d e r
`8 E l b o w
`9 Wrist & Hand
`1 0 F a c e
`11 Hip
`1 2 K n e e
`13 Upper Leg
`14 Lower Leg
`1 5 A n k l e
`1 6
`
`F o o t
`
`,
`
`*
`-
`F h y s M o D y n a m M c s A i
`
`1 - 8 0 0 - 7 7 5 - 2 6 5 2
`7200 E Dry Creek Rd, Ste A-202
`Centennial, CO 80112
`Phone; 303-713-0605
`Fax: 303-713-0581
`
`R E V N 0 5 / 2 8 / 2 0 0 2
`
`

`

`
`
`

`

`The second method involves the interferential
`process. Interference current therapy consists of
`two (or more) medium frequency currents that are
`independent of each other. These medium
`frequency currents penetrate into the treatment
`area in order to interfere with each other and
`produce a low frequency. This low frequency
`produces a physiological response in tissue;
`however, with the production of this lower
`frequency also comes a loss of power. It has been
`expressed within the industry that power and
`frequency are the keys to effective electrical
`stimulation and therapy.
`THERASTIM does not use either of the above
`techniques as its basis for action. Rather,
`PhysioDynamics Inc., has produced a signal with
`simultaneous high and low frequencies as a
`multi-phase signal with polarity. This produces a
`high power factor rather than just high voltages
`without producing discomfort to the patient. On
`the contrary, an almost immediate numbing
`occurs around the treatment area and an
`immediate, long lasting therapeutic response is
`obtained, often with as little as one treatment.
`DO YOU USE THE THERASTIM THE
`SAME WAY AS OTHER MACHINES?
`Yes, while the operation and application through
`diagnostic placement of electrode pads quite
`similar to other machines, THERASTIM
`differences are linked to the additional features o^^
`the machine. For example, there is a trave ing
`sensation of the stimulation that offers bene it to
`areas not being treated directly. This sensation is
`extremely useful in the treatment of migraine
`headaches. Also it is important for the
`understand the advanced penetration ef ^
`therapist must think on a multi-dimensiona or,
`"3-D" level. Treatment extends beyond the
`surface area. Techniques for specific regions are
`discussed later in this manual with app ications
`for specific conditions.
`^-1
`
`I n t r o d u c t i o n
`
`1P
`
`hysioDynamics, Inc. is proud to introduce
`THERASTIM, a new solution to old problerns
`associated with traditional electrical therapeutic
`stimulation. THERASTIM also presents new
`applications not previously addressed by
`traditional methods. THERASTIM ^ is a
`neuromuscular stimulator which introduces
`electrical signals to the body through conductwe
`electrode pads to provide therapeutic treatment or
`a variety of conditions.
`WHAT MAKES DIFFERENT?
`Traditionally^ there have been two major methods
`in use for applying non-invasive electnca
`stimulation to the human body. The first method is
`to apply a single polarity, low frequency,
`alternating signal. The concept appears sound but
`runs into difficulty because the electrical resistance
`in the area of treatment may be relatively high at
`low frequencies. Due to this high electrical
`resistance, the treatment can be quite
`uncomfortable for the patient. Using low
`frequency signals at the necessary high voltages,
`there is a loss in the intensity of the stimulation
`within the treatment area, limiting the value of the
`t r e a t m e n t
`
`

`

`TheraStim Training Guide
`
`W I L L
`
`I N E E D A D D I T I O N A L T R A I N I N G ?
`
`C A U T I O N :
`
`PhysioDynamics offers comprehensive technical
`support to present new and innovative treatment
`techniques for the therapist.
`
`T E R M I N O L O G Y
`
`All special terms or terms with more than one
`common usage used in this manual are defined
`below. This definition as stated in this section
`represents the intended meaning of the term
`throughout this manual.
`0 Continuous mode—Main Pulse stimulation is
`present at all times, DUTY CYCLE dial is at
`20/20.
`0 Duty cycle —Variable amount of the time the
`main pulse is generated during a 20 second
`i n t e r v a l
`0 Electrode pads —Pliable, conducting pads
`used to deliver electrical energy to the body
`areas being treated.
`0 Frequency —Number of main pulses per
`second.
`0 Intermittent mode —Method of operation
`when DUTY CYCLE dial is less than 20/20.
`0 Polarity —Indicates direction of electron
`flow.
`0 Power —Effective stimulation intensity,
`which is determined by amplitude and
`frequency.
`
`t h e v a s o d i l a t i o n e f f e c t s o f
`B e c a u s e o f
`electromagnetic stimulation, people with
`unknown conditions (epileptic, cardiac, cerebral,
`and vascular conditions, etc.) may experience
`untoward affects such as, dizziness, nausea,
`profuse perspiration, or fainting. If this occurs,
`cease treatment immediately and recommend
`treatment by a physician to ascertain the
`underlying cause(s) of said untoward effects.
`
`F E AT U R E S & B E N E F I T S
`
`THERASTIM features a blend of two signals: a
`main pulse and a background signal. The unique
`signal provides a "3-D" stimulation of the body
`area being treated. Patient participation is another
`feature of the treatment system, resulting in self-
`directed therapy. Additional detail of treatment
`techniques can be found in the TheraStim Training
`Guide. Electrostimulation therapy has been found
`to be beneficial for a variety of conditions:
`* Relaxation of muscle spasms
`* Prevention and retardation of disuse atrophy
`* Increase of local blood circulation
`* Muscle re-education
`* Immediate post-surgical stimulation of calf
`muscle to prevent venous thrombosis
`* Maintaining and increasing range of motion of
`body limbs
`
`SPECIFICATIONS
`Main Pulse Frequency 40 to 500 pulses per second; adjustable
`Background Frequency —High frequency carrier signal.
`Output Power —Between 0 and 2.5 watts.
`Polarity —^Direction of electron flow is reversible.
`Battery —Sealed lead-acid 12 volt modular battery.
`Battery Charger —120 volts, 50/60 hertz
`External Power Supply — 120/240 volts, 50/60 hertz input; 12 volt output
`
`

`

`Operation
`
`In this chapter the following information will be discussed:
`
`Description of Operator Controls
`A c c e s s o r i e s
`Pad Placement Considerations
`The Hunting Technique
`E l e c t r o n F l o w
`Connecting the Cables
`Pad Placement Techniques
`How to Begin Treatment
`Care, Maintenance & Technical Support
`Troubleshooting
`Warranty
`
`Polarity Switch
`
`Output Power Dial
`
`Power Switch
`
`B a l a n c e D i a l
`
`Output Jacks
`
`/
`
`Duty Cycle Dial
`
`Pulse Present Indicator
`
`Main Pulse Frequency Dial
`
`T i m e r
`
`

`

`TheraStim Training Guide
`
`D E S C R I P T I O N O F T H E O P E R A T O R
`C O N T R O L S
`
`jPJtysiolfyn amies,KTn c.
`_ 1-800-775-2652 V
`
`P O W E R S W I T C H
`The on/off switch is a front panel rocker switch
`which connects (ON) and disconnects (OFF) the
`power produced by the power supply from the
`remainder of the circuit.
`
`CYCLE *
`PULSEPRESEI^
`iS/ZO
`
`Maim Pi
`preq(p
`70
`
`INDICATOR
`PULSE PRESENT
`This small green light, located on the front
`panel, indicates the presence of the main pulse
`in the output signal. The brightness is relative to
`the strength of the main pulse signal; off when
`there is no main pulse, to full brightness at full
`main pulse power.
`
`O U T P U T P O W E R
`
`OUTPUT POWER DIAL
`This dial controls the output power of
`THERASTIM. This control adjusts the power for
`any combination of electrode pads. Turning the
`dial in a clockwise direction increases the output
`p o w e r .
`
`^ - 2
`
`

`

`P iP h y s i o D y n a m i c s A I n c .
`
`1-800-775-2652 V
`
`TheraStim Training Guide
`
`B A L A N C E D I A L
`This dial is used to adjust the relative Power
`delivered to the electrode pad-pairs and
`balances power between three or more pads.
`When the dial is turned completely to either
`the right or left channel, power is absent in the
`opposite channel.
`
`POLARITY
`
`n o r m
`
`REV
`
`POLARITY SWITCH
`This rocker switch, labeled NORM and REV,
`reverses the polarity of the output signal.
`When switching polarity, the output power
`will reduce to the "Off level, then gradually
`increase back to the initial output level to
`avoid any unnecessary discomfort to the
`patient. In the "Normaf position the black
`pad is negative and the red pad is positive,
`conforming to normal electrical conventions.
`Treatment Tip
`Before changing polarity, the power level
`should be low, yet perceptible by the patient.
`
`

`

`TheraStim Training Guide
`
`I fl\PhysioDvnamics,KJlnc.
`
`_ 1-800-775-2652 V
`
`MAIN PULSE FREQUENCY CONTROL DIAL
`This dial is used to adjust the frequency of the
`main pulse. Rotating the control clockwise will
`increase the main pulse frequency. NOTE: PPS is
`an abbreviation for pulses per second.
`
`Treatment Tip
`
`Increasing the frequency results in the patient
`feeling a deeper sensation with less muscle
`contraction.
`
`DUTY CYCLE DIAL
`The duty cycle period is equal to about 20 seconds.
`This dial is used to select the main pulse active
`duty cycle. When rotated completely clockwise,
`the main pulse output will be continuously present
`at the frequency selected. When the dial is rotated
`completely counter-clockwise, the main pulse
`output will be disabled. Any other duty cycle
`(ratio of main pulse present/absent) can be selected
`between these two limits. This is called the
`intermittent mode.
`
`^REQ(PPSf
`
`70
`
`'■ •. 1 J
`1. . '
`v
`
`m
`
`100
`J2S
`
`500
`
`CYCLE
`'S^CO^Ds,
`to/20
`
`i
`■
`
`i y
`/ •
`
`15/20
`
`20/20
`£ o n t
`
`10/20 Duty Cycle Setting
`
`— Tr e a t m e n t Ti p
`
`Main Pulse
`P r e s e n t
`
`M a i n P u l s e
`A b s e n t
`
`1 0 S e c o n d s
`
`1 0 S e c o n d s
`
`^ 2 0 S e c o n d s To t a l
`
`^ - 4
`
`Use the Intermittent Mode when the therapist
`wishes to check on progress during the treatment
`time. The intermittent mode can be used to remove
`the stimulation for a period of time. During this
`lull, the patient can be questioned about the feeling
`in the area being treated.
`
`

`

`y t^PhysioDynamicSfKInc.
`A I 1-800-775-2652 V
`
`TheraStim Training Guide
`
`T I M E R
`
`10 0:0 01
`
`S T O P
`S T A R T
`
`R E S E T
`
`M I N S
`
`N o t e :
`The entire THERASTIM timer display begins to
`flash on and off when the battery voltage is low
`and the battery needs to be exchanged for a fully
`charged battery. If the patient Is being treated at
`this point, finish the treatment and then exchange.
`It is Important that the batteries are exchanged
`soon after the timer display begins to flash since
`they are lead-acid and will be damaged if deep
`discharged.
`
`t h e A C A d a p t e r
`N o t e s o n
`1. Your power supply operates on 100V-240V AC
`5 0 / 6 0 H Z .
`2. Do not share the AC outlet with other power-
`consuming equipment such as a copy machine or
`shredder.
`3. Do not place any objects on the power cord or power
`u n i t .
`4. To disconnect the cord pull it out by the plug, never
`pull the cord itself.
`5. When the AC adapter is not used, unplug it from the
`AC outlet.
`6. Use only the AC adapter supplied. Do not use any
`other AC adapter.
`7. The AC adapter is for indoor use only and must be
`kept away from liquids.
`
`T I M E R
`The operator selects the treatment time (in
`whole minutes) using the MINS button. Each
`time the MINS button is pressed, the timer
`count advances one minute. If the MINS
`button is held down, the timer will continue to
`advance. Pressing the START/STOP button
`will begin the countdown. When the timer
`counts down to zero, an audible tone is
`activated. The RESET button will allow the
`operator to reset the timer counter to zero and
`to turn off the audible tone.
`- ^ Ti p
`The timer is NOT a control feature. It dpes
`not turn the machine off; it is for monitonng
`the length of the treatment only.
`
`R E A R PA N E L C O N T R O L S
`THERASTIM can be powered by either a lead
`add batte^ or an external power supply. The
`POWER SOURCE SELECTION switch on
`the back panel is used to select the power
`
`s o u r c e .
`
`TO USE BATTERY POWER: 1. Flip.the
`POWER SOURCE SELECTION s\^tch
`toward the battery door. 2. Firmly push in
`the release button on the bottom of the unit
`(located under the serial# decal) wrnitjirmiy
`•pulling on the metal tab on the lower po^on
`of the oattery door with your finger^. . ■' o
`insert battery: battery decal must be uprigm
`and the arrow on the decal pointing towara
`the machine. Slide the battery in as lar ^ it
`will go. 4. Snap the battery door closed, o.
`To remove battery, push the release button on
`the bottom and the battery will pop out.
`If external power is desired, plug the oxtemd
`power supply connection intp the Power jacK
`m the back panel and flip the
`SOURCE SELECTION switch toward the
`J a c k .
`The external power supply can be osed with a
`battery in the case with no harm to the battery
`and the battery will not be charged.
`
`2 - 5
`
`

`

`TheraStim Training Guide
`
`m P h y s i o D y n a m i c S f k l n c .
`
`1-800-775-2652 V
`
`S A F E T Y C I R C U I T R Y
`
`To prevent the delivery of sudden or unexpected power to a patient, protective circuitry and an audible
`alarm has been designed into the THERASTIM unit
`
`1. If the unit is turned on with the OUTPUT POWER dial set above "1" or, if the OUTPUT POWER dial
`is turned up too soon (10 seconds) after the POWER switch is turned on, an alarm will sound and the
`output power will be disabled. To correct the problem:
`0 turn the POWER switch off
`0 reset the OUTPUT POWER dial to zero
`0 tum the POWER SWITCH on , wait 5-10 seconds,
`
`2. If the BALANCE dial is turned too quickly, an alarm may sound and the output power will be disabled.
`To correct the problem:
`0 tum the POWER switch off
`0 reset the OUTPUT POWER dial to zero
`0 tum the POWER SWITCH on , wait 5-10 seconds,
`
`3. If a cable plug should disconnect from an electrode during treatment, an alarm may sound and the
`output power will be disabled. To correct the problem:
`0 tum the POWER switch off
`0 reconnect the cable
`0 reset the OUTPUT POWER dial to zero
`0 turn the POWER SWITCH on , wait 5-10 seconds,
`proceed with the treatment.
`
`^ - 6
`
`

`

`W P h y s i o D y n a m i c s A J n c .
`t| 1-800-775-2652 V
`
`TheraStIm Training Guide
`
`I N D I C A T I O N S
`THERASTIM\s indicated for the following:
`Relaxation of muscle spasms
`Prevention or retardation of disuse atrophy
`Increasing local blood circulation
`Muscle re-education
`Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
`Maintaining or increasing range of motion
`However, THERASTIM should only be used under medical supervision for adjunctive therapy for
`the treatment of medical diseases and conditions.
`
`C O N T R A I N D I C AT I O N S
`
`THERASTIM s\\o\x\d not be used:
`On patients with cardiac Pacemakers
`O v e r k n o w n c a n c e r s
`On pregnant women
`W A R N I N G S
`PhysioDynamics, Inc. makes the following warnings:
`Long term effects of chronic electrical stimulations are unknown.
`Adequate precautions should be taken in the case of persons with suspected or diagnosed heart
`problems.
`Adequate precautions should be taken in the case of persons with suspected or diagnosed
`. . .
`e p i l e p s y .
`.
`DO NOT stimulate over the carotid sinus nerves, especially in patients with a known sensitivity
`to the carotid sinus reflex.
`Severe spasm of the laryngeal and pharyngeal muscles may occur when the electrodes are
`positioned over the neck or mouth. The contractions may be strong enough to close the airway
`or cause difficulty in breathing.
`THERASTIM NOT be applied transcerebrally (across the head).
`THERASTIM should NOT be used over swollen, abraded, infected or inflamed areas or skin
`eruptions, e.g., phlebitis, thrombophlebitis, or varicose veins.
`DO NOT use THERASTIM an external power source during storms.
`„ , . r p n t
`,
`D o n o t u s e
`i n m o v i n g
`v e h i c l e s .
`Caution should be used in the transthoracic application in that introduction of electrical curreni
`into the heart may cause arrhythmias.
`THERASTIM be kept out of the reach of children.
`
`P R E C A U T I O N S
`
`PhysioDynamics, Inc. further states that precautions should be observed in the presence of the following.
`0 when there is a tendency to hemorrhage following acute trauma or fracture,
`0 after recent surgical procedures when muscle contractions may disrupt the healing process,
`0 over a menstruating uterus, or
`0 when sensory nerve damage is present by a loss of normal skin sensation.
`
`

`

`TheraStim Training Guide
`
`^JMPhysioDynamicSfKInc.
`Mm 1-800-775-2652 V
`
`P A D P L A C E M E N T C O N S I D E R A T I O N S
`
`M U S C L E T H E R A P Y
`The ultimate choice of pad placement for the
`various uses of TheraStim must rely on analysis
`of the particular situation and the judgment of
`the therapist. The objective is to stimulate either
`a particular muscle or muscle groups. Normally,
`the most efficient and effective way to achieve
`this objective is to place the pads so that
`electrons flow along the long axis of the muscle
`or muscles being treated.
`This simple concept is extremely difficult to
`achieve in practice since muscles run in different
`directions at different depths and different
`locations in the body. Generally, it is
`recommended to identify carefully the muscle or
`muscle groups desired for treatment, determine
`the direction of the longitudinal axis and place
`the pads so that the maximum amount of
`longitudinal stimulation is achieved.
`For consistency only, initially place the positive
`and negative charged pads so that electrons flow
`toward the extremities of the body or away from
`the head. This means that the negative (black)
`pad(s) should be placed closest to the torso and
`the positive (red) pad(s) should be placed closest
`to the body extremities.
`The therapist should confer with the patient as to
`the location of the pain. The damaged areas
`need to be exposed to the current for full
`therapeutic relief to be obtained. There are times
`when the pain is difficult to isolate and
`traditional treatments may not be effective.
`Using the "Hunting Technique", the damaged
`area can be isolated and treated effectively.
`
`Longitudinal Axis
`
`"^-8
`
`

`

`WWI^P^ysioDynamics^Inc.
`1-800-775-2652 V
`
`TheraStim Training Guide
`
`J O I N T T H E R A P Y
`As with muscle therapy, the ultimate choice of pad placement for the various uses of THERASTIM
`rely on analysis of the particular situation and the judgment of the therapist.
`When the objective is to increase the range of motion of the joint being treated, sandwich pad
`placement on the restricted joint is suggested. Voluntary movement of the restricted joint during
`stimulation is recommended. At times however, joints need to be "tightened". T-Formation and
`Box pad placement techniques are recommended for this purpose.
`
`HUNTING TECHNIQUE
`Normally, the techniques described in this manual will handle the majority of the situations
`encountered; however, on some occasions, "hunting" the pain will be required.
`This involves moving the pads around on the body until the patient can report a stimulation effect
`exactly in the injured portion of the body. DO NOT move the pads while the power is on unless
`you drag them across the surface of the skin. Picking them up while power is on will cause
`unnecessary discomfort. If it is necessary to move the pads a considerable distance, it is best to turn
`the power dial down to zero and start over with new pad placements. Use of the POLARITY switch
`is advised in this exercise to determine which direction of electron flow gives the greatest sensation.
`Once located, an attempt should be made to "bracket" the injured area with the electrode pads.
`
`" T R A V E L I N G "
`The current may flow beyond the region between the pads. This feature rapidly identifies trigger
`points associated with referred pain.
`
`.
`.
`,
`.
`.
`P A T I E N T O R I E N T A T I O N
`Most patients are unfamiliar with electrical stimulation techniques; therefore expect them to ave
`anxieties and questions. Discuss the principles involved with electrostimulation.
`Explain that the unit is turned on with no power applied to the pads. The initial stimulation is at low
`power and it will gradually increase to higher, more useful levels of stimulation without painful
`sensations.
`It is vital to involve the patient in the treatment. The therapist can vary control settings during a
`treatment session so that effective stimulation is attained within the patients' comfort zone. The
`patients' optimum level of stimulation will be achieved by encouraging them to communicate their
`feelings of comfort or discomfort and location of stimulation to the trained therapist.
`
`^ - 9
`
`

`

`TheraStIm Training Guide
`
`E L E C T R O N F L O W
`
`^jMPhysioDyxiamics,KInc.
`•T 1-800-775-2652 V
`
`Either two, three, or four electrode pads may be used to introduce the electrical signal to the patient. If
`two pads are used, the electrical signal is developed between the two electrodes. If four pads are used,
`the signal is developed across both pairs of pads as well as across the individual pads. If three pads are
`used, operation is similar to that using four pads, with one pad disconnected. A polarity reversal
`switch is provided to change the direction of the signal current at the pads.
`
`B l a c k
`
`O
`
`R e d
`
`2 P a d s
`
`B l a c k
`
`3 P a d s
`
`B l a c k
`
`B l a c k
`
`o
`
`o
`
`4 P a d s
`
`THERASTIM Signal Path, Normal Polarity
`
`

`

`T) (M^PhysioDynamicSjKInc.
`A J 1-800-775-2652 v
`
`TheraStim Training Guide
`
`C O N N E C T I N G T H E C A B L E S
`
`When connecting the cables to the front panel,
`notice the OUTPUT plugs are colored. Notice
`that the blocks where the cable splits are
`colored the same color as the plug on that wire.
`Performance
`from each OUTPUT
`jack
`is
`i d e n t i c a l .
`
`There are a variety of pad placement techniques
`used for specific conditions as discussed later
`in this chapter. Cable connections vary
`between the 2-pad placements and the 3-4 pad
`placements. Please refer to the particular pad
`placement technique for further information on
`the cable connections to the front panel.
`
`-N/2-11
`
`

`

`TheraStim Training Guide
`
`WWiP^vsioDynamicsMnc.
`A 1 1-800-775-2652 v
`
`PAD PLACEMENT TECHNIQUES
`
`S A N D W I C H F O R M A T I O N
`
`N o t e :
`Some people have occasionally experienced
`a slight "bump" if they are connected to the
`device while it is being turned on or off, even
`if the power dial is set at zero. To eliminate
`this situation, turn down the power dial as
`usual and disconnect the patient from Thera
`Stim before turning off, or connect to the
`patient after it is turned on. If the patient
`already has pads applied prior to turning the
`device on, disconnect the pad cabte(s) from
`the front panel, turn on, then reconnect the
`cable(s).
`
`C A B L E C O N N E C T I O N S
`Connect either cable into the left or right
`receptacle on the THERASTIM front panel
`Attach the red and black pads to the
`corresponding red and black leads.
`
`P A T I E N T P A D P L A C E M E N T
`Attach the pads to the affected area as
`illustrated. The electrons will flow
`from
`the
`black pad to the red pad with normal polarity
`selected. Reversing polarity will reverse the
`electron flow.
`
`"^-12
`
`

`

`\PhysioDynamicsAJnc.
`I 1-800-775-2652 V
`
`TheraStim Training Guide
`
`M O D I F I E D S A N D W I C H F O R M A T I O N
`
`C A B L E C O N N E C T I O N S
`Connect either cable into the left or right
`receptacle on the THERASTIM front panel.
`Attach the red and black pads to the
`corresponding red and black leads.
`
`P A T I E N T P A D P L A C E M E N T
`Attach the pads to the affected area as
`illustrated. The electrons will flow from the
`black pad to the red pad with normal polarity
`selected. Reversing polarity will reverse the
`electron flow.
`
`-^-13
`
`

`

`TheraStim Training Guide
`
`U P h y s i o D y i t a m i c S i K I n c .
`£1 1-800-775-2652 V
`
`L O N G I T U D I N A L F O R M A T I O N
`
`C A B L E C O N N E C T I O N S
`Connect either cable into the left or right
`receptacle on the THERASTIM front panel
`Attach the red and black pads to the
`corresponding red and black leads.
`
`P A T I E N T P A D P L A C E M E N T
`Attach the pads to the affected area as
`illustrated. The electrons will flow
`from
`the
`black pad to the red pad with normal polarity
`selected. Reversing polarity will reverse the
`electron flow.
`
`^-14
`
`

`

`^^^PhysioDynamicsJjJnc.
`A J I-800-77S-2652 V
`
`TheraStim Training Guide
`
`T - F O R M A T I O N
`
`C A B L E C O N N E C T I O N S
`Connect either of the colored cables into the
`right or left receptacles on the THERASTIM
`front panel. On one of the cables attach the
`red and black pads to the corresponding red
`and black leads. On the other cable attach the
`red pad to the corresponding red lead and take
`the unattached black connection and insert it
`in the hole in the cable junction. The electrons
`will flow from the black pad to the red pads
`with normal polarity selected. Reversing
`polarity will reverse the electron flow.
`
`PAT I E N T PA D P L A C E M E N T
`Attach the pads to the affected area as
`illustrated. The electrons will flow from the
`black pad to the red pads with normal polarity
`selected. Reversing polarity will reverse the
`electron flow.
`
`"W.2 - 1 5
`
`

`

`TheraStim Training Guide
`
`WWjiPhysioDynamicSjKInc.
`m
`: % 1 - 8 0 0 - 7 7 5 - 2 6 5 2 V
`
`B O X - F O R M A T I O N
`
`C A B L E C O N N E C T I O N S
`Connect either of the colored cables into the
`right or left output jacks on the THERASTIM
`front panel. On each of the cables attach the red
`and black pads to the corresponding red and
`black leads.
`
`PAT I E N T PA D P L A C E M E N T
`Attach the pads to the affected area as
`illustrated. The electrons will flow from the
`black pad to the red pads with normal polarity
`selected. Reversing polarity will reverse the
`electron flow.
`
`^-16
`
`

`

`iPhysioDynamicSfKJnc.
`1-800-775-2652 V
`
`TheraStim Training Guide
`
`H O W T O B E G I N T R E A T M E N T
`Most patients are unfamiliar with electrical
`stimulation techniques; therefore, expect them to
`have anxieties and questions. Discuss the
`principles involved with electrostimulation.
`Explain that the unit is turned on with no power
`applied to the pads. The initial stimulation is at
`low power and it will gradually increase to higher,
`more useful levels of stimulation without painful
`sensations.
`
`It is vital to involve the patient in the treatment.
`The therapist can vary control settings during a
`treatment session so that effective stimulation is
`attained within the patient's comfort zone. The
`patient's optimum level of stimulation will be
`achieved by encouraging them to communicate
`their feelings of comfort or discomfort and
`location of stimulation to the trained therapist.
`
`1. PREPARE THE THERASTIM
`
`is ON.
`the POWER switch
`• Make sure
`. Set DUTY CYCLE to CONT. {20/20)
`• S e t O U T P U T P O W E R d i a l
`t o Z E R O .
`. Set the MAIN PULSE FREQ (PPS)
`dial to desired setting, normally lOOPPS
`• Set the BALANCE dial to the appropri
`ate setting, (refer to treatment tip below)
`• S e t
`t h e P O L A R I T Y s w i t c h
`t o N O R M .
`
`Treatment Tip
`
`The BALANCE dial setting will start in the center
`when using a 3 or 4 pad placement technique. The
`BALANCE dial will be turned completely to the
`output jack being used when using a 2 pad
`placement technique. Please refer to the specific
`condition to determine pad placement.
`
`2 . P L A C E T H E PA D S O N T H E PAT I E N T
`• Connect pads to the front panel using
`connecting cable(s).
`• Thoroughly saturate sponge pads with
`water before placing on the electrode
`pad. If sponge pads are not used, be sure
`to moisten the conducting surface of the
`electrode pads with conducting gel
`before application to the patient.
`• Secure pads with straps or weights or
`hold if necessary. Note: the conductive
`rubber pads can be cut to custom-fit the
`location of treatment and the patient.
`• Refer to the specific condition as noted
`in this manual to determine pad
`placement.
`• Confer with the patient on the comfort
`and location of pads.
`3. START THE TREATMENT PERIOD
`• Preset the TIMER to desired minutes
`of treatment.
`• Rotate the OUTPUT POWER dial
`slowly clockwise.
`• Maintain a dialogue with the patient as
`to comfort, feeling of sensation, etc.
`• If three or more pads are being used,
`use the BALANCE dial to best reach
`the desired treatment area. NOTE. Use
`caution when adjusting the BALANCE
`as the BALANCE dial will increase or
`decrease the power to a pad pair when
`the dial is rotated away from the center
`p o s i t i o n .
`_
`. Continue to rotate the OUTPUT
`POWER dial slowly clockwise without
`creating an intense sensation.
`
`^-17
`
`

`

`TheraStim Training Guide
`
`IPhysioDynamicStKInc.
`1 - 8 0 0 - 7 7 5 - 2 6 5 2
`v
`
`3. START THE TREATMENT PERIOD {Continued)
`• Inform the patient about a reverse in
`polarity.
`• Turn the power output dial down below
`sensation threshold and place the
`P O L A R I T Y
`s w i t c h
`t o R E V
`t h e n
`increase power output to previous
`treatment level. Ask the patient to
`indicate which sensation best reaches the
`desired treatment area.
`• When the most effective polarity is
`established, continue the treatment by
`slowly rotating the OUTPUT POWER
`dial clockwise until the patient indicates
`the power is sufficient.
`• The therapist should also rely on visual
`observation of the muscle or muscle
`groups being treated and make every
`effort to use stimulation levels sufficient
`to achieve muscle contraction.
`• S t a r t
`t h e T I M E R .
`
`4. THE TREATMENT PERIOD
`• The ideal situation is to use enough power
`to keep the patient on the edge of comfort
`but not to the point of muscle cramping or
`extreme discomfort. The patient should
`feel the trauma area being stimulated.
`• After the patient accommodates to the
`stimulation at a level of power, slowly
`r o t a t e
`t h e O U T P U T P O W E R d i a l
`clockwise until the patient indicates the
`sensation from the new power level is
`sufficient.
`
`5.
`
`frequency adjustments
`• Use for deep stimulation of joints to
`increase range of motion.
`• Inform the patient to expect an "increase
`in the depth of sensation" as frequency is
`increased.
`
`^-18
`
`• Continue dialogue with the patient to
`monitor stimulation sensation.
`• Increased power setting may be used
`at higher frequency settings
`consistent with patient comfort.
`• Communicate with the patient during
`the treatment period.
`
`6 . C O N C L U D I N G T H E T R E A T M E N T
`P E R I O D
`• When total treatment period time has
`elapsed, rotate
`the OUTPUT
`P O W E R d i a l c o u n t e r c l o c k w i s e
`t o
`Z E R O .
`• Remove the pads and ask the patient
`how he or she feels. Listen carefully
`and record the patient's response.
`• Schedule another treatment session if
`necessary, and counsel the patient
`about suggested future activities.
`
`A C C E S S O R I E S
`The following accessories are available for
`T H E R A S T I M .
`Electrode pads
`0
`0
`Adhesive electrodes
`0
`Connecting cables
`0
`Sponge pads
`0
`Straps in varied sizes
`0
`Batteries
`External power supply
`0
`0
`Small table for unit
`
`Contact your sales representative to order
`accessories.
`
`

`

`W^^PhyssoDynamicsJilnc.
`Mr^ 1-800-775-2652 V
`
`TheraStjm Training Guide
`
`T H E R A S T I M ' S ®
`S T E R I L I Z A T I O N P R O C E D U R E S
`
`Sponge Conducting Pads
`The Sponge Conducting Pads are manufactured for the specific use with an electric modality such as the
`TheraStim®. Other types of sponges will not provide equal conductivity over the treatment area. We
`highly recommended that each patient have their own set of sponges for sanitary reasons. If you are
`using the same sponges on several patients, it is imperative that you sanitize these sponges between
`treatments. The sponges will become discolored and sometimes fray after several uses. This is the time
`to replace them and begin using new sponges. Use of typical sponge material could become harmful to
`the patient. We recommend using only the sponges manufactured for use with an electric modality.
`To sanitize the sponges follow the recommended procedure below:
`1. Use only antibacterial nontoxic disinfectant solutions.
`• Nontoxic antibacterial soap
`• Hibiclens (Clorhexidine)
`• Phisohex (Hexachlorophene)
`
`2. Combine a solution of an antibacterial soap and very hot water to clean the sponges,
`squeezing them several times for sanitizing. Rinse the sponges completely
`in very hot water to release oils and any excess disinfectant.
`In addition to sanitizing the sponges we recommend that you also use a disinfectant solution between
`treatments on the red and black electro conducting pads.
`
`DO NOT USE THE FOLLOWING:
`Alcohol, Ammonia, Bleach products or compounds. Iodine based solutions, i.e. Betadine/Poyidone
`Iodine, and Quantinary Compounds, i.e. Zepharm Solution.
`Do not use any sanitizing devices such as steam or autoclave.
`
`-^-19
`
`

`

`TheraStim Training Guide
`
`IPhysioDynamicSf^Ittc.
`I 1-800-775-2652 V
`
`The Patient Data Sheet has been included for your convenience.
`Plea

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