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OMNISTIM

PRO USER MANUAL

SYMBOLS ON THE PRODUCT

Symbol

Used for

Symbol

Used for

Serial number

Type BF medical device per:

IEC 60601

Date of manufacture

Manufacturer

Caution, consult accompanying

documents

Caution, electrical precautions

Remote Control connection

CE mark of confidence compliant

to MDD (93/42/EEC)

Connection Electrode Cable

IP2X

Classification against intrusion of

water, dust, accidental contact of

a body part.

Proper disposal required. Do not

dispose of with regular

household waste. Follow state

and/or local regulations.

Alternating current device.

Observe the user manual

Consult instructions for use

Protect the product from

humidity

ON / OFF push button

Содержание 100FX2C

Страница 1: ......

Страница 2: ...e used for any other purpose Any additional copies of the Manual shall be ordered from ACP No changes or modifications shall be made to the Manual without prior review and written authorization from ACP No authorization is given to market sell disclose or exploit this Manual except as for purposes of using the Equipment as contemplated by the Lease Agreement ACCELERATED CARE PLUS MAKES NO WARRANTY...

Страница 3: ...se Systems Our MEGAPULSE NEUROPROBE OMNISTIM OMNISOUND OMNIBAND OMNITEST OMNICYCLE and OMNIVR represent the most recent world wide advances available for therapeutic application of electromedical devices and other rehabilitation technology ACP is internationally recognized for its contribution to research in the development of medical applications for therapeutic rehabilitation The Company sponsor...

Страница 4: ...uments Caution electrical precautions Remote Control connection CE mark of confidence compliant to MDD 93 42 EEC Connection Electrode Cable IP2X Classification against intrusion of water dust accidental contact of a body part Proper disposal required Do not dispose of with regular household waste Follow state and or local regulations Alternating current device Observe the user manual Consult instr...

Страница 5: ...sal Precautions Body Substance Isolation 21 Cleaning Disinfecting of the Omnistim FX Pro 21 Cleaning and Low Level Disinfection 21 Intermediate Level Disinfection and Barriers 21 Use of Barriers Intermediate Level Disinfection 22 MODES OF OPERATON Protocol Reference Sheets 23 Pain Control 23 Neuro Re Education 24 Muscle Re Education 25 Functional Re Education 25 Functional Re Ed Assisted 25 OMNIST...

Страница 6: ...scle stimulator devices should only be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions Contraindications Do not use this device on patients who have a cardiac pacemaker implanted defibrillator or other implanted metallic or electronic device because this may cause electric shock burns electrical interference or death Note There is no contr...

Страница 7: ...rmy and through induction convert it into an electrical field transmit the energy into the patient increasing the current density at the electrodes of applicators Since the patient may not feel the 27 MHz frequency they lack the protective sensation and tissue burns could result Short wave field could potentially damage or reset medical devices in close proximity to the drum applicator Treatment s...

Страница 8: ...potential electric shock hazard exists once the device outer casing has been in part or fully removed Only qualified service personnel should perform Service and repairs Warranty will be voided if the outer casing has been removed or tampered with Use caution when the patient has a tendency to bleed internally such as following an injury or fracture Do not apply over areas of hemorrhage or active ...

Страница 9: ...n may disrupt the healing process Caution should be used for patients with suspected or diagnosed epilepsy Patients with suspected or diagnosed epilepsy should follow precautions recommended by their physicians Electrodes should not be placed in direct contact or in close proximity one inch or less of each other during treatment Electrodes placed in contact or in close proximity can lead to high e...

Страница 10: ...ing to operate the Omnistim FX2 Pro If questions remain unanswered contact your ACP sales representative or call 800 350 1100 Outside the USA call 1 775 685 4000 Introduction The Omnistim FX2 Pro provides Patterned Electrical Neuromuscular Stimulation PENS which is a form of stimulation that replicates the correct firing patterns of muscles agonist and antagonist or reciprocal muscle pairs in trip...

Страница 11: ...play SELECT PROTOCOL TREATMENT OFF E LEAD WIRE TESTER indicator LED When lead wires are properly connected to the LEAD WIRE TESTER the LED will display green if lead wires function properly and it will be red if lead wires are faulty or are not connected to the LEAD WIRE TESTER properly F Connector for the distal patient end of the lead wire when testing lead wire in the LEAD WIRE TESTER Observe p...

Страница 12: ...operation indicator LED This light is on when the power supply is plugged in and power is supplied to the unit V Solid carrying handle for easy transport of the unit Factory Settings The Omnistim FX2 Pro comes with the following factory settings Button Speed A B Output 87 Audio ON These are generally suitable for most clinicians To adjust these default settings proceed as follows 1 When the main s...

Страница 13: ...t and the unit will be in the SELECT PROTOCOL TREATMENT OFF mode 2 At this time select the treatment protocol desired and the appropriate treatment program by using the PROTOCOL buttons 2 to select PAIN NEURO RE ED MUSCLE RE ED FUNCTIONAL RE ED or FUNCTIONAL RE ED ASSISTED 3 Press the SELECT PARAM button to modify any settings Press the MODIFY TIME PARAM UP of DOWN buttons to adjust the desired tr...

Страница 14: ...cols using alternate or delayed modes the system will allow set up of output A followed by set up of output B 5 Adjust the output intensity by pressing the up down arrow buttons 3 for channel A and Channel B When the desired output is obtained press the START STOP button 4 to begin treatment The following screen will be displayed At this time the timer display on right side of the screen will disp...

Страница 15: ...sed in Bipolar or in Quadripolar Interferential mode for patient treatment With medium frequency currents the energy of each individual pulse is low providing for stimulation of only one or two neurons Since the pulses are coming in very rapid succession stimulation of surrounding neurons occurs prior to completion of the previous neurons refractory period This allows for asynchronous activation o...

Страница 16: ...technique for muscle stimulation This technique utilizes two electrodes but not exclusively of the same size One electrode should be applied over the motor point and the other electrode over the belly of the muscle as far away from the motor point as possible This technique allows for more effective muscle and nerve fiber recruitment since the entire neural innervation of the muscle is furnished w...

Страница 17: ...NARIS FINGERS FLEXOR DIGITORUM SUPERFICIALIS PROFUNDUS WRIST EXTENSOR CARPI ULNARIS EXTENSOR CARPI RADIALIS LONGUS BREVIS FINGERS EXTENSOR DIGITORUM EXTENSOR DIGITI MINIMI CH B CH A PATIENT IS PASSIVE DURING STIMULATION WRIST AND FINGER FLEXION AND EXTENSION BICEPS BRACHII CH A CH B TRICEPS BRACHII ELBOW FLEXION AND EXTENSION PATIENT IS PASSIVE DURING STIMULATION ...

Страница 18: ...EL OF UMBILICUS WAY BETWEEN THE ASIS AND THE ANTERIOR MIDLINE OVER THE TRANSVERSE ABDOMINAL MUSCLE PATIENT IS PASSIVE DURING STIMULATION FOR UNILATERAL INVOLVEMENT APPLY CH A TO THE MOST INVOLVED SIDE CH B CH A CH A CH B MID ANTERIOR DELTOID MID BICEPS BRACHII MID POSTERIOR DELTOID MID TRICEPS BRACHII SHOULDER FLEXION AND EXTENSION PATIENT IS PASSIVE DURING STIMULATION ...

Страница 19: ...EDIALIS VMO CH A KNEE FLEXION AND EXTENSION PATIENT IS PASSIVE DURING STIMULATION Over the iliopsoas just distal to the inguinal ligament medial and proximal to the sartourius and the lateral femoral artery Over the distal part of the rectus femoris PATIENT IS PASSIVE DURING STIMULATION PATIENT NEEDS TO BE SUPINE WITH HIPS EXTENDED CH B CH A CH B GLUTEUS MAXIMUS OR GLUTEUS HAMSTRINGS HIP FLEXION A...

Страница 20: ...ISH A TOE DOWN POSITION WHILE SEATED PLACE A TOWEL ROLL UNDER HEEL PLACE A PILLOW UNDER THIGH RAISE SEAT HEIGHT ANKLE DORSIFLEXION ANKLE DORSIFLEXION AND EVERSION PLANTAR FLEXION ANTERIOR AND INFERIOR TO THE FIBULAR HEAD MID TIBIALIS ANTERIOR ANTERIOR AND INFERIOR TO THE FIBULAR HEAD MID TIBIALIS ANTERIOR PERONEUS LONGUS BREVIS CH A CH B CH A TRICEPS SURAE GASTROCNEMIUS SOLEUS ...

Страница 21: ...sites to decrease or eliminate skin irritation on electrically sensitive patients If skin irritation persists with alternate site applications decrease the treatment times and lower the intensities if necessary discontinue treatment If an allergic reaction is suspected attempt to identify and change the allergic substance s If skin irritation persists discontinue treatment until the source of irri...

Страница 22: ...ty infection control policy ACP recommends the following guidelines Cleaning and Low Level Disinfection This is a recommended daily housekeeping practice to keep the equipment clean and free of contaminants which could contribute to transmission of infection The following practices are recommended for use when treating intact skin without the presence of physiologic fluids such as blood and urine ...

Страница 23: ... 2 Apply Intermediate Level Disinfection prior to barrier application 3 Select tear or cut with clean scissors a length of barrier film to fit over the operator surfaces of the Omnistim FX2 Pro unit 4 Select and cut with clean scissors a 2 foot length of plastic sleeve and fit over the lead wire and the electrode cabling 5 Prepare any items which may become in contact with the therapist during tre...

Страница 24: ...C MOTOR Set Outputs A and B until the patient feels the desired sensation Press START STOP and T15 will display in upper right corner Adjust treatment time if necessary using the TIME PARAMETER button The treatment will end at the end of the preset time or if the patient safety switch is pressed TENS LVPC MOTOR Symptomatic relief of superficial pain with inflammation or pain of a generalized or mu...

Страница 25: ...eatment will end at the end of the preset time or if the patient safety switch is pressed LE TRIPHASIC PENS Neuro re education FX2 before Therex 70 µS phase duration L E Triphasic EMG Pattern Treatment time of 15 minutes This program is used tore educate L E agonist and antagonist muscle pairs where fine motor control and positioningis required Place the and electrodes as indicated in the clinical...

Страница 26: ...tional movement Press FUNCTIONAL RE ED ASSIST button until screen reads MFAC HAND CONTROL Set Outputs A and B until the desired contraction level is obtained Press START STOP and T15 will display in upper right corner Adjust treatment time if necessary using the TIME PARAMETER button The treatment will end at the end of the preset time or if the patient safety switch is pressed LVPC HAND CONTROL A...

Страница 27: ...IER FREQ 5 0 kHz N BURST FREQUENCY 100 Hz N BURST RATE SCAN 20 N RATE SCAN ON N RATE SCAN TIME 20 s Y 2 VECTOR Slow 45 Fast 45 Slow 90 Fast 90 OFF Fast 90 Y 1 TREATMENT TIME 0 99 min 15 min B TENS LVPC SENSORY This program is used for symptomatic relief of superficial pain from localized dermatome or segmental origin Sensory stimulation activates A beta fibers causing the release of spinal Enkepha...

Страница 28: ...i segmental nature Motor level stimulation activates motor and A delta fibers causing the release of Bendorphin systemically Duration of relief is typically from 2 to 6 hours Slow onset of relief is usually within 15 minutes to 1 hour Target tissue is superficial Bipolar placement over local and distal acu trigger point or a spinal segmental level Intensity should be set to elicit a moderate muscl...

Страница 29: ...ry Subprogram 2 User Adjustable Parameter Y N Order in Parameter Set Loop Parameter Name Adjustable Range unit Default unit N CARRIER FREQ 5 0 kHz N BURST FREQUENCY 2 0 Hz N BURST RATE SCAN 50 N RATE SCAN ON N RATE SCAN TIME 15 s Y 2 VECTOR Slow 45 Fast 45 Slow 90 Fast 90 OFF OFF Y 1 TREATMENT TIME 0 99 min 15 min IFC Motor Sensory Subprogram 3 User Adjustable Parameter Y N Order in Parameter Set ...

Страница 30: ...uscular function PENS helps re boot the sense position system and neuromuscular junction to improve recruitment and muscle function It should be used prior to Therex to improve recruitment and motor performance It s also used to decrease spasticity and muscle tone User Adjustable Parameter Y N Order in Parameter Set Loop Parameter Name Adjustable Range unit Default unit Y 2 PHASE DURATION 40 100 μ...

Страница 31: ...euromuscular junction to improve recruitment and muscle function It should be used prior to Therex to improve recruitment and motor performance It s also used to decrease spasticity and muscle tone User Adjustable Parameter Y N Order in Parameter Set Loop Parameter Name Adjustable Range unit Default unit Y 2 PHASE DURATION 40 100 μs 70 μs N PULSE RATE 50 Hz Y 1 TREATMENT TIME 0 99 min 15 min N CHA...

Страница 32: ...parameter is shown only when the Channel Mode is set to B DELAYED Muscle Re Ed A MFAC SURFACE DEEP MUSCLE Program used for strength development and treatment of muscle disuse atrophy Activation of muscle with electrical stimulation at a high intensity for a short time with long ON OFF ramps reduces atrophy and improves strength The patient should participate to the extent possible by contracting d...

Страница 33: ...s 70 μs Y 7 PULSE RATE 0 0 250 Hz 50 0 Hz N PHASE DURATION MOD 0 N MODULATION OFF N RATE SCAN TIME 0 s Y 1 TREATMENT TIME 0 99 min 10 min Y 2 9 2 B OUTPUT DELAY 0 0 9 9 s 0 0 s Y 4 RAMP UP 0 0 9 9 s 2 0 s Y 5 RAMP DOWN 0 0 9 9 s 2 0 s Y 2 T ON 0 30 s 10 s 1 Y 3 T OFF 0 199 s 50 s 1 Y 8 CHANNEL MODE A B SIMULTANEOUS A B ALTERNATE B DELAYED A B SIM 1 When T OFF 0 T ON CONTINUOUS 2 B OUTPUT DELAY par...

Страница 34: ...sitting with hips and knees flexed A light resistance using weight cuffs or exercise band can be applied The stimulation should cause a light to moderate contraction Transition to standing with weight shifting activities then to walking in place in later rehab User Adjustable Parameter Y N Order in Parameter Set Loop Parameter Name Adjustable Range unit Default unit Y 2 PHASE DURATION 40 100 μs 70...

Страница 35: ...MENT TIME 0 99 min 15 min Functional Re Ed Assisted A MFAC HAND CONTROL Program provides for active assisted treatment to develop functional movement of superficial and deep muscle Activation of muscle with electrical stimulation occurs during functional movement The patient should participate to the extent possible with the functional movement by contracting during the stimulation ON time Target ...

Страница 36: ...ovement by contracting during the stimulation ON time Target tissue is smaller superficial muscle groups Bipolar set up over agonist and antagonist muscles for target muscle Set intensity to elicit a grade 3 5 muscle contraction Reduce treatment time based on muscle fatigue User Adjustable Parameter Y N Order in Parameter Set Loop Parameter Name Adjustable Range unit Default unit Y 2 PHASE DURATIO...

Страница 37: ...use temporary nerve membrane depolarization while present This effect is known as Wedensky Inhibition or nerve block Medium frequency currents have an inhibitory effect on pain transmission and sensation within the field of treatment This effect is responsible for the decreased sensation under the stimulation electrodes Medium frequencies are also selected due to their excellent tissue penetration...

Страница 38: ... field interferential current therapy may be described as follows a Stimulation of deep and surface tissues b May be used to produce deep and surface analgesia via nerve block Wedensky Inhibition when MF mode is used 3 Vector Technique In order to move the position of the deep interferential fields researchers developed systems to alter the relative amplitudes between stimulation channels in inter...

Страница 39: ...ase intensity to maximum patient tolerance during each contraction Place electrodes in a monopolar bipolar or quadripolar pattern on the muscles in spasm The treatment time should be of approximately 20 minutes duration repeated 2 or 3 times per week c Increased Blood Flow Edema Reduction Long and short term electrical stimulation of muscle has been shown to alter the vascular dynamics affecting l...

Страница 40: ...onds CHANNEL TIMING Simultaneous alternate or delayed channels DELAY MODE Adjustable from 0 9 9 seconds AUTO INTENSITY Adjusts the output during treatment automatically from 0 to 20 user programmable Low Voltage Pulsed Current LVPC LOW VOLTAGE PULSED CURRENT WAVEFORM LVPC is generally used for surface and smaller muscle stimulation and pain control with TENS technique MFAC WAVEFORM ...

Страница 41: ...lectrodes Replace with correct and adequate conductive medium LEAD WIRE TESTER Plug the distal patient end of the lead wire into the test connectors while observing polarity red black Plug the device end of the lead wire into the receptacle labeled LEAD WIRE TESTER When the POWER is on green LED will turn on if the lead wire passes the test LED will be red if the lead wires are faulty and need to ...

Страница 42: ...timulator unit Hold the metal contact plate in place with one finger Use a small piece of sand paper to clean the surface of the metal contact thoroughly as needed Figure 3 Figure 3 3 Verify the switch inside the battery compartment is set to the RECHARGEABLE BAT position assuming rechargeable batteries are being used which is recommended 4 Install the rechargeable batteries into the unit 5 Verify...

Страница 43: ... end of the lead wire into the receptacle labeled LEAD WIRE TESTER When the POWER is on green LED will turn on if the lead wire passes the test LED will be red if the lead wires are faulty and need to be replaced When lead wires pass the test check for loose connections by holding the lead wire about 3 inches from plug in connectors and slowly rotate the lead wire in a circular motion while the wi...

Страница 44: ...D then there is sufficient output present on the selected channel Change the output tester to channel B and follow the above process Service Center For repair or service of ACP Products and accessories please call 800 350 1100 and follow the prompts Normal hours of operation are 6 00am to 5 00pm Pacific Standard Time After hours please leave a message and a technician will return your call during ...

Страница 45: ...rm AC sine wave into physiologic load IFC and MFAC modes and biphasic square wave LVPC or mono phasic pulsed current HVPC mode Output Amplitude IFC FD and NMES modes 0 to 70 mA RMS current into a 500Ω LVPC mode 75mA P P HVPC mode 250VDC peak into 500Ω loads Channel Isolation Independent transformer isolation Line Leakage 50 µA when operated with the charger system MFAC MEDIUM FREQUENCY ALTERNATING...

Страница 46: ...taneous modes the output is simultaneous In delayed mode channel B is delayed TIMING SELECTIONS Ramp Time Adjustable from 0 1 to 9 9 seconds in 0 1 second increments Ramps overlap in NMES Alt mode or with channel delay ON Time Adjustable from 1 to 30 seconds in 1 second increments OFF Time Adjustable from 0 continuous to 199 seconds in 1 second increments PATIENT SAFETY SYSTEMS Activation Patient ...

Страница 47: ...h MFAC Russian style NMES and Low Volt Pulsed Current LVPC Shipping Weight 5 lbs 2 3 kg ITEM ITEM NO DESCRIPTION 48758 Lead Wire Standard Blue Green pair 24248 Lead Wire Bifurcated Blue Green pair 39555 Patient Safety Switch 51122 Omnistim Power Supply 110v 19856 Omnistim Power Cord A C Hospital Grade 13331 Omnistim Output Tester 67652 Omnistim Leatherette Soft Carry Case 65662 Rechargeable Batter...

Страница 48: ... NO DESCRIPTION 52479 Barrier Film for Surfaces Infection Control 4 x 6 perforated sheets 1200 sheets roll 66431 Barrier Film for Surfaces Infection Control 6 x 9 perforated Sheets 1200 sheets roll 50593 Barrier Film for Surfaces Infection Control 12 x 14 perforated Sheets 800 sheets roll 63574 Protective Barrier Tubing 3 1200ft roll 55536 Super Sani Cloth Wipes Single Use Packets 50 pkt bx 44425 ...

Страница 49: ...oid if any of the following have occurred 1 The product contains repairs or replacement parts not furnished by ACP 2 The product is damaged resulting from misuse or negligence 3 The product has been tampered with and or altered including serial number alteration Note Use of the Equipment with accessories and or supplies not approved by ACPL for use with the Equipment may void the warranty if such ...

Страница 50: ... warranty ACP is not responsible for any loss or damage to the Equipment prior to receipt at the ACP Service Center Equipment returned for warranty service must be shipped complete with all accessories except for manuals in its original packing or equivalent so as not to be damaged while in transit Note Any Equipment sent to the ACP Service Center that is not covered by the ACP Limited Product War...

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