Acp Omnistim fx2 User manual

OMNISTIM®FX2

PORTABLE PENS

Patient User Manual

Revised 10.14.2021

Part No. MNL-0004 Rev 8

This manual and all content therein is owned exclusively by Accelerated Care Plus ("ACP") and

is protected by copyright. This manual or any portion thereof may not be photocopied,

reproduced or translated to another language without the express prior written consent of ACP.

This manual may only be used by entities that have purchased the equipment or have

implemented the ACP program and are covered by an executed lease agreement. This manual

may not be 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 OF ANY KIND WITH REGARD

TO THIS MANUAL, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED WARRANTIES

OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE. Accelerated

Care Plus shall not be liable for errors contained herein or for incidental or consequential

damages in connection with the furnishing, performance or use of this Manual. The information

contained in this document is subject to change without notice

OMNISTIM

PORTABLE PENS PATIENT USER MANUAL

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ACP manufactures a premier line of rehabilitation technologies to assist health care professionals

with improved outcomes and quality-of-life for Patients. The ACP product line includes Pain

Control Systems, Muscle Stimulators, Interferential Therapy, Therapeutic Ultrasound, Pulsed

Shortwave Diathermy devices, and advanced Therapeutic Exercise Systems. Our OMNISTIM®,

OMNICYCLE®, OMNIVR®, OMNISTAND®, OMNIVERSA®, OMNISWD®and

SYNCHRONY represent the most recent worldwide 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 sponsors and conducts research at

leading health care institutions and major universities throughout the world.

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OMNISTIM

PORTABLE PENS PATIENT USER MANUAL

TABLE OF CONTENTS

ELECTROTHERAPY INDICATIONS & CONTRAINDICATIONS .................... 3

Indications........................................................................................................................................... 3

Contraindications ................................................................................................................................ 3

Adverse Reactions .............................................................................................................................. 3

Warnings ............................................................................................................................................. 4

Precautions .......................................................................................................................................... 5

THE OMNISTIM® FX2 PORTABLE PENS ...................................................... 7

Delivery of the Omnistim® FX2 Portable PENS ............................................................................... 7

Introduction......................................................................................................................................... 7

Controls and Functions ....................................................................................................................... 8

Patient Operational Sequence ............................................................................................................. 9

TREATMENT PREPARATION.........................................................13

Treatment Site / Skin Inspection....................................................................................................... 13

ACP Reusable Pre-gelled Surface Electrodes .................................................................................. 13

Lead Wires ........................................................................................................................................ 13

CLEANING ..................................................................................................... 14

TROUBLESHOOTING.................................................................................... 14

TECHNICAL SPECIFICATIONS .................................................................... 15

STANDARD AND OPTIONAL ACCESSORIES ............................................ 16

TREATMENT CHART .................................................................................... 17

STANDARD LIMITED PRODUCT WARRANTY............................................ 17

OMNISTIM

PORTABLE PENS PATIENT USER MANUAL

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ELECTROTHERAPY INDICATIONS & CONTRAINDICATIONS

CAUTION: Federal law restricts this device for sale or use by, or on the order of,

a Practitioner licensed by the laws of the state in which he/she practices to use

or order the use of the device.

Please note that Accelerated Care Plus cannot provide medical advice. If you

have specific medical questions, please contact your healthcare professional.

Indications

The Omnistim®FX2Portable PENS is indicated for:

Relaxation of muscle spasms.

Re-education of muscle action.

Prevention or retardation of disuse atrophy.

Immediate post surgical stimulation of calf muscles to prevent venous thrombosis.

Increased local blood circulation.

Maintaining or increasing range of motion.

Symptomatic relief and management of chronic intractable pain and as an adjunctive

treatment in the management of acute pain, post-surgical pain and pain associated with

post-traumatic injury.

Electrical muscle stimulator devices should 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,

Never connect lead wires to the power line or electro-surgery equipment. Use only the

lead wires recommended or approved by the manufacturer

Never connect lead wires to the power line or electro-surgery equipment. Use only the

lead wires recommended or approved by the manufacturer

Note:

There is no contraindication to the application of Transcutaneous Electrical Stimulation or

Powered Muscle Stimulation over metal implants.

Adverse Reactions

Skin irritation and burns, beneath the electrodes, have been reported with the use of powered

muscle stimulators. Patients may experience skin irritation and burns beneath the stimulation

electrodes applied to the skin.

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OMNISTIM

PORTABLE PENS PATIENT USER MANUAL

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.

Patients should stop using the device and should consult with their physicians if they experience

adverse reactions from the device.

Warnings

•

The long-term effects of electrical stimulation are unknown;

•

Do not apply stimulation over the patient’s neck 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

•

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. Stimulation should not be applied transthoracically in the vicinity of the heart, as

introduction of electrical current into the heart may cause cardiac arrhythmias.

•

Do not apply stimulation when the patient is in the bath or shower

•

Do not apply stimulation while the patient is sleeping; and

•

Do not apply stimulation while the patient is driving, operating machinery, or during any

activity in which electrical stimulation can put the patient at risk of injury.

•

Consult with the patient’s physician before using this device because the device may cause

lethal rhythm disturbances to the heart in susceptible individuals

•

Apply stimulation only to normal, intact, clean, healthy skin.

•

Do not operate this device until the User Manual, including all Indications for Use,

Contraindications, Warnings and Precautions, have been carefully read and understood.

•

Operation of this device or placement of lead wires, probes, pads and electrodes in close

proximity (less than 5 feet) to an operating shortwave or microwave diathermy unit may

produce instability in the device output or burns at the treatment site. Lead wires and

device can pick up the magnetic field output of the diathermy 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 should not be applied over the carotid sinus nerves, (located in the anterior neck

triangle), including, stellate ganglion, vagus nerve, or laryngeal or pharyngeal muscle.

Particular care should be taken for patients with a known sensitivity to the carotid sinus

reflex, as carotid sinus stimulation may alter blood pressure and cardiac contractility.

•

Do not apply treatment over testes, heart or eyes. Electrical stimulation may affect organ

function.

•

Do not apply over or in close proximity to active cancer (except in terminal / palliative /

hospice care), as therapy may increase blood flow to the tumor.

•

Treatment should not be applied when high fever is present over swollen, severe infection

(osteomyelitis, sepsis, tuberculosis, etc.) or inflamed areas/skin eruptions (phlebitis,

thrombophlebitis, varicose veins, etc.).

•

Do not apply over the lumbar or abdominal region, or over the uterus during pregnancy (to

prevent uterine contraction), or during menstruation as therapy may temporarily increase

menstrual flow.

•

Treatment should not be applied transcranially. 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 should not be applied to patients connected to patient monitoring equipment,

as the stimulation may have an effect on the proper operation of the monitoring equipment.

OMNISTIM

PORTABLE PENS PATIENT USER MANUAL

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•

Stimulation should not be applied directly over external stimulator systems with lead wires

•

Neuromuscular electrical stimulation (NMES) should not be applied directly over or in

close proximity to Deep Vein Thrombosis (DVT), as it activates the muscle and causes

muscle contractions. This should be avoided in tissue following an acute DVT when the

thrombosis is not completely resolved. Therapists should follow the guidelines provided

by the referring physician on recommended activity level and modality use. If the patient

is not permitted exercise, NMES therapy should be avoided. Generally, NMES over a

DVT of six weeks or less should be avoided altogether.

Precautions

•

The safety of electrical stimulation during pregnancy has not been established;

•

Some patients may experience skin irritation or hypersensitivity due to the electrical

stimulation or electrical conductive medium. The irritation can usually be reduced by using

an alternate conductive medium, or alternate electrode placement.

•

Application site and settings should be based on the guidance of the prescribing practitioner.

•

All equipment and accessories should be kept out of the reach of children or unqualified

persons.

•

Do not connect this device to any wall outlet that has not been properly grounded, or to any

electrically non-isolated medical device Powered muscle stimulators should be used only

with the leads and electrodes recommended for use by the manufacturer. Use this device

only with the leads, electrodes, and accessories recommended by the manufacturer. Use only

ACP specified accessories and/or supplies with ACP devices. Do not use any power cords,

or power supplies, other than the ones provided or specified for this device. Use of any other

power supply could seriously damage the device and will void the warranty.

•

The use of conductive mediums other than specifically approved pre-gelled or self-adhering

electrodes such as ultrasound gel or lotion, hand or body lotion, electrolyte spray mist, paper

towels, non-approved reusable or disposable pre-gelled or self-adhering electrodes— are not

advised for use with Omnistim Systems.

•

When cleaning the device, never immerse them or wash them with water. See the infection

control section in this manual for cleaning instructions. Devices should not be submerged in

water or other liquids.

•

Failure to follow the manufacturer’s prescribed maintenance for this device may lead to

device failure and transient or unreliable performance. State and federal survey and JCAHO

require all equipment to be maintained and calibrated according to the manufacturer

recommended schedules.

•

A 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 bleeding.

•

Inspect and cleanse the skin prior to application. Following treatment check the skin for

evidence of irritation or burns, and if present, treat as appropriate. If the patient has, or

complains of, skin irritation following treatment; shorten the treatment time on the next

treatment session, or use an alternative type of therapy or electrode placement.

•

Gradually increase the output intensity/power to required dose or patient tolerance while

monitoring the device display.

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OMNISTIM

PORTABLE PENS PATIENT USER MANUAL

•

Caution should be taken with patient exhibiting psychological or physical hypersensitivity

to the therapeutic treatment. Several attempts should be made to place them at ease so that

their confidence and cooperation can be gained during the treatment.

•

The treatment area should be checked from time to time, and if there is evidence of, or if the

patient complains of, pain during treatment, adjust the output downward until it is tolerated

by the patient. If the patient continues to complain of pain, discontinue the treatment and

shorten the treatment time on the next treatment session, or use an alternative type of therapy

or electrode placement.

•

Do not apply treatment directly over/under hot or cold packs. Caution is recommended when

treatment follows the application of hot or cold therapy, which may alter the patient’s

sensation. Application of thermal agents over areas of impaired circulation should be

performed with caution as the circulation may be insufficient to heat or cool the tissue,

altering the patient’s perception of warmth and pain, and burns or tissue necrosis may result

from subsequent treatment.

•

Caution is recommended when treatment follows the application of medicated patches,

salves, or creams which may alter the patient’s sensation. If there is a medical necessity to

perform such treatments, these patients should be monitored diligently during application.

The effect of electrical stimulation may be altered by the presence of these materials on the

patient’s skin.

•

Caution should be used over areas of body where circulation is impaired, or which lack

normal sensation. Absent or diminished sensation should be avoided or, if unavoidable,

treated with caution. Establishment of acceptable intensity levels for desensitized areas may

be related to the intensity levels tolerated on normal skin in opposite or related body parts.

•

Caution should be used in the presence of recent surgical procedures, fractures or healing

bone and soft tissue when muscle contraction 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 energy density and skin burns under or between the electrodes.

•

Care should be used when removing electrodes after treatment, in order to minimize the

potential for skin tearing. Skin should be inspected after removal of electrodes for any signs

of tearing or irritation.

•

Do not connect the stimulator to any electrical equipment for combination therapy except

the Omnisound® family of ultrasounds.

OMNISTIM

PORTABLE PENS PATIENT USER MANUAL

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THE OMNISTIM®FX2 PORTABLE PENS

Delivery of the Omnistim®FX2 Portable PENS

Upon receipt of your Omnistim®FX2Portable PENS,

inspect the shipping container and contents for any obvious

or concealed damage. All ACP products are packaged

carefully for rapid, safe delivery. We guarantee delivery in

perfect condition to the postal or delivery services. However

any damage or loss incurred during transportation or

delivery is the postal or delivery company responsibility. If

damage or loss to the product and/or container is obvious or

suspected, appropriate notation must be made on the signed

freight bill at the time of delivery. All damage claims should

be promptly filed with the delivering carrier and must be

initiated by the addressee where the package was to be

delivered. Retain the original shipping container and inserts

for validation of damage claim or use at a later date.

Introduction

The Omnistim®FX2Portable PENS 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 Upper and Lower Extremity Triphasic

(ballistic), or Upper Extremity Biphasic (reciprocal) patterns. This approach to neuro re-ed

provides a comfortable, precisely timed sensory input, which duplicates the firing activity of

sensory nerves and muscles during voluntary activity.

The Omnistim®FX2Portable PENS also provides Medium Frequency Alternating Currents

(MFAC) for pain management applications. Its generator produces medium frequency 5000 Hz

current. Two output circuits with independent intensity controls are provided. The output of

each circuit is easily determined in milliamps through the display screen. The digital timer

allows the operator to select the length of the total treatment time in minutes.

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OMNISTIM

PORTABLE PENS PATIENT USER MANUAL

Controls and Functions

(1)

Main Power Switch – is used to turn the device on and/or off.

(2)

Program Button A – is used to select the first program prescribed.

(3)

Program Button B – is used to select the second program prescribed.

(4)

Output Adjustment Channel A – is used to adjust the intensity level of channel A.

(5)

Output Adjustment Channel B – is used to adjust the intensity level of channel B.

(6)

Channel A Connection – plug the green marked lead into the green channel,

which corresponds to the Program Button A being used.

(7)

Channel B Connections – plug the blue marked lead into the blue channel, which

corresponds, to the Program Button B being used.

(8)

Display – displays program information and intensity readings. The A and B at the

top of the display mark the channels.

(9)

Battery Compartment – this is where the 9-volt battery is located.

OMNISTIM

PORTABLE PENS PATIENT USER MANUAL

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Patient Operational Sequence

Follow the sequence below. The number in parenthesis references the location of the

button from the control section on the previous page.

Install battery in compartment located on the back of the unit (9).

Connect lead wires to corresponding bar code under the display window (green lead

wire in the left input (6), blue lead in the right input (7).

Wash the skin with water, (use soap if dirty).

Connect black unit lead wires to white electrode wires.

Press the power on/off button (1) to power on the device.

At power on, the display (8) will default to the pre-set program selected for your

condition.

If a second program has been ordered by your physician, press Program

Button B (3) to access the additional program.

To return to the first program, press Program Button A (2).

Apply electrodes to treatment area prescribed by your physician or therapist.

Adjust stimulation intensity to level prescribed by your physician or therapist.

Increase / decrease (4) Output A. Press (+) button to increase intensity in

channel A. Press the (-) button to decrease intensity in channel A.

NOTE: If the channel indicator flashes or you see this symbol you must

reset the output level. (See troubleshooting section).

Attention/Caution

Increase / decrease (5) Output B. Press (+) button to increase intensity in

channel B. Press the to decrease intensity in channel B. See note above.

NOTE: Shortly after reaching the desired intensity setting, the unit will

lock the setting preventing an accidental increase in the intensity. A lock

icon will be indicated on the display. To unlock, you must first press the (-

) button to decrease the intensity, and then press the (+) button to increase

the intensity to the new desired level. If you see the reset output symbol

you must press (-) button to decrease the intensity, and then press the (+)

button to increase the intensity to the new desired level.

Lock Decrease

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OMNISTIM

PORTABLE PENS PATIENT USER MANUAL

The treatment timer will automatically end the treatment in the time prescribed.

Treatment ends when bars show up on the display (8).

10.

Turn the unit off by pressing the Power Button (1).

11.

Remove the stimulation electrodes. Repack the re-useable electrodes into their foil

pouch electrodes and follow the directions on the label for electrode care and

storage.

NOTE: If you are using single use electrodes, discard after each use.

12.

Clean unit with ACP Germicidal Wipes.

13.

Store unit in carrying case.

14.

Record treatment activity and setting on form provided.

1). Install battery in compartment located on

the back of the unit.

2). Connect lead wires to corresponding

bar code under the display window

(green lead wire in the left input,

blue lead in the right input.

3). Wash the skin with water (use soap if

dirty).

4). Connect black unit lead wires to

white electrode wires.

OMNISTIM

PORTABLE PENS PATIENT USER MANUAL

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5). Press the power on/off button to power on

the device.

6). Select Program Button A or Program

Button B as directed by your

physician or therapist.

7). Apply electrodes to treatment area

prescribed by your physician or therapist.

8). Adjust stimulation intensity to level

prescribed by your physician or

therapist.

NOTE: To readjust stimulation intensity,

remove the lock by pressing (-) Button and

then (+) Button to preferred level.

9). Treatment is completed when bars

appear in the Display Window.

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OMNISTIM

PORTABLE PENS PATIENT USER MANUAL

10). Remove the stimulation electrodes.

Repack the re-useable electrodes into

their foil pouch electrodes and follow the

directions on the label for electrode care

and storage.

NOTE: If you are using single-use

electrodes, discard after each use.

11). Turn the unit off by pressing the

Power Button.

12). Clean unit with ACP Germicidal Wipes. 13). Store the device in carry case.

14). Record treatment activity and setting on

form provided.

OMNISTIM

PORTABLE PENS PATIENT USER MANUAL

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Treatment Preparation

Treatment Site / Skin Inspection

Thoroughly cleanse the treated area with soap and water to remove oils, creams, dirt, and sweat; this

will ensure uniform current conduction across the skin. After cleansing, inspect and evaluate the

skin’s integrity and sensation prior to treatment. Avoid absent or diminished sensation; if

unavoidable, treat with caution. Establishment of acceptable intensity levels for desensitized areas

may be related to the intensity levels tolerated on normal skin in opposite or related body parts.

Frequently monitor the intensity level and skin response during all treatments.

Stinging, burning or other painful sensation under the electrodes on normal or desensitized areas

is an indication of increased current density under part or the entire electrode surface. In this case,

slowly but immediately reduce the current intensity to zero; remove the electrodes to inspect the

surface skin. Recheck your application techniques.

Immediately after treatment, clean and thoroughly inspect the skin under the electrode. Peripheral

vasodilatation along with systemic vasomotor responses can lead to redness (hyperemia) directly

under both electrodes. Inform the patient of this normal after effect and that the redness will

disappear within an hour or two. Apply topical agents to the reddened area under the electrodes if

needed to decrease post-treatment irritation. Persistent skin irritation could be due to repeated

stimulation of the same electrode site or a possible allergic reaction to the conductive mediums,

tapes, elastic wraps, and/or cleaning and disinfectant solutions. Therefore, use additional electrode

stimulation 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 irritation is determined.

By far the most common error with reported faulty machines is inadequate or improper conductive

medium interface or lead wire breakage. Because of the increased current density available with

pulsed or continuous medium frequency currents, a proportionally greater degree of conductive

medium interface problems exists and should be monitored by the clinician.

ACP Reusable Pre-gelled Surface Electrodes

Remove the electrodes from their foil packaging. Connect the electrodes to the device. Cleanse

the skin, and then apply the electrodes over the treatment site points according to the electrode

placements techniques described in this manual. Various sizes of electrodes are available

dependent upon muscle size of the area to be treated. Follow the enclosed infection control

procedures. Review the warnings and application directions on the electrode packaging.

Lead Wires

Inspect the full length of the lead wires for signs of frayed or cut wires and loose connections

where the lead wires join the jack plug and tip pins. Insert the plug completely. Allow the lead

wires to hang freely with no excessive strain on the connector.

NOTE: The use of conductive mediums other than specifically approved pre-gelled or self

adhering electrodes such as ultrasound gel or lotion, hand or body lotion, electrolyte spray

mist, paper towels, non-approved reusable or disposable pre-gelled or self-adhering

electrodes—are contraindicated for use with Omnistim®Systems.

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OMNISTIM

PORTABLE PENS PATIENT USER MANUAL

CLEANING

Cleaning / Disinfecting of the OMNISTIM®FX2PORTABLE PENS

It is recommended to clean the device and lead wire attachments after each use to control the

spread of infection.

•Clean the Omnistim®FX2Portable PENS after each use with ACP germicidal wipes. Wipe

common contact surfaces, such as control panel, lead wires, and probe tips with germicidal

disposable wipes and allow to air dry. This technique will inactivate most bacteria and viruses.

This will also facilitate removal of contaminants from the equipment and accessories.

•Disposable/reusable electrodes are for individual patient use only and should not be shared

with others.

•All disposable electrodes should be discarded after each use. Do not attempt to clean and

reuse disposable electrodes.

TROUBLESHOOTING

The following table lists machine problem symptoms and possible areas to check for the problem

causes. If these suggested measures do not correct the machine malfunction, call your physician

for assistance.

PROBLEM

CAUSE

REMEDY

Unit will not power on

•

No batteries

•

Low batteries

•

Install batteries

•

Replace batteries

•

Verify type of batteries

•

Inspect battery contacts

Display shows low

battery symbol

•

Battery voltage is too low

•

Replace batteries for future use

Channel indicator

flashing and caution

symbol is displayed

•

Batteries are too low to perform treatment

•

Lead wires not properly connected

•

Lead wire to electrode not connected

•

Improper skin preparation

•

Replace batteries

•

Replace lead wire(s) if defective

•

Properly connect leads as needed

•

Properly prepare skin prior to treatment

Patient feels surging or

spiking sensation

•

Lead wire(s) breakage

•

Electrode(s) lead wire breakage

•

Replace lead wire(s) if defective

•

Replace electrode(s)

Patient cannot detect

output

•

Failure of lead wire(s)

•

Electrode(s) failure, or electrode gel

dried out

•

Device failure

•

Replace lead wire(s) if defective

•

Remove electrode(s) and replace

if necessary

•

Contact ACP customer service

Symbols

Caution or Attention. There is a problem. No patient detected.

Output locked. Decrease output to unlock then increase output.

Reduce output before increasing the channel to desired level.

OMNISTIM

PORTABLE PENS PATIENT USER MANUAL

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TECHNICAL SPECIFICATIONS

GENERAL:

Dimensions: 1.5" (38mm) D x 2.5" (65mm) W x 5.4" (137mm) H

Weight (Including batteries): 0.35lbs. (0.16kgs)

Operating Power: 9V alkaline

Battery Life:

New alkaline batteries operate the system for 40 hours

at full output and over 100 hours at normal settings.

Battery voltage emblem is displayed when battery low

voltage is indicated.

Display System: LCD Display

Push Buttons:

Polyester embossed overlay for tactile feel and infection

control.

System Memory:

The system remembers all prior custom settings from

treatment to treatment-in non-volatile memory.

System Architecture:

CMOS integrated micro-controller with on board memory

and instruction set.

STIMULATION SYSTEM:

Output:

Constant current up to maximum preset current limit of

60mA into a 500 ohm load.

PENS (PATTERNED ELECTRICAL NEUROMUSCULAR STIMULATION) PROGRAMS:

Waveform:

Asymmetric Biphasic Pulsed Current 0-60mA average single

pulse current into a 500 ohm load.

Phase Duration: Set at 70µs; Variable from 50µs to 120µs

Pulse Rate: Set at 50 Hz burst pattern

TENS (MEDIUM FREQUENCY CURRENT) PROGRAMS:

Carrier Frequency:

Output channel A, or B fixed at 5.0 KHz. Modulated at

Burst Rate.

Burst Rate:

Three programs, Sensory 80-120 BPS, Motor 2-15 BPS,

Sensory Motor 15-2-100 BPS

Rate Scan: 0-20 seconds for rate sweep

TIMER FUNCTIONS:

Treatment Timer:

Set to 20 minutes by default; Adjustable for 1-30

minutes in one minute increments.

CAUTION: Federal law restricts this device to sale by or on the order of a physician (or other

health practitioner licensed by their State).

ACP reserves the right to change technical specifications and product availability without notice.

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OMNISTIM

PORTABLE PENS PATIENT USER MANUAL

OMNISTIM®FX2PORTABLE PENS

STANDARD AND OPTIONAL ACCESSORIES

ITEM

ITEM NO.

DESCRIPTION

300200A

OMNISTIM®FX2

PORTABLE PENS

Offers 2 channels of

programmable

stimulation with PENS

and TENS programs.

28126

OMNISTIM®FX2a

PORTABLE PENS

Hard Carry Case

74747 9V Alkaline battery

38155

2x2 Reusable E-stim

Electrodes

(4 ea/pkg, 10 pkg/bx)

61227

2x4 Reusable E-stim

Electrodes

(4 ea/pkg, 10 pkg/bx)

https://acplus.com/acp-

technology-user-

manuals

OMNISTIM®FX2

PORTABLE PENS

Professional User

Manual

https://acplus.com/acp-

technology-user-

manuals

OMNISTIM®FX2

PORTABLE PENS

Patient User Manual

Infection Control Supplies

ITEM

ITEM NO.

DESCRIPTION

55536 Super Sani-Cloth®Wipes, Single

Use Packets (50 pkt/bx)

44425

Super Sani-Cloth®Wipes, Tub (160

wipes/tub)

96849 Sani-Cloth®Wipes w/ Bleach, Tub

(75 wipes/tub)

63574 Barrier Tubing

3" x 1200’/roll

OMNISTIM

PORTABLE PENS PATIENT USER MANUAL

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TREATMENT CHART

Mark the prescribed program, button, and intensity prescribed. Place date and time in the column

provided, and comment on the intensity level.

DAY

TIME

PROGRAM

(PENS 1, 2, 3,

TENS 1, 2, 3)

BUTTON

( A / B )

INTENSITY

( 1 to 100 )

COMMENTS

( TWITCH OR

TINGLE)

ELECTRODE PLACEMENT GUIDE

Provide the patient with the Patient Electrode Placement Guide and indicate the electrode placement

for each treatment prescribed. Mark each electrode location with (+) or (–) sign to indicate the polarity

of the electrodes, or use red and black marker to identify the color code for each wire. Red represents

(+) and Black represents (-). Mark the blue (B) and Green (A) channels.

STANDARD LIMITED PRODUCT WARRANTY

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OMNISTIM

PORTABLE PENS PATIENT USER MANUAL

The warranty information provided in this section is applicable only to products

purchased from ACP, directly or through an authorized dealer. This section does

not apply to leased products. The terms of maintenance and repair of any leased

products are detailed in the separately executed agreement between the parties.

Warranty Coverage

This warranty provides coverage, for Equipment purchased, against manufacturer’s defects in

material and workmanship, and extends to the original owner of the product during the warranty

period for that product. Only those items returned to the ACP Service Center within the warranty

period, and also within thirty (30) days after notification to ACP of the defect, shall be eligible

for repair under the Standard Limited Product Warranty. Buyer is responsible for shipping cost

associated with sending the Equipment to the ACP Service Center. ACP shall ship Equipment

to Buyer after repair at no cost to the Buyer provided repair is deemed to be under warranty.

ACP may, at its discretion and only for valid warranty claim, repair or replace any part(s) that

prove to be defective during the warranty period.

Warranty Exclusion

Any and all warranty coverage will be void if any of the following have occurred:

The product contains repairs or replacement parts not furnished by ACP.

The product is damaged resulting from misuse or negligence.

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 accessory or supply item caused damage to the

Equipment.

Warranty Period

The following coverage is provided at no additional cost to the Buyer:

New Equipment / Product. Products purchased as new from ACP are warranted against

manufacturer’s defects in material and workmanship for a period of two (2) years from the

date of purchase.

Refurbished Equipment / Product. Products purchased specifically as Refurbished

Equipment are warranted against manufacturer’s defects in material and workmanship for a

period of one (1) year from the date of purchase.

Accessories. All accessories for ACP equipment / products are warranted against

manufacturer’s defects in material and workmanship for a period of three (3) months from the

date of purchase.

Warranty Validation

The following information needs to be provided to the ACP Customer Support

representative prior to the product being returned under warranty coverage:

Buyer name or account number as it appears under the “Bill TO” on the ACP or

recognized ACP Dealer invoice.

Invoice Date and Number

Model number, description, and serial number of equipment

Detailed description of the problem

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