ACP OmniSWD User manual

COPYRIGHT © 2019-2020, ACCELERATED CARE PLUS CORP., ALL RIGHTS RESERVED
OmniSWD®
Shortwave Diathermy System
User Manual
Issued 08.04.2020
Part No. 2903030M Rev 7
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.

OMNISWD®USER MANUAL
© COPYRIGHT 2019-2020, ACCELERATED CARE PLUS CORP., ALL RIGHTS RESERVED
OmniSWD®
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 OMNISWD®, MEGAPULSE®, OMNIVERSA®, NEUROPROBE, OMNISTIM®,
OMNISOUND®, OMNICYCLE®, OMNISTAND®, OMNIVR®, and SYNCHRONY DYSPHAGIA
SOLUTIONS by ACP®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.

OMNISWD®USER MANUAL 1
© COPYRIGHT 2019-2020, ACCELERATED CARE PLUS CORP., ALL RIGHTS RESERVED
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
IP2X Classification against water
intrusion
0120
CE mark of confidence
compliant to MDD
(93/42/EEC)
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
RF Emitting Device Rx Only
Consult Tuning Instructions

2 OMNISWD® USER MANUAL
COPYRIGHT © 2019-2020, ACCELERATED CARE PLUS CORP., ALL RIGHTS RESERVED
TABLE OF CONTENTS
SYMBOLS ON THE PRODUCT...................................................................................................................1
DIATHERMY INDICATIONS & CONTRAINDICATIONS ............................................................................3
Indications...........................................................................................................................................3
Contraindications................................................................................................................................4
DIATHERMY WARNINGS & PRECAUTIONS.............................................................................................5
Warnings.............................................................................................................................................5
Precautions.........................................................................................................................................7
THE OmniSWD®...........................................................................................................................................8
Delivery of the OmniSWD®.................................................................................................................8
Introduction.........................................................................................................................................8
Controls and Functions.......................................................................................................................9
TREATMENT GUIDELINES.......................................................................................................................10
Inductive Shortwave .........................................................................................................................10
Depth of Penetration.........................................................................................................................11
Thermal and Subthermal Dosage.....................................................................................................11
INFECTION CONTROL EQUIPMENT AND PRINCIPLES OF USE.........................................................12
Definitions.........................................................................................................................................12
Universal Precautions - Body Substance Isolation...........................................................................12
Cleaning / Disinfecting of the OmniSWD®........................................................................................12
Cleaning and Low Level Disinfection................................................................................................13
Intermediate Level Disinfection.........................................................................................................13
Use of Barriers..................................................................................................................................14
MODES OF OPERATION ..........................................................................................................................15
Thermal Effect Variables ..................................................................................................................15
Operating Instructions.......................................................................................................................17
User Interface ...................................................................................................................................18
Setup Procedure for Drum Inductive Applicator...............................................................................19
Safety Features / Error Messages....................................................................................................20
Testing the Output............................................................................................................................20
Output Tuning Bar ............................................................................................................................21
Using Tuning Bar..............................................................................................................................21
Output Tuning is Recommended (>10% variance) ..........................................................................21
Output Tuning is Required (>20% variance)....................................................................................22
End Of Treatment: QR Code ...……………………………………………………………………………22
SYSTEMS INFORMATION........................................................................................................................22
Systems Information.........................................................................................................................22
DRUM REMOVAL AND REINSTALLATION ………….……………………………………………..………...23
Inductive Applicator Removal / Reinstallation ...………………………………………..….………….23
TROUBLESHOOTING...............................................................................................................................24
Verify Calibration
Accuracy..............................................................................................................244
ACP Customer Support...................................................................................................................24
CERTIFICATE OF CONFORMANCE INSPECTION AND GOOD OPERATING PRACTICE.........……25
TECHNICAL SPECIFICATIONS......................................................................................................26
Technical Data - OmniSWD®............................................................................................................26
Standards..........................................................................................................................................26
Diagrammatic Representation of Pulse Trains.................................................................................27
OmniSWD®Average Output Power..................................................................................................28
OmniSWD®STANDARD AND OPTIONAL ACCESSORIES....................................................................29
Infection Control Supplies:................................................................................................................29
STANDARD LIMITED PRODUCT WARRANTY .......................................................................................30

OMNISWD®USER MANUAL 3
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RETURN DEFECTIVE EQUIPMENT ..................................................................................................31

4 OMNISWD® USER MANUAL
COPYRIGHT © 2019-2020, ACCELERATED CARE PLUS CORP., ALL RIGHTS RESERVED
DIATHERMY 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 notice that Accelerated Care Plus cannot provide medical advice. If you have specific
medical questions, please contact your healthcare professional.
Indications
Diathermy is used therapeutically to increase the temperature of tissues. It is generally accepted that heat
produces the following desirable therapeutic effects:
•Relieves pain
•Increases the extensibility of collagen tissues
•Decreases joint stiffness
•Relieves muscle spasm
•Increases local blood flow
OmniSWD Shortwave Diathermy system is indicated for use in the following conditions or applications:
•Disorders of the musculoskeletal system
oMuscle spasm
oJoint stiffness
oJoint contractures
•Chronic inflammatory or infective conditions
oTenosynovitis
oBursitis
oSynovitis
oChronic inflammatory pelvic diseases

OMNISWD®USER MANUAL 5
COPYRIGHT © 2019-2020, ACCELERATED CARE PLUS CORP., ALL RIGHTS RESERVED
Contraindications
•Do not apply shortwave diathermy if the patient does not understand the potential risks.
•Do not apply shortwave diathermy if the patient is not able to cooperate with the operator in maintaining the
proper position and in reporting the presence of a heating sensation which is the only indication of an adequate
or excessive dose.
•Do not apply shortwave diathermy on pregnant patients.
•Do not apply thermal shortwave diathermy if there are open wounds, hemorrhage, ischemic tissue, tuberculous
joints, or acute infections within the treatment area.
•Do not apply shortwave diathermy on patients who do not possess normal pain and thermal sensation in the area
to be treated.
•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.
•Do not apply shortwave diathermy on patients, or within 10 feet of a person, with Cardiac Pacemakers or
implanted defibrillators.
•Do not apply shortwave diathermy on patients, or within 10 feet of patients, who have ANY implanted systems
with RF programming, or metallic lead, or any implanted system that may or may not contain a lead. Both the
thermal and sub-thermal modes of operation pose a risk of tissue destruction.
oIf you are a physician who implants or monitors patients with leads or implanted systems with or without
leads, explain to the patient what diathermy is, and stress that they should NOT receive shortwave or
microwave diathermy therapy.
oIf you are a health care professional who uses diathermy (shortwave) in your practice:
•Be sure to ask the patient about possible implants before deciding to administer shortwave or
microwave diathermy therapy. If the patient has an implanted lead or an implant with or without a
lead, diathermy should not be used even if the implant has been turned off. Examples of implanted
systems that may or may not contain a lead include cardiac pacemakers and defibrillators, cochlear
implants, bone growth stimulators, deep brain stimulators, spinal cord stimulators, other nerve
stimulators, and infusion pumps.
•Do not administer shortwave diathermy therapy to a patient who has had an implant in the past unless
you are absolutely certain that the implant and all leads in their entirety have been removed.
NOTE: Leads are often left implanted after the implant is removed.
NOTE: If there is a scar in or near the treatment area, check with the patient and/or the patient’s
chart to determine if there is metal under the scar.

6 OMNISWD® USER MANUAL
COPYRIGHT © 2019-2020, ACCELERATED CARE PLUS CORP., ALL RIGHTS RESERVED
DIATHERMY WARNINGS & PRECAUTIONS
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 notice that Accelerated Care Plus cannot provide medical advice. If you have specific
medical questions, please contact your healthcare professional.
Warnings
•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.
•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. Electromagnetic effects may affect organ function.
•Treatment should not be applied when high fever is present, over swollen, severe infection, (osteomyelitis,
sepsis, tuberculosis, etc.), or inflamed areas or skin eruptions, (e.g., phlebitis, thrombophlebitis, varicose veins,
etc.).
•Do not apply over the lumbar or abdominal region, or over the uterus during menstruation as therapy may
temporarily increase menstrual flow.
•Do not apply treatment over exposed spinal cord (i.e. following laminectomy, spinal fusion, etc.).
•Do not apply directly over the cranial region, as little is known about the electromagnetic effects on the
cerebrum to determine if it represents a serious hazard when shortwave diathermy is applied to the head.
•Do not apply directly over the epiphysis of growing bones in children and adolescents because shortwave
diathermy may enhance or inhibit bone growth.
NOTE: The mean age for skeletal maturity in females is 15.5 years; in males, 17.5 years.
•Do not apply treatment on a patient connected to patient monitoring devices, or within 5 feet of any active
patient monitoring devices.
•Thermal Shortwave Diathermy should not be performed when metal is present in tissues in the treatment field.
This includes Total Knee Arthroplasty, Total Hip Arthroplasty, other joint replacements, screws, wires, shrapnel,
some stents, etc. Shunts may contain a valve rather than a pump. Good clinical practice with either sub thermal or
thermal Short Wave Diathermy (SWD) is to remove all external metal from the treatment field such as buttons,
snaps, under-wire bra, belt buckle, metal zippers on clothing or pillowcase covers, intra-uterine device, shrapnel,
body piercing, jewelry.
•Do not apply directly over or in close proximity to Deep Vein Thrombosis (DVT). Thermal agents should be
avoided in early phases of a DVT. Therapists should follow the guidelines provided by the referring physician
on recommended activity level and modality use.
•Do not apply shortwave diathermy through synthetic blend clothing. Certain plastics and synthetics (e.g., nylon,
polyvinyl chloride, and polyethylene terephthalate), which are usually regarded as good insulators, can also be

OMNISWD®USER MANUAL 7
COPYRIGHT © 2019-2020, ACCELERATED CARE PLUS CORP., ALL RIGHTS RESERVED
heated significantly by shortwave diathermy units. Some fabric blends that contain synthetics can also be
heated. Additionally, synthetics can trap moisture near the body, which can rapidly heat and burn a patient.
•Always keep cables spaced apart. Route cables as designed for the unit, using all spacing insulators and cable
supports provided. Do not put anything else between the cables and never cross cables.
•Keep cables at least several inches away from any objects or material, especially metal or grounded objects.
•Do not lean on or hold the cables while the generator is activated. In addition to the strong heating effect, a
deteriorated cable could break down and expose the user to high voltages.
•Keep all line cords away from the diathermy unit cables. Do not store or coil line cords where they can come close
to the cables on an operating diathermy unit.
•Before increasing generator output in response to a report of inadequate patient heating, verify that cables are
properly routed, evenly spaced, and away from any metal or grounded objects. The heating effect may be "stolen"
from the patient at a spot where the cables are close to a metal object or each other. Increasing the generator output
under these circumstances will cause increased heating at that spot.
•Use a nonconductive treatment table and a mattress or couch without metal parts (e.g., decorative buttons, springs)
near the patient, applicators, or cables. Do not use conductive mattresses or mattress covers.
•During application of shortwave diathermy, the operator and any other patients should stand at least 2 feet from the
device.
•Do not apply shortwave diathermy over areas with excess adipose tissue.
•All equipment and accessories should be kept out of the reach of children or unqualified persons.
•Do not apply over areas of hemorrhage or active bleeding.
•Avoid applying to the body if wet. Dry the area thoroughly, as water in the treatment field may lead to uneven
heating.
•All hearing aids should be removed during shortwave diathermy treatment.
•Do not turn on the output of the OmniSWD®until the head (Drum) is properly placed above/over the treatment
area.
•Caution should be used when applying thermal shortwave over areas of body 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.

8 OMNISWD® USER MANUAL
COPYRIGHT © 2019-2020, ACCELERATED CARE PLUS CORP., ALL RIGHTS RESERVED
Precautions
•Application site and settings should be based on the guidance of the prescribing practitioner.
•Do not connect this device to any wall outlet that has not been properly grounded, or to any electrically non-
isolated medical device.
•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.
•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 (Joint Commission on Accreditation
of Healthcare Organizations) 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.
•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 drum
inductive applicator placement.
•The treatment area should be checked from time to time, and if there is evidence of, or if the patient complains
of, pain or overheating during treatment, adjust the output downward until it is tolerated by the patient. If the
patient continues to complain of pain or overheating, discontinue the treatment and shorten the treatment time
on the next treatment session, or use an alternative type of therapy or drum inductive applicator placement.
•Do not apply treatment directly over/under hot or cold packs due to possible activation of chemical packs with
diathermy treatment. 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. Burns or tissue necrosis may result from subsequent treatment.
•Treatment should not follow the application of medicated patches, salves, or creams. The presence of RF energy
may be altered by the presence of these materials on the patient’s skin. Some medications can alter the patient’s
sensation. Heat can also increase the absorption of medication and may be contraindicated. If there is a medical
necessity to perform such treatments, these patients should be monitored diligently during application.
•Caution should be used in the presence of recent surgical procedures, fractures or healing bone and soft tissue
when therapy may disrupt the healing process. Thermal shortwave diathermy should be applied with caution
over bone where minimal or no soft tissue is present.
•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.
•If the device operator is pregnant, she should remain at least 5 meters away from the applicator when the unit is
turned on.