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OMNISWD

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

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

Содержание OmniSWD

Страница 1: ...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 O...

Страница 2: ...my 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 th...

Страница 3: ...companying 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 Emit...

Страница 4: ...rriers 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 Inform...

Страница 6: ...r 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 f...

Страница 7: ...ead 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 o If 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 o If you are a h...

Страница 8: ... 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 ...

Страница 9: ...nt 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 shor...

Страница 10: ... 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 app...

Страница 11: ...understood it is well established that this energy causes vibration of ions and molecules within the cells and tissues Depending on the intensity of the high frequency energy applied this vibrating effect causes more or less tissue heating Significant stimulatory effects may occur in the tissue at thermal and sub thermal levels of high frequency energy exposure When the frequency used is high e g ...

Страница 12: ... this section corresponds to the labeling in FIGURE 1 A Mains AC Power ON OFF switch This is a two position rocker switch up for ON down for OFF The switch is located on the bottom back portion of the device base B Membrane push button ON OFF switch This is a membrane switch to control the display C The mode LED will illuminate when the display screen is activated D All other controls will be via ...

Страница 13: ... commonly used pulsed shortwave electrode Drum inductive applicators are generally referred to as monodes Drum inductive applicators are operated in the pulsed mode to avoid overheating of the coils Historically inductive electrodes were manually coiled or circumferentially wound around the area of the body to be treated PANCAKE COIL CIRCUMFERENTIAL COIL Modern drum inductive applicators are heavi...

Страница 14: ...al Dosage Pulsed shortwave diathermy provides outputs capable of producing thermal or subthermal effects Average power output in watts is controlled by the peak power and the duty factor The duty factor is controlled by the pulse duration and the pulse rate The higher the average output the greater the thermal effects in the tissue AVERAGE POWER WATTS PEAK POWER WATTS x DUTY FACTOR DUTY FACTOR PUL...

Страница 15: ...when occupational exposure to blood body fluids containing blood semen and vaginal secretions is likely to occur Health care workers with exudating lesions or weeping dermatitis should refrain from all direct patient care and from handling patient care equipment until the condition resolves Equipment must be cleaned disinfected and protective barriers used when appropriate Cleaning Disinfecting of...

Страница 16: ...t bacteria and viruses This will also facilitate removal of organic material contaminants from equipment Clean diathermy head with ACP germicidal wipes after each patient use Intermediate Level Disinfection This method is recommended to keep the equipment clean and free of contaminants when used between patients for treatment of non intact skin or incontinence management where there is an increase...

Страница 17: ...r the operatory surfaces of the OmniSWD unit 4 Select tear and place barrier film over adjustment points of the drum inductive applicator arm such that if the position of drum inductive applicator needs to be adjusted during treatment parts of the drum inductive applicator arm that may be touched are covered 5 Apply plastic cover over drum inductive applicator 6 Prepare any items which may come in...

Страница 18: ... water is used for the calculation of the SAR Estimate of in vivo tissue volume heated under the shortwave field The area of the treatment area is estimated at 200 cm2 based on the applicator coil diameter and field calculations for a depth of 2 5 cm measured in prior research by BYU researchers 9 10 for a total volume of 500 cm3 or 0 5 Kg of tissue Total Energy required to heat to 4o C in vivo To...

Страница 19: ...t peak power is fixed at 200 watts Schliephake and Lehman developed the following dosage pattern Dose Variable VAR Barely detectable warmth pulse duration 65 µsec and rate 100 400pps for pain and to increase local blood flow Dose 1 1 T Mild warmth pulse duration 100 µsec and rate 800pps for pain and to increase local blood flow Dose 2 2 T Moderate warmth pulse duration 200 µsec and rate 800pps for...

Страница 20: ...up for ON down for OFF The switch is located on the bottom back portion of the device base 2 Press the membrane switch on the control panel surface This will power on the display 3 The LED will illuminate with the display 4 All other controls will utilize the touch screen controller built into the terminal display Select the desired protocol or output parameters The connecting cables associated wi...

Страница 21: ...i will open a set of screens that will contain detailed information about the selected indication including text and pictures describing parameters and electrode placement The up down arrows enable the user to scroll through the various pages of applicable information on each topic The back arrow will take you back to your starting point Touching the highlighted description button in the Indicatio...

Страница 22: ...brane control panel and the green LED light will illuminate Select INDICTIIONS or MANUAL MODE using the touchscreen controls 4 INDICATIONS MODE There are two to three protocols marked 1ΔT 2ΔT 4ΔT or VAR under the desired indication The protocol default settings cannot be changed in the Indications mode 5 MAUAL MODE There are four 4 protocols marked 1ΔT 2ΔT 4ΔT or VAR The VARIABE MODE VAR defaults ...

Страница 23: ...icator is damaged It will also appear if a fault occurs in the cable or applicator during a treatment Treatment will be prevented from starting unless a functioning applicator cable combination is plugged in If it persists then contact ACP Customer Support at 1 800 350 1100 System Fault Warning Service Due Pop Up This is just a message that appear as a flag from the hours of use The message is not...

Страница 24: ...to display the most amount of green and the least amount of yellow on the bar below Press DONE when complete Tuning POP UPs Output Tuning is Recommended 10 variance If the Output tuning is greater than 10 variance but less than 20 an Output tuning is recommended caution will pop up on the screen User has the option to select IGNORE to continue without tuning or TUNE to be taken to the Device Outpu...

Страница 25: ...he least amount of yellow on the bar below Adjust the tuning dial for minimum reflected power while achieving forward power as close to 200 watts as possible The goal for reflected power is less than or equal to 2 watts but anything less than 10 watts is acceptable Press DONE when complete Upon completion of tuning user is prompted to select DONE When DONE is pressed User is returned to the previo...

Страница 26: ... press gently on the drum applicator pin to dislodge the drum applicator from the articulating arm The drum applicator can now be applied to a patient where the articulating arm might have obstructed the therapy Drum Inductive Applicator Reinstallation To reinstall the drum applicator reverse the above process Be sure the pin is properly seated and the locking collar has been properly adjusted clo...

Страница 27: ...ng dial to get the forward power reading to be close to 200 watts with the reflected still reading around 2 watts Treatment will not start No program selected Select desired treatment program and touch START button Patient cannot detect output when unit is ON and treatment is running Drum inductive applicator is not emitting output Observe Device Output tuning bar Retune the unit with the knob on ...

Страница 28: ...e Certificate of Conformance Inspection is recommended to be performed at least biennially every two years This should include at minimum a safety inspection and to verify proper operation of your OmniSWDTM Always keep the system clean by disinfecting drum head and control panel Routinely check for power cord fraying or any other damage to the power cord ...

Страница 29: ...0 65 40 20 µs available Pulse Repetition Rate 50 100 200 400 600 800 PPS available Timer The digital treatment timer indicates the set time in minutes and seconds prior to the start of treatment and treatment time remaining during treatment The maximum setting of the timer is 30 minutes The timer increments in 1 or 10 minute units Timer accuracy 1 second at all settings Electrode Manually Tunable ...

Страница 30: ...c Representation of Pulse Trains 20 MICROSECOND µSec PULSES 800 PULSES PER SECOND PPS 65 µSec PULSES 400 PPS 200 µSec PULSES 200 PPS 400 µSec PULSES 100 PPS CONTINUOUS TRAIN OF PULSES PULSES CONTAIN 27 12 MHz SINUSOIDAL R F AT 200 WATTS PEAK POWER 50 OHM LOAD IMPEDANCE PULSE ON PERIOD PULSE OFF PERIOD ...

Страница 31: ... 400 µSec 4 0W 8 0W 16 0W 32 0W 48 0W 64 0W 4o C 200 µSec 2 0W 4 0W 8 0W 16 0W 24 0W 32 0W 2o C 100 µSec 1 0W 2 0W 4 0W 8 0W 12 0W 16 0W 1o C 65 µSec 65W 1 3W 2 6W 5 2W 7 8W 10 4W SUBTHERMAL Barely Perceptible Warmth 40 µSec 40W 8W 1 6W 3 2W 4 8W 6 4W 20 µSec 20W 40W 80W 1 6W 2 4W 3 2W PULSE RATE 50 PPS 100PPS 200PPS 400PPS 600PPS 800PPS Calculated values in watts ...

Страница 32: ...OmniSWD Locking Power Cord Hospital Grade 10ft 57896 Cable Applicator Head Coaxial BNC to BNC 83454 OmniSWD User Manual Infection Control Supplies ITEM ITEM NO DESCRIPTION 55536 Super Sani Cloth Wipes Single Use Packets 50 pk bx 44425 Super Sani Cloth Wipes Tub 160 Tub 96849 Sani Cloth Wipes w Bleach Tub 75 wipes tub 52479 Protective Film for Surfaces Infection Control 4 x 6 600 ft roll 50593 Prot...

Страница 33: ...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 acce...

Страница 34: ...ng charges and related costs to return the unit to the customer provided repair is deemed to be under 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...

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