Mettler Electronics Sonicator Plus 921 Operation Manual

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2-Channel Electrotherapy/Ultrasound Combo

Sonicator® Plus 921

OPERATION MANUAL

1333 South Claudina Street • Anaheim, CA 92805, U. S. A.

Toll Free: (800) 854–9305 • Telephone: (714) 533–2221 • FAX: (714) 635–7539

Web Site: http://www.mettlerelectronics.com • Email: mail@mettlerelectronics.com

IR8–46 Rev. B_10/11/18

oensurecorrectuse,pleasereadthismanualcarefully beforeoperatingtheunit.Afterreading,storetheman- ualinasafeplaceforfuturereference.

contents

Symbols ···································································································· 1 To Ensure Correct and Safe Use

Intended use ···························································································· 2 Contraindications ······················································································ 2 Precautions ····························································································· 4 Storage condition ······················································································ 7 Precautions on Handling ············································································· 7

Maintenance and Inspection ········································································ 7 Device Configuration ··················································································· 9 Specifications ··························································································· 11 Names of Parts ························································································· 12 Preparations for Electrotherapy ···································································· 14 Display of Electrotherapy Screen ·································································· 24 Operation for Electrotherapy ······································································· 26 Setting Parameters for 4-Pole Interferential Mode ············································ 29 Setting Parameters for 2-Pole Interferential Mode ············································ 32 Setting Parameters for EMS Mode ······························································· 35 Setting Parameters for Russian Mode ··························································· 38 Setting Parameters for Hi-Voltage Mode ························································ 41 Setting Parameters for TENS Mode ······························································ 44 Setting Parameters for Microcurrent Mode ····················································· 48 Setting Parameters for Galvanic Mode ·························································· 51 Preparing for Ultrasound Therapy ································································· 74 Ultrasound Therapy Screen ········································································· 76 Operation for Ultrasound Therapy ································································· 78 Preparing for Combination Therapy ······························································ 82 Combination Therapy Screen ······································································ 84 Operation for Combination Therapy ······························································ 86 Display of Clinical Program Screen ······························································· 90 Operation of Clinical Program ······································································ 92 Saving Programs ······················································································ 94 Loading Programs ····················································································· 96 Setting Screen·························································································· 98 Error Screen ·························································································· 101 EMC····································································································· 102

Symbols & Abbreviations

Symbol for “CAUTION”

Symbol for “CONSULT INSTRUCTIONS FOR USE”

Symbol for “ELECTROSTATIC SENSITIVE DEVICES

Symbol for “POWER ON” (Power switch)

Symbol for “TEMPERATURE LIMIT”

Symbol for “HUMIDITY LIMITATION”

Symbol for “ATMOSPHERIC PRESSURE LIMITATION”

Symbol for “AC (alternating current)”

Symbol for “TYPE BF APPLIED PART”

Symbol for “NON-IONIZING ELECTROMAGNETIC RADIATION”

Symbol for “POWER OFF” (Power switch)

Symbol for “PAUSE” (Pause switch)

Symbol for “STOP” (Stop switch)

Symbol for “US applicator output port”

Symbol for cTUVus certification

Symbol for prescription only

List of Abbreviations

cm² — Square centimeters Hz — Hertz (pulses per second) LCD — Liquid crystal display

LED — Light Emitting Diode MHz — Megahertz (1 x 10

s — Microsecond (1 x 10 mA — Milliampere (1 x 10 ms — Millisecond (1 x 10

min — Minutes sec — Seconds

S/N — Serial Number W — Watts W/cm² — Watts per square centimeter

cycles per second)

-6

second)

-3

ampere)

-3

second)

Federal law restricts the sale of this device to, or on the order of a physician, dentist, veterinarian or any other practitioner licensed by law of the state in which he practices.

Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous exposure to ultrasonic energy. Treatment should be administered only under the direct supervision of a health care professional.

The electric energy delivered by this device may possibly be lethal. Treatment should be administered only under the direct supervision of a health care professional. The stimulus delivered by this device may be sufficient to cause electrocution. Electrical current above 25 µC must not flow through the thorax because it may cause a cardiac arrhythmia.

Intended use

Indications for electrotherapy

Intended use for Interferential (IF-4), Interferential (IF-2), TENS, Microcurrent, Galvanic

1. Symptomatic relief of chronic intractable pain

2. Post-traumatic pain

3. Post-surgical pain

Indications for EMS, Russian, Hi-Voltage and TENS modes

1. Relaxation of muscle spasms

2. Increase local blood circulation

3. Prevention or retardation of disuse atrophy

4. Muscle re-education

5. Maintaining or increasing range of motion

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

Indications for DC (Direct Current) waveform

1. Relaxation of muscle spasm

Indications for therapeutic ultrasound

1. Relief of pain, muscle spasms and joint contractures:

2. Relief of pain, muscle spasms and joint contractures that may be associated with:

● Adhesive capsulitis

● Bursitis with slight calcification

● Myositis

● Soft tissue injuries

● Shortened tendons due to past injuries and scar tissues

3. Relief of pain, muscle spasms and joint contractures resulting from:

● Capsular tightness

● Capsular tightening

Contraindications

Contraindications for Neuromuscular Electrical Stimulation

1) Anterior neck of the carotid sinus region

2) Electrical neuromuscular stimulation should not be administered to individuals who are or may be pregnant.

3) Do not stimulate a patient who has a cardiac demand pacemaker.

4) Patients with implanted electronic devices should not be subjected to stimulation.

5) Placement of electrodes across the chest laterally or ante¬rior/posterior creates a possible hazard with cardiac patients and is therefore not recommended. Do not use transthoracically in any mode. Great care should be exercised in applying the electrical stimulus current to any region of the thorax because the stimulus current may produce cardiac arrhythmia. In patients with known heart disease, electrical stimulation should be used only after careful physician evaluation and patient instruction.

6) Place electrodes in such a way to avoid stimulation of the carotid sinus (neck) region.

7) Patients with arterial or venous thrombosis or thrombophlebitis are at risk of developing embolisms when electrical stimulation is applied over or adjacent to the vessels containing the thrombus. If a patient has a history of deep vein thrombosis, even many years past, the affected area should not be stimulated.

8) Do not use over swollen, infected, or inflamed areas. Do not place electrodes over skin eruptions.

9) Fresh fractures should not be stimulated in order to avoid unwanted motion.

10) Do not apply stimulation transcerebrally (through the head).

11) Do not use on cancer patients.

12) Stimulation should not be applied immediately following trauma or to tissues susceptible to hemorrhage.

13) Positioning electrodes over the neck or mouth may cause severe spasm of the laryngeal or pharyngeal muscles. These contractions may be strong enough to close the airway or cause difficulty in breathing.

14) Do not apply stimulation for undiagnosed pain syndromes, until etiology is established.

15) Do not apply electrodes directly over the eyes or inside body cavities.

16) Do not use electrical stimulation in conjunction with high frequency surgical equipment or microwave or shortwave therapy systems.

Contraindications for therapeutic ultrasound

1) Therapeutic ultrasound should not be applied over the pregnant or potentially pregnant uterus. Therefore, therapeutic ultrasound should not be applied over the uterus unless specific assurance can be attained from the patient that she is not pregnant.

2) Patients who have cardiac pacemakers should be protected from direct ultrasound exposure over the thorax to protect the lead wires and pacer from such exposure.

3) Therapeutic ultrasound should not be applied to the eye.

4) Applications of therapeutic intensities of ultrasound should be avoided over the heart.

5) Neoplastic tissues or space occupying lesions should not be exposed to ultrasound.

6) Ultrasound should not be applied to the testes to avoid increases in temperature.

7) Areas of thrombophlebitis should not be treated with therapeutic ultrasound due to the increased possibility of clotting or dislodging a thrombus. Conditions where this might occur are deep vein thrombosis, emboli and severe atherosclerosis.

8) Tissues previously treated by deep x–ray or other radiation should not be exposed to therapeutic ultrasound.

9) Ultrasonic treatment over the stellate ganglion, the spinal cord after laminectomy, subcutaneous major nerves and the cranium should be avoided.

10) Do not treat ischemic tissues in individuals with vascular disease where the blood supply would be unable to follow the increase in metabolic demand and tissue necrosis might result.

11) Do not apply therapeutic ultrasound over a healing fracture.

12) Ultrasound should not be applied over the epiphyseal areas (bone growth centers) of the bones of growing children.

Contraindications for combination therapy of therapeutic ultrasound and electrotherapy

1) Contraindication for combination therapy refers to the contraindications under therapeutic ultrasound and electrotherapy

Warnings

Warnings for Neuromuscular Electrical Stimulation

1) Electrical stimulation is ineffective for pain of central origin.

2. Electrical stimulation must be applied by a physician or other qualified practitioner and should be used for only the prescribed purposes.

3. Electrical stimulation is of no curative value.

4. Electrical stimulation is a symptomatic treatment and as such suppresses the sensation of pain, which could serve as a protective mechanism.

5. The safety of electrical stimulators for use on children has not been determined. Keep out of reach of children.

6. Electronic monitoring equipment (such as ECG monitors and ECG alarms) may not operate properly when electrical stimulation is in use.

Precautions

Precautions for Neuromuscular Electrical Stimulation

1) Care should be taken in the treatment of patients receiving another type of electrotherapeutic treatment (such as conventional TENS) or having indwelling electrodes, lead wires, or transmitters (for electrophrenic pacing or cerebellar or urinary bladder stimulation). Stimulation currents should not cross the lead wires or electrodes.

2) It is advisable to insulate patients, preferably by use of a wooden treatment table or one that is completely padded by non–conductive material. Added safety is provided if the patient cannot touch any grounded metal parts.

3) Limit treatment intensity to 50 mA (50 V) or less, when using small electrodes (2" diameter), to reduce the chance of thermal burns due to high current density. Avoid current densities exceeding 2 mA/cm² when using this device.

4) Isolated cases of skin irritation may occur at the site of electrode placement following long– term application.

5) Avoid placing electrodes directly over open wounds since current density tends to concentrate in these areas.

6) Use extreme caution when treating desensitized areas or on patients who may not be able to report discomfort or pain.

7) Use caution in applying electrical stimulation over areas where there is a loss of normal skin sensation.

8) Adequate precautions should be taken in the case of persons with suspected or diagnosed epilepsy.

9) Patients should not be left unattended during any treatment.

10) Care should be taken following recent surgical procedures when muscle contraction may disrupt the healing process.

11) Do not apply electrical stimulation over the menstruating uterus.

12) The long–term effects of chronic electrical stimulation are unknown.

13) Electrode placement and stimulation settings should be based on the guidance of the prescribing practitioner.

14) Effectiveness for pain management is highly dependent upon patient selection by a person qualified in the management of pain patients.

15) The Sonicator Plus 921 should be used only with electrode cables and electrodes recommended for use by Mettler Electronics Corp.

16) Turn on the Sonicator Plus 921 before applying electrodes to the patient.

Precautions for Therapeutic Ultrasound

1) Ultrasound should not be applied in areas of reduced sensation or circulation. Patients having reduced sensation will not be able to notify the practitioner of discomfort if ultrasound intensities are too high. Patients with compromised circulation may have an excessive heat buildup in the treatment area.

2) Operators should not routinely expose themselves to therapeutic ultrasound. The applicator handles for the Sonicator Plus 921 have been designed to allow the practitioner to perform

General precautions

1) Do not operate this device near high frequency devices such as shortwave or microwave therapeutic devices. For example, distance of more than 1.5 m is recommended.

2) Do not use this device if the patient is connected to a high-frequency surgical instrument as this could cause skin irritations or burns and possible damage to the device.

3) Electronic monitoring equipment (such as ECG monitors and ECG alarms) may not operate properly when stimulation of this device is in use.

4) When using this device for the purpose of Symptomatic relief of pain, the etiology of the pain should be established or the pain syndrome should be diagnosed.

5) Make sure the patient is free of contagious disease or conditions, since these can be transmitted to other individuals via the device or accessories.

6) Over the uterus during menstruation

7) Treatment over bony areas may cause irritation.

8) Areas with implanted metals near the skin surface.

9) Determining treatment intensity can be problematic with babies or infants (aged 6 or under), patients with senile dementia, or other patients who for any other reason are unable to express their preferences. Proceed carefully before deciding whether to use this device on such patients.

10) Have the patient remain in a relaxed and comfortable position during treatment.

11) Accessories from other devices should not be used with this device

12) Note the power supply frequency, voltage, and allowable current (or power consumption).

13) Use an outlet set aside exclusively for this device.

14) To avoid the risk of electric shock, this device must only be connected to a supply mains with

protective earth.

15) Do not paste the self-adhesive electrode (adhesive pad) to the coated surface of the product.

The product may be stained or its coating may be damaged.

16) Before initiating therapy with this device, check for any short circuiting of the attached electrodes

(probe). Do not place the electrodes (probe) too close to each other or else they may short circuit. If the output is activated with short-circuited electrodes (probe), the output may be delivered abruptly as soon as the short circuiting is cleared. Meanwhile if adjacent channels are used in the same electrotherapy mode, do not bring the electrodes (probe) too close to each other. Such proximity could cause overlapping outputs, depending on the mode in use, resulting in excessively intense stimulation.

17) When using this device keep a distance where the device is reachable.

Precautions before use

1) Carefully review the patient’s diagnosis and prescription for special precautions or instructions.

①Make sure pacemakers or other medical devices are not implanted in the treatment area. ②For areas in which skin sensation is reduced, carefully consider the relevant factors before

determining whether to use this system with the patient.

2) Have the patient inform the operator, incase of experiencing unusual sensations (e.g., pain, heat sensations, or pressure) during treatment.

3) Carefully weigh all pertinent factors before determining to use this device with the following individuals or on the following areas:

①Carefully select the output level and treatment durations when treating facial areas. ②Do not place the electrode on the chest; doing so will increase the risk of cardiac fibrillation.*

③When using the device on a child according to a physician’s prescription, take great care when

treating bony regions that no irritations occur.*

4) Check the switches and keys to determine that the device is operating properly.

5) Make sure all cables are correctly connected and safely configured.

6) Make sure that the ultrasound probe is clean and free of any cracks.*

Precautions during use

1) Make sure the treatment duration and intensity are suitable for the treatment purpose.

2) Monitor the device and the patient to ensure that no problems arise. In the event of any trouble, take appropriate measures, safely shut down the device and contact the distributor or Mettler Electronics.

3) To prevent accidents, make sure the patient does not operate or touch the device.

4) When using the strap for electrotherapy, make sure the strap will not be in contact with bare skin for many hours. The strap may cause allergic symptoms, such as itching, redness, hives, swelling, fever, breathing difficulties, asthma-like symptoms, drop in blood pressure, and shock. Should such symptoms appear, immediately halt operations and take adequate measures.

5) If the patient reports abnormal pain or heat sensation, halt treatment and see if the pain goes away. A problem may have occurred, or heat may have built up in the patient’s body, in which case burns may result if treatment is continued, even at a reduced output.

6) If a rash, redness, itching or any other symptoms emerge, halt use immediately and take adequate measures.

7) Only touch one point on the touch panel at a time; do not touch multiple points simultaneously.

8) If the patient complains of periosteal pain, reduce the intensity.*

9) Make sure the ultrasound probe is positioned correctly on the treatment area. Incorrect positioning can affect effectiveness and results.*

10) Do not leave the device with the output turned on. Buildup of heat may damage the device.*

11) When the ultrasound probe is not in use, return and set the probe on the probe holder.*

12) Please be careful not to put excessive pressure between the electrode and the treatment area

while the device is outputting. Please avoid actions such as putting pressure on the electrode between the treatment area and the bed or the back of the chair during treatment lying down or sitting. Those actions may cause an accident.*

Precautions after use

1) After using this device, go through the specified steps, turn off the power and disconnect the power supply cord from the outlet.

2) When disconnecting the power supply cord from the outlet, make sure the power switch is off. Always grasp the cable by the plug when connecting or disconnecting.

3) Rinse the ultrasound probe with lukewarm water lightly and thoroughly wipe it dry.*

4) Keep the device and accessories clean to avoid inconvenience for the next therapy session and store them in a safe place.

*1: Precautions relating to electrotherapy *2: Precautions relating to ultrasound Unmarked precautions apply to all modes.

Storage conditions

1) To avoid malfunctions, follow the instructions given below when storing and installing the device. ①Avoid locations where the device will be subjected to water. Water entering the device may

cause malfunction.

②Avoid locations where the system may be unduly affected by atmospheric pressure,

temperature, humidity, sunlight, dust, salt, sulfur or any other adverse factors.

③Make sure the device is kept on a stable surface. Avoid tilting the device, or applying vibrations

and shock (these warnings also apply during transportation).

④Avoid flammable atmospheres, such as flammable anesthetic gas mixed with oxygen, nitrous

oxide and air, and flammable disinfectant or cleanser mixed with air.

⑤Avoid locations where chemicals are stored or where gas may be generated. ⑥Do not install the device near a flame. Doing so may result in deformation or accidents.

Precautions on Handling

1） Do not operate the main unit with wet hands.

2） Do not subject the product to strong vibrations or impact, whether by knocking it against another

object, tipping it over, or dropping it. Even if the product appears to function normally after being exposed to impact or vibration, internal damage may gradually progress and result in

equipment malfunctions or accidents.

3） When disposing of consumable parts, residual materials, or end-of-life equipment/accessories,

observe all applicable local laws and regulations in the area where the equipment is installed to minimize environmental effects.

Maintenance and Inspection

Precautions

1） In the event of product malfunction or failure, do not attempt to correct the problem. Contact the

Mettler Electronics or distributor.

2） Do not modify the product. 3

）Do not open the product case.

4） Do not clean the main unit or accessories by wiping with volatile oils (such as thinner, gasoline,

and kerosene), polishing powder, hot water, or chemicals. Such materials can discolor or degrade the product. To clean, soak a cloth with alcohol, cold water, lukewarm water, or neutral detergent, wring thoroughly, then wipe.

5） The probe head features a waterproof structure. Do not remove the probe head. Removing

the head may degrade waterproofing performance and oscillator performance and lead to equipment malfunctions.

To Ensure Correct and Safe Use

Maintenance and inspection by the user

1） Inspect the product and accessories routinely before use to ensure proper functioning.

2） If any abnormalities are found (insulation damage in accessories, scratches/cracking on cord

sheaths, almost disconnected wires, faulty connector contacts, etc.) during pre-operation checks or inspections, contact the dealer or the Mettler Electronics.

3） When using the product after an extended period without use, make sure the product functions

normally and safely before use.

Maintenance and inspection by a contractor

1） Ask the distributor or Mettler Electronics for periodic inspections (about once a year) to

maintain equipment performance and ensure safety.

2.) To assure compliance with FDA, 21 CFR 1050.10 ultrasound standard, the ultrasound portion of the Sonicator Plus 941 should be calibrated and safety tested on an annual basis. This service may be obtained from the manufacturer by sending the Sonicator Plus 941 in its original shipping container to Mettler Electronics Corp., 1333 South Claudina Street, Anaheim, CA 92805, ATTN: Service Department. (Telephone toll free: (800) 854–9305, Alternate telephone number: 1 (714) 533–2221) This service may also be performed by qualified biomedical engineers or technicians trained in ultrasound calibration.

3) Replace consumable parts (including accessories) periodically to prevent hazardous situations resulting from use of equipment/accessories in improper condition.

Maintenance and inspection items

Item Description Method

Exterior and

display

Operation

Accessories

Safety

inspection

Ultrasound

output check

Check the exterior for damage. Check the LCD panel to make sure there is no deformation or flickering of the display.

Turn on the power switch and confirm that the product functions normally, without problems.

Confirm that the product functions normally as described in the operation manual.

Check the accessories for damage.

Confirm that there are no wire breaks in the cords or cables.

While the product is producing low frequency output, disconnect the electrode cable from the output port. Confirm that an error indication appears and that the output stops.

Connect and disconnect the ultrasound probe from the product during treatment. Confirm that an error indication appears and that the output stops.

Set the ultrasound output level and allow the product to stand at least three minutes without operating it. Confirm that the output stops automatically.

Place water on the probe head and turn output on. Check to make sure that the water vibrates.

Visual inspection

Operational

inspection

Visual inspection

Operational

inspection

Operational

inspection

probe check

Ultrasound

Make sure that the head section has no cracks and that the cable connecting areas have no flaws that may allow water, ultrasound gel, or other materials to enter the probe head.

Check the cable and connector for faulty connections.

Visual and operational inspections

Operational

inspection

Device Configuration

●Main unit and standard accessories

①



Your new Sonicator Plus 921 comes complete with all the necessary components to perform therapeutic ultrasound, neuromuscular electrical stimulation and combination therapy. Below is a list of items that are included in the shipping carton.

1. Sonicator Plus 921

2. Large ultrasound applicator, ~5.5 cm² at 1 and 3 MHz, (ME 9411)

3. Sonigel, ultrasound couplant gel, one sample tube, 100 ml, (ME 1846)

4. Two electrode cable sets, (ME 2266)

5. One package V Trodes, 2" diameter (ME 2702))

6. Two 4"x 4" sponge electrodes, (ME2002)

7. Two pin to banana adapters, (ME 2027)

8. Detachable U.L. listed, hospital–grade line cord

9. Instruction Manual on a CD ROM

●Optional accessories

1. Small applicator (9412)

2. Sponge Electrode 2x2 (2000)

3. Sponge Electrode 4x4 (2002)

4. Sponge Electrode 3.5 x 7 (2004)

5. Sponge Electrode 8 x 10 (2006)

6. Banana Jack (2027)

7. Electrode straps 24 " (2008)

8. Electrode straps 48 " (2009)

9. Vtrode (2703)

10. Vtrode (2704)

11. Vtrode (2705)

12. EZ Trode Electrode (2221)

13. EZ Trode Electrode (2222)

14. EZ Trode Electrode (2223)

15. EZ Trode Electrode (2224)

16. High Voltage Probe (2267

Specifications

●Main unit specifications

Power supply 120 V 60 Hz

Power consumption 140 VA

Electrotherapy

Output current Output voltage

Output frequency Max. 10 kHz ±10% Timer Max. 60 min. ±5%

Ultrasound frequency 1.0 MHz, 3.0 MHz ±10%

Intensity

Pulse frequency 16 Hz, 48 Hz, 100 Hz ±5%

Output mode Duty 5%, 10%, 20%, 30%, 40%, 50%, 100% ±5% Timer Max. 30 min. ±5%

Ultrasoun

Oscillator

ERA

BNR

Output stability ±20%

Applicator maximum temperature

Certification

Safety class according to IEC 60601-1

Class of protection against ingress of harmful water

Dimensions 13.8" (W) x 10.6" (D) x 5.7" (H)

Weight Approx. 7.7 lb.

Environmental conditions

Max. 600 mA ±15% peak (500 Ω load), Max. 70 mA rms ±15% (500 Ω load) Max. 300 V ±15% peak (500 Ω load)

Limit value and accuracy: 3.0 W/cm2 ±20% Maximum effective intensity: 2.0 W/cm Peak intensity: 3.0 W/cm2 ±20% (pulsed)

Ultrasound Probe (L) 1 MHz: 5.5 cm

Ultrasound Probe (S) 1 MHz: 0.9 cm2 ±20%

Ultrasound Probe (L) 1 MHz: 4.6 ±30% 3 MHz: 2.9 ±30%

Ultrasound Probe (S) 1 MHz: 2.9 ±30%

3 MHz; 6.0 cm

3 MHz: 0.9 cm

3 MHz: 2.9 ±30%

43°C

The Sonicator Plus 921 complies with the ultrasound performance standards set forth in the Code of Federal Regulations, Title 21 (Food and Drugs), Part

1050.10.

Class I, Type BF

Main unit: IPX 0 Ultrasound probe: IPX 7

Temperature Humidity Pressure In use 10−40°C 30−75% 800−1060 hPa Storage -10−60°C 30−95% 700−1060 hPa Transportation -10−60°C 30−95% 700−1060 hPa

cTUVus ME 921

±20% (continuous)

±20%

Names of Parts

● Main Unit

①

②

③ ④

①LCD touch panel ②Stop switch ③Current intensity control dial (CH1) ④Current intensity control dial (CH2)

⑤Ultrasound intensity control dial (US)

⑥ ⑦

⑥Electrode cable connection port (CH1) ⑦Electrode cable connection port (CH2)

⑧

⑤

⑨

⑧LED ⑨Ultrasound Probe connection port

⑪

⑫

⑪

11 Power switch

12 Power supply cord connection port



Make sure the power switch for the Main Unit is

turned off.

Connect the power supply cord to the power supply

cord connection port on the Main Unit.

Connect the power supply cord to an AC power

outlet.

Select the electrode suitable for the treatment to be

performed and the treatment area, then connect the electrode cable to the electrode cable connection port on the Main Unit.

● The Rubber Electrode and Self-adhesive Electrode (optional) can be used in any treatment mode.

● The HV/DC Probe can be used only in Hi-Voltage and Galvanic modes.

* For information on using each electrode, see pages 15 to 23.

Turn on the power switch for the Main Unit.

When the power switch is turned on, the LED on the front panel of the Main Unit lights up. After the initial check is completed, the treatment screen appears.

Maintenance Electrode Sponges

● Electrode Sponge: Wash thoroughly in lukewarm water containing neutral detergent after each use. Completely rinse off all detergent, allow to dry, then store.

● Using the Self-adhesive Electrode

Connect the electrode cable to the Self-adhesive Electrode.

Insert the connection pins of the electrode cable into the cord for the corresponding parts of the Self-adhesive Electrode.

* The electrode cable has two connection pins. Be

sure to connect the two corresponding parts of the Self-adhesive Electrode to the two pins.

* While the tips of the two electrode cables are black

and gray, the pins can be interchangeably connected with the two parts of the Self-adhesive Electrode.

Apply the two parts of the Self-adhesive Electrode securely

to the treatment area.

Insert each pin fully until you can no longer see the metal portion.

* If the two parts of the Self-adhesive Electrode are

not securely applied when treatment (output) starts, an error will result.

Connect the connector for the electrode cable to the

electrode cable connection port on the Main Unit.

When the power switch is turned on, an icon appears.

How to peel Self-adhesive Electrode

To peel the Self-adhesive Electrode from the transparent film or skin, hold a corner of the pad and lift slowly. Do not pull the cord to peel.

(Incorrect) (Correct)

CAUTION About the Self-adhesive Electrode

①Do not use the Self-adhesive Electrode on

injured areas of the skin.

②Do not use the Self-adhesive Electrode if it

loses its adhesion strength. The electric current may concentrate in a certain area, depending on conditions of contact with the skin, resulting in burns or inflammation.

③If the skin gets red or burn / inflammation

occurs, stop using the product immediately.

④If a cosmetic product such as lotion or oil is

left on the skin, the Self-adhesive Electrode will not adhere well to the skin. Clean the skin with soap and lukewarm water and dry thoroughly before attaching the Self-adhesive Electrode.

⑤If the skin surface is wet with sweat, such as

after exercising or warming (with a hot pad, etc.), wipe off the sweat with a dry towel or other material before attaching the Selfadhesive Electrode. Do not heat the treatment area by placing hot packs or similar products on top of the Self-adhesive Electrode. Heat may concentrate in a small area and cause burns or inflammation.

⑥Make sure the connection pins of the electrode

cords are free of dirt before use. If dirty, wipe with a soft cloth moistened with lukewarm water or alcohol. Dirty pins can cause contact failures, resulting in a sudden change of electric current and resulting in burns or inflammation. Contact failures can also occur if the Selfadhesive Electrode has a loose connection. If you notice any loose connections, replace the Self-adhesive Electrode with new ones.

⑦Insert each pin of the electrode cable into the

end of each cord firmly until you can no longer see the metal portion.

⑧When removing the Self-adhesive Electrode

from the storage plate or the skin, grasp a corner and slowly lift. Never pull the cord to

remove.

⑨When attaching the Self-adhesive Electrode,

make sure they are in firm contact with the skin. If there is any space between the Selfadhesive Electrode and the skin, simulation will be unusually strong causing pain and in some cases resulting in burns or other injury to the skin.

⑩Be sure to turn off the power switch for the

Main Unit before removing the Self-adhesive Electrode from the skin.

⑪After use, return the Self-adhesive Electrode to

the storage plate, then place in the bag. Store at room temperature.

⑫The validity period for the Self-adhesive

Electrode is indicated on the bag. Do not use past the expiration date.

⑬The Self-adhesive Electrode features consum-

able parts. When adhesion weakens, replace the Self-adhesive Electrode with new ones.

⑭Note: If a patient has a transmittable

disease, the disease may be transmitted to other people via the Self-adhesive Electrode.

⑮Be careful when using the Self-adhesive

Electrode on people who tend to display skin rash reactions to poultices or adhesive plaster, etc. The Self-adhesive Electrode may cause skin rashes or reddening of the skin with such individuals.

⑯If using the Self-adhesive Electrode causes a

skin rash, redness of the skin, skin irritation, etc. during use, immediately stop using the

product and consult your distributor.

⑰When attaching the Self-adhesive Electrode,

do not place over or in contact with metal items (necklace, belt, watch, etc.).

⑱Do not apply excessive force to the Self-

adhesive Electrode during use, for example, by placing it under the body. The electric current will concentrate in a small area, causing burns or inflammation.

⑲Do not use the Self-adhesive Electrode past

its expiration date or if it has poor adhesion strength. Using the electrode in these states as well as compensating with tape, bands, underwear, etc. will not provide appropriate effects and may in some cases result in sudden and strong stimulation, causing burns or other injury to the skin.

⑳Use only genuine Self-adhesive Electrodes

manufactured under rigid quality control to ensure safety. The Mettler Electronics is not responsible for burns, equipment malfunctions, or other problems resulting from use of counterfeit products.

● Using HV/DC Probe

* Do not use the HV/DC Probe in any mode other than Hi-Voltage, Galvanic, Diadynamic, Faradic, or Traebert

mode.

* When the HV/DC probe is connected, the output sets automatically to 1/10 (except for Hi-Voltage mode),

and the open error detection function will be turned off.

Names of parts of HV/DC Probe

Self-adhesive Electrode (optional)

Connection pin

Main body of HV/DC Probe

Connector

Electrode Sponge (with slit) (optional)

* Apply the Self-adhesive Electrode to an area of the body close to the treatment area, and use the

HV/DC Probe as the active electrode.

Connect the electrode cable to the

Circular pad

(L: Ø60 mm, S: Ø40 mm)

Flat sponge

Pin-type electrode

Circular electrode (large)

Pin-type pad

(4×16 mm)

Circular electrode (small)

Self-adhesive Electrode.

Insert the connection pin of the HV/DC Probe into the cord for the Self-adhesive Electrode.

Insert the pin fully until you can no longer see the metal portion.

Soak the pad and sponge thoroughly with water and wring gently so that no water drips

from them. Attach them to the electrode.

[When using the pin-type electrode] [When using the flat sponge and circular pad]

Circular pad

Pin-type pad

Flat sponge

* The sponge is not used with the pin-type

electrode. Make sure the pad is sufficiently wet during use.

* Place the flat sponge inside the circular pad.

[When using the Electrode Sponge (with slit) (optional)]

①

Electrode Sponge (with slit)

Folded-back sections

②

When using the Electrode Sponge (with slit), slide it from the side so that the steel plate of the circular electrode is enclosed by the sponge, then cover the steel plate with the folded-back sections of the felt.

Insert the electrode pin into the tip of the HV/DC Probe.

ON OFF ON

Electric current is outputted while the switch is pressed forward or backward. To turn off the current, release the switch.

* The output level cannot be increased or decreased unless the switch is in the ON position.

Connect the connector to the electrode cable connection port on the Main Unit.

When the power switch is turned on, an icon appears.

CAUTION About HV/DC Probe

①Thoroughly soak the pad at the tip of the HV/DC Probe with water before each treatment. Be careful

to avoid burns when using the HV/DC Probe.

②Limit the use of HV/DC Probe to 3 to 10 seconds (or less than 5 seconds) at each treatment area. ③Apply the Self-adhesive Electrode so that the heart is not positioned between the Self-adhesive

Electrode and HV/DC Probe. Make sure the Self-adhesive Electrode is at a safe distance from the HV/DC Probe.

Display of Electrotherapy Screen

Treatment screen

CH1

①

IF-2

⑧

P01

⑨ ⑩

⑪

⑬

⑫



②



100

④

9:51

⑥

③

2.0

CH1



①Treatment mode selection button

This button is used to select electrotherapy mode or measurement mode. Touch the button to display the sub-window for selecting treatment mode.

②Parameter setting buttons

These buttons are used to set treatment parameters. The parameters that can be set vary depending on the treatment mode.

* For information on setting parameters for each treatment mode, see pages 29 to 65.

③Channel selection buttons

These buttons are used to select the channel for which treatment parameters are to be set. The channel selection buttons show the treatment mode, remaining time, pause button (only during output operation), and output level of each channel.

⑦

10:00

0.0

CH2

30:00

⑤

0.00

⑭

④Treatment mode icons

These icons indicate the treatment modes of individual channels.

⑤Remaining time display

The remaining treatment time of each channel is shown.

⑥Pause button

This button appears only for the channel in output operation. It is used to pause, resume, or stop the output from each channel. When the pause button is touched, the output from the corresponding channel pauses. When the button is touched again, the output resumes. When the pause button is pressed and held, the output from the corresponding channel

stops and the treatment ends.

⑦Output level display

The output level of each channel is shown. The unit displayed will automatically switch according to the current output control. CC: mA, µA CV: V

⑧Program load button

This button is used to change the display to the load screen.

* The button is inoperable for the channel in output operation. * For information on loading a program, see pages 96 to 97.

⑨Program save button

This button is used to change the display to the save screen.

* The button is inoperable for the channel in output operation. * For information on saving a program, see pages 94 to 95.

⑩Clinical program button

This button is used to change the display to the clinical program screen.

* The button is inoperable for the channel in output operation. * For details of clinical programs, see pages 90 to 93.

⑪Electrode selection button

The type of connected electrodes is indicated with an icon. When the Vacuum Unit is connected, this button is used to switch between the electrodes connected to the Main Unit and Vacuum Electrodes.

* The button is inoperable for the channel in output operation.

⑫CC/CV selection button

This button is used to change the current output control system. CC: Constant current system CV: Constant voltage system

* The button is inoperable for the channel during output operation. * The button can’t be selected according to the treatment mode or electrode connected to the device.

For details refer to the page of each treatment mode.

⑬Config button

This button is used to change the display to the setting screen.

* This button is inoperable during output operation. * For details of the setting screen, see pages 98 to 100.

⑭Ultrasound channel selection button

This button is used to change the display to the treatment screen for ultrasound therapy and combination therapy.

* For details of ultrasound therapy, see pages 74 to 81. For details of combination therapy, see

pages 82 to 89.

F-2

Operation for Electrotherapy

* Make sure the electrodes that are used for the treatment are connected to the Main Unit and attached to the

treatment area.

* If Vacuum Electrodes are used, turn on the power switch for the Vacuum Unit and attach the Vacuum

Electrodes to the treatment area.

Select the channel to use.

Touch the appropriate channel selection button and display the channel (CH1 and CH2) to use.

* Use a combination of CH1 and CH2 for all IF-4 (4-

pole interferential) modes as well as IF-2 (2-pole interferential), EMS, Russian, TENS, and Hi-Voltage (Co-Cont mode and Alternate mode) modes.

Select the treatment mode.

Touch the treatment mode selection button. A sub-window opens. Select the treatment mode to use, then touch the OK button to close the sub-window.

Set the treatment parameters.

Touch each parameter setting button and set the treatment parameters.

* The parameters that can be set vary depending on

the selected treatment mode. For information on setting parameters for each treatment mode, see pages 29 to 65.

* To save the selected treatment parameters, see

pages 94 to 95. To retrieve saved treatment parameters, see pages 96 to 97.

* To use a clinical program, see pages 90 to 93.

IF-2

P01

Russian

Microcurre

IF-2

Hi-Voltage

Galvanic

P01

EMS

TENS

Select the electrode to use.

The icon displayed on the electrode selection button shows the connected electrode.

* If an electrode that cannot be used for the selected treatment

mode is connected, the electrode selection button indicates .

* Regarding the electrodes that can be used in each treatment

mode, see pages 29 to 65.

Set the current output control system.

Set the current output control system to CC (Constant Current) or CV (Constant Voltage).

* The button is inoperable for the channel during output

operation.

* The button can’t be selected according to the treatment

mode or electrode connected to the device. For details

refer to the page of each treatment mode.

Start the output.

Turn the intensity control dial for the selected channel to the right and set the output level.

Carrier

The channel selection button displays the pause button when output starts. The LED around the intensity control dial lights up, and a treatment melody will play.

* There will be no treatment melody if the treatment melody

sound level is set to Mute. For information on setting

treatment melody, see page 98.

* The settings of the timer, output level, and parameters can

be changed during output operation (some parameters

cannot be changed).

* Note that if the frequency, pulse duration or duty is changed

during the output operation, the stimulation felt by the

patient changes.

CH1

Operation for Electrotherapy

Pausing treatment

To pause treatment, touch the pause button for the channel in output operation. The output indication flashes and the output pauses.

To resume the treatment, touch the pause button again or increase the output level by operating the intensity control dial. The output will be produced for the remaining treatment time.

* During the pause phase of the treatment, when the current

intensity control dial is set to “0”, the treatment will end.

To end treatment

To stop treatment, either press and hold the pause button or set the current intensity control dial to “0” or press the stop switch.

9:51

2.0

* When the stop switch is pressed, all channels in output

operation will stop.

When the timer reaches “00:00,” the end melody plays and the output stops.

*There will be no end melody if the sound level setting is set to Mute.

For information on setting end melody, see page 98.

Turn off the power switch for the Main Unit and remove the electrodes from the treatment

area.

If the Vacuum Unit is used, also turn off the power switch for the Vacuum Unit before removing the electrodes.

Unplug the power supply cord from the AC power outlet.

* Store the Main Unit and accessories neatly to ensure trouble-free operation in the next treatment.

Setting Parameters for 4-Pole Interferential Mode

Connectable

electrodes

Usable channels

Treatment screen

1 2 3

Rubber Electrode, Self-adhesive Electrode (optional), Vacuum Electrode (optional)

Combination of CH1 and CH2

4 5

Output mode setting button

Carrier frequency setting button

Vector sweep setting button

Timer setting button

Interferential frequency setting button

Output mode setting

When the output mode setting button is touched, a subwindow opens. Touch either (Constant) or (Sweep), then touch the OK button to close the sub-window.

Timer setting

When the timer setting button is touched, the up/down keys will appear to the right of the button. Set the treatment time by using the up/down keys.

Carrier frequency setting

When the carrier frequency setting button is touched, the up/down keys will appear to the right of the button. Set the carrier frequency by using the up/down keys.

Interferential frequency setting

When (Constant) is selected as the output mode

When the interferential frequency setting button is touched, the up/down keys will appear to the right of the button. Set the interferential frequency by using the up/down keys.

Constant mode

When (Sweep) is selected as the output mode

Touch the minimum frequency or maximum frequency indication. The selected numeric indication becomes highlighted, and up/down keys will appear to the right of the button.

Sweep mode: Minimum

frequency setting

Set each frequency by using the up/down keys.

Vector sweep setting

Touch the vector sweep setting button and set the vector sweep angle. Set the vector sweep angle by using the up/down keys.

* If the target area is not clear, set a wide vector sweep

angle. When the vector sweep angle is wide, the

stimulation will feel gentle.

0° : No sweeping (to be used when target section is clear)

15°: 33% of area surrounded by electrodes can be

stimulated.

30°: 50% of area surrounded by electrodes can be

stimulated

45°: 100% of area surrounded by electrodes can be

stimulated

Sweep mode: Maximum

frequency setting

Parameter setting range for 4-Pole Interferential mode

Output mode: Constant, Sweep Carrier frequency: 2 kHz, 4 kHz, 5 kHz, 8 kHz, 10 kHz Interferential frequency: 1 to 250 Hz [1 to 10 Hz (1-Hz steps), 10 to 250 Hz (10-Hz steps)] Vector sweep angle: 0°, 15°, 30°, 45° Timer: 1 to 60 minutes [1 to 30 minutes (1-minute steps), 30 to 60 minutes (5-minute steps)] Output current (peak current value): 0.5 to 100 mA (0.5-mA steps) Output voltage (peak voltage value at 500 Ωload): 0.2 to 50 V (0.2-V steps) Waveform:

CH1

CH2

interferential frequency

Connectable

electrodes

Usable channels

Treatment screen

1 2 3

Self-adhesive Electrode, Sponge Electrode, (optional)

CH1 and CH2

Output mode setting button

Carrier frequency setting button

Timer setting button

Interferential frequency setting button

Output mode setting

When the output mode setting button is touched, a subwindow opens. Touch either (Constant) or (Sweep), then touch the OK button to close the sub-window.

Timer setting

When the timer setting button is touched, the up/down keys will appear to the right of the button. Set the treatment time by using the up/down keys.

Carrier frequency setting

When the carrier frequency setting button is touched, the up/down keys will appear to the right of the button. Set the carrier frequency by using the up/down keys.

Interferential frequency setting

When (Constant) is selected as the output mode

When the interferential frequency setting button is touched, the up/down keys will appear to the right of the button. Set the interferential frequency by using the up/down keys.

Constant mode

Setting Parameters for 2-Pole Interferential Mode

When (Sweep) is selected as the output mode

Touch the minimum frequency or maximum frequency indication. The selected numeric indication becomes highlighted, and up/down keys will appear to the right of the button. Set each frequency by using the up/down keys.

Parameter setting range for 2-Pole Interferential mode

Output mode: Constant, Sweep Carrier frequency: 2 kHz, 4 kHz, 5 kHz, 8 kHz, 10 kHz Interferential frequency: 1 to 250 Hz [1 to 10 Hz (1-Hz steps), 10 to 250 Hz (10-Hz steps)] Timer: 1 to 60 minutes [1 to 30 minutes (1-minute steps), 30 to 60 minutes (5-minute steps)] Output current (peak current value): 0.5 mA to 100 mA (0.5-mA steps) Output voltage (peak voltage value at 500 Ωload): 0.2 to 50 V (0.2-V steps) Waveform:

Sweep mode: Minimum

frequency setting

Sweep mode: Maximum

frequency setting

Setting Parameters for EMS Mode

Connectable

electrodes

Usable channels

Treatment screen

1 2 3

Self-adhesive Electrode, Sponge Electrode, (optional)

Surge Independent: CH1 and CH2 Surge Co-Cont, Surge Alternate: Combination of CH1 and CH2

4 5

Output mode setting button

Carrier frequency setting button

On/Off setting button

Timer setting button

Interferential frequency setting button

Setting Parameters for EMS Mode

Output mode setting

When the output mode setting button is touched, a subwindow opens. Touch (Surge Independent), (Surge Co- Cont), o (Surge Alternate), then touch the OK

button to close the sub-window.

* For Surge Co-Cont and Surge Alternate use two channels.

: Simultaneous output from 2 channels

: Alternating output from 2 channels

Timer setting

When the timer setting button is touched, the up/down keys will appear to the right of the button. Set the treatment time by using the up/down keys.

Carrier frequency setting

When the carrier frequency setting button is touched, the up/down keys will appear to the right of the button. Set the carrier frequency by using the up/down keys.

Interferential frequency setting

When the interferential frequency setting button is touched, the up/down keys will appear to the right of the button. Set the interferential frequency by using the up/down keys.

On/Off setting

When the On/Off button is touched, a sub-window opens.

Touch the item to change, and set the parameters using the up/down keys on the right side of the sub-window.

① ②

③ ④ ⑤ ②

①On time setting button ②Off time setting button

③Ramp up time setting button ④Hold time setting button ⑤Ramp down time setting button ⑥Timer setting button

⑦Number-of-contractions setting button

⑥

⑦



Parameter setting range for EMS mode

Output mode: Surge Independent, Surge Co-Cont, Surge Alternate Carrier frequency: 2 kHz, 4 kHz, 5 kHz, 8 kHz, 10 kHz Interferential frequency: 20 to 250 Hz (10-Hz steps) On time: 0.1 to 36 sec

Ramp up time: 0 to 3 sec. (0.1-sec. steps) Hold time: 0 to 30 sec. (0.5-sec. steps)

Ramp down time: 0 to 3 sec. (0.1-sec. steps) Off time: 1 to 99 sec. (0.5-sec. steps) Timer: 1 to 60 minutes [1 to 30 minutes (1-minute steps), 30 to 60 minutes (5-minute steps)] Output current (peak current value): 0.5 to 100 mA (0.5-mA steps)

Output voltage (peak voltage value at 500 Ωload): 0.2 to 50 V (0.2-V steps)

Output

voltage

Ramp up

Hold time

Ramp down

Off time

Interferential frequency

Waveform:

On time

Setting Parameters for Russian Mode

Connectable

electrodes

Usable channels

Treatment screen

1 2 3

Self-adhesive Electrode, Sponge Electrode, (optional)

Independent: CH1 and CH2 Co-Cont/Alternate: Combination of CH1 and CH2

Output mode setting button

Duty setting button

Timer setting button

On/Off setting button

Output mode setting

When the output mode setting button is touched, a subwindow opens. Touch (Surge Independent), (Surge Co- Cont), o (Surge Alternate), then touch the OK button to close the sub-window.

* For Surge Co-Cont and Surge Alternate use two channels.

Timer setting

When the timer setting button is touched, the up/down keys will appear to the right of the button. Set the treatment time by using the up/down keys.

Duty setting

: Simultaneous output from 2 channels

: Alternating output from 2 channels

When the duty setting button is touched, the up/down keys will appear to the right of the button. Set the duty by using the up/down keys.

Setting Parameters for Russian Mode

On/Off setting

⑥

① ②

⑦



When the On/Off button is touched, a sub-window opens. Touch the item to change, and set the parameters using the up/down keys on the right side of the sub-window.

①On time setting button ②Off time setting button ③Ramp up time setting button ④Hold time setting button ⑤Ramp down time setting button ⑥Timer setting button

⑦Number-of-contractions setting button



Parameter setting range for Russian mode

③ ④ ⑤ ②

Output mode: Surge Independent, Surge Co-Cont, Surge Alternate Carrier frequency: 2.5 kHz (fixed) Duty: 10 to 100% (10% steps) On time: 0.1 to 36 sec

Ramp up time: 0 to 3 sec. (0.1-sec. steps)

Hold time: 0 to 30 sec. (0.5-sec. steps)

Ramp down time: 0 to 3 sec. (0.1-sec. steps)

Off time: 1 to 99 sec. (0.5-sec. steps) Timer: 1 to 60 minutes [1 to 30 minutes (1-minute steps), 30 to 60 minutes (5-minute steps)] Output current (peak current value): 0.5 to 100 mA (0.5-mA steps)

Output voltage (peak voltage value at 500 Ωload): 0.2 to 50 V (0.2-V steps) Waveform:

Output voltage

Ramp up

Hold time

Ramp down

Off time

On time

10 ms*

20 ms

Duty set at 50%

Setting Parameters for Hi-Voltage Mode

Connectable

electrodes

Usable channels

* When HV/DC Probes are connected, the open error detection function turns off.

Treatment screen

1 2 3

Self-adhesive Electrode, Sponge Electrode, (optional)

Constant, Sweep, Burst, Surge Independent: CH1 and CH2 Surge Co-Cont, Surge Alternate: Combination of CH1 and CH2

Polarity/output mode setting button

Frequency setting button

Timer setting button

On/Off setting button

* The On/Off setting button appears only when Surge Independent, Surge Co-Cont, or Surge

Alternate is selected.

* In Hi-Voltage mode, CV is automatically set. CC cannot be selected.

Setting Parameters for Hi-Voltage Mode

Polarity/output mode setting

When the polarity/output mode setting button is touched, a sub-window opens. Select the output mode by touching the (Constant),

(Sweep), (Bur (Surge Independent)

(Surge Co-Cont), or (Surge Alternate) button.

t),

Select the polarity from , , or , then touch the OK button to close the sub-window.

* For Surge Co-Cont and Surge Alternate use two channels.

: Simultaneous output from 2 channels

: Alternating output from 2 channels

Timer setting

* The set polarity applies to the

gray connection pins of the electrode cable.

When the timer setting button is touched, the up/down keys will appear to the right of the button. Set the treatment time by using the up/down keys.

Frequency setting

When the frequency setting button is touched, the up/ down keys will appear to the right of the button. Set the frequency by using the up/down keys.

When selecting modes other than (Sweep) as the output mode

When the frequency setting button is touched, the up/ down keys will appear to the right of the button. Set the frequency by using the up/down keys.

When selecting (Sweep) as the output mode

Touch either minimum frequency or maximum frequency indication. The selected numeric indication becomes highlighted, and up/down keys will appear to the right of the button. Set each frequency by using the up/down keys.

Mode other than Sweep mode

Sweep mode: Minimum

frequency setting

Sweep mode: Maximum

frequency setting

On/Off setting (Surge mode only)

When (Surge Independent), (Surge Co- Cont), o (Surge Alternate) is selected, the On/Off

r setting button appears. When the On/Off setting button is touched, a subwindow opens.

Touch the item to change, and set the parameters using

⑥

the up/down keys on the right side of the sub-window.

①On time setting button ②Off time setting button ③Ramp up time setting button ④Hold time setting button ⑤Ramp down time setting button ⑥Timer setting button

⑦Number-of-contractions setting button

① ②

⑦



③ ④ ⑤ ②



Parameter setting range for Hi-Voltage mode

Output mode: Constant, Sweep, Burst, Surge Independent, Surge Co-Cont,

Surge Alternate Polarity: positive, negative, alternate Frequency:

Constant 0.5 to 200 Hz [0.5 Hz, 0.7 Hz, 1 to 10 Hz (1-Hz steps), 10 to 200 Hz (10-Hz steps)] Sweep 1 to 200 Hz [1 to 10 Hz (1-Hz steps), 10 to 200 Hz (10-Hz steps)] Burst 0.5 to 7 Hz [0.5 Hz, 0.7 Hz, 1 to 7 Hz (1-Hz steps)] Surge Independent, Surge Co-Cont, Surge Alternate 20 to 200 Hz (10-Hz steps)

Pulse duration: 10 µs (fixed)*

* Pulse width at half the output voltage (500 Ωload).

On time: 0.1 to 36 sec

Ramp up time: 0 to 3 sec. (0.1-sec. steps) Hold time: 0 to 30 sec. (0.5-sec. steps)

Ramp down time: 0 to 3 sec. (0.1-sec. steps) Off time: 1 to 99 sec. (0.5-sec. steps) Timer: 1 to 60 minutes [1 to 30 minutes (1-minute steps), 30 to 60 minutes (5-minute steps)] Output voltage (peak voltage value): 0.5 to 300 V [0.5 to 100 V (0.5-V steps), 100 to 300 V (1-V steps)] Waveform:

Output voltage

Frequency

(Alternate polarity)

Connectable

electrodes

Usable channels

Treatment screen

1 2 3

4 5

Self-adhesive Electrode, Sponge Electrode, (optional)

Constant, Sweep, Burst, Surge Independent: CH1 and CH2 Surge Co-Cont, Surge Alternate: Combination of CH1 and CH2

Polarity/output mode setting button

Frequency setting button

On/Off setting button

Timer setting button

Pulse duration setting button

* The On/Off setting button appears only when Surge Independent, Surge Co-Cont, or Surge

Alternate is selected.

Polarity/output mode setting

When the polarity/output mode setting button is touched, a sub-window opens. Select the output mode by touching the (Constant),

(Sweep), (Bur (Surge Independent)

(Surge Co-Cont), or (Surge Alternate) button.

Select (Symmetrical Waveform) or (Asymmetrical Waveform).

* When symmetrical waveform is chosen, the polarity cannot

be changed.

* For Surge Co-Cont and Surge Alternate use two channels.

: Simultaneous output from 2 channels

: Alternating output from 2 channels

Timer setting

t),

* The set polarity applies to the

gray connection pins of the electrode cable.

When the timer setting button is touched, the up/down keys will appear to the right of the button. Set the treatment time by using the up/down keys.

Frequency setting

When the frequency setting button is touched, the up/ down keys will appear to the right of the button. Set the frequency by using the up/down keys.

When selecting modes other than (Sweep) as the output mode

When the frequency setting button is touched, the up/ down keys will appear to the right of the button. Set the frequency by using the up/down keys.

Mode other than Sweep mode

When selecting (Sweep) as the output mode

Pulse duration setting

When the pulse duration setting button is touched, the up/down keys will appear to the right of the button. Set the treatment time by using the up/down keys.

On/Off setting (Surge mode only)

When (Surge Independent), (Surge Co- Cont), o (Surge Alternate) is selected, the On/Off setting button appears. When the On/Off setting button is touched, a subwindow opens. Touch the item to change, and set the parameters using the up/down keys on the right side of the sub-window.

⑥

Sweep mode: Minimum

frequency setting

Sweep mode: Maximum

frequency setting

① ②

⑦

③ ④ ⑤ ②



①On time setting button ②Off time setting button ③Ramp up time setting button ④Hold time setting button ⑤Ramp down time setting button ⑥Timer setting button

⑦Number-of-contractions setting button

Parameter setting range for TENS mode

Output mode: Constant, Sweep, Burst, Surge Independent, Surge Co-Cont,

Surge Alternate Waveform setting: Symmetrical waveform, asymmetrical waveform Polarity: positive, negative, alternate Frequency:

Constant 0.5 to 250 Hz [0.5 Hz, 0.7 Hz, 1 to 10 Hz (1-Hz steps), 10 to 250 Hz (10-Hz steps)] Sweep 1 to 250 Hz [1 to 10 Hz (1-Hz steps), 10 to 250 Hz (10-Hz steps)] Burst 0.5 to 7 Hz [0.5, 0.7, 1 to 7 Hz (1-Hz steps)]

Surge Independent, Surge Co-Cont, Surge Alternate 20 to 250 Hz (10-Hz steps) Pulse duration: 50 to 300 µs (10-µs steps) On time: 0.1 to 36 sec

Ramp up time: 0 to 3 sec. (0.1-sec. steps) Hold time: 0 to 30 sec. (0.5-sec. steps)

Output voltage (peak voltage value at 500 Ωload): 0.2 to 50 V (0.2-V steps) Waveform:

Output voltage

Pulse duration

Frequency

Setting Parameters for Microcurrent Mode

Connectable

electrodes

Self-adhesive Electrode, Sponge Electrode, (optional)

Usable channels

Treatment screen

1 2 3

4 5 6

CH1 and CH2

Phase 1 polarity setting button

Phase 1 frequency setting button

Phase 2 timer setting button

Phase 1 timer setting button

Phase 2 polarity setting button

Phase 2 frequency setting button

* In Microcurrent mode, electric currents of different settings can output continuously.

When using only Phase 1, set the Phase 2 timer to “0.”

* In Microcurrent mode, CC is automatically set. CV cannot be selected.

Phase 1 polarity mode setting

When the Phase 1 polarity setting button is touched, a sub-window opens. Select the Phase 1 polarity from , , or , and touch the OK button to close the sub-window.

* The set polarity applies to the gray

connection pins of the electrode cable.

Phase 1 timer setting

When the Phase 1 timer setting button is touched, the up/down keys will appear to the right of the button. Set the Phase 1 treatment time by using the up/down keys.

* The timer can be set to up to 60 minutes for the total time of

Phase 1 and Phase 2.

Phase 1 frequency setting

When the Phase 1 frequency setting button is touched, the up/down keys will appear to the right of the button. Set the Phase 1 frequency by using the up/down keys.

Phase 2 setting

When using Phase 2, set the Phase 2 polarity, timer, and frequency in the same manner.

Setting Parameters for Microcurrent Mode

Parameter setting range for Microcurrent mode

Polarity: positive, negative, alternate Frequency: 0.2 to 400 Hz [0.2 Hz, 0.3 Hz, 0.5 Hz, 0.7 Hz, 1 to 10 Hz (1-Hz steps),

10 to 400 Hz (10-Hz steps)] Pulse duty: 50% (fixed) Timer: 1 to 60 minutes [1 to 30 minutes (1-minute steps), 30 to 60 minutes (5-minute steps),

Phase 1 + Phase 2 ≤ 60 min)] Output current (peak current value): 10 to 750 µA (10-µA steps) Waveform:

Output

(Alternate polarity)

Frequency

Pulse Duty:50%

Setting Parameters for Galvanic Mode

Connectable

electrodes

Usable channels

* When HV/DC Probes are connected, output is automatically set to 1/10, and the open error detection

function turns off.

* When HV/DC Probes are connected, CV is automatically set. CC cannot be selected.

Treatment screen

Sponge Electrode, (optional), HV/DC Probe (optional)

CH1 and CH2

1 2 3

Polarity/output mode setting button

Pulse duration setting button

Timer setting button

* The pulse duration setting button appears only when the output mode is set to Positive/Interrupted

or Negative/Interrupted.

Setting Parameters for Galvanic Mode

Polarity/output mode setting

When the polarity/output mode setting button is touched, a sub-window opens. Select (Positive/Continuous), (Negative/ Continuous), (Positive/Interrupted), or (Negative/Interrupted), and touch the OK button to close the sub-window.

* The set polarity applies to the gray

connection pins of the electrode cable.

Timer setting

When the timer setting button is touched, the up/down keys will appear to the right of the button. Set the treatment time by using the up/down keys.

Pulse duration setting

When the pulse duration setting button is touched, the up/down keys will appear to the right of the button. Set the treatment time by using the up/down keys.

* The pulse duration setting button appears only when the

output mode is set to Positive/Interrupted or Negative/ Interrupted.

Parameter setting range for Galvanic mode

Output mode: Continuous, Interrupted Polarity: positive, negative Pulse duration (interrupted): 60 ms, 100 ms, 300 ms, 500 ms, 1000 ms

(pulse duty fixed at 95%) Frequency (interrupted): 0.95 to 15.8 Hz Timer: 1 to 60 minutes [1 to 30 minutes (1-minute steps), 30 to 60 minutes (5-minute steps)]

Output current (peak current value): 0.2 to 20 mA (0.2-mA steps)

Output voltage (peak voltage value at 500 Ωload): 0.1 to 10 V (0.1-V steps) Waveform:

Continuous

Output voltage

Interrupted

Output voltage

Pulse duration

Pulse interval

Setting Parameters for Faradic Mode Preparing for Ultrasound Therapy

Make sure the power switch for the Main Unit is

turned off.

Connect the power supply cord to the power supply

cord connection port on the Main Unit.

Connect the power supply cord to an AC power

outlet.

Connect one of the Ultrasound Probe (L) and Ultrasound Probe (S) (optional), or both to the Ultrasound Probe connection port.

* The Ultrasound Probe cable can be connected to either

connection port.

* Do not connect Ultrasound Probes of the same size to the

Main Unit at the same time.

Turn on the power switch for the Main Unit.

After the initial check is completed, the treatment screen will appear.

1. To avoid the risk of electric shock, this equipment must only be

WARNING

CAUTION

connected grounded power connection.

2. MULTIPLE SOCKET-OUTLET or extension cord shall not be connected to the SONICATOR PLUS 921.

1. In order to disconnect from a wall socket, pull the plug.

2. Do not position the SONICATOR PLUS 921 where it is difficult to

WARNING

To avoid electric shock, do not perform any operations other than the operation of the Ultrasound Probe when your hands are wet.

Caution regarding auto contact function

● The auto contact function adjusts output to minimum levels when the Ultrasound Probe is moved away from the treatment area (skin) but does not completely shut off output. Do not leave the Ultrasound Probe unattended while the power switch is turned on. Be sure to turn off the power switch when not performing a treatment with the Ultrasound Probe. Avoid leaving ultrasound gel on the probe head. Be sure to wipe off ultrasound gel after each use.

● To prevent burns, check the temperature of the probe head before resuming use of the Ultrasound Probe after allowing it to stand for more than 1 minute.

● If the Ultrasound Probe is left unused for 3 minutes or more, the output will shut down automatically.

Do not hold the head of the ultrasound probe or LED

CAUTION

area of the probe for a long period during treatment, due to heating of these locations.

CH2

CH1

Ultrasound Therapy Screen

Treatment screen

⑧

P01

⑫



⑪



100

10:00

0.0



⑬

①Treatment mode selection button

This button is used to select the treatment mode for ultrasound therapy or combination therapy. Touch the button to display the sub-window for selecting treatment mode.

②Parameter setting buttons

These buttons are used to set ultrasound therapy parameters.

Frequency setting button

Duty setting button

29:51

10:00

0.0

Timer setting button

Pulse frequency setting button

⑦ ③

29:51

1.00

②

④ ⑤

⑥

③Ultrasound channel selection button

This button is used to change the display to the treatment screen for ultrasound therapy and combination therapy. The channel selection button shows the treatment mode, remaining time, pause button (during output operation only), and output level.

④Treatment mode icon

This icon indicates the treatment mode.

⑤Remaining time display

The remaining treatment time is shown.

⑥Pause button

This button appears during output operation only. It is used to pause, resume, or stop output. When the pause button is touched, the output pauses. When the button is touched again, the output resumes. When the pause button is pressed and held, the output stops and the treatment ends.

⑦Output level display

The output level is shown.

⑧Program load button

This button is used to change the display to the load screen.

* The button is inoperable for the channel in output operation. * For information on loading a program, see pages 96 to 97.

⑨Program save button

This button is used to change the display to the save screen.

* The button is inoperable for the channel in output operation. * For information on saving a program, see pages 94 to 95.

⑩Clinical program button

This button is used to change the display to the clinical program screen.

* The button is inoperable for the channel in output operation. * For details of clinical programs, see pages 90 to 93.

⑪Ultrasound Probe selection button

The size of the selected Ultrasound Probe and type of coupler is shown.

* When both the Ultrasound Probe (L) and Ultrasound Probe (S) is connected, size selection of the

probe is accessible by pressing this button.

* For details of the Ultrasound coupler settings, see page 99.

⑫Config button

This button is used to change the display to the setting screen.

* This button is inoperable during output operation. * For details of the setting screen, see pages 98 to 100.

⑬Electrotherapy channel selection buttons

These buttons are used to change the display to the treatment screen for electrotherapy and measurement mode.

* For details of electrotherapy, see pages 29 to 65. For details of measurement mode, see pages 66

to 73.

F-2

Connectable

electrodes

Ultrasound Probe (L), Ultrasound Probe (S) (optional)

Usable channels

US only

* Make sure the Ultrasound Probe to be used is connected to the Main Unit.

Select the US channel.

Touch the ultrasound channel selection button to

ultrasound P01

display the US channel.

Select the treatment mode.

Touch the treatment mode selection button. A sub-window opens. Select Ultrasound, then touch the OK button to close the sub-window.

Ultrasound

TENS Comb. Faradic Comb.

Select the Ultrasound Probe to be used.

I Comb. Microcurrent Comb. Diadynamic Comb.

GEL

Hi-Voltage Comb.

Galvanic Comb.

Traebert Comb.

Touch the ultrasound probe selection button and select the size of the Ultrasound Probe to be used.

* When only one Ultrasound Probe is connected, the

button cannot be selected.

* Ultrasound coupler can be set on the setting screen.

For details of the Ultrasound coupler settings, see page 99.

Duty

Set the frequency.

Touch the frequency setting button to set the ultrasound frequency. Touch the button to toggle between “1 MHz” and “3 MHz.”

Set the timer.

When the timer setting button is touched, up/down keys will appear to the right of the button. Set the treatment time by using the up/down keys.

Set the duty.

When the duty setting button is touched, up/down keys will appear to the right of the button. Set the duty by using the up/down keys.

Set the pulse frequency.

Freq.

Time

30:00

Duty

100

MHz

When the pulse frequency setting button is touched, up/down keys will appear to the right of the button. Set the pulse frequency by using the up/down keys.

* Settings cannot be changed during output operation. * When duty is set at 100%, settings cannot be changed. * To save the set treatment parameters, see pages 94 to 95.

To retrieve saved treatment parameters, see pages 96 to

97.

* To use a clinical program, see pages 90 to 93.

Pulse Freq.

100

Apply ultrasound gel to the probe head.

* When using ointment as the ultrasound coupler, select

OTM with the GEL/OTM setting button on the setting screen/treatment setting. For information on GEL/OTM settings, see page 99.

Start output.

Turn the ultrasound intensity control dial to the right to increase output and start treatment.

When output starts, the LED around the ultrasound intensity control dial will light up.

* A treatment melody will play during output operation. There

will be no treatment melody if the treatment melody is set to mute. For information on setting the treatment sound, see page 98.

* The timer and output level settings can be changed during

output operation.

Pausing treatment

To pause treatment, touch the pause button. The output indication flashes and the output pauses.

To resume the treatment, touch the pause button again or increase the output level by operating the ultrasound intensity control dial. The output will be produced for the remaining treatment time.

* During the pause phase of the treatment, when the ultrasound intensity control dial is set to “0”, the

treatment will end.

To end treatment

To stop treatment, either press and hold the pause button, set the ultrasound intensity control dial to “0” or press the stop switch.

* When the stop switch is pressed, all channels in output operation stop.

10 When the timer reaches “00:00,” the end melody plays and the output stops.

*There will be no end melody if the sound level setting is set to Mute.

For information on setting end melody, see page 98.

11 Turn off the power switch for the Main Unit.

Wipe off ultrasound gel from the probe head and disconnect the Ultrasound Probe from the Main Unit.

12 Unplug the power supply cord from the AC power outlet.

* Store the Main Unit, accessories, etc. neatly to ensure trouble-free use during the next treatment.

Note:

Basis for the measurement conditions for sound pressure level is determined as the distance able to be reached by hand (about 60 cm away).

Parameter setting range for Ultrasound mode

Ultrasound frequency: 1 MHz, 3 MHz Duty: 5%, 10%, 20%, 30%, 40%, 50%, 100% Pulse frequency: 16 Hz, 48 Hz, 100 Hz Timer: 1 to 30 minutes (1-minute steps) Intensity (max.): 2.0 W/cm

(Continuous), 3.0 W/cm2 (Pulse)

Preparing for Combination Therapy

Make sure the power switch for the Main Unit is

turned off.

Connect the power supply cord to the power supply

cord connection port on the Main Unit.

Connect the power supply cord to an AC power

outlet.

Select the electrode for electrotherapy and connect

the electrode to the connection pin of the electrode cable for CH2 that has a “Comb.” tag.

● Only rubber electrodes, self-adhesive electrodes (optional) and vacuum electrodes(optional) can be used for combination therapy.

* For information on using each electrode, see pages 15 to

17 and 21 to 23.

Attach the electrode securely close to the treatment

area.

Connect the electrode cable to the electrode cable

connection port for CH2.

* Only the combination of CH2 and US channels can be used

in Combination mode.

Connect one of the Ultrasound Probe (L) and Ultrasound Probe (S) (optional), or both to the Ultrasound Probe connection port.

* The Ultrasound Probe cable can be connected to either

connection port.

* Do not connect Ultrasound Probes of the same size to the

Main Unit at the same time.

Turn on the power switch for the Main Unit.

After the initial check is completed, the treatment screen will appear.

Combination Therapy Screen

Treatment screen

①

⑨ ⑩ ⑪

⑭

⑫ ⑬

② ③



④



①Treatment mode selection button

This button is used to select ultrasound therapy mode or combination therapy mode. Touch this button to display a sub-window for selecting a treatment mode.

②Electrotherapy parameter setting area

This area is used to set treatment parameters for electrotherapy. The parameters that can be set depend on the treatment mode.

* For information on setting electrotherapy parameters, see pages 29 to 61. * All output modes of IF-4, EMS, Russian, Hi-Voltage Surge mode, and TENS Surge mode cannot be

set for combination therapy.

③Ultrasound parameter selection area

This area is used to set treatment parameters for ultrasound therapy.

* For information on setting ultrasound therapy parameters, see pages 76 to 81.

⑮

⑤

⑥

⑦ ⑧

④Treatment mode icon

The treatment mode is indicated with an icon.

⑤Remaining time display

The remaining treatment time is shown.

⑥Pause button

⑦Electric current output level display

The electric current output level is shown.

⑧Ultrasound output level display

The ultrasound output level is shown.

⑨Program load button

This button is used to change the display to the load screen.

* The button is inoperable for the channel during output operation. * For information on loading a program, see pages 96 to 97.

⑩Program save button

This button is used to change the display to the screen to save programs.

* The button is inoperable for the channel in output operation. * For information on saving a program, see pages 94 to 95.

⑪Clinical program button

This button is used to change the display to the clinical program screen.

* The button is inoperable for the channel in output operation. * For details of clinical programs, see pages 90 to 93.

⑫Ultrasound Probe selection button

The size of the selected Ultrasound Probe is shown.

⑬Electrode selection button

The type of connected electrodes is indicated with an icon. When the Vacuum Unit is connected, this button is used to switch between the electrodes connected to the Main Unit and Vacuum Electrodes.

* The button is inoperable for the channel during output operation.

⑭Config button

This button is used to change the display to the setting screen.

* This button is inoperable during output operation. * For details of setting screen, see pages 98 to 100.

⑮Electrotherapy channel selection button

This button is used to change the display to the treatment screen for electrotherapy and measurement mode.

* For details of electrotherapy, see pages 29 to 65. For details of measurement mode, see pages 66 to 73.

F-2

Connectable

electrodes

Electrotherapy: Sponge Electrode, (optional), HV/DC Probe

(optional)

Ultrasound therapy: Ultrasound Probe (L), Ultrasound Probe (S) (optional)

Usable channels

Combination of CH2 and US only

* Make sure the Ultrasound Probe is connected to the Main Unit.

Select the US channel.

Touch the ultrasound channel selection button to display the US channel.

Select the treatment mode.

Touch the treatment mode selection button. A sub-window opens. Select the combination therapy mode to use, then touch the OK button to close the sub-window.

* IF-4, EMS, and Russian modes cannot be set for

combination therapy.

Select the Ultrasound Probe to be used.

ultrasound P01

Ultrasound

TENS

Comb.

I Comb. Microcurrent Comb.

GEL

Hi-Voltage Comb.

Galvanic Comb.

Touch the electrode selection button and select the size of the Ultrasound Probe to be used.

* When only one Ultrasound Probe is connected,

the button cannot be selected.

* Ultrasound coupler can be set on the setting screen.

For details of the ultrasound coupler settings, see page 99.

Duty

Set the treatment parameters for electrotherapy.

The parameters that can be set depend on the treatment mode set.

* Surge Independent, Surge Co-Cont, and Surge Alternate

modes for Hi-Voltage and TENS cannot be used for combination therapy.

* For information on setting electrotherapy parameters, see

pages 29 to 61.

* The set polarity applies to the Ultrasound Probe side.

* During combination therapy, the current output will

automatically be set to CV mode.

Set the treatment parameters for ultrasound

therapy.

* For information on setting ultrasound therapy parameters,

see pages 76 to 81.

Set the timer.

When the timer setting button is touched, up/down keys will appear to the right of the button. Set the treatment time by using the up/down keys.

* To save the set treatment parameters, see pages 94 to 95.

To retrieve saved treatment parameters, see pages 96 to

97.

* To use a clinical protocol, see pages 90 to 93.

Apply ultrasound gel to the probe head.

* When using ointment as the ultrasound coupler, select OTM

with the GEL/OTM setting button on the setting screen/ treatment setting.

For information on the GEL/OTM setting, see page 99.

Start ultrasound output.

Turn the ultrasound intensity control dial to the right to increase output and start treatment.

When output starts, the LED around the ultrasound intensity control dial will light up.

* A treatment melody will play during output operation. There

will be no treatment melody if the treatment melody is set to mute. For information on setting the treatment sound, see page 98.

* The timer and output level settings can be changed during

output operation.

Start the output for electrotherapy.

Turn the current intensity control dial for CH2 to the right to set the output level.

When output starts, the pause button will appear in the channel selection button for CH2. The LED around the current intensity control dial will light up.

* The settings for the timer, output level, and parameters

can be changed during output operation (some parameters cannot be changed).

* Note that if the pulse duration is changed during output

operation, the stimulation felt by the patient changes.

Pausing treatment

To pause treatment, touch the pause button. The output indication flashes and the output pauses.

To resume the treatment, touch the pause button again or increase the output level by operating the ultrasound intensity control dial. The output will be produced for the remaining treatment time.

* During the pause phase of the treatment, when the ultrasound intensity control dial is set to “0”, the

treatment will end.

To end treatment

To stop treatment, either press and hold the pause button or set the ultrasound intensity control dial to “0” or press the stop switch.

* When the stop switch is pressed, all channels in output operation stop.

10 When the timer reaches “00:00,” the end melody plays and the output stops.

*There will be no end melody if the sound level setting is set to Mute.

For information on setting end melody, see page 98.

11 Turn off the power switch for the Main Unit

Wipe off ultrasound gel from the probe head and disconnect the Ultrasound Probe from the Main Unit.

12 Unplug the power supply cord from the AC power outlet.

* Store the Main Unit, accessories, etc. neatly to ensure trouble-free use during the next treatment.

CAUTION

• Avoid short circuits between the Self-adhesive Electrode and Ultrasound Probe head.

• Set the output level low at the beginning and increase gradually.

• Do not perform combination therapy in water.

• When performing combination therapy, make sure the Ultrasound Probe head is in firm contact with the skin of the treatment area. Otherwise, electric current density will increase in certain areas and may lead to electric shock or burns.

• The maximum electric current density must be kept below 2 mArms/cm² during combination therapy. Note that the electric density of the Ultrasound Probe (S) [size: 16 mm] may exceed 2 mArms/cm². Adjust the output to appropriate levels and do not allow electric current density to exceed this limit.

Display of Clinical Program Screen

Clinical program selection screen

⑤

①



②



①Upper-/lower-body selection button

This button is used to change the treatment area of the body. Press the button to toggle between the upper body and lower body.

②Treatment area selection buttons

These buttons are used to select the treatment area.

③Clinical program list

This area displays the names of clinical programs associated with the selected treatment area.

④Treatment program selection buttons

These buttons are used to select the treatment program. Press a button to change the display to the corresponding treatment guidance screen.

⑤Back button

This button returns the display to the treatment screen.

③ ④

Treatment guidance screen

①



⑥

② ⑤ ③ ④



①Treatment area display

This screen area shows treatment areas. Blue or green square: This indicates the electrode attachment position for electrotherapy.

Orange area: This shows the ultrasound therapy area.

②Parameter display

This screen area shows the parameters of the treatment program.

③Treatment guidance

This screen area displays information on the treatment program.

④OK button

This button is used to confirm the selection of the treatment program. Touch this button to change the display to the treatment program.

⑤Cancel button

This button returns the display to the clinical program selection screen.

If the polarity is set, a “+” or “-” sign is also indicated. When two channels are used, the squares are displayed in different colors to make it possible to distinguish channels.

⑥Back button

This button returns the display to the treatment screen.

Operation of Clinical Program

Clinical programs are reference examples and should not be considered the

CAUTION

* Make sure the electrode and Ultrasound Probe used are connected to the Main Unit. * When using a Vacuum Electrode, turn on the power switch for the Vacuum Unit and attach the Vacuum

Electrode to the treatment area.

most suitable programs for specific indications. When performing a treatment, qualified persons should determine the program based on the

atient’s condition and symptoms.

Select the channel to be used.

Touch the channel selection button and display the channel to be used.

* The clinical program button is inoperable for the channel

in output operation. Be sure to select a channel that is

not in use.

Display the clinical program screen.

Touch the clinical program button to display the clinical program selection screen.

Select the treatment area.

Touch the upper-/lower-body selection button and the treatment area selection button, then select the treatment area.

Carrier

Select the treatment program.

After the treatment area is selected, the right half of the screen will display the names of clinical programs based on the treatment area selected. Touch the desired treatment program from the programs available for the indications to be treated. The display changes to the treatment guidance screen.

* In the case of treatment programs that require use of

a combination of channels (IF-4 or Surge Co-Cont and Alternate modes for EMS, Russian, Hi-Voltage, and TENS, or Combination), an error sound is generated if one of the combination channels is in use and the program cannot be selected.

* Treatment program can’t be specified for the active channels.

* When ultrasound channel is selected and the clinical

program screen is displayed, treatment program of electrotherapy can’t be selected.

Attach the electrode to the treatment area.

Confirm the parameters and treatment guidance, then attach the electrode as indicated in the treatment area display.

* Blue or green square:

This indicates the electrode attachment position for electrotherapy. If the polarity is set, a “+” or “-” sign is also indicated. If two channels are used, the squares are displayed in different colors to make it possible to distinguish channels.

Orange area: This shows the ultrasound treatment area.

* To select a treatment program once again, touch the cancel

button to return to the clinical program selection screen.

Start output.

Touch the OK button to change the display to the treatment screen. Turn the intensity control dial for the selected channel to set the output level.

* For information on operation during output operation, see

the pages describing corresponding treatment modes.

Saving Programs

Up to 10 programs can be saved for each treatment mode

Select a channel.

Touch the channel selection button to display the channel for which the parameters to be saved are set.

Display the save screen.

Touch the program save button to display the sub-window.

Select the program number for the program

to be saved.

In the program list on the right side of the

screen, touch the program number for the program to be saved. Confirm the parameters and touch the OK button to save the program.

* The upper side of the screen on the left side

shows the parameters to be saved. The lower side displays the parameters currently saved in the selected program number.

* To stop saving the program, touch the cancel

button.

P01

ime

②

①



To rename a program

Touch the edit button in the program save subwindow to change the display to the program name editing screen.

Use the keyboard to rename the program. Touch OK to confirm the change and to return to the subwindow.

* To cancel renaming, touch the back button at the

upper right corner of the screen.

* To enter a signed character, press and hold the

desired key to display candidate characters.

To cancel the input, touch

Loading Programs

Select the channel.

Touch the channel selection button to display the channel for which a previously saved program is to be loaded.

Display the loading screen.

Touch the program load button to display the sub-window.

Select the program number of the program

to be loaded.

In the program list, select the program number

to be loaded. Confirm the parameters and touch the OK button to load the program.

* The upper left side of the screen shows the current

parameter setting and the lower side displays the newly selected parameters ready to be uploaded.

* To stop loading the program, touch the cancel

button.

P01

Time

②

①



The program number display.

After the program is loaded, the display returns to the treatment screen. Confirm that the program load button indicates the program number of the loaded program.

* If any parameters in the loaded program have

changed, the color of the program number display will change.

P03

Setting Screen

Screen/Sound screen

Config.

②

④

⑧

⑤

⑨

Brightness

①

⑩

Initialization



①Brightness setting buttons

These buttons are used to set screen brightness.

②Key sound setting button

This button is used to set the volume of the key sound. Touch this button to display a sound level setting sub-window.

③Error sound setting button

This button is used to set the volume of the error sound. Touch this button to display a sound level setting sub-window.

③

⑥

⑦



[Sound level setting sub-window]

④Treatment melody selection button

This button is used to select the type of melody to play during treatment.

⑤Treatment melody sound level setting button

This button is used to set the volume of the treatment melody. Touch this button to display a sound level setting sub-window.

⑥End melody selection button

This button is used to select the type of melody to play at the end of treatment.

⑦End melody sound level setting button

This button is used to set the volume of the end melody. Touch this button to display a sound level setting sub-window.

⑧Contact sound setting button

This button is used to set the contact sound to play during ultrasound therapy.

A sound plays when the Ultrasound Probe is in contact with the treatment area.

A sound plays when the Ultrasound Probe is not in contact with the treatment area.

⑨Contact sound level setting button

This button is used to set the volume of the contact sound. Touch this button to display a sound level setting sub-window.

⑩Initialization button

This button returns settings and all program content to factory set conditions.

⑪OK button

This button finalizes the settings and returns the display to the treatment screen.

US Indication screen

Config.

GEL/OTM

W/cm2 W

③

Initialization



W/cm

①GEL/OTM setting button

This button is used to set the type of ultrasound coupler. [GEL, OTM (ointment)]

②Unit setting button

This button is used to set the measurement unit of ultrasound output. [W/cm

③Initialization button

This button returns settings and all program content to factory set conditions.

④OK button

This button finalizes the settings and returns the display to the treatment screen.

GEL

①



②



O K

④

, W]



Setting Screen

Language screen

Config.

①

English

Italiano

②

Initialization

①Language setting button

These buttons are used to select the language of the display. Set the language to any of the following nine languages: English, German, French, Italian, Spanish, Portuguese, Turkish, Vietnamese, or Chinese



Deutsch

Espanol

Francais

Portugues

Tieng Viet

O K

③



②Initialization button

This button returns settings and all program content to factory set conditions.

③OK button

This button finalizes the settings and returns the display to the treatment screen.

Error Screen

● Error 1: Open error

This error is displayed if the electrode or Ultrasound Probe is disconnected from the Main Unit or if the electrode detaches from the treatment area. If this error occurs, connect the electrode or Ultrasound Probe securely to the Main Unit. Also, confirm that the electrodes are attached securely to the treatment area.

* This error will not be display when using HV/

DC Probes or when in Microcurrent mode or Combination mode.

* This error will not be display when CV is set.

● Error 2: Overcurrent error

This error will be displayed when there is a decline in amount of resistance, such as when electrodes make contact with each other. Check to make sure the electrodes are properly attached to the treatment area.

* This error will not be displayed in Microcurrent mode.

● Error 3: Ultrasound probe temperature error

This error is displayed when the probe head becomes extremely hot. Terminate treatment and restart when the probe head has cooled down.

● Error 4: Probe error

This error is displayed if a broken wire inside the Ultrasound Probe is detected. If this error occurs, replace the Ultrasound Probe.

* When two Ultrasound Probes are connected to the

Main Unit, disconnect both probes and reset the probe error.

● Error 5: System error

This error is displayed if the Main Unit generates any abnormality. Turn off the Main Unit, then turn it back on.

Error 1

Error 2

Error 3

Error 4

Error 5

● Always consider EMC issues when using electronic medical equipment. Be sure to observe the EMC information provided in the accompanying document when installing and using the product.

● Using a mobile or portable RF communication device may affect the operation of electronic medical devices.

● Cable lengths ①Ultrasound Probe (L): 2.0 m ②Ultrasound Probe (S): 2.0 m

③Electrode Cable: 2.0 m ④HV/DC Probe: 2.09 m

⑤Power Supply Cord: 2.44 m

● Using accessory products other than replacement parts sold by the Mettler Electronics may increase product emissions and decrease immunity.

● Avoid using the product when it is placed next to or on top of other equipment. If the product must be placed next to or on top of other equipment, make sure the product and other equipment function properly before use.

Guidance and manufacturer’s declaration — electromagnetic emissions

This unit is intended for use in the electromagnetic environment specified below. The customer or the user of this unit should assure that it is used in such an environment.

Emissions test Compliance Electromagnetic environment — guidance

RF emissions CISPR 11

Harmonic emissions IEC 61000-3-2

Voltage fluctuations/ flicker emissions IEC 61000-3-3

Group 1

Class B

Class A

Complies

This unit uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

This unit is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Guidance and manufacturer’s declaration — electromagnetic immunity

This unit is intended for use in the electromagnetic environment specified below. The customer or the user of this unit should assure that it is used in such an environment.

Immunity test

IEC 60601-1-2

test level

compliance

level

Electromagnetic environment

— guidance

EIectrostatic discharge (ESD) IEC 61000-4-2

EIectrical fast transient/burst IEC 61000-4-4

Surge IEC 61000-4-5

Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

±6 kV contact ±8 kV air

±2 kV for power supply lines ±1 kV for input/output lines

±1 kV line(s) to line(s) ±2 kV line(s) to earth

<5%U for 0.5 cycle 40%U for 5 cycles 70%U for 25 cycles <5%U for 5 sec

(>95% dip in UT)

(60% dip in UT)

(30%dip in UT)

(>95% dip in UT)

±2 kV for power supply lines

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %.

Mains power quality should be that of a typical commercial or hospital environment.

Mains power quality should be that of a typical commercial or hospital environment. If the user of this unit requires continued operation during power mains interruptions, it is recommended that this unit be powered from an uninterruptible power supply or a battery.

Power frequency (50/60 Hz) magnetic field IEC 61000-4-8

NOTE 1 UT is the a.c. mains voltage prior to application of the test level. NOTE 2 To prevent electrostatic discharge, the operator must remove any static charge from his or

her body before connecting or disconnecting the connector near the symbol .

3 A/m

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

Guidance and manufacturer’s declaration — electromagnetic immunity

This unit is intended for use in the electromagnetic environment specified below. The customer or the user of this unit should assure that it is used in such an environment.

Immunity test

IEC 60601-1-2

test level

compliance

level

Electromagnetic environment

— guidance

Conducted RF IEC 61000-4-6

Radiated RF IEC 61000-4-3

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by

3 Vrms 150 kHz ~80 MHz

3 V/m 80 MHz ~2.5 GHz

absorption and reflection from structures, objects and people.

3 Vrms

3 V/m

Portable and mobile RF communications equipment should be used no closer to any part of this unit. including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance d = 1.2 P d = 1.2 P 80 MHz to 800 MHz d = 2.3 P 800 MHz to 2.5 GHz where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than the compliance level in each frequency range. Interference may occur in the vicinity of equipment marked with the following symbol:

a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones

and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which this unit is used exceeds the applicable RF compliance level above, this unit should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating this unit.

b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Recommended separation distances between portable and mobile RF communications equipment and this unit

This unit is intended for use in an electromagnetic environment in which radiated RF disturbances are

controlled. The customer or the user of this unit can help prevent electromagnetic interference by maintaining

a minimum distance between portable and mobile RF communications equipment (transmitters) and this

unit as recommended below, according to the maximum output power of the communications equipment.

Rated maximum output

power of transmitter

0.01 0.12 0.12 0.23

0.1 0.38 0.38 0.73

Separation distance according to frequency of transmitter m

150 kHz to 80 MHz

d = 1.2 P

80 MHz to 800 MHz

d = 1.2 P

800 MHz to 2.5 GHz

d = 2.3 P

1 1.2 1.2 2.3

10 3.8 3.8 7.3

100 12 12 23

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by

absorption and reflection from structures, objects and people.

1333 South Claudina Street • Anaheim, CA 92805, U. S. A. Toll Free: (800) 854–9305 • Telephone: (714) 533–2221 • FAX: (714) 635–7539 Web Site: http://www.mettlerelectronics.com • Email: mail@mettlerelectronics.com

Mettler Electronics Sonicator Plus 921 Operation Manual

Specifications and Main Features

Frequently Asked Questions

User Manual