Mettler Electronics Sonicator Plus 921 Bedienungsanleitung

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

beforeoperatingtheunit.Afterreading,storetheman-

ualinasafeplaceforfuturereference.

oensurecorrectuse,pleasereadthismanualcarefully

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

Symbol for “CAUTION”

Symbol for “ELECTROSTATIC

SENSITIVE DEVICES

Symbol for “CONSULT

INSTRUCTIONS FOR

USE”

Symbol for “POWER ON” (Power

switch)

Symbol for

“TEMPERATURE LIMIT”

Symbol for “POWER OFF” (Power

switch)

Symbol for

“HUMIDITY

LIMITATION”

Symbol for “PAUSE” (Pause switch)

Symbol for

“ATMOSPHERIC

PRESSURE

LIMITATION”

Symbol for “STOP” (Stop switch)

Symbol for “AC (alternating current)” Symbol for “US applicator output port”

Symbol for “TYPE BF APPLIED

PART”

Symbol for cTUVus certification

Symbol for “NON-IONIZING

ELECTROMAGNETIC RADIATION”

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 106cycles per second)

s — Microsecond (1 x 10-6 second)

mA — Milliampere (1 x 10-3 ampere)

ms — Millisecond (1 x 10-3 second)

min — Minutes

sec — Seconds

S/N — Serial Number

W — Watts

W/cm² — Watts per square centimeter

Symbols & Abbreviations

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 orinstructions.

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.*1

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.*2

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.*2

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 adequatemeasures.

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.*2

9) Make sure the ultrasound probe is positioned correctly on the treatment area. Incorrect positioning

can affect effectiveness and results.*2

10) Do not leave the device with the output turned on. Buildup of heat may damage the device.*2

11) When the ultrasound probe is not in use, return and set the probe on the probe holder.*2

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.*1

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.*2

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.

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