Mettler Electronics Sonicator Plus 941 User manual

Sonicator® Plus 941
4-Channel Electrotherapy/Ultrasound Combo
Instruction Manual
1333 South Claudina Street • Anaheim, CA 92805, U. S. A.
Toll Free: (800) 854–9305 • Telephone: [phone] • FAX: [phone]
Web Site: http://www.mettlerelectronics.com • Email: [e-mail]
IR8–49 Rev.B_10/11/18
Copyright © 2018 by Mettler Electronics Corp.—Anaheim, CA
To ensure correct use, please read this manual carefully before
operating the unit. After reading, store the manual 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

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

To Ensure Correct and Safe Use
To Ensure Correct and Safe Use
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.
INDICATIONS FOR 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

To Ensure Correct and Safe Use
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 941 should be used only with electrode cables and electrodes
recommended for use by Mettler Electronics Corp.
16) Turn on the Sonicator Plus 941 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 941 have been designed to allow the practitioner to perform

To Ensure Correct and Safe Use
underwater treatments without exposing the hands to ultrasound.
3) If a patient complains of periosteal pain (deep, achy pain) during ultrasonic treatment, intensity
should be reduced to a comfortable level.
4) Any bleeding tendency is increased by heating because of the increase in blood flow and
vascularity of the heated tissues. Care, therefore, should be used in treating patients with
therapeutic ultrasound who have hemorrhagic diatheses or bleeding disorders.
5) Moving technique of the applicator should be used when applying therapeutic ultrasound at
intensities greater than 0.5 W/cm² to assure even exposure of tissues to ultrasound.
6) Heating of the joint capsule in acute or subacute arthritis should be avoided.
7) Electric treatment tables or whirlpools which may come in contact with the patient during a
treatment with the Sonicator Plus 941 should be adequately grounded and safety tested to insure
safe operation with the Sonicator Plus 941.
Precautions for combination therapy of therapeutic ultrasound and Neuromuscular
Electrical Stimulation
1) Precautions for combination therapy refers to the precautions under therapeutic ultrasound and
electrotherapy
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 1.5m 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 grounded outlet.
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. 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, 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 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.
●Make sure pacemakers or other medical devices are not implanted in the treatment area.
●For areas in which skin sensation is reduced, carefully consider the relevant factors
determining whether to use this system with the patient.
2) Have the patient inform the operator, in case 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:
●Carefully select the output level and treatment durations when treating facial areas.
●Do not place the electrode on the chest; doing so will increase the risk of cardiac fibrillation.*1
●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

To Ensure Correct and Safe Use
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 your distributor or
Mettler Electronics.
3) To prevent accidents, make sure the patient does not operate or touch the device.
4) 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.
5) If a rash, redness, itching or any other symptoms emerge, halt use immediately and take
adequate measures.
6) Only touch one point on the touch panel at a time; do not touch multiple points simultaneously.
7) If the patient complains of periosteal pain, reduce the intensity.*2
8) Make sure the ultrasound probe is positioned correctly on the treatment area. Incorrect positioning
can affect effectiveness and results.*2
9) Do not leave the device with the output turned on. Buildup of heat may damage the device.*2
10) When the ultrasound probe is not in use, return and set the probe on the probe holder.*2
11) 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.
Side Effects/Adverse Reactions
Side Effects/Adverse Reactions for Neuromuscular Electrical Stimulation
1. Skin irritation and burns beneath the electrodes have been reported with the use of electrical muscle
stimulators.
2. Possible allergic reactions to tape, gel or electrodes may occur.

Storage condition
1) To avoid malfunctions, follow the instructions given below when storing and installing the device.
●Avoid locations where the device will be subjected to water. Water entering the device may
cause malfunction.
●Avoid locations where the system may be unduly affected by atmospheric pressure, humidity,
sunlight, dust, salt, sulfur or any other adverse factors.
●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).
●Avoid flammable atmospheres, such as flammable anesthetic gas mixed with oxygen, nitrous
oxide and air, and flammable disinfectant or cleanser mixed with air.
●Avoid locations where chemicals are stored or where gas may be generated.
●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 applicator features a waterproof structure. Do not remove the applicator. Removing thehead
may degrade waterproofing performance and oscillator performance and lead to equipment
malfunctions.

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 your distributor 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 service person
1. Ask your 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
Check the exterior for damage. Check the LCD panel to make
sure there is no deformation or flickering of the display.
Visual inspection
Operation
· Turn on the power switch and confirm that the product functions
normally, without problems.
· Confirm that the product functions normally as described in the
instruction manual.
Operational
inspection
Accessories
· Check the accessories for damage.
· Confirm that there are no wire breaks in the cords or cables.
Visual inspection
Safety
inspection
· 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.
Operational
inspection
Ultrasound
output check
Place water on the applicator and turn output on. Check to make
sure that the water vibrates.
Operational
inspection
To Ensure Correct and Safe Use

Ultrasound
probe check
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 applicator.
Visual and
operational
inspections
Check the cable and connector for faulty connections. Operational
inspection

●Main unit and standard accessories
Your new Sonicator Plus 941 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 941
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. Four 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)
Device Configuration

●Main unit specifications
Power supply 120 V 60 Hz
Power consumption 190 VA
Electrotherapy
Output current Max. 600 mA ±15% peak (500 Ω load), Max. 70 mA rms ±15% (500 Ω load)
Output voltage Max. 300 V ±15% peak (500 Ω load)
Output frequency Max. 10 kHz ±10%
Timer Max. 60 min. ±5%
Ultrasound
Ultrasound frequency 1.0 MHz, 3.0 MHz ±10%
Intensity
Limit value and accuracy: 3.0 W/cm
2
±20%
Maximum effective intensity: 2.0 W/cm
2
±20% (continuous)
Peak intensity: 3.0 W/cm
2
±20% (pulsed)
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%
Oscillator characteristics
ERA
Ultrasound Probe (L) 1 MHz: 5.5 cm
2 ±20%
3 MHz; 6.0 cm
2 ±20%
Ultrasound Probe (S) 1 MHz: 0.9 cm 2 ±20%
3 MHz: 0.9 cm
2 ±20%
BNR
Ultrasound Probe (L) 1 MHz: 4.6 ±30%
3 MHz: 2.9 ±30%
Ultrasound Probe (S) 1 MHz: 2.9 ±30%
3 MHz: 2.9 ±30%
Output stability ±20%
Applicator maximum
temperature 43°C
Certification The Sonicator Plus 941 complies with the ultrasound performance standards
set forth in the Code of Federal Regulations, Title 21 (Food and Drugs), Part
1050.10.
Safety class according to
IEC 60601-1
Class of protection against
ingress of harmful water
Class I, Type BF
Main unit: IPX 0
Ultrasound probe: IPX 7
Dimensions 13.8" (W) x 10.6" (D) x 5.7" (H)
Weight Approx. 9.6 lb.
Environmental
conditions
Temperature Humidity Pressure
In use 10−40°C30−75% 800−1060 hPa
Storage -10−60°C30−95%700−1060 hPa
Transportation -10−60°C30−95% 700−1060 hP
cTUVus ME 941
Specifications

⑪
●Main Unit
LCD touch panel
Current intensity control dial (CH1) Current intensity control dial (CH2)
Current intensity control dial (CH3) Current intensity control dial (CH4)
Ultrasound intensity control dial (US) Stop switch
Electrode cable connection port (CH1) Electrode cable connection port (CH2)
Electrode cable connection port (CH3) Electrode cable connection port (CH4)
LED Ultrasound Probe connection port
11 Power switch
12 Power supply cord connection port


Names of Parts



 
⑪
⑫

1 Make sure the power switch for the Main Unit is
turned off.
2 Connect the power supply cord to the power supply
cord connection port on the Main Unit.
3 Connect the power supply cord to an AC power
outlet.
4 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.
●Self-adhesive Electrodes can be used in any
treatment mode except continuous direct current.
●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.
5 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 of Electrode Sponges
●Electrode Sponge: Wash thoroughly in lukewarm water containing neutral detergent after
each use. Completely rinse off all detergent, allow to dry, thenstore.

Preparations for Electrotherapy
●Using the Self-adhesive Electrode
1 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.
2 Apply the two parts of the Self-adhesive Electrode securely
to the treatment area.
* If the two parts of the Self-adhesive Electrode are
not securely applied when treatment (output) starts,
an error will result.
3 Connect the connector for the electrode cable to the
electrode cable connection port on the Main Unit.
4 When the power switch is turned on, an icon appears.
(Incorrect)(Correct)
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.
Insert each pin fully until you can
no longer see the metal portion.

CAUTION About the Self-adhesive Electrode
●Do not use the Self-adhesive Electrode on
injured areas of the skin.
●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.
●If the skin gets red or burn / inflammation
occurs, stop using the product immediately.
●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.
●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 Self-
adhesive 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.
●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 Self- adhesive Electrode has a loose
connection. If you notice any loose
connections, replace the Self-adhesive
Electrode with new ones.
●Insert each pin of the electrode cable into the
end of each cord firmly until you can no longer
see the metal portion.
●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.
●When attaching the Self-adhesive Electrode,
make sure they are in firm contact with the
skin. If there is any space between the Self-
adhesive Electrode and the skin, simulation will
be unusually strong causing pain and in some
cases resulting in burns or other injury to the
skin.
●Be sure to turn off the power switch for the
Main Unit before removing the Self-adhesive
Electrode from the skin.
●After use, return the Self-adhesive Electrode
to the storage plate, then place in the bag.
Store at room temperature.
●The validity period for the Self-adhesive
Electrode is indicated on the bag. Do not use
past the expiration date.
●The Self-adhesive Electrode features consum-
able parts. When adhesion weakens, replace
the Self-adhesive Electrode with new ones.
●Note that if a patient has a transmittable
disease, the disease may be transmitted to
other people via the Self-adhesive Electrode.
●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.
●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.
●When attaching the Self-adhesive Electrode,
do not place over or in contact with metal items
(necklace, belt, watch, etc.).
●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.
●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.
●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.

Preparations for Electrotherapy
●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.
1 Connect the electrode cable to the
Self-adhesive Electrode.
Insert the connection pin of the HV/DC
Probe into the cord for the Self-adhesive
Electrode.
2 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.
Names of parts of HV/DC Probe
Self-adhesive Electrode (optional)
Connection pin
Main body of
HV/DC Probe
Connecto
r
Circular pad
(L: Ø60 mm, S: Ø40 mm)
Flat sponge
Pin-type Pin-type pad
electrode (4×16 mm)
Electrode Sponge
(with slit) (optional) Circular electrode
(large)
Circular electrode
(small)
* 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.
Insert the pin fully until you can no
longer see the metal portion.