Mettler Electronics Sonicator Plus 994 User manual

Sonicator®Plus 994
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: [email protected]
IR7–96 Rev.G_09/13/17
Copyright © 1999-2017 by Mettler Electronics Corp.—Anaheim, CA

Mettler Electronics Corp. — Rev.G_09/13/17
2
FCC Frequency Interference Statement
Warning:
This equipment generates and uses radio frequency energy and, if not installed and
operated in strict accordance with the manufacturer’s instructions, may cause radio
frequency interference.
Notice 1:
This equipment has been verified to comply with the specifications in Part 18 of FCC
Rules, which are designed to provide reasonable protection against radio frequency
interference. However, there is no guarantee that interference will not occur in a particular
installation.
Notice 2:
If this equipment is found to be the source of radio frequency interference, which can be
determined by turning the equipment off and on, the user should try to correct the
interference by one or more of the following measures:
•Reorient the receiving antenna (as applicable).
•Relocate the Sonicator Plus 994 with respect to the receiver.
•Move the Sonicator Plus 994 away from the receiver.
•Plug the Sonicator Plus 994 into a different outlet than the receiver.
•If necessary, the user should consult with the dealer or manufacturer for additional
suggestions. (The user may find FCC’s “Interference Handbook” helpful. It is available
from the U.S. Government Printing Office, Washington, D.C. 20402, Stock No. 004–000–
00450–7.)
Notice 3:
The manufacturer is not responsible for any interference caused by unauthorized
modification to this equipment.
Mettler Electronics Corp.
1333 S. Claudina St.
Anaheim, CA 92805
Toll Free: (800) 854–9305
Or (714) 533–2221

Sonicator Plus 994 Instruction Manual — Rev.G_09/13/17
3
Table of Contents
Section Title Page
1 Introduction 5
1.1 Introduction to the Sonicator Plus 994 5
1.2 Introduction to this Manual 6
1.3 Safety Precautions 6
1.4 Caution 7
1.5 Shipping Damage 7
1.6 Package Contents 7
1.7 Limited Warranty 8
2Symbol Glossary and List of Abbreviations 9
2.1 Symbol Glossary 9
2.2 Treatment Status Indicator Icons 12
2.3 List of Abbreviations 13
3Installation 15
3.1 Installation Instructions 15
3.2 EMC Guidance 17
4Operating Instructions 21
4.1 A Note About Electrodes 21
4.2 General Operating Instructions 22
4.3 General Set-up Procedure 23
4.4 Stimulation Set-up Procedure 24
4.5 Ultrasound Set-up Procedure 28
4.6 Combination Therapy Set-up Procedure 30
4.7 Electrode Positioning 33
5Indications, Contraindications, Precautions and Adverse Reactions 37
5.1 Indications for Therapeutic Ultrasound 37
5.2 Indications for Neuromuscular Electrical Stimulation 37
5.3 Contraindications for Therapeutic Ultrasound 38
5.4 Contraindications for Neuromuscular Electrical Stimulation 38
5.5 Warnings for Neuromuscular Electrical Stimulation 39
5.6 Precautions for Therapeutic Ultrasound 39
5.7 Precautions for Neuromuscular Electrical Stimulation 40
5.8 Side Effects/Adverse Reactions for Neuromuscular Electrical Stimulation 41
6Maintenance and Troubleshooting 43
6.1 Cleaning the Sonicator Plus 994 43
6.2 Routine Maintenance 43
6.3 Troubleshooting the Sonicator Plus 994 43
7Ultrasound Theory of Operation 47
7.1 Introduction to Ultrasound 47
7.2 Output Levels 50
7.3 Continuous and Pulsed Waves 51
8 References 53
9 Specifications 55
9.1 General Specifications 55
9.2 Ultrasonic Generator Specifications 55
9.3 Ultrasonic Applicator Specifications 57
9.4 Waveform Specifications 58

Mettler Electronics Corp. — Rev.G_09/13/17
4
9.5 Amplitude Modulation Specifications 62
10 Accessories 63
10.1 Ordering Information 63
10.2 Sonicator Plus 994 Accessories 63
List of Figures
No. Title Page
1.1 Sonicator Plus 994 5
3.1 Sonicator Plus 994, Back view—Mains Power Switch, Line Cord connection and
Applicator Clamp
16
3.2 Sonicator Plus 994, Front View—Electrode Cable and Ultrasound Applicator
Connections
16
3.3 Connecting the Applicator to the Universal Applicator Cable 16
4.1 Front membrane panel and LED indicators 21
4.2 Electrode Sizes and Current Density 22
4.3 Quadpolar Electrode Placement Technique 33
4.4 Bipolar Electrode Placement Technique 34
4.5 Monopolar Electrode Placement Technique 34
4.6 Using the Pencil Electrode 35
7.1 Ultrasound Absorption, Skin 47
7.2 Ultrasound Absorption, Fat 48
7.3 Ultrasound Absorption, Muscle with the Ultrasound Beam Perpendicular to the
Muscle Fibers
48
7.4 Ultrasound Absorption, Bone 48
7.5 High Frequency Sound Waves 49
7.6 Ultrasound Application Techniques 50
7.7 Underwater Treatment Technique 50
7.8 Differences Between Transducers 50
9.1 Pulse Waveform—20% Duty Cycle 56
9.2 Pulse Waveform—50% Duty Cycle 56
9.3 Continuous Waveform—100% Duty Cycle 56
9.4 10 cm² Applicator (1 MHz)—Three Dimensional Beam Patterns 57
9.5 5 cm² Applicator (1 MHz)—Three Dimensional Beam Patterns 57
9.6 5 cm² Applicator (3.2 MHz)—Three Dimensional Beam Patterns 58
9.7 1 cm² Applicator (3.3 MHz)—Three Dimensional Beam Patterns 58
9.8 Interferential Waveform 58
9.9 Premodulated Waveform 59
9.10 Medium Frequency (Russian) Waveform 59
9.11 Biphasic Waveform 60
9.12 High Volt Waveform 60
9.13 Microcurrent Waveform 61

Sonicator Plus 994 Instruction Manual — Rev.G_09/13/17
5
Section 1: Introduction
1.1 Introduction to the Sonicator Plus 994
Thank you for purchasing the Sonicator Plus 994 four-channel combination unit for
therapeutic ultrasound and muscle stimulation. The microprocessor controlled Sonicator
Plus 994 provides interferential, premodulated, medium frequency, symmetrical biphasic,
high volt and microcurrent waveforms with enhanced reliability and ease of use. In
addition the Sonicator Plus 994 offers 1 and 3 MHz ultrasound using a variety of
interchangeable applicators.
The four–channel Sonicator Plus 994 allows you to utilize up to four different waveforms
using four channels simultaneously. You can choose between several different amplitude
modulation options such as surge, reciprocation and vector rotation. The interferential and
premodulated modes offer frequency modulation as well as a static frequency option.
Figure 1.1— Sonicator Plus 994
The membrane panel provides both tactile and audio feedback when buttons are pressed.
Blinking LED’s guide you through the easy setup routine. The new Treatment Status
Indicator shows you which stimulation waveform has been chosen for treatment. The
status display moves when treatment output is active.
Large, soft-touch control knobs make adjusting power for ultrasound and stimulation easy
to accomplish with no guesswork involved. Two LED output displays allow you to
monitor two channels simultaneously for two channel or combination treatment protocols.
These also allow you to adjust both channels of an interferential protocol simultaneously
while monitoring the current.
The Sonicator Plus 994 can provide electrical stimulation only, ultrasound only and
combination therapy with the premodulated, biphasic, high volt and medium frequency
waveforms. Add the optional treatment cart to create a mobile treatment center for your
office.
The Sonicator Plus 994 was certified by Intertek Testing Services to meet the requirements
for ETL Listing per the following standards:

Mettler Electronics Corp. — Rev.G_09/13/17
6
UL 2601-1-UL Standard for Safety Medical Electrical Equipment, Part 1:
General Requirements for Safety Second Edition.
CSA C22.2 NO 601.1 – Medical Electrical Equipment – Part 1: General
Requirements for Safety General Instruction No 1; Supplement 1; 1994
R(1997)
IEC60601-2-5 – Safety of Ultrasonic Therapy Equipment
IEC60601-2-10 – Safety of Nerve and Muscle Stimulators
In addition, the Sonicator Plus 994 meets the following standards for radio frequency
emissions:
FCC Part 15–B
EN–55011 (CISPR–11)
Mettler Electronics Corp. has been certified by VTT Expert Services LTD to be compliant
with EN ISO 13485:2003 and MDD 93/42/EEC Annex II requirements. In addition, Mettler
is certified by DQS Medizinprodukte GMBH to be compliant with ISO 13485:2003
(CMDCAS) Canadian Medical Device requirements.
1.2 Introduction to This Manual
Read the contents of this manual before treating patients with the Sonicator Plus 994.
This manual has been written to assist you with the safe operation of the Sonicator Plus
994. It is intended for use by the owners and operators of the Sonicator Plus 994. The goal
of this manual is to direct the correct operation and maintenance of this unit.
The specifications and instructions presented in this manual are in effect at the time of its
publication. These instructions may be updated at any time at the discretion of the
manufacturer.
1.3 Safety Precautions
The Sonicator Plus 994 operates with high voltages. Qualified biomedical technicians with
training in ultrasound and neuromuscular stimulator service should perform servicing of
the Sonicator Plus 994 or it should be returned directly to the factory. To maximize safety
during use, the unit should be plugged into a grounded wall outlet. General safety
guidelines for medical electronic equipment should be followed.
To assure compliance with FDA, 21 CFR 1050.10 standards, the ultrasound portion of the
Sonicator Plus 994 should be calibrated and safety tested on an annual basis. This service
may be obtained from the manufacturer by sending the Sonicator Plus 994 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 or by Email: [email protected]) This service may also
be performed by qualified biomedical engineers or technicians trained in ultrasound
calibration.
NOTE: All warranty repairs must be performed by Mettler Electronics Corp. or by a
service facility authorized by Mettler Electronics to perform warranty repair work.

Sonicator Plus 994 Instruction Manual — Rev.G_09/13/17
7
A service manual for the Sonicator Plus 994 is available from Mettler Electronics Corp. for a
small fee. To receive additional information, contact Customer Service using the above
numbers or by Email: [email protected].
1.4 Caution
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. 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.
1.5 Shipping Damage
Your new Sonicator Plus 994 is shipped complete in one carton. Upon receipt, please
inspect the carton and the unit for visible and hidden damage. If you discover any
damage, hold all shipping materials, including the carton, and call the shipping agent who
delivered the unit. They are responsible for all damage in transit; therefore, all claims
should be filed directly with them. The factory will not be responsible for any damage in
shipment, nor allow any adjustments unless a proper formal claim has been filed by the
receiver against the carrier.
The carton in which your new Sonicator Plus 994 was received is specially designed to
protect the unit during shipping. Please retain all shipping materials in the event that you
will need to return your unit for servicing. NOTE: All warranty repairs are to be
performed by Mettler Electronics Corp. or an authorized Mettler Electronics warranty
repair center.
1.6 Package Contents
Your new Sonicator Plus 994 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 994
2. Ultrasound applicator, 5 cm² at 1 and 3 MHz, (ME 7513), other applicators available
3. Hooded, water-proof universal applicator cable, (ME 7392)
4. Sonigel, ultrasound couplant gel, one tube, (ME 1846)
5. Four electrode cable sets, (ME 2260)
6. One single wire electrode cable for combination therapy (ME 2261)
7. Two gray pin to banana adapters, (ME 2027)
8. One package each EZ Trodes, 2" diameter (ME 2221) and 2.75" diameter (ME 2222)
9. One 3.5" x 7" sponge electrode for combination therapy (ME 2004)
10. Detachable U.L. listed, hospital–grade line cord, (ME 7293)
11. Instruction Manual and warranty registration instructions

Mettler Electronics Corp. — Rev.G_09/13/17
8
1.7 Limited Warranty
The Sonicator Plus 994 combination unit for neuromuscular electrical stimulation and
therapeutic ultrasound is warranted against defects in materials and workmanship for a
period of two years from date of purchase. . The Sonicator Plus 994 applicators are
warranted against defects in materials and workmanship for a period of one year from
date of purchase. During the applicable warranty period Mettler Electronics Corp. will, at
its discretion, either repair or replace the Product without charge for these types of defects.
For service under this warranty, the Product must be returned by the buyer within the
applicable warranty period to Mettler Electronics Corp. Shipping charges to Mettler
Electronics Corp. under this warranty must be paid by the buyer. The buyer must also
include a copy of the sales receipt or other proof of the date of purchase. If the Product
is returned without proof of the date of purchase, it will be serviced as an out–of–
warranty product at Mettler Electronics Corp.'s prevailing service rates.
Alteration, misuse, or neglect of the Product voids this warranty. Except as specifically
set forth above, Mettler Electronics Corp. makes no warranties, express or implied,
including without limitation any implied warranty of merchantability or fitness for a
particular purpose, with respect to the Product. If any implied warranties apply as a
matter of law, they are limited in duration to one year.
Mettler Electronics Corp. shall not be liable for any indirect, special, consequential or
incidental damages resulting from any defect in or use of the Product.
Any legal action brought by the buyer relating to this warranty must be commenced
within one year from the date any claim arises and must be brought only in the state or
federal courts located in Orange County, California.
Some states do not allow limitations on how long an implied warranty lasts, or the
exclusion or limitation of incidental or consequential damages, so the above limitations or
exclusions may not apply to the buyer. This warranty gives the buyer specific legal rights,
and the buyer may also have other rights which vary from state to state.

Sonicator Plus 994 Instruction Manual — Rev.G_09/13/17
9
Section 2—Symbol Glossary
and List of Abbreviations
2.1 Symbol Glossary

Electrical Stimulation Selector

Therapeutic Ultrasound Selector

Combination Therapy Selector

Time display
1
5. 0 0
min s

Time display LED’s. Displays treatment time and numeric values for
frequency, phase duration, on/off times and alphanumeric error codes.
s
 s
Hz

These LED’s will illuminate to prompt the clinician to input either time
in seconds or microseconds or frequency in Hz. The time or the
frequency will be displayed in the numeric time display.

Treatment Status Indicator
12
34

Channel display indicator and selector
Ultrasound display indicator and selector
1
Numeric keypad for time, frequency or phase duration entry.
Starts treatment and stimulation or ultrasound output.
Stops treatment for the treatment displayed in timer window or acts as
an “Enter” button during treatment setup.

Mettler Electronics Corp. — Rev.G_09/13/17
10
Stops all ultrasound and stimulation output.
Active ultrasound output indicator on solid when ultrasound output is
present, flashing when coupling is inadequate.
1 MHz
3 MHz
Frequency selector for 5 cm² 1 and 3 MHz applicator. Displays
frequency for all applicators.
W
W/cm²
Ultrasound output display selector
100%
50%
20%
Ultrasound duty cycle selector

Interferential waveform selector—LED is illuminated when this function
is activated.

Premodulated waveform selector—LED is illuminated when this
function is activated.

Medium frequency waveform selector—LED is illuminated when this
function is activated.

Symmetrical biphasic waveform selector—LED is illuminated when this
function is activated.

High volt waveform selector—LED is illuminated when this function is
activated.

Microcurrent waveform selector—LED is illuminated when this function
is activated.
 s

Phase duration control selector—Press this button during a biphasic
treatment to display phase duration.
Hz

Frequency control selector—Press this button during a stimulation
treatment to display frequency.
+
–

Polarity selector for high volt and microcurrent waveforms.
Amplitude modulation (Vector rotation), used for interferential
waveform only. LED is illuminated when this function is activated.

Sonicator Plus 994 Instruction Manual — Rev.G_09/13/17
11
Continuous stimulation selector
Surge selector to set on and off times
Reciprocation selector, use for channel pairs 1 & 2 or 3 & 4.
Stimulation or ultrasound output displays
000
LED’s that display the output intensity during a treatment. When the
unit is in the “Hold” mode for electrical stimulation, “--- ---“ will be
displayed. When the unit is in the “Hold” mode for therapeutic
ultrasound, the output intensity will be displayed but the “Active
Ultrasound Output” indicator will be off and the timer will not be
running.
1324
LED indicators are lit to define which output intensity is being
displayed in the two windows.
VmA
W

A
W/cm²
mA
LED indicators are lit to show the measurement units of the output
intensity being displayed in the window.
Output intensity control knob, rotate knob clockwise to increase output
and counterclockwise to decrease output.
IMains On.
O Mains Off.
Attention, consult instruction manual.
Symbol for “Consult instructions for use.”
Diagram of Pulsed Mode duty cycle
Type BF Equipment—Class I

Mettler Electronics Corp. — Rev.G_09/13/17
12
IPX0 Not suitable for use in the presence of a flammable anaesthetic mixture
with air or with oxygen or nitrous oxide.
IPX7 Protected against the effects of immersion.
CE Mark
2.2 Treatment Status Indicator Icons
Stimulation selected, waiting for waveform type to be selected.
Ultrasound selected
Combination therapy selected, waiting for waveform type to be selected.
Interferential waveform selected. Display will move to the right when
the outputs are active.
Interferential vector rotation control selected. Display appears to rotate.
Premodulated waveform selected. Display will move to the right when
the outputs are active.
Premodulated waveform selected for combination therapy. Display will
move to the right when the outputs are active.
Medium frequency (Russian) waveform selected. Display will move to
the right when the outputs are active.
Medium frequency (Russian) waveform selected for combination
therapy. Display will move to the right when the outputs are active.

Sonicator Plus 994 Instruction Manual — Rev.G_09/13/17
13
Biphasic waveform selected. Display will move to the right when the
outputs are active.
Biphasic waveform selected for combination therapy. Display will move
to the right when the outputs are active.
High volt waveform selected. Display will move to the right when the
outputs are active.
High volt waveform selected for combination therapy. Display will
move to the right when the outputs are active.
Microcurrent waveform selected. Display will move to the right when
the outputs are active.
2.3 List of Abbreviations
cm² — Square centimeters
Hz — Hertz (pulses per second)
LED — Light Emitting Diode
MHz — Megahertz (1 x 106cycles per second)
A — Microampere (1 x 10-6 ampere)
s — Microsecond (1 x 10-6 second)
mA — Milliampere (1 x 10-3 ampere)
ms — Millisecond (1 x 10-3 second)
min — Minutes
s — Seconds
S/N — Serial Number
V — Volts
W — Watts
W/cm² — Watts per square centimeter

Mettler Electronics Corp. — Rev.G_09/13/17
14

Sonicator Plus 994 Instruction Manual — Rev.G_09/13/17
15
Section 3—Installation
3.1 Installation Instructions
1. Connect the line cord to the back of the Sonicator Plus 994. (See Figure 3.1)
2. Plug the line cord (ME 7293) into a grounded wall outlet that is rated between 90–240
VAC, 50–60 Hz. Your power supply must match the voltage requirements listed on the
serial number label of your device. Do not connect the Sonicator Plus 994 to a power
supply rated differently than that described above.
3. The line cord comes equipped with a standard 3–prong plug. This plug provides
grounding for the Sonicator Plus 994. Do not defeat its purpose by using 3–to–2 prong
adapters or any other means of attaching to a wall outlet.
4. Push the hooded, water-proof applicator cable connector (ME 7392) into the round
BNC receptacle located on the front of the Sonicator Plus 994. (See Figure 3.2) Connect
applicator to universal applicator cable using the BNC connector. (See Figure 3.3)
Secure both connectors by rotating them ¼ turn clockwise. To maintain waterproof
characteristics of the BNC connectors make sure that all connections are dry before
attempting to connect them. Please Note: The applicator model 7513, comes standard with
the Sonicator 994. Other applicators that may be used with the Sonicator Plus 994 are the
models 7331 and 7310. Verifiy that the applicator is labeled for use with the Sonicator Plus 994
before attaching it to the unit. This information is contained on the applicator label.
5. Place the applicator into the applicator clamp. It may be attached to the back as seen in
Figure 3.1 or to the side as seen in Figure 1.1.
6. Plug the electrode cables (ME 2260) into the electrode cable connections as seen in
Figure 3.2. For combination therapy procedures, plug the single line electrode cable
(ME 2261) into the electrode connection for Channel 1.
7. The Sonicator Plus 994 may be susceptible to interference originating from shortwave
diathermy units operating in close proximity to it. Avoid operating the Sonicator Plus
994 adjacent to and simultaneously with operating shortwave devices.
8. Do not use sharp objects to operate the membrane panel switches. If the tough outer
layer of the membrane is broken, moisture may leak into the switches resulting in
switch failure.
9. Once you have verified proper functioning of your Sonicator Plus 994, using the
instructions in Section 4, please go online to register it at
http://www.mettlerelectronics.com/product-registration/...

Mettler Electronics Corp. — Rev.G_09/13/17
16
Mains Power Switch
Line Cord Connection
A
pplicator Clamp
Figure 3.1— Sonicator Plus 994, Back View—
Mains Power Switch, Line Cord Connection and Applicator Clamp
Electrode Cable Connections Applicator Cable Connection
Figure 3.2— Sonicator Plus 994, Front View—
Electrode Cable and Ultrasound Applicator Connections
Figure 3.3—Connecting the Applicator to the Universal Applicator Cable, line up pegs, push
in all the way and rotate ¼ turn clockwise

Sonicator Plus 994 Instruction Manual — Rev.G_09/13/17
17
3.2 EMC Guidance
CAUTION: Medical Electrical Equipment needs special precautions regarding Electromagnetic
Compatibility (EMC) and needs to be installed and put into service according to the EMC
information provided in the following tables.
Portable and mobile Radio Frequency (RF) communications equipment can affect Medical
Electrical Equipment.
Accessories: Hospital Medical grade power cord of a maximum length of 120 inches
WARNING: The use of accessories, other than those specified, except those supplied or sold by Mettler
Electronics Corp., as replacement parts for internal or external components, may result in
increased EMISSIONS or decreased IMMUNITY of the Sonicator Plus 994.
Guidance and manufacturer’s declaration – electromagnetic emissions
The Sonicator Plus 994 is intended for use in the electromagnetic environment specified below. The
customer or the user of the Sonicator Plus 994 should assure it is used in such an environment.
Emissions Test Compliance Electromagnetic environment-guidance
RF emissions
CISPR 11
Group 1 The Sonicator Plus 994 must emit electromagnetic energy in
order to perform its intended function. Nearby electronic
equipment may be effected.
RF emissions
CISPR 11
Class B The Sonicator Plus 994 is suitable for use in all establishments
other than domestic and those directly connected to the public
low-voltage power supply network that supplies buildings
used for domestic purposes.
Harmonic emissions
IEC 61000-3-2
Applicable
Voltage
fluctuations/flicker
emissions
IEC 61000-3-3
Applicable

Mettler Electronics Corp. — Rev.G_09/13/17
18
Guidance and manufacturer’s declaration – electromagnetic immunity
The Sonicator Plus 994 is intended for use in the electromagnetic environment specified below. The
customer or the user of the Sonicator Plus 994 should assure that it is used in such an environment.
Immunity test IEC 60601
test level
Compliance level Electromagnetic environment —
guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
Floors should be wood, concrete or
ceramic tile. If floors are covered
with synthetic material, relative
humidity should be at least 30%.
Electrical fast
transient/burst
IEC 61000-4-4
±2 kV for power
supply lines
±1 kV for
input/output lines
±2 kV for power
supply lines
±1 kV for
input/output lines
Mains power quality should be that
of a typical commercial or hospital
environment.
Surge
IEC 61000-4-5
±1 kV differential
mode
±2 kV common mode
±1 kV differential
mode
±2 kV common mode
Mains power quality should be that
of a typical commercial or hospital
environment.
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
<5% UT
(>95% dip in UT)
for 0.5 cycle
40% UT
(60% dip in UT)
for 5 cycles
70% UT
(30% dip in UT)
for 25 cycles
<5% UT
(>95% dip in UT)
for 5 seconds
<5% UT
(>95% dip in UT)
for 0.5 cycle
40% UT
(60% dip in UT)
for 5 cycles
70% UT
(30% dip in UT)
for 25 cycles
<5% UT
(>95% dip in UT)
for 5 seconds
Mains power quality should be that
of a typical commercial or hospital
environment. If the user of the
Sonicator Plus 994 requires continued
operation during power mains
interruptions, it is needed that the
Sonicator Plus 994 be powered from
an uninterruptible power supply.
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m 3 A/m Power frequency magnetic fields
should be at levels characteristic of a
typical location in a typical
commercial or hospital environment.
NOTE UTis the A.C. mains voltage prior to application of the test level.

Sonicator Plus 994 Instruction Manual — Rev.G_09/13/17
19
Guidance and manufacturer’s declaration – electromagnetic immunity
The Sonicator Plus 994 is intended for use in the electromagnetic environment specified below. The
customer or the user of the Sonicator Plus 994 should assure that it is used in such an environment.
Immunity test IEC 60601 test level Compliance
level
Electromagnetic environment – guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to 80 GHz
3 V/m
80 MHz to 2,5 GHz
3 V
3 V/m
Portable and mobile RF communications
equipment should be used no closer to any part
of the Sonicator Plus 994, 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√P80MHz to 800 MHz
d= 2,3√P800MHz to 2,5 GHz
where Pis the maximum output power rating of
the transmitter in watts (W) according to the
transmitter manufacturer and dis the
recommended separation distance in meters (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey, a
should be less than the compliance level in each
frequency range.b
Interference may occur in the vicinity of
equipment marked with the following symbol:
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
absorption and reflection from structures, objects and people.
aField 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 the Sonicator Plus 994 is used exceeds the applicable RF compliance level above, the Sonicator Plus
994 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such
as reorienting or relocating the Sonicator Plus 994.
bOver the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Mettler Electronics Corp. — Rev.G_09/13/17
20
Recommended separation distances between portable and mobile RF communications
equipment and the Sonicator Plus 994
The Sonicator Plus 994 is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the Sonicator Plus 994 can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the Sonicator Plus 994 as recommended below, according to
the maximum output power of the communications equipment.
Rated maximum output
power of transmitter
W
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
0,01 0,12 0,12 0,23
0,1 0,38 0,38 0,73
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 meters (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.
Guidance and manufacturer’s declaration
No. Mode of Operation Essential Performance
Degradation Allowed
1 Unit tested to 230
VAC for CE
Unit tested to 120
VAC for US/Canada
Unit designed to be failure safe in
abnormal condition
2 Unit has four stim
channels with
ultrasound
Reset allowed as long as failure safe