Sonicator Plus 992 Instruction Manual Rev G May 2013

Mettler Electronics Corp.- Rev.G_04/05/13

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 992 with respect to the receiver. • Move the Sonicator Plus 992 away from the receiver. • Plug the Sonicator Plus 992 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

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Sonicator Plus 992 Instruction Manual- Rev.G_04/05/13

Table of Contents Section

Title

1

Introduction Introduction to the Sonicator Plus 992 Introduction to this Manual Safety Precautions Caution Shipping Damage Package Contents Limited Warranty Symbol Glossary and List of Abbreviations Symbol Glossary Treatment Status Indicator Icons List of Abbreviations Installation Installation Instructions EMC Guidance Operating Instructions A Note About Electrodes General Operating Instructions General Set-up Procedure Stimulation Set-up Procedure Ultrasound Set-up Procedure Combination Therapy Set-up Procedure Electrode Positioning Indications, Contraindications, Precautions and Adverse Reactions Indications for Therapeutic Ultrasound Indications for Neuromuscular Electrical Stimulation Contraindications for Therapeutic Ultrasound Contraindications for Neuromuscular Electrical Stimulation Warnings for Neuromuscular Electrical Stimulation Precautions for Therapeutic Ultrasound Precautions for Neuromuscular Electrical Stimulation Side Effects/Adverse Reactions for Neuromuscular Electrical Stimulation Maintenance and Troubleshooting Cleaning the Sonicator Plus 992 Routine Maintenance Troubleshooting the Sonicator Plus 992 Ultrasound Theory of Operation Introduction to Ultrasound Output Levels Continuous and Pulsed Waves References Specifications General Specifications Ultrasonic Generator Specifications Ultrasonic Applicator Specifications Waveform Specifications

1.1 1.2 1.3 1.4 1.5 1.6 1.7 2 2.1 2.2 2.3 3 3.1 3.2 4 4.1 4.2 4.3 4.4 4.5 4.6 4.7 5 5.1 5.2 5.3 5.4 5.5 5.6 5.7 5.8 6 6.1 6.2 6.3 7 7.1 7.2 7.3 8 9 9.1 9.2 9.3 9.4

Page 5 5 6 6 7 7 7 8 9 9 12 13 15 15 17 21 21 22 23 24 28 30 33 37 37 37 38 38 39 39 40 41 43 43 43 43 47 47 50 51 53 55 55 55 57 58

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Mettler Electronics Corp.- Rev.G_04/05/13

9.5

Amplitude Modulation Specifications

62

10 10.1 10.2

Accessories Ordering Information Sonicator Plus 992 Accessories

63 63 63

List of Figures No. Title 1.1 3.1 3.2 3.3 4.1 4.2 4.3 4.4 4.5 4.6 7.1 7.2 7.3 7.4 7.5 7.6 7.7 7.8 9.1 9.2 9.3 9.4 9.5 9.6 9.7 9.8 9.9 9.10 9.11 9.12 9.13

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Sonicator Plus 992 Sonicator Plus 992, Back view-Mains Power Switch, Line Cord connection and Applicator Clamp Sonicator Plus 992, Front View-Electrode Cable and Ultrasound Applicator Connections Connecting the Applicator to the Universal Applicator Cable Front membrane panel and LED indicators Electrode Sizes and Current Density Quadpolar Electrode Placement Technique Bipolar Electrode Placement Technique Monopolar Electrode Placement Technique Using the Pencil Electrode Ultrasound Absorption, Skin Ultrasound Absorption, Fat Ultrasound Absorption, Muscle with the Ultrasound Beam Perpendicular to the Muscle Fibers Ultrasound Absorption, Bone High Frequency Sound Waves Ultrasound Application Techniques Underwater Treatment Technique Differences Between Transducers Pulse Waveform-20% Duty Cycle Pulse Waveform-50% Duty Cycle Continuous Waveform-100% Duty Cycle 10 cm² Applicator (1 MHz)-Three Dimensional Beam Patterns 5 cm² Applicator (1 MHz)-Three Dimensional Beam Patterns 5 cm² Applicator (3.2 MHz)-Three Dimensional Beam Patterns 1 cm² Applicator (3.3 MHz)-Three Dimensional Beam Patterns Interferential Waveform Premodulated Waveform Medium Frequency (Russian) Waveform Biphasic Waveform High Volt Waveform Microcurrent Waveform

Page 5 16 16 16 21 22 33 34 34 35 47 48 48 48 49 50 50 50 56 56 56 57 57 58 58 58 59 59 60 60 61

Sonicator Plus 992 Instruction Manual- Rev.G_04/05/13

Section 1:

Introduction

1.1 Introduction to the Sonicator Plus 992 Thank you for purchasing the Sonicator Plus 992 two-channel combination unit for therapeutic ultrasound and muscle stimulation. The microprocessor controlled Sonicator Plus 992 provides interferential, premodulated, medium frequency, symmetrical biphasic, high volt and microcurrent waveforms with enhanced reliability and ease of use. In addition the Sonicator Plus 992 offers 1 and 3 MHz ultrasound using a variety of interchangeable applicators. The two–channel Sonicator Plus 992 allows you to utilize up to two different waveforms using two channels simultaneously. You can choose between several different amplitude modulation options such as the 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 992 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 992 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 992 has been certified by Intertek Testing Services to meet the requirements for ETL Listing per the following standards: 5

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 UL 60601-1 Standard for Safety Medical Electrical Equipment, Part 1: General Requirements for Safety Second Edition.  CAN/CSA C22.2 NO 601.1-M90 – 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 992 meets the following standards for radio frequency emissions:  FCC Part 18  IEC/EN 60601-1-2 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 992. This manual has been written to assist you with the safe operation of the Sonicator Plus 992. It is intended for use by the owners and operators of the Sonicator Plus 992. 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 992 operates with high voltages. Qualified biomedical technicians with training in ultrasound and neuromuscular stimulator service should perform servicing of the Sonicator Plus 992 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 992 should be calibrated and safety tested on an annual basis. This service may be obtained from the manufacturer by sending the Sonicator Plus 992 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. 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. A service manual for the Sonicator Plus 992 is available from Mettler Electronics Corp. for a nominal charge. 6

Sonicator Plus 992 Instruction Manual- Rev.G_04/05/13

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. 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.

1.5 Shipping Damage Your new Sonicator Plus 992 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 proper formal claim has been filed by the receiver against the carrier. The carton in which your new Sonicator Plus 992 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 992 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 992 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. Two 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 3" 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 7

Mettler Electronics Corp.- Rev.G_04/05/13

1.7 Limited Warranty The Sonicator Plus 992 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 992 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.

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Sonicator Plus 992 Instruction Manual- Rev.G_04/05/13

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 s Hz

s

Time display LED’s. Displays treatment time and numeric values for frequency, phase duration, on/off times and alphanumeric error codes. 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

1

 Channel display indicator and selector  2

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. Stops all ultrasound and stimulation output. Active ultrasound output indicator on solid when ultrasound output is present, flashing when coupling is inadequate. 9

Mettler Electronics Corp.- Rev.G_04/05/13

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

      s

Hz + –

  

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. Phase duration control selector-Press this button during a biphasic treatment to display phase duration. 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. Continuous stimulation selector Surge selector to set on and off times Reciprocation selector, use for channel pair 1 & 2.

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Sonicator Plus 992 Instruction Manual- Rev.G_04/05/13



Stimulation or ultrasound output displays

00 0 1 mA

LED indicators are lit to define which output intensity is being displayed in the two windows.

2 V

mA W

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.

A W/cm²

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.

I O

Mains On. Mains Off. Attention, consult instruction manual. Diagrams of Pulsed Mode duty cycles Type BF Equipment-Class I

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. ETL Listed (USA) C–ETL Listed (Canada)

ETL and C–ETL Listed (new logo)

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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.

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.

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Sonicator Plus 992 Instruction Manual- Rev.G_04/05/13

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 Hz LED MHz

- - - -

Square centimeters Hertz (pulses per second) Light Emitting Diode Megahertz (1 x 106 cycles per second)

A

-

Microampere (1 x 10-6 ampere)

s mA ms min s S/N V W W/cm²

- - - - - - - - -

Microsecond (1 x 10-6 second) Milliampere (1 x 10-3 ampere) Millisecond (1 x 10-3 second) Minutes Seconds Serial Number Volts Watts Watts per square centimeter

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Sonicator Plus 992 Instruction Manual- Rev.G_04/05/13

Section 3-Installation 3.1 Installation Instructions 1. Connect the line cord to the back of the Sonicator Plus 992. (See Figure 3.1) 2. Plug the line cord (ME 7293) into a grounded wall outlet that is rated 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 992 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 992. 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 992. (See Figure 3.2) Connect the applicator model 7513 to universal applicator cable using the BNC connector. (See Figure 3.3). Secure both connectors by lining up the pegs, pushing in all the way and rotating 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 992. Other applicators that may be used with the Sonicator Plus 992 are the models 7331 and 7310. Verify that the applicator is labeled for use with the Sonicator Plus 992 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 992 may be susceptible to interference originating from shortwave diathermy units operating in close proximity to it. Avoid operating the Sonicator Plus 992 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 992, using the instructions in Section 4, please register the warranty for your Sonicator Plus 992 on line at http://www.mettlerelectronics.com/product-registration/.

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Mains Power Switch

Applicator Clamp Line Cord Connection

Figure 3.1- Sonicator Plus 992, Back View- Mains Power Switch, Line Cord Connection and Applicator Clamp

Electrode Cable Connections

Applicator Cable Connection

Figure 3.2- Sonicator Plus 992, 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 16

Sonicator Plus 992 Instruction Manual- Rev.G_04/05/13

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., Incorporated as replacement parts for internal or external components, may result in increased EMISSIONS or decreased IMMUNITY of the Sonicator Plus 992.

Guidance and manufacturer’s declaration – electromagnetic emissions The Sonicator Plus 992 is intended for use in the electromagnetic environment specified below. The customer or the user of the Sonicator Plus 992 should assure it is used in such an environment. Emissions Test RF emissions

Compliance Group 1

The Sonicator Plus 992 must emit electromagnetic energy in order to perform its intended function. Nearby electronic equipment may be effected.

Class B

The Sonicator Plus 992 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.

CISPR 11 RF emissions CISPR 11 Harmonic emissions

Electromagnetic environment-guidance

Applicable

IEC 61000-3-2 Voltage fluctuations/flicker emissions

Applicable

IEC 61000-3-3

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Guidance and manufacturer’s declaration – electromagnetic immunity The Sonicator Plus 992 is intended for use in the electromagnetic environment specified below. The customer or the user of the Sonicator Plus 992 should assure that it is used in such an environment. Immunity test Electrostatic discharge (ESD)

IEC 60601 test level

Compliance level

±6 kV contact

±6 kV contact

±8 kV air

±8 kV air

Electrical fast transient/burst

±2 kV for power supply lines

±2 kV for power supply lines

IEC 61000-4-4

±1 kV for input/output lines

±1 kV for input/output lines

Surge

±1 kV differential mode

±1 kV differential mode

±2 kV common mode

±2 kV common mode

<5% UT (>95% dip in UT) for 0.5 cycle

<5% UT (>95% dip in UT) for 0.5 cycle

40% UT (60% dip in UT) for 5 cycles

40% UT (60% dip in UT) for 5 cycles

70% UT (30% dip in UT) for 25 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 5 seconds

3 A/m

3 A/m

IEC 61000-4-2

IEC 61000-4-5 Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

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

NOTE UT is the A.C. mains voltage prior to application of the test level.

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Electromagnetic environment - guidance Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, 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. Mains power quality should be that of a typical commercial or hospital environment. If the user of the Sonicator Plus 992 requires continued operation during power mains interruptions, it is needed that the Sonicator Plus 992 be powered from an uninterruptible power supply.

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

Sonicator Plus 992 Instruction Manual- Rev.G_04/05/13

Guidance and manufacturer’s declaration – electromagnetic immunity The Sonicator Plus 992 is intended for use in the electromagnetic environment specified below. The customer or the user of the Sonicator Plus 992 should assure that it is used in such an environment. Immunity test

IEC 60601 test level

Compliance level

Electromagnetic environment – guidance Portable and mobile RF communications equipment should be used no closer to any part of the Sonicator Plus 992, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance

Conducted RF IEC 61000-4-6

3 Vrms 150 kHz to 80 GHz

3V

d = 1,2√P

Radiated RF IEC 61000-4-3

3 V/m 80 MHz to 2,5 GHz

3 V/m

d = 1,2√P 80MHz to 800 MHz d = 2,3√P 800MHz 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 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. 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 the Sonicator Plus 992 is used exceeds the applicable RF compliance level above, the Sonicator Plus 992 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 992.

b

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

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Recommended separation distances between portable and mobile RF communications equipment and the Sonicator Plus 992 The Sonicator Plus 992 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Sonicator Plus 992 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Sonicator Plus 992 as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter W 0,01 0,1 1 10 100

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

0,12 0,38 1,2 3,8 12

0,12 0,38 1,2 3,8 12

0,23 0,73 2,3 7,3 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. 1

Mode of Operation Unit tested to 230 VAC for CE

Essential Performance Degradation Allowed Unit designed to be failure safe in abnormal condition

Unit tested to 120 VAC for US/Canada 2

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Unit has two stimulation channels with ultrasound

Reset allowed as long as failure safe