TECHNICAL MANUAL METRON VECTORSONIC INTERFERENTIAL ... · The two modalities, electrotherapy and...

Metron Medical Australia Pty LtdA.C.N.050 240 527

P.O. Box 2164, 57 Aster Avenue

Carrum Downs Victoria Australia 3201Tel: (03) 9775 1234 Fax: (03) 9775 1990Int: 61 3 9775 1234 Int: 61 3 9775 1990

TECHNICAL MANUALTECHNICAL MANUAL

METRON VECTORSONIC

INTERFERENTIAL

&

ULTRASOUND ELECTROTHERAPY

UNIT

MODEL VU 270

Prepared byMetron Medical Australia P/LVersion 1V6 January 2008

Metron Vectorsonic

Metron Medical Australia Pty LtdA.C.N.050 240 527

P.O. Box 2164, 57 Aster Avenue

Carrum Downs Victoria Australia 3201Tel: (03) 9775 1234 Fax: (03) 9775 1990Int: 61 3 9775 1234 Int: 61 3 9775 1990

EC DECLARATION OF CONFORMITY

Metron Medical Australia Pty Ltd57 Aster AvenueCarrum Downs, Australia, 3201

declares that the medical devices described hereafter:

Metron VectorsonicCombined InterferentialUltrasound Therapy Unit

Models: VU 270

is in conformity with the essential requirements and provisions of Council Directive 93/42/EEC

is subject to the procedure set out in Annex II of Directive 93/42/EEC under the supervision of Notified Body Number 0805, Therapeutic Goods Administration, Office of Devices, Blood & Tissues, Po Box 100 Woden, ACT 2606, Australia

Melbourne, November 2007

Ashley WilliamsManaging Director

Metron Medical Australia Pty Ltd

___________________________________________________________________ Version: 1V6 Jan 2008

Metron Vectorsonic

0805The Metron Vectorsonic Combined Interferential Ultrasound Therapy Unit bears the above marking in accordance with the requirements of Council Directive 93/42/EEC.

Should you as the purchaser and/or user of this product wish to make any comment about the product or the manner in which it may be used our Authorised Representative within the European Union may be contacted as follows:

Metron Medicalc/- Physiomed ServicesAttention: Kevin Lee8-11 Glossop Brook Business ParkSurrey StreetGlossopDERBYSHIRE SK13 91J UNITED KINGDOM

___________________________________________________________________ Version: 1V6 Jan 2008

Metron Vectorsonic

CONTENTSSection Page

1. Specifications .................................................................................................. 1

2. Introduction ...................................................................................................... 4

3. Schematic Diagram Description ..................................................................... 6

3.1 General ................................................................................................ 63.2 Schematic Description ........................................................................ 6

3.2.1 DC Power Supplies .............................................................. 63.2.2 Microcontroller and Memory ................................................. 63.2.3 User Controls ......................................................................... 73.2.4 Displays and Drivers ............................................................. 73.2.5 Interferential Output Waveform Generators ....................... 73.2.6 Output Drivers and Current Monitors .................................. 73.2.7 Ultrasound Frequency Generator & Output Stage ............ 8

3.3 Ultrasonic Treatment Applicators ....................................................... 8

4. Preventative Maintenance & Quality Assurance .......................................... 9

4.1 Disassembling/Assembling the Unit ................................................ 94.2 Calibration and Adjustment ................................................................ 9

4.2.1 Calibration Procedure - Interferential Section ...................... 94.2.2 Calibration Procedure - Suction Section .............................. 10

4.3 Electrical Safety Inspection ................................................................ 11

5. Schematic Diagrams ....................................................................................... 12

5.1 Board Schematic ................................................................................. 12

5.2 Ultrasound Treatment Head Schematic ............................................ 13

___________________________________________________________________ Version: 1V6 Jan 2008

1. SPECIFICATIONSMAINS POWER SUPPLY REQUIREMENTS:

Voltage 90 - 264 AC Frequency 50/60 HzPower 140 VA Maximum

FUSES:

Secondary 1 of 4 A 5x20 mm DelayExternal 2 of 1 A 5x20 mm Delay

POWER SUPPLY:

Integrated switch mode power supplies complying with EN60601 and EN60950.

Power Supply Voltages 48 Volts @ 1.35 A

MODES OF OPERATION:Available modes: Interferential

UltrasoundCombined

OUTPUT SPECIFICATION - INTERFERENTIAL THERAPY:

Maximum current in each patient circuit 80 mA

Indicator resolution 1 Segment = 4 mA

Indicator accuracy +/- 10% for currents greater than and inclusive of 40 mA+/- 30% for currents less than 40 mA

Maximum voltage in each patient circuit 160 V peak-to-peak

Current Surge Programmes Disabled or EnabledEnabled Rise 0 - 20 seconds

On 0 - 20 secondsFall 0 - 20 secondsOff 0 - 80 seconds

Waveform Beat FrequenciesPreset Ranges 0 - 15 Hz

0 - 150 Hz80 - 150 Hz

Adjustable Range 0 - 250 Hz

Current Waveform Type Sinewave

Waveform Pulse Frequencies 2.5, 4 or 10 kHz

Metron _____________ Vectorsonic

___________________________________________________________________Version: 1V6 Jan 2008 Page 1 of 13

Frequency accuracy Better than +/- 1%

Waveform Pulse Widths 50, 125 or 200 µsCurrent Delivery Modes 2 or 4 Pole

OUTPUT SPECIFICATION - ULTRASOUND THERAPY:Frequency 1.1 MHz +/- 10%Output intensity in 2.4 Watts/cm2 +/- 20% maximum

continuous mode (Equivalent to 12 watts absolute)Power/intensity display Accurate to +/- 20% of reading for

output in excess of 0.2 Watt/cm2.

Effective Radiating Area 5.0 square cms +/- 20%

Frequency 3.3 MHz +/- 10%Output power in 1.5 Watts/cm2 +/- 10% maximum

continuous mode (Equivalent to 7.5 watts absolute, 5 sqcm. head)3.0 Watts/cm2 +/- 10% maximum(Equivalent to 2.4 watta absolute, 0.8 sqcm head)

Effective Radiating Area 5.0 square cms +/- 20%0.8 square cms +/- 20%

Power/intensity display accurate to +/- 10% of reading.

Beam Non-Uniformity Ratio 5:1 +/- 20%

Ultrasound ModulationModulation modes continuous or pulsedPulsed modulation:

Pulse frequency 100 Hz +/- 3%Pulse period 10 milliseconds +/- 3%Pulse width 1.0, 2.0, 5.0 milliseconds +/- 3%Pulse duty cycle 1:9 (10%), 1:4 (20%), 1:1 (50%)

respectively +/- 3%

TIMER:Operating range 0 - 30 minutesTimer accuracy Better than +/- 2.5 %

SAFETY FEATURES:Lead Off Detector Alarm indicates when electrode

impedance exceeds 10 KohmsCurrent Limit Current increases limited to +10% of

set level



REGULATORY APPROVAL: FDA Clearance No: 030880

ELECTRICAL SAFETY:Manufactured to Australian standards:

AS 3100 - 1985 Definitions and general requirements for electrical materials and equipment.

AS 3200.1 - 1990 Approval and test specification - Electromedical equipment - General requirements (direct equivalent of IEC 601-1, 1988, Second edition).

Applied parts Patient ConnectionsApplied part classification BFChassis classification IIDIMENSIONS:Width 300 mmHeight 120 mmDepth 280 mmWEIGHT:Packed 2.5 kgUnpacked 3.5 kgENVIRONMENTAL CONDITIONS:

Operating: Temperature Range 10 - 40 oCRelative Humidity 30% - 90%

Transport & Storage: Temperature Range 0 - 70 oCRelative Humidity 10% - 100%



2. INTRODUCTIONThis manual presents all the relevant technical information for the Metron Vectorsonic, Model VU 270. This information is provided as a service to medical, paramedical, engineering and technical personnel. This information is intended for the fair purposes of evaluation, maintenance and repair of the Vectorsonic. It is provided as commercial-in-confidence material to the distributor or equipment purchaser and shall not be made available to any other organisation or person without the specific written permission of Metron Medical Australia Pty Ltd. Refer to the Metron Vectorsonic Operator Manual for operation information.

All functions of the schematic diagram are described. Necessary preventative maintenance calibration adjustments are presented in tabular step - by - step format. Recommended electrical safety inspection procedures are discussed.

While every attempt has been made to ensure that this manual is accurate and complete, no responsibility is taken for any errors or omissions. Specifications and component types are subject to change without notice.

If you , as a user of this manual, have any relevant comments or questions, your communication with us would be welcomed. You may contact us by mail or fax as detailed below:

Metron Medical Australia Pty LtdP.O. Box 2164CARRUM DOWNS AUSTRALIA 3201

Fax: (03) 9775-1990 from within Australia or +61 3 9775 1990 International.

The Vectorsonic has been designed to provide interferential and ultrasound therapy combined in a single housing. The two modalities, electrotherapy and ultrasound, are independent of each other and can be operated independently, either singularly or simultaneously, or can be operate in combined mode.

The Vectorsonic section utilises microprocessor technology to control all functions and provide a user friendly interface to the operator. All settings are implemented with one control knob and push button switches.

The two output channels of interferential are fully isolated and the output indication is a true measure of the patient current being derived from current transformers located in series with the patient connections.

The carrier frequency is 2.5, 4 or 10 kHz and a wide selection of sweep frequencies is available. The channel signals are derived from the microprocessor which creates the carrier frequencies and manipulates these frequencies to achieve the sweep parameters chosen by the operator.

The ultrasound section provides therapy at both 1 and 3 MHz with dynamic contact sensing. The treatment applicators are plug connected and removable for ease of cleaning and replacement.



WARNING* The output current available to each patient circuit is of a magnitude

sufficient to cause strong muscle contractions.

* The Vectorsonic is a therapy device and may only be operated by qualified personnel.

* The Vectorsonic must not be used in a trans-thoracic application (the patient circuit electrodes must not be positioned such that current flow through the chest area is possible).



3. SCHEMATIC DIAGRAM DESCRIPTION3.1 General

This section describes the Vectorsonic schematic diagrams. The unit comprises a single printed circuit board (PCB). All the electronic functions are incorporated on to this PCB. Reference should be made to the Printed Circuit Board (PCB) Component Legend and the Schematic Diagram contained in Section 5.

The following should assist with the interpretation of the Schematic Diagram.

3.2 Schematic DescriptionThe schematic details the electronics located on the PCB. It includes the following functions:

A. DC Power SuppliesB. Microcontroller and MemoryC. User ControlsD. Displays and Drivers E. Output Waveform GeneratorsF. Output Drivers and Current MonitorsG. Ultrasound Frequency Generator & Output Stage

3.2.1 DC Power SuppliesThe DC supplies for the unit are derived from two switchmode supplies located in the base of the unit. One switchmode supplies 48 volts DC which is used to derive the +5 volt supply and power the ultrasound section. The other switchmode supplies +48V which is fed directly to the interferential output stage driver circuit.

IC4 is a fixed voltage step down switching regulator which generates the +5 volt supply. IC1 is a variable voltage step down switching regulator which generates the drive voltage for the ultrasound output stage under the control of the main processor, IC18.

3.2.2 Microcontroller and Memory

This schematic shows the main microcontrollers, IC8 and IC18. These units provide the overall control of the unit. IC18 controls the ultrasound section and IC8 controls the interferential section. They each monitor the user controls and the output current monitors for either the interferential and ultrasound sections. IC4 also monitors the data stored in the individual ultrasound treatment applicators to determine the generator set-up required for optimal operation of the ultrasonic transducers. They each drive respective display controllers and generate the appropriate drive signal for the output stages. As well as digital control internal analog to digital conversion is employed for signals used to monitor or control the outputs. The programs are held in internal EEPROM.

3.2.3 User Controls

The user controls fall into two categories, switches and the rotary control. The switches, incorporated into the front panel membrane, enter the circuit via J3 and connect directly to the appropriate microprocessor input ports. Likewise the rotary control, RE1, interfaces directly to the microprocessor IC8 input ports. All these lines are fitted with pull-up resistors.



3.2.4 Displays and Drivers

The LED displays, 7 segment, bargraph and individual, are all driven by MM5451 display drivers, IC15 - 17, IC19 and IC20. These are two wire devices which connect directly to the microprocessor output ports. ICs15-17 are driven from IC8 and the clock line is shared between all the drivers. ICs19 and 20 are driven from IC18

3.2.5 Interferential Output Waveform Generators

The output waveforms are generated by two small microprocessors, IC9 and IC10. One generator, IC9, runs at the fixed carrier frequency, which is clocked directly from IC8, and the other generator, IC10, runs at the variable frequency required to generate the desired beat frequency. This variable frequency is generated by the phased locked loop frequency generator comprising IC5, 6 and 7.

The sinewaves are constructed using the resistor summing networks made up of resistors R53 through R68.

3.2.6 Output Drivers and Current Monitors

The outputs from the sinewave generators are fed to the dual digital potentiometer IC13. These pots are controlled by the IC8 and are used to set the output amplitude as required by the operational requirements.

The outputs from the digital pots are AC coupled to the output drivers housed in IC4. The static outputs of these drivers are biased at 24 volts by zener ZD1.

The output signals are coupled to the patient circuits through output transformers T1 and T2. The contact sets of RL1B allow the output to be disconnected for safety purposes and when output is not being specifically delivered.

Transformers T3 and T4 provide current monitoring of the patient current. The circuitry on the secondary of these transformers rectifies and filters the current signals before they are passed to IC8.

3.2.7 Ultrasound Frequency Generator & Output Stage

IC2 & IC3 form a PLL up convertor to generate the 1MHz or 3 MHz signal for the output stage. An input frequency of 61Hz is applied to pin 14 of IC3 from the microcontroller and is multiplied by the PLL circuit 16385 times to a value of 1MHz on pin 9 of IC2. This signal is than buffered by IC11to drive Q4 and Q5 in the output stage.

Alignment of the treatment applicators is controlled by the microcontroller and the tune point of the applicators is stored in the eeprom located in the connector of the treatment applicator.

L6 monitors supply current level in the output stage. Comparing this value with preset values stored in eeprom, signals an in-contact or contact loss. If an contact loss condition is encountered, the microcontroller reduces the output power to 1W total (0.2 Watts/cm2) and pauses the timer. When contact is reestablished the timer is restarted & power level is restored to that selected. IC18 drives the LEDs in the treatment applicators for contact status.

Two output connectors are provided, J1 and J2, and the selection of one particular connector is controlled by the “Applicator” key on the front panel and the microprocessor. Relays RL2 and RL3 provide the necessary switching.



3.3 ULTRASONIC TREATMENT APPLICATOR/S(see Schematic page 14)

The ultrasonic treatment applicator consists of a plastic and aluminium assembly with the ultrasonic transducer bonded in position. The contact loss indicator LED is driven by the LED signal from the contact sense circuit on the main PCB. The LED has a capacitor connected in parallel with it to prevent the transducer drive RF from turning it on.

The piezoelectric resonator which generates the ultrasound energy is permanently bonded to the cap of the applicator. It can be replaced by simply unscrewing the cup and resonator and attaching a new cup and resonator.

The connector of the treatment applicator contains a small printed circuit board which houses IC1 and filter capacitor C1. IC1 is an EEPROM which is programmed during the calibration sequence, see page 10, and stores the critical information relating to optimum tune frequency and supply voltage levels for each output setting necessary to maintain calibration.

This symbol indicates that the applied parts (treatment applicators) of this equipment are rated as Type “BF”. This means that the patient applied parts are suitable for placement on the external surface of the patient without creating a safety hazard.



4. PREVENTATIVE MAINTENANCE & QUALITY ASSURANCE4.1 Disassembling/Assembling the Unit

Disassembling and assembly of the unit should be undertaken with extreme care to avoid damage to the surfaces of the enclosure. Whenever the unit has to be turned upside down, place it on a soft surface or thick cloth.

Disassembly of the unit is as follows:

- Remove all items from the storage compartment in the top of the unit.

- Place the unit upside down on a soft cloth and remove the four pozi-head self tapping screws around the perimeter of the base. Two of these screws are located close to the front edge of the base and two are located close to the rear edge.

- Place the unit right side up with the front display panel facing towards you. Carefully lift the top cover away from the base and lay it on the right side with the lid open.

Assembly is a reverse procedure of the above with several precautions. They are:

- Observe that any connectors, cables, hoses or wires that were removed are correctly reinstated.

- Observe that hoses, cables or wires are not fouled or crushed.

- Avoid over tightening the four screws securing the base to the top cover. Make sure these screws have internal shakeproof washers on them.

4.2 Calibration and Adjustment

4.2.1 Calibration Procedure - Interferential Section

Equipment Required:

A. Two 1 kohm 10 Watt resistorsB. Dual Trace Oscilloscope with 1 MHz BandwidthC. Vectorsonic Operator's Manual

Procedure:1 There is no calibration procedure for the interferential section of the unit.

2 Connect the 1 kohm resistors across the patient output channels and connect the oscilloscope probes across the resistors.

3 Set the unit to deliver interferential currents and observe on the oscilloscope that stimulus is present. One channel should operate at a fixed frequency and the other channel should indicate varying carrier frequency.

4 The gain can be verified by observing the amplitude generated across the patient load resistors and comparing with the front panel indicated current.



4.2.2 Calibration Procedure - Ultrasound Section

The following equipment is a minimum requirement for the calibration of the Metron Vectorsonic.

Ultrasound Power Meter: Ohmic Instruments UPM-30Bio-Tek Instruments UW-IIUMA Inc UMT-2A or equivalent

Connect the applicator to be calibrated to either input on the Vectorsonic.NOTE: It is recommended that treatment applicators only be attached and

removed from the unit when the power is turned OFF.Calibration mode can only be accessed by pressing the ultrasound power “up” and “down” buttons at the same time and then turning the power ON. This will place the unit into alignment mode (Timer will display an "F").

The first part of the calibration procedure is to align the frequency of the selected applicator. Remove any water, gel etc from face of the applicator and place in free air (face of applicator not in contact with anything). Select the appropriate head size (LF displayed for the large, 5 sq.cm head) by pressing the power “down” button and select the desired frequency by pressing the power “up” button. Start the calibration by pressing the “Applicator” button for 4 seconds and wait until the power display counts from 0 to 99

When this has finished the timer will display a "P" indicating the second part of calibration procedure, the alignment of the applicator’s output power and contact sense control, is ready to be undertaken. Place the ultrasound treatment applicator into a suitable ultrasound power meter.

Press the “Applicator” button on the Vectorsonic and adjust the applicator output power using the power “up”/”down” buttons. The power output displayed on the Vectorsonic should be adjusted to match the power output displayed on the ultrasound power meter. The power output level for each head and frequency combination is adjusted at three points in the usable range, low mid and high. When the first adjustment is completed press the “Applicator” button to move on to the next power level for adjustment.

Repeat the above procedure for all three power settings, for example 8, 2 and 15 watts (for 1 MHz 5 sq.cm applicator) or the values displayed for the 3 MHz applicator, then press the “Applicator” button again. This will place the unit into the contact sense alignment mode and it will automatically scan each power level for its correct contact setting. This step may take some minutes to complete.

The treatment applicator should not be removed from the ultrasound power meter until this procedure has finished.

The calibration procedure for that particular treatment applicator is now completed. If another applicator needs to be calibrated repeat the above procedure.

At the completion of the calibration procedure it is required that the mains power be turned OFF and then turned ON again before the unit is used. This ensures that the new calibration values are loaded into the microprocessor prior to use.

WARNING: If the mains power is removed or turned OFF prior to the completion of the calibration procedure the whole procedure will need to be repeated.



4.3 Electrical Safety Inspection

It is recommended that a program of regular electrical safety inspections be instituted for this equipment. Information on the type and frequency of testing may be obtained from locally published standards. In Australia, the relevant standards are:

AS 3511 - 1988 Acceptance testing and in-service testing - Electromedical equipment.

AS 2500 - 1986 Guide to the safe use of electricity in patient care.

A hospital biomedical engineering department or third party service organisation nominated by the manufacturer or distributor would be capable of performing the necessary testing and providing suitable documentation.

Programmed electrical safety inspections are recommended to confirm continued operator and patient safety. Mandatory, statutory requirements for electrical safety inspections may also apply.



5. SCHEMATIC DIAGRAMS

5.1 Board Schematic

Note: Component changes, C17 & C19 to 10 uF, Q4 & Q5 to IRL 510.



5.2 Ultrasound Treatment Head Schematic



TECHNICAL MANUAL METRON VECTORSONIC INTERFERENTIAL ... · The two modalities, electrotherapy and...

Documents

Transcript of TECHNICAL MANUAL METRON VECTORSONIC INTERFERENTIAL ... · The two modalities, electrotherapy and...