Phyaction PERFORMA + Operating and installation instructions

SERVICE INFORMATION
PERFORMA +
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1. TABLE OF CONTENTS
1. TABLE OF CONTENTS ................................................................................................ 2
2. GENERAL INFORMATION ......................................................................................... 4
2.1 Introduction..........................................................................................................................4
2.2 Safety aspects.......................................................................................................................4
2.2.1 Electrical safety.............................................................................................................4
2.2.2 Explosion safety............................................................................................................4
2.2.3 Safety of use. ................................................................................................................4
2.2.4 Radio interference suppression and electromagnetic compatibility..............................4
2.2.5 Medical device directive (MDD) ..................................................................................5
2.3 Installation............................................................................................................................5
2.3.1 Incoming inspection......................................................................................................5
2.3.2 Mains voltage................................................................................................................5
2.3.3 Functional test...............................................................................................................5
2.3.4 Selecting the operating language. .................................................................................5
2.3.5 Location and transportation. .........................................................................................5
3. Technical specifications .................................................................................................. 6
3.1 Performance: ........................................................................................................................6
4. OPERATION .................................................................................................................. 7
4.1 General information. ............................................................................................................7
5. Yearly checkup and safety test........................................................................................ 8
5.1 Safety inspection..................................................................................................................8
5.2 Inspection interval................................................................................................................8
5.3 Inspection results..................................................................................................................8
5.3.2 General Functional Inspection ......................................................................................9
5.3.3 Functional Inspection Shortwave therapy.....................................................................9
5.3.4 Electrical Safety Test According to IEC 601.1.............................................................9
5.3.5 Result of safety inspection..........................................................................................10
6. Circuit description......................................................................................................... 11
6.1 Block diagram. ...................................................................................................................11
6.2 ...................................................................................................................................................11
6.3 Mains power and mains transformer..................................................................................11
6.4 Power supply (A100). ........................................................................................................12
6.5 Transistor power generator. ...............................................................................................12
6.5.1 The quartz stable generator.........................................................................................12
6.5.2 The level control circuit..............................................................................................12
6.5.3 The amplification circuits. ..........................................................................................12
6.5.4 Impedance matching and filter circuits.......................................................................13
6.5.5 Power and mismatching meter....................................................................................13
6.5.6 Setpoint and actual value comparator.........................................................................14
6.5.7 Channel switch PCB. ..................................................................................................14
7. System diagnostics software ......................................................................................... 15
7.1 The service screens. ...........................................................................................................16
7.2 Measuring point 6 ..............................................................................................................17
7.3 Measuring point 7 ..............................................................................................................17
7.4 Measuring point 8 ..............................................................................................................17
7.5 Measuring point 9 ..............................................................................................................17
7.6 Measuring point 10 ............................................................................................................18
7.7 Measuring point 11 ............................................................................................................18
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7.8 Measuring point 12 ............................................................................................................18
8. Calibration of the generator. ......................................................................................... 19
8.1 Generator calibration procedure.........................................................................................19
8.1.1 Calibration of the start-up point of the generator........................................................19
8.1.2 Calibration of the maximum average power...............................................................19
9. Unit checkup procedure ................................................................................................ 21
9.1 Generator power check. .....................................................................................................21
9.2 Check of the SWR..............................................................................................................21
10. Calibration of the coil field electrode. .......................................................................... 22
10.1 General...............................................................................................................................22
10.2 Different types of coil field plods. .....................................................................................22
10.3 Performance check of the electrode. ..................................................................................23
10.4 Recalibration of the plode. .................................................................................................23
10.5 Contact control...................................................................................................................23
10.6 Opening the coil field electrode. ........................................................................................24
11. Photo’s of the different parts......................................................................................... 25
11.1.1 .........................................................................................................................................25
12. Spare parts..................................................................................................................... 26
13. Circuit diagrams ............................................................................................................ 27
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2. GENERAL INFORMATION
2.1 Introduction.
The PERFORMA + is an appliance for pulsed shortwave therapy. The unit has 2 output channels and
there are 2 different coil-field applicators.
In this chapter the important features from the users manual for service personnel are listed. In the next
chapter the theory of operation will be explained. In chapter 3 is described how service personnel can
check the operation of the Performa+ and in chapter 4 the adjustments which can be executed by
technicians. The next chapter contains information which could be very useful for trouble shooting such
as the description of the automatic self test and a list of the error numbers. The schematic diagrams are
in chapter 6, together with the reference list and the spare parts list.
2.2 Safety aspects.
2.2.1 Electrical safety.
The equipment can only be used in areas with provisions in accordance with current statutory
requirements. Pay particular attention to the use of protective earth, otherwise the patient leakage
current can rise above the permitted limit for type BF equipment.
2.2.2 Explosion safety.
The equipment is not suitable for use in areas where flammable gasses or vapours are present.
Therefore, remove the mains plug from the socket before the area in which the equipment is located is
disinfected, since some disinfecting solutions evaporate and subsequently form an explosive mixture.
2.2.3 Safety of use.
- Patients who have electrical implants (i.e. pacemaker) may only be treated following medical
advice.
- The equipment is not suitable for use in damp areas.
- The equipment may not be disinfected or sterilised.
- The device is fit for continuous use.
- Only use the original accessories.
2.2.4 Radio interference suppression and electromagnetic compatibility.
This equipment meets the guidelines for ISM equipment relating to electromagnetic compatibility and is
radio interference suppressed according to IEC 601.1.
However, the 27.12 MHz signal might disturb …
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2.2.5 Medical device directive (MDD)
This device complies with the essential requirements of the Medical Device Directive of the
European Committee (93/42/CEE ) as most recently changed.
2.3 Installation.
2.3.1 Incoming inspection.
Check that the equipment has not been damaged during transportation and that the accessories are intact
and complete. In the event of damage and/or defect you should inform your supplier.
2.3.2 Mains voltage.
The appliance operates at a nominal voltage of 115 or 230 Volt AC( +/- 15%), 50-60 Hz. On the back
of the appliance, you will find a label with the mains voltage. Check if the voltage is selected
correctly (setting of another value than the value which should be used in your region can lead to
irreversible damage of the equipment).
2.3.3 Functional test.
During production the equipment is tested for electrical safety. Whenever the equipment is switched on,
the processor performs an extensive test to ensure that the equipment is operating correctly. In addition
you must check whether the display and the indicator lamps are operating correctly. If this is not the
case, do not use the equipment and contact Uniphy bv.
2.3.4 Selecting the operating language.
The device gives several language options.
To change the language settings, press the SELECT < and > keys while switching on the unit.You can
now select the desired language by turning the rotary, the equipment will use the language you have
chosen.
2.3.5 Location and transportation.
The equipment must be set up horizontally and stable. You must ensure that the perforated sections on
the backside of the casing are not covered up, thus hindering air circulation.
For transportation only use the original packaging.
The appliance is capable, while packed for transport and storage, of being exposed to environmental
conditions not outside the following ranges:
• a ambient temperature range of -20ºC to +60ºC;
• a relative humidity range of 10% to 100%, including condensation;
• an atmospheric pressure range of 500hPa to 1060 HPa.
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3. Technical specifications
Mains power indications:
Mains voltage: 110 VAC, 230 VAC (+/- 15%) 50-60 Hz
Current consumption : 2.6 A (230 V) /600 VA
Mains fuses : 2 x 6.3F
3.1 Performance:
Frequency : 27.12 MHz
Channels : 2
Maximum peak power: 200 Watts
Maximum average power: 90 Watts
Maximum frequency 1 channel: 1125 Hz
Maximum frequency 2 channel: 800 Hz
Maximum treatment time: 60 min
Hardware information:
Dimensions: 38 x 44 x 95 (Width x Depth x Height)
Weight: 43 Kg
Weight of electrode-arm: 3.5 Kg
Classification: Class I, type BF
Electrical safety standard: IEC 601.1
Medical device directive (MDD): CE 0197
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4. OPERATION
4.1 General information.
The Phyaction performa+ is able to generate a maximum peak power of 200 Watts.
However, this power cannot be reached under all circumstances.
The maximum power under all circumstances = 230/SWR, with a maximum of 200 watts.
Under ideal circumstances S = 1 (perfect contact between plode and patient).
Suppose that the set power is 200 watts and S = 1.3: the output power is now 230/1.3= 177 watts
instead of 200 Watts !
The unit has a contact control circuit: when S>1.4 the unit will give the message ‘improve position of
the applicator’. This means that S can never reach a value higher than 1.4.
In other words, if the set power = 165 Wpeak the unit is able to deliver this power within the range
between good and bad contact.
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5. Yearly checkup and safety test
5.1 Safety inspection.
To prevent the Performa+ from having hidden defects acquired during its lifecycle it is strongly
recommended to have the device checked regularly for its proper functioning by qualified personnel.
In some countries this is mandatory or your insurer may be requiring it. A record of these inspections
should be filed so the measurements can be compared with earlier values to alert for a possible
potentially dangerous tendency. For this purpose you can e.g. make copies of these pages.
5.2 Inspection interval.
The design of the device is based on a yearly inspection. If the legislation of your country or your
insurer calls for a shorter period you should adhere to the latter.
5.3 Inspection results.
The inspection is passed when all items as presented on the standard document on the next page are
passed. In the unlikely event the device fails the deviation should be repaired before using it. Repairs
are only to be made by technicians authorised by Uniphy bv. Contact your supplier on this matter.
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Checkup and safety document
5.3.1.1 Visual inspection
Pass Fail
The device record is present and kept up to date
The user manual and the safety manual are present
Device label and suppliers label are clearly readable
The enclosure of the appliance is undamaged
Mains entry and mains cable are undamaged
Coax cables are undamaged
The control knobs, keys and display are undamaged
Only accessories listed in the user manual are being used
5.3.2 General Functional Inspection
Pass Fail
The automatic self test on power up does not report any errors
The display does not show any defective pixels or lines
All keys are functioning
The control knobs operate properly.
5.3.3 Functional Inspection Shortwave therapy
Pass Fail
Check the different thermoplodes and adjust if necessary (chapter)
Check the power output with the dummy load (chapter)
5.3.4 Electrical Safety Test According to IEC 601.1
Parameter Meas. Value Limit Comments
Pass Fail
Protective earth resistance Ω< 0.2 Ω
Enclosure leakage current µA < 1000 µA
Patient leakage current µA < 5000 µA
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5.3.5 Result of safety inspection
The Performa+ with serial number …………….. has passed / failed
Safety Inspector
Name:
Date:
Sign:
........................................
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