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Performa Professional Series

Performa

™

Professional Series

TENSity Professional Series

USER MANUAL

Operation Instructions For:

Performa

™

Combin8 Quattro

Performa

™

Combin8 Duo

Performa

™

Stimul8

Performa

™

Gener8

Содержание Performa Combin8 Quattro

Страница 1: ...rforma Professional Series Performa Professional Series InTENSity Professional Series USER MANUAL Operation Instructions For Performa Combin8 Quattro Performa Combin8 Duo Performa Stimul8 Performa Gener8 ...

Страница 2: ...notice Amendments will however be published in a new edition of this manual All Rights Reserved 42 PH8000 MAN_00 2017 Conformity to safety standards Performance Health declares that the Performa Professional Series comply with following normative documents IEC60601 1 IEC60601 1 2 IEC60601 2 10 IEC60601 2 5 ISO7010 IEC61689 ISO14971 ISO10993 1 ISO10993 5 ISO10993 10 Complies with MDD 93 42 EEC and ...

Страница 3: ...rential Premodulated 2 Pole 15 TENS Biphasic Asymmetrical Symmetrical 16 RAAS Biphasic 17 Russian 18 High Volt 19 Microcurrent 20 NMS 21 Ultrasound Specifications 22 23 Package Contents 24 25 Operating Controls 26 33 Stimul8 Operating Controls 26 27 Combin8 Quattro Operating Controls 28 29 Combin8 Duo Operating Controls 30 31 Gener8 Operating Controls 32 33 Device Descriptions 34 37 Home Screen Di...

Страница 4: ...Manual Operation 47 Parameters 48 Treatment Time Adjustment 48 Start Therapy 48 Combination Therapy Set Up Manual Operation 49 Parameters Electrotherapy 49 Treatment Parameter Adjustment 49 Parameters Ultrasound 50 Treatment Time Adjustment 50 Storing Favorites 50 Operating Details 51 System Settings 51 Setting Adjustment 51 Adjusting Current Amplitude 51 CC CV Mode 51 Current Polarity 51 Maintena...

Страница 5: ...d supervision of a physician or licensed practitioner These devices have been thoroughly tested and inspected to assure proper Performance and operation Specifications put forth in this manual were in effect at the time of publication However to ensure continual improvement measures changes to these specifications may be made at any time without obligation on the part of manufacturer IMPORTANT SAF...

Страница 6: ...ESE CONDITIONS If a patient has a cardiac pacemaker implanted defibrillator or other implanted metallic or electronic device Such use could cause electric shock burns electrical interference or death Together with a life supporting medical electronic device such as an artificial heart or lung or respirator In the presence of electronic monitoring equipment e g cardiac monitors ECG alarms which may...

Страница 7: ...while administering electrotherapy as this could cause an increase in stimulation WARNING cont DO NOT USE ON THESE INDIVIDUALS Pregnant women because the safety of electrical stimulation during pregnancy has not been established Children or infants because the device has not been evaluated for pediatric use Persons incapable of expressing their thoughts or intentions NEVER APPLY THE ELECTRODES TO ...

Страница 8: ...ain during ultrasonic treatment intensity should be reduced to a comfortable level WARNING cont GENERAL WARNINGS Make certain the unit is electrically grounded by connecting only to a grounded electrical service receptacle conforming to the applicable national and local electrical codes To avoid the risk of electric shock this equipment must only be connected to a grounded outlet The Performa Prof...

Страница 9: ...fore should be used in treating patients with therapeutic ultrasound who have hemorrhagic diathesis or bleeding disorders Do not use a conductive medium with an alcohol based content CAUTION CAUTION WHILE USING THE STIMULATOR If the stimulator is not functioning properly or the patient feels discomfort immediately stop using the device Do not use for any other purpose except for what it is intende...

Страница 10: ...ical procedure may disrupt the healing process Use caution if stimulation is applied over areas of skin that lack normal sensation GENERAL PRECAUTIONS Keep unit out of the reach of young children The unit contains small pieces that may be swallowed The electrode cord can cause strangulation Immediately DIAL 911 should any of these things occur It is highly recommended that only clinical grade elec...

Страница 11: ...ain relief unless etiology is established or unless a pain syndrome has been diagnosed This device should not be used on patients with demand type cardiac pacemakers This device should not be used over cancerous lesions Electrode placements that apply current to the carotid sinus region anterior neck must be avoided Electrode placements that apply current transcerebrally through the head must be a...

Страница 12: ...und should not be applied over the uterus unless specific assurance can be attained from the patient that she is not pregnant Areas of thrombophlebitis should not be treated with therapeutic ultrasound due to the increased possibility of clotting or dislodging a thrombus Conditions where this might occur are deep vein thrombosis emboli and severe atherosclerosis Tissues previously treated by deep ...

Страница 13: ...tment area during and following treatment and discontinue if an adverse reaction does occur COUPLING Coupling is described as contact between the applicator and the treatment site and may be accomplished through the use of a coupling agent such as gel or lotion Anything used as a coupling agent must be highly conductive Air is a very poor conductor of ultrasonic waves DO NOT use a conductive mediu...

Страница 14: ...Vector Auto is a form of amplitude modulation and is a percentage of the set interferential amplitude intensity and will decrease from its maximum level over 6 seconds Vector Manual Vector Manual is a form of amplitude modulation When Vector Manual is set to a different angle the output intensities of two channels are different The rhythmical change in position of the interference pattern results ...

Страница 15: ... L of 4150 will yield a 150 pps beat frequency Cycle Time Cycle time refers to the time that the current is On and Off in seconds Example For a cycle time of 10 50 the current will be flowing for 10 seconds and resting for 50 seconds Ramp Time Ramp time is used to set a gradual increase in intensity during the on time Ramps occur at the beginning and ending of a cycle Stimulator Output Parameters ...

Страница 16: ...uce accommodation Example When the pulse frequency is set to 80 Hz and the frequency modulation is set to 40 Hz the final frequency will vary from 80 120 Hz Amplitude Modulation Amplitude Modulation is rhythmical fluctuation of the intensity to prevent accommodation Stimulator Output Parameters TENS Asymmetrical Biphasic Output Mode Electrodes Mode selection CC Constant Current or CV Constant volt...

Страница 17: ...in Hz or Pulses Per Second pps Burst Duration The time elapsed from the beginning to the end of one burst and is denoted in ms Pattern Frequency The Pattern Frequency refers to the num ber of the sequential pulse train pattern be repeated in a one second period of time and is denoted in Hz Stimulator Output Parameters RAAS Asymmetrical Symmetrical Biphasic Output Mode Electrodes Mode selection CC ...

Страница 18: ...ty is the percentage of the total treatment time that the current is actually flowing Cycle Time Cycle time refers to the time that the current is On and Off in seconds Example for a Cycle Time of 10 50 the current will be flowing for 10 seconds and resting for 50 seconds Ramp Ramp is used to set a gradual increase in intensity during the on time Ramps occur at the beginning and ending of a cycle ...

Страница 19: ... red lead wire connect the lead wire to the active electrode Cycle Time Cycle Time refers to the time that the current is on and off in seconds Example for a Cycle Time of 10 50 the current will be flowing for 10 seconds and resting for 50 seconds Ramp Ramp is used to set a gradual increase in intensity during the on time Ramps occur at the beginning and ending of a timed on cycle NOTE When admini...

Страница 20: ...ood yet but has previously been shown to help with reduction in healing time PARAMETERS Frequency In a pulsed current the Frequency refers to the number of pulses that occur in a one second period of time and is denoted in Hz or Pulses Per Second pps Polarity This refers to the polarity of the red lead wire connect the lead wire to the active electrode Stimulator Output Parameters Frequency 0 1 1 ...

Страница 21: ...e of nerve recruited Cycle Time Cycle time refers to the time that the current is on and off in seconds Example for a Cycle Time of 10 50 the current will be flowing for 10 seconds and resting for 50 seconds Ramp Ramp time is used to set a gradual increase in intensity during the on time Ramps occur at the beginning and ending of a timed on cycle Stimulator Output Parameters Output Mode Electrodes...

Страница 22: ...plitude Expressed in Watt cm is the quotient of Ultrasound Power and Effective Radiation Area The ultrasound output display can be toggled between Watt and Watt cm In pulsed mode the Amplitude during the pulse is displayed The time averaged Amplitude can be obtained by multiplying this value by the Duty Cycle Ultrasound Parameters Frequency 1 MHz 3 MHz Duty Cycles 10 100 Continuous Stepping 10 Pul...

Страница 23: ...the socket on the back of the device and plug it into a grounded wall outlet DISCONNECTION FROM POWER When you have finished treatments turn the device off by setting the power switch on the back of the device to Off When the green power LED turns off the device is now disconnected from the power supply CAUTION Do not place the device in a location where the power cord could be tripped over or pul...

Страница 24: ...Cart 081716364 1 1 cm Sound Head 7000764 1 Description SKU Qty Performa Combin8 Quattro 4 channel Electrotherapy Ultrasound Combo Device 081716349 1 Printed Manual N A 1 Quick Start Guide N A 1 Medical Grade Power Cord PH8000X 1 Patient Stop Switch 7000766 1 5 cm Sound Head 7000765 1 Performa Cloth 2 Square 4 pk 081067438 1 Performa Cloth 2 x 3 5 Rectangle 4 pk 081067461 1 ValuTrode Cloth 3 x 5 Re...

Страница 25: ... 2 channel Electrotherapy Ultrasound Combination Device 081716372 1 Printed Manual N A 1 Quick Start Guide N A 1 Medical Grade Power Cord PH8000X 1 5cm Sound Head 7000765 1 Performa Sonishield Antimicrobial Ultrasound Gel 8 5 oz 081710748 1 Patient Stop Switch 7000766 1 Performa Cloth 2 Square 4 pk 081067438 1 Performa Cloth 2 x 3 5 Rectangle 4 pk 081067461 1 ValuTrode Cloth 3 x 5 Rectangle 2 pk 0...

Страница 26: ...ent Stop Switch Button 5 Central Control Dial with Light Ring 6 Patient Stop Switch Connection 7 Channel 1 Lead Wire Connections 8 Channel 2 Lead Wire Connections 9 Channel 3 Lead Wire Connections 10 Channel 4 Lead Wire Connections 11 Clinical Protocol Button 12 Favorites Button 2 1 5 3 6 8 4 7 9 10 11 12 Operating Controls ...

Страница 27: ...tic Port 17 On Off Switch 18 Power Cord Connection DEVICE SYMBOLS Symbol Meaning Electrode Cable Connection BF Application Part Patient Stop Button Connection Please refer to the manual for detailed instructions USB Diagnostic Port is used for repairs and or maintenance issues and should only be used by a certified technician 13 15 17 14 16 18 ...

Страница 28: ...ing 6 Patient Stop Switch Connection 7 Channel 1 Lead Wire Connections 8 Channel 2 Lead Wire Connections 9 Channel 3 Lead Wire Connections 10 Channel 4 Lead Wire Connections 11 Ultrasound Therapy Button 12 Combination Therapy button 13 Ultrasound Indicator Light 14 5 cm Ultrasound Head 15 Ultrasound Head Cradle 16 Ultrasound Head Connection 2 1 5 3 6 8 4 7 9 13 14 15 16 10 11 12 Operating Controls...

Страница 29: ...Switch 22 Power Cord Connection DEVICE SYMBOLS Symbol Meaning Electrode Cable Connection BF Application Part Ultrasound Applicator Connection Patient Interrupt Button Connection Please refer to the manual for detailed instructions USB Diagnostic Port is used for repairs and or maintenance issues and should only be used by a certified technician 17 19 21 18 20 22 ...

Страница 30: ... 5 Central Control Dial with Light Ring 6 Patient Stop Switch Connection 7 Channel 1 Lead Wire Connections 8 Channel 2 Lead Wire Connections 9 Ultrasound Therapy Button 10 Combination Therapy button 11 Ultrasound Indicator Light 12 5 cm Ultrasound Head 13 Ultrasound Head Cradle 14 Ultrasound Head Connection 2 1 5 3 6 8 4 7 11 12 13 14 9 10 Operating Controls ...

Страница 31: ...Switch 20 Power Cord Connection DEVICE SYMBOLS Symbol Meaning Electrode Cable Connection BF Application Part Ultrasound Applicator Connection Patient Interrupt Button Connection Please refer to the manual for detailed instructions USB Diagnostic Port is used for repairs and or maintenance issues and should only be used by a certified technician 15 17 19 16 18 20 ...

Страница 32: ...ton 5 Central Control Dial with Light Ring 6 Channel 1 Ultrasound Head Connection 7 Clinical Protocol Button 8 Favorites Button 9 Ultrasound Indicator Light Same on Both 10 Ultrasound Head 5cm or 1cm on Either Channel 11 Ultrasound Head Cradle Same on Both Sides 12 Channel 2 Ultrasound Head Connection 2 1 5 3 6 4 9 10 11 12 7 8 Operating Controls ...

Страница 33: ... USB Diagnostic Port 17 On Off Switch 18 Power Cord Connection DEVICE SYMBOLS Symbol Meaning BF Application Part Ultrasound Applicator Connection Please refer to the manual for detailed instructions USB Diagnostic Port is used for repairs and or maintenance issues and should only be used by a certified technician 13 15 17 14 16 18 ...

Страница 34: ...ed or independent channels With independent channels two or four different protocols can be performed simultaneously PERFORMA COMBIN8 QUATTRO The Performa Combin8 Quattro is a combination device combining the functions of the Performa Stimul8 and the Ultrasound Therapy in a single device With the Performa Combin8 Quattro the simultaneous application of ultrasound and electrotherapy combination the...

Страница 35: ...igate back to the previous screen by touching the back arrow at the top of the screen Anywhere in the navigation you can jump back to the Home Menu by touching the home button Performa Performa Performa Stimul8 Combin8 Gener8 Quattro Duo MAIN THERAPY DISPLAY After navigating from the Home Menu the below screen will be the main therapy display content subject to change This display is organized in ...

Страница 36: ...nd the treatment timer suspends counting down Start Continue Start Continue treatment The output current increases to the previous value and the treatment timer resumes counting down Accept Accept the selected option Stop Stop the treatment reset the treatment time and intensity ELECTROTHERAPY TREATMENT SCREEN Applies to the Performa Stimul8 Combin8 Devices 1 Electrode Output Indicator 2 Channel I...

Страница 37: ...reatment Time 2 Output Value 3 Unit of Output Value w cm2 COMBINATION THERAPY SCREEN Applies to the Performa Combin8 Quattro Duo 1 Ultrasound Output Indicator 2 Electrode Output Indicator 3 Remaining Treatment Time Electrotherapy 4 Output Value 5 Unit of Output Value mA Ultrasound 6 Output Value 7 Unit of Output Value w cm2 1 2 3 5 6 7 4 1 3 2 Product Description ...

Страница 38: ... to ensure good conductivity Self Adhesive Electrodes Self adhesive electrodes have higher series impedance than flexible rubber electrodes This can cause the stimulator to terminate treatment at higher current amplitudes When this occurs it is recommended to continue the treatment with flexible rubber electrodes properly moistened with a conductive medium Self adhesive electrodes are not recommen...

Страница 39: ...rotocols button 2 Clinical Protocols cont Use the central control dial to scroll through the pages then select the desired clinical protocol button For more information about the clinical protocol press the button next to the desired protocol Use the central control dial to scroll through the information The last page will show suggested electrode placement This manual contains instructions for th...

Страница 40: ...central control dial NOTE Some parameters have more options to choose from and on the next screen another list appears from which to choose from Touch the button if you want to switch to parameters of channels 3 4 Only Available on the Combin8 Quattro Stimul8 5 Treatment Time Adjustment Touch the timer The color will change to orange Adjust the treatment time with the central control dial 6 Start ...

Страница 41: ... When a treatment screen is completely set as required you can save those settings as a favorite for later use As long as the treatment has not been started a store button will be available on the navigation bar To store your settings to Favorites touch the store button Enter the name of your favorite using the keyboard Press to store your favorite under the name just entered NOTE Once saved Favor...

Страница 42: ...vailable for another therapy When channels 1 2 or 3 4 are selected both channels have the same parameters Only the intensity can be set differently For the Combin8 Duo only Channel 1 2 or 1 2 will be an available option 4 Parameters Adjust the parameters by touching the desired parameter button and change the value with the central control dial NOTE Some parameters have more options to choose from...

Страница 43: ...n the navigation bar To stop the treatment touch the STOP button in the navigation bar NOTE To restart after pressing stop you will need to re enter the treatment time first 7 Storing Your Favorite Settings When a treatment screen is completely set as required you can save those settings as a Favorite for later use As long as the treatment has not been started a store button will be available on t...

Страница 44: ...r If the body surface is very irregular making it difficult to obtain good contact between the ultrasound applicator and the body or if direct contact must be avoided e g due to pain the affected area may be treated under water subaqual method The water should be degassed by previous boiling in order to prevent air bubbles arising on the ultrasound applicator and the body Before Treatment Check th...

Страница 45: ...asound Menu gives you access to the following functions 1 Clinical Protocols 2 Favorites 3 Manual Operation Select Clinical Protocols button 2 Clinical Protocols cont Use the central control dial to scroll through the pages then select the desired clinical protocol button For more information about the clinical protocol press the button next to the desired protocol Use the central control dial to ...

Страница 46: ...r and the body The best medium for the transfer of ultrasound energy is a gel 5 Start Therapy Once your parameters and timer are set make contact with the treatment area Then start the therapy by touching the output intensity on the bottom of the screen The color will change to orange Use the central control dial to adjust the output level Note The current intensity can only be adjusted after the ...

Страница 47: ...he name of your favorite using the keyboard Press to store your favorite under the name just entered NOTE Once saved favorites can be retrieved from the Electrotherapy Ultrasound and Combination menus 4 polar treatments are automatically saved and loaded as a dual channel treatments Ultrasound Therapy Set Up Manual Operation 1 Home The Home Menu gives access to all functions of the unit Select the...

Страница 48: ...edium for the transfer of ultrasound energy is a gel 5 Start Therapy Once your parameters and timer are set make contact with the treatment area Then start the therapy by touching the output intensity on the bottom of the screen The color will change to orange Use the central control dial to adjust the output level NOTE The current intensity can only be adjusted after the timer has been set The co...

Страница 49: ...ns of the unit Select the Combination button 2 Manual Operation The Combination Menu provides access to the following functions 1 Favorites 2 Manual Operation Select Manual Operation button 3 Setting Electrotherapy Parameters The first parameter screen that is shown is for electrotherapy parameters Select the desired electrotherapy waveform by pressing the button NOTE Some selections have more opt...

Страница 50: ... with the central control dial Adjust the parameters by touching the desired parameter button and change the value with the central control dial 7 Storing Your Favorite Settings When a treatment screen is completely set as required you can save those settings as a favorite for later use As long as the treatment has not been started a store button will be available on the navigation bar To store yo...

Страница 51: ... to the Home Menu Adjusting Current Amplitude The unity of the displayed current amplitude depends on the previously selected current waveform and can be expressed in mA or V by pressing the CC CV button CC CV Mode Depending on the selected current waveform the electrotherapy channels can be used in the Constant Current or Constant Voltage mode In CV mode the output current depends on the electric...

Страница 52: ...the cleaning agent to a soft cotton cloth and carefully clean the panel CAUTION Do not spray the cleaning agent directly on the glass panel Do not use cleaning agents that contain strong alkali lye acid detergents with fluoride or detergents with ammonia Care and Storage of Electrodes Performa Stimul8 and Combin8 devices only The life of the electrodes varies depending on skin conditions storage t...

Страница 53: ...he insulation and dramatically shorten their life Ultrasound Applicator Performa Stimul8 and Combin8 devices only To prevent corrosion clean and dry the contact surface immediately after use Make sure that no ultrasound gel remains on the applicator We further recommend cleaning the applicator and cable daily using lukewarm water The applicator can be disinfected using a cloth moistened with a 70 ...

Страница 54: ...xternal stim board self check has failed 119 Stim board may be defective Error Code Reason for Tone Solution Problem Still Exists 120 The storage for favorites is full Delete some of the favorite programmings 121 The password is wrong Contact manufacturer 122 The SD socket is broken or the SD card falls off the socket Restart the device Contact manufacturer tech support 123 The communication betwe...

Страница 55: ...s secure firmly Damaged or worn electrodes or lead wires Replace CAUTION Electrical safety of the device relies on a properly grounded electrical connection via the power cord To ensure continued compliance with the 21 CFR 1050 10 standard this unit should be adjusted and safety tested once each year Procedures specified in the service manual should be followed This may be carried out by your supp...

Страница 56: ... the unit find out about local regulations concerning waste management Safety and Performance Standards IEC 60601 1 General requirements for the safety of electrical medical systems including Annex 1 national differences for Australia Canada and the United States Safety Class According to IEC 60601 1 Class I type BF IEC 60601 2 5 Particular requirements for the safety of ultrasonic therapy equipme...

Страница 57: ...orma Professional Series RF emissions according to CISPR 11 Class A The Performa Combin8 Quattro device is suitable for use in all establishments other than domestic and those directly connected to a low voltage power supply network which supplies buildings used for domestic purposes Harmonic emissions according to IEC 61000 3 2 Class A Voltage fluctuation emissions and flicker according to IEC 61...

Страница 58: ...agnetic Interference Immunity The Performa Professional Series device is intended for operation in the electromagnetic environment specified below The customer or user of the Performa Professional Series should ensure that it is used in such an environment Interference Immunity Tests IEC 60601 Test Level Compliance Level Electromagnetic Environment Guidelines Conducted RF disturbance variables acc...

Страница 59: ...onal Series device is intended for operation in an electromagnetic environment where RF disturbances are monitored The customer or user of the Performa Professional Series device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF telecommunications 4 series transmitters and the Performa Professional Series device according to the output p...

Страница 60: ...oper packaging or shipment If Performance Health determines in its sole reasonable discretion that the Product contains defective workmanship or materials Performance Health will replace the product with a new or factory certified refurbished product at Performance Health s expense or refund the purchase price to the original purchaser for the price of the defective product minus shipping costs If...

Страница 61: ...Performa Professional Series 61 Notes NOTES ______________________________________________________________ ______________________________________________________________ ...

Страница 62: ...Performa Professional Series 62 NOTES ______________________________________________________________ ______________________________________________________________ Notes ...

Страница 63: ...Performa Professional Series 63 NOTES ______________________________________________________________ ______________________________________________________________ Notes ...

Страница 64: ...Manufactured for Performance Health Supply Inc Cedarburg WI 53012 www Performancehealth com 42 PH8000 MAN_00 ...

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