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1. Phonophoresis is used to enhance transdermal transport of several drugs especially anti inflammatory NSAID and local anestetics 1 2 4 Use the drugs gel ointment instead of the US contact gel Press Select Objectives Select Phonophoresis The frequency is 1 MHz the duty cycle is 20 and the time is at least 5 minutes ci A suniphy Phyaction U 4 5 3 Read out values for ultrasound therapy 1 Channel 2 Ultrasound therapy 3 Type of US head 4 Remaining treatment time 5 5 Iset 6 Oy 7 Contact of the US head Iset Wem Fok 8 48 Contact of the US head The contact of the US head with the skin o Bad contact US head switched off 0 W Badcontact Sufficient contact _ Good contact mm Very good contact Test the US head if its conduction is bad See 85 7 7 W cm The power W of the US head per cm Py W The peak power of the US head ERA The peak power delivered therefore depends on the size of the US head and the contact with the skin This value is 0 0 W if the contact with the skin is bad In this case the ultrasound treatment of the equipment is stopped to prevent overheating of the transducer 4 5 4 Parameters for ultrasound therapy Treatment time mm ss The duration of the treatment
2. 31 select a program Reset 2 Make the changes the 1 Reset uorkina hours 2 Change therapy programs program 3 Erase total memory Press 8 Select Reset Menu Select Change therapy programs 6 Select Save new ther progr settings twice to change the program settings Restore this therapy program Change the program back to the manufacture s settings 1 Use the Therapy menu to select a program 2 Goto the Change therapy programs menu 3 Select Restore this therapy program twice Restore all therapy programs Change all therapy programs back to the manufacture s settings 1 Goto the Change therapy programs menu 2 Select Restore ALL therapy program twice 4 8 6 Set text for start up screen You can set your own text for the start up screen For example you can put your name or address information here 1 Press BM SYSTEM SETTINGS 2 Select Text for start up screen Text for start up screen Textbox ofl Textbox 1 Move cursor to the left 2 Move cursor to the right 3 Hove to next line 4 Erase line 5 Readu and save 30 Phyaction U Enter the name for the start up screen Select a character with A and V Select Move cursor to the left right to change the cursor position Select Move to next line to enter a line Select Ready and save 31 A suniphy Phyaction U 32 Phyaction U 5 INSPEC
3. e ar te 34 6 MALFUNCTIONS SERVICE AND GUARANTEE 3b 6 1 MALFUNCTIONS ense se enema snis nnn 35 6 2 SERVICE xe wcaiss i3 E cra m Ri Pete rua 36 6 3 GUARANTEE sc veces a uc lE ee py CY X SUN EE Pa 36 Phyaction U 6 4 TECHNICAL LIFE TIME ccccecceeecceccceeeceeseeeeaeeeseesaseeanes 37 TECHNICAL INFORMATION 39 751 GENERALS eie bee p x E EAS SAT Rena 39 7 2 ULTRASOUND THERAPY ssssesee esee eese nna nn 39 7 3 ENVIRONMENTAL CONDITIONS cccccceceeeeeeeeeeeseeeaueeaaes 40 7 4 TRANSPORT AND STORAGE ccccccecceeeseeeeeeeeeesuueegueeaaes 41 7 5 STANDARD ACCESSORIES ccccceecceeseeeeeeceeeeseeesaueeaueeaaes 41 7 6 OPTIONAL ACCESSORIES ccccccecsceeeeeeeseeeeeeseeeeuaeeugueeaues 42 APPENDICES 1 43 8 1 US HEAD PLACEMENTS 43 8 2 EMG DIRECTIVE E 44 8 3 TECHNICAL SAFETY INSPECTION senes 48 8 4 DISPOSAL xov eM top Me Meis ee 50 REFERENCE 51 9 1 FUNCTION OVERVIEW 51 9 2 LITERATURE 2 2 e tit m vow IIR RII sex TRY veel eee RT 53 9 3 TERMINOLOGY ssesssseeen essen eme asina nissan ases nnn 53 qoe 55 Phyaction U 1 SAFETY 1 1 Purpose The Phyac
4. The Phyaction U can be used in combination with the Phyaction See 84 6 Phyaction See 84 6 H A suniphy Phyaction U 2 6 Transport and storage Take account of the following matters if the equipment has to be transported or stored Transport or store the equipment in the original packaging The maximum period for transport or storage is 15 weeks Temperature 20 to 60 Relative humidity 10 to 100 Atmospheric pressure 200 hPa to 1060 hPa 2 7 Reselling This medical equipment must be traceable The equipment the US head and some other accessories have a unique serial number Provide the dealer with the name and address of the new owner Phyaction U 3 DESCRIPTION OF THE EQUIPMENT 3 1 Phyaction U and standard accessories 1 Phyaction U See 3 2 3 Contact gel 2 Power cord 4 US head 13 A suniphy 3 2 Phyaction U Components of Phyaction U Display See 3 3 Select menu option or parameter Scroll through the list numbers Increase or set a parameter Decrease or set a parameter Therapy menu Guide menu Memory menu System settings menu Back Pause 12 Stop 13 14 15 16 17 19 20 21 22 23 Indicator lamp device on off Intensity of channel A Indication Read manual Connectors for US head Indication Floating patient circuit On off switch Fuse holder Connection to mains supply Type
5. Duty cycle 10 20 30 40 5096 continuous Ratio of the pulse duration to the period duration Continuous Continuous ultrasound 100 10 20 30 40 5096 Pulsating ultrasound Select a high duty cycle for an intensive treatment Select a low duty cycle for a mild treatment 22 Phyaction U ERA cm The effective radiating area expressed in cm of the treatment head connected This area equals the cross sectional area of the beam at the treatment surface The ERA depends on the frequency This parameter remains empty if no US head is connected Head placement Instructions for placing the US head This is only available with treatment selection via Indication list US frequency MHz The frequency of the US head The absorption at a US frequency of 3 MHz is three times higher and the penetration depth is three times less than at a US frequency of 1 MHz Use 3 MHz for superficial tissue and 1 MHz for deeper tissue 4 5 5 Indicator light of the US head The indicator light of the US head provides the following information Indication light Situation Blinking green The US head is properly connected Continuous green The US head is selected Continuous yellow The US emission is in progress Alternating yellow green Bad contact of the US head with the skin Blinking yellow End of the treatment 23 suniphy 4 6 Phyaction U Combination therapy 4 6 1 Performing combined therapy MA ms cm is advised Excee
6. Select Recall by list Recall bu list 3 Select the desired program Ss If necessary scroll through the End gt mue 4 0 Wen Empty list with q or P punt Empty 5155 4 501 382 383 584 585 386 gt 26 Phyaction U Selecting a program by the number 1 2 3 Press 7 Select Recall by number Select the desired program with A or V Select Go to selected number 4 7 3 Erase a saved program Erase a program by the list T 2 3 Press 7 Select Erase by list Select the desired program If necessary scroll through the list with 4 or gt Select Erase memory number to delete the program Erase a program by the number 1 2 Press 3 Select Erase by number Select the desired program with A or V Select Erase selected number twice to delete the program 27 Recall bu number Hr 588 3HhHzeoias z Memory number 1 Bo to selected number 8 Icet 4 6 Pok 8 881 ua o Lc gas by list JOHH Empty Empty Empty Empty Emptu 3nHzoisi28 3 1 20 8 00 T Erase bu number 588 3hHzo1ia za Memory numbers 1 Erase selected number 2 Do not erase Ag uniphy Phyaction U 4 8 System settings With the system settings you can adapt the Standard settings of the equipment You cannot change
7. 17 Service 36 Sound Set 29 Sound settings 28 Stand by time 11 28 Stop 20 Stop treatment 20 Storage 12 conditions 41 System information 28 System setting parameters 28 System settings 28 changing 28 T Technical information 39 Technical life time 37 Terminology 53 Text for start up screen 28 Text start up screen set 30 Therapy program selection 18 selection via indication list 18 selection via objectives 18 set 20 Start 20 Therapy menu 51 selection 17 Transport 12 conditions 41 Treatment interruption 20 stop 20 Treatment time 22 Trophic 53 improve condition 51 U Ultrasound therapy 21 optional accessories 42 parameters 22 Perform 21 Read out values 22 safety 8 technical information 39 US frequency 23 US head cleaning 34 contact 22 Indicator light 23 placement 23 test 33 A suniphy Uniphy is a division from GymnaUniphy Tel 32 0 89 510 51 Fax 32 0 89 510 51 www gymna uniphy com E mail info gymna uniphy com Your dealer
8. 3 Terminology trophic The state of nourishment s A suniphy Phyaction U 54 Phyaction U 10 INDEX A Abbreviations 4 Accessories 41 optional ultrasound therapy 42 standard 41 Cell function improve 51 Change therapy program 30 Cleaning 34 Combination therapy 24 Combined therapy perform 24 Connection 11 combination therapy 25 Contra indication 52 selection 19 Contrast 11 28 Counter working hours 29 D Diagnostic program selection 19 Diagnostics 52 Display 15 symbols 16 Disposal 50 Duty cycle 22 E Electrical safety 8 EMC 8 EMC directive 44 Environmental conditions 40 ERA 23 Erase list 27 number 27 Error history 29 Extensibilty increase 51 F First screen 28 Function overview 51 Functional test 11 G Guarantee 36 Guide menu selection 18 Indication list 18 52 Inspections 33 Installation 11 Intensity screen 20 Interruption 20 L Language 11 28 Liability 9 M Maintenance 34 Malfunctions 35 Medical Devices Directive 9 Memory 26 Objectives 18 51 Cet 22 Parameter symbols ultrasound therapy 16 parameters sound settings 29 Phonophoresis 51 Placing 11 suniphy Phyaction U 22 Prevention of explosion 8 Program erase 27 number selection 18 saving 26 selecting 26 Purpose 7 R Recall list 26 number 27 Replacing a fuse 35 Reselling 12 Reset menu 29 S Safety 7 instructions 7 technical inspection 33 48 Selection therapy
9. Initials T Cross out what does not apply If a specific test does not apply to this equipment place a mark in the NA not applicable column 8 3 7 Test 7 General Yes No NA 1 The results of earlier safety inspections are available 2 logbook is present 3 The type plate and the supplier s label are legible 4 The housing adjusting knobs keys and display are undamaged 5 The power connection and power cord are undamaged 6 The output connectors are undamaged 7 The cables and connectors of the US head s are undamaged 8 The US head s do not display any cracks or other damage that can endanger the insulation 9 The automatic self test at switch on does not give an error message 10 The display does not show any defective points or lines 48 Phyaction U 8 3 2 Test 2 Ultrasound 6 7 The maximum power transfer takes place at the operating frequencies I Connect the treatment head and place it in an ultrasound measurement device Select an ultrasound therapy Select 1 MHz continuous duty cycle 10096 2 W cm The measured value is within 20 of the Ppk value in the channel window Select 1 MHz duty cycle 5096 3 W cm The measured value is within 20 of half the Ppk value in the channel window Select 3 MHz continuous duty cycle 10096 2 W cm The measured value is within 20 of th
10. Malfunctions Component Problem Solution Phyaction U Equipment cannot be See 86 7 7 switched on Equipment does not react See 86 7 3 commands or a fault report appears Foreign language on the Change the language See screen 84 8 2 6 1 1 Equipment cannot be switched on 1 Check if the mains voltage has failed 2 Check if the main switch is switched I 3 Check if the power cord and the fuses are in order If necessary replace the fuse See 86 7 2 4 Contact your dealer if the equipment still cannot be switched on 6 7 2 Replacing a fuse 1 Switch the main switch off O 2 Unplug the power cord from the equipment 3 Pull the fuse holder carefully out of the equipment If necessary use a screwdriver 4 Replace the fuse If necessary order new fuses from your dealer 5 Install the fuse holder and plug in the power cord 6 Switch the main switch on again 1 6 7 3 Equipment does not react to commands or a fault report appears The safety system of the equipment has ascertained a fault You cannot continue to work An instruction usually appears on the screen 1 Disconnect the connection to the patient 2 Switch the main switch off O 3 Wait 5 seconds and switch the main switch on again I 4 Contact your dealer if the error message reappears 33 A suniphy Phyaction U 6 2 Service the equipment or the accessories to perform repairs The equipme
11. least once a month During the check look for dents cracks and other damage that could allow liquids to ingress Check whether the insulation of the cable is still intact Check whether all pins are present and straight in the connectors Replace the US head if the head the cable or the connector is damaged See 85 7 Move the US head evenly over the skin during the treatment Phyaction U 1 3 Medical Devices Directive The device complies with the essential requirements of the Medical Device Directive of the European Committee 93 42 EEC as most recently changed 1 4 Liability The manufacturer cannot be held liable for injury to the therapist the patient or third parties or for damage to or by the equipment used if for example incorrect diagnosis is made the equipment or the accessories are used incorrectly the user instructions are wrongly interpreted or ignored the equipment is badly maintained maintenance or repairs are performed by people or organisations that are not authorised to do so GymnaUniphy Neither the manufacturer nor the local GymnaUniphy dealer can be held liable in any way whatsoever for the transfer of infections by accessories suniphy Phyaction U Phyaction U 2 INSTALLATION 2 1 Receipt 1 Check whether the equipment has been damaged during transport 2 Check whether the accessories are intact and complete See 7 5 and 7 6 Inform your supplier of any damage o
12. series devices are intended for use in the electromagnetic environment specified below The customer or the user of a Phyaction series device should assure that it is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Conducted RF IEC 61000 4 6 Radiated RF IEC 61000 4 3 Radiated RF ENV 50204 3 Vims AM 1 kHz 8096 150 kHz to 80 MHz 3 V m AM 1 kHz 8096 80 MHz to 2 5 GHz 3 V m CW 200 Hz d c 5096 895 MHz to 905 MHz 10 V 0 15 80 Mhz B1 EE 6 78 Mhz 13 56 Mhz 50 V 27 12 Mhz 45 V 40 68 Mhz 10 V m 0 08 1 0 Ghz 26 V m 1 4 2 0 Ghz 30 V m 433 92 Mhz 30 V m 915 Mhz 30 V m 895 905 Mhz Portable and mobile RF communications equipment should be used no closer to any part of a Phyaction series device including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 0 35vp d 0 07 vp d 0 06 vp d 0 07 d 0 08 vp d 0 35vp d 0 70vp d 0 12vp d 0 23vp d 0 23 vp 80 MHz to 800 MHz 800 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watts VV according to the transmitter manufacturer and d is the recommended separation distance in metres m Field strengths from fixed RF transmitters as determined by an electromagn
13. 2 4 SETTING CONTRAST LANGUAGE AND STAND BY TIME 11 2 5 USE IN COMBINATION WITH AN OTHER DEVICE 11 2 6 TRANSPORT AND STORAGE 12 2 7 RESELLING ne eee enean ass sr ann nan 12 3 DESCRIPTION OF THE EQUIPMENT 13 3 1 PHYACTION U AND STANDARD ACCESSORIES 13 3 2 COMPONENTS OF PHYACTION U 14 4 3 DISPLAY wsiisi bg TR Vil Wen ge Si 15 3 4 DISPLAY SYMBOLS 16 3 5 PARAMETER SYMBOLS 16 4 OPERATION icixexscecuc ra E a ce De Se EE On a a 17 4 1 THERAPY SELECTION nee ehe nnne nn 17 4 2 SELECTION BY THE THERAPY MENU ccesceecceeseeeeeeeaeeees 17 4 3 SELECTION BY THE GUIDE MENU cse nnn 18 4 4 PERFORMING THERAPY sssssese eene sense nsn nn 20 4 5 ULTRASOUND THERAPY hse asina nn 21 4 6 COMBINATION THERAPY ssessseseeen een esses sinn nn 24 4 7 MEMORY esee hme ashes aenea snae nane nn 26 4 8 SYSTEM SETTINGS NAR SG 28 5 INSPECTIONS AND MAINTENANCE 33 5 1 INSPECTIONS dows node acta eens 3 deae gis ds 33 5 2 MAINTENANCE 4 5 nier Ii un aa ga ar Fa
14. PR 11 for their internal function Therefore their RF emissions are very low and are not likely to cause any interference in nearby electronic equipment Class B The Phyaction series devices are suitable for use B in all establishments including domestic Harmonic ass establishments and those directly connected to the public low voltage power supply network that IEC 61000 3 3 supplies buildings used for domestic purposes Voltage Complies fluctuations flicker emissions IEC 61000 3 3 44 Phyaction U Guidance and manufacturer s declaration electromagnetic immunity The Phyaction series devices are intended for use in the electromagnetic environment specified below The customer or the user of a Phyaction series device should assure that it is used in such an environment Immunity IEC 60601 Compliance level Electromagnetic environment test test level guidance Electrostatic 6 contact 6 Floors should be wood concrete Discharge 8 kV air contact ceramic tile If floors are covered ESD 8 kV air with synthetic material the relative No loss o humidity must be at least 3096 EC 61000 4 2 performance Electrical fast x2 for power x2 kV power 1 kV Mains power quality should be that ransient burst supply lines of a typical commercial or hospital 1 kV for input loss o environment EC 61000 4 4 output l
15. TIONS AND MAINTENANCE 5 1 Inspections Component Check Frequency US head Dents cracks or other At least 1x per month damage Test US head See 85 7 7 With bad operation or at least 1x per year Cable of US head Damage At least 1x per month Pins in connector straight Equipment Technical safety At least 1x per year inspection See 85 7 2 5 1 1 US head test Test the US head if its conduction is bad This is the case when the indication bar for the Ppk value displays __ __ EM _ __ 1 Select an ultrasound therapy 2 Place the US head in a bowl with water 3 Rotate intensity knob to start the treatment 4 Check in the screen of the channel to see if the Ppk value is increasing 5 Contact your local GymnaUniphy dealer if the indication bar still displays wm _ __ 5 1 2 Technical safety inspection The Directive on Medical Devices from the European Commission 93 42 EEG requires that safe devices are used It is recommended to perform a yearly technical safety inspection If the legislation in your country or your insurer prescribes a shorter period you must adhere to this shorter period the equipment or the accessories The inspection may only be performed by a suitably qualified person In some countries this means that the person must be accredited Only technician authorised by GymnaUniphy N V may open 33 A suniphy Phyaction U Inspect
16. art the treatment The intensity now increases gradually to the set level and the treatment time continues again 4 4 4 Immediately stop treatment 1 Press All active treatments are stopped immediately Stop appears on the screen The parameter settings are retained 2 Setthe intensity of the channel again to continue the treatment 20 4 5 Phyaction U Ultrasound therapy 4 5 1 Performing ultrasound therapy N Move the US head evenly over the skin during the treatment R This prevents internal burns Connects the US head into one of the two connectors of the Phyaction U You can connect two US heads but only one US head can be in operation at one time The device detects which US head is connected to the connector Select the desired ultrasound therapy With Indication list treatments the parameter Head placement is available Set the parameter ERA to 1 or 4 cm The corresponding US head is selected the green indication led on the US head is on Apply contact gel to the skin to be treated and to the US head Place the head on the skin Rotate intensity knob to start the ultrasound therapy Move the US head evenly over the skin during the treatment This prevents internal burns Check the patient s reaction and the effect of the treatment Repeat this check regularly during the treatment The equipment stops the treatment and indicates that the treatment is completed 4 5 2
17. c pressure 200 hPa to 1060 hPa Transport classification Single pieces by post The transport and storage specifications apply to equipment in the original packaging 7 5 Standard accessories Quantity Description Art no 2i 1 US head 1 3 MHz ERA 4 incl 323 584 holder E 1 Contact gel 500 ml 114 827 1 Power cord 100 689 EN 322 835 NL 322 879 1 User manual Phyaction U FR 322 923 DE 322 967 1 This power cord has a CEE 7 7 type plug For countries with other outlets a different power cord with the appropriate plug is supplied i A suniphy Phyaction U 7 6 Optional accessories Quantity Description Art no Qs 1 MHz ERA 323 595 1 Contact gel can 5 100 019 lt 1 Pump for can 5 I 100 020 1 Combination therapy cord 112 823 Article numbers can change in the course of time Check the article numbers in the most recent catalogue or ask your dealer The drawings are merely indicative no rights can be derived from them 42 Phyaction U 8 APPENDICES 8 1 US head placements Select the therapy via indication list to get information about the placement See 84 3 2 8 7 7 Ultrasound therapy Select the US head placement parameter to show the optimal location for the placement of the US head You can select the numbers in the illustration with the blue keys for more information 1 Gives information on the precise anatomic location 2 Numbers with a black background gives specif
18. can select a therapy with different keys Therapy Menu Select a therapy method See 4 2 Guide Menu 4 Gives access to Objectives Select a therapy on the basis of an objective See 84 3 1 Indication list Select a therapy on the basis of a medical indication See 84 3 2 Program number Select a certain program number See 34 3 3 Diagnostic programs Perform a diagnosis See 84 3 4 Contra indications Display an overview with contra indications for the ultrasound therapy See 84 3 5 Memory Menu 7 Select a saved therapy See 84 7 Besides this you can change the system settings See 4 8 4 2 Selection by the Therapy menu Press gt The Ultrasound screen THERAPY rs Ultrasound therapy 1 Treatment time 7 38 2 ERA 4 8 cm F 3 US frequency 1 1 MHz 4 Duty cycle 100 On tine Period time 10 19 ne pk B E SC 5 Contact detection beep ON m A suniphy Phyaction U 4 3 Selection by the Guide menu 4 3 1 Therapy selection via objectives 1 Press to go to the Guide Objectives menu Ultrasound therapu 2 Select Objectives 1 Improve throphic condition 2 Increase extenzibilitu 3 Select Ultrasound therapy or 3 Inprove cell function Phonophoresis 4 Follow the on screen options to select the desired treatment 4 3 2 Therapy selection via indication list 1 Press 2 Select Indication list 3 Use 4 and gt to select th
19. create the difference User Manual Phyaction U 2004 GymnaUniphy N V All rights reserved Nothing from this publication may be copied stored in an automated data file or made public in any form or in any way be it electronically mechanically by photocopying recordings or in any other way without prior written permission from GymnaUniphy N V Phyaction U User Manual Phyaction U Device for ultrasound therapy Manufacturer GymnaUniphy N V Main office Pasweg 6A B 3740 BILZEN Telephone 32 0 89 510 510 Fax 32 0 89 510 511 E mail info gymna uniphy com Website www gymna uniphy com Version 1 1 February 2005 suniphy Phyaction U Abbreviations EMC Electromagnetic Compatibility ESD Electrostatic Discharge HAC Hospital Antiseptic Concentrate US Ultrasound Symbols on the equipment N Read the manual Symbols in the manual N Warning or important information Phyaction U TABLE OF CONTENTS 1 7 1 1 PURPOSE DR exo t Ra ejus iis 7 1 2 SAFETY INSTRUCTIONS ssssssssn nene annees nan 7 1 3 MEDICAL DEVICES DIRECTIVE sese 9 1 4 LIABILITY der 9 2 INSTALLATION nennen nnn nnn nennen nn 11 Zod RECEIPT Riiie aa EE OPERI UD iaa 11 2 2 PLACING AND CONNECTION e enne 11 2 3 PERFORMING THE FUNCTIONAL TEST esee 11
20. ding this current density can result With combination therapy a maximum current density of 2 0 o 5 cv D in skin irritation and burns The intensity depends on the surface area of the US head For US U92 9 cm the current setting may be a maximum of 18 MA ms for US U91 3 cm a maximum of 6 MArms Select an alternating current shape TENS or interferential on the Phyaction E or l Put the current shape in CV mode Select a Ultrasound therapy on the Phyaction U Connect the electrode and the US head See 4 6 2 Place the electrode on the patient See the User Manual of the Phyaction E or l Apply contact gel to the skin to be treated and to the US head Place the head on the skin Rotate intensity knob from the Phyaction U to start the ultrasound therapy Rotate intensity knob A or B from the Phyaction E or to start the electrotherapy Set the desired voltage Check the contact between the US head and the skin The following indications can indicate a bad contact on the Phyaction U The treatment stops The peak power of the ultrasound treatment goes to 0 0 Watt Check the patient s reaction and the effect of the treatment Repeat this check regularly during the treatment The equipment stops the treatment and indicates that the treatment is completed 24 Phyaction U 4 6 2 Connection for combination therapy 1 Connect the two ply electrode to the connector Ya or V B of the Phyact
21. e This depends on the local organisation of the waste processing 50 Phyaction U 9 REFERENCE 9 1 Function overview 9 1 1 Therapy menu Press s The numbers refer to the program numbers Ultrasound therapy Ultrasound therapy 31 9 7 2 System settings Press E Contrast Language Sound settings Stand by time Text start up screen First screen System information Error history Counter working hours Reset menu Stop time if bad US 9 7 3 Objectives Press and select Objectives The numbers refer to the program numbers Ultrasound therapy Improve trophic condition Tendinitis Stage or 4 subacute 63 Stage 1 or 2 chronic 62 Ligament lesions SUbaQute eite 64 CRONIC ceu tec rer t 144 Muscle lesions 64 CHON 144 Osteo chondral lesions 144 Neurogenic lesions 64 Increase extensibilty Superficial contractures 65 Partial joint contractures 145 Improve cell function Acute joint lesions 66 Acute muscular lesions 66 Acute neurogenic lesion 66 Fracture healing 67 Phonophoresis 66 A suniphy Phyaction U 9 7 4 Indication list Press and select Indication list US U
22. e Arthrosis US x x E Bechtereu US following indications See 59 1 4 Bursitis US Contractures US 4 Select the desired indication US Ultrasound therapy Epicondulitis US Frozen shoulder US 5 With selection via indication list Neuropathy US you can view the placement Select US head placement f necessary select the 4 B 11 14 21 26 location You get an advice to place the US head f available select a number for the precise anatomic location See 88 7 4 3 3 Program number selection 1 Press Program number 2 Select Program number 3 Select the desired program with T 7 30 V See 9 1 Program number 4 Select 1 1 to selected program Select nr with T4 keys Phyaction U 4 3 4 Diagnostic program selection With the diagnostic programs you can search for stress fractures 1 Press IBI Diagnostics 2 Select Diagnostic programs Diagnostic programs 3 Select Diag nosis stress 1 Diagnosis stress fracture fracture 4 3 5 Contra indication selection 1 Press 2 Select Contra indications Ultrasound therapy 3 Scroll through the text with 4 or GENERAL CONTRA INDICATIONS gt B Geuere cardidvasbulas problems Psychological problems Cancer with tumor metastasis Generalized tuberculosis SPECIFIC RELATIVE FOR CONTIHUOUS ULTRASOUND Infections Acute inflammations Thrombosis
23. e Ppk value in the channel window Select 3 MHz duty cycle 5096 3 W cm The measured value is 20 of half the Ppk value in the channel window Select 3 MHz duty cycle 5096 0 5 W cm With a dry treatment surface the Ppk value becomes O Select 1 MHz duty cycle 5096 0 5 W cm With a dry treatment surface the Ppk value becomes O Yes No f the equipment does not function at the correct frequency this results in a too low output power It is therefore not necessary to check the operating frequencies 6 3 3 Test 3 Electrical safety test VDE 0757 1 The resistance of the safety earth is less than 0 2 2 The housing leakage current is less than 1000 pA 3 The patient leakage current is less than 5000 pA Notes 49 Yes No A suniphy Phyaction U 8 4 Disposal Take account of the following environmental aspects when disposing of the equipment and the accessories basic device and the cables fall under small chemical waste electronic waste These components contain lead tin copper iron various other metals and various plastics etc Consult the applicable national regulations Gels contain only organic material and do not require any special processing Packaging materials and manuals can be recycled Deliver them to the appropriate collection points or include them with the normal household wast
24. e on the purchase invoice acts as proof This guarantee covers all material and production faults Consumables such as sponges adhesive electrodes and rubber electrodes do not fall under this guarantee period 36 Phyaction U This guarantee does not apply to the repair of defects that are caused incorrect use of the equipment an incorrect interpretation or not accurately following these user instructions e by carelessness or misuse as aconsequence of maintenance or repairs performed by people or organisations that are not authorised to do so by the manufacturer 6 4 Technical life time The expected life time of the equipment is 10 years calculated from the date of manufacture See the type plate for this information In so far as possible GymnaUniphy will supply service spare parts and accessories for a period of 10 years from the date of manufacture d A suniphy Phyaction U 38 Phyaction U 7 TECHNICAL INFORMATION 7 1 General Dimensions Phyaction U w x h x d 265 x 275 x 122 mm Weight Phyaction U 3 650 kg Weight including accessories 4 6 kg Mains voltage 100 240 VAC 50 60 Hz Maximum power in operation 85 VA Safety class Class earthed socket required Insulation Type BF floating patient circuit Fuses 2 x T2AL250 V 7 2 Ultrasound therapy 7 2 1 General Insulation classification Type BF Peak power 0 2 W cm duty cycle 100 0 3 W cm duty cycle 100 Accurac
25. ec The time that the accessories for electrotherapy or ultrasound therapy have been in use For this the output of the channel must have been higher than zero Reset menu Reset working hours Set the number of working hours of a plate electrode or an US head to zero Change therapy programs Change the settings from the programs in the Therapy menu See 84 8 5 Erase total memory Restores the standard settings of the standard programs and of the edited programs Stop time if bad US on off When there is a bad US contact the treatment time counter stops When the contact is restored the counting continues 4 6 3 Setting the sound 1 Press uu SYSTEM SETTINGS 2 Select Sound settings Sound settings 3 Change the desired sound 1 at end of treatment 2 at pressing of setting 3 Beep volume 4 US bad contact beep 4 8 4 parameters sound settings End of treatment On A sound signal will be heard at the end of the treatment Pressing a key On A sound signal will be heard every time a key is pressed Beep volume min 1 standard 5 max 10 The volume of the sound signals i A suniphy Phyaction U US bad contact On A sound signal will be heard if the US head does not make good contact with the skin 4 8 5 Change therapy programs Save new therapy program settings Change the program to your required settings 1 Use the Therapy menu to
26. etic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol Q NOTE1 At80 MHz and 800 MHz the higher frequency range applies 2 The 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 and 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 can be considered If the measured field strength in the location in which a Phyaction series device is used exceeds the applicable RF compliance level above the Phyaction series devices should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the Phyaction series device b Over the frequency range 150 kHz to 80 MHz field strengths must be less than 10 V m 46 Phyaction U Recommended separation distances between portable and mobile RF communications equipment and the Phyaction series device The Phyaction series device is intended for use in the electromagnetic environment in whic
27. h radiated RF disturbances are contolled The customer or the user of a Phyaction series device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Phyaction series devices as recommended below according to the maximum output power of the communications equipment Rated maximum Separation distance according to frequency of transmitter output power of m 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz d 0 35vp d 0 35vp d 0 70 0 01 0 04 0 04 0 07 0 1 0 11 0 11 0 22 1 0 35 0 35 0 70 10 1 11 1 11 2 21 100 3 50 3 50 7 00 For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres 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 NOTE1 At80 MHz and 800 MHz the higher frequency range applies NOTE2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people id A suniphy Phyaction U 8 3 Technical safety inspection Phyaction U with serial number is is not in good working order Inspection performed by Owner Location Name Name Date Initials
28. ic recommendations Relevant bone structures are shown for detailed information on the treated area The number of points below the US head gives an indication of the dimensions of the treated area The information in the illustration recommends a treatment technique This illustration shown an example of the dynamic technique If other areas are possible for the US head placement a black area is shown Select the corresponding number 2 for information on the screen If the area is on the rear a transparent area is shown A suniphy Phyaction U 8 2 EMC directive Use only US heads that are specified in this manual See 87 The use of other accessories can have a negative effect on the electromagnetic compatibility of the equipment If you use the Phyaction U in the vicinity of other equipment you must check that the Phyaction U 15 functioning normally The following paragraphs contain information about the EMC properties of the equipment 8 2 1 Guidance and declarations Guidance and manufacturer s declaration electromagnetic emissions The Phyaction series devices are intended for use in the electromagnetic environment specified below The customer or the user of a Phyaction series device should assure that it is used in such an environment Emission test Compliance Electromagnetic environment guidance RF emissions Group 1 The Phyaction series devices use RF energy only CIS
29. ines performance Surge 1 1 kV diff 2 kV Mains power quality should be that differential comm of a typical commercial or hospital EC 61000 4 5 mode No loss o environment 2 kV common performance mode Voltage dips lt 5 gt 95 Ur 100 0 5 Mains power quality should be that short dip in for period of a typical commercial or hospital interruptions 0 5 cycle No loss of environment If the user of a and voltage performance Phyaction series device requires variations on 40 Ur 60 Uz 6096 5 periods Continued operation during power power supply dip in Ux for No loss of mains interruptions it is input lines 5 cycles performance recommended that the Phyaction 70 Ux 30 Us 30 series device be powered from an IEC 61000 4 11 47 9 ae uninterruptible power supply or a dip in Uy for 25 periods battery 25 cycles No loss of lt 5 gt 9590 U1 10096 dip in for 5 seconds 5 sec Device resets to a safe state 60601 1 49 2 Power 3 A m ot applicable Power frequency magnetic fields frequency 50 60 Hz magnetic field IEC 61000 4 8 should be at levels characteristic of a typical location in a typical commercial or hospital environment NOTE is the a c mains voltage prior to application of the test level 45 suniphy Phyaction U Guidance and manufacturer s declaration electromagnetic immunity The Phyaction
30. ion E or l 2 Connect the electrode to the red plug of the two ply electrode cable 3 Connect the black plug of the two ply electrode cable via the 4 mm V V test connector on the combination therapy cord See 7 6 4 Connect the combination therapy cord to the combination plug connector of the Phyaction U 5 Connect the US head to a US connector of the Phyaction U 25 A suniphy Phyaction U 4 7 Memory You can save 50 of your own programs for later use programs 500 up to and including 549 You can modify these programs for much used settings for a certain patient 4 7 1 Saving a program 1 Select a therapy See 4 1 2 Change the settings for the patient See 84 4 Therapy 2 3MHzolo 28 3 Press 2 Recall bu list 4 Select Save 3 Recall by number 4 Erase bu list 5 Selecta free program number or 5 Erase by number overwrite an existing program number If desired scroll through the list with 4 or gt 6 Enter the name of the program Use the name or the number of Save at number 999 the patient for example Therapy 2 3MHz amp 16 36 T Select a character with A lae s V 1 Move cursor to the left e Select Move cursor to the 2 Move cursor to the right 3 Ready and save left right to change the cursor position 7 Select Ready and save Select character with t keys 4 7 2 Selecting a saved program Selecting a program by the list 1 Press 7 2
31. ion points The technical safety inspection contains the following tests 1 Test 1 General Visual inspection and check on the operating functions 2 Test 2 Ultrasound therapy 3 Test 3 Electrical safety inspection measurement of the earth leakage current and patient leakage current according to DIN VDE 0751 1 ed 2 0 Inspection result 1 A registration must be maintained of the technical safety inspections Use the inspection report in the appendix for this purpose See 8 3 2 Copy this appendix 3 Complete the copied appendix 4 Keep the inspection reports for at least 10 years The inspection is successful if all inspection items are passed Repair all faults on the equipment before the equipment is put back into operation By comparing the registered measurement values with previous measurements a possible slowly deteriorating deviation can be ascertained 5 2 Maintenance Component Check Frequency US head Cleaning See 85 2 1 After each use must be washed with pure water after the disinfection to prevent Accessories that come in contact with the body of the patient allergic reactions 5 2 1 Cleaning the US head 1 Clean the US head with a lightly moistened soft cloth 2 Disinfect the treatment surface with a cotton bud that is soaked in a 1096 HAC solution 3 Rinse the US head thoroughly with clean water 34 Phyaction U 6 MALFUNCTIONS SERVICE AND GUARANTEE 6 1
32. ltrasound therapy The numbers refer to the program numbers Arthrosis US 64 Chronic 144 Bechterew 5 62 Bursitis US 62 Contractures US 65 62 Decubitus 88 Dupuytren US 65 Epicondylitis US Subacute eee 63 Chronic 62 Fractures US 67 Frozen shoulder US 145 Myalgia US 144 Neuropathy US 66 9 7 5 Diagnostics Stress fracture search 112 9 7 6 Contra indication Ultrasound therapy General High fever Severe cardiovascular problems Psychological problems Cancer with tumor metastasis Generalised tuberculosis Posttraum diseases US Sprain US Acute Subacute Tendinitis US Subacute C IIEOTIIG sace iere tei remite Ulcus Cruris US Specific relative for continuous ultrasound Infections Acute inflammations Thrombosis thrombophlebitis Varices Increased risk to haemorrhage Pacemaker Epiphyseal disc children Decreased sensibility Menses Cement of endoprosthesis Diabetes mellitus 52 Phyaction U Specific relative for pulsing ultrasound Pacemaker Pregnancy 9 2 Literature A literature list can be sent on request Please contact GymnaUniphy 9
33. nt does not contain any components that may be replaced by the user f possible open the screen with the system settings before you contact the technical service department See 4 8 Only a technician authorised by GymnaUniphy N V may open Service and guarantee are provided by your local GymnaUniphy dealer The conditions of delivery of your local GymnaUniphy dealer apply If you have qualified technical personnel that are authorised by GymnaUniphy to perform repairs your dealer can provide diagrams spare parts lists calibration instructions spare parts and other information on request for a fee 6 3 Guarantee GymnaUniphy and the local GymnaUniphy dealer declares itself to be solely responsible for the correct operation when all repairs modifications extensions or adjustments are performed by authorised people the electrical installation of the relevant area meets the applicable legal regulations equipment is only used by suitably qualified people according to these user instructions the equipment is used for the purpose for which it is designed maintenance of the device is regularly performed in the way prescribed See 85 the technical life time of the equipment and the accessories is not exceeded legal regulations with regard to the use of the equipment have been observed The guarantee period for the equipment is 2 two years beginning on the date of purchase The dat
34. plate Ventilation opening Combination plug connector Phyaction U Ultrasound therapy 9 1 Treatment time Li 2 US head placement T p 3 ERR z 1 0 8 4 US frequency Fpk 1 1 S Duty cycle On time Period time w 0 _ 6 Contact detection beep 4 2 1 Selected channel 8 Screen for channel A here 2 Title of the screen ultrasound therapy See 4 5 3 3 Program number 9 Remaining treatment time 4 Ultrasound therapy 10 set 5 Type of US head 11 Ppk 6 Parameters of the selected 12 Contact of the US head channel 13 Numbers selection with the 7 Explanation or recommendation blue keys below display 13 A suniphy 3 4 gt 3 5 1 10 20 rL 30 TL 40 50 100 I set Ppk W cm Phyaction U Display symbols Ultrasound therapy Channel A Parameter symbols US duty cycle 10 US duty cycle 20 US duty cycle 30 US duty cycle 40 US duty cycle 50 US duty cycle 100 Set US intensity Peak US output power Unit of the set US intensity 0 00 1 10 ms 2 10 ms 3 10 ms 4 10 ms 5 10 ms 10 10 ms gt Treatment time Treatment completed US on period time 10 US on period time 20 US on period time 30 US on period time 4096 US on period time 5096 US on period time 10096 US head ERA 4 cm US head ERA 1 cm Phyaction U 4 OPERATION 4 1 Therapy selection You
35. r defects by no later than within 3 working days after receipt Report the damage by telephone fax e mail or letter Do not use the equipment if it is damaged or defective 2 2 Placing and connection 1 Place the equipment on a horizontal and stable base Keep the ventilation openings at the bottom and rear of the equipment free Do not place the equipment in the sun or above a heat source not use the equipment in a wet area 2 Check whether the mains voltage that is stated on the rear of the equipment corresponds with the voltage of your mains supply The equipment is suited for a nominal mains voltage from 100 V to 240 VAC 50 60 Hz 3 Connect the device to an outlet with protective earth terminal 2 3 Performing the functional test 1 Switch the equipment on with the switch at the rear of the equipment 2 When the equipment is switched on it automatically performs a test 2 4 Setting contrast language and stand by time Press 8 The System settings menu appears See 4 8 Select Contrast with the corresponding blue key 12 key in the row If necessary change the contrast with A and V Select Language with the corresponding blue key If necessary change the language with A and V Select Stand by time with the corresponding blue key If necessary change the stand by time with A and V Press to return to the Guide menu 2 5 Use in combination with an other device
36. the system settings during a therapy 4 8 1 Changing the system settings 1 Press Ej The System settings menu appears SYSTEM SETTINGS 2 Change the desired system 1 Contrast T 2 Language English setting 3 Sound settings 4 Stand bu time 5 Text for start up screen First screen GUIDE System information Error history 9 Counter working hours 18 Reset Menu 11 Stop time if bad US 4 8 2 Parameters Contrast 1 20 The contrast of the display Language The language selection select the language with which the read out must work Sound settings Sound settings See 4 8 3 Stand by time 5 10 15 20 minutes off If the device is not used during the stand by time the device goes to the stand by mode Press any key to reactive the device Text for start up screen The text that appears in the top of the start up screen after the equipment is switched on See 84 8 6 First screen guide menu therapy menu The first screen you see when activating the device System information System information of the equipment Always have this information available when you contact the technical service department 28 Phyaction U Error history The total number of error reports that the equipment has had and details about the last 10 error reports Always have this information available when you contact the technical service department Counter working hours hours minutes s
37. thrombophlebitis Varices A suniphy Phyaction U 4 4 Performing therapy 4 4 1 Set and start therapy 1 Press to go to the Guide Ultrasound therapu menu 2 Select the desired menu item until 9949 3 US frequency the treatment appears 4 Duty cuele Select the desired parameters 5 Contact detection beep You can only change the pre numbered parameters 4 Set the Treatment time as follows Select treatment time once to set the minutes select treatment time twice to set the seconds 5 Change the value of the parameter with A and V The setting range of the parameter is shown at the bottom of the screen You can change the parameter as long as the parameter has a black background 6 Rotate intensity knob to start the treatment and to set the desired intensity The set intensity is displayed in the screen 4 4 2 Opening the intensity screen 1 treatment See 84 4 1 2 Rotate intensity knob to start the treatment 3 Once the treatment is started 0 1 W cm press the therapy key to go to the intensity screen J0 4 Press toreturn to the setting Tset 18 Wien 8 68 mm mm mm mm menu Without clear pain awareness 4 4 3 Temporary interruption of treatment 1 Press Q during the treatment The treatment time is stopped Pause appears on the screen The parameter settings are retained 2 Press Q to rest
38. tion U is intended solely for medical applications You can use the Phyaction U for ultrasoundtherapy The device is suited for continuous use 1 2 Safety instructions 7 2 1 General Only qualified people who are trained the application of the therapies may use the appliance Only a technician authorised by GymnaUniphy N V may open the equipment or the accessories Follow the instructions and directions in these user instructions Place the equipment on a horizontal and stable base Keep the ventilation openings at the bottom and rear of the equipment free Do not place any objects on the equipment Do not place the equipment in the sun or above a heat source Do not use the equipment in a damp area Do not let any liquid flow into the equipment Do not disinfect or sterilise the equipment Clean the equipment with a dry or moistened cloth See 85 Only treat patients with electrical implants pacemaker after obtaining medical advice The Directive on Medical Devices from the European Commission 93 42 EEG requires that safe devices are used It is recommended to perform a yearly technical safety inspection See 55 1 2 For optimum treatment a patient investigation must first be performed On the basis of the findings of the investigation a treatment plan with objectives will be formulated Follow the treatment plan during the therapy This will limit possible risks related to the treatment to a minimum Alwa
39. y of intensity 1096 of maximum at set values above 1096 of this maximum Treatment time 0 30 min Deviation of time clock 0 596 Modulation frequency 100 Hz Modulation type CW rectangular on off Repetition period of pulses 10 ms 7 2 2 Modulation and pulse duration Modulation duty cycle 100 50 40 30 20 10 Pulse time oo 5 4 3 2 1 ms Ratio of Pim p 1 2 2 50 3 33 5 10 oe suniphy Phyaction U 7 2 3 US heads US head model U92 Acoustic operating 1 1 3 2 MHz frequency Output power 8 0 9 6 W Effective intensity of output 2 0 2 0 W cm voltage Effective Radiating Area 4 0 4 8 cm ERA Beam Non uniform Ratio 7 5 7 5 BNR Maximum intensity of beam 15 0 15 0 W cm Beam type Collimated Collimated US head model U91 Acoustic operating 1 1 3 2 MHz frequency Output power 1 2 2 0 W Effective intensity of output 2 0 20 W cm voltage Effective Radiating Area 0 6 1 0 cm ERA Beam Non uniform Ratio 5 0 5 0 BNR Maximum intensity of beam 10 0 10 0 W cm Beam type Divergent Collimated 7 3 Environmental conditions Temperature 10 C to 40 C Relative humidity 30 to 75 Atmospheric pressure 700 hPa to 1060 hPa 40 Phyaction U 7 4 Transport and storage Transport weight 5 5 kg Storage temperature 20 C to 60 C Relative humidity 10 to 100 including condensation Atmospheri
40. ys keep these user instructions with the equipment 1 A suniphy Phyaction U 7 2 2 Electrical safety applicable legal regulations Connect the equipment to an outlet with a protective earth terminal The outlet must meet the locally applicable requirements for medical areas Only use the equipment in an area with facilities that meet the 7 2 3 Prevention of explosion Do not use the equipment in an area where combustible gases or vapours are present Switch off the equipment when it is not used 7 2 4 Electro Magnetic Compatibility Electro Magnetic Compatibility EMC Follow the instructions for the installation of the equipment See 82 Do use mobile telephones or other radio shortwave or microwave equipment in the vicinity of the equipment This kind of equipment can cause disturbances Only use the accompanying accessories that are supplied by GymnaUniphy See 7 5 and 87 6 Other accessories can lead to an increased emission or a reduced immunity Mledical electrical equipment requires special precautions for 7 2 5 Ultrasound therapy This prevents internal burns The US treatment heads are exchangeable The device detects the characteristics and supplies the right power at the right frequency Handle the US heads carefully With rough handling the characteristics can change Test the US head if it falls on the ground or knocks against something See 85 7 7 Check US head at

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