OrthoPulse Ultra Operations Manual
Contents
1. Instruction in the operation and designated use of the device with practical exercises Mechanism of action and function of the device and the energies delivered by it All component settings Indications for use of the device Contraindications and side effects of the therapy waves Explanation of the warnings in all operating modes Instruction in how to perform the functional checks 9 Principles 19 320 02 0914 10 Principles Further training requirements vary from country to country It is the operator s responsibility to ensure that the training meets the requirements of all applicable local laws and regulations Further information about training in the operation of this system can be obtained from your CuraMedix representative However you can also contact the following address directly CuraMedix Telephone 401 333 6500 877 699 8399 Fax 401 633 6565 Email info curamedix com 40 Albion Road Suite 101 Lincoln RI 02865 10 Principles 19 320 02 0914 11 System Description 3 System Description 3 1 Control and functional elements The OrthoPulseTM Ultra is exclusively controlled using the operating and display elements on the handpiece 1 main switch 1 Fig 3 1 Front side of OrthoPulseTM Ultra 6 5 4 3 2 1 Fig 3 2 Rear side OrthoPulseTM Ultra 1 Handpiece connector D ACTOR 2 Handpiece connector V ACTOR 3 USB B 1 1 Device inter2. Setting treatment parameters 15 4 3 Start up 16 4 4 Functional checks 16 4 5 Standard settings 17 2 Table of Contents 19 320 02 0914 3 Table of Contents 4 6 Treatment 17 4 6 1 Setting parameters 18 4 6 2 Coupling the handpiece 18 4 6 3 Triggering pulses 19 4 6 4 Functions overview of the D ACTOR handpiece 19 5 Cleaning Maintenance Overhaul 20 5 1 Cleaning 20 5 1 1 Cleaning of the handpieces 20 5 1 2 Fuse replacement 20 5 2 Maintenance and safety checks 21 5 3 Disposal 22 5 4 Repair 22 5 5 Service life 22 6 Accessories 23 7 Technical 24 7 1 Technical 24 7 2 Type plate OrthoPulseTM Ultra 25 7 3 Conformity with directives 25 7 4 Conformity with standards 25 7 4 1 EMC guidelines and manufacturer s declaration 26 7 5 Symbols and labels 30 8 Warranty and Service 31 8 1 Warranty for the control device 31 8 2 Warranty for the handpiece 31 8 3 Service 31 3 Table of Contents Preface Warning notes in accordance with liability regulations DANGER refers to a situation of acute danger which if not avoided could lead to serious or fatal injury DANGER The source of the danger is stat
3. e g mobile phones can interfere with medical electrical equipment This device is subjected to special precautions regarding EMC and needs to be installed according the EMC guidelines in CHAPTER 7 4 1 EMC GUIDELINES AND MANUFACTURER S DECLARATION The use of accessories or cables that are not authorised by the manufacturer can result in increased interference emissions or reduced resistance to interference emissions by the device 6 General Safety Information 19 320 02 0914 7 General Safety Information The OrthoPulseTM Ultra is not allowed to be positioned immediately next to or jointly with other devices If the operation near or jointly with other devices is required the OrthoPulse according to technical specification TM Ultra must be tested in that particular environment to ensure operation The system must be connected to a surge supressor Set up and operation There are ventilation slits on the side of the device which must not be covered by other objects Check that the system is in perfect working order before each use Read about this in CHAPTER 4 4 FUNCTIONAL CHECKS Never cover the device when in use Make absolutely sure that no liquid can seep into the system housing or handpiece Storage and transport Incorrect storage and transport can result in damage to the device and device failure Make sure that no cables are crushed or sheared Disposal Comply with national disposal regulations
4. 02 0914 24 7 Technical 7 1 Technical OrthoPulseTM Ultra D ACTOR operating mode single pulse mode continuous pulse mode 1 21 Hz 1 5 bar in steps of 0 1 bar V ACTOR operating mode 31 Hz 2 4 bar Mains input voltage 100 240 VAC Mains frequency 50 60 Hz Mains fuse T4AL 250 VAC Power consumption max 200 VA Compressed air output 1 5 bar Ambient temperature during operation 10 40 C Ambient temperature during storage and transport 0 60 C frost free Ambient pressure during operation 800 1060 hPa Ambient pressure during storage and transport 500 1060 hPa Air humidity 5 95 non condensing Control device weight 10 5 kg Housing dimensions W x H x D 426 x 144 x 340 mm Class IIa device manual for your particular handpiece Equipment safety essential performance according to IEC 60601 1 3rd edition of 10 24 Technical Speci cations 19 320 02 0914 25 NOTE When the medical product is distributed to third parties the following must be observed The complete device documentation must be delivered together with the medical product The medical product may only be exported to a foreign country when the medical product and the corresponding indications are allowed there 7 2 Type plate OrthoPulseTM Ultra 7 3 Conformity with directives This medical product bears the CE mark in accordance with the Medical
5. HF disturbances are controlled The customer or the user of the OrthoPulseTM Ultra can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile HF communications equipment transmitters and the OrthoPulseTM Ultra as recommended below according to the maximum output power of the communications equipment Rated power of transmitter W Safety distance according to frequency of transmitter m 150 kHz to 80 MHz d 1 2 P 80 MHz to 800 MHz d 1 2 P 800 MHz to 2 5 GHz d 2 3 P 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended safety distance can be estimated using the equation applicable to the frequency of the transmitter where P is the rated power of the transmitter in watts W according to the transmitter manufacturer NOTE 1 An additional factor of 10 3 was used for calculating the recommended safety distance of transmitters in the frequency range from 80 MHz to 2 5 GHz in order to reduce the probability that a mobile portable communications device brought into the patient area might inadvertently lead to a malfunction NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption 29 Technical Speci cations 19 320 02 0914 31 7 5 Symbols and labels The following
6. distance Conducted RF IEC 61000 4 6 3 Vrms 150 kHz to 80 MHz 3 Vrms 150 kHz to 80 MHz d 1 2 P Radiated HF interference according to IEC 61000 4 3 3 V m 80 MHz to 2 5 GHz 3 V m 80 MHz to 2 5 GHz d 1 2 P for 80 MHz to 800 MHz d 2 3 P for 800 MHz to 2 5 GHz Where P is the rated power of the transmitter in watts W according to the transmitter manufacturer and d is the recommended safety distance in metres m on an on site inspection a should be less than the compliance level b Interference may occur in the vicinity of devices marked with the following symbol NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by a and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be the location in which the OrthoPulseTM Ultra is used exceeds the applicable HF compliance level above the OrthoPulseTM Ultra should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the OrthoPulseTM Ultra b 28 Technical Speci cations 19 320 02 0914 29 Recommended safety distances between portable and mobile HF communications equipment and the OrthoPulseTM Ultra The OrthoPulseTM Ultra is intended for use in an electromagnetic environment in which radiated
7. have assessed them Transmitters and overhaul kits are not covered by the handpiece s warranty 8 3 Service Should you have any further questions or require additional information please feel free to contact CuraMedix 31 Warranty and Service
8. pulse frequency 5 Hz 15 Hz Check that the triggered pulses are correctly counted on the treatment pulse counter 16 Operation 19 320 02 0914 17 Operation 4 5 Standard settings Before each treatment make sure that the pulse counter is set to zero NOTE Set the nominal value counter to the required value D ACTOR Start the D ACTOR treatment at a pressure of 2 bar and a frequency of 5 Hz V ACTOR 2 4 bar and a frequency of 31 Hz 4 6 Treatment CAUTION The transport bag is provided only to transport the device If the device is left in the transport bag during treatment the device beco mes hot due to lack of ventilation Burns and damages of the device are possible Take the device out of the transport bag during treatment Safety information Before using the device the user must make sure it is functioning safely and in proper condition Read CHAPTER 1 GENERAL SAFETY INFORMATION before beginning treatment CAUTION Handpiece not positioned correctly Impairment to health due to ineffective treatment position always corresponds to the treatment zone Make sure that the treatment is only administered by users who meet the conditions in CHAPTER 2 2 PRECONDITIONS FOR OPERATION CHAPTER 1 GENERAL SAFETY INFORMATION is not permitted 17 Operation 19 320 02 0914 18 Operation CAUTION Malfunction of the device or its components Various injuries are possible Im
9. when disposing of the OrthoPulseTM Ultra or individual components Comply with the relevant information in the operating manuals for the additional devices 7 General Safety Information 19 320 02 0914 8 Principles 2 Principles 2 1 Physical principles The OrthoPulseTM Ultra is a compressed air operated ballistic pulse generator The pulses in the OrthoPulseTM Ultra are generated with a precision ballistic mechanism in the handpiece A projectile is accelerated by compressed air The motion and weight of the projectile produce kinetic energy When the projectile impacts against an im movable surface the transmitter this kinetic energy is converted into sound energy This acoustic pulse is transmitted into the tissue to be treated either directly or via an acoustic impedance adapter with the help of a gel 2 1 1 Indications The OrthoPulseTM Ultra utilizes Extracorporeal Pulse Activation Technology EPAT to relieve minor muscle aches and pains trigger points tendon and or tendon insertion pain 2 1 2 Contraindications CAUTION No claims are made regarding the completeness or unlimited validity of this list of contraindications Treatment with the OrthoPulseTM Ultra is not permitted in the following cases Coagulation disorders haemophilia Use of anticoagulants especially Marcumar Thrombosis Tumour diseases carcinoma patients Pregnancy Epiphyseal f
10. 0 UT 30 drop in UT for 25 periods lt 5 UT gt 95 drop in UT for 5 s lt 5 UT gt 95 drop in UT for period 40 UT 60 drop in UT for 5 periods 70 UT 30 drop in UT for 25 periods lt 5 UT gt 95 drop in UT for 5 s Mains power quality should be that of a typical commercial or hospital environment If the user of the OrthoPulseTM Ultra requires continued operation during power mains interruptions it is recommended that the OrthoPulseTM Ultra be powered from an uninterruptible power supply or a battery Power frequency 50 60 Hz magnetic 3 A m 3 A m be those of a typical business or hospital environment NOTE UT is the mains alternating voltage prior to application of the test level 27 Technical Speci cations 19 320 02 0914 28 Guidelines and manufacturer s declaration Resistance to emitted electromagnetic interference The OrthoPulseTM Ultra model is intended for operation in the electromagnetic The customer or the user of the OrthoPulseTM Ultra should ensure that it is used in such an environment Immunity tests IEC 60601 test level Compliance level Electromagnetic environment guidelines Portable and mobile RF equipment should be used no closer to any part of the OrthoPulseTM Ultra including cables than the recommended safety distance calculated from the equation applicable to the frequency of the transmitter Recommended safety
11. Device Directive MDD 93 42 EEC 7 4 Conformity with standards This device complies with the applicable standards EN 60601 1 CAN CSA C22 2 No 601 1 UL Std No 60601 1 Acc to EN 60601 1 Type of protection against electric pulses Protection class 1 Application unit of type B 25 Technical Speci cations 19 320 02 0914 26 7 4 1 EMC guidelines and manufacturer s declaration Guidelines and manufacturer s declaration emitted electromagnetic interference The OrthoPulseTM Ultra The customer or the user of the OrthoPulseTM Ultra should ensure that it is used in such an environment Interference emission measurements Compliance Electromagnetic environment guidelines HF emissions acc to CISPR 11 Group 1 The OrthoPulseTM Ultra uses HF energy only for its internal functioning Therefore its HF emissions are very low and are not likely to cause any interference in nearby electronic equipment According to EN IEC 60601 2 36 1997 Section 36 this does not apply during the generation and release of the pressure pulse HF emissions acc to CISPR 11 Class B The OrthoPulseTM Ultra is suitable for use in all establishments including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Harmonic emissions according to IEC 61000 3 2 Class A r emissions according to IEC 61000 3 3 Compl
12. OPERATING MANUAL OrthoPulse TM Ultra 24861 0S Part No 23300 0100 OPERATIONS MANUAL Distributed by CuraMedix 40 Albion Road Suite 101 Lincoln RI 02865 401 333 6500 www curamedix com 19 320 02 0914 2 Table of Contents Table of Contents 1 General Safety Information 5 1 1 Instructions for safe use 5 1 1 1 Designated use and operational safety 5 1 1 2 Safety during treatment of the patient 6 1 2 Warning against damage to equipment and the device 6 2 Principles 8 2 1 Physical principles 8 2 1 1 Indications 8 2 1 2 Contraindications 8 2 1 3 Side effects 9 2 2 Preconditions for operation 9 2 2 1 Operating personnel 9 2 2 2 Training of the operator 9 3 System Description 11 3 1 Control and functional elements 11 3 2 Scope of supply 12 3 3 Unpacking 12 3 4 Installation Instructions 12 3 4 1 Mounting of the handpiece holder 12 3 4 2 Connecting the electrical power supply 13 3 4 3 Connecting handpiece 13 3 5 Compatibility 14 4 Operation 15 4 1 Switching on and off 15 4 2
13. ance with its designated use the user manual The device is only allowed to be used for the applications described in CHAPTER 2 1 1 INDICATIONS Only perform treatments approved by CuraMedix Furthermore the device is only allowed to be operated by trained personnel who comply with the PRECONDITIONS FOR OPERATION in CHAPTER 2 2 All status and error messages signaled during treatment must always be attended to without delay Checks and inspections prior to treatment Before using the device the user must make sure it is functioning safely and that it is in proper condition It is essential to perform the functional checks after switching on the OrthoPulseTM Ultra before starting treatment Read about this in CHAPTER 4 4 FUNCTIONAL CHECKS Have the maintenance procedures recommended by the manufacturer carried out by authorised personnel see also CHAPTER 5 2 MAINTENANCE AND SAFETY CHECKS Protection against electrical hazard Sources of voltage can give rise to currents as a result of body resistance which not only ow through the patient but can also impair or even endanger the physician and the nursing staff Devices which are not medical products in accordance with EN 60601 must be set up outside the vicinity of the patient Do not touch electrical connectors while you are touching the patient 5 General Safety Information 19 320 02 0914 6 General Safety Information Disconnect the OrthoPulseTM Ultra t
14. ded openings on the OrthoPulseTM Ultra There are openings for 4 handpiece holders 2 on the right side and 2 on the left side of the OrthoPulseTM Ultra 12 System Description 19 320 02 0914 13 System Description 3 4 2 Connecting the electrical power supply Connect the supplied mains cable to the mains connector on the rear side of the device 1 1 Mains connector Fig 3 4 Connecting the electrical power supply insert the mains cable into the socket ATTENTION When setting up the instrument make sure that the air outlets on the housing of the OrthoPulseTM Ultra are not blocked The instrument must only be connected to properly earthed andcorrectly installed shockproof sockets The device must be positioned in a way so that disconnection from the mains is easy to do 3 4 3 Connecting handpiece Insert the plug of the handpiece into the corresponding handpiece connector on the left rear side of the device 1 Handpiece connector D ACTOR 2 Handpiece connector V ACTOR 1 2 Fig 3 5 Handpiece connectors Make sure that the red dot on the socket is aligned with the red dot on the handpiece connector Place the handpiece into the handpiece holder NOTE Please also refer to the separate operating manual for your handpiece 13 System Description 19 320 02 0914 14 System Description 3 5 Compatibility The OrthoPulseTM Ultra is allowed to be operated with the following hand
15. ed here These are the possible consequences The instructions for avoiding the danger are given here WARNING refers to a situation of potential danger which if not avoided could lead to serious injury WARNING The source of the danger is stated here These are the possible consequences The instructions for avoiding the danger are given here CAUTION indicates that incorrect operation could lead to minor injuries CAUTION The source of the danger is stated here These are the possible consequences The instructions for avoiding the danger are given here ATTENTION indicates that incorrect operation could lead to damage to the device ATTENTION The source of the danger is stated here These are the possible consequences The instructions for avoiding the danger are given here Other instructions NOTE preceded by the term NOTE 4 Preface 1 General Safety Information 1 1 Instructions for safe use The following chapter contains all safety information that has to be followed when working with the OrthoPulseTM Ultra WARNING Incorrect handling of the device Possibility of injuries to the patient and the operating personnel Read this chapter carefully before you start using the OrthoPulseTM Ultra Read the separate operating manuals for all devices associated with the OrthoPulseTM Ultra 1 1 1 Designated use and operational safety In order for the user to use this device in accord
16. face 4 USB A 1 1 Host interface 5 Mains connector 6 Mains Fuse holder NOTE The USB connection Fig 3 2 3 is only used for service purposes The USB connection Fig 3 2 4 is only used for connecting a USB memory stick for software update which supports the USB V1 1 protocol or higher 11 System Description 19 320 02 0914 12 System Description 3 2 Scope of supply The standard scope of supply of the OrthoPulseTM Ultra includes the following items OrthoPulseTM Ultra control device Mains cable EU USA Gel bottle User manual operating manual system logbook and training records D ACTOR handpiece set Handpiece holder 3 3 Unpacking Carefully remove the instrument and accessories from the packaging container Check that all items are included in the packaging container and that they are not damaged Contact your supplier or the manufacturer immediately if any items are missing or damaged Retain the original packaging It may prove useful for any later equipment trans port 3 4 Installation Instructions 3 4 1 Mounting of the handpiece holder There are two different handpiece holder for the D ACTOR handpiece for the V ACTOR handpiece 1 1 Openings for insertion of the handpiece holder Fig 3 3 Mounting of the handpiece holder The mounting of the handpiece holder is equal for both models Push the holder into the provi
17. g 4 2 10 key combination For the total overview of the functions and the description of the handpiece please read the SEPERATE OPERATING MANUAL FOR YOUR HANDPIECE 4 3 Start up Set the energy of the pulses to an initial value of 2 bar The maximum pressure is limited to 5 0 bar The minimum pressure that can be set is 1 0 bar Activate the trigger button The D ACTOR handpiece can be operated in single pulse mode and in continuous pulse mode To work in D ACTOR single pulse mode select the symbol dash in the Frequency selection box and activate the trigger button To work in D ACTOR continuous pulse mode select a continuous pulse frequency in the range from 1 0 to 21 Hz in the Frequency selection box Activate the trigger button NOTE If the set nominal pulse value e g 400 pulses is reached during treatment the handpiece automatically stops releasing pulses Further treatment is possible As soon as a multiple of the set nominal value is reached e g 800 pulses 1 200 pulses etc the handpiece stops anew 4 4 Functional checks Perform the following functional checks after the system has been installed Check the device and the handpieces for any signs of damage Put the device into operation Set the energy level to 2 bar Reset the treatment pulse counter on the handpiece display Release individual pulses in single pulse mode Release pulses in continuous pulse mode
18. he OrthoPulseTM Ultra as waste electronic equipment 5 4 Repair Repair work on defective devices must only be carried out by personnel suitably authorised by CuraMedix Only original CuraMedix spare parts may be used for this purpose The personnel suitably authorised can be from CuraMedix or be representatives of CuraMedix agencies and dealers 5 5 Service life The average expected service life is approx 3 500 operating hours for the OrthoPulseTM Ultra For information about the service life of the other handpieces please refer to the separate operating manuals for the respective handpiece Exceeding the service life can be expected to result in a failure of the device and accessories This also applies to handpieces No warranty claims shall be accepted beyond the information given in CHAPTER 8 1 WARRANTY FOR THE CONTROL DEVICE of the OrthoPulseTM Ultra 22 Cleaning Maintenance Overhaul 19 320 02 0914 23 Accessories 6 Accessories Mains cable CEE 4 m long 13455 Mains cable CH 3 m long 13448 D ACTOR handpiece set 23213 0001 D ACTOR overhaul kit 17212 C15 transmitter 19222 F15 transmitter 21356 DI15 transmitter 21374 D20 S transmitter 21004 D20 T transmitter 21125 D35 S transmitter 21122 V ACTOR handpiece 19365 0001 V ACTOR ball V10 21348 Gel bottle 500 ml 18189 Transport bag 24926 OrthoPulseTM Ultra operating manual 24861 23 Accessories 19 320
19. he mains before starting any cleaning or maintenance work Disconnect the connected handpieces from the device before carrying out cleaning and maintenance work Do not reconnect them until they have been completely reassembled Protection against noise The noise level during administration of pulses is within the safe area Nevertheless we recommend wearing suitable ear protection during treatment in order to minimise exposure to noise 1 1 2 Safety during treatment of the patient General note Organs with gas inclusions in particular parts of the lung are NOT allowed to be exposed to pulses As it passes through tissue the pulse energy is slightly reduced this reduction is significantly weakened by bone structure Pulses can give rise to undesirable heart reactions The patient must be continuously observed during the treatment Only perform treatments approved by CuraMedix The user is responsible for correctly positioning the handpieces and correctly selecting the treatment zone No more than 6 000 pulses are allowed to be administered without interruption 1 2 Warning against damage to equipment and the device Any damage to the device resulting from incorrect operation is not covered by the manufacturer s warranty Electromagnetic compatibility This device complies with the requirements of the applicable standard on electromagnetic compatibility Nevertheless portable and mobile HF communications equipment
20. he trigger button on the handpiece Pressing the trigger button anew stops the pulse release 4 6 4 Functions overview of the handpiece D ACTOR For the total overview of the functions and the description of the handpiece please refer to the seperate OPERATING MANUAL HANDPIECE D ACTOR 19 Operation 5 Cleaning Maintenance Overhaul 5 1 Cleaning Regular cleaning of the system ensures perfect hygiene and operation of the OrthoPulseTM Ultra CAUTION Electrical hazard Disconnect the device and the accessories from the mains before starting any cleaning and overhauling work Overall external cleaning depends on the frequency of use and application of the device All parts which come into contact with the patient must be cleaned after each treatment Wipe down the device parts with a damp cloth For cleaning use a lukewarm dilute solution of non vegetable soapy water ATTENTION tubing Ventilation slits Keep the ventilation slits clear 5 1 1 Cleaning of the handpieces For information about cleaning and overhauling the handpieces refer to the corresponding chapters for the corresponding handpiece 5 1 2 Fuse replacement The mains fuse holder is located on the rear of the OrthoPulseTM Ultra Push the slide of the mains fuse holder down and release the holder from the housing 20 Cleaning Maintenance Overhaul 19 320 02 0914 21 Cleaning Maintenance Overhaul Fig 5 3 Main
21. ies 26 Technical Speci cations 19 320 02 0914 27 Guidelines and manufacturer s declaration Resistance to emitted electromagnetic interference The OrthoPulseTM Ultra model is intended for operation in the electromagnetic The customer or the user of the OrthoPulseTM Ultra should ensure that it is used in such an environment Immunity tests IEC 60601 test level Compliance level Electromagnetic environment guidelines Electrostatic discharge ESD acc to IEC 61000 4 2 6 kV contact discharge 8 kV air discharge 6 kV contact discharge 8 kV air discharge Floors should be wood concrete or ceramic material the relative humidity should be at least 30 Electrical fast transient disturbances bursts according to IEC 61000 4 4 2 kV for power supply lines 1 kV for input output lines 2 kV for power supply lines 1 kV for input output lines Mains power quality should be that of a typical commercial or hospital environment Surges according to IEC 61000 4 5 1 kV line s to line s 2 kV line s to earth 1 kV line s to line s 2 kV line s to earth Mains power quality should be that of a typical commercial or hospital environment Voltage drops short interruptions and voltage variations on power supply input lines according to IEC 61000 4 11 lt 5 UT gt 95 drop in UT for period 40 UT 60 drop in UT for 5 periods 7
22. mediately comply with all status and error messages which appear during the treatment see Operating Manual of the handpiece CAUTION Over extended periods the noise of the pulses can be perceived as unpleasant Offer ear protection to the patient Recommendation The user should also wear ear protection 4 6 1 Setting parameters Treatment should always start at a low energy level This also applies to resuming treatment after an interruption The pulse energy should be increased gradually during treatment The low levels are used less for therapy and more for familiarising the patient Select a low energy level and frequency see CHAPTER 4 2 SETTING TREATMENT PARAMETERS NOTE The selection of energy levels is based on the medical opinion of the doctor administering treatment The maximum energy level used during treatment must not cause the patient undue pain under any circumstances 4 6 2 Coupling the handpiece D ACTOR area and to the applicator transmitter Avoid excessive pressure of the applicator transmitter to the patient s skin Excessive pressure is not needed for the success of the treatment V ACTOR and to the V ACTOR II transmitter 18 Operation 19 320 02 0914 19 Operation 4 6 3 Triggering pulses Once all necessary preparations have been taken it is possible to start the treatment Make sure that the pulse counter is at zero and a low energy level has been set Press t
23. pieces handpiece D ACTOR part no 21700 xxxx handpiece D ACTOR part no 23213 xxxx 14 System Description 19 320 02 0914 15 Operation 4 Operation 4 1 Switching on and off Switch on the device using the main switch on the front side of the device 1 1 main switch with LED lightening during power on Fig 4 1 Main switch 4 2 Setting treatment parameters This device can be controlled directly using the handpiece Corresponding setting buttons can be used for selecting the treatment parameters The indicator window shows which setting has been selected 1 2 6 5 4 3 10 9 8 7 11 1 decrease energy 2 increase energy 3 decrease frequency 4 increase frequency 5 Trigger button 6 Display energy 7 Set nominal pulse 8 Pulse counter 9 Display frequency 10 key combination with double function 11 key combination with double function 10 and 11 see separate operating manual of the handpiece Fig 4 2 Display and setting buttons of the D ACTOR handpiece For operation of the handpiece using the embedded display read the separate OPERATING MANUAL OF THE D ACTOR HANDPIECE 15 Operation 19 320 02 0914 16 Operation Set the treatment parameters by pressing the and buttons on the hand spiece Each selected nominal value is shown on the display Reset the pulse counter by pressing simultaneously button 1 and 3 on the standard display see Fi
24. s fuse holder Pull the old fuses out of the mains fuse holder Replace the fuses T 4 AL 250 VAC Push the mains fuse holder back into the opening until it engages 5 2 Maintenance and safety checks Preventive maintenance is not necessarily required However regular maintenance may help to identify possible defects at an early stage and thus increase the safety and service life of the device Maintenance services can be ordered from our regional representatives in your area or directly from CuraMedix Independently of the national accident prevention regulations and test and inspection intervals prescribed for medical devices we recommend that functional checks see CHAPTER 4 4 FUNCTIONAL CHECKS and safety checks in accordance with MPBetreibV Germany MPBV Austria MepV Switzerland be performed at least once a year The following checks should be performed to ensure that the OrthoPulseTM Ultra operates safely 1 Earth leakage current test according to national regulations 2 Earth impedance test with mains cable incl applicator housing according to national regulations NOTE For further details on content and performance of the safety checks please contact your local dealer 21 Cleaning Maintenance Overhaul 19 320 02 0914 22 Cleaning Maintenance Overhaul 5 3 Disposal When disposing of this medical product no special measures have to be observed expiration of its service life dispose of t
25. symbols and labels are attached to the OrthoPulseTM Ultra 2 1 Label Name 1 Type plate 2 You must read the operating manual 3 WEEE symbol Tabelle 1 1 Labelling 30 Technical Speci cations 19 320 02 0914 32 Warranty and Service 8 Warranty and Service ATTENTION personnel will relieve the manufacturer of its liability and responsibility for safe system operation This will automatically void the warranty even before the end of the warranty period 8 1 Warranty for the control device During the two year warranty period from the date of delivery of the product to the end customer defects will be remedied at no charge to the customer upon the customer furnishing adequate proof that the defect is due to defects in material or workmanship The warranty does not extend to wear parts Transport costs and the risk of loss during the shipping of returned products shall be borne by the customer Please complete the attached warranty card and return it as soon as possible to the address below CuraMedix 40 Albion Rd Suite 101 Lincoln RI 02865 8 2 Warranty for the handpiece The warranty conditions for the handpiece can be found in the operating manual for the corresponding handpiece Warranty claims will only be accepted if the handpiece is returned in its complete and Missing components will be replaced subject to charge Accessories also sent will be checked and if necessary replaced after we
26. usion areas in children CAUTION tissue lungs nor to any regions near large nerves vessels the spi nal column or head apart from the face 8 Principles 19 320 02 0914 9 Principles 2 1 3 Side effects Treatment with the OrthoPulseTM Ultra may cause the following side effects Swelling reddening haematomas Petechiae Pain Skin lesions after previous cortisone therapy These side effects generally abate after 5 to 10 days 2 2 Preconditions for operation 2 2 1 Operating personnel The OrthoPulseTM Ultra is intended exclusively for use by medical specialists and may only Such a specialist is expected to have practical knowledge of medical procedures and applications as well as of the technology and should be experienced in treating the indications stated in CHAPTER 2 1 1 INDICATIONS Users must have basic physical and cognitive abilities such as vision hearing and literacy and have basic functional use of their upper extremities The device is designed for a demographic target group between 18 and 65 years 2 2 2 Training of the operator Operators of the OrthoPulseTM Ultra must have been adequately trained in using handbook An introduction to the principles of operation will be provided by your CuraMedix representative dealer with reference to this operating manual and will be documented in the system logbook The operator must be instructed in the following points
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