Enraf Nonius Endomed 482 Operating Instructions Manual Download Page 1

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4-Series

Operating Instructions

Summary of Contents for Endomed 482

Page 1: ...4 Series Operating Instructions ...

Page 2: ...ght Enraf Nonius B V P O Box 12080 Vareseweg 127 3004 GB Rotterdam The Netherlands Tel 31 0 10 20 30 600 Fax 31 0 10 20 30 699 info enraf nonius nl www enraf nonius com Part number 1498751_41 October 31 2013 ...

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Page 4: ...ery 24 7 Application Information 25 7 1 Electrotherapy 25 7 1 1 Before treatment 25 7 1 2 Flexible rubber electrodes 25 7 1 3 Vacuum electrodes 26 7 1 4 Self adhesive electrodes 26 7 1 5 Electrolytic effects 26 7 1 6 Current density 26 7 1 7 Connection and disconnection reactions 26 7 2 Ultrasound 27 7 2 1 Contact Control 27 7 2 2 The contact medium 27 7 2 3 Before treatment 27 7 2 4 During treatm...

Page 5: ...User Maintenance 43 9 3 1 Optimize Contact Control Ultrasound Applicator 43 9 3 2 Back up and Restore Favorites 43 9 3 3 Firmware Update 44 9 4 Technical Maintenance 44 9 5 End of life 44 10 Specifications 45 10 1 Ultrasound parameters 45 10 2 Stimulator output parameters 46 10 3 Technical Data 49 10 4 Safety and Performance standards 50 10 5 EMC details 50 11 Ordering information 53 ...

Page 6: ...f advised of the possibility thereof and regardless of the legal or equitable theory contract tort or otherwise upon which the claim is based In any case Enraf Nonius s entire liability under any provision of this agreement shall not exceed in the aggregate the sum of the fees paid for this product and fees for support of the product received by Enraf Nonius under a separate support agreement if a...

Page 7: ...and local electrical codes Do not operate the unit in an environment of short wave or micro wave diathermy This 4 series is not suitable for use in the presence of flammable anesthetics mixture with air oxygen or nitrous oxide This device should be kept out of the reach of children CAUTION Read understand and practice the precautionary and operating instructions Know the limitations and hazards as...

Page 8: ... have not been established for pain of central origin This device is to be used as a symptomatic treatment for pain and has no curative value Patients should be cautioned and their activities regulated if pain that would otherwise serve as a protective mechanism is suppressed The long term effects of chronic electrical stimulation are unknown Safety has not been established for the use of therapeu...

Page 9: ...cle Stimulation Adequate precautions should be taken when treating individuals with suspected or diagnosed heart problems or epilepsy Caution should be used when there is a tendency to hemorrhage following acute trauma or fracture Caution should be used following recent surgical procedures when muscle contraction may disrupt the healing process Caution should be used over the menstruating uterus C...

Page 10: ...urrent amplitude of the stimulation depends on the direction of the currents and can vary from 0 to 100 100 modulation depth only occurs at the diagonals and hence at the intersection of the two currents This is of course a theoretical situation based on the assumption that the tissue is homogeneous In reality the tissue is heterogeneous so that the current balance between the two channels has to ...

Page 11: ...tor modes Frequency Modulation expressed in Hz defines a variable frequency range that is summed to the Beat frequency i e when the Beat frequency is set to 80 Hz and the Frequency modulation is set to 40 Hz the final frequency will vary from 80 120 Hz Frequency modulation is often used to prevent accommodation to stimulation or to improve patient tolerance Modulation Program defines the time and ...

Page 12: ...would be too painful Each burst lasts for 100ms and the burst rate can be adjusted separately With this milder TENS waveform it is easier to exceed the motorial threshold stimulus Parameters Phase Duration expressed in µs is the elapsed time from the beginning to the end of the initial pulse phase See fig 4 1 4 4 3 for details Pulse Frequency expressed in Hz or pps pulses per second defines the re...

Page 13: ...es that amplitude modulation occurs in the equipment allowing it to be applied with a single electrode pair The Premodulated alternating current is often used where the objective is to strengthen the muscle and change the distribution of muscle fibers twitch speed The Beat frequency is used to affect the muscle fiber distribution The optimum carrier frequency for this purpose varies between 2000 4...

Page 14: ...details 4 1 3 5 Micro Current Micro Current is a monophasic rectangular waveform with manually selectable or alternating polarity See fig 4 1 4 10 for a graphical representation Many therapists prefer Micro Current therapy because of the low current amplitudes used Alternating polarity can be used to average out the DC component thereby reducing the formation of electrolysis by products Parameters...

Page 15: ...Fixe rectified alternating current The frequency was directly derived from the mains supply resulting in sinusoidal pulses with a duration of 10ms This phase time of 10ms will mainly depolarize thick fibers Stimulation of thin fibers can only be obtained at higher current amplitudes 2 Bernard Pierre D La thérapie diadynamique Paris Editions Physio 1962 CAUTION Diadynamic currents are monophasic cu...

Page 16: ... increased patient comfort CAUTION The MF interrupted galvanic current is a monophasic current that produces electrolysis by products These by products can result in burns beneath the electrodes Always use properly moistened sponge electrode combinations to absorb these by products during treatment See paragraph 7 1 5 for details 4 1 3 9 Faradic Current 4 1 3 9 1 Faradic Rectangular or Triangular ...

Page 17: ...ffered no explanation for the choice of these parameters Nevertheless many specialists have adopted the therapy and it is still applied with success A remarkable effect is that patienst are free from pain which can appear from just the first treatment and which can last for several hours See fig 4 1 4 5 1 for a graphical representation 1 Träbert H Ultra Reizstrom ein neues therapeutisches Phänomen...

Page 18: ...ncy fb Beat frequency 4 1 4 2 Russian Stimulation fc Carrier frequency fB Burst frequency 4 1 4 3 Biphasic Pulsed Current TENS 4 1 4 4 4 1 4 4 1 Asymmetrical t Phase duration fp Pulse frequency 4 1 4 4 2 Asymmetrical Alternating t Phase duration fp Pulse frequency 4 1 4 4 3 Burst Asymmetrical fB Burst frequency ...

Page 19: ...rval fp Pulse frequency 4 1 4 4 6 Burst Symmetrical fB Burst frequency 4 1 4 5 Faradic Current 4 1 4 5 1 Träbert 2 5 Current tp Phase duration 2 ms ti Phase interval 5 ms 4 1 4 5 2 Rectangular Pulsed current tp Phase duration fp Pulse frequency 4 1 4 5 3 Triangular Pulsed Current tp Phase duration fp Pulse frequency ...

Page 20: ...terrupted f Carrier frequency 8 kHz fixed Duty cycle 90 fixed 4 1 4 8 Galvanic Continuous 4 1 4 9 High Voltage t Peak interval 64 µs fixed fp Pulse frequency 4 1 4 10 Micro Current f Frequency 4 1 4 11 Diadynamic Current 4 1 4 11 1 MF 4 1 4 11 2 DF ...

Page 21: ...19 4 1 4 11 3 LP 4 1 4 11 4 CP 4 1 4 11 5 CPid ...

Page 22: ...ulation 4 1 4 12 2 Modulation program 6 6 or 12 12 6 6 or 12 12 fp Pulse frequency fm Frequency modulation 4 1 4 12 3 Modulation program 1 30 1 30 fp Pulse frequency fm Frequency modulation 4 1 4 13 Surge program parameters tr Ramp up time th Hold time tf Ramp down time ti Interval time td Delay time ...

Page 23: ...of metal implants of any type Patients with sensory loss on the area to be treated The gonads or to the developing fetus The heart The brains The testicles The eyes Facial sinus as this exposes the eyes to the same hazards Ultrasound should not be used on unconscious patients 4 2 3 Precautions and Warnings Ultrasound Precaution should be taken when using therapeutic ultrasound on patients with hem...

Page 24: ...y can be toggled between W and W 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 4 3 Combination Therapy Combination therapy is the combined application of ultrasound and electrical stimulation With combination therapy the metal surface of the ultrasound applicator becomes the negative electrical ...

Page 25: ... 65 mm set of 4 for vacuum electrodes Ø 60 mm 2 x 3444507 Vacuum lead hose red 2 x 3444508 Vacuum lead hose black 6 Installation 6 1 Systems without a Vacotron Remove the 4 series device and any additional items ordered from the carton and inspect for damage that may have occurred during shipment Place the device on a desk or EN Car Ensure that there is sufficient air flow below the device do not ...

Page 26: ...e power line connector 1 Place the 4 Series device upside down and on a soft surface Remove the two screws from the battery cover using the supplied screwdriver Slide and lift the battery cover Align the battery on the bottom of the main unit with the polarity of battery terminals in the correct position The polarity is marked at the bottom of the battery compartment Locate the black wire and atta...

Page 27: ... Prior to initial use thoroughly rinse the sponge pads in warm tap water to remove the impregnating agent Before application saturate the sponge pads with tap water In areas with soft tap water use a saline solution instead This will improve electrical conduction The supplied sponge pads have three layers With AC currents apply one sponge layer between the skin and the electrode for minimum resist...

Page 28: ...nt 7 1 6 Current density In the particular standard for Electrical Nerve and Muscle Stimulators IEC 60601 2 10 it is recommended not to exceed a current density of 2 mA r m s cm otherwise skin irritations or burns can occur For current types that contain a DC component we recommend not to exceed a current density of 0 2 mA cm To find the maximum recommended current amplitude in mA for the Interfer...

Page 29: ...rising on the ultrasound applicator and the body 7 2 3 Before treatment Check the patient for contra indications See section 4 2 2 for details Test the warmth sensibility of the treatment area To optimize ultrasound transmission clean the skin of the treatment area with soap or a 70 alcohol solution Strong hair growth has to be shaved 7 2 4 During treatment The ultrasound applicator has to be move...

Page 30: ...g sticker Provides information on the apparatus such as type and serial number as well as connection data such as mains voltage and maximum current consumption 3 Remote Control connection This connection has two functions 1 Attachment of optional remote control unit Used to remotely adjust the output current on the electrotherapy channels or to stop the treatment on all channels 2 Attachment of a ...

Page 31: ... Ultrasound applicator B CAUTION Connection of accessories other than the ones specified by the manufacturer can adversely affect the safety of the patient and correct functioning of the equipment and is therefore not permitted For combined applications only use Enraf Nonius type BF equipment The very low leakage current of this type of equipment ensures absolute safe therapy The ultrasound applic...

Page 32: ...s for several functions See paragraph 8 2 5 1 for details e Screen header Shows the name of the screen such as Manual Operation or a the name of the selected Clinical Protocol f Parameters are indicated with icons When a parameter is selected its name appears here g Screen body Shows the parameters of a selected channel or when no channels are selected the menu buttons h Channel tab Used to select...

Page 33: ...Just select a menu item by touching the button to navigate to the next screen You can navigate 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 8 2 3 Navigation 8 2 3 1 Electrotherapy Home The Home menu gives access to all functions of the unit Select the desired function or the...

Page 34: ...e for another therapy When Channel 1 2 is selected both channels have the same parameters Only the intensity can be set differently Parameter screen therapy screen In this screen the user can adjust the intensity or change the parameter by touching the button and changing the value with the central controller If there is a vacuum unit available the user can set the vacuum settings direct from the ...

Page 35: ...elections are groups and in the next screen another list appears from which the current wave can be selected Channel Selection Here you can select the channels for electrotherapy When channel 1 is selected channel 2 is still available for another therapy When Channel 1 2 is selected both channels have the same parameters Only the intensity can be set differently Parameter screen Adjust the paramet...

Page 36: ... in the navigation bar 8 2 3 2 Ultrasound Therapy The Home menu gives access to all functions of the unit Select in the Home menu ultrasound therapy by touching the button Ultrasound Therapy The next screen appears Ultrasound Therapy Clinical Protocols The Ultrasound Therapy menu gives access to functions Clinical Protocols Favorites Manual Operation Select Clinical Protocols by touching the butto...

Page 37: ...e accept button in the navigation bar The parameter screen appears The count down starts when the contact control is de activated Parameters can always be changed before or during the treatment 8 2 3 3 Combination Therapy This therapy combines ultrasound and electrotherapy The Home menu gives access to all functions of the unit Select in the Home menu combination therapy by touching the button Com...

Page 38: ...tton The next screen appears Select in this menu the current waveform by touching the button Adjust the current parameters and treatment time Touch the parameter button and adjust with the central controller 7 Select the ultrasound button to adjust the ultrasound parameters Touch the electrotherapy button to return to the previous screen ...

Page 39: ... the pressure using the central controller 7 The vacuum cups are automatically selected when the pump starts to run Continuous Pulsed mode Touch the button and select the desired massage rhythm using the central controller 7 You can choose between Continuous Pulsed mode 1 s and Pulsed mode 2 s 8 2 3 5 Storing Favorites When a treatment screen is completely set as required its settings can be store...

Page 40: ...xecuted in a sequence until the end of the protocol is reached Select Programming in the electrotherapy menu When a treatment screen is completely set as required touch the next button to add a next step Continue with the remaining treatment steps until you have reached the end of your protocol Touch the Store button in the navigation bar Enter the name of your sequential protocol as described in ...

Page 41: ...owing buttons can appear in the navigation bar d Button Meaning Back return to previous screen Home return to Home screen Page number number of pages in multi page menu screens or treatment step number number of treatment steps in sequential protocols Store therapy settings or a programmed sequential protocol in a favorite Delete Favorite Pause treatment The output current decreases to 0 and the t...

Page 42: ... is advised to use the CV mode with dynamic electrode applications In CV mode the output current depends on the electrical contact with the patient and can therefore vary You can change the CC CV setting in the parameter menu 8 2 5 5 Current polarity When DC currents are used the red connection is the positive connection and the black one the negative connection Manually changing the polarity duri...

Page 43: ...ton cloth or micro fiber tissue to clean the panel To remove fingerprints or grease use a non abrasive glass cleaning agent Apply a small amount of the cleaning agent to a soft cotton cloth and then carefully clean the panel CAUTION Do not spray the cleaning agent directly on the glass panel Do not use cleaning agents that contain strong alkalis lye acid detergents with fluoride or detergents with...

Page 44: ...N to 5 CHINOSOL to 1 CHLORAMIN solution ELMOCID Gamma to 2 MEFAROL to 1 MERCKOJOD to 1 MERFEN PERHYDROL PERODIN SAGROTAN to 2 ZEPHIROL to 5 9 2 Warning Messages Error Messages and Troubleshooting 9 2 1 Error code When the apparatus is turned on it will first execute a self test When an error is detected both during the self test and during normal operation a pop up screen will appear on the displa...

Page 45: ... 1 Optimize Contact Control Ultrasound Applicator When you experience difficulties with the contact control function of the ultrasound applicator you can try to resolve the problem as follows Ensure that the surface of the ultrasound applicator is clean and dry Place the ultrasound applicator in the holder Go to System Settings Maintenance and select Optimize Applicator A or B Touch the OK button ...

Page 46: ...e necessary to have this connection checked annually To ensure continued compliance with the 21 CFR 1050 10 standard this unit should be adjusted and safety tested once each year Procedures laid down in the service manual should be followed This may be carried out by your supplier or by another agency authorized by the manufacturer It is also recommended that a service history record is maintained...

Page 47: ... 3 1ms 20 48Hz 50 10 4ms 2 16Hz 10 6 3ms 10 48Hz 80 16 7ms 1 25 16Hz 20 12 5ms 5 48Hz 100 20 8ms 1 16Hz 33 20 6ms 3 100Hz 5 0 5ms 20 16Hz 50 31 3ms 2 100Hz 10 1ms 10 16Hz 80 50ms 1 25 100Hz 20 2ms 5 16Hz 100 62 5ms 1 100Hz 33 3 3ms 3 33 48Hz 5 1ms 20 100Hz 50 5ms 2 48Hz 10 2 1ms 10 100Hz 80 8ms 1 25 48Hz 20 4 2ms 5 100Hz 100 10ms 1 48Hz 33 6 9ms 3 33 continuous mode Generator Peak output Amplitude...

Page 48: ... energy with a decreasing Amplitude at increasing distance from the applicator surface This field distribution applies to the radiation emitted into the equivalent of an infinite medium of distilled degassed water at 30 ºC and with line voltage variations in the range of 10 of the rated value The ultrasonic beam is characterized by the Effective Radiation Area ERA and the Beam Non uniformity Ratio...

Page 49: ...3 3 5 4 5 6 7 8 9 10 kHz Beat Frequency AMF 0 200 Hz in steps of 1 Hz Amplitude 0 100 mA Rotation time 1 10 s in steps of 1 s Dipole Vector Manual Carrier Frequency 2 2 5 3 3 5 4 5 6 7 8 9 10 kHz Beat Frequency AMF 0 200 Hz in steps of 1 Hz Frequency Modulation spectrum 0 180 Hz in steps of 1 Hz Modulation Program 1 1 6 6 12 12 1 30 1 30 s Amplitude 0 100 mA Resolution vector 2 25 per step 160 ste...

Page 50: ...s Amplitude 0 100 mA High Voltage Twin Pulse Frequency 1 200 Hz in steps of 1 Hz Frequency Modulation spectrum 0 180 Hz in steps of 1 Hz sum of Pulse frequency and Frequency Modulation can not exceed 200 Hz Modulation Program 1 1 6 6 12 12 1 30 1 30 s Surge Program Yes Polarity Positive or Negative Amplitude 0 500 Volt in steps of 1V High Voltage Alternating Twin Pulse Frequency 1 200 Hz in steps ...

Page 51: ...plitude 0 80 mA Träbert 2 5 Rectangular Pulsed Current Phase duration 2 ms Interval 5 ms Polarity Positive or Negative Amplitude 0 80 mA 10 3 Technical Data Mains voltage 100 240 V 10 Mains frequency 50 60 Hz Main unit Dimensions stand alone 24 x 32 x 12 cm w x d x h Dimensions on inclination foot 24 x 30 5 x 18 2 cm w x d x h Dimensions on Vacotron 24 x 30 5 x 21 6 cm w x d x h Weight 2 Kg Weight...

Page 52: ... communication systems e g mobile phones may interfere with medical electrical 4 series The 4 series should only be operated with the original mains cable specified in the list of contents delivered Operating the device with any other mains cable can lead to increased emissions or reduced interference immunity of the device Guidelines and manufacturer s declaration electromagnetic interference The...

Page 53: ...V for power supply lines not applicable Mains power quality should be that of a typical commercial or hospital environment Surge IEC 6100 4 5 1 kV differential mode 2 kV common mode 1 kV differential mode 2 kV common mode Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4...

Page 54: ... the recommended separation distance in meters m According to an investigation in situa the field strength of stationary radio transmitters should be less than the compliance level at all frequencies Interference may occur in the vicinity of 4 series devices which is marked with the following symbol NOTE 1 At 80 MHz and 800 MHz the higher frequency range is applicable NOTE 2 These guidelines may n...

Page 55: ... applicable in all cases Electromagnetic propagation is affected by absorption and reflection from structures objects and people 11 Ordering information Model numbers 1498901 Sonopuls 490 with large ultrasound applicator 1498902 Sonopuls 490 with small ultrasound applicator 1498903 Sonopuls 490 with large and small ultrasound applicator 1498911 Sonopuls 492 with large ultrasound applicator 1498912...

Page 56: ...x 3444503 Vacuum electrodes Ø 60 mm set of 2 pcs 3444505 Sponges Ø 65 mm set of 4 for vacuum electrodes Ø 60 mm 2 x 3444507 Vacuum lead hose red 2 x 3444508 Vacuum lead hose black Optional accessories Ultrasound contact gel 3442929 Contact gel bottle 250 ml box of 12 3442930 Contact gel bottle 850 ml box of 12 3442931 Contact gel canister of 5 l 3442932 Dispenser set for 5 l canister electrodes an...

Page 57: ...atient cable 2 core 2 mm male plug black with coloured clips Bag 3444675 Carrierbag 4 series Battery 2501016 Battery 12 0V 1 8AH Vacuum accessories Vacotron 460 3444509 Vacuum electrodes Ø 30 mm set of 2 3444503 Vacuum electrodes Ø 60 mm set of 2 3444504 Vacuum electrodes Ø 90 mm set of 2 3444516 Sponges Ø 30 mm set of 4 for vacuum electrodes Ø 30 mm 3444505 Sponges Ø 65 mm set of 4 for vacuum ele...

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