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Enraf Nonius ENDOMED 484, Инструкция по эксплуатации

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Page 2 of 56 

EN109-1498740-40 IFU 

 

Table of contents 

1

 

Introduction ...................................................................................................................................................... 3

 

2

 

Description-symbols used and device markings ............................................................................. 13

 

3

 

Device components .................................................................................................................................... 15

 

4

 

Package contents ......................................................................................................................................... 16

 

5

 

Installation ...................................................................................................................................................... 18

 

6

 

Intended use and intended user ............................................................................................................ 20

 

7

 

Indications ...................................................................................................................................................... 22

 

8

 

Contraindications ......................................................................................................................................... 24

 

9

 

Precautionary instructions ........................................................................................................................ 26

 

10

 

Operation ........................................................................................................................................................ 27

 

11

 

Application information............................................................................................................................. 42

 

12

 

Maintenance and troubleshooting ........................................................................................................ 48

 

13

 

Specifications ................................................................................................................................................. 52

 

14

 

Contact ............................................................................................................................................................. 55

 

15

 

Product liability ............................................................................................................................................. 55

 

 

 

Содержание ENDOMED 484

Страница 1: ...EN109 1498740 40 IFU ENDOMED 484 EN109 1498740 40 IFU August 20 2019 Instructions for use ...

Страница 2: ... 13 3 Device components 15 4 Package contents 16 5 Installation 18 6 Intended use and intended user 20 7 Indications 22 8 Contraindications 24 9 Precautionary instructions 26 10 Operation 27 11 Application information 42 12 Maintenance and troubleshooting 48 13 Specifications 52 14 Contact 55 15 Product liability 55 ...

Страница 3: ... screen in a PC ABS plastic housing The Endomed 484 is mains powered and can optionally be equipped with a battery for mains independent operation for use in an ambulatory setting e g home treatment It has a modified front panel for electrode connections 4 pairs of electrodes in total The Endomed 484 is equipped with a full color touch screen and a turning knob for easy operation of the device The...

Страница 4: ...s For convenience if one considers that there are two primary pain relief mechanisms which can be activated the Pain Gate Mechanism and the Endogenous Opioid System The variation in stimulation parameters is used to activate these two systems TENS as a treatment technique is non invasive and has few side effects when compared with drug therapy TENS is administered via carbon rubber electrodes or a...

Страница 5: ...mmetrical pulsed current waveform The interphase interval which is the elapsed time between two successive phases of a single biphasic pulse is an additional stimulation parameter that can be adjusted to influence the induced force of contraction and muscle fatigue TENS PENS In this section the main treatment variables will be outlined Output Intensity Amplitude The Endomed 484 can output a curren...

Страница 6: ...s is that the targets are the sensory nerves which tend to have relatively low thresholds i e they are quite easy to excite and that they will respond to a rapid change of electrical state There is generally no need to apply a prolonged pulse in order to force a sensory nerve to depolarise therefore stimulation for less than a millisecond is sufficient Modulation Modes The following stimulation pa...

Страница 7: ...ity will need to be relatively high though not as high as the brief intense TENS PENS more like the Lo TENS PENS It is proposed that the application of Burst mode TENS PENS can effectively stimulate both the Pain Gate and the Opioid mechanisms simultaneously 4 Modulated TENS PENS In modulation mode the device delivers a less regular pattern of TENS PENS stimulation in an attempt to reduce or minim...

Страница 8: ... electrical stimulation mode duration and frequency of treatment electrodes type size and electrode placement Current waveforms Biphasic current wave forms seem to be the most effective Some researchers have published evidence which supports the asymmetric over the symmetric waveform because the asymmetric current produced more force output However force of contraction is not only depending on the...

Страница 9: ...used tetanic muscle contraction because research has established that the mean fusion frequency for skeletal muscles is approximately 50 Hz or pps bups lnitially low frequencies 20 Hz and short contraction long relaxation times can be used to minimize muscle fatigue It is worth noting that the rate of muscle fatigue during NMES is greater than that seen during voluntary contraction The stimulation...

Страница 10: ...e to the combined ON and OFF times expressed as a percentage For example an ON OFF ratio of 10s 20s sets up a duty cycle of 33 which means that the muscle contraction occurs during 10 s which is 1 3 of the elapsed time 30s between two successive electrically evoked muscle contractions To recap an ON OFF ratio of 10s 20s means that the resting time between two successive evoked contractions is two ...

Страница 11: ...nel 2 e g D 0 sec channel 1 ON 5 sec OFF 15 sec channel 2 ON 5 sec OFF 15 sec Both channels are thus synchronously activated ON and deactivated OFF for the full duration of application This mode allows synchronous stimulation of two different muscle groups or two muscle parts within a muscle group 2 Alternating reciprocal The alternating mode is achieved by setting the delay time D equivalent to t...

Страница 12: ...us mode in which the surge program ends on all channels immediately The specified hold time is the hold time on channel 1 Duration and frequency of treatment The frequency of sessions and the number of contractions can also be increased over time and generally follow the same principles as used in voluntary exercise strengthening programmes that is 8 15 maximum contractions per session for three t...

Страница 13: ...s used to mean You must Type BF applied part complying with the specified requirements to provide a higher degree of protection against electric shock than that provided by type B applied parts Temperature Range Indicates acceptable temperature range Humidity Limits Indicates acceptable relative humidity Atmospheric Pressure Indicates the range of atmospheric pressure to which the medical device c...

Страница 14: ...FU CE Mark along with number indicates conformity with European Council of directive concerning Medical Devices and this device is under the direct supervision of the Notified Body On Off Switch USB connection Do not unplug the device ...

Страница 15: ...nel 4 Connection point for the patient cable 2 LCD Touch Screen User Interface that allows the operator to control the device and change parameters of treatment protocols 3 Power supply source indication LED Green Device connected to mains supply When a battery is present it is charged Orange Device operating from battery 4 On Off switch This button is used to turn the device On or Off 5 Battery c...

Страница 16: ... Trode Ø 3 2 cm 2 mm female packing of 10 sheets of 4 pcs 3444 135 EN Trode Ø 5 0 cm 2 mm female packing of 10 sheets of 4 pcs 3444 057 EN Trode 5x5 cm 2 mm female packing of 10 sheets of 4 pcs 3444 058 EN Trode 5x9 cm 2 mm female packing of 10 sheets of 4 pcs Point electrode 3444 180 Point Electrode 2 mm female connector in transparent case incl 10 silicone conductive caps 3444 181 Silicon conduc...

Страница 17: ...ale connector set of 2 Patient cable 3444 211 Patient cable black 2 core with 2mm male plugs colored clips Bag 3444 675 Carrier bag Battery 2501 016 Battery Pb 12 V 2 Ah spare part Ordering Information For the ordering data of the Endomed 484 standard accessories and optional accessories we refer to the website www enraf nonius com ...

Страница 18: ...s switch to On Power LED indicator is lit green indicating that the device is connected to the mains supply Turn on the device with On Off button The device will initialize and perform a self test This may take a while At the end of the self test the device enters the Home menu and is ready for use Placing the optional battery Do not interchange the black and red wires as this will damage your dev...

Страница 19: ...utton We recommend to use the apparatus from the powerline whenever possible This will increase the service life of the battery Disconnection of mains supply Systems without a battery When you have finished treatment turn the device off by setting the mains switch to Off The device is now disconnected from the mains supply Systems with a battery Turn off the device with On Off button Power indicat...

Страница 20: ...y Therefore this procedure should only be performed by medical professionalists that have a profound knowledge and experience in the field of Traditional Chniese Medicine and or Electro Acupuncture Enraf Nonius does not supply percutaneous electrodes such as disposable acupuncture needles and needle like electrode pads The user must ensure that sterile percutaneous electrodes for single use are be...

Страница 21: ... with chronic progressive diseases such as chronic obstructive pulmonary disease COPD and congestive heart failure NMES is also used for Incontinence stimulation of pelvic floor muscles increase abdominal strength in heathy individuals The electrical stimulation is applied to skeletal muscles with the objective to elicit contraction caused by the electrical depolarization of intramuscular nerve br...

Страница 22: ...euralgia Cancer pain including metastatic bone pain Complex Regional Pain Syndrome PENS Chronic pain due to trauma Other chronic pain Acute pain due to trauma Adjunctive treatment for post surgical acute pain Other acute pain Joint pain Myalgia and myositis unspecified Neuralgia neuritis and radiculitis unspecified Neuropathic pain Pain related to musculoskeletal conditions Pain associated with ac...

Страница 23: ...uction in spasticity Dropfoot gait re training Dysphagia swallowing disorders Children strengthening atrophied muscle in neurological conditions Stimulation to the trunk or upper and lower limb muscles in children with cerebral palsy Critical illnesses and advanced disease states Ventilated patients in ICUs Intensive Care Units Chronic Obstructive Pulmonary Disease COPD Congestive Heart Failure ...

Страница 24: ...nus Electrode placement through the chest i e anterior and posterior electrode positions Electrode placement over testes Electrode placement over active epiphyseal regions in children Electrode placement over damaged skin or open wounds Electrode placement over dermatological lesions e g dermatitis eczema or on frail skin Electrode position over areas where there is ischaemic tissue and or thrombo...

Страница 25: ...on therapy within the previous 6 months Recent surgery skin sutures bone fracture or osteoporosis avoid areas involved Electrode placement over dermatological lesions e g dermatitis eczema or on frail or damaged skin Electrode placement over specific body areas o Eyes o Anterior aspect of the neck or carotid sinus o Head o Chest heart intercostal muscles o Lower abdomen and internal organs o Repro...

Страница 26: ... amounts of dust moisture vibrations and mechanical shocks Before administering any treatment to a patient you should become acquainted with the operating procedures for each mode of treatment available as well as the indications contra indications warnings and precautions Consult other resources for additional information regarding the application of electrotherapy Know the limitations and hazard...

Страница 27: ... test the device enters the Home Menu and is ready for use Display Screen The display is organized as a spreadsheet of 4 sheets one for each channel The channels refer to the patient connector groups accessible at the front of the unit A sheet can be selected by touching its tab The tab shows important information such as the output amplitude and the remaining treatment time A Device name B Naviga...

Страница 28: ...ications two three or four channels can be linked Linked channels are indicated by a combined tab The tab halves show the output amplitude of each channel while the parameters on the remainder of the sheet apply to the linked channels Navigation Bar The following operation keys can appear in the navigation bar Home Return to Home screen Back Return to previous screen in Multi step Programming retu...

Страница 29: ... Home menu The Home menu gives access to all functions of the unit The Home menu provides a structured access to all therapies available within the unit with appropriate parameter defaults 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 j...

Страница 30: ... steps that are sequentially executed Each treatment step has its own current waveform parameter settings and treatment time Use the central controller to scroll through the list and select the clinical protocol by touching the button For therapy information touch the info button on the left side of the protocol and the therapy information will appear Select the desired therapy and touch the accep...

Страница 31: ...lected Example Modulated TENS Select TENS Manual Operation Modulated 3 modulation modes can be selected FM involves a rhythmic change of frequency PWM involves a rhythmic change of pulse duration Pulse Width AM involves a rhythmic change of amplitude After selecting the desired modulation mode the pattern setup screen will appear Example Modulated TENS FM Modulation Pattern Setup Select the desire...

Страница 32: ...ration 5 Channel Selection 6 Variable setting depending on selected therapy a Interphase interval b Frequency modulation FM c Pulse width modulation PWM d Amplitude modulation AM e HAN stimulation f Surge Program g Automated frequency modulation 1 Current Wave Form Depending on the selected stimulation mode the following current wave forms are available Asymmetrical Biphasic Pulsed Current Symmetr...

Страница 33: ...ted via quick start buttons Fine tuning of the selected frequency can be done by turning the central controller Select the accept button in the navigation bar to return to the parameter screen 4 Pulse Duration Touching the pulse duration button will bring up another screen Nine basic pulse durations can be selected via quick start buttons Fine tuning of the selected frequency can be done by turnin...

Страница 34: ...herapies after selecting Symmetrical Pulsed Current Select the button and adjust the interval time with the central controller Range 0 250 μs 6 b Frequency Modulation FM 2 modulation patterns can be selected gradual change of frequencies from low to high and vice versa alternating between low and high in a continuous rhythm 3 frequency modes can be selected from 2 to 100 Hz from 2 to 15 Hz from 15...

Страница 35: ...es from short duration pulses to long duration in 6 sec and back in 6 sec 6 d Amplitude Modulation AM 2 Amplitude Modulation AM patterns with fixed frequencies and pulse durations can be selected LF Low Frequency 2 Hz and 200 s HF High Frequency 100 Hz and 120 s 3 AM ranges can be selected 20 drop 20 less intensity than set intensity set intensity 100 50 drop 50 less than set intensity 80 drop 80 ...

Страница 36: ...omatic adjustment of pulse width increases the therapeutic effects and eliminates the uncomfortable feeling due to frequency changes The selected modulation will run in 6 different time periods 6 f Surge Program With NMES a surge program is available Surge programs allow you to program sequential increases and decreases in current amplitude The following parameters can be set 1 Ramp up time 2 Up t...

Страница 37: ...is based on 50Hz in relation to set frequency Auto mode is manually set and serves as an anti accommodation button to prevent adaptation Note When AUTO FM mode is enabled the Pulse Duration is automatically modulated too It combines increasing frequencies with decreasing pulse durations in a 3 sec period followed by a period of 3 sec with descending frequencies and increasing pulse durations ...

Страница 38: ...ler The therapy will start and the treatment timer will run down to 0 and stop automatically To pause the treatment touch the pause button in the navigation bar To continue the treatment touch the start button in the navigation bar To immediately stop the treatment touch the STOP button in the navigation bar Note With NMES muscle stimulation after setting the parameters for wave form treatment tim...

Страница 39: ... the Store button in the Navigation bar Storing your favorite After pressing the Store icon you can enter a name for your favorite Select the accept button in the navigation bar to save your favorite Once saved favorites can be retrieved from the TENS NMES PENS menus You can restart your favorite by going to the Favorite menu and pressing your preferred favorite To delete a favorite press the butt...

Страница 40: ... a treatment screen is completely set as required touch the next button to add a next step touch the back to go back one 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 and press the accept button in the navigation bar to save your Favorite Sequential protocols a...

Страница 41: ... End of Treatment sound Backup Favorites not accessible without USB Restore Favorites not accessible without USB When a USB stick is plugged into the USB port at the back if the unit the option to backup or restore favorites to USB becomes available System info displays SD card and software versions Maintenance menu for service technicians Shut Down the Device Turn off the device as described in D...

Страница 42: ...o an operating pulsed shortwave or microwave machine Do not use electrodes on open wounds Treatment Before treatment The skin of the area in question is cleaned removal of grease with soap or 70 alcohol Shaving hairy skin is recommended Test the sensitivity of the treatment area Position the electrodes and or sponges do not forget to moisten During treatment Intensity is set at the desired level T...

Страница 43: ...de leads from an electronic stimulator to connect to the inserted needles Because these moveable clips may pull out the inserted needles when attached one must make sure that the needles are first securely taped in place It is also wise to fasten the electrode wires to a secure anchor so that these wires will not drag on the needles and pull them out by accident Precautions It is vital that the el...

Страница 44: ...ges and tell them what to do should these changes occur Document treatment parameters electrode set up and patient positioning in enough detail that the treatment can be easily reproduced by yourself or another qualified clinician Use valid outcome measures and evaluate whether the change in the outcome measure between sessions exceeds the values established the minimum detectable change MDC or mi...

Страница 45: ...figuration Step 3 place the pen electrode somewhere over the targeted muscle area Slowly increase the intensity while manually scanning the skin surface with the pen electrode until a clear muscle contraction is visualized Stop scanning and begin to slowly decrease the intensity until the muscle contraction becomes barely visible Step 4 Mark this electrode position which corresponds to a motor poi...

Страница 46: ...nd patient discomfort can occur Self adhesive electrodes should never be shared between patients Self adhesive electrodes have higher series impedance than flexible rubber electrodes This can cause the stimulator to terminate treatment at higher current amplitudes When this occurs it is recommended to continue the treatment with flexible rubber electrodes combined with properly moistened sponge pa...

Страница 47: ...in irritations or etching can occur For all current waveforms the stimulator output current can never exceed 50 mA r m s This implies that with an electrode surface of 25 cm the current density can never exceed 2 mA r m s cm As a rule of thumb for smaller electrodes such as the 3 2 mm self adhesives the maximum current setting available on the stimulator for a given current waveform should proport...

Страница 48: ...se a soft and dry cotton 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 Electrodes sponges and accessories Between patient uses the rubber electrodes should be cleaned with lukewarm water To disinfect the electrodes or to remo...

Страница 49: ...shown when trying to use upgrade the Firmware of the device while operating on battery power Firmware upgrades are only allowed when operating on mains power Patient circuit interrupted There is insufficient or no output current available at the outputs Possible causes Poor electrical contact or broken patient cable Insufficiently moistened sponges If necessary use a saline solution to improve the...

Страница 50: ...is complete Detach the USB stick It is mandatory to have the Endomed 484 checked yearly by authorized personnel of Enraf Nonius or by its authorized distributor It is also recommended that a service history record is maintained In some countries this is even obligatory On request a service manual can be made available containing spare part list descriptions calibration instructions and other infor...

Страница 51: ...rt the update procedure During the update a progress bar will be shown When the update has been finished a message will be shown mentioning that the update has been completed To leave the update procedure select the home button Detach the USB stick when the update has been completed If an error occurs during the update operation i e No updates found this will be displayed in a pop up message Expec...

Страница 52: ...tor of 1 kΩ Intensity PENS 0 40 mA in steps of 0 1 mA with load resistor of 1 kΩ Max current output per pulse 10 45 μC Pulse duration 10 1000 μs for symmetrical biphasic and 5 450 μs for asymmetrical biphasic in steps of 5 μs Range of interphase interval 0 250 μs Frequency 0 5 200 Hz increment 0 5 Hz from 1 Hz upwards in steps of 1 Hz Active rest Yes fixed stimulation frequency of 8 Hz active duri...

Страница 53: ...therapy IEC 60601 1 2 Electromagnetic disturbances requirements and tests IEC 60601 2 10 Particular requirements for the basic safety and essential performance of nerve and muscle stimulators IEC 62304 Medical device software IEC 62366 Application of usability engineering to medical devices Essential Performance and Basic Safety The essential performance of the Endomed 484 is to apply electrothera...

Страница 54: ...ternal antennas should be used no closer than 30 cm to any part of the Endomed 484 including cables specified by the manufacturer Otherwise degradation of the performance of this equipment could result The Endomed 484 should only be operated with the original power cable specified in the list of contents delivered Operating the device with any other power cable can lead to increased emissions or r...

Страница 55: ... to use the product including without limitation damages for loss of goodwill work and productivity computer failure or malfunction or any and all other commercial damages or losses even if 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 entire liability under any provision of this ...

Страница 56: ...EN109 1498740 40 IFU Copyright Enraf Nonius B V Vareseweg 127 3047 AT Rotterdam The Netherlands Tel 31 0 10 20 30 600 info enraf nonius nl ...

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