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EN109-1634750-40 IFU

Endomed 182

EN109-1634750-40 IFU
September 21, 2020

Instructions for use

Содержание Endomed 182

Страница 1: ...Page 1 of 52 EN109 1634750 40 IFU Endomed 182 EN109 1634750 40 IFU September 21 2020 Instructions for use ...

Страница 2: ...ents 9 4 Package contents 13 5 Installation 15 6 Intended use and intended user 16 7 Indications 17 8 Contra indications 18 9 Precautionary instructions 20 10 Operation 23 11 Application information 37 12 Maintenance and troubleshooting 44 13 Specifications 48 14 Contact 51 15 Product liability 51 ...

Страница 3: ...uch screen The graphic user interface allows for maximum operator comfort Three versions of the Endomed 182 are available Endomed 182 versions Name Endomed 182 Type 1 Endomed 182 Type 2 Endomed 182 Type 3 Article number 1634903 1634901 1634902 Article number base unit 1634910 1634900 1634900 Current Wave Forms Direct current TENS continuous biphasic pulsed current conventional TENS mode trains of ...

Страница 4: ...essories mains and connecting cables handpiece applicator return electrode footswitch optional and product documentation Consumables such as disposable acupuncture needles are not delivered with the product Enraf Nonius B V does not supply percutaneous electrodes or disposable acupuncture needles The Endomed 182 Type 2 and 3 include 16 preset clinical protocols for TENS and Interferential currents...

Страница 5: ...ion The pain reducing effect generally does not appear for some twenty to thirty minutes unlike the effect of Conventional TENS which usually occurs fairly rapidly However the effect lasts for considerably longer than that of Conventional TENS after stimulation has ended The pain reducing effect of Burst TENS is due to the release of endorphins at both spinal and supraspinal level If Conventional ...

Страница 6: ...be used to compensate for differences in sensation occurring under the electrodes In the four pole method the modulation depth is only 100 at the diagonals The four pole method with Isoplanar vector With the Isoplanar vector the total area between the 4 electrodes is optimal stimulated The electrode positioning can be done simple and quick The modulation depth is 100 everywhere Isoplanar Interfere...

Страница 7: ...plied 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 can be safely exposed Waste electri...

Страница 8: ...able electrotherapy Connections vacuum cables electrotherapy ON power OFF power 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 ...

Страница 9: ...Page 9 of 52 EN109 1634750 40 IFU 3 Device components Endomed 182 Type 1 Endomed 182 Type 2 7 8 1 9 1 2 1 3 1 1 4 1 6 1 5 1 10 11 ...

Страница 10: ...Page 10 of 52 EN109 1634750 40 IFU Endomed 182 Type 3 12 13 16 15 14 17 18 19 21 20 ...

Страница 11: ...e Endomed 182 11 Connection 2 Current Module Connection channel 2 for patient cable for adhesive or rubber electrodes on Current Module Endomed 182 12 Vacuum electrode holder Holder for vacuum electrodes 13 Vacuum Module Vacuum Module integrated with Endomed 182 with connections for adhesive or rubber electrodes and vacuum electrodes 14 Vacuum Module electrode cables Vacuum Module electrode cables...

Страница 12: ...his connection is used for connecting the water reservoir No vacuum can be created unless the water reservoir is connected The water reservoir ensures that any excess water from the sponges is collected and cannot be blown out through the pump The reservoir should be emptied daily Please refer to the section on Maintenance ...

Страница 13: ... cm 2 mm female set of 2 1460266 Moist pads for rubber electrodes 6x8 cm set of 4 3444211 2x Patient cable 2 core 2 mm male plugs black with color clips Additional standard accessories Endomed 182 Type 3 3444503 2x Vacuum electrodes Ø 60 mm set of 2 3444505 Sponges Ø 65 mm set of 4 for vacuum electrodes Ø 60 mm 3444507 2x Vacuum lead hose red 3444508 2x Vacuum lead hose black Optional accessories ...

Страница 14: ...dapter plug 2 mm female 4 mm male red Patient cables 3444211 Patient cable 2 core 2 mm male plug black with colored clips Additional optional accessories Endomed 182 Type 3 Vacuum electrodes 3444503 Vacuum electrodes Ø 60 mm set of 2 3444504 Vacuum electrodes Ø 90 mm set of 2 3444509 Vacuum electrodes Ø 30 mm set of 2 Sponges 3444505 Sponges Ø 65 mm set of 4 for vacuum electrodes Ø 60 mm 3444506 S...

Страница 15: ...oving the contents of the pack Device setup Endomed 182 Type 2 Connect the cable from the Current Module 9 to Connector B 8 Endomed 182 Type 3 Connect the cable from the Current Module 9 to Connector B 8 Connect the cable from the Vacuum Module 13 to Connector A 7 Refer to chapter 3 Device components in this manual Connection to mains supply Use of any other cable other than the supplied cable is ...

Страница 16: ...on is applied to the skin via surface electrodes with the objective to stimulate specific types of nerve fibers Pain relief pain modulation can be achieved by 1 blocking the information travelling along the nociceptive fibers i e those that produce pain through stimulation of the large diameter afferent A fibers 2 through the release of the body s endogenous opioids by stimulation of the small dia...

Страница 17: ...st labour pain Dysmenorrhea Orofacial pain including dental procedures Physical trauma including fractured ribs and minor medical procedures Relief of chronic pain Low back pain Arthritic pain including osteoarthritis rheumatoid arthritis Muscle pain including myofascial pain muscle tension post exercise soreness Neuropathic pain including post amputation phantom pain post herpetic trigeminal neur...

Страница 18: ...ndocrine glands Patients with impaired sensitivity Patients with central and peripheral neurological disorders Patients with neurovegetative disorders Paediatric patients Complicated medical conditions Cognitive impairment Drug or alcohol abuse Points where treatments should not be applied Blood vessels Endocrine glands Organs Peripheral nerves endoneurium Head eyes neck and thorax or upper part o...

Страница 19: ...dermatitis eczema or on frail skin Electrode position over areas where there is ischaemic tissue and or thrombosis Note There are no known adverse effects of administering IFC TENS on skin over or close to metal implants TENS IFC can be used on the intact skin overlying implants containing metal plastic or cement Persons with joint replacements that include metal components have been treated with ...

Страница 20: ...ice after extreme temperature fluctuations Before starting the treatment please make sure you have read and understood the content of this manual Before starting the treatment please make sure you strictly follow the WARNINGS and CAUTIONS mentioned under precautionary instructions Before starting the treatment please make sure you have checked the patient for any possible contra indications Connec...

Страница 21: ...n and restart the device If the problem persists contact the supplier or Enraf Nonius B V for service Errors and warnings indicate an internal problem with the device that must be tested by a field service technician certified by Enraf Nonius B V before any further operation or use of the system Use of a device that indicates an error or warning may pose a risk of injury to the patient user or ext...

Страница 22: ...nications equipment including peripherals such as antenna cables and external antennas should be used no closer than 30 cm to any part of the Endomed 182 including cables specified by the manufacturer Otherwise degradation of the performance of this equipment could result The Endomed 182 should only be operated with the original power cable specified in the list of contents delivered Operating the...

Страница 23: ... measured continuously and compared to the requested output Whenever a faulty situation is detected the unit will switch off the current immediately Navigation 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 The Endomed 182 is equipped with touch screen techno...

Страница 24: ...er Tone and Buzzer Duration are only available in the Endomed 182 Type 2 and 3 Set Language 1 Select System Settings 2 Select Language 3 Select the preferred language with the buttons 4 Push OK to confirm and to return to the previous menu Set Brightness To change the Brightness of the screen 1 Select Brightness 2 Adjust the brightness via the buttons Range 10 100 3 Push OK to confirm and to retur...

Страница 25: ... found The currently installed software version is shown 2 Push BACK to return to the previous menu Acoustic Feedback Endomed 182 Type 2 and 3 Select this option to turn on or off audio signals at the end of treatment 1 Select Acoustic Feedback 2 Turn Acoustic Feedback On or Off 3 Push BACK to return to the previous menu ...

Страница 26: ... end of a treatment Maintenance Restore Factory Defaults will delete any favorites stored on the device and clear any system settings returning the device in its original factory state The Service menu is intended for Enraf Nonius qualified service organizations and can only be entered with an access code Tank Cleaning will activate the pump See chapter 12 Maintenance and troubleshooting Applies o...

Страница 27: ...reen Select K to set treatment time Select L to set intensity 2 Set treatment time Option 3 s 10 s 60 s Or via the buttons 3 Set intensity Option 1 mA 3 mA 5 mA Or via the buttons 4 Press the Start button or the foot switch when connected to start treatment 5 Press the Stop button or the foot switch when connected to stop treatment Treatment stops automatically when the treatment time has elapsed ...

Страница 28: ...e set clinical protocols are adjustable and rewritable See chapter 11 for connection of electrodes 1 Select Clinical Protocols in the Home screen to activate the list 2 Select the button to scroll through the list 3 Select icon for more information about the protocol 4 Select the chosen Clinical Protocol to go to the Parameter Screen Protocol information screen 5 Touch the button to scroll through...

Страница 29: ... or 2 at the bottom of the screen to change the intensity level 10 Adjust the intensity level via the buttons 11 Push OK to confirm and return to the previous screen 12 The protocol will start after setting the intensity level 13 The protocol can be stopped by pressing the stop icon A on the touchscreen The protocol stops automatically when the treatment time has elapsed A ...

Страница 30: ...hannel touch the channel tab on the bottom of the screen See chapter 11 for connection of electrodes 1 Select Manual Operation in the Home Screen 2 Select the desired Current Wave Form the parameter screen will appear 3 Depending on the selected Current Wave Form various parameters can be set Setting Parameters Frequency 1 Select Frequency B 2 Adjust Frequency via the buttons Range 1 Hz 200 Hz 3 P...

Страница 31: ...C 2 Set Burst Frequency Option 1 Hz 2 Hz 4 Hz 3 Push OK to confirm and return to the parameter screen Setting Parameters Modulation Frequency 1 Select Modulation Frequency D 2 Adjust Modulation Frequency via the buttons Range 1 Hz 180 Hz 3 Push OK to confirm and return to the parameter screen D C ...

Страница 32: ... Set Modulation Time Option 1 1 seconds 6 6 seconds 1 30 seconds 3 Push OK to confirm and return to the parameter screen Setting Parameters Treatment Time 1 Select Treatment Time F 2 Set treatment time via the buttons Range 0 to 60 minutes 3 Push OK to confirm and return to the parameter screen E F ...

Страница 33: ...e automatically selected when the pump starts to run Setting Parameters Intensity 1 Push the channel tab 1 or 2 H at the bottom of the screen to set the intensity level after setting the treatment time 2 Adjust the intensity level via the buttons 3 Push OK to confirm and return to the previous screen 4 The program will start after setting the intensity level 5 The program can be stopped by pressin...

Страница 34: ...ity of Channel 1 will automatically decrease the intensity of Channel 2 and vice versa 1 Select Balance Control I 2 Set Balance Control parameters 3 Push OK to confirm and return to the parameter screen Setting Parameters Vector View For 4P Isoplanar Vector a vector view screen is available after treatment has started 1 Select Vector View J In this screen an animation of rhythmic shrinking and swe...

Страница 35: ...een are completely set as required you can choose to save the settings as favorites by pressing the store button Favorites can be stored as long as treatment has not been started 1 Push Store M to save the program settings 2 Select the program number via the buttons 20 store locations are available for the Endomed 182 3 Push OK to confirm 4 Enter a name for your favorite 5 Push OK to save the favo...

Страница 36: ...elect Favorites in the Home menu 2 To load a program select a Favorite via the buttons The parameter screen will appear 3 To delete a Favorite press the delete button N and select the Favorite to be removed via the buttons 4 Press OK to permanently delete the Favorite N ...

Страница 37: ...e affected by close proximity to an operating pulsed shortwave or microwave machine Stimulation should not be applied across or through the head directly on the eyes covering the mouth on the front of the neck especially the carotid sinus or from electrodes placed on the chest and the upper back or crossing the heart Application of electrodes near the thorax may increase the risk of cardiac fibril...

Страница 38: ...reatment is modified Ending treatment Treatment can be stopped by pressing the stop icon on the touchscreen Treatment stops automatically when the treatment time has elapsed After treatment Remove the electrodes and or sponges Clean the patient s skin with a towel or tissue The expected effects are checked e g pain circulation and mobility The patient is asked to comment subsequently on any reacti...

Страница 39: ...ated therapeutic effect initiate a controlled inflammatory process Acupuncture needle The use of high quality single use sterile acupuncture needles that have medical CE approval including the Notified Body number is recommended Enraf Nonius does not supply any needles The needle should be compatible with the application of ultrasound guided electrolysis For as far as it concerns needle dimensions...

Страница 40: ...emove the electrodes from the patient s skin Endomed 182 Type 2 and 3 Flexible rubber electrodes We recommend using the flexible rubber electrodes in combination with the supplied sponge pads When properly moistened the sponge pads ensure low impedance between the skin and the stimulator during treatment and they are easily cleaned afterwards Follow the guidelines below when using these electrodes...

Страница 41: ...s to rapid loss of conductivity and deteriorating adhesiveness The loss of adhesion and drying of the gel will cause the edges to begin lifting which can dramatically increase current density cause uneven distribution of current across the electrode surface increasing the risk of burn and potentially result in electrode movement Changes that occur in self adhesive electrodes over time result in an...

Страница 42: ...e electrodes one by one from the smooth surface to the body of the patient Set the vacuum intensity to the desired value Follow the operating instructions in chapter 10 on how to adjust the settings and start and stop the treatment Correct the vacuum intensity if necessary a low vacuum is sufficient If required select pulsed vacuum Keep the sponge pads well moistened close to dripping when lightly...

Страница 43: ... as the 3 2 mm self adhesives the maximum current setting available on the stimulator for a given current waveform should proportionally be reduced For a precise calculation of the r m s value of a pulsed current waveform the following formula can be used 𝐼𝑅𝑀𝑆 𝐼𝑝𝑒𝑎𝑘 𝑝ℎ𝑎𝑠𝑒 𝑑𝑢𝑟𝑎𝑡𝑖𝑜𝑛 µ𝑠 𝑝𝑢𝑙𝑠𝑒 𝑓𝑟𝑒𝑞𝑢𝑒𝑛𝑐𝑦 𝐻𝑧 106 Note that electrodes should be placed with care ensuring good electrical contact over the en...

Страница 44: ...fully clean the panel Electrodes electrode holder sponges and accessories Between patient uses the rubber electrodes should be cleaned with lukewarm water To disinfect the electrodes or to remove stubborn stains of dirt use a 70 alcohol solution The alcohol solution can cause the black color of the rubber electrodes to be stained but this does not affect the operation of the electrodes Between pat...

Страница 45: ...until the water reservoir is full Empty the water reservoir as described below water reservoir full The following registered products may be used for disinfecting the water reservoir BAKTONIL BAKTOLAN to 5 CHINOSOL to 1 CHLORAMIN solution DETTOL ELMOCID Gamma to 2 PERODIN ZEPHIROL to 5 Observe the application information of the corresponding manufacturer Troubleshooting The device should not be us...

Страница 46: ...act Ensure that the sponges are sufficiently damp Clean the electrodes Check for poor contact In areas where the water is soft it is possible that the water may conduct poorly resulting in abnormally low currents In this case it is possible to use a saline solution to improve the conductivity of the water Water reservoir full The water separation tank of the Vacuum Module is full Continue the trea...

Страница 47: ...able for use according to the specifications End of Life The Endomed 182 contains materials which can be recycled and or are noxious for the environment Technical Maintenance Opening of the equipment by unauthorized agencies is not allowed and will terminate any claim to warranty The manufacturer will not be held responsible for the results of maintenance or repairs by unauthorized persons Only se...

Страница 48: ...60 gram Endomed 182 Type 3 2750 gram These values represent the weight of the housings without electrodes and power cords Specifications Type 1 Channels 1 Output Constant Current Direct Current Polarity Negative Intensity 0 15 mA Treatment time 0 300 seconds Specifications Type 2 and 3 Channels 2 Output Constant Current Intensity 0 100 mA Timer 0 60 min in steps of 1 min 2 pole interferential Carr...

Страница 49: ...Considering the different therapy forms the essential performance is built out of five requirements 1 The maximum TENS current rms may not exceed 50 mA 2 The maximum Interferential current rms may not exceed 100 mA 3 The maximum TENS pulse energy may not exceed 300 mJ 4 The maximum Interferential pulse energy may not exceed 300 mJ 5 The maximum Direct current rms may not exceed 80 mA The electroth...

Страница 50: ...unications equipment including peripherals such as antenna cables and external antennas should be used no closer than 30 cm to any part of the Endomed 182 including cables specified by the manufacturer Otherwise degradation of the performance of this equipment could result The Endomed 182 should only be operated with the original power cable specified in the list of contents delivered Operating th...

Страница 51: ...esellers be liable for any indirect special incidental or consequential damages arising from the use of or inability 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 to...

Страница 52: ...EN109 1634750 40 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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