Enraf Nonius ENDOMED 484 Instructions For Use Manual
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Enraf Nonius ENDOMED 484 Instructions For Use Manual

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ENDOMED 484
EN109-1498740-40 IFU
August 20, 2019
Instructions for use
EN109-1498740-40 IFU

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  • Page 1 ENDOMED 484 EN109-1498740-40 IFU August 20, 2019 Instructions for use EN109-1498740-40 IFU...

  • Page 2: Table Of Contents

    Table of contents Introduction ..............................3 Description-symbols used and device markings ................13 Device components ............................ 15 Package contents ............................16 Installation ..............................18 Intended use and intended user ......................20 Indications ..............................22 Contraindications ............................24 Precautionary instructions ........................26 10 Operation ................................

  • Page 3: Introduction

    This manual has been written for the owners and operators of the Endomed 484. In order to maximize the use, efficiency and lifespan of your unit, please read this manual thoroughly and become familiar with the controls as well as the accessories before operating the device.
  • Page 4 treatment goal. Enraf-Nonius does not supply percutaneous electrodes (such as disposable acupuncture needles or needle-like electrode pads). In a TENS/PENS/NMES electrode circuit, one electrode is positively charged (anode) and the other negatively charged (cathode). An action potential (nerve impulse) is initiated in the underlying nerve fibers by the flow of current between two electrodes.
  • Page 5 In this section the main treatment variables will be outlined. Output Intensity (Amplitude) The Endomed 484 can output a current intensity in the range of 0-140 mA. When the objective is to elicit motoric reactions like in NMES, large size surface electrodes are used. However in PENS, smaller (needle) electrodes are being used.
  • Page 6 In view of the above and in order to provide additional safety, the current output of the Endomed 484 is limited to max. 40 mA when choosing PENS. Pulse Frequency The Endomed 484 can deliver discrete ‘pulses’...
  • Page 7 minutes will need to be delivered as a minimally effective dose. It takes some time for the opioid levels to build up with this type of TENS/PENS and hence the onset of pain relief may be slower than with the traditional mode. Once sufficient opioid has been released however, it will keep on working after cessation of the stimulation.
  • Page 8 One of the first to investigate the combined application of acupuncture and electrical stimulation was professor Han. He investigated the best settings to use for maximum production of the two central opioid peptides that are associated with pain relief. His method is called Han stimulation. Low Frequency stimulation at 2 Hz accelerates the release of enkephalin, whereas High Frequency stimulation at 100 Hz selectively accelerates the release of dynorphin.
  • Page 9 the number of motor units activated, and the larger the evoked muscle contraction output of force. The higher the current amplitude, the higher the effectiveness of NMES for muscle strengthening in both healthy individuals and patients. Current output CC Stimulators used for NMES are constant current type (CC-type) stimulators. This means that a set currrent amplitude (e.g.
  • Page 10 intensities, where longer ramp-up and ramp-down times (5 seconds) may be more appropriate. There is evidence that if the ON-time is 10 seconds then the OFF-time must be at least 60 seconds to avoid fatigue. If the aim of treatment is to strengthen muscle then treatment can be progressed over a number of sessions by increasing the frequency up to 100 Hz and altering the duty cycle so that the contraction time is lengthened and the relaxation time reduced.
  • Page 11 (2 - 4 sec) than ramp down times (1 - 2 sec). Electrical stimulation modes The Endomed 484 features a time delay switch, allowing channels to be triggered or activated independently. This allows the practitioner to choose between the following stimulation modes: 1.
  • Page 12 4. P.E.M.S. Progressive Electrical Muscle Stimulation offers the possibility to create a “normal functional” sequential contraction of muscles within a movement chain. The P.E.M.S. mode is a special case of the asynchronous mode, in which the surge program ends on all channels immediately. The specified hold-time is the hold-time on channel 1.

  • Page 13: Description-Symbols Used And Device Markings

    2 Description-symbols used and device markings Symbol used Description Follow the instructions in the Instructions for Use. It is important that you read, understand and observe the precautionary and operating instructions General Prohibition Sign. Prohibition is used to mean “You MUST NOT” Warning or Caution: Indicates a hazardous situation which, if not avoided, could result in: Death or serious injury to the patient (or)
  • Page 14 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 Page 14 of 56 EN109-1498740-40 IFU...

  • Page 15: Device Components

    3 Device components Parts Description Numbered Description Purpose Part Central controller with light ring Use this controller to scroll through the pages and to adjust the parameters. The light ring is illuminated when the controller is ready to use. ET-1 Electrotherapy output channel 1 Connection point for the patient cable ET-2...

  • Page 16: Package Contents

    4 Package contents 1498.981 Endomed 484 Standard accessories Below you will find the Standard accessories that are present in the packaging: 1498.740 CD-ROM with Instructions For Use (PDF on CD-ROM) 1498.742 Information Booklet 3444.290 Mains cable 230V-EUR 1498.010 Device base (inclination support ; spare part) 3444.211...
  • Page 17 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. Page 17 of 56 EN109-1498740-40 IFU...

  • Page 18: Installation

    Enraf-Nonius B.V. (part number 2501.016). Remove the mains cable from the mains connector. • Place the Endomed 484 device upside down and on a soft surface. • Remove the two screws from the battery cover using a screwdriver.
  • Page 19 Operation from battery Leave mains switch in the Off position and turn on the device on using push button. • Power LED indicator is lit orange, indicating that the device is operating from the battery. • When you have finished the treatments, turn off the device using push button. •...

  • Page 20: Intended Use And Intended User

    6 Intended use and intended user Intended use The Endomed 484 is a 4 channel electro-stimulator designed for use by health professionals to ensure electric stimulation treatments for Pain Management (TENS and PENS) and Muscle Stimulation (NMES). The Endomed 484 is a valuable supplement to medical and therapeutic treatment for use in hospitals, clinics, general practices and at patient’s home by a therapist.
  • Page 21 Intended user The Endomed 484 is intended to be used, and shall only be used, by or under the supervision of professional users in the field of physical therapy and rehabilitation, who understand the benefits and limitations of electrotherapy.

  • Page 22: Indications

    7 Indications The Endomed 484 can be used for the below mentioned symptoms or medical conditions: TENS Relief of acute pain Postoperative pain • o Abdominal o Thoracic o p.o. orthopedic pain Labour pain and post-labour pain • Dysmenorrhoea •...
  • Page 23 Neurological conditions (stroke rehab) Increase muscle strength • Reduction of shoulder subluxation • Increase in range of movement of the wrist / fingers extensors • Reduction 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 •...

  • Page 24: Contraindications

    8 Contraindications The Endomed484 MUST NOT be used for the below mentioned symptoms or medical conditions. TENS/PENS Absolute contraindications Undiagnosed pain • Active implants (incl. cardiac pacemakers and implantable cardioverter defibrillators - ICDs) • Tissue bleeding (haemorrhage) • Patients who do not comprehend the practitioner’s / physical therapist’s instructions or who are •...
  • Page 25 NMES Absolute contraindications NMES should NOT be applied in case of: Active deep vein thrombosis (DVT) or thrombophlebitis • Active implants (incl. cardiac pacemakers and implantable cardioverter defibrillators - ICDs) • Areas of impaired circulation • Pregnancy • Tissue bleeding or to persons with untreated hemorrhagic disorders •...

  • Page 26: Precautionary Instructions

    9 Precautionary instructions This device should be used only under the continued supervision of a physician or licensed practitioner. This device should be kept out of the reach of children. The patient and the device must be in sight of the therapist at all times. Use of accessories, electrodes and cables other than those specified or provided by the manufacturer of this device could result in increased electromagnetic emissions or decreased electromagnetic immunity of this device and result in improper operation.

  • Page 27: Operation

    10 Operation Set up Do not use the device after extreme temperature fluctuations! Frequently Used Functions The Frequently Used Functions are: Selecting the Clinical Protocols, Favourite and Manual Operation buttons in the touch screen. • Switch On Before using the device, verify the patient is not in contact with the device, the electrode connection cable, the electrodes, or other devices or metal objects.
  • Page 28 A selected sheet gives an overview of the parameters belonging to that channel. A parameter can be selected by touching it, which causes its colour to be changed into white and the light ring around the central controller to be illuminated. The parameter can now be adjusted with the central controller.
  • Page 29 Channel Tab Information Channel Tab Illustration Output Indicator Electrodes Channel Status Channel stopped Channel paused Channel running Remaining treatment time. When a sequential protocol has been loaded, the value indicates the total remaining treatment time of the sequential protocol. Output value Unit of Output value: mA Navigation Home Menu...
  • Page 30 • Clinical Protocols The Endomed 484 provides a number of pre-programmed protocols. These protocols only serve as a guide and you should use your own expertise in applying them. The clinical protocols guide you through a wide range of treatment suggestions.
  • Page 31 Manual Operation With Manual Operation, depending on the selected therapy (TENS/NMES/PENS), several stimulation modes are available. Note: some of these selections are groups and in the next screen another list appears from which the stimulation mode can be selected. Example: Modulated TENS Select TENS>Manual Operation>Modulated 3 modulation modes can be selected.
  • Page 32 Parameter screen In this screen all the parameters can be set before starting the therapy. ❶ ❷ Adjust the parameters by touching the button ❸ ❹ and change the value with the central controller. ❺ ❻ Note: some parameters are grouped and in the next screen the settings can be changed the same way as above.
  • Page 33 2. Treatment Time Treatment time can be adjusted by turning the central controller. Time in minutes is shown. Range: 1-90 min Increments: steps of 1 min Default: 30 min 3. Frequency Touching the frequency button will bring up another screen. Six ‘basic’ frequencies can be selected via quick start buttons.
  • Page 34 5. Channel selection The channel selection screen consists of 4 buttons. It allows the user to select one or multiple channels in any combination. Selected channel(s) are recognizable by the inversed color. Select the accept button in the navigation bar ✓...
  • Page 35 6 (c). Pulse Width Modulation (PWM) 2 Pulse Width Modulation (PWM) patterns with fixed frequencies can be selected. - LF = Low Frequency (2 Hz) - HF = High Frequency (100 Hz). 3 Pulse Width modulation ranges can be selected: - from 80 to 125 s - from 125 to 200 s - from 200 to 300 s...
  • Page 36 6 (e). HAN Stimulation Three stimulation frequencies and three pulse durations can be selected. Pulse width is automatically modulated, combining decreasing and increasing pulse widths. Pulse width increases during low frequency stimulation, providing a typical wave form of electroacupuncture treatment. The pulse width decreases during high frequency stimulation, providing a typical wave form of transcutaneous electrical nerve...
  • Page 37 6 (g). Automated Frequency Modulation Default setting is OFF (disabled). When activated, frequency changes in a fixed pattern (3/3s with slopes). Modulation frequency is based on  +/- 50Hz in relation to set frequency. Auto-mode is manually set and serves as an ‘anti-accommodation button’ (to prevent adaptation).
  • Page 38 Ready to set intensity and start therapy The 4 stimulation channels can be used in combination (linked) or totally independent, and each channel can run different programs. Intensity can be regulated separately for each channel. For example, after setting the parameters for High Frequency TENS on channel tab 1, touching channel tab 3 will bring up the option to set the parameters for another program.
  • Page 39 Favorites When a treatment screen is completely set as required, its settings can be stored in a Favorite for later use: As long as the treatment has not been • started, a Store button is available on the navigation bar. To store your settings, touch the Store button in the Navigation bar.
  • Page 40 Programming a sequential protocol (multi- step-programming) A sequential protocol consists of a series of treatment steps that are executed in a sequence until the end of the protocol is reached. Select Multi-step Programming in the • TENS/NMES/PENS menu. Set the desired parameters. •...
  • Page 41 System Settings The following setting can be changed by selecting the option and turning the central controller: - Language: change language of user interface - Keyboard sound: on/off - LCD brightness - 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...

  • Page 42: Application Information

    11 Application information Before starting the treatment please make sure: You have read and understood the content of this manual You strictly follow the WARNINGS and CAUTIONS mentioned under precautionary instructions Check the patient for any possible contra-indications. 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.
  • Page 43 Ensure TENS/PENS device is still switched off and connect the electrode wire to the TENS/PENS • device Switch the TENS/PENS device on • Gradually (slowly) increase the intensity until the patient experiences the first 'tingling' sensation • from the stimulator Gradually (slowly) increase the intensity further until the patient experiences a strong but •...
  • Page 44 - post treatment muscle soreness can be expected if muscle fatigue is a treatment goal. Most risks can be mitigated by establishing clear lines of communication between the therapist and patient and creating a therapeutic relationship that encourages frequent and honest patient feedback.
  • Page 45 Electrodes – placement In general, both electrodes are placed on the muscle belly. When placing an electrode over the target muscle, practitioners should always consider placing it over the muscle's motor points. A motor point is defined as the surface entry point of a bundle of motor nerve fibers into a fascicle of muscle fibers.
  • Page 46 Securing electrodes is very important when applying NMES as the skin moves when the muscle • contracts. Unsecured electrodes can lead to electrical burns and very uncomfortable stimulation. Use the stimulator in the Constant Current (CC) mode. This will maintain the set current •...
  • Page 47 Securing electrodes Non-adhesive electrodes should be secured firmly with tape or straps. • It is important that electrodes remain in complete contact without edges lifting throughout the • treatment. Securing electrodes is very important when applying NMES as the skin moves when the muscle •...

  • Page 48: Maintenance And Troubleshooting

    12 Maintenance and troubleshooting Cleaning and Disinfection Before performing any user maintenance, switch off the device and disconnect the plug from the mains supply. 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 ammonia.
  • Page 49 Troubleshooting In the event that an error message or warning appears, immediately stop all use of the device. Shutdown 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.
  • Page 50 If this equipment is modified, appropriate inspection and testing must be conducted to ensure continued safe use of the equipment. It is mandatory to have the Endomed 484 checked yearly by authorized personnel of Enraf-Nonius or by its authorized distributor.
  • Page 51 The service engineer will decide whether the device is suitable for use according to the specifications. End of Life Your Endomed 484 contains materials which can be recycled and/or are noxious for the environment. Please ensure that you are well informed of the local rules and regulations regarding the removal of equipment and accessories.

  • Page 52: Specifications

    13 Specifications Technical Data Electrical info Power: Battery and/or mains Mains voltage: 100 - 240 Volt Frequency: 50/60 Hz Max. power input: 100 VA Battery: Battery Pb 12 V, 2 Ah Dimensions Main device (length x width x height): 24 x 28.6 x 9.3 cm Weight unit (excl.
  • Page 53 Application of usability engineering to medical devices. Essential Performance and Basic Safety The essential performance of the Endomed 484 is to apply electrotherapy in synchronous or asynchronous, dosed pulses following a pattern to the body of a patient without unacceptable risk.
  • Page 54 Portable RF communications equipment (including peripherals such as antenna cables and external 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.

  • Page 55: Contact

    14 Contact For assistance, please visit our website http://www.enraf-nonius.com The latest version (in electronic or printed format) of this Instructions for Use can be obtained free of charge from our website www.enraf-nonius.com or by contacting distributor or by calling the telephone number: +31-(0)10-2030600.
  • Page 56 Copyright: Enraf-Nonius B.V. Vareseweg 127 | 3047 AT | Rotterdam | The Netherlands Tel: +31 (0)10-20 30 600 | info@enraf-nonius.nl EN109-1498740-40 IFU...

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