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Zimmer enPulsPro Instructions For Use Manual

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Instructions for Use
enPulsPro
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Summary of Contents for Zimmer enPulsPro

  • Page 1 Instructions for Use enPulsPro...
  • Page 2 Illustrations Front of the device Fig. 1 Selection and 1 Control unit operating elements 2 Pulse energy controller 3 Display 4 Frequency controller 5 Slot for SD card 6 Mains switch Handpiece 7 Handpiece 8 Vents, front 9 Vents with fan, rear 10 Holder for handpiece Foot switch 11 Foot switch...

  • Page 3: Rear Of The Device

    Illustrations Rear of the device Fig. 2 Switches / ports 13 Port for power cable 14 Mains fuse 15 Port for handpiece channel I 16 Port for handpiece channel II 17 Port for foot switch 18 Serial no./identification plate...

  • Page 4: Screens / Display

    Illustrations Screens / display Fig. 3 Display/ 19 Status line therapy screen 20 Buttons on the screen 21 Heading 22 Navigation menu Fig. 4 Navigation menu (A) Home Switches back to start page Description of the (B) Back Moves one step back functions (C) Evaluation Switches to the VAS evaluation...

  • Page 5: Applicator Heads And Accessories

    Illustrations Applicator heads and accessories Fig. 5 Applicator heads 23 Applicator head, 25 mm 24 Applicator head, 15 mm 25 Applicator head, 6 mm Accessories 26 Silicone protection cap...

  • Page 6: Explanation Of Symbols

    Explanation of symbols In the instructions for use this symbol indicates “Danger”. In the instructions for use this symbol indicates "Caution" with regard to Caution possible damage of the device. Connection port for handpiece Connection port for foot switch Instructions for use Follow instructions for use.

  • Page 7: Table Of Contents

    Applicator heads and accessories Explanation of symbols Page Indications / Contraindications Side effects Application information Warnings enPulsPro – in brief Device set-up Default settings Operation instructions 8.1 Device description 8.2 Information on operation 8.3 Performing the treatment 8.4 Displays and buttons 8.5 SD card...
  • Page 8 Error messages / troubleshooting / disposal Manufacturer's EMC declaration Valid for the device enPulsPro. These instructions for use are an integral part of the device. They must be stored with the device and kept accessible at all times for anyone authorised to operate this device.

  • Page 9: Indications / Contraindications

    Indications / Contraindications Indications • Radial and ulnar epicondylitis • Calcifying tendonitis / shoulder problems • Condition post blunt muscle injuries • Chronic patellar tendon syndrome • Patellar tendonitis • Chronic tendinopathy of the Achilles tendon • Plantar fasciitis • Heel spurs •...

  • Page 10: Side Effects

    Side effects Side Effects Treatments with enPulsPro may occasionally cause irritation, petechiae, haematoma, swelling, or pain. Page 2...

  • Page 11: Application Information

    X-ray or diathermy equipment) may interfere with the operation of the device. Please keep a safe distance of several meters. enPulsPro is not suitable for use in areas with an explosive, flammable or combustive environment. During use, the device is to be located in a position allowing direct access to the device´s central mains supply so that it can be disconnected from the mains...

  • Page 12: Warnings

    Warnings Treatment instructions regarding treatment location, duration and intensity require medical knowledge and may only be given by authorised physicians, therapists and medical paraprofessionals. These instructions must be followed. The patient must not be left unattended during treatment. Persons undergoing simultaneous treatment with reduction and/or alteration of blood clotting or a prolongation of clotting time (e.g.

  • Page 13: Enpulspro - In Brief

    It generates shock waves by means of an ergonomic handpiece and emits enPulsPro do? shock waves through special applicators. The enPulsPro can penetrate human tissue for up to approximately 35 mm. How are shock waves A coil generates an electromagnetic field in the rear of the handpiece.

  • Page 14: Device Set-Up

    Device set-up Mounting the cables Note: If the enPulsPro is not mounted on the intended system wagon, ensure that the enPulsPro is placed on a stable surface. Note: Make sure that the power switch of the device is set to “0”.

  • Page 15: Default Settings

    Default settings Note: Changes to the default settings can only be made from the start-up screen. Start-up screen After the device has been switched on and the self-test performed, the start-up screen opens. Note: Activating the "instant start" button (2) switches immediately to the therapy screen.
  • Page 16 Default settings (1) Start settings 1. Start menu: Options to individually select the start-up settings. 2.Start-up image: Option to select from two start-up images The selection is made directly in the corresponding line. 3. Welcome text: Activating the “Welcome text” field opens a window with an alphabetical keyboard to enter an individual welcome text in the start-up screen.
  • Page 17 Default settings (9) Handpiece In this display panel, the meter reading of any connected handpiece(s) is shown. Maintenance The “Service” menu is not relevant for the user. The points listed here are only used in the event of service by customer service. Page 9...

  • Page 18: Operation Instructions

    Zimmer MedizinSysteme GmbH guarantees unrestricted use at a rate of at least two million shocks per shock wave generator. In some cases, depending on power and frequency, well over 2 million shocks can be emitted.
  • Page 19 In addition to temperature monitoring, the enPulsPro regulates the temperature using a temperature sensor in the handpiece. The fan in the handpiece is started when activated by the foot switch and automatically stops when it reaches a certain temperature.

  • Page 20: Information On Operation

    8.2 Information on operation Therapy Please hold the handpiece as shown in the picture below. The enPulsPro uses mechanical energy, which is transferred to the patient via a handpiece. In order to achieve this, the handpiece with the applicator head is placed perpendicular to the treatment area or the point of treatment.

  • Page 21: Performing The Treatment

    Set pulse energy Use the left-hand controller to set pulse energy. Note: enPulsPro offers two pulse emission options. Pulse emission with pre-set number of pulses For pulse emission with a pre-set number of pulses, treatment is terminated by the device after the pre-set number of pulses has been emitted.

  • Page 22: Displays And Buttons

    Operation instructions 8.4 Displays and buttons Description of the display elements and buttons (1) Pulse energy Displays the set pulse energy. During active therapy, the bar graph is filled in. Pulse energy can be set before and during pulse emission. Pulse energy can be set in 10 mJ increments to between 60 and 185 mJ.
  • Page 23 Operation instructions 8.4 Displays and buttons (5) Mode Displays the set operating mode. Activating the “Mode” window pulls up the selection menu with the operating modes: Series Pulse, Burst 4 Pulse, Burst 8 Pulse, Burst 12 Pulse. The desired operating mode is selected directly in the corresponding line. (6) Frequency Displays the set frequency.

  • Page 24: Sd Card

    Operation instructions 8.5 SD card SD card The user-defined settings as well as the list of indications are saved on the SD card. If the SD card is not inserted, the following message appears when the "Favourites", “Memory” and "VAS" buttons are activated: "No SD card found."...

  • Page 25: Therapy Recommendations

    Operation instructions 8.6 Therapy recommendations The “Therapy recommendations” menu assists in therapy selection. Therapy Activating the therapy button opens the “Therapy recommendations” menu. Note: The “Therapy” menu offers two ways of selecting the desired therapy: - via the body regions - via the list Therapy selection The body region is selected by clicking on the blue circle.
  • Page 26 Operation instructions 8.6 Therapy recommendations Note: Regardless of whether the indication is selected via the body regions or the list, the program steps leading to the therapy screen are similar, and are therefore described only once below. Select differentiated The differentiated condition of the clinical picture is selected directly in the condition of the corresponding line (here: acute).

  • Page 27: Favourites And Memory Lists - Retrieve Programs, Edit List

    Operation instructions 8.7 Favourites and memory lists – Retrieve programs, edit list The parameters of the predefined programs can be individually modified and saved. Save and name Activating the “Save” button opens the field to enter the program name. program The program name is entered via the keyboard.
  • Page 28 Operation instructions 8.7 Favourites and memory lists – Retrieve programs, edit list The individually saved programs are listed in the Favourites list. These can be 1. retrieved here for therapy, 2 . edited (moved in the sequence and deleted). Note: The steps to retrieve and edit the Favourites/Memory list are identical, so only retrieving and editing the favourite list is described.
  • Page 29 Operation instructions 8.7 Favourites and memory lists – Retrieve programs, edit list Edit Favourites Activating button (1) leads back to the program. Activating the button (2) moves the program up. Activating the button (3) moves the program down. Activating the button (4) deletes the program. Note: Activating button (4) triggers a confirmation prompt: “Do you really want to delete the program?“...

  • Page 30: Vas - Visual Analogue Scale

    Operation instructions 8.8 VAS – Visual analogue scale Information on VAS enPulsPro has a visual analogue scale, also called a pain scale. The pain scale is often used in pain therapy. It measures the patient's subjective pain intensity. The patient rates the current pain on a scale of 0–10, whereby 0 = "no pain"...
  • Page 31 Operation instructions 8.8 VAS – Visual analogue scale Enter new patient Activating the "VAS Pre" field in the therapy screen opens the VAS screen. Activating the “New” button opens the field to enter the patient’s name. Enter the patient's name. Activating the “Save” button transfers the data and the pain scale screen opens automatically.
  • Page 32 Operation instructions 8.8 VAS – Visual analogue scale Repeating Patients that have already been entered are activated in the VAS list directly on measurement the corresponding line. Once the line has been activated, the screen opens automatically with the pain scale so that a new measurement can be performed.

  • Page 33: Technical Information

    10 Hz max. 185 mJ Operating mode Interval operation Accuracy ± Dimensions enPulsPro with H 138 cm x W 53 cm x L 52 cm SysCart enPulsPro H 30 cm x W 35 cm x D 20 cm SysCart...
  • Page 34 Technical information Note: Storage and transport only in original packaging. Subject to technical changes! Page 26...

  • Page 35: Cleaning/Disinfection

    Cleaning Disinfection – Before starting any maintenance and cleaning measures the device must always be switched off at the main switch and the mains cable must be disconnected. – Make sure that when cleaning and disinfecting the labelling of the device (such as warnings, labels of control devices, identification plate) is not damaged.
  • Page 36 Cleaning Disinfection Disinfection (only manually): Tools: Disposable wipes (cellulose, paper)  Commercially available alcohol-free disinfectant for metal and plastic, with  bactericidal, virucidal and fungicidal properties or wipes. Observe the instructions for use of the respective manufacturer. We recommend that disinfection is carried out at least once a week, as well as if there is any indication of contamination.
  • Page 37 Cleaning Disinfection Alcohol-free plastic cleaner (e.g. cleaner for medical devices)  Remove the silicone protection cap from the applicator head prior to cleaning. Prepare a solution of the cleaning agent following the instructions of the manufacturer. Put the silicone protection cap in the solution. Use the brush to clean all the inner and outer surfaces of the protection cap.
  • Page 38 Cleaning Disinfection Note: Use the device only in a hygienic environment. Page 30...

  • Page 39: Ce Mark / Manufacturer

    CE mark / manufacturer The device has a CE mark in accordance with the EC directive on medical devices 93/42/EEC. Manufacturer Zimmer MedizinSysteme GmbH Junkersstraße 9 89231 Neu-Ulm, Germany Tel. +49 731. 9761-291 Fax +49 731. 9761-299 www.zimmer.de Page 31...

  • Page 40: Scope Of Delivery And Accessories

    Scope of delivery Accessories Scope of delivery in combination with SysCart Item no. 5430 enPulsPro control unit 9160 SysCart with tray mount 5413 Handpiece complete 93133521 Applicator head, 6 mm 93133511 Applicator head, 15 mm 93133502 Applicator head, 25 mm...

  • Page 41: Device Combination

    Device combinations For enPulsPro no combination devices are provided by the manufacturer. Anyone who combines devices against these guidelines and thus creates a medical system does so under his/her own responsibility. Page 33...

  • Page 42: Safety And Maintenance

    Safety and maintenance 14.1 Safety enPulsPro is manufactured according to the DIN EN 60601-1 safety regulations. As the manufacturer, Zimmer MedizinSysteme can only consider itself to be responsible for safety and reliability if • the device is operated using a proper power outlet with earth contact and the electrical installation complies with DIN VDE 0100 part 710, •...

  • Page 43: Maintenance

    Before starting any cleaning and maintenance measures the device must always be switched off at the main switch and the mains cable must be disconnected. Zimmer guarantees 150,000 shocks per applicator head. It is recommended that the applicator head be replaced after this number of shocks has been reached.

  • Page 44: Functional Test

    Functional test enPulsPro performs a self-test when switched on, checking all internal components. If an error occurs, an error message will appear. In addition, an enhanced functional test as described below can be performed. This test should be performed monthly or if the proper functioning of the device is in doubt.

  • Page 45: Legal Notice

    Legal notice The enPulsPro device is not listed in annex 1 of the MPBetreibV (German Medical Devices Operation Ordinance). The device is not listed in annex 2 of the MPBetreibV (German Medical Devices Operation Ordinance). In Germany, the German Social Accident Insurance (DGUV) (Regulation 3 –...

  • Page 46: Error Messages Troubleshooting Disposal

    Error messages Troubleshooting Disposal Handpiece loss of The message "Ready" appears in the status bar but no pulse is triggered function although the foot switch has been activated Possible cause 1 Handpiece / foot switch not properly connected or defective. Remedy for cause 1 Check whether the foot switch and handpiece are correctly connected.
  • Page 47 Error messages Troubleshooting Disposal Applicator not found The message “No applicator found” appears in the status bar. Possible cause Handpiece not (or not correctly) connected. Remedy for cause Check whether the handpiece is correctly connected. The connector must be fully engaged. Device malfunction No response to the main switch / display remains dark Possible cause 1...
  • Page 48 In the case of other malfunctions, switch the device off and then on again after a 5-second delay. If the error is still present, please inform customer service via the main office in Neu-Ulm. Main office Zimmer MedizinSysteme GmbH Junkersstraße 9 89231 Neu-Ulm, Germany Tel. +49 731. 9761-291 Fax +49 731.

  • Page 49: Manufacturer's Emc Declaration

    Portable and mobile HF communication devices (such as mobile phones, cell phones) can affect medical electrical devices. enPulsPro may only be operated with the original power cable indicated in the list of the scope of delivery and accessories. Operation of the device with a different power cable can lead to increased emissions or reduced interference immunity of the device! Guidelines and manufacturer's declaration –...
  • Page 50 Manufacturer's EMC declaration Guidelines and manufacturer's declaration – Electromagnetic immunity The enPulsPro device is intended to be operated in the electromagnetic environment indicated below. The customer or user of the enPulsPro device should ensure that it is used in such an environment..
  • Page 51 Uninterruptible operation is not necessary to the intended use. Guidelines and manufacturer's declaration – Electromagnetic immunity The enPulsPro device is intended to be operated in the electromagnetic environment indicated below. The customer or user of the enPulsPro device should ensure that it is used in such an environment..
  • Page 52 If the measured field strength in the location in which the enPulsPro device is used exceeds the above compliance level, the enPulsPro device must be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the enPulsPro device.
  • Page 53 Instructions for Use Zimmer MedizinSysteme GmbH Junkersstraße 9 89231 Neu-Ulm, Germany Tel. +49 7 31. 97 61-291 Fax +49 7 31. 97 61-299 export@zimmer.de www.zimmer.de...

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