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Zimmer enPuls User Manual

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User Manual
enPuls
Version 2.0
USA

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Summary of Contents for Zimmer enPuls

  • Page 1 User Manual enPuls Version 2.0...
  • 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 Handpiece 6 Handpiece 7 Vent, front 8 Vent with fan, rear Footswitch 9 Footswitch...

  • Page 3: Illustrations

    Illustrations Rear of the device Fig. 2 Switches / 10 Power switch Connector sockets 11 Mains fuse 12 Socket for mains cable 13 Socket for handpiece 14 Socket for footswitch 15 Identification plate...

  • Page 4: Screens / Displays

    Illustrations Screens / Displays Fig. 3 Displays / Therapy 16 On-screen buttons screen 17 Status bar 18 Navigation bar Fig. 4 Navigation bar (A) Back Takes you back one step Description of the (B) Therapy Switches to the therapy screen functions (C) Programs Switches to the program list...

  • Page 5: Applicator Heads And Accessories

    Illustrations Applicator heads and accessories Fig. 5 Applicator heads 19 Applicator head, 25 mm 20 Applicator head, 15 mm 21 Applicator head, 6 mm Accessories 22 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 a "Caution" with regard to Caution possible damage of the device. Socket for handpiece Socket for footswitch User Manual Follow user manual Serial number Article number Manufacturer...

  • Page 7: Table Of Contents

    Applicator heads and accessories Explanation of Symbols Page Indications / Contraindications Side Effects Application Information Warnings enPuls Version 2.0 – in brief Device Set-Up Settings Operating Instructions 8.1 Device Description 8.2 Notes on Operation 8.3 Performing the Treatment 8.4 Display and Buttons 8.5 SD card...
  • Page 8 Error Messages / Troubleshooting / Disposal Manufacturer´s EMC Declaration Valid for the device enPuls Version 2.0 (NG). This user manual is an integral part of the device. It must be stored with the device and kept accessible at all times for anyone authorized to operate this device.

  • Page 9: Indications / Contraindications

    Indications / Contraindications Indications • For relief of minor muscle aches and pains and for temporary increase in local blood circulation. Contraindications • vascular diseases present in or near the treatment area • local infections in the treatment area • around malignant or benign tumours •...

  • Page 10: Side Effects

    Side Effects Side Effects Treatments with enPuls Version 2.0 may occasionally cause irritation, petechial, bruising, swelling or pain. Page 2...

  • Page 11: Application Information

    Please keep a safe distance of several meters. enPuls Version 2.0 is not suitable for use in areas with an explosive, flammable or combustive environment. When in operation, the device must be positioned in such a way that direct access to the device's central power supply is possible, so that it can be disconnected from the mains at any time.

  • Page 12: Warnings

    15 min. If the treatment time is exceeded, the handpiece may overheat. Users of the enPuls Version 2.0 radial pulse therapy device must be instructed Caution in the proper use of the system and must possess the appropriate skills.
  • Page 13 Warnings In worst case condition maximum therapy time is limited to 4 minutes treatment time and a break time of 5 min. If you will exceed this duty cycle the handpiece can be in overtemperature. Page 5...

  • Page 14: Enpuls Version 2.0 - In Brief

    The impact energy delivered from the applicator head results in radial pulses developed in the target tissue. With enPuls Version 2.0, a maximum penetration depth of about 35 mm into human tissue can be achieved.

  • Page 15: Device Set-Up

    Device Set-Up Note: If enPuls Version 2.0 is not mounted on the designated system trolley, please make sure that it is standing on a stable surface. We recommend using the optional swivel base. Note: Make sure that the power switch on the device is set to "0".

  • Page 16: Settings

    Settings Note: Changes to the basic settings can only be made from the start –up screen. Start –up screen Once the device has been switched on and the self-test performed, the home start – up screen opens. Note: Pressing the "Therapy" button (1) immediately switches to the therapy screen Configuration menu The factory settings can be changed and adjusted individually using the configuration menu.
  • Page 17 Settings (1) Startup settings 1. Start menu: Individual startup settings options. The selection is made directly in the corresponding row. (2) Language Selecting the language. The selection is made directly in the corresponding row. (3) Welcome Pressing the "Welcome" field opens a window with an alphabetic keyboard to enter a welcome message for the start-up screen.

  • Page 18: Operating Instructions

    The generator in the handpiece is a wear part and must be replaced after a certain period of operation, as its ability to function decreases with time. Zimmer MedizinSysteme GmbH guarantees unrestricted use of at least 2 million shocks per radial pulse generator.
  • Page 19 In addition to temperature monitoring, enPuls Version 2.0 features temperature regulation by means of a temperature sensor in the handpiece. The fan in the handpiece starts upon activation using the footswitch and automatically stops when a certain temperature is reached.

  • Page 20: Notes On Operation

    While the radial pulse is enabled, it is possible to work either with the handpiece stationary on one point, or dynamically, across a whole area. In order to reduce friction on the skin, the use of the enPuls lotion provided is recommended.

  • Page 21: Performing The Treatment

    Applying the Place the handpiece on the selected treatment point / area. In order to avoid handpiece / friction on the skin, enPuls lotion can be applied to the treatment area prior to applicator treatment when necessary. When using lubricants, the applicator head must be covered using the silicone Caution protection cap.

  • Page 22: Display And Buttons

    Operating Instructions 8.4 Display and Buttons Description of the display elements and buttons (1) Pulse energy Displays the pulse energy setting. During active therapy, the bar graph is filled. The pulse energy can be set both before and during the delivery of pulses. The pulse energy is adjustable between 60 and 185 mJ, in 10mJ increments.
  • Page 23 Operating Instructions 8.4 Display and Buttons (8) Start Starts the program (9) Reset For ascending counting direction, this resets to 0; for descending counting direction, this resets to the pre-set number of pulses. (10) Status line Displays the name of the currently selected program. Page 15...

  • Page 24: Sd Card

    Operating Instructions 8.5 SD Card SD card Custom settings are stored on the SD card. If the SD card is not inserted, the following message appears when the "Favorites" is pressed: "No SD card found". The use of "Favorites" requires an SD card. Insert the card and confirm with "OK".
  • Page 25 Operating Instructions 8.6 Favourites List Retrieving Programs and Editing Lists The parameters of the pre-defined programs can be individually modified and saved. Saving and naming Pressing the "Save" button opens the field for entering the program name. the program The program name is entered via the keyboard. Note: There are 120 memory locations available for each.
  • Page 26 Operating Instructions 8.6 Favourites List Retrieving Programs and Editing Lists The individually stored programs are listed in the Favorites list. Here these can be 1. retrieved for treatment 2. edited (the sequence altered or entries deleted). Select favorites list Pressing the "Favorites" button opens the favorites list. Retrieve program The selection of the desired program is carried out directly on the corresponding line.
  • Page 27 Operating Instructions 8.6 Favourites List Retrieving Programs and Editing Lists Edit favorites Pressing button (1) returns you to the program. Pressing button (2) moves the program up. Pressing button (3) moves the program down. Pressing button (4) deletes the program. Pressing button (5) confirmed the processing.

  • Page 28: Technical Information

    H 322 mm × W 235 mm × L 130 mm Weight 2.7 kg IP class IPX0 Device IPX5 Footswitch IPX0 Handpiece enPuls 2.2 handpiece Dimensions 230 mm long, 50 mm diameter Weight 850 g Lifetime 2,000,000 pulses (at least)

  • Page 29: Info-Chart Duration Of Treatment

    Technical Information 9.1 Info-Chart Duration of Treatment Maximum pulses per treatment Maximum shocks per treatment Frequency (Hz) Page 21...

  • Page 30: 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 unplugged. - Make sure that when cleaning and disinfecting the labels of the device (such as warnings, labels of control devices, identification plate) are not damaged.
  • Page 31 Cleaning Disinfection Applicator head / Cleaning (only manually) handpiece Tools:  Disposable wipes (cellulose, paper)  Alcohol-free plastic cleaner (e.g. cleaner for medical devices) Remove the silicon protective cap from the applicator head before cleaning. Then proceed as indicated under “housing / foot switch”. Disinfection (only manually): Tools: ...
  • Page 32 Cleaning Disinfection the inner and outer surfaces of the protective are wetted. Leave the protective cape in the solution as long as defined by the manufacturer of the disinfection agent. Rinse off the protection cap under running water. Cleaning / Disinfection, by machine: Preparation: Visible contaminations must be removed by manually before performing cleaning / disinfection.

  • Page 33: Scope Of Delivery And Accessories

    Holder for handpiece 93133521 Applicator head, 6 mm 93133511 Applicator head, 15 mm 93133501 Applicator head, 25 mm 50500017 Silicone protection caps 50500018 enPuls Lotion 94130411 Footswitch Mains cable 87053009 Transport case with foam insert 10102381 User Manual Page 25...

  • Page 34: Device Combination

    Device Combinations For enPuls Version 2.0 no combinations devices are provided by the manufacturer. Anyone who, acting contrary to this specification, combines devices and thus operates a medical system does so at their own risk. Page 26...

  • Page 35: Safety And Maintenance

    Safety and Maintenance 14.1 Safety The enPuls Version 2.0 is manufactured in accordance with the DIN EN 60601-1 safety regulations. Zimmer MedizinSysteme GmbH shall only be held responsible for the safety and reliability of the device 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 36: Maintenance

    Safety and Maintenance 14.2 Maintenance Before commencing cleaning and maintenance, the machine must always be switched off at the main switch and the mains socket. Checking the impact During the course of normal use, a deformation / shortening of the rear impact dome dome on the applicator heads may occur.

  • Page 37: Function Test

    Function Test enPuls Version 2.0 performs a self-test when switched on checking all the internal components. In the event of a fault, an error message appears. In addition, a further function test can be performed as described below. This test should be performed monthly or in case of doubt about the proper function of the device.

  • Page 38: Safety Check Metrological Control

    Safety Check Metrological Control Neither a safety check (STK) nor a metrological control (MTK) is required for the enPuls Version 2.0 in Germany. In Germany, the Medical Devices Operator Ordinance (Medizinprodukte- Betreiberverordnung, MPBetriebV) and the DGUV (Vorschrift 3 Elektrische Anlagen und Betriebsmittel) apply in their current version, amongst other regulations.

  • Page 39: Error Messages Troubleshooting Disposal

    Error Messages Troubleshooting Disposal Loss of function In the status bar the message "Ready" appears and no pulse is emitted even handpiece though the footswitch has been activated. Possible cause 1 Handpiece / footswitch not properly connected or defective. Remedy for cause 1 Make sure that the footswitch and handpiece are correctly connected.
  • Page 40 Error Messages Troubleshooting Disposal Applicator not found In the status bar, the message "No applicator found" appears. Possible cause Handpiece not or improperly connected. Remedy for cause Make sure that the handpiece is properly connected. The connector must be fully inserted. Device malfunction No response to the main switch / display remains dark Possible cause 1...
  • Page 41 Fax +49 (0)731. 9761-118 www.zimmer.de export@zimmer.de Disposal Please observe the national regulations regarding disposal. Contact your distributor if necessary. The device may only be returned to the factory in the original packaging. It must be disposed of by Zimmer MedizinSystems. Page 33...

  • Page 42: Manufacturer's Emc Declaration

    Manufacturer's EMC Declaration Medical electrical equipment such as the enPuls Version 2.0 are subject to special precautions with regard to EMC (electromagnetic compatibility) and must be installed and commissioned in accordance with the EMC information contained in the user instructions or the accompanying documents.
  • Page 43 Guidelines and manufacturer's declaration - electromagnetic immunity The enPuls Version 2.0 device is intended for use in the electromagnetic environment specified below. The customer or the user of the enPuls Version 2.0 device should ensure that it is used in such an environment.
  • Page 44 Guidelines and manufacturer's declaration - electromagnetic immunity The enPuls Version 2.0 device is intended for use in the electromagnetic environment specified below. The customer or the user of the enPuls Version 2.0 device should ensure that it is used in such an environment.
  • Page 45 RF transmitters, a study of the electromagnetic phenomena at the location should be considered. If the measured field strength in the location in which the enPuls Version 2.0 device is used exceeds the above compliance level, the enPuls Version 2.0 device must be monitored to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as the realignment or relocation of the enPuls Version 2.0.
  • Page 46 Version 2.0 User Manual Zimmer MedizinSystems 3 Goodyear, Suite B Irvine, CA 92618 Tel: (800)-327-3576 Fax: (949)-727-2154 www.zimmerusa.com info@zimmerusa.com...

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