Zimmer enPulsPro Instructions For Use Manual
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Zimmer enPulsPro Instructions For Use Manual

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Instructions for Use
enPulsPro
USA

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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 Power switch 6 Mains on/off switch Handpiece 7 Handpiece 8 Vents, front 9 Air vents with fan, rear 10 Holder for hand piece 10 Handpiece holder Footswitch...

  • Page 3: Illustrations

    Illustrations Rear of the device Fig. 2 Switches / Socket for mains cable Connector sockets Mains fuse Socket for handpiece channel I Socket for handpiece channel II Socket for footswitch Serial number/name plate...

  • Page 4: Screens / Displays

    Illustrations Screens / Displays Fig. 3 Displays / Therapy 19 Status bar screen 20 On-screen buttons 21 Title bar 22 Navigation bar 23 VAS- Pre scale 24 VAS- Post scale Fig. 4 Navigation bar (A) Home Returns to the home page Description of the (B) Back Takes you back one step...

  • 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 a "Caution" with regard to Caution possible damage of the device. Connector socket for handpiece Connector socket for footswitch Operation instruction Follow instructions for use Serial number Article number...

  • Page 7: Table Of Contents

    Applicator heads and accessories Explanation of Symbols Page Indications / Contraindications Side Effects Application Information Warnings enPulsPro – in brief System 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 enPulsPro device. This instructions for use 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 enPulsPro may occasionally cause irritation, petechial, bruising, swelling or pain. Page 2...

  • Page 11: Application Information

    Please keep a safe distance of several meters. enPulsPro 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

    Warnings Users of the enPulsPro radial pulse therapy device must be instructed in the Caution proper use of the system and must possess the appropriate skills. The device is intended to be used exclusively by medical professionals. Caution Any treatment instructions regarding treatment location, duration and intensity...

  • Page 13: Enpulspro - In Brief

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

  • Page 14: System Set Up

    System Set Up Installation of Cables Note: If enPulsPro is not mounted on the designated system trolley, please make sure that it is standing on a stable surface. We recommend using the optional swiveling base. Note: Make sure that the power switch on the device is set to "0".

  • Page 15: 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 "instant start" button (2) immediately switches to the therapy screen Configuration menu The factory settings can be changed and adjusted individually using the...
  • Page 16 Settings (1) Startup settings 1. Start menu: Individual startup settings options. 2. Startup image: Choice between two startup images. The selection is made directly in the corresponding row. 3. Greeting: Activating the "Welcome" field opens a window with an alphabetic keyboard for entering a custom welcome message on the home screen.

  • Page 17: 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 18 In addition to temperature monitoring, enPulsPro 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 19: Notes On Operation

    8.2 Notes on Operation Therapy Please hold the handpiece as shown in the picture below. enPulsPro works using 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 20: Performing The Treatment

    Set the pulse energy using the left controller. energy Note: enPulsPro offers two options for the pulse output. Pulse output with a preset number of pulses In the case of pulse output with a preset number of pulses, the device itself stops therapy after reaching the preset number of pulses.

  • Page 21: Display And Buttons

    Operating Instructions 8.4 Display / 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 22 Operating Instructions 8.4 Display / Buttons (5) Mode Displays the selected operating mode. Upon activation of the "mode" menu, the selection menu appears with the following operating modes: Series Pulse, Burst - 4 pulses, Burst - 8 pulses, Burst - 12 pulses. The desired operating mode is selected directly in the corresponding row.

  • Page 23: 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", "Memory" and "VAS" buttons are pressed: "No SD card found". The use of "Favorites", "Memory" and "VAS" requires an SD card. Insert the card and confirm with "OK".

  • Page 24: Favorites And Memory Lists - Calling Up Programs, Editing Lists

    Operating Instructions 8.6 Favourites and Memory Lists – Calling up Programs / Editing Lists The parameters of the pre-defined programs can be individually modified and saved. Storing and naming Pressing the "Save" button opens the field for entering the program name. the program The program name is entered via the keyboard.
  • Page 25 Operating Instructions 8.6 Favourites and Memory Lists – Calling up Programs / Editing Lists The individually stored programs are listed in the Favorites list. Here these can be 1. called up in order to implement therapy or 2. edited (the sequence altered or entries deleted). Note: The steps for calling up and editing the favorites / memory lists are identical, therefore only the calling up and editing of the favorites list is described.
  • Page 26 Operating Instructions 8.6 Favourites and Memory Lists – Calling up Programs / Editing Lists Editing 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. Note: Pressing button (4) triggers a confirmation prompt: "Are you sure you want to delete the program?"...
  • Page 27 8.7 VAS – Visual Analogue Scale VAS information enPulsPro features a visual analogue scale, also referred to as the pain scale. The pain scale is commonly used in pain therapy. The pain scale is used to measure the patient's subjective pain intensity.
  • Page 28 Operating Instructions 8.7 VAS – Visual Analogue Scale Entering a new Activating the "VAS-Pre" field in the therapy screen opens the VAS screen. The patient "New" button opens the field for entering the patient's name. Enter the name of the patient. By pressing the "Save" button, the data is accepted and the screen with the pain scale opens automatically.
  • Page 29 Operating Instructions 8.7 VAS – Visual Analogue Scale Repeating a Already existing patients are activated in the VAS list, directly in the measurement corresponding row. After pressing the row, the screen with the pain scale automatically opens for a new measurement. Note: 40 measurements can be saved per patient.

  • Page 30: Technical Information

    Interval operation Accuracy ± Dimensions enPulsPro with H 54.33 Inch (138 cm) x W 20.87 Inch (53 cm) x L 20.47 Inch (52 cm) column enPulsPro H 11.81 Inch (30 cm) x W 13.78 Inch (35 cm) x L 7.87 Inch (20 cm) Column H 42.91 Inch (109 cm) x W 20.87 (53 cm) x L 20.47 Inch (52 cm)

  • Page 31: Cleaning Disinfection

    Cleaning Disinfection – Before starting any maintenance and cleaning measures the device must always be turn off at the main switch and unplugged. - Make sure that during cleaning and disinfection no liquids penetrate the device. Do not use sprays. - If during cleaning or disinfecting liquid penetrates the device, please put the unit out of service, protect it from getting used again and contact your service representative.
  • Page 32 Cleaning Disinfection Housing / Footswitch Cleaning: In the event of visible contamination, the housing, the footswitch and all cables can be cleaned using commercially available alcohol-free plastic cleaners. Wipe the surfaces until the dirt is removed, using a cloth that has been dampened according to the instructions given by the manufacturer of the cleaning agent, but that is not dripping.

  • Page 33: Scope Of Delivery And Accessories

    Scope of Delivery Accessories Scope of delivery in combination with column Part No. 5431 1 enPulsPro control unit 9160 1 Column with tray mount 5413 1 Handpiece, complete 93133521 1 Applicator head, 6 mm 93133511 1 Applicator head, 15 mm...
  • Page 34 Equipment Combinations For enPulsPro 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 enPulsPro is manufactured according to the DIN EN 60601-1 safety regulations. As manufacturer, Zimmer MedizinSysteme can only be considered responsible for safety and reliability if  the device is operated using a proper power outlet with a properly grounded 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 enPulsPro 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 regarding the correct functioning of the device.

  • Page 38: Safety Check Metrological Control

    Safety Check Metrological Control In Germany inter alia, the Medical Devices Operator Ordinance (Medizinprodukte- Betreiberverordnung, MPBetriebV) and the BG Electrical Plant and Equipment regulations (BG-Vorschrift Elektrische Anlagen und Betriebsmittel, BGV A3) apply in their current version. The devices are products in accordance with Appendix 1 MPBetreibV. In Germany, a safety inspection is to be performed every 12 months in accordance with §...

  • Page 39: Error Messages Troubleshooting Disposal

    Error Messages Troubleshooting Disposal Loss of function in In the status bar the message "Ready" appears and no pulse is triggered in the handpiece spite of activating the footswitch Possible cause 1 Handpiece / footswitch not properly connected or defective. Remedy for cause 1 Check that the footswitch and handpiece are connected correctly.
  • Page 40 Error Messages Troubleshooting Disposal Applicator not found In the status bar, the message "No applicator found" appears. Possible cause Handpiece not connected, or not correctly connected. Remedy for cause Make sure that the handpiece is properly connected. The connector must be fully engaged.
  • Page 41 Zimmer MedzinSystems Distributor 29 Mauchly, Suite 300 Irvine, CA 902618 Tel: (800)-327-3576 Fax: (949)-727-2154 www.zimmerusa.com Manufacturer Zimmer MedizinSysteme GmbH Junkersstraße 9 D-89231 Neu-Ulm Tel. +49 (0)731. 9761-0 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.

  • Page 42: Manufacturer's Emc Declaration

    Manufacturer's EMC Declaration Medical electrical equipment such as the enPulsPro 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 Manufacturer's EMC Declaration Guidelines and manufacturer's declaration - electromagnetic immunity The enPulsPro device is intended for use in the electromagnetic environment specified below. The customer or the user of the enPulsPro device should ensure that it is used in such an environment.
  • Page 44 Continuous operation is not required for the intended use. Guidelines and manufacturer's declaration - electromagnetic immunity The enPulsPro device is intended for use in the electromagnetic environment specified below. The customer or the user of the enPulsPro 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 enPulsPro device is used exceeds the above compliance level, the enPulsPro 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 enPulsPro.
  • Page 46 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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