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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 Power switch Handpiece 7 Handpiece 8 Vent, front 9 Vent with fan, rear 10 Holder for hand piece Footswitch 11 Footswitch...

  • Page 3: Illustrations

    Illustrations Rear of the device Fig. 2 Switches/sockets 13 Socket for mains cable 14 Mains fuse 15 Socket for handpiece channel I 16 Socket for handpiece channel II 17 Socket for footswitch 18 Identification plate...

  • Page 4: Screens / Displays

    Illustrations Screens / Displays Fig. 3 Display/ 19 On-screen buttons treatment screen 20 Status bar 21 Navigation bar 22 VAS- Pre scale 23 VAS- Post scale Fig. 4 Navigation bar (A) Back Takes you back one step Description of the (B) Therapy Switches to the therapy screen functions...

  • Page 5: Applicator Heads And Accessories

    Illustrations Applicator heads and accessories Fig. 5 Applicator heads 24 Applicator head, 25 mm 25 Applicator head, 15 mm 26 Applicator head, 6 mm Accessories 27 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 Instructions for use 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 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 enPulsPro (NG). These instructions for use is an integral part of the device. They must be stored with the device and be accessible at all times to anyone authorised to operate the 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 tendinitis • Chronic tendinopathy of the Achilles tendon • Plantar fasciitis • Heel spurs •...

  • Page 10: Side Effects

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

  • Page 11: Application Information

    The handpiece of the device is not designed for continuous operation. After a Caution max. 6,000 strokes, a treatment pause of 15 min is required. If the enPulsPro is not mounted on a designated wagon, ensure that the Caution enPulsPro is placed on a stable surface.

  • Page 12: Warnings

    15 min. If the treatment time is exceeded, the handpiece may overheat. Users of the enPulsPro shockwave treatment device must be instructed in the proper use of the system and have the appropriate knowledge.

  • Page 13: Enpulspro - In Brief

    It generates shock waves by means of an ergonomic handpiece and emits enPulsProdo? shock waves through special applicators. With the enPulsPro, a maximum penetration depth of approx. 35 mm can be achieved in human tissue. How are shock waves Using a coil, an electromagnetic field is generated in the back end of the generated with handpiece.

  • Page 14: Device Set-Up

    Device Set-Up Note: If the enPulsPro not mounted on the intended wagon, ensure that the enPulsPro is placed on a stable surface. Note: Make sure that the power switch on the device is set to "0" . Connect mains cable Connect the mains cable to the corresponding socket (13) on the device and connect the cable to the power.

  • Page 15: Settings

    Settings Note: Changes to the default settings are only possible 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 In the configuration menu, the factory default settings can be individually changed and adjusted.
  • Page 16 Settings (1) Start settings 1. Start menu: Individual options for the start settings. The selection is made directly on the corresponding line. (2) Language Selection of the language. The selection is made directly on the corresponding line. (3) Welcome Pressing the "Welcome" field opens a window with an alphabetic keyboard to enter a welcome message for the start-up screen.

  • Page 17: Operating Instructions

    Zimmer MedicalSysteme GmbH guarantees the unrestricted use of at least two million shocks per shockwave generator. Depending on power and frequency, the generator can produce far in excess of 2 million radial pulses.
  • Page 18 In addition to temperature monitoring, the enPulsPro regulates the temperature using a sensor in the handpiece. The fan in the handpiece is started when activated by the footswitch and automatically stops when it reaches a certain temperature.

  • Page 19: Notes On Operation

    8.2 Notes on Operation Treatment 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 20: Performing The Treatment

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

  • Page 21: Display And Buttons

    Operating Instructions 8.4 Display and Buttons Description of the display elements and buttons (1) Pulse energy Displays the set pulse energy. In the case of active treatment, the bar graph is filled in. The pulse energy can be set before and during the emission of pulses. The pulse energy can be adjusted from 60 to 185 mJ in 10 mJ increments.
  • Page 22 Operating Instructions 8.4 Display and Buttons (5) Mode Displays the selected mode. Upon activation of the window, the selection menu with the operating modes is displayed: Series Pulse, Burst 4 Pulse, Burst 8 Pulse, Burst 12 Pulse. The desired mode of operation is selected directly on the corresponding line. (6) Frequency Displays the set frequency.

  • Page 23: Sd Card

    Operating Instructions 8.5 SD card SD card User-defined settings and the list of indications are saved on the SD card. If the SD card is not inserted, the following message appears after pressing the "Favourites" and "VAS" keys: “SD card was not found”. The use of "Favourites"...

  • Page 24: Protocols

    Operating Instructions 8.6 Protocols The “Protocols” menu helps users to select the appropriate treatment. Protocols Pressing the (1) key opens the menu with the "treatment recommendations". Note: In the "Protocols" menu there are two ways to choose the desired treatment: - via the body region - via the list Treatment selection...
  • Page 25 Operating Instructions 8.6 Protocols Select differentiated The differentiated state of the disease is selected directly on the state of the disease corresponding line (here: acute). Treatment information After selecting the differentiated disease, another window with detailed treatment and treatment information opens. Pressing the (2) key opens additional treatment and treatment information.

  • Page 26: Favourites List - Retrieving Programs And Editing Lists

    Operating Instructions 8.7 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.
  • Page 27 Operating Instructions 8.7 Favourites List – Retrieving Programs and Editing Lists The individually saved programs are listed in the favourites list. These can be 1. retrieved for treatment 2. edited (shifted in the sequence and deleted). Select favourites list Pressing the “Favourites” button opens the favourites list. Retrieve program The desired program is selected directly in the corresponding row.
  • Page 28 Operating Instructions 8.7 Favourites List – Retrieving Programs and Editing Lists Edit favourites Pressing the (1) key returns you to the program. Pressing the (2) key moves the program upward. Pressing the (3) key moves the program downward. Pressing the (4) key deletes the program. Pressing the (5) key confirms the editing.

  • Page 29: Vas - Visual Analogue Scale

    8.8 VAS – Visual Analogue Scale Information on VAS The enPulsPro features a visual analogue scale, or pain scale. The pain scale is often used when treating pain. The pain scale is used to measure the subjective pain intensity of the patient.
  • Page 30 Operating Instructions 8.8 VAS – Visual Analogue Scale Editing the VAS list Pressing button (3) as well as button (4) and selecting the program to be edited directly in the corresponding row opens the screen for editing the data. Pressing the "Delete" button deletes the program. Pressing the "Scroll"...
  • Page 31 Operating Instructions 8.8 VAS – Visual Analogue Scale Perform VAS Post The pain sensation after treatment is establishes by activating the "VAS Post" field. Note: "VAS Post“ is identical to "VAS Pre“ and is therefore not described again. Repeating Existing patients are activated in the VAS list directly on the corresponding line. measurement After activating the line, the screen with the pain scale automatically opens for a new measurement.
  • Page 32 Operating Instructions 8.8 VAS – Visual Analogue Scale Table Pressing button (1) also displays the therapy progress in tabular form. Page 24...

  • Page 33: Technical Information

    10 Hz max. 185 mJ Operating mode Interval operation Accuracy ± Dimensions enPulsPro with H 138 cm × W 53 cm × L 52 cm SysCart enPulsPro H 30 cm × W 35 cm × L 20 cm SysCart H 109 cm ×...
  • Page 34 Technical Information Handpiece enPuls (Version 2.2) Dimensions 230 mm long, 50 mm diameter Weight 850 g Lifetime 2,000,000 shocks (shockwave generator) Applicator heads 6/15/25 mm Diameter can be changed without tools 150,000 shocks guaranteed Handpiece ZWave (version 2.2) Dimensions 230 mm long, 50 mm diameter Weight 850 g Lifetime...

  • Page 35: Info-Chart Duration Of Treatment

    Technical Information 9.1 Info-Chart Duration of Treatment Maximum shocks per treatment Frequency (Hz) Page 27...

  • Page 36: Cleaning / Disinfection

    Cleaning Desinfection - 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 37 Cleaning Desinfection 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 38 Cleaning Desinfection 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 39: Ce Mark

    CE mark The product bears the CE mark in accordance with EC directive 93/42/EEC concerning medical devices. Page 31...

  • Page 40: Scope Of Delivery And Accessories

    Scope of delivery Accessories Scope of delivery in combination with SysCart ItemNo. 5430 enPulsPro controller unit 9160 SysCart with tray mount 5413 Handpiece (version 2.2) 93133521 Applicator head, 6 mm 93133511 Applicator head, 15 mm 93133502 Applicator head, 25 mm...

  • Page 41: Device Combinations

    Device 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 33...

  • Page 42: Safety And Maintenance

    Safety and Maintenance 14.1 Safety The enPulsPro 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 43: 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 44: Functional Test

    Functional 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 about the proper function of the device.

  • Page 45: Safety Check Metrological Control

    Metrological Control Neither a safety check (STK) nor a metrological control (MTK) is required for the device enPulsPro in Germany. In Germany, the MPBetreibV (Medical Devices Operator Ordinance) and the DGUV (Regulation 3 – Electrical systems and equipment) apply in their current versions.

  • Page 46: Error Messages Troubleshooting Disposal

    Error Messages Troubleshooting Disposal Loss of function In the status bar the message "Ready" appears and no pulse is triggered in handpiece spite of activating the footswitch 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 47 Error Messages Troubleshooting Disposal Applicator not found In the status line, 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 plug must be fully inserted.
  • 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 headquarters in Neu-Ulm. Headquarter Zimmer MedizinSysteme GmbH Junkersstraße 9 D-89231 Neu-Ulm Tel: 0731. 9761-0 Fax: +49 731.

  • Page 49: Manufacturer's Emc Declaration

    Guidelines and manufacturer’s declaration – electromagnetic interference emissions The enPulsPro is intended for use in one of the electromagnetic environments specified below. The customer or the user of the enPulsPro should ensure that it is only used in such an environment.
  • Page 50 Guidelines and manufacturer’s declaration – electromagnetic interference resistance The enPulsPro is intended for use in one of the electromagnetic environments specified below. The customer or user of the enPulsPro should ensure that it is only used in such an environment.
  • Page 51 Guidelines and manufacturer’s declaration – electromagnetic interference resistance The enPulsPro is intended for use in one of the electromagnetic environments specified below. The customer or user of the enPulsPro should ensure that it is only used in such an environment.
  • Page 52 Recommended separation distances between portable and mobile RF communications equipment and the enPulsPro The enPulsPro is intended for use in one of the electromagnetic environments specified below. The customer or the user of the enPulsPro can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the enPulsPro –...
  • 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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