Zimmer emFieldPro Instructions For Use Manual
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Zimmer emFieldPro Instructions For Use Manual

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Instructions for Use
emFieldPro
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Summary of Contents for Zimmer emFieldPro

  • Page 1 Instructions for Use emFieldPro...
  • Page 3 Illustrations Front of the Device Fig. 1 Front of the device Applicator (large) Applicator quick-connector Applicator arm Applicator (medium) Display Central control knob Control unit Swiveling wheels...
  • Page 4 Illustrations Rear of the Device Fig. 2 Rear of the device Connectors for applicator tube Cooling Power connector Power switch Serial no / Identification plate...
  • Page 5 Illustrations Screens and Displays Fig. 3 Screens and displays Time remaining Total operation time Configuration icon Intensity in % Start/Stop Channel selector (CH1 Large or CH2 Medium) Applied program Mode selector (Programs / Favourites / Expert mode) Program information screen...
  • Page 6 Illustrations Accessories Mains cable Hex key...

  • Page 7: Explanation Of Symbols

    In the instructions for use this symbol indicates “Danger”. In the instructions for use this symbol indicates "Caution" with regard to possible Caution damage of the device. Applied part BF type emFieldPro Operation instructions Please refer to the notes. Follow instructions for use...

  • Page 8: Table Of Contents

    Explanation of Symbols Page Indications / Contraindications 1.1.1. Side Effects 1.1.2. Application Information 1.1.1. Warnings 1.1.1. emFieldPro - in brief Intended use 1.1.2. Device set up 6 - 7 1.1.3. Settings 8 - 9 1.1.1. Operation Instructions 10 - 18...
  • Page 9 Contents Technical Information Cleaning Disinfection 1.1.2. CE-Mark 1.1.3. Scope of Delivery and Accessories 1.1.4. Device Combinations Safety and Maintenance 1.1.5. Functional Test 25 - 26 Safety Check 1.1.6. Error Messages / Troubleshooting 28 - 30 Disposal Manufacturer’s EMC declaration 31 - 34...
  • Page 10 Contents Valid for emField Pro devices. 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. The instructions for use is valid as of February 2020...

  • Page 11: Indications / Contraindications

    Be ensured that magnetic stimulation doesn’t penetrate the heart region. The emFieldPro should be used with caution in persons with Grave’s disease, active bleeding disorders or seizure disorders. Patients in the following categories cannot be treated, prior to permission of the doctor in charge: ...

  • Page 12: Side Effects

    Side Effects Side effects There are no side effects reported. However, if the patient experiences any abnormal symptoms the operator must stop the treatment immediately and contact the doctor in charge. Page 2...

  • Page 13: Application Information

    To avoid the risk of electric shock; the device´s main plug must be disconnected from the mains supply before performing any maintenance or cleaning activities. The emFieldPro is not suitable for use in areas with an explosive, flammable or combustive environment.

  • Page 14: Warnings

    Warnings Users of the emFieldPro must be trained in how to use the device properly and have the appropriate skills. The patient must not be left unattended during therapy. The device is intended to be used exclusively by medical professionals.

  • Page 15: Emfieldpro - In Brief Intended Use

    Pro - in brief / Intended use What is the emFieldPro is a most reliable and powerful pulsed inductive therapy device. emFieldPro? What does the emFieldPro generates max. 3 Tesla electromagnetic field to treat acute and chronic emFieldPro do? pains. What are the Non-invasive treatment ...

  • Page 16: Device Set Up

    ‘locked’ position. Note: Make sure that the emFieldPro is placed on a stable and flat surface Connect mains cable Connect the mains cable (23) to the socket on the device (11) and connect it to the mains.
  • Page 17 Device Set Up After using the emFieldPro for a long time, the transducer arm may be stuck down or Caution up. In this case, the position of the transducer arm can be changed by adjusting the gas spring pressure. To lower the arm supporter, turn the hexagonal wrench bolt in the () direction as shown in the figure below, and turn it in the () direction to lift it...

  • Page 18: Settings 1.1.3

    Once the device has been switched on and the self-test performed, the start-up screen opens. Standard screen After the self-test has been performed, the emFieldPro goes automatically in the standard screen. Selecting configuration Pressing the Configuration button (A) immediately switches to the configuration menu.
  • Page 19 Settings Configuration menu (B) Brightness Adjust the brightness by using the left and right arrows. Adjust the volume by using left and right arrows. (C) Volume (D) Language Selection of the language by using the left and right arrows. (E) Admin Only for service partners (F) Version Shows information about the current software version...

  • Page 20: Operation Instructions

    Operation Instructions Device description The emFieldPro consists of a main body and 2 transducers connected to it. It relieves the muscular pain using electromagnetic fields. The transducer is generally placed on the area of the pain with some distance to the skin.
  • Page 21 Operation Instructions Transducer placement You can adjust the position and angle of the CH1 transducer according to the patient and the stimulation area. The CH1 transducer arm can be moved up and down and left and right. The angle of the CH1 transducer can be adjusted using the transducer holder.
  • Page 22 Operation Instructions (H) Time remaining (I) Total operation time (J) Configuration icon (K) Intensity in % (L) Start/Stop (M) Channel selector (CH1 Large or CH2 Medium) (N) Applied program (O) Mode selector (Programs / Favourites / Expert mode) (P) Program information screen (H) Time remaining Shows graphical the course of the treatment time.
  • Page 23 Operation Instructions (M) Channel Selector Select either CH1 (Large transducer) or CH2 (Medium/Hand-held transducer). The color of the button indicates that the channel has been darkened as active. (N) Applied program By using one of the buttons (0) followed by selecting one of the stored programs by using the central control knob (6), the selected mode is displayed in the mode selection window located at the lower left part of the display.
  • Page 24 Operation Instructions Change settings of the Favourites mode like following: Press the Favourites button for 2 ~ 3 seconds to set the parameters on touch screen. The user is able to set the parameter values after appearance of the parameter setting screen Choose the parameter to change.
  • Page 25 Operation Instructions After pressing about 2 seconds on one of the Favourites a screen will appear in which a name of the region can be changed. After changing the name, press Exit to close the screen. Expert Mode The Expert Mode has 20 free to store modes; the user can set the parameter values directly.
  • Page 26 Operation Instructions The parameter settings are: - Wave : Select one of the following waves: Sinus; Triangle; Downward Triangle; Upward Triangle or Flat by selecting the according symbol. - L (Hz) : Low limit of waveform (6-149 Hz). This frequency has to be lower than H (Hz).
  • Page 27 Operation Instructions By pressing on the Name for about 2 seconds, an alphabet screen appears and the pre- programmed name can be changed. By pressing the Parameter section, setting screen appears and the parameter values change. Choose the parameter to change. Wave, L (Hz), H (Hz), T1, Off, T2,, Strength, Repetition can be set in this mode by using the central control knob (6) which changes the parameter values.
  • Page 28 Operation Instructions Each mode has 9 sub-modes with different parameter sets. The Expert mode operates sequentially from sub mode 1. A sub-mode is added by pressing a pencil figure at the end of the top right parameter setting screen. To remove a sub-mode, press the bin figure in the right top corner after choosing the specific sub-mode.

  • Page 29: Technical Information

    Technical Information Power supply Input power: 100-120/220-240 V 50/60Hz Power consumption: max 1500VA Mains fuse T12,5AT/250Vac Protection class Class 1 Applied class Type BF Dimensions 542 (L)  501 (W)  993 (H) mm Weight Approx. 60 kg Operation Magnetic field strength: CH1: 3.0 T –...

  • 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 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 being used again and contact your service representative.

  • Page 31: Ce-Mark

    CE-Mark The product bears the CE-mark in accordance with the EC Directive on Medical Devices 93/42/EWG. Page 21...

  • Page 32: Scope Of Delivery And Accessories

    Scope of Delivery and Accessories Scope of delivery Art. no. 5030 1 emFieldPro including 2 transducers 1 applicator arm 1 Instructions for use 1 Mains cable 1 Hex Key Accessories Art. no. 54209200 1 Applicator arm 67300124* 1 Mains cable type...

  • Page 33: Device Combinations

    Device Combinations For emFieldPro no combination devices are provided by the manufacturer. Anyone who, acting contrary to these specifications combines devices and thus operates a medical system does so at its own risk. Page 23...

  • Page 34: Safety And Maintenance

    Safety and Maintenance The emFieldPro is manufactured according to the safety regulations of IEC 60601-1. As manufacturer, Zimmer MedizinSysteme GmbH can only be considered responsible for the safety and reliability if: - the device is operated using a proper power outlet that is properly grounded and...

  • Page 35: Functional Test

    If any of the above occurs, contact your servicepartner for help. Safety inspection In order to ensure safe use, internal cleaning should be performed once per year by a person authorized by Zimmer MedizinSysteme GmbH In order to ensure safe use, be sure to check the equipment including internal components and output voltage from the person who has been given authorization from the company once per year.
  • Page 36 Functional Test Self-troubleshooting Symptom What to do References in the User Guide Check if the power connector of the • Chapter 6; device set up equipment is properly connected. Equipment does not turn on. Check if the power switch of equipment is •...

  • Page 37: Safety Check

    Safety Check The emFieldPro is listed in attachment 1 of the MPBetreibV (Medical Device Operator Ordinance). Please observe the measures which are necessary as a result. Note: These requirements apply to the operation of the device in Germany. Divergent regulations may apply in your country.

  • Page 38: Error Messages / Troubleshooting

    Messages: Over Temperature The emFieldPro is an equipment that generates a magnetic field by applying a high current to a transducer. As heat is generated from the transducer using the high current used to create the magnetic field, cooling is performed by circulating the cooling oil inside the emFieldPro transducer.
  • Page 39 Disposal Transducer Error The emFieldPro always checks the connection of the transducer cable. If the cable is disconnected or damaged, the message is shown as in figure 27. In this case, equipment cannot be used anymore, and the user must contact authorized personnel of our local distributor maintenance.
  • Page 40 Disposal The device may only be returned to the factory in the original packaging. It must be disposed by Zimmer MedizinSysteme GmbH. In foreign (European) countries, please refer to national regulations for disposal. Contact your distributor if necessary. Page 30...

  • Page 41: Manufacturer's Emc Declaration

    Portable and mobile HF communications equipment (e.g mobile telephones, cell phones) can impact medical electrical devices. The emFieldPro may only be operated using the original power cable indicated in the scope of delivery list. Operating the device with another power cable can lead to increased emissions or reduced interference resistance of the device.
  • Page 42 Manufacturer´s EMC declaration Guidelines and manufacturer declaration - electromagnetic interference resistance The emField Pro device is intended for operation in the electromagnetic environment indicated below. The emField Pro customer or user should ensure that it is used in such an environment. Interference resistance IEC 60601- Test Compliance level...
  • Page 43 Manufacturer´s EMC declaration Guidelines and manufacturer declaration - electromagnetic interference resistance The emField Pro device is intended for operation in the electromagnetic environment indicated below. The emField Pro customer or user should ensure that it is used in such an environment. Interference IEC 60601 test Compliance...
  • Page 44 Manufacturer´s EMC declaration The field strength of stationary transmitters such as base stations for portable telephones and mobile land radios, wireless keyboard stations, AM and FM radios and televisions cannot be accurately theoretically predetermined. To determine the electromagnetic environment with regards to the stationary transmitters, a study of the electromagnetic phenomena of the location should be considered.
  • Page 48 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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