Zimmer Z Field Dual Instructions For Use Manual
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Zimmer Z Field Dual Instructions For Use Manual

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Instructions for use
ZField
Dual (MFG-03)
EN

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Summary of Contents for Zimmer Z Field Dual

  • Page 1 Instructions for use ZField Dual (MFG-03)
  • Page 3 Illustrations Front of the device Fig. 1 Front of the device Applicator, left side Applicator, right side Display Central control knob Control unit Swiveling castors...
  • Page 4 Illustrations Rear of the device Fig. 2 Rear of the device Connections for applicator hose Ventilation grid Mains connection On/off switch Identification plate...
  • Page 5 Illustrations Screens and displays Fig. 3 Screen and displays Remaining time Total operating time Configuration icon Intensity in % Start/stop Channel selection (channel 1 and/or channel 2) Applied program Mode selection (Programs/Region/Manual Mode) Program information screen...
  • Page 6 Illustrations Accessories Mains cable Fixingbelt...

  • Page 7: Explanation Of Symbols

    Explanation of symbols In the instructions for use, this symbol indicates "Danger". In the instructions for use, this symbol warns of "caution" regarding possible damage to the Caution device. Applied part of type BF Consult instructions for use Follow the instructions for use No access for people with pacemakers Do not push the device Do not sit on the device...
  • Page 8 Explanation of symbols Disposal of electrical and electronic equipment as well as used batteries and accumulators. This product must not be disposed of with household waste. Washing, maximum 40°C Do not bleach Do not dry clean Do not tumble dry Do not iron Do not stack Keep dry...

  • Page 9: Table Of Contents

    Contents Illustrations Front of the device Rear of the device Screens and displays Accessories Explanation of symbols Page Indications / Contraindications / Side Effects Warnings Z Field – overview Dual Intended purpose Setting up the device Settings Operating instructions Technical information Cleaning and disinfection CE marking Scope of delivery and accessories...
  • Page 10 Contents Device combinations Safety Function check Legal Notice Error messages/troubleshooting Disposal Manufacturer's Declaration on Electromagnetic Compatibility (EMC) Material Safety Data Sheet Valid for Z Field (MFG-03) devices. Dual These operating instructions form part of the device. They must be stored together with the device and kept accessible at all times to all persons who are authorised to operate this device.

  • Page 11: Indications / Contraindications / Side Effects

    Indications / Contraindications / Side Effects Indication Muscular atrophy Recommended application To strengthen and tighten the abdominal, gluteal and thigh muscles. Operating environment Z Field is only to be used in medical facilities. The device is intended for indoor use. Dual Contraindications Placing an active applicator over implanted electrical devices like pacemakers,...
  • Page 12 Indications / Contraindications / Side Effects Side effects There are no reports of side effects. However, if the patient experiences abnormal symptoms, the operator must stop treatment immediately and contact the appropriate physician. The adverse effects may include, but are not limited to: Muscular pain •...

  • Page 13: Warnings

    Dual Check the device before use. If damage can be seen on it, it must not be used. Only accessories from Zimmer MedizinSysteme GmbH may be used. The patient should not be left unattended during treatment. Page 3...
  • Page 14 Warnings The device is intended for use by medical professionals only. All treatment instructions regarding treatment location, duration, and intensity require medical knowledge and should be issued by authorised physicians, therapists, and medical assistants. It is imperative that these instructions are followed. Please refer to chapter 16, Material Safety Data Sheet, in case of leaking oil or contact your service engineer.

  • Page 15: Z Field Dual - Overview Intended Purpose

    Z Field – overview Dual Intended purpose Intended Use Z Field is an electrically operated medical device and provides electromagnetic Dual impulses. Z Field generates an electromagnetic field and is able to contract/stimulate Dual the muscles. Intended Purpose An electromagnetic field is generated by electricity. These impulses are delivered to the muscle tissue via the applicators.

  • Page 16: Setting Up The Device

    Setting up the device After transport and before switching on the device, make sure that the swivel wheels are in Caution the "locked" position. Note: Make sure the Z Field is on a stable and level surface. Dual Connecting the mains Plug the mains cable (21) into the socket on the device (9) as shown below and connect it to cable the mains.

  • Page 17: Settings

    Settings Home screen When the device is switched on, a self-test is carried out and the home screen opens. Default screen After performing the self-test, the Z Field will automatically switch to the default screen. Dual Selecting the By pressing the configuration button (A), you will immediately switch to the configuration configuration menu.
  • Page 18 Settings Configuration menu Adjust the brightness using the arrow keys to the left and right. (B) Brightness (C) Volume Adjust the volume using the arrow keys to the left and right. (D) Language Select the language using the arrow keys to the left and right. Only for service partners (E) Administrator Displays information about the current software version.

  • Page 19: Operating Instructions

    Operating instructions Description of the device Z Field consists of a main body and two equally sized applicators that are connected to it. Dual The input power for this device is 230 V AC. The repair, enhancement and installation of the device may only be carried out by specialists who have been authorised by the manufacturer.
  • Page 20 Operating instructions Placing the applicator Place the applicators onto the treatment area so that the connection cables face the foot end. Secure the applicators using the fixingbelt supplied with the device. The fixingbelt is available in S and M versions. The larger one is for the abdomen and buttocks area and the small one is for the legs.
  • Page 21 Operating instructions (H) Time remaining Shows the progress of the treatment time in a graphic representation. (I) Total operating time At the beginning: displays the total treatment time. During operation: counts down the treatment time. (J) Configuration menu See chapter 5, settings for setting options. (K) Intensity After pressing the start button: displays the applied intensity in graphic form and as a percentage (0 –...
  • Page 22 Operating instructions Region mode The region mode has four preprogrammed recommended applications. The regions are regions of the body: "buttocks", "abdomen", "legs". These programmes are not adjustable. Manual mode The manual mode has five freely storable modes and allows one to create individual protocols for patients and treatment.
  • Page 23 Operating instructions After the parameter setting screen appears, the user can set the parameter values. After pressing Name for about 2 seconds, an on-screen keyboard appears and the pre- programmed name can be changed. Pressing the Parameter section will display the settings screen and the parameter values will change.
  • Page 24 Operating instructions Select the parameter to be modified. Freq1, on time, off time, strength and repetitions can be set in this mode by changing the parameter values on the central control knob (4). Each mode has 5 sub-modes with different parameter sets. The manual mode works sequentially from sub-mode 1 up.

  • Page 25: Technical Information

    Technical information Input power: 220–240 V 50/60 Hz Power supply Power consumption: max. 1500 VA Mains fuse 16 A circuit breaker in mains switch Protection class Class 1 Applied part Type BF Dimensions 542 (L) × 501 (W) × 993 (H) mm Weight About 60 kg Magnetic field strength:...

  • Page 26: Cleaning And Disinfection

    Cleaning Disinfection Before starting cleaning work, always turn off the device at the main switch and unplug the mains cable. Make sure that no liquids get into the device during cleaning and disinfection. Please do not use sprays. If liquid gets into the device during cleaning or disinfection, please take the device out of operation, protect it from being reused, and contact your service partner.
  • Page 27 Cleaning Disinfection Monitoring: 1. Check whether the fixingbelts are free from punctures or other damaged areas. 2. Check whether the fixingbelts show uniform thickness over the entire surface. Packaging: Pack the fixingbelts in cloth or foil pouches or other suitable dust cover to protect them from dust and dirt.

  • Page 28: Ce Marking

    CE marking The product Z Field (MFG-03) bears the CE marking Dual 0123 in accordance with EC Directive 93/42/EEC concerning medical devices. Zimmer MedizinSysteme GmbH Manufacturer Junkersstraße 9 89231 Neu-Ulm, Germany www.zimmer.de Page 18...

  • Page 29: Scope Of Delivery And Accessories

    1 Fixingbelt S (50-70 cm) 54209410 1 Fixingbelt M (80-105 cm) Subject to technical changes. Note: The device may only be operated with original Zimmer MedizinSysteme GmbH accessories. Otherwise, the function and the safety of patients, users and others cannot be guaranteed. Page 19...
  • Page 30 Dual IEC 60601-1 ed. 3.1. maintenance As a manufacturer, Zimmer MedizinSysteme GmbH can only be held responsible for safety and reliability if: the device is operated at a properly earthed socket and the electrical installation •...

  • Page 31: Function Check

    If any of the above occur, please ask your service partner for help. Safety check To ensure safe use, internal cleaning should be performed once a year by a person authorised by Zimmer MedizinSysteme GmbH. To ensure safe use, have the system, including its internal components and output voltage, checked once a year by a person authorised by the company.

  • Page 32: Legal Notice

    Legal notice The Z Field is listed in attachment 1 of the MPBetreibV (Medical Devices Operator Dual Ordinance). Please observe the measures which are necessary as a result. The device is not listed in attachment 2 of the MPBetreibV. In Germany, the German Social Accident Insurance (DGUV) Regulation 3 (Electrical systems and equipment), as amended, must also be observed.

  • Page 33: Error Messages/Troubleshooting Disposal

    Error messages/troubleshooting Disposal Messages: Error messages Overheating Z Field is a device that generates a magnetic field by applying high current to an Dual applicator. While the applicator generates heat due to the high current used to generate the magnetic field, it is cooled by means of cooling oil being circulating inside the Z Field Dual applicator.
  • Page 34 Error messages/troubleshooting Disposal Applicator error The Z Field always checks the connection of the applicator cable. If the cable is Dual disconnected or damaged, the message shown in 25 will appear. In this case, the device may no longer be used. Please contact the authorised service staff of our local distributor. Note: The Z Field always checks the connection status of the cable connected to the applicator.
  • Page 35 Fax +49 731 / 9761-299 export@zimmer.de www.zimmer.de Device Disposal The device must be returned to the factory. It must be disposed of by Zimmer MedizinSysteme GmbH. In (European) foreign countries, please observe the national disposal regulations. If necessary, contact the distributor. Page 25...

  • Page 36: Manufacturer's Declaration On Electromagnetic Compatibility (Emc)

    Manufacturer's Declaration on Electromagnetic Compatibility (EMC) The MFG-03 is developed according to the recognized standards of technology; the information on the intended use of the components is taken into account. The MFG-03 must not be operated near active HF surgery devices or magnetic resonance tomography that can cause high levels of electromagnetic interference.
  • Page 37 Manufacturer's Declaration on Electromagnetic Compatibility (EMC) Table 1 Guidance and Manufacturing Declaration- Electromagnetic Emissions The device MFG-03 is intended for use in the electromagnetic environment specified below. The customer or user of the device MFG-03 should ensure that it is used in such environment. Emission Measurement Compliance Electromagnetic Environment-Guidelines...
  • Page 38 Manufacturer's Declaration on Electromagnetic Compatibility (EMC) Guidance and Manufacturing Declaration- Electromagnetic Immunity The device MFG-03 is intended for use in the electromagnetic environment specified below. The customer or user of the device MFG-03 should ensure that it is used in such environment. Immunity IEC 60601- Test Level Compliance Level...
  • Page 39 Manufacturer's Declaration on Electromagnetic Compatibility (EMC) Table 4 Electromagnetic immunity to HF radio communication equipment Test Maximum Immunity Test Band Distance Frequency Service Modulation Energy Level (MHz) (MHz) (V/m) 380-390 TETRA 400 Pulse Modulation 18 Hz 430-470 GMRS 460, Pulse FRS 460 Modulation 18 Hz...

  • Page 40: Material Safety Data Sheet

    Material Safety Data Sheet Page 30...
  • Page 41 Material Safety Data Sheet Page 31...
  • Page 42 Material Safety Data Sheet Page 32...
  • Page 43 Material Safety Data Sheet Page 33...
  • Page 44 Material Safety Data Sheet Page 34...
  • Page 45 Material Safety Data Sheet Page 35...
  • Page 46 Material Safety Data Sheet Page 36...
  • Page 47 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-aesthetics.com...

This manual is also suitable for:

Mfg-03

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