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Zimmer emFieldPro, Instructions For Use Manual, Page: 3 / 48

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Zimmer emFieldPro Instructions For Use Manual Download Page 3

 

Illustrations 
 

Front of the Device 

 

 

 

Fig. 1 Front of the device 

 

 
 

 

 

 

 

 
 

 

 

 

 
 

 

 

 

 

 

 
 

 

 

 

 

 
 

 

 

 

 
 

 

 

 

 
 

1

 

Applicator (large) 

2

 

Applicator quick-connector 

3

 

Applicator arm 

4

 

Applicator (medium) 

5

 

Display 

6

 

Central control knob 

7

 

Control unit 

8

 

Swiveling wheels 

 

1 
2 

3 

4 

5 

7 

8 

6 

Summary of Contents for emFieldPro

Page 1: ...Instructions for Use emFieldPro EN ...

Page 2: ......

Page 3: ... Front of the Device Fig 1 Front of the device 1 Applicator large 2 Applicator quick connector 3 Applicator arm 4 Applicator medium 5 Display 6 Central control knob 7 Control unit 8 Swiveling wheels 1 2 3 4 5 7 8 6 ...

Page 4: ...Illustrations Rear of the Device Fig 2 Rear of the device 9 Connectors for applicator tube 10 Cooling 11 Power connector 12 Power switch 13 Serial no Identification plate 9 10 11 12 13 ...

Page 5: ... 14 Time remaining 15 Total operation time 16 Configuration icon 17 Intensity in 18 Start Stop 19 Channel selector CH1 Large or CH2 Medium 20 Applied program 21 Mode selector Programs Favourites Expert mode 22 Program information screen 14 15 16 17 17 19 20 21 22 ...

Page 6: ...Illustrations Accessories 23 Mains cable 24 Hex key ...

Page 7: ...ard to possible damage of the device Applied part BF type emFieldPro Operation instructions Please refer to the notes Follow instructions for use Serial number Article number Manufacturer Date of manufacture Disposal of electrical and electronic equipment as well as used batteries and accumulators This product must not be disposed of with household waste ...

Page 8: ...ays Accessories Explanation of Symbols Page 1 Indications Contraindications 1 1 1 1 2 Side Effects 2 1 1 2 3 Application Information 3 1 1 1 4 Warnings 4 1 1 1 5 emFieldPro in brief Intended use 5 1 1 2 6 Device set up 6 7 1 1 3 7 Settings 8 9 1 1 1 8 Operation Instructions 10 18 ...

Page 9: ...2 11 CE Mark 21 1 1 3 12 Scope of Delivery and Accessories 22 1 1 4 13 Device Combinations 23 14 Safety and Maintenance 24 1 1 5 30 15 Functional Test 25 26 16 Safety Check 27 1 1 6 17 Error Messages Troubleshooting Disposal 28 30 18 Manufacturer s EMC declaration 31 34 ...

Page 10: ...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: ...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 Patients with high fever Pregnant woman Elderly and Children Patients with hearing aids Patients with implants such as artificial hip joint Patients wit...

Page 12: ...e Effects 2 Page 2 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 13: ...al stress Operation of this equipment in the vicinity of strong electromagnetic fields e g tomographs x ray or diathermy equipment may interfere with the operation of the device Please keep a safe distance of several meters During use the device is to be located in a position allowing direct access to the device s central mains supply so that it can be disconnected for the mains at any time To avo...

Page 14: ...tructions regarding treatment location duration and intensity require medical knowledge and should be given by authorised physicians therapists and health paraprofessionals It is imperative that these instructions are followed The use in wet areas is not permitted and may in case of non compliance lead to considerable damage to the device and endanger both the patient and the user Dispose packagin...

Page 15: ...her advantages of emFieldPro Two types of transducer for wider application Intended use The emFieldPro is an electrically powered device intended for medical purposes that repeatedly contracts muscle tissue by passing electrical currents through electrodes non contacting the affected body area In addition the device is intended to provide entirely non invasive electromagnetic stimulation of pelvic...

Page 16: ... that connecting the power cable with the power switch turned on may cause malfunction If the transducer is used while in a tilted position the cooling oil will not reach all sections of the transducer and damage the transducer due to overheating For this reason it is recommended to place the transducer in a horizontal position as much as possible When separating the transducer from the transducer...

Page 17: ... 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 upwards To adjust the transducer arm use only the supplied hex key 24 The device is switched off using the power switch 12 In order to completely disconnect the device all phase from the mains remove the mains ...

Page 18: ...nd 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 A ...

Page 19: ...ght arrows C Volume Adjust the volume by using left and right arrows 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 G Close Closes and stores the configuration menu F G B C D E ...

Page 20: ...n technicians assistants and patients must not hold any items which can be affected by the magnetic field Note When equipment is operated do not use any items as wristwatches mobile phones radio sets transmitters or wireless toys as the may be damaged by magnetic fields So please be careful and keep them separately Note To avoid electrical noise during use the equipment shall be installed at a sig...

Page 21: ...ngle of the CH1 transducer can be adjusted using the transducer holder The height of the CH1 transducer arm is adjusted by the weight of the CH1 transducer using gas spring pressure To adjust the angle of the CH1 transducer hold the CH1 transducer holder in the unlocked position and adjust the angle The holder must be locked after adjustment is complete Please refer the figure below Do not use the...

Page 22: ...use the central control knob 6 to set change the total operation time J Configuration menu Refer to Chapter 7 Settings for setting possibilities K Intensity After pressing the start button shows graphical and in percentage 0 100 the applied intensity Set change the intensity by using the central control knob 6 Turn to the right to increase intensity and or turn to the left to decrease the intensit...

Page 23: ... programmed treatment recommendations A more detailed description can be found in the treatment guide Every recommendation can be further specified by selecting Chronic or Acute Favourites Mode P Program Information Screen The Favourites Mode has 20 free to store programs Frequency of the magnetic field continuous output time and pause time are set in advance The waveform of the selected mode is a...

Page 24: ...een The user is able to set the parameter values after appearance of the parameter setting screen Choose the parameter to change Freq1 Freq2 On Time Off Time can be set in this mode By using the central control knob 6 parameter values are set After finishing all the settings close the parameter setting screen by pressing a closing window X at the upper right corner ...

Page 25: ...pear 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 To change settings press Expert Mode on the touch screen for 2 3 seconds to set the parameter values ...

Page 26: ... High limit of waveform 7 150 Hz This frequency has to be higher than L Hz T1 Duration of the stimulation phase 1 10 seconds The setting ranges are different according to the value of the frequencies OFF Hz Frequency during the Off phase 0 4 Hz T2 Duration of the Off phase 4 10 seconds The setting ranges are different according to the value of the frequencies STR 1 100 multiplying factor for the m...

Page 27: ...s 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: ... 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 After specifying the name and parameter values for the Expert Mode Program click close window X at the top right to close the parameter setting screen ...

Page 29: ...3 0 T pp 20 CH2 2 5 T pp 20 Modes Programs Mode A1 A20 Favorites Mode M1 M20 Expert Mode U1 U20 Transport Transport with the device in a vertical position 1 Packaging 1 device Operation Operation environment Temperature 0 30 Humidity 10 90 RH Air Pressure 700 1060 hPa Storage and Transport Storage and transport environment Temperature 0 30 Humidity 10 90 RH Air Pressure 700 1060 hPa Notice Storage...

Page 30: ...dirt is removed using a soft cloth soaked according to the specifications of the manufacturer of the cleaning agent but not dripping wet Disinfection We recommend that disinfection to be carried out at least once a week as well as in the event of evidence of possible contamination Consult with your health professional when doing so Always perform cleaning prior to disinfection Housing and applicat...

Page 31: ...CE Mark 11 Page 21 The product bears the CE mark in accordance with the EC Directive on Medical Devices 93 42 EWG ...

Page 32: ...ieldPro 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 10102817 1 Instruction for use Subject to change Individual mains cable available Please contact your distributor ...

Page 33: ...ations 13 Page 23 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 34: ...uthorized by Zimmer MedizinSysteme GmbH the user is satisfied regarding the functional safety the proper condition and mechanical integrity prior to using of the device the device is operated only by properly trained personnel the device is not operated in hazardous areas and or a combustive atmosphere the device is immediately disconnected from the mains in the event of the penetration of liquids...

Page 35: ...mmer 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 Please clean the transducer before storing After storing the device for a long period of time be sure to check the device before using it Please note the following regarding storage condi...

Page 36: ...to overheat Maintain a horizontal position as much as possible 17 Error Messages and Troubleshooting If the room temperature is too high disorder can be caused in the cooling Maintain the room temperature at less than 25 as much as possible 17 Error messages and Troubleshooting In the following cases stop the operation by cutting off the power to the equipment and contact the service center The ma...

Page 37: ...d 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: ...al position When transducer is overheated the operation is temporarily suspended and the Over Temperature message as shown in figure 25 is displayed When this message is displayed put the transducer away from the patient for a while Do not turn off the equipment until the message disappears and the equipment returns to a normal state Caution It is highly recommended to use the transducer in a hori...

Page 39: ...ransducer 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 Note The emFieldPro always checks the connection state of the cable connected to the transducer 27 ...

Page 40: ...lm Germany Tel 49 731 9761 291 Fax 49 731 9761 299 export zimmer de www zimmer de 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 41: ...as indicated below The emFieldPro customer or user should ensure that it is operated in such an environment Emitted interference Compliance Electromagnetic environment guideline HF emissions in accordance with CISPR 11 Group 1 The emFieldPro device uses HF energy solely for its internal function Therefore its HF emissions are very low and it is improbable that it will interfere with neighboring el...

Page 42: ... in accordance with IEC 6100 4 5 1 kV differential mode voltage 2 kV common mode voltage 1 kV differential mode voltage 2 kV common mode voltage The quality of the supply voltage should correspond with a typical business or hospital environment Drops in voltage temporary interruptions and fluctuations in the supply voltage in accordance with IEC 61000 4 11 5 UT 95 drop in the UT for period 40 UT 6...

Page 43: ...ables should not be used at distances to the Cryo 6 less than the recommended safety distance which is calculated based on the applicable equation for the transmission frequency Recommended safety distance d 1 17 P d 1 17 P for 80MHz to 800 MHz d 2 33 P for 800 MHz to 2 5 GHz with P as the nominal output of the transmitter in watt W in accordance with the specifications of the transmitter manufact...

Page 44: ...eration in an electromagnetic environment in which the HF interference variables are controlled The emField Pro device customer or user can help avoid electromagnetic interference by maintaining a minimum distance between portable and mobile HF telecommunications devices transmitters and the emField Pro device depending on the output capacity of the communications device as specified below Nominal...

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Page 48: ...tions for Use EN 10 102 817 TW 0120 I Version 2 I Right of modification reserved 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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