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Manufacturer's Declaration on

Electromagnetic Compatibility (EMC)

Page 29

Table 4
Electromagnetic immunity to HF radio communication equipment
Test

Frequency

(MHz)

Band

(MHz)

Service

Modulation

Maximum

Energy

(W)

Distance

(m)

Immunity Test

Level

(V/m)

385

380-390 TETRA 400

Pulse

Modulation

18 Hz

1,8

450

430-470 GMRS 460,

FRS 460

Pulse

Modulation

18 Hz

710

704-787 LTE Band 13, 17

Pulse

Modulation

217Hz

0,2

745
780
810

800-960 GSM 800/900,

TETRA 800, iDEN 820, CDMA

850, LTE Band 5

Pulse

Modulation

217Hz

870
930
1720

1700-

1990

GSM 1800;

CDMA 1900;

GSM 1900; DECT;

LTE Band 1,3, 4, 25;

UMTS

Pulse

Modulation

217 Hz

1845
1970

2450

2400-

2570

Bluetooth, WLAN, 802.11 b/g/n,

RFID 2450, LTE Band 7

Pulse

Modulation

217 Hz

5240

5100-

5800

WLAN 802.11 a/n

Pulse

Modulation

18 Hz

0,2

5500
5785

Содержание MFG-03

Страница 1: ...Instructions for use ZFieldDual MFG 03 EN ...

Страница 2: ......

Страница 3: ...Illustrations Front of the device Fig 1 Front of the device 1 Applicator left side 2 Applicator right side 3 Display 4 Central control knob 5 Control unit 6 Swiveling castors 1 2 3 4 5 6 ...

Страница 4: ...Illustrations Rear of the device Fig 2 Rear of the device 7 Connections for applicator hose 8 Ventilation grid 9 Mains connection 10 On off switch 11 Identification plate 10 11 7 8 9 ...

Страница 5: ... Remaining time 13 Total operating time 14 Configuration icon 15 Intensity in 16 Start stop 17 Channel selection channel 1 and or channel 2 18 Applied program 19 Mode selection Programs Region Manual Mode 20 Program information screen 12 13 14 15 16 17 17 18 20 19 ...

Страница 6: ...Illustrations Accessories 21 Mains cable 22 Fixingbelt ...

Страница 7: ...warns of caution regarding possible damage to the 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 Warning magnetic field Protective earth Serial number Catalogue number Manufacturer Date of manufacture ...

Страница 8: ...d 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 Fragile handle with care Temperature limit This way up Danger or Warning Systemic health hazards ...

Страница 9: ...tion of symbols Page 1 Indications Contraindications Side Effects 1 2 Warnings 3 3 Z Field Dual overview Intended purpose 5 4 Setting up the device 6 5 Settings 7 6 Operating instructions 9 7 Technical information 15 8 Cleaning and disinfection 16 9 CE marking 18 10 Scope of delivery and accessories 19 ...

Страница 10: ...r s Declaration on Electromagnetic Compatibility EMC 26 16 Material Safety Data Sheet 30 Valid for Z Field Dual MFG 03 devices 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 Information as of August 2019 ...

Страница 11: ...ified with Z Field Dual treatments therefore we recommend not undergoing treatment during this time of the month Other contraindications to treatment include the following Fever Application over menstruating uterus Application over areas of the skin that lack normal sensation Metal or electronic implants in the treatment area Cardiac pacemakers Implanted defibrillators Implanted neurostimulators D...

Страница 12: ...ent 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 Temporary muscle spasm Temporary joint or tendon pain Local erythema or skin redness Premature menstruation and or lower abdominal cramps ...

Страница 13: ...f castors are not in transport position Sitting on the device is prohibited Before use make sure that the device is supplied with power via a properly earthed plug with a safety plug electrical installation in accordance with DIN VDE 0100 Part 710 The device must only be operated with the supplied mains cable The mains cable must be protected against mechanical stress Use of this device in the pre...

Страница 14: ...act your service engineer In case of leaking oil please wear gloves providing adequate chemical resistance specifically to aromatic hydrocarbons while cleaning Ventilate the room in case of leaking oil Disposal of the gloves and the oil soaked cloth according to local regulations Do not dispose of in domestic waste It is not permitted to use the device in a wet area if this is disregarded this may...

Страница 15: ...d on the frequencies and intensities used these contractions can be adjusted to different strengths The effect is based on the principle that repeated contractions of muscles leads to muscle growth through multiplication of muscle fibres What are the advantages of the Z Field Dual Non invasive treatment Deep penetration of a pulsed electromagnetic field of 1 0 Tesla per applicator Touch screen dis...

Страница 16: ... Switching on the device Switch on the device using the on off switch 10 Caution Note that connecting the mains cable while the on off switch is on may cause malfunctions Caution If the applicator is used in a slanting position the cooling oil does not reach all areas of the applicator and damage is caused due to overheating For this reason it is recommended to place the applicator in a horizontal...

Страница 17: ...is carried out and the home screen opens Default screen After performing the self test the Z Field Dual will automatically switch to the default screen Selecting the configuration By pressing the configuration button A you will immediately switch to the configuration menu A ...

Страница 18: ... 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 E Administrator Only for service partners F Version Displays information about the current software version G Close Closes the configuration menu and saves changes F G B C D E ...

Страница 19: ...ation device operators assistants and patients must not carry any objects on them that may be affected by the magnetic field Note When operating the device do not use objects such as wristwatches mobile phones radios transmitters or wireless toys as they can be damaged by magnetic fields Please therefore be careful and keep these devices separated from one other Note While the device is in operati...

Страница 20: ...ngbelt serves to fix the applicators and helps to minimize the movements of the applicators during the treatment The applicators should be placed into the pocket of the fixingbelt The underside of the applicators should be in complete contact with the fixingbelt Before applying the fixingbelt always check the VelcroTM closures are working It should be applied by an expert In case the fixingbelt ha...

Страница 21: ...ton changes to STOP Pressing this button again will stop the treatment and reset the treatment time as well as the applied energy M Channel selection Selection of channel 1 and or channel 2 Channels can be operated simultaneously or individually The small triangle in the corner indicates that the channel is active N Applied programme By pressing one of the programme buttons O and then selecting on...

Страница 22: ... manual mode is selected this screen displays a graph representing the selected parameters Manual mode The manual mode has five freely storable modes the user can set the parameter values directly The setting ranges for the parameters are as follows Frequency 1 150 Hz On time 1 4 s the setting ranges differ depending on the value of the frequency Off time 0 10 s the setting ranges differ depending...

Страница 23: ...reen 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 ...

Страница 24: ...ifferent parameter sets The manual mode works sequentially from sub mode 1 up Pressing the pen icon at the end of the parameter setting screen at the top right adds a sub mode To remove a sub mode select the sub mode in question and press the rubbish bin icon in the top right corner After entering the name and parameter values for the manual mode programme click the close icon X at the top right t...

Страница 25: ...0 Channel 2 0 5 1 0 T 20 Modes Programme mode A1 A20 Region mode M1 M20 Manual Mode U1 U20 Transport Transport the device in an upright position 1 unit of packaging 1 device Environmental conditions for operation Temperature 10 30 C Humidity 30 85 RH Air pressure 700 hPa 1060 hPa Environmental conditions for Storage and transport Temperature 0 60 C Humidity 10 90 RH Air pressure 700 hPa 1060 hPa S...

Страница 26: ...ove rough soiling to prevent it from drying Needed aids Washing machine for chemical disinfection Laundry net Disinfectant detergent which is compatible to the components of the fixingbelt see above and that has a validated disinfecting effect at 40 C e g Eltra 40 Extra Cleaning Disinfection It is recommended to clean and disinfect the belt before each patient and at the end of the day 1 Put the f...

Страница 27: ...etergent according to the manufacturer s instructions but is not dripping wet until the dirt is removed Disinfection we recommend disinfecting at a minimum after each patient and at the end of the day and whenever there is evidence of possible contamination Contact your health expert on this topic Always perform cleaning prior to disinfection The housing and applicator can be disinfected with disi...

Страница 28: ...8 The product Z Field Dual MFG 03 bears the CE marking 0123 in accordance with EC Directive 93 42 EEC concerning medical devices Manufacturer Zimmer MedizinSysteme GmbH Junkersstraße 9 89231 Neu Ulm Germany www zimmer de ...

Страница 29: ...t S 50 70 cm 54209410 1 Fixingbelt M 80 105 cm Accessories Catalogue number 10102932 1 instructions for use 54209400 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 ...

Страница 30: ...ated in accordance with the instructions for use enhancements readjustments or changes are only made by persons authorised by Zimmer MedizinSysteme GmbH before using the device the user has satisfied himself that it functions safely is in a proper condition and displays mechanical integrity the device is operated only by personnel who has read and understood the instructions for use the device is ...

Страница 31: ...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 Please clean the applicator before storing it Check the device before use if you have had it in storage for a long time Please note the following directions concerning storage conditions Protect agains...

Страница 32: ...sures 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 Note These requirements apply to operation of the device in Germany Different regulations may apply in your country ...

Страница 33: ...izontal position If the applicator overheats operation will be temporarily suspended and the Overheating message will be displayed see 23 If this message appears remove the applicator from the patient for a while do not turn off the device until the message disappears and the device returns to a normal state Caution It is strongly recommended to place the applicator in a horizontal position Lifesp...

Страница 34: ...k that the output level is set by pressing the start button and then turning the knob Chapter 6 Operating instructions The message Overheating will be displayed When the applicator is in an upright position the applicator overheats easily If possible place the transducer in a horizontal position Chapter 14 Error messages and troubleshooting If the room temperature is too high this may cause coolin...

Страница 35: ...vice can be reached via the head office in Neu Ulm Head office Zimmer MedizinSysteme GmbH Junkersstraße 9 89231 Neu Ulm Germany Tel 49 731 9761 291 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 necessa...

Страница 36: ...ent could result in increased electromagnetic emission or decreased electromagnetic immunity of this equipment and result in improper operation The device MFG 03 contains no interchangeable components cables or other that leads to a deterioration of the EMC WARNING Portable RF communication equipment including peripherals such as antennas should be used no closer than 30 cm 12 inches to any part o...

Страница 37: ...0 3 2 Class A Emissions of voltage fluctuations flickers in accordance with IEC 61000 3 3 Not performed Table 2 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 Tests IEC 60601 Test Level Complia...

Страница 38: ...e phase at 0 Voltage interruptions accordance with IEC 61000 4 11 0 UT 250 300 cycles 0 UT 250 cycles Magnetic field of supply frequency 50 60 Hz in accordance with IEC 61000 4 8 30 A m 50 Hz oder 60 Hz 30 A m 50 Hz Magnetic fields at mains frequency should have the typical values found in a business or hospital environment Note UT is the mains AC Voltage before application of the test level Table...

Страница 39: ... 430 470 GMRS 460 FRS 460 Pulse Modulation 18 Hz 2 3 28 710 704 787 LTE Band 13 17 Pulse Modulation 217Hz 0 2 3 9 745 780 810 800 960 GSM 800 900 TETRA 800 iDEN 820 CDMA 850 LTE Band 5 Pulse Modulation 217Hz 2 3 28 870 930 1720 1700 1990 GSM 1800 CDMA 1900 GSM 1900 DECT LTE Band 1 3 4 25 UMTS Pulse Modulation 217 Hz 2 3 28 1845 1970 2450 2400 2570 Bluetooth WLAN 802 11 b g n RFID 2450 LTE Band 7 P...

Страница 40: ...Material Safety Data Sheet 16 Page 30 ...

Страница 41: ...Material Safety Data Sheet 16 Page 31 ...

Страница 42: ...Material Safety Data Sheet 16 Page 32 ...

Страница 43: ...Material Safety Data Sheet 16 Page 33 ...

Страница 44: ...Material Safety Data Sheet 16 Page 34 ...

Страница 45: ...Material Safety Data Sheet 16 Page 35 ...

Страница 46: ...Material Safety Data Sheet 16 Page 36 ...

Страница 47: ...teme 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 Instructions for use EN 10 102 932 VK 0819 I MFG 03 I Version 2 I Subject to change ...

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