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General information

9.5. Legal

information

9

36

Legal Information

National laws and regulations must be observed when installing and

operating this treatment device.

This device is manufactured by:

Zimmer MedizinSysteme GmbH

Junkersstraße 9

89231 Neu-Ulm – Germany
Phone +49 (0)731 9761-291

Fax

+ 49 (0)731 9761-299

[email protected]

www.zimmer-aesthetics.com

This device is distributed by:

Zimmer MedizinSystems

25 Mauchly

Suite 300

Irvine, CA 92618
Phone (800) 327-3576

Fax

(949) 727-2154

[email protected]

www.zimmerusa.com

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Содержание ZWave

Страница 1: ...USA User Manual ZWave ...

Страница 2: ...switch Selection and control elements 1 Control unit 2 Pulse energy controller 3 Touch pen in holder 4 Display 5 Frequency controller 6 SD card slot Handpiece 7 Handpiece 8 Air vents front 9 Air vents with fan rear Footswitch 10 Footswitch 5 4 3 2 1 10 8 6 7 9 ...

Страница 3: ...Figures Front view of device 2 Display Screen readouts 11 Status bar 12 Buttons on the screen 13 Title bar 14 Navigation bar 14 13 12 11 ...

Страница 4: ...of device 3 Switch and connector sockets 15 16 17 18 19 Switch Connector sockets 15 Main switch 16 Mains fuse 17 Port for mains cable 18 Port for handpiece 19 Port for footswitch 20 Serial number manufacturer s plate 20 ...

Страница 5: ...Figures Accessories 4 21 Silicone cap 22 2 applicator head 21 22 ...

Страница 6: ...How to use ZWave 1 4 Handpiece 1 5 Applicator heads 1 6 Footswitch 7 8 11 13 14 15 2 Installation 2 1 Fitting the cables starting the system 2 2 Settings 16 17 3 SD card 19 4 Application screen 20 5 Favorites and Memory list 5 1 Saving modified programs 5 2 Retrieving and editing Favorites and Memory list 23 24 6 Description of the selection keys 26 7 Application menu 28 8 Medical information 8 1 ...

Страница 7: ...rer s declaration of Electromagnetic Compatibility 45 Valid for the ZWave devices These operating instructions are an integral part of the device They must be stored with the device and kept accessible at all times for anyone authorised to operate this device These operating instructions are valid from July 2014 U S A Federal Law restricts this device to sale by or on the order of a practitioner l...

Страница 8: ...icator head at the front of the handpiece and generates pulses which spread out radially in the tissue What are the advantages of ZWave The innovative technology allows a compact design with no need for a compressor The clear and modern color display showing all parameters relevant for application and the modern touch operation ensure pleasure and motivation when providing application Individual p...

Страница 9: ...e all based on the factory settings Note All buttons menus and submenus are activated directly on the screen by touching it or using the touch pen or finger Starting the program Press the Start button to open the application screen Select the application Select the required application ...

Страница 10: ...s of the selected program Selecting the application program Positioning handpiece applicator Position the handpiece on the selected treatment point field To avoid any friction on the skin lotion for treatment should be applied first to the treatment area When using lubricants the applicator head must be covered with the silicone cap to protect it ...

Страница 11: ...changes from Ready to Active Note Only activate the pulses via the footswitch once the handpiece has been positioned on the client Ending application Deactivating the footswitch interrupts or ends the application The display in the bottom status bar changes from Active to Ready The device ends the treatment automatically once the preselected number of pulses has been reached Note During applicatio...

Страница 12: ... skin The weight of the handpiece means that it is normally not necessary to apply pressure to the treatment area point The handpiece is placed on the treatment area point and held loosely in position with one hand If required additional pressure may be applied in the direction of the tissue and the working angle can be varied When using treatment lotion or other lubricants the applicator head mus...

Страница 13: ...lications Number of sessions Applications per week Frequency Power level Pulses per application Cellulite stage I 8 10 2 3 14 16 Hz 60 120 mJ 2500 to 3000 Cellulite stage II 9 12 2 3 10 16 Hz 90 120 mJ 2500 to 3400 Cellulite stage III 10 14 2 3 10 16 Hz 90 120 mJ 3200 to 3700 ...

Страница 14: ...be delivered For more information on the need to replace the pulse generator see chapter 11 To work with the handpiece on a client it is essential that one of the applicator heads is screwed tightly into the handpiece as far as possible The cable should not be stretched beyond its maximum length and must be protected against pinching or any other mechanical damage To avoid heat accumulation in the...

Страница 15: ...e handpiece there should no longer be any thread visible Note Applicator heads are expendable parts and must be replaced after a certain period of use Minor slight deformation or shortening of the rear impact dome does not affect functionality In case of greater deformation of the rear impact dome or shortening the applicator head must be replaced A test template is supplied with the device that e...

Страница 16: ...directional so it is not necessary to align the footswitch exactly To avoid damage please note that only slight pressure needs to be exerted on the switch Use the front part of your foot not the heel to operate the footswitch The switch does not have a locking device which means that it only remains actuated as long as pressure is applied ...

Страница 17: ...ble Connect the mains cable to the designated port 17 on the device and then plug into the mains Connecting the handpiece Plug the handpiece into the appropriate socket 18 on the device and place it on the table Note Ensure that the applicator head is inserted into the handpiece and is properly screwed in as far as possible Connecting the footswitch Plug the footswitch into the appropriate socket ...

Страница 18: ...e message Option to configure an individual welcome message Activate the welcome message field to open the keyboard to enter a welcome message Audio graphic settings Brightness Volume Option to adjust the brightness of the screen Adjust the brightness using the two arrow keys Option to adjust the volume of the signals when activating the control fields Adjust the volume using the two arrow keys Ha...

Страница 19: ...tion Press the Touch Calibration button to open the screen to carry out the touch calibration This can be done to improve the touch input if it is not sufficiently accurate First press the symbol in the top left corner A symbol then appears in the lower right corner Then precisely press the symbol in the lower right corner Repeat the procedure to complete the touch calibration Alternative language...

Страница 20: ...ications list are saved on the SD card Note If the SD card is not inserted the message SD card not found appears when the Favorites and Memory buttons are pressed Deactivate the message by pressing the button OK insert the SD card and then continue ...

Страница 21: ... word Ready and if an application is running the text Active appears Mode Shows the operational mode selected Continuous in this case Press the Mode button to open the Input window and select the Operational mode Continuous Burst 4 Pulses Burst 8 Pulses Burst 12 Pulses Frequency Shows the selected frequency Change the required frequency using the right controller Frequency range 1 Hz 22 Hz adjusta...

Страница 22: ...rection Press to set the count direction increasing or decreasing of the number of pulses Number of pulses Shows the preselected pulse numbers as well as the current number of pulses delivered to the patient Also the count direction decreasing in this case is shown Pressing the Number of pulses field opens the Input window defining preselection and count direction Note ZWave offers two options for...

Страница 23: ...has been reached The footswitch is deactivated and pulse delivery is no longer possible The application can be continued by resetting the current number of pulses or by adjusting the preselection When the number of pulses is preselected the count direction is automatically set to decreasing By pressing the Count direction button on the application screen the increasing count direction button can b...

Страница 24: ... list and automatically save the program The program is saved in the first free space in the list Memory Press the Memory button to open the Memory list and automatically save the program The program is automatically saved in the first free space in the list Note If the Memory or Favorites button is pressed without entering a program name an error message appears Acknowledge this message with OK e...

Страница 25: ...ory list Individually saved programs are listed in the Favorites or Memory list From here they can be 1 retrieved for application or 2 edited sequence changed or deleted Selecting the Memory or Favorites list In the navigation bar press the Favorites or Memory button to open the accordant list Retrieving a program In the list select the desired program by pressing the appropriate row ...

Страница 26: ...etrieving and editing Favorites and Memory list 5 25 Editing Press the Edit button to open the Edit Favorites screen Activate the desired program by pressing the appropriate row You are now able to move or delete the selected program ...

Страница 27: ...ting direction to the preset value by decreasing counting direction Press the button to move an item of the list upwards by one position Press the button to move an item of the list downwards by one position Press the button to delete the selected program from the list Scrolling forwards Press the button to scroll one page down the list Scrolling backwards Press the button to scroll one page up th...

Страница 28: ...ber of the pulses in steps of 1000 Activation of the button increase the pulse rate in increments of 100 activation of the button reduces the number of the pulses in steps of 100 Press the button to return to the Start screen Activation of the button opens a window with application information Note The medical information can only be accessed via the application menu of the application screen ...

Страница 29: ...menu helps you to select the appropriate application The application can be selected using the application list Application information After selecting the detailed state of the cellulite stage another window opens showing detailed application information ...

Страница 30: ...plication button to open the application screen with the program Retrieving application information Press the Info button to open the window with the application information The application should always be conducted in the direction arrows of the lymphatic outward flow ...

Страница 31: ...Medical information 8 1 Application 8 30 High energy radial pulse application for the temporary reduction in the appearance of cellulite ...

Страница 32: ...amage such as metal implants after a fracture In general we advise against treatments if blood clotting disorders are present or the client is receiving application that results in a change in the blood clotting behaviour during pregnancy on clients with neurological diseases resulting in impairment of the vasomotor function in the area of application over air filled cavities such as application o...

Страница 33: ...n the operating instructions this symbol stands for Caution with regard to possible damage to property Handpiece port Footswitch socket Follow Operating Instructions Value of the accessible fuses Instrument type BF according IEC60601 1 Degree of protection against electric shock Device must not be used at heart ...

Страница 34: ...ncurrently receiving treatment involving a reduction and or modification of blood clotting or prolongation of the blood clotting time e g with acetylsalicylic acid should consult their therapist about possibly stopping this treatment as these patients may be more prone to greater haemorrhaging and bruising when radial pulses are applied Radial Pulses are strongly scattered in air pockets and creat...

Страница 35: ...0 Handpiece Ergonomic model with anodized aluminium case and fan cooling Dimensions 9 in length 2 diameter max Weight 2 lbs with cable Service life 2 000 000 pulses minimum Applicator heads exchangeable without any tools 2 diameter Dimensions complete with case W 23 D 19 H 10 Total weight 25 lbs total with case Environmental conditions Operational environment 10 to 25 C 50 to 95 F 700 hPa 1060 hPa...

Страница 36: ...erated in accordance with the Operating instructions if extensions reconfigurations or modifications are implemented only by persons authorised by Zimmer MedizinSysteme users must ensure that the device and the handpiece is operating correctly is mechanically intact and is in good repair before using it the device must be operated by appropriately trained personnel only disconnect the device from ...

Страница 37: ...nt device This device is manufactured by Zimmer MedizinSysteme GmbH Junkersstraße 9 89231 Neu Ulm Germany Phone 49 0 731 9761 291 Fax 49 0 731 9761 299 export zimmer de www zimmer aesthetics com This device is distributed by Zimmer MedizinSystems 25 Mauchly Suite 300 Irvine CA 92618 Phone 800 327 3576 Fax 949 727 2154 info zimmerusa com www zimmerusa com ...

Страница 38: ...l to pull the silicone cap over the applicator head If you do not use the protective cap the lubricant can get inside the applicator head and handpiece which can lead to permanent soiling and malfunctioning Note In this case the warranty becomes void Cleaning disinfection Clean the device and handpiece with soap lotion or cleaning agents that do not contain alcohol or solvent Conventional disinfec...

Страница 39: ...mperature switch This triggers an internal switch off if the temperature becomes too high forcing the handpiece to cool down If the temperature reaches a critical level this is indicated by a message on the display and pulses can no longer be emitted After acknowledging the message with OK the treatment screen comes to the foreground with the message in the status bar when the handpiece reaches th...

Страница 40: ...9 Monitoring the handpiece temperature As soon as the handpiece has reached the operating temperature the message Overtemperature is replaced by the message Ready in the status bar and the application can be continued ...

Страница 41: ...ce and clean the rear dome thoroughly Then hold the handpiece without the applicator head with the opening downward and at 2 or 5 Hz frequency release a few pulses maximum 10 at the lowest energy level Then reinsert the applicator head If the error still occurs the applicator head has to be changed Possible cause 2 Wear of pulse generator The pulse generator is an expendable part and should be rep...

Страница 42: ...wire fuses which isolate the mains voltage in the event of any electrical problem Unplug the mains cable Open the flap and check the fuses Replace any faulty fuses Only replace a fuse with one of exactly the same name or one that is equivalent Before doing this check the entire power supply for any possible faults If the error occurs again it is essential to inform the service after sales service ...

Страница 43: ...itch are connected correctly to the device Check the mains cable is connected properly to the device and the network connection is established Function test Testing Switch on the device Depress the footswitch briefly the fan and pulse generator will start immediately whereby the pulse generator has to operate at the frequency indicated on the display 5 Hz as default value Note On conclusion of the...

Страница 44: ...ce has reached the operating temperature the message Overtemperature is replaced by the message Ready in the status bar and the treatment can be continued In the status bar the message Ready appears and despite depressing the footswitch no pulses is triggered Check that the pulse energy is set Check that the footswitch is correctly connected Inspect the footswitch cable for any damage or kinks Che...

Страница 45: ... 67250130 1 Mains cable 10101833 1 Operating Instructions 63061010 1 Test template 65800410 2 Touch pen 87053010 1 Transport case with foam insert Accessories Item No 5511xxxx Handpiece applicator head 2 included 63130411 Holder for handpiece 93133530 2 applicator head 65137110 Silicone caps 50500038 Lotion for treatment 94130411 Footswitch 67250130 Mains cable 87053010 Transport case with foam in...

Страница 46: ...the ZWave should ensure that it is operated in such an environment Interference tests Conformity Electromagnetic environment guideline RF emissions according to CISPR 11 Group 1 The device ZWave uses RF energy solely for its internal functioning Its RF emission is therefore very low and it is unlikely that this will cause interference to neighbouring electronic equipment RF emissions according to ...

Страница 47: ...IEC 6100 4 5 1 kV differential mode 2 kV common mode 1 kV differential mode 2 kV common mode Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 seco...

Страница 48: ... 3 Veffektive value 150 kHz to 80 MHz 3 V m 80 MHz to 2 5 GHz Portable and mobile radio equipment should not be used any closer to the ZWave including cables than the recommended separation distance calculated from the equation applicable to the transmission frequency Recommended separation distance d 1 2 P d 0 35 P for 80 MHz to 800 MHz d 0 7 P for 800 MHz to 2 5 GHz Where P is the rated power of...

Страница 49: ...ce is intended for operation in an electromagnetic environment where RF disturbances are monitored The customer or user of the ZWave device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF telecommunications equipment transmitters and the ZWave device according to the output power of the communications device as indicated below Rated ou...

Страница 50: ...mmer MedizinSystems 25 Mauchly Suite 300 Irvine CA 92618 800 327 3576 949 727 2154 fax www zimmerusa com info zimmerusa com User Manual USA 10 101 833 FB0615 I version 1 I Rights of modification reserved ...

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