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Illustrations Front of the Device Fig.1 Selection and control 1 Control unit elements 2 Pulse energy controller 3 Display 4 Frequency controller 5 Slot for SD card 6 Power switch Handpiece 7 Handpiece 8 Air vents, front 9 Air vents with fan, rear 10 Holder for handpiece Footswitch 11 Footswitch...
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Illustrations Rear of the Device Fig.2 Switches / Connector 13 Socket for power cord sockets 14 Mains fuse 15 Socket for handpiece channel I 16 Socket for handpiece channel II 17 Socket for footswitch 18 Identification plate...
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Illustrations Screens / Displays Fig 3. Display / Application 19 Status bar screen 20 Buttons on the screen 21 Navigation bar Fig 4. Navigation bar (A) Back Move back one step Description of the (B) Menu Move to the selected menu functions (C) Scrollbar Scroll forward or backward in the list...
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Illustrations Applicator Head and Accessories Fig.5 Applicator head 22 39 mm applicator head Accessories 23 Silicone cap...
Explanation of the Symbols In this instructions for use, this symbol stands for “Danger”. In this instruction for use, this symbol indicates “Caution” with regard to possible Caution damage of the device. Connection socket handpiece Connection socket footswitch Instructions for use Products marked with the adjacent symbol must not be disposed of with household waste.
Table of Contents Illustrations Front of the Device Rear of the Device Screens / Displays Applicator Head and Accessories Explanation of the Symbols Page Scope of Application / Restrictions on use Application Information Warnings ZWave – in brief Set-up Device Installation of Cables Settings Operation Instructions...
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Table of Contents Page Safety and Maintenance 11.1 Safety 11.2 Maintenance Functional Test Error Messages / Troubleshooting / Disposal Declaration of Conformity Valid for the device ZWave 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.
Scope of Application / Restrictions on Use Areas of ● stage I cellulite application ● stage II cellulite ● stage III cellulite ● weakness of muscle and connective tissue in the upper arm ● weakness of muscle and connective tissue in the lower abdomen ●...
Inspect the device before use. If there is any damage, do not use the device. Only use accessories from Zimmer MedizinSysteme GmbH. Caution The handpiece of the device is not designed for continuous operation. After a max.
Warnings Users of ZWave must have the appropriate skills. Any treatment instructions regarding treatment location, duration and intensity of application requires medical knowledge and may only be provided by persons with the appropriate expertise. These instructions must be followed. The patient must not be left unattended during use. People who are undergoing simultaneous treatment to reduce and/or alter blood clotting or to prolong blood-clotting time (e.g.
The ZWave – in brief What is the ZWave An ultramodern and innovative shock wave device. Shock wave application Radial, ballistic shock wave application is a versatile method for the improvement of cellulite and weakness in connective tissue. What does the It generates shock waves by means of an ergonomic handpiece and emits them ZWave through a special applicator.
Set-up Device Installation of Cables Note: If the ZWave is not mounted on the designated wagon, ensure that it is placed on a stable surface. Note: Make sure that the power switch of the device is set to “0”. Connect the power Connect the power cable to the appropriate socket (13) in the device, and connect cable the cable to the power supply.
Settings Note: Changes in the basic settings are only possible from the start-up screen. Start-up screen After switching on the device and performing the self-test, the start-up screen opens. Note: Activation of the “Protocols” button (2) immediately switches to the application screen.
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Settings (1) Start settings Start menu: Individual options of the start menu. If you select the “Protocols (Body)” setting, application is selected via the body region in the start menu. If you select the “Protocols (List)” setting, application is selected via the list of application areas is in the start menu.
The pulse generator in the handpiece is a wear part and needs to be replaced after a certain period as its ability to function decreases with time. Zimmer MedizinSystemeGmbH guarantees unrestricted use of at least two million pulses per one pulse generator. Depending on the power and frequency, more than two million pulses can be generated.
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Operation Instructions 7.1 Device Description Temperature The generation of the mechanical pulses causes a substantial build-up of heat in the monitoring / handpiece. To avoid reducing the life of the handpiece, a temperature switch is regulation handpiece integrated. An internal shutdown mechanism forces the handpiece to cool if excessive temperatures are reached.
Operation Instructions 7.2 Notes on Operation Application Please hold the handpiece as shown below. The ZWave operates with mechanical energy; it is transferred to the patient through a handpiece. For this purpose, the handpiece with the applicator is placed vertically on the application area.
Operation Instructions 7.3 Performing the application Note: All buttons, menus, and sub-menus can be directly activated on the screen by touching with your finger. Programme start Activating the right button in the start screen opens the screen selected in the settings menu.
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Operation Instructions 7.3 Performing the application Application selection The choice of the body region is made by clicking the orange circle. by the body region Select the body region After selecting the desired region of the body (in this case, the upper arm), the window for the application recommendations in the upper arm area opens.
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Operation Instructions 7.3 Performing the application Application selection The application is selected in the corresponding row. from list Note: Regardless of whether the body regions or the list are selected for application, the programme steps and application screen are analogously and are therefore described only once below.
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Operation Instructions 7.3 Performing the application Application After selecting the differentiated application, another window with detailed recommendation application recommendation will open. Select application Activation of the “Application” button opens the application screen with the programme appropriate programme. All relevant application recommendations are pre-set, but the pulse energy must be individually stepped up for each application.
Operation Instructions 7.4 Display and Buttons Description of the display elements and buttons (1) Energy Displays the set pulse energy. When the application is active, the bar graph is filled in. The pulse energy can be set before and during the delivery of pulses. The pulse energy is adjustable between 60–185 mJ in 10 mJ steps.
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Operation Instructions 7.4 Display and Buttons (5) Number of pulses Display of the preselected number of shocks and the currently emitted pulses as well as the total number of emitted pulses if the total number of emitted pulses is not pre- selected.
Operation Instructions 7.5 SD-Card SD-Card On the SD-card, the user-defined settings as well as the body regions and the application list are stored. If the SD-card is not inserted, the display application recommendation will not open upon activation of the start button on the home page. The following message appears: “SD card not found.
Operation Instructions 7.6 Favourites List – Retrieving Programs and Editing Lists The parameters of the pre-defined programs can be individually modified and saved. Store and Activating the “save” button opens the field for entering the program name. name program The program name is entered via the keyboard. Note: The programs can be saved in the favourites list.
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Operation Instructions 7.6 Favourites List – Retrieving Programs and Editing Lists Individually stored programs are listed in the favourites list. These can be retrieved here for application, 2. for editing (moving and deleting). Activation of the “Favourites” button opens the favourites list. Select favourite list The desired program is directly selected in the corresponding row Open program...
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Operation Instructions 7.6 Favourites List – Retrieving Programs and Editing Lists Edit favourites Activation of button (1) moves the program to the bottom. Activation of button (2) moves the program to the top. Activation of button (3) deletes the program. Activation of button (4) saves the modifications and returns you to the program.
Technical Information Basic device Power supply 100 – 240 V / 50/60 Hz; 220 V/60 Hz Safety 2 × T3A15L, 250V Power consumption 250VA Protection class Frequency range 1 Hz – 22 Hz, adjustable in 1 Hz steps 3 burst modes with 4, 8, or 12 pulses Pulse energy levels 60 –...
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Technical Information 8.1 Info-Chart Duration of Treatment Max. possible pulses per application frequency Page 22...
Cleaning Disinfection - Before starting any maintenance and cleaning measures, the device must always be turned off with the main switch, and the mains cable must be disconnected. - Make sure that during the cleaning and disinfection the labelling the of the device (such as warnings, label of control devices and identification plate) are not damaged.
The ZWave is manufactured according to the DIN EN 60601-1 safety regulations. Zimmer MedizinSysteme GmbH can only be held responsible for safety and reliability of the device if • the device is operated using a proper power outlet with earth contact and the electrical installation complies with DIN VDE 0100 part 710, •...
Safety and Maintenance 11.2 Maintenance Before cleaning and maintenance, the device must always be switched off with the main switch, and the power cord must be disconnected. Checking the impact During the course of normal use, a deformation/shortening of the rear impact dome dome on the applicator head may occur.
Functional Test After the device is switched on, the ZWave performs a self-test, which checks all internal components. In the event of a fault, an error message appears. In addition, an extended function test can be performed as described below. This test should be performed monthly or if there are any doubts about the viability of the device.
Error Messages Troubleshooting Disposal Loss of function Despite activating the foot switch, no pulse is triggered handpiece Possible cause 1 Handpiece / footswitch is not properly connected, or defective. Fix for cause 1 Make sure that the foot switch and handpiece are connected correctly. The plug must be properly snapped in.
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Error Messages Troubleshooting Disposal The message “Handpiece not found” appears. Applicator not found Possible Cause Handpiece not connected or incorrectly connected. Fix for cause 2 Make sure the handpiece is properly connected. The plug must be properly snapped Device malfunction No response to the main switch / display remains dark Possible cause 1 Mains power connection...
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In the case of other malfunctions, switch the device off and then switch it on after waiting for 5 seconds. If the problem persists, please contact the customer service department in Neu-Ulm. Headquarter Zimmer MedizinSysteme GmbH Junkersstraße 9 D-89231 Neu-Ulm Tel. +49 731. 9761-291 Fax +49 731.
Declaration of Conformity EC Declaration of Conformity For the electro-mechanical shock wave device ZWave We hereby declare that the product ZWave (with handpiece) meets the basic safety and health requirements of the EC Low Voltage Directive 2006/95/EC and the EMC Directive 2004/108/EC. The device bears the CE marking Applied standards: IEC 60601-1: 2005 + Corr.
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