Zimmer Z Wave Med Instructions For Use Manual Download Page 1

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Instructions for Use

Wave

Med

Summary of Contents for Z Wave Med

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

Page 2: ...l unit 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 Accessories optional 12 Swivelling base 2 5 7 8 4 3 10 11 1 9 12 6 ...

Page 3: ...of the Device Fig 2 Switches Connector sockets 13 Socket for power cord 14 Mains fuse 15 Socket for handpiece channel I 16 Socket for handpiece channel II 17 Socket for footswitch 18 Identification plate 16 15 17 13 18 14 ...

Page 4: ...plication screen 19 Status bar 20 Buttons on the screen 21 Navigation bar Fig 4 Navigation bar Description of the functions A Back Move back one step B Menu Move to the selected menu C Scrollbar Scroll forward or backward in the list B A C 21 20 19 ...

Page 5: ...Illustrations Applicator Head and Accessories Fig 5 Applicator head 22 39 mm applicator head Accessories 23 Silicone cap 22 23 ...

Page 6: ...ble damage of the device Connection socket handpiece Connection socket footswitch Instructions for use Follow instructions for use Products marked with the adjacent symbol must not be disposed of with household waste Serial number Applied part type BF Article number Manufacturer Date of manufacture Value of accessible fuses Interval operation note the instructions for use ...

Page 7: ...mation 3 4 Warnings 4 5 ZWaveMed in brief 5 6 Set up Device 6 7 Settings 7 8 Operation Instructions 8 1 Device Description 8 2 Notes on Operation 8 3 Performing the Treatment 8 4 Display and Buttons 8 5 Treatment of Hamstring Tendinopathy 8 6 SD Card 8 7 Favourites Lists Retrieving Programs and Editing List 9 11 12 16 18 19 20 9 Technical Information 9 1 Info chart Duration of Treatment 23 24 10 C...

Page 8: ... 31 16 Safety Check Metrological Control 32 17 Error Messages Troubleshooting Disposal 33 18 Manufacturer s EMC Declaration 36 Valid for the device ZWaveMed 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 May 2021 ...

Page 9: ...orm of vibration could results in damage to tissue e g metal implants Following a fracture in cases of muscle fibre tears or muscle tears It is generally recommended to avoid treatment In cases of blood coagulation disorders or treatments that result in a change in blood coagulation During pregnancy In cases of diseases affecting the vasomotor system in the treatment area Over air filled cavities ...

Page 10: ...Side Effects 2 Page 2 Side Effects Treatments with ZWaveMed may occasionally cause irritation petechiae bruising swelling or pain ...

Page 11: ...ance of several meters ZWaveMed is not suitable for use in explosive flammable or combustive environments During use the device must be located in a position that allows direct access to the mains power supply so that this can be disconnected at any time To prevent the risk of electric shock the plug must be disconnected from the power supply before performing any maintenance or cleaning activitie...

Page 12: ...otting time e g acetylsalicylic acid should consult their therapist about a possible suspension of this application because there is an increased risk of bleeding and haematoma with the use of radial shock wave in these individuals Pulses are strongly scattered in air filled areas and produce reflections that can have negative effects Therefore do not perform direct applications on the pulmonary i...

Page 13: ...WaveMed This innovative technology allows for a compact design with no compressor The modern clear colour display that presents all relevant application parameters the modern touch operation and the simultaneous connection option of two handpieces provide for an enjoyable and motivating application Individual programme start up settings and clear and simple menu navigation provide maximum comfort ...

Page 14: ...nected to power outlets with grounding contact Connect the handpiece Connect the handpiece to one of the provided sockets channel I 15 or channel II 16 Note Make sure that an applicator head is inserted to the handpiece and that it is correctly and completely screwed in Connect the foot switch Connect the footswitch to the appropriate socket 17 and place it on the floor Switch on the device Turn o...

Page 15: ...rforming the self test the start up screen opens Settings menu In the settings menu the factory settings can be individually changed and adjusted Settings select Activating the Settings button 1 opens the settings screen The settings options are described below The default settings are pre programmed as shown in the screen 1 2 3 4 5 6 7 2 1 8 9 10 ...

Page 16: ... default 9 Colour scheme 10 Handpiece Option to adjust the volume of the signal tones when activating the control panels The volume is adjusted via the two arrow keys Option to adjust the brightness of the screen The brightness is adjusted via the two arrow keys The maintenance menu is not relevant for the user The points listed here are used only if maintenance is performed by customer service Ac...

Page 17: ...temperature of the applicator increases with increasing duration of application to the extent that thermal damage to the patient cannot be excluded Please refer to the maximum values for the treatment in the figure in Chapter 9 1 After reaching the specific values the treatment must be interrupted and can only be resumed once the applicator head has cooled down to room temperature Note Please note...

Page 18: ...dpiece cannot be selected any longer and the time is indicated until the handpiece will reach normal operating temperature again Meanwhile the application can be continued with the second handpiece Application head A large applicator with Ø 39 mm is available for the application Changing the applicator heads To change the applicator head hold the handpiece with one hand and unscrew the applicator ...

Page 19: ...s placed and held in a relaxed posture using the hand If required additional pressure can be applied in the direction of the tissue and the angle of use can be varied Depending on the application a different position of the handpiece and the formation of a skin fold between applicator and the applicant s hand can be useful These and other instructions are noted in the operation instructions see fo...

Page 20: ... application specific instructions In order to avoid friction on the skin some lotion should be applied to the application area prior to application Caution When using lubricants the applicator must be covered with the silicone protective cap Setting the pulse energy Set the pulse energy using the controller on the left side Start of treatment By activating the foot switch the application starts N...

Page 21: ...e handpiece If only one handpiece is connected the window selection displays the channel of the connected handpiece The handpiece is automatically activated regardless of the connected channel Connection of two handpieces When connecting two handpieces the handpiece at channel I is activated first The desired handpiece is activated by directly selecting the handpiece in the selection window The ac...

Page 22: ...number of shocks The pre selection can be done in 100 or 1000 steps 6 Counting direction Activation of the button determines the counting direction ascending or descending of the number of pulses delivered 7 Reset 8 Save Resets to 0 in the case of ascending counting order and to the pre set number of shocks in the case of descending counting order Activation of the button opens the field for enter...

Page 23: ...oses is intended for healthcare professionals e g ph assistants only Application Press the Application button in the Navigation bar to reach the application screen Setting the energy Adjust the pulse energy to 90 mJ Selecting the frequency Select a frequency between 5 10 Hz Number of shocks A total number of 2000 3000 shocks should be applied ...

Page 24: ... 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 Use of treatment recommendations requires a SD card Insert the card and restart the device If you lose your card please contact the customer service department ...

Page 25: ... programs can be saved in the favourites list 99 storage locations are available Save in favourites list Activation of the button with the green arrow button closes the screen and imports the program into the favourite list The program is always stored in the first available space of the list Activation of the button with the red cross interrupts the save process Note If no program name is entered...

Page 26: ... be retrieved here 1 for application 2 for editing moving and deleting Select favourite list Activation of the Favourites button opens the favourites list Open program The desired program is directly selected in the corresponding row Edit favourites list Activation of button 1 opens the Edit screen Select the favourites that are to be edited directly in the line 1 ...

Page 27: ... program to the top Activation of button 3 deletes the program Activation of button 4 saves the modifications and returns you to the program Note Activation of button 3 leads to a confirmation request Do you really want to delete this programme Activating the button with the green arrow deletes the application Activation of the button with the red cross will cancel the deletion process 1 2 4 3 ...

Page 28: ... Dimensions ZWaveMed with syscart H 138 cm W 53 cm L 52 cm ZWaveMed H 30 cm W 35 cm L 20 cm Syscart H 109 cm W 53 cm L 52 cm Weight ZWaveMed with syscart 19 3 kg ZWaveMed 3 8 kg Syscart 15 5 kg IP Class Device IPX0 Footswitch IPX5 Handpiece IPX0 Operation 10 to 25 C 20 to 80 relative humidity without condensation at 700 1060 hPa Storage Transport 10 to 50 C 10 to 90 relative humidity without conde...

Page 29: ...Technical Information 9 1 Info chart Duration of Treatment 9 Page 21 Max possible pulses per application pulses frequency ...

Page 30: ... use a commercially available alcohol free disinfectant for metal and plastic with bactericidal virucidal and fungicidal properties Observe the application instructions of the manufacturer Wipe all surfaces using a cloth soaked according to the specifications of the manufacturer of the disinfectant but not dripping or use pre impregnated disinfectant wipes so called wipes If applicable also observ...

Page 31: ...CE mark 11 Page 23 The product bears the CE marking in accordance with EC Directive 93 42 EEC concerning medical devices ...

Page 32: ...ate Scope of delivery Tabletop device Art no 5532 1 ZWaveMed control unit 5511 2 Handpieces 93133530 3 Applicator heads 39 mm 65137110 10 silicone caps 50500038 1 ZWave Lotion 94130411 1 Footswitch 65410410 1 Storage tray for accessories 117 1 Mains cable 50500021 2 Holder for handpieces 10102403 1 Instructions for Use 63061010 1 Template Accessories Art no 5511 Complete Handpiece 65410110 Holder ...

Page 33: ...Combination 13 Page 25 For ZWaveMed no combination devices are provided by the manufacturer Anyone who contrary to this specification combines devices and thus operates a medical system does so at its own risk ...

Page 34: ...eadjustments or modifications are only performed by persons authorised by Zimmer MedizinSysteme GmbH the user has been instructed in the functional safety proper operating condition and mechanical integrity of the device and handpiece prior to use the device is only operated by properly trained personnel the device is not operated in hazardous areas and or a combustive atmosphere the device is imm...

Page 35: ...functionality In cases of more extensive deformation of the dome or considerable shortening the applicator head must be replaced To check the condition of the applicator head a test template is supplied with the device which can be used to check whether the wear limit has been reached Depending on the frequency of use the device should be inspected at least once per month To do so the applicator h...

Page 36: ... the hand piece and foot switch are properly connected to the device Check to see whether the power cable is properly connected to the device and whether it is connected to the network Function test Switch the device on Briefly press the foot switch the fan and shock wave generator start immediately The shock wave generator must work at the frequency on the display 10 Hz is the standard value Note...

Page 37: ...dinance Medizinprodukte Betreiberverordnung MPBetriebV and the BG Electrical Plant and Equipment regulations BG Vorschrift Elektrische Anlagen und Betriebsmittel BGV A3 apply in their current version amongst other regulations Note These regulations apply to the operation of the device in Germany Observe any divergent national regulations that apply in your country if applicable ...

Page 38: ... abrasion Fix for cause 1 The applicator head is a wear part and must be replaced after a certain number of shocks Removal of parts rubbed off Remove the applicator head from the handpiece and thoroughly clean the rear dome Then hold the handpiece without applicator head with the opening facing downwards and produce some shocks maximum 10 with 2 or 5 Hz frequency at the lowest energy level Then re...

Page 39: ... is properly plugged into the electrical outlet and whether the plug is firmly inserted into the socket of the device Check the power cord for damage Check the power supply and mains socket Possible cause 2 Fuse Fix for cause 2 In the power input socket of the device there are micro fuses that disconnect the power supply in the event of an electrical problem Open the cover and check the fuses If n...

Page 40: ...to cool down After receiving this message no more pulse input is possible After confirming the message with the button with the green arrow the handpiece cannot be selected any longer and the time is indicated until the handpiece will reach normal operating temperature again Meanwhile the application can be continued with the second handpiece In the case of other malfunctions switch the device off...

Page 41: ...t in increased electromagnetic emission or decreased electromagnetic immunity of this equipment and result in improper operation The device ZWaveMed 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 of the device ...

Page 42: ...lickers in accordance with IEC 61000 3 3 Compliant Table 2 Guidance and Manufacturing Declaration Electromagnetic Immunity The device ZWaveMed is intended for use in the electromagnetic environment specified below The customer or user of the device ZWaveMed should ensure that it is used in such environment Immunity Tests IEC 60601 Test Level Compliance Level Electromagnetic Environment Guidelines ...

Page 43: ...ond to that of a typical commercial or hospital environment If the user of the device ZWaveMed requires continued operation even in the case of interruptions in the power supply it is recommended that the device ZWaveMed be powered from an uninterrupted power supply or a battery 0 UT 1 cycle and 70 UT 25 30 cycles Single phase at 0 0 UT 1 cycle and 70 UT 25 30 cycles Single phase at 0 Voltage inte...

Page 44: ...es bearing the following symbol interference is possible Radiated RF EM fields according IEC 61000 4 3 3 V m 80 MHz 2 7 GHz 80 AM to 1 kHz 3 V m 80 MHz 2 7 GHz 80 AM to 1 kHz 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 0 3 27 4...

Page 45: ...e 37 Electromagnetic immunity to HF radio communication equipment Test Frequency MHz Band MHz Service Modulation Maximum Energy W Distance m Immunity Test Level V m 5240 5100 5800 WLAN 802 11 a n Pulse Modulation 217 Hz 0 2 0 3 9 5500 5785 ...

Page 46: ...inSysteme 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 10 102 403 I 0521 I Version 5 I Subject to change ...

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