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Zimmer Z Wave Pro Скачать руководство пользователя страница 38

Manufacturer’s declaration of

Electromagnetic Compatibility

14

Page 29

The

Zwave

Pro

is developed according to the recognized standards of technology; the information on the

intended use of the components is taken into account.

The

Zwave

Pro

must not be operated near active HF surgery devices or magnetic resonance tomography that

can cause high levels of electromagnetic interference.

The

Zwave

Pro

is exclusively for professional health care facilities such as hospitals provided and tested.

The

Zwave

Pro

has no essential performance features that could be caused by electromagnetic interference.

WARNING:

Use of this equipment adjacent to or stacked with other equipment should be avoided because it

could result in improper operation. If such use is necessary, this equipment and the other equipment should
be observed to verify that they are operating normally.

The electromagnetic compatibility of the

Zwave

Pro

device has been tested on the original device with

handpiece

WARNING:

Use of accessories, transducers and cables other than those specified or provided by the

manufacturer of this equipment could result in increased electromagnetic emission or decreased
electromagnetic immunity of this equipment and result in improper operation.

The device

Zwave

Pro

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

Zwave

Pro

including cables specified by the

manufacturer. Otherwise, degradation of the performance of this equipment could result.

The device was tested for RF immunity only at selected frequencies. Nearby transients at other frequencies
may result in degraded operation. The frequencies tested are listed in Table 4.

The

Zwave

Pro

is developed according to the recognized standards of technology; the information on the

intended use of the components is taken into account.

The device

Zwave

Pro

does not contain any components which age over the course of the device life time and

could lead to a deterioration of the electromagnetic compatibility. Thus, no maintenance is required during

the life of the device to ensure basic safety. All tests according to standard IEC 60601-1-2 Ed. 4.0 were
performed. No other standards and regulations for electromagnetic compatibility have been applied.

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Содержание Z Wave Pro

Страница 1: ...Instructions for Use ZWavePro USA ...

Страница 2: ......

Страница 3: ...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 ...

Страница 4: ...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 ...

Страница 5: ...s Displays Fig 3 Display Application 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 B A 21 20 19 ...

Страница 6: ...Illustrations Applicator Head and Accessories Fig 5 Applicator head 22 39 mm applicator head Accessories 23 Silicone cap 22 23 ...

Страница 7: ...ymbol indicates Caution with regard to possible damage of the device Connection socket handpiece Connection socket footswitch Instructions for use Follow instruction for use Serial number Article number Manufacturer Date of manufacture Value of accessible fuses Interval operation note the instructions for use Instrument type BF ...

Страница 8: ...gs 3 4 ZWavePro in brief 4 5 Set up Device Installation of Cables 5 6 Settings 6 7 Operation Instructions 7 1 Device Description 7 2 Notes on Operation 7 3 Performing the Application 7 4 Display and Buttons 7 5 SD Card 7 6 Favorites List Retrieving Programs and Editing List 8 10 11 13 15 16 8 Technical Information 8 1 Info Chart Duration of Application 19 20 9 Cleaning Disinfection 21 10 Scope of ...

Страница 9: ...r the device ZWavePro 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 July 2019 U S A Federal Law restricts this device to sale by or on the order of a practitioner licensed by the law of the State in which he she practices to use or or...

Страница 10: ...gy in the form of vibrations may lead to tissue damage such as metal implants after a fracture In general we advise against applications if blood clotting disorders are present or the client is receiving treatment that results in a change in the blood clotting behavior as for example during pregnancy on clients with neurological diseases resulting in impairment of the vasomotor function in the are...

Страница 11: ... Please keep a safe distance of several meters ZWavePro 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 maintenan...

Страница 12: ...their therapist about a possible suspension of this application because there is an increased risk of bleeding and haematoma with the use of radial pulses in these individuals Radial 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 intercostal space or gastrointestinal tract Use in...

Страница 13: ...st the applicator head at the front of the handpiece and generates pulses which spread out radially in the tissue What are the advantages of ZWavePro 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 applicatio...

Страница 14: ... 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 on the device with the power switch 6 S...

Страница 15: ... 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 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 1 2 ...

Страница 16: ...h the red cross takes you back to the configuration menu 4 Volume 5 Brightness 6 Maintenance 7 Version 8 Load default 9 Color 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 r...

Страница 17: ...heat the 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 figure in section 8 1 the maximum values for the applications After reaching the specified values the application must be interrupted it can only be resumed after cooling the applicator to room temperature Note Please note ...

Страница 18: ...he 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 Application head A large applicator with Ø 39 mm is available for the application Change of applicator To change the applicator hold the handpiece with one hand and unscrew the app...

Страница 19: ...he handpiece is placed and held in a relaxed posture using the hand If required additional pressure can be applied in the direction of the fabric 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 instr...

Страница 20: ...our finger Program start Activating the right button in the start screen opens the screen selected in the settings menu If Protocols Body or the Protocols List is selected in the start settings menu a screen appears in which the application can be set via the list of application areas Application selection The application is selected in the corresponding row ...

Страница 21: ...e necessary 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 cap Setting the pulse energy Set the pulse energy using the controller on the left side Application launch By activating the foot switch the application starts N...

Страница 22: ... handpiece If only one handpiece is connected the window selection displays the channel of the connected handpiece The handpiece is activated automatically 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 selecting directly the handpiece in the selection window The act...

Страница 23: ...d number of pulses 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 pulses in the case of descending counting order Activation of the button opens the field for ent...

Страница 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 ...

Страница 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 ...

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

Страница 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 program Activating the button with the green arrow deletes the application Activation of the button with the red cross will cancel the deletion process 4 3 2 1 ...

Страница 28: ...ro with syscart H 138 cm W 53 cm L 52 cm ZWavePro H 30 cm W 35 cm L 20 cm Syscart H 138 cm W 53 cm L 52 cm Weight ZWavePro with syscart 19 3 kg ZWavePro 3 8 kg Syscart 15 5 kg Handpiece Dimensions 230 mm long 50 mm diameter Weight 850 g Lifetime 2 000 000 pulses pulse generator Application head 39 mm diameter tool free changeable 150 000 pulses guaranteed Operation 10 to 25 C 20 to 80 relative hum...

Страница 29: ...Technical Information 8 1 Info Chart Duration of Application 8 Page 20 Max possible pulses per application pulses frequency ...

Страница 30: ... Housing footswitch and all cables can be disinfected using disinfectant wipes To do so 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 dripp...

Страница 31: ...pe of delivery Tabletop device Set Art no 5531 X03 5531 1 ZWavePro 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 67250131 1 Mains cable US hospital grade 93130411 2 Holder for handpieces 10102386 1 Instructions for Use 63061010 1 Template Accessories Art no 5511 Handpi...

Страница 32: ...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 dis...

Страница 33: ... 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 head is remove...

Страница 34: ...re that the hand piece and foot switch are connected properly to the device Check to see whether the power cable is connected properly 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 pulse generator start immediately The pulse generator must work at the frequency on the display 10 Hz as standard value Note Upon c...

Страница 35: ...cator head stiffness through abrasion Fix for cause 1 The applicator head is a wear part and must be replaced after a certain number of pulses Removal of parts rubbed off Remove the applicator head from the handpiece and clean thoroughly the rear dome Then hold the handpiece without applicator head with the opening facing downwards and produce some pulses maximum 10 with 2 or 5 Hz frequency at the...

Страница 36: ... the power cord is plugged properly 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...

Страница 37: ...Over temperature in handpiece Please allow the handpiece to cool down After receiving this message no more pulse input is possible After confirming the message with OK the application screen appears and indicates when the handpiece will reach the operating temperature again In the case of other malfunctions switch the device off and then switch it on after waiting for 5 seconds If the problem pers...

Страница 38: ...nt could result in increased electromagnetic emission or decreased electromagnetic immunity of this equipment and result in improper operation The device ZwavePro 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 ...

Страница 39: ...luctuations flickers in accordance with IEC 61000 3 3 Compliant Table 2 Guidance and Manufacturing Declaration Electromagnetic Immunity The device ZwavePro is intended for use in the electromagnetic environment specified below The customer or user of the device ZwavePro should ensure that it is used in such environment Immunity Tests IEC 60601 Test Level Compliance Level Electromagnetic Environmen...

Страница 40: ...y must correspond to that of a typical commercial or hospital environment If the user of the device ZwavePro requires continued operation even in the case of interruptions in the power supply it is recommended that the device ZwavePro 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 ...

Страница 41: ...cinity of devices 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 ...

Страница 42: ...ibility 14 Page 33 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 ...

Страница 43: ......

Страница 44: ...MedizinSystems 3 Goodyear Suite B Irvine CA 92618 800 327 3576 949 727 2154 fax www zimmerusa com info zimmerusa com Instructions for Use USA 10 102 386 BäZi 0719 I Version 7 I Rights of modification reserved ...

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