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Illustrations

Front of the device

Fig. 1

Selection and

operating elements

1 Control unit

2 Pulse energy controller

3 Display

4 Frequency controller

5 Slot for SD card

Handpiece

6 Handpiece with applicator head 25 mm

7 Vents, front

8 Vents with fan, rear

Foot switch

9 Foot switch

Содержание enPuls

Страница 1: ...Instructions for Use enPuls Version 2 0 EN ...

Страница 2: ......

Страница 3: ...ion and operating elements 1 Control unit 2 Pulse energy controller 3 Display 4 Frequency controller 5 Slot for SD card Handpiece 6 Handpiece with applicator head 25 mm 7 Vents front 8 Vents with fan rear Foot switch 9 Foot switch 2 3 4 5 6 7 8 9 1 ...

Страница 4: ...lustrations Rear of the device Fig 2 Switches ports 10 Mains switch 11 Mains fuse 12 Port for power cable 13 Port for foot switch 14 Port for handpiece 15 Serial no identification plate 15 10 11 12 14 13 ...

Страница 5: ... Navigation menu Description of the functions A Back Moves one step back B Therapy Switches to the therapy screen C Protocols Switches to Protocols D Programs Switches to the program list E Favourites Switches to Favourites F Scroll forwards Goes forward one page G Scroll backwards Goes back one page 17 18 16 E D C B A F G ...

Страница 6: ...Illustrations Applicator heads and accessories Fig 5 Applicator heads 19 Applicator head 25 mm 20 Applicator head 15 mm 21 Applicator head 6 mm Accessories 22 Silicone protection cap 19 20 21 22 ...

Страница 7: ...ndicates Caution with regard to possible damage of the device Connection port for handpiece Connection port for foot switch Instructions for use Follow instructions for use Serial number Item number Manufacturer Date of manufacture Applied part type BF Rating of the accessible fuses Interval operation Follow instructions for use ...

Страница 8: ...3 Application information 3 4 Warnings 4 5 enPuls version 2 0 in brief 5 6 System set up 6 7 Default settings 7 8 Operation instructions 8 1 Device description 8 2 Information on operation 8 3 Performing the treatment 8 4 Displays and buttons 8 5 SD card 8 6 Protocols 8 7 Favourites list Retrieve programs Edit list 9 11 12 13 15 16 18 9 Technical information 21 10 Cleaning Disinfection 22 ...

Страница 9: ...ional test 30 16 Legal notice 31 17 Error messages troubleshooting disposal 32 18 Manufacturer s EMC declaration Error Bookm k t Valid for the device enPuls version 2 0 NG These instructions for use 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 Last updated April 2019 ...

Страница 10: ...ces or in the area of the small facet joints in the spine Application directly via implanted electronic devices e g pacemakers pain pumps etc In areas where mechanical energy in the form of vibrations leads to damage of the tissue e g metal implants After fracture in the case of torn muscle fibres or muscle tears In general treatments are not recommended For bleeding disorders or treatments that r...

Страница 11: ...Side effects 2 Page 2 Side Effects Treatments with enPuls version 2 0 may occasionally cause irritation petechiae haematoma swelling or pain ...

Страница 12: ...suitable for use in areas with an explosive flammable or combustive environment During use the device is to be located in a position allowing direct access to the device s central mains supply so that it can be disconnected from the mains at any time To avoid the risk of electric shock the plug must be disconnected from the power supply before performing any cleaning or maintenance activities Insp...

Страница 13: ...dergoing simultaneous treatment with reduction and or alteration of blood clotting or a prolongation of clotting time e g acetylsalicylic acid should consult their therapist about a possible discontinuation of this treatment as the use of radial shock waves can readily lead to increased bleeding and bruising in these patients Shock waves are strongly scattered in air filled areas and produce refle...

Страница 14: ...ages of enPuls version 2 0 The innovative technology allows for a compact design without a compressor The modern clear colour display showing all therapy related parameters and the modern touch operation ensure enjoyment and motivation during treatment Individual program start adjustment and clear simple menus offer the user maximum convenience Different continuously adjustable frequencies and a c...

Страница 15: ...power outlets with a protective contact Connect handpiece Connect the handpiece to the provided port 14 and set it down Note Ensure that an applicator head is inserted in the handpiece and that it is screwed in correctly and completely Connect foot switch Connect the foot switch to the port provided 13 and put it on the floor Switch device on Switch on the device using the toggle switch 10 Switch ...

Страница 16: ...te Activating the therapy button 1 switches immediately to the therapy screen Configuration menu Factory settings can be changed and individually adjusted in the configuration menu Select configuration Activating the Configuration button 2 opens the Configuration screen The setting options are described below The default settings are pre programmed in the factory as shown on the screen 1 2 3 8 4 5...

Страница 17: ...h information on the current software version 6 Load default Activating the Load Default button restores the factory default settings 7 Colour scheme Activating the button switches between two screen settings A bright or dark screen background can be selected 8 Brightness The brightness can be adjusted using the two arrow buttons 9 Sound The volume can be adjusted using the two arrow buttons 10 Ha...

Страница 18: ...generator is given in chapter 17 To work with the handpiece on the patient one of the applicator heads must be screwed firmly and completely into the handpiece Interval operation The handpiece is not suitable for continuous operation Frictional heat causes the temperature of the applicator head to rise with increasing duration of treatment so much so that thermal damage to the patient cannot be ex...

Страница 19: ...ctivated handpiece and instead of the start button the display shows the time remaining until the handpiece is ready for use again As soon as the handpiece has returned to operating temperature the foot switch symbol appears with the text Start and treatment can continue Applicator heads Three different applicator heads are available for treatment Changing the applicator heads To change the applic...

Страница 20: ...ecessary to press down firmly on the treatment area point The handpiece is applied and held in position with the hand in a relaxed posture If required pressure can also be applied in the direction of the tissue and the angle of use can be varied Caution Note The silicone protection cap must be pulled over the applicator head when using lubricants in order to avoid soiling If the protective cap is ...

Страница 21: ... number of pulses treatment is terminated by the device after the pre set number of pulses has been emitted The foot switch is deactivated and pulses can no longer be emitted Treatment can be continued by resetting the current number of pulses or adjusting the preselection Pulse emission without pre set number of pulses For pulse output without a pre set number of pulses treatment is not terminate...

Страница 22: ...the right hand controller The maximum selectable frequency depends on the energy level set 4 Saving Activating the button opens the field to enter the individual name of a program The program is automatically stored in the favourites list 5 Counting direction Activating the button sets the counting direction ascending or descending of the number of pulses emitted 6 Pulse count Display of the prese...

Страница 23: ...cending counting direction this resets to 0 for descending counting direction this resets to the pre set number of pulses 10 Information Activating the button returns to the therapy and treatment information 11 Status line Displays the name of the currently selected program ...

Страница 24: ... list of indications are saved on the SD card If the SD card is not inserted the following message appears when the Favourites buttons are pressed No SD card found The use of Favourites requires an SD card Insert the card and confirm with OK Note Deactivate the message as described in section 7 ...

Страница 25: ...list Therapy selection via body region The body region is selected by clicking on the black square Select body region After selecting the desired body region in this case the elbow the window for therapy recommendations in the elbow region opens The clinical picture is selected directly in the corresponding line Note Regardless of whether the indication is selected via the body regions or the list...

Страница 26: ...ng line Therapy information After selecting the differentiated condition of the clinical picture another window with detailed therapy and treatment information opens Activating button 2 gives access to additional therapy and treatment information Button 3 returns to the previous information Select therapy program Activating button 1 opens the therapy screen with the corresponding program 1 2 3 ...

Страница 27: ...yboard Note There are 120 storage locations available Saving in the Favourites list Activating the button 1 opens the Favourites list and automatically saves the program in the Favourites list The program is always saved in the first open space in the list Activating button 2 interrupts the save procedure Note If button 1 is activated without a program name being entered the following message appe...

Страница 28: ...tes list These can be 1 retrieved here for therapy 2 edited moved in the sequence and deleted Select Favourites list Activating the Favourites button opens the favourites list Retrieve program The desired program is selected directly in the corresponding line Edit Favourites list Activating the button 1 opens the Edit Favourites screen 1 ...

Страница 29: ...e button 2 moves the program up Activating the button 3 moves the program down Activating the button 4 deletes the program Activating button 5 confirms the edit Note Activating button 4 triggers a confirmation prompt Do you really want to delete the program Activating the Yes button deletes the program Activating the No button interrupts the deletion process 1 3 4 2 5 ...

Страница 30: ...cy 20 Dimensions 322 mm x 235 mm x 130 mm Weight 2 7 kg IP class Device IPX0 Foot switch IPX5 Handpiece IPX0 Handpiece enPuls 2 2 Dimensions Length 230 mm diameter 50 mm Weight 850 g Length of service 2 000 000 shocks at least Applicator heads 6 15 25 mm diameter no tools needed for switching 150 000 shocks guaranteed Total device Dimensions 580 mm x 250 mm x 470 mm complete with bag Total weight ...

Страница 31: ...er e g cleaner for medical devices In the event of visible contamination the housing foot switch and all cables can be cleaned using commercially available alcohol free plastic cleaners Wipe the surface until the dirt is removed using a soft cloth soaked according to the specifications of the manufacturer of the cleaning agent but not dripping wet Disinfection only manually Tools Disposable wipes ...

Страница 32: ...ol free plastic cleaner e g cleaner for medical devices Remove the silicone protection cap from the applicator head prior to cleaning Prepare a solution of the cleaning agent following the instructions of the manufacturer Put the silicone protection cap in the solution Use the brush to clean all the inner and outer surfaces of the protection cap Finally rinse the protection cap under running water...

Страница 33: ... 55 C Disinfection 5 minutes at 93 C Note The material is suitable for steam sterilisation at 134 C Caution If flammable solutions are used for cleaning and disinfecting sufficient time must be allowed for the solutions to evaporate before using the device Otherwise it may lead to inflammation Suitable disinfection agents The following agents are suitable for manual disinfection mikrozid sensitive...

Страница 34: ...ge 25 The device has a CE mark in accordance with the EC directive on medical devices 93 42 EEC Manufacturer Zimmer MedizinSysteme GmbH Junkersstraße 9 89231 Neu Ulm Germany Tel 49 731 9761 291 Fax 49 731 9761 299 www zimmer de ...

Страница 35: ...oot switch 93130312 1 Holder for handpiece 118 1 power cable 10102380 1 instructions for use 87053009 1 transport bag Accessories Item no 5413 Handpiece version 2 2 93130312 Holder for handpiece 93133521 Applicator head 6 mm 93133511 Applicator head 15 mm 93133501 Applicator head 25 mm 65135110 Silicone protection cap 50500038 enPuls ZWave lotion 94130411 Foot switch 118 Power cable 87053009 Trans...

Страница 36: ...s 13 Page 27 For enPuls version 2 0 no combination devices are provided by the manufacturer Anyone who combines devices against these guidelines and thus creates a medical system does so under his her own responsibility ...

Страница 37: ... modifications are carried out only by persons authorised by Zimmer MedizinSysteme the user has ascertained the functional safety the proper operating condition and mechanical integrity before using the device and handpiece the device is operated only by properly trained personnel the device is not operated in hazardous areas and or a combustive atmosphere the device is immediately disconnected fr...

Страница 38: ...s cable must be disconnected Zimmer guarantees 150 000 shocks per applicator head It is recommended that the applicator head be replaced after this number of shocks has been reached The applicator head should also be replaced if therapy starts to become less successful or the applicator is observed to be deformed Visual checks should be carried out regularly for this reason ...

Страница 39: ...foot switch are correctly connected to the device before carrying out the functional test Check whether the power cable is correctly connected to the device and live Functional test Switch device on Briefly activate the foot switch the fans and generator should start immediately and the shock wave generator must operate at the frequency shown on the display 5 Hz is the default value Note Switch of...

Страница 40: ...ot listed in annex 2 of the MPBetreibV German Medical Devices Operation Ordinance In Germany the German Social Accident Insurance DGUV Regulation 3 Electrical systems and equipment as amended must also be observed Note This information applies to the operation of the unit in Germany Please consider divergent national regulations in your country if applicable ...

Страница 41: ...late due to wear Remedy for cause 1 The applicator heads are subject to wear and need to be replaced after a certain number of shock waves Removal of worn parts Remove the applicator head from the handpiece and clean the rear dome thoroughly Then hold the handpiece without applicator head with the opening facing downwards With the frequency set to 2 or 5 Hz at the lowest energy level trigger a sma...

Страница 42: ... plugged into the socket and the device plug is firmly inserted in the port of the device Check the power cable for damage Replace it if it is visibly damaged Check the mains and socket Possible cause 2 Fuse Remedy for cause 2 The mains input socket of the device contains microfuses which disconnect the device from the mains in the event of an electrical problem Open the flap and check the fuses I...

Страница 43: ...le when this message appears After confirming the message with OK the therapy screen moves to the foreground with the message in the status bar when the handpiece returns to operating temperature In the case of other malfunctions switch the device off and then on again after a 5 second delay If the error is still present please inform customer service via the main office in Neu Ulm Main office Zim...

Страница 44: ...enPuls version 2 0 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 enPuls version 2 0 contains no interchange...

Страница 45: ...nment specified below The customer or user of the device enPuls version 2 0 should ensure that it is used in such environment Emission Measurement Compliance Electromagnetic Environment Guidelines RF Emissions in accordance with CISPR 11 Group 1 The device enPuls version 2 0 must emit electromagnetic energy in order to ensure its intended function Nearby electronic equipment may be affected RF Emi...

Страница 46: ...ironment Surges in accordance with IEC 6100 4 5 Line to Line 0 5 kV 1 kV 0 5 kV 1 kV Surges in accordance with IEC 6100 4 5 Line to Earth 0 5 kV 1 kV 2 kV 0 5 kV 1 kV 2 kV Voltage dips in accordance with IEC 61000 4 11 0 UT 0 5 cycle At 0 45 90 135 180 225 270 and 315 0 UT 0 5 cycle At 0 45 90 135 180 225 270 and 315 The supply voltage quality must correspond to that of a typical commercial or hos...

Страница 47: ...nity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment Guideline Conducted Disturbances induced by RF fields according IEC 61000 4 6 3 V 0 15 MHz to 80 MHz 6 V in ISM Band between 0 15 MHz and 80 MHz 80 AM at 1 kHz 3 V 0 15 MHz to 80 MHz 6 V in ISM Band between 0 15 MHz and 80 MHz 80 AM at 1 kHz In the vicinity of devices bearing the following symbol interference is possible R...

Страница 48: ... 5kHz Derivation 1kHz Sine 2 0 3 28 710 704 787 LTE Band 13 17 Pulse Modulation 217Hz 0 2 0 3 9 745 780 810 800 960 GSM 800 900 TETRA 800 iDEN 820 CDMA 850 LTE Band 5 Pulse Modulation 18Hz 2 0 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 0 3 28 1845 1970 2450 2400 2570 Bluetooth WLAN 802 11 b g n RFID 2450 LTE Band 7 Pulse Modulation...

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Страница 52: ...419 I Version 5 I Modifications reserved enPuls Version 2 0 Zimmer MedizinSysteme 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 de Instructions for Use ...

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