Zimmer enPulsPro Instructions For Use Manual Download Page 45 | Manualshive

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Zimmer enPulsPro Instructions For Use Manual Download Page 45

Safety Check

Metrological Control

16

Page 37

Neither a safety check (STK) nor a metrological control (MTK) is required for

the device enPulsPro in Germany.

In Germany, the MPBetreibV (Medical Devices Operator Ordinance) and the

DGUV (Regulation 3 – Electrical systems and equipment) apply in their current

versions.

Note:

These requirements apply to the operation of the device in Germany. Please

observe the national regulations in your country.

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Summary of Contents for enPulsPro

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

Page 2: ...rol unit 2 Pulse energy controller 3 Display 4 Frequency controller 5 Slot for SD card 6 Power switch Handpiece 7 Handpiece 8 Vent front 9 Vent with fan rear 10 Holder for hand piece Footswitch 11 Footswitch Optional accessories 12 Rotatable swivel foot 2 5 7 8 4 3 10 11 1 9 12 6 ...

Page 3: ...ear of the device Fig 2 Switches sockets 13 Socket for mains cable 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: ...cale 23 VAS Post scale Fig 4 Navigation bar Description of the functions A Back Takes you back one step B Therapy Switches to the therapy screen C History D Protocols Switches to the VAS evaluation Switches to protocols E Programs Switches to the program list F Favorites Switches to the favorites area 20 21 19 F E D C B A 22 23 ...

Page 5: ...Illustrations Applicator heads and accessories Fig 5 Applicator heads 24 Applicator head 25 mm 25 Applicator head 15 mm 26 Applicator head 6 mm Accessories 27 Silicone protection cap 24 25 26 27 ...

Page 6: ...s symbol indicates a Caution with regard to possible damage of the device Socket for handpiece Socket for footswitch Instructions for use Follow instructions for use Serial number Article number Manufacturer Date of manufacture Applied part type BF Value of accessible fuses Interval operation Follow instructions for use ...

Page 7: ... Warnings 4 5 enPulsPro in brief 5 6 Device Set Up 6 7 Settings 7 8 Operating Instructions 8 1 Device Description 8 2 Notes on Operation 8 3 Performing the Treatment 8 4 Display and Buttons 8 5 SD Card 8 6 Protocols 8 7 Favourites List Retrieving Programs and Editing Lists 8 8 VAS Visual Analogue Scale 9 11 12 13 15 16 18 21 9 Technical Information 9 1 Info Chart Duration of Treatment 25 27 10 Cle...

Page 8: ...afety Check Metrological Control 37 17 Error Messages Troubleshooting Disposal 38 18 Manufacturer s EMC Declaration 41 Valid for the device enPulsPro NG These instructions for use is an integral part of the device They must be stored with the device and be accessible at all times to anyone authorised to operate the device The instructions for use is valid as of February 2016 ...

Page 9: ...on directly to cartilage surfaces or in the area of the small facet joints of the spine Application directly via implanted electronic devices e g pacemakers or pain pumps In areas where mechanical energy in the form of vibrations leads to damage of the tissue e g metal supply After fracture in the case of torn muscle fibres or muscle tears In general treatments are not recommended For bleeding dis...

Page 10: ...Side Effects 2 Page 2 Side Effects Treatments with the enPulsPro may occasionally cause irritation petechiae haematoma swelling or pain ...

Page 11: ...a safe distance of several metres The enPulsPro 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 cl...

Page 12: ... during treatment Persons undergoing simultaneous treatment with reduction and or alteration of blood clotting or a prolongation of clotting time e g acetylsalicylic acid should consult a health care professional about a possible discontinuation of this treatment as the use of radial shock waves can readily lead to increased bleeding and bruising Shock waves are strongly scattered in air filled ar...

Page 13: ...e innovative technology allows for a compact design without a compressor The clearly understandable colour display shows all parameters relative to the treatment The modern touch screen controls and the simultaneous connectivity of two handpieces facilitate treatment Individual programme start settings as well as clear and simple menu navigation provide the user with the maximal comfort Different ...

Page 14: ...ece to one of the sockets provided Channel I 15 or Channel II 16 and set it down Note Make sure that an applicator head is used in the handpiece and that this is correctly and completely screwed on Connect the footswitch Connect the footswitch to the designated socket 17 and place it on the floor Switching the device on Switch on the device with the power switch 6 Switching the device off The devi...

Page 15: ...te Pressing the Therapy button 1 immediately switches to the therapy screen Configuration menu In the configuration menu the factory default settings can be individually changed and adjusted Selecting Configuration Pressing the Settings button 2 opens the Settings screen The setting options are described below By default the factory settings are pre programmed as shown on the screen 1 2 4 5 6 7 2 ...

Page 16: ...re version 6 Load default Pressing the Load default key restores the default factory settings 7 Colour scheme Pressing the key switches between the two display settings A bright or dark screen can be selected 8 Brightness The brightness is adjusted via the two arrow keys 9 Volume The volume is adjusted via the two arrow keys 10 Handpiece counter status In this display panel the meter reading of an...

Page 17: ...tion As a result of the frictional heat the temperature of the applicator increases with increasing duration of treatment to the extent that thermal damage to the patient cannot be excluded Please refer to the chart in Chapter 9 1 for the maximum values for treatment After reaching the specified values the treatment must be interrupted it can be resumed only after the applicator has cooled to room...

Page 18: ...g the message with OK the treatment screen comes to the foreground In the selection window of the handpiece the handpiece is shown a deactivated The time required for the applicator to cool down is displayed Applicator heads Three different applicator heads are available for the treatment Changing the applicator heads To change the applicator head hold the handpiece with one hand and turn the appl...

Page 19: ... lotion provided is recommended Due to the weight of the handpiece it is usually not normally necessary 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 When using the enPuls Lotion or other lubricant the...

Page 20: ...se emission with pre set number of pulses the treatment is terminated by the device after the pre set number of pulses has been emitted The footswitch is deactivated and the emission of pulses is no longer possible Treatment can be continued by resetting the current pulse rate or by adjusting the pre set Pulse emission without pre setting the number of pulses With pulse output without pre setting ...

Page 21: ...tion window The handpiece is activated automatically regardless of the connected channel Connection of two handpieces If two handpieces are connected the handpiece on Channel I is initially activated The desired handpiece can be activated by directly selecting the handpiece in the selection window The activated handpiece is highlighted 3 VAS Pre Activating the VAS Pre window opens the screen to me...

Page 22: ...in the favourites list 8 Counting direction Pressing the key sets the counting direction ascending or descending of the number of pulses emitted 9 Pulse count Display of the preselected number of pulses and the currently emitted pulses as well as the total number of pulses emitted in the case of non pre set pulse number Ascending or descending display the counting direction Activating the pulse nu...

Page 23: ...cations are saved on the SD card If the SD card is not inserted the following message appears after pressing the Favourites and VAS keys SD card was not found The use of Favourites and VAS requires an SD card Insert the card and confirm with OK Note Disable the message as described in Chapter 17 ...

Page 24: ...e list Treatment selection via body region The body region is selected by clicking the black square Select body region After selecting the desired body region in this case the elbow the window for treatment recommendations in the elbow area opens The disease is selected directly on the corresponding line Note Regardless of whether the indication is selected via body region or list the program step...

Page 25: ...e here acute Treatment information After selecting the differentiated disease another window with detailed treatment and treatment information opens Pressing the 2 key opens additional treatment and treatment information Key 3 switches back to the previous information Select treatment program Pressing the 1 key opens the screen with the corresponding treatment program 1 2 3 ...

Page 26: ...d via the keyboard Note There are 120 memory locations available for each Saving to the Favourites list Pressing the 1 key opens the favourites list and automatically saves the program to the list The program is always saved to the first available space of the list Pressing the 2 key cancels the saving process Note If the 1 key is pushed without entering a program name the following message will a...

Page 27: ...he favourites list These can be 1 retrieved for treatment 2 edited shifted in the sequence and deleted Select favourites list Pressing the Favourites button opens the favourites list Retrieve program The desired program is selected directly in the corresponding row Edit favourites list Pressing the 1 key opens the Edit favourites screen 1 ...

Page 28: ...ressing the 2 key moves the program upward Pressing the 3 key moves the program downward Pressing the 4 key deletes the program Pressing the 5 key confirms the editing Note Pressing the 4 key triggers a security query Are you sure you want to delete this program Pressing the Yes key deletes the program Pressing the No key cancels the operation 1 3 4 2 5 ...

Page 29: ... is carried out before and after each treatment With repeated documentation this method gives a preliminary overview of the temporal progress and success of a treatment VAS list Activating the VAS Pre VAS Post field in the therapy screen opens the VAS screen In the VAS list 1 New patients are entered for measurements 2 Already existing patients are called up for further measurement 3 Data is edite...

Page 30: ...through the pages of the VAS list Enter new patient Activating the VAS Pre field in the treatment screen opens the VAS screen The New button opens the field for entering the patient s name Enter the name of the patient By pressing the 1 key the data is accepted and the screen with the pain scale opens automatically The button 2 cancels the operation Performing VAS Pre The patient marks his current...

Page 31: ...be saved per patient Once this number has been reached the following message appears The maximum number of measurements that can be saved per patient has been reached A maximum of 40 measurements can be stored To be able to perform more measurements on this patient the patient must be entered again Pressing the OK key closes the information window with the message Evaluation of VAS By pressing the...

Page 32: ...Operating Instructions 8 8 VAS Visual Analogue Scale 8 Page 24 Table Pressing button 1 also displays the therapy progress in tabular form ...

Page 33: ...pplicator freely adjustable in 10 mJ increments at 22 Hz max 90 mJ at 16 Hz max 120 mJ at 10 Hz max 185 mJ Operating mode Interval operation Accuracy 20 Dimensions enPulsPro with SysCart H 138 cm W 53 cm L 52 cm enPulsPro H 30 cm W 35 cm L 20 cm SysCart H 109 cm W 53 cm L 52 cm Weight of enPulsPro with SysCart 19 3 kg enPulsPro 3 8 kg SysCart 15 5 kg IP class IPX0 Device IPX5 Footswitch IPX0 Handp...

Page 34: ...ads 6 15 25 mm Diameter can be changed without tools 150 000 shocks guaranteed Handpiece ZWave version 2 2 Dimensions 230 mm long 50 mm diameter Weight 850 g Lifetime 2 000 000 shocks shockwave generator Applicator heads 39 mm Diameter can be changed without tools 150 000 shocks guaranteed Note Storage and transport only in original packaging Subject to technical changes ...

Page 35: ...Technical Information 9 1 Info Chart Duration of Treatment 9 Page 27 Maximum shocks per treatment Frequency Hz Shocks ...

Page 36: ...g foot switch and the tubing can be cleaned with commercially available alcohol free plastic cleaners Wipe the surface until the contamination 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 cellulose paper Commercially available alcohol free disinfectant for metal ...

Page 37: ...e cap Cleaning only manually Tools Drinking water lukewarm Vessel e g kidney dish Brush e g tooth brush medium hard Alcohol free plastic cleaner e g cleaner for medical devices Remove the silicon protective cap from the applicator head before cleaning Prepare a solution of the cleaning agent following the instructions of the manufacturer Put the silicon protective cap into the solution Clean the i...

Page 38: ... Caution If flammable solutions are used for cleaning and disinfecting sufficient time must be allowed for the solution to evaporation before using the device Otherwise it may lead to inflammation Suitable Disinfection agents For manual disinfection the following agents are suitable mikrozid sensitiv wipes Antifect FF Gigasept FF Quartamon Med Observe the application information of the correspondi...

Page 39: ...CE mark 11 Page 31 The product bears the CE mark in accordance with EC directive 93 42 EEC concerning medical devices ...

Page 40: ... 93133521 1 6 mm applicator head 93133511 1 15 mm applicator head 93133502 1 25 mm applicator head 65135110 10 Protective silicone caps 50500038 1 enPulse lotion 94130411 1 Footswitch 65410410 1 Storage tray for accessories 117 1 Mains cable 65410110 1 Holder for handpiece 63061010 1 Template 10102382 1 Instructions for use Accessories ItemNo 5413 Handpiece enPuls version 2 2 5411 Handpiece ZWave ...

Page 41: ...ations 13 Page 33 For enPulsPro no combinations devices are provided by the manufacturer Anyone who acting contrary to this specification combines devices and thus operates a medical system does so at their own risk ...

Page 42: ...nly performed by persons authorised by Zimmer MedizinSysteme GmbH the user has been instructed in the functional safety proper operating condition and the 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 immediately disconnected from the ...

Page 43: ...ted In cases of more extensive deformation of the impact dome or considerable shortening the applicator head must be replaced To check the proper condition of the applicator head a test template is supplied with the device in order to test whether the wear limit has been reached The test should be performed at least once a month regardless of the frequency of use To do so the applicator head is re...

Page 44: ...e handpiece and footswitch are properly connected to the device Check that the mains cable is properly connected to the device and that it is connected to the mains Function test Switch the device on Briefly activate the footswitch the fans and generator should start immediately whereby the radial pulse generator must operate at the frequency shown on the display 5 Hz is the default value Note Aft...

Page 45: ... for the device enPulsPro in Germany In Germany the MPBetreibV Medical Devices Operator Ordinance and the DGUV Regulation 3 Electrical systems and equipment apply in their current versions Note These requirements apply to the operation of the device in Germany Please observe the national regulations in your country ...

Page 46: ...1 Wear to the applicator head restricted movement due to wear Remedy for cause 1 The applicator heads are wear parts and must be replaced after a certain number of pulses Removal of wear parts 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 With the frequency set to 2 or 5 Hz at the l...

Page 47: ...t and that the device connector is firmly inserted into the socket of the device Check the mains cable for damage Replace it in the event of visible damage Check the power supply and mains socket Possible cause 2 Fuse Remedy for cause 2 In the power supply 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 ...

Page 48: ...t is no longer possible 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 headquarters in Neu Ulm Headquarter Zimmer ...

Page 49: ...e that it is only used in such an environment Interference emission measurements Accordance Electromagnetic environment guidelines RF emissions in accordance with CISPR 11 Group 1 The enPulsPro uses RF energy for its internal function only The RF emissions are therefore extremely low and are not likely to cause any interference in nearby electronic equipment RF emissions in accordance with CISPR 1...

Page 50: ...ronment Impulse voltages surges in accordance with IEC 6100 4 5 1 kV Normal mode voltage 2 kV Common mode voltage 1 kV Normal mode voltage 2 kV Common mode voltage The quality of the supply voltage should correspond to that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations in accordance with IEC 61000 4 11 5 UT 95 dip in UT for period 40 UT 60 ...

Page 51: ...m 80 MHz to 2 5 GHz Portable and mobile RF communications equipment including cables should be used no closer to the enPulsPro than the recommended separation distance which is calculated according to the equation for the transmission frequency Recommended separation distance d 1 2 P d 0 35 P for 80 800 MHz d 0 7 P for 800 MHz to 2 5 GHz where P is the nominal rating of the transmitter in watts W ...

Page 52: ...gnetic environments specified below The customer or the user of the enPulsPro can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the enPulsPro depending on the output power of the communications equipment as specified below Nominal capacity of the transmitter W Protective distance dependent on the...

Page 53: ...R 0716 I Version 3 1 I Modifications reserved enPulsPro 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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