Zimmer enPulsPro, User Manual

Page 1: ...User Manual enPulsPro USA...

Page 2: ......

Page 3: ...ol 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 Foot...

Page 4: ...the device Fig 2 Switches Connector 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 pla...

Page 5: ...le 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 Swit...

Page 6: ...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 7: ...for use this symbol indicates a Caution with regard to possible damage of the device Socket for handpiece Socket for footswitch User Manual Follow user manual Serial number Article number Manufacture...

Page 8: ...mation 3 4 Warnings 4 5 enPulsPro in brief 6 6 Device Set Up 7 7 Settings 8 8 Operating Instructions 8 1 Device Description 8 2 Notes on Operation 8 3 Performing the Treatment 8 4 Display and Buttons...

Page 9: ...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 Full observation of these instructions is a requirement...

Page 10: ...vibrations may lead to tissue damage such as metal implants after a fracture In general we advise against treatments if blood clotting disorders are present or the patient is receiving treatment that...

Page 11: ...Side Effects 2 Page 2 Side Effects Treatments with enPulsPro may occasionally cause irritation petechial bruising swelling or pain...

Page 12: ...ioned in such a way that direct access to the device s central power supply is possible so that it can be disconnected from the mains at any time To avoid the risk of electric shock the device must be...

Page 13: ...time e g acetylsalicylic acid should consult their therapist regarding a possible suspension of this therapy as the use of radial pulse in such patients may cause bleeding and bruising in varying deg...

Page 14: ...arnings 4 Page 5 In worst case condition maximum therapy time is limited to 4 minutes treatment time and a break time of 5 min If you will exceed this duty cycle the handpiece can be in overtemperatur...

Page 15: ...g radial pulses that spread radially into the tissue Why enPulsPro The innovative technology allows for a compact design without a compressor The modern multi color display showing all therapy relevan...

Page 16: ...ecting the handpiece Connect the handpiece to one of the designated sockets Channel I 15 or Channel II 16 and set it down Note Make sure that an applicator head is placed inserted to handpiece and tha...

Page 17: ...te Pressing the Therapy button 1 immediately switches to the therapy screen Configuration menu The factory settings can be changed and adjusted individually using the configuration menu Selecting Conf...

Page 18: ...fault Pressing the Load default button restores the default factory settings 7 Color scheme Pressing the key switches between the two display settings A bright or dark screen can be selected 8 Brightn...

Page 19: ...ting from friction increases the temperature of the applicator head with increasing duration of treatment to such a degree that thermal damage to the patient cannot be ruled out Please refer to the ma...

Page 20: ...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 There are 3 differ...

Page 21: ...on 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 t...

Page 22: ...er of pulses For pulse 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 emissi...

Page 23: ...ection window The handpiece is activated automatically regardless of the connected channel Connecting two handpieces If two handpieces are connected the handpiece on Channel I is initially activated T...

Page 24: ...ram The program is automatically stored in the favourites list 8 Counting direction Pressing the button sets the counting direction ascending or descending for the number of pulses emitted 9 Pulse cou...

Page 25: ...d on the SD card If the SD card is not inserted the following message appears when the Favorites and VAS buttons are pressed No SD card found The use of Favorites and VAS requires an SD card Insert th...

Page 26: ...gram name is entered via the keyboard Note There are 120 memory locations available for each Saving to the Favorites list Pressing button 1 opens the list of favorites and automatically stores the pro...

Page 27: ...orites list Here these can be 1 retrieved for treatment 2 edited the sequence altered or entries deleted Select favorites list Pressing the Favorites button opens the favorites list Retrieve program T...

Page 28: ...ing button 2 moves the program up Pressing button 3 moves the program down Pressing button 4 deletes the program Pressing button 5 confirmed the processing Note Pressing button 4 triggers a confirmati...

Page 29: ...e measurement 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 Activatin...

Page 30: ...hrough 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 na...

Page 31: ...40 measurements can 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...

Page 32: ...Operating Instructions 8 7 VAS Visual Analogue Scale 8 Page 23 Table Pressing button 1 also displays the therapy progress in tabular form...

Page 33: ...mJ at 10 Hz max 185 mJ Operating mode Interval operation Accuracy 20 Dimensions enPulsPro with SysCart H 54 33 Inch 138 cm x W 20 87 Inch 53 cm x L 20 47 Inch 52 cm enPulsPro H 11 81 Inch 30 cm x W 1...

Page 34: ...heads 0 24 0 59 0 98 Inch 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...

Page 35: ...Technical Information 9 1 Info Chart Duration of Treatment 9 Page 26 Maximum pulses per treatment Frequency Hz Pulses...

Page 36: ...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 spec...

Page 37: ...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 prote...

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 Suit...

Page 39: ...2 2 93133521 1 Applicator head 6 mm 93133511 1 Applicator head 15 mm 93133502 1 Applicator head 25 mm 65135110 10 Silicone protection caps 50500038 1 enPuls lotion 94130411 1 Footswitch 65410410 1 St...

Page 40: ...ations 12 Page 31 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...

Page 41: ...rried out by persons authorized by Zimmer MedizinSysteme the user is satisfied regarding the functional safety the proper condition and the mechanical integrity prior to using the device and the handp...

Page 42: ...ed 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 sup...

Page 43: ...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 B...

Page 44: ...y In Germany the Medical Devices Operator Ordinance Medizinprodukte Betreiberverordnung MPBetriebV and the DGUV Vorschrift 3 Elektrische Anlagen und Betriebsmittel apply in their current version among...

Page 45: ...ar 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...

Page 46: ...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 Possi...

Page 47: ...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...

Page 48: ...herwise 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 o...

Page 49: ...environment Surges in accordance with IEC 61000 4 5 Line to Line 0 5 kV 1 kV 0 5 kV 1 kV Surges in accordance with IEC 61000 4 5 Line to Earth 0 5 kV 1 kV 2 kV 0 5 kV 1 kV 2 kV Voltage dips in accord...

Page 50: ...IEC 60601 Test Level Compliance Level Electromagnetic Environment Guideline Conducted disturbances induced by RF fields according to IEC 61000 4 6 3 V 0 15 MHz to 80 MHz 6 V in ISM band between 0 15...

Page 51: ...M 5k Hz Derivation 1k Hz sine 2 0 3 28 710 704 787 LTE band 13 17 Pulse modulation 217 Hz 0 2 0 3 9 745 780 810 800 960 GSM 800 900 TETRA 800 iDEN 820 CDMA 850 LTE band 5 Pulse modulation 18 Hz 2 0 3...

Page 52: ...0 102 383 UR 0919 I Version 4 I Modifications reserved enPulsPro Zimmer MedizinSystems 3 Goodyear Suite B Irvine CA 92618 Tel 800 327 3576 Fax 949 727 2154 www zimmerusa com info zimmerusa com User Ma...