Zimmer enPuls User Manual Download Page 38 | Manualshive

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Safety Check

Metrological Control

15

Page 30

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

the en

Puls

Version 2.0 in Germany.

In Germany, the Medical Devices Operator Ordinance (Medizinprodukte-

Betreiberverordnung, MPBetriebV) and the DGUV (Vorschrift 3 Elektrische

Anlagen und Betriebsmittel) apply in their current version, amongst other

regulations.

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 enPuls

Page 1: ...User Manual enPuls Version 2 0 USA...

Page 2: ...e 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 7 Vent front 8 Vent with fan rear Footswitch...

Page 3: ...rations Rear of the device Fig 2 Switches Connector sockets 10 Power switch 11 Mains fuse 12 Socket for mains cable 13 Socket for handpiece 14 Socket for footswitch 15 Identification plate 15 10 11 12...

Page 4: ...n bar Fig 4 Navigation bar Description of the functions A Back Takes you back one step B Therapy Switches to the therapy screen C Programs Switches to the program list D Favorites Switches to the favo...

Page 5: ...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...

Page 6: ...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 7: ...tion Information 3 4 Warnings 4 5 enPuls Version 2 0 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 D...

Page 8: ...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 9: ...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 10: ...Side Effects 2 Page 2 Side Effects Treatments with enPuls Version 2 0 may occasionally cause irritation petechial bruising swelling or pain...

Page 11: ...d 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 dis...

Page 12: ...tting 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 varyin...

Page 13: ...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 14: ...field crashing into the applicator head at the front of the handpiece generating radial pulses that spread radially into the tissue Why enPuls Version 2 0 The innovative technology allows for a compa...

Page 15: ...thing contact Connecting the handpiece Connect the handpiece to one of the designated socket 13 and set it down Note Make sure that an applicator head is placed inserted to handpiece and that it is co...

Page 16: ...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 17: ...lt Pressing the Load default button restores the default factory settings 7 Colour scheme Pressing the key switches between the two display settings You can choose from either a light or dark backgrou...

Page 18: ...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...

Page 19: ...ed handpiece and appears instead of the start key until the handpiece is once again ready for operation Once the handpiece has reached operating temperature the footswitch symbol appears with the text...

Page 20: ...s 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...

Page 21: ...number 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 e...

Page 22: ...the right controller Here the maximum selectable frequency depends on the selected power level 4 Saving Pressing the key opens the field to enter the individual name of a program The program is autom...

Page 23: ...ons 8 Page 15 8 Start Starts the program 9 Reset For ascending counting direction this resets to 0 for descending counting direction this resets to the pre set number of pulses 10 Status line Displays...

Page 24: ...gs are stored on the SD card If the SD card is not inserted the following message appears when the Favorites is pressed No SD card found The use of Favorites requires an SD card Insert the card and co...

Page 25: ...rogram 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 p...

Page 26: ...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 The sele...

Page 27: ...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 28: ...ion Precision 20 Dimensions H 322 mm W 235 mm L 130 mm Weight 2 7 kg IP class IPX0 Device IPX5 Footswitch IPX0 Handpiece enPuls 2 2 handpiece Dimensions 230 mm long 50 mm diameter Weight 850 g Lifetim...

Page 29: ...Technical Information 9 1 Info Chart Duration of Treatment 9 Page 21 Maximum pulses per treatment Maximum shocks per treatment Frequency Hz Pulses...

Page 30: ...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 31: ...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 32: ...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 33: ...on caps 50500018 1 enPulse lotion 94130411 1 Footswitch 93130312 1 Holder for handpiece 118 1 Mains cable 10102381 1 User Manual 63061010 1 Template Accessories Art No 5413 Handpiece version 2 2 93130...

Page 34: ...12 Page 26 For enPuls Version 2 0 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...

Page 35: ...re only performed by persons authorized by Zimmer MedizinSysteme GmbH the user has been instructed in the functional safety proper operating condition and the mechanical integrity of the device and ha...

Page 36: ...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 37: ...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 Br...

Page 38: ...ny In Germany the Medical Devices Operator Ordinance Medizinprodukte Betreiberverordnung MPBetriebV and the DGUV Vorschrift 3 Elektrische Anlagen und Betriebsmittel apply in their current version amon...

Page 39: ...he 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 radial pulse emissions Removal of wear debris R...

Page 40: ...al outlet and that the plug is firmly inserted into the socket of the device Check the power cord for damage Replace it in the event of visible damage Check the power supply and mains socket Possible...

Page 41: ...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...

Page 42: ...he user of the enPuls Version 2 0 must ensure that it is operated in such an environment Emissions measurements Compliance Electromagnetic environment guidelines RF emissions in accordance with CISPR...

Page 43: ...ment Surges in accordance with IEC 6100 4 5 1 kV differential mode voltage 2 kV common mode voltage 1 kV differential mode voltage 2 kV common mode voltage The supply voltage quality must correspond t...

Page 44: ...VRMS 150 KHz to 80 MHz 3 V m 80 MHz to 2 5 GHz Portable and mobile RF communications equipment should not be used any closer to the enPuls Version 2 0 including cables than the recommended separation...

Page 45: ...s intended for use in an electromagnetic environment in which RF disturbances are controlled The customer or the user of the enPuls Version 2 0 device can thus help to prevent electromagnetic interfer...

Page 46: ...381 UR 1118 I Version 3 2 I Modifications reserved enPuls Version 2 0 Zimmer MedizinSystems 3 Goodyear Suite B Irvine CA 92618 Tel 800 327 3576 Fax 949 727 2154 www zimmerusa com info zimmerusa com U...

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