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Summary of Contents for Zimmer enPuls 2.0
- Page 2 Illustrations Fig. 1 Selection and operating elements Handpiece Footswitch...
- Page 3 Illustrations Fig. 2 Switches / Connector sockets...
- Page 4 Illustrations Fig. 3 Displays / Therapy screen Fig. 4 Navigation bar...
- Page 5 Illustrations Fig. 5 Applicator heads Accessories...
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Page 6: Explanation Of Symbols
Explanation of Symbols danger. "Caution" with regard to Caution possible damage of the device. -
Page 7: Table Of Contents
Contents Illustrations Explanation of Symbols Indications / Contraindications Side Effects Application Information Warnings enPuls Version 2.0 – in brief Device Set-Up Settings Operating Instructions Technical Information Cleaning / Disinfection... - Page 8 Contents CE mark Scope of Delivery and Accessories Device Combinations Safety and Maintenance Functional Test Safety Check / Metrological Control Error Messages / Troubleshooting / Disposal Manufacturer’s EMC Declaration Puls...
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Page 9: Indications/Contraindications
Indications/contraindications Indications Contraindications In general, treatments are not recommended Care is required for patients... -
Page 10: Side Effects
Side Effects Side Effects... -
Page 11: Application Information
Application Information Caution Caution Caution Caution Pulse Caution Pulse Caution... -
Page 12: Warnings
Warnings Pulse... -
Page 13: Enpuls Version 2.0 - In Brief
enPuls Version 2.0 – in brief What is enPulse Version 2.0? Shockwave treatment What does enPulse Version 2.0 ? Pulse How are shock waves generated with enPulse Version 2.0 ? What are the advantages of enPuls Version 2.0? Intended Use Pulse Note: The device may only be used by healthcare professionals... -
Page 14: Device Set-Up
Device Set-Up Note: Before commissioning the enPuls Version 2.0, remove the system from the carrying case. Do not operate the device whilst it is in the case. Ensure that the enPuls Version 2.0 is on a stable surface. Note: Make sure that the power switch on the device is set to "0". Connect power cable Note: The device may only be connected to earthed sockets. -
Page 15: Settings
Settings Note: Changes to the default settings are only possible from the start-up screen. Start-up screen Note: Pressing the "Therapy" (1) key immediately switches to the therapy screen. Configuration menu Select configuration... - Page 16 Settings (1) Start settings 1. Start menu: (2) Language (3) Welcome Welcome (4) OK (5) Version (6) Load default (7) Colour scheme (8) Brightness (9) Volume (10) Counter status of handpiece (11) Maintenance...
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Page 17: Operating Instructions
Operating Instructions Handpiece Note: The shockwave generator in the handpiece is a wear part and must be replaced after a certain service life because its functionality decreases with time. must Interval operation Note: Please note that the temperature control of the handpiece (described on page 11) is only a technical shutdown to protect the mechanical parts inside the handpiece. - Page 18 Operating Instructions Temperature monitoring/regulation of the handpiece Puls Applicator heads Changing the applicator heads Note: The applicator heads are wear parts and must be replaced after a certain operating life (see Chapter 14.2 Maintenance). Footswitch...
- Page 19 Operating Instructions Treatment Puls Puls Puls Caution Note: Despite high internal attenuation through the weight and construction of the handpiece, the hand of the user can be strained through vibrations. Recommended precautions: - Limitation of the exposure time - Passive support Note: The patient should be carefully monitored during the treatment.
- Page 20 Operating Instructions Note: All keys, menus, and sub-menus can be activated directly on the screen by finger pressure. Program start-up Select applicator Attach the handpiece / Puls applicator Caution Set pulse energy Note: The enPuls Version 2.0 offers two options for emitting pulses. Pulse emission with pre-set 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.
- Page 21 Operating Instructions Description of the display elements and buttons (1) Pulse energy (2) Mode (3) Frequency (4) Saving (5) Counting direction (6) Pulse count (7) Back...
- Page 22 Operating Instructions (8) Start (9) Reset (10) Information (11) Status line...
- Page 23 Operating Instructions SD card Note: Disable the message as described in Chapter 17.
- Page 24 Operating Instructions Protocols Note: In the "Protocols" menu there are two ways to choose the desired treatment: - via the body region - via the list Treatment selection via body region Select body region Note: Regardless of whether the indication is selected via body region or list, the program steps from here up to the treatment screen are analogous and are therefore only described once below.
- Page 25 Operating Instructions Select differentiated state of the disease Treatment information Select treatment program...
- Page 26 Operating Instructions Saving and naming the program Note: There are 120 memory locations available for each. Saving to the Favourites list Note: If the (1) key is pushed without entering a program name, the following message will appear: “Please enter a name!” Confirm the message, enter the program name and repeat the saving process.
- Page 27 Operating Instructions 1. retrieved for treatment 2. edited (shifted in the sequence and deleted). Select favourites list Retrieve program Edit favourites list...
- Page 28 Operating Instructions Edit favourites 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.
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Page 29: Technical Information
Technical Information Basic unit Power supply Fuse Power consumption Protection class Application class Application part Frequency range Pulse energy levels Operating mode Precision Dimensions Weight IP class enPuls 2.2 handpiece Dimensions Weight Lifetime Applicator heads Total unit Dimensions Total weight Operation Storage and transport... - Page 30 Techn nical Info ormation ximum sh hocks p p er treatm m ent...
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Page 31: Cleaning / Disinfection
Cleaning / Disinfection Housing / Cleaning (only manually) Foot switch Disinfection (only manually):... - Page 32 Cleaning / Disinfection Applicator head / Cleaning (only manually) handpiece Disinfection (only manually): Silicon protective Cleaning (only manually) Disinfection, manually:...
- Page 33 Cleaning / Disinfection Cleaning / Disinfection, by machine: Preparation: Performance: 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 Note:...
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Page 34: Ce Mark
CE mark... -
Page 35: Scope Of Delivery And Accessories
Scope of Delivery and Accessories Scope of delivery Art. No. Pulse Pulse Accessories Art. No. Puls... -
Page 36: Device Combinations
Device Combinations Puls... -
Page 37: Safety And Maintenance
Safety and Maintenance Puls... - Page 38 Safety and Maintenance Checking the impact dome Air gap Applicator in order Template sits flush or there is an air gap at the top Wear limit reached...
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Page 39: Functional Test
Functional Test Puls Note: Before performing the function test, check that the 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 Note: After completing the function tests, switch off the enPuls Version 2.0. -
Page 40: Safety Check Metrological Control
Safety Check Metrological Control Puls These requirements apply to the operation of the device in Germany. Please Note: observe the national regulations in your country. -
Page 41: Error Messages Troubleshooting Disposal
Error Messages Troubleshooting Disposal Loss of function handpiece Possible cause 1 Remedy for cause 1: Possible cause 2 Remedy for cause 2 Handpiece malfunction Possible cause 1 Remedy for cause 1: Possible cause 2: Remedy for cause 2: To replace the shockwave generator, please contact your sales representative or the headquarters in Neu-Ulm... - Page 42 Error Messages Troubleshooting Disposal Applicator not found Possible cause Remedy for cause Device malfunction Possible cause 1 Remedy for cause 1: Possible cause 2: Remedy for cause 2:...
- Page 43 Error Messages Troubleshooting Disposal Error message SD card Over temperature warning Headquarter Disposal...
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Page 44: Manufacturer's Emc Declaration
Manufacturer's EMC Declaration Puls Puls Guidelines and manufacturer’s declaration – electromagnetic interference emissions Puls Interference emission measurements Accordance Electromagnetic environment – guidelines Puls Puls... - Page 45 Manufacturer's EMC Declaration Guidelines and manufacturer’s declaration – electromagnetic interference resistance Puls Puls Interference checks IEC 60601 – test level Compliance level Electromagnetic environment – guidelines...
- Page 46 Manufacturer's EMC Declaration Puls Guidelines and manufacturer’s declaration – electromagnetic interference resistance Puls Interference IEC 60601 test level Conformity Electromagnetic environment – guidelines tests level Recommended separation distance:...
- Page 47 Manufacturer's EMC Declaration Puls Puls Puls Recommended separation distances between portable and mobile RF communications equipment and the Puls Pulse Puls Nominal capacity of the transmitter Protective distance dependent on the transmission frequency 150 KHz to 80 MHz 80–800 MHz 800 MHz to 2.5 GHz...
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