User's Manual
45 Pages
Preview
Page 1
User Manual enPuls
Version 2.0
USA
Figures Front view of device
Control unit / Handpiece / Footswitch
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3 1
5
2
9
6 10
8
7
Selection and control elements
1 2 3 4 5 6
Control unit Pulse energy controller Touch pen in holder Display Frequency controller SD card slot
Handpiece
7 8 9
Handpiece with applicator head 25 mm Air vents, front Air vents with fan, rear
Footswitch
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Footswitch
1
Figures Front view of device
Display 13 14
12
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Screen readouts
11 12 13 14
Status bar Screen controls Title bar Navigation bar
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Figures Rear view of device
Switch and connector sockets
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15 16 17 Switch / Connector sockets
15 16 17 18 19 20
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19
Main switch Mains fuse Port for mains cable Port for handpiece Port for footswitch Serial number / manufacturer's plate
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Contents
enPuls
Front view of device Figures - Control unit / Handpiece / Footswitch Figures - Display Rear view of device Figures – Switch and connector sockets Accessories Figures
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enPuls briefly 1.1. Summary 1.2. Quick operation instruction How to use enPuls 1.3. 1.4. Handpiece Applicator heads 1.5. 1.6. Footswitch
7 8 10 11 12 13
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Installation 2.1. Fitting the cables, starting the system Settings 2.2.
14 15
SD-Card
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Treatment screen
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5
Favorites and Memory list 5.1. Saving modified programmes 5.2. Retrieving and editing Favorites list and the Memory list
21 22
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Description of the selection keys
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Medical information 7.1. Indications 7.2. Contraindications
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3 4
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Contents
General Information 8.1. Explanation of symbols 8.2. Warnings 8.3. Technical data 8.4. Technical information 8.5. CE Marking / Legal information
28 29 30 31 32
9 10 11 12 13
Maintenance
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Troubleshooting
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Function test
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Error messages
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Scope of delivery - Accessories
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Manufacturer’s declaration of Electromagnetic Compatibility
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Valid for the enPuls V.2.0 devices These operating instructions are an integral part of the device. They must be stored with the device and kept accessible at all times for anyone authorized to operate this device. These Instructions form is a part of the appartures and must be kept with it at all times. Full observation of these instructions is a requirement for the correct application and operation of the equipment and for consequent saftey for patient and operator. These operating instructions are valid from 01 June 2011.
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enPuls briefly 1.1.
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Summary
What is enPuls?
A state of the art therapeutic massager
Radial Pulse Therapy
Radial Pulse Therapy is a procedure for relief of minor muscle aches and pains and for temporary increase in local blood circulation
What does enPuls do?
Creation of radial pulses using an ergonomic handpiece and the transmittal of the radial pulses via special applicators. enPuls has a maximum penetration depth of about 35 mm in human tissue.
How are radial pulses generated with enPuls?
An electromagnetic field is generated via a coil in the back of the handpiece. A projectile is accelerated as a result of the field; this strikes against the applicator head at the front of the handpiece and generates pulses, which spread out radially in the tissue.
What are the advantages of enPuls?
The innovative technology allows a compact design with no need for a compressor. The clear and modern colour display shows all relevant parameters for treatment and the modern touch operation ensures pleasure and motivation when providing treatment. Individual program start configuration and clear, simple menu navigation make operation of the device easy and comfortable for users. Infinitely variable frequencies and various applicators allow treatment to be adapted to the particular condition of the patient. The compact design saves room in the practice and is highly suited for use in home visits. The unit must only be operated by medical practitionars.
Note:
enPuls has been constructed and designed solely for the treatment of superficial orthopaedic problems in humans and animals.
! Caution
Federal law restricts this device to sale by or on the order of a physician.
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enPuls briefly 1.2.
Quick operation instruction
1
Note:
The following descriptions are all based on factory settings.
Note:
All buttons, menus and submenus are activated directly on the screen by touching or using the touch pen.
Starting the program
Press the “Start” button to open the treatment screen for program P 02. Treatment screen
Applicator
Select the appropriate applicator head for the treatment you wish to carry out and screw this correctly onto the handpiece.
Positioning handpiece / applicator
Position the handpiece on the selected treatment point / field. To avoid any friction on the skin, enPuls lotion may first be applied onto the treatment area.
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enPuls briefly 1.2.
Quick operation instruction
1
! Caution
When using lubricants, the applicator head must be covered with a silicone cap to protect it.
Setting the frequency
Adjust the frequency using the right controller, if necessary.
Setting the pulse energy
Adjust the pulse energy using the left controller.
Starting treatment
Depress the footswitch to start the treatment. The display in the bottom status bar changes from ‘Ready’ to ‘Active’.
Note:
Only activate the unit via the footswitch once the handpiece has been positioned on the patient.
Ending treatment
Deactivating the footswitch interrupts or ends the treatment. The display in the bottom status bar changes from ‘Active’ to ‘Ready’. The device ends the treatment automatically once the preselected number of pulses has been reached.
Note:
During treatment, the patient must be observed closely and the treatment must be adjusted, if necessary, or discontinued, should any problems arise.
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enPuls briefly 1.3.
Start treatment
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How to use enPuls
enPuls operates with mechanical energy. The energy is transmitted to the patient via a handpiece, which is usually held in one hand. To do this, the handpiece is placed on the area or point of treatment with the applicator head held vertically. When the unit is activated, it is possible to work either steadily on a single site or dynamically over an area. It is advisable to use enPuls lotion (included in the accessories) in order to reduce friction on the skin. The weight of the handpiece means that it is normally not necessary to apply pressure to the treatment area / point. The handpiece is placed on the treatment area / point and held loosely in position with one hand. If required, additional pressure may be applied in the direction of the tissue, and the working angle can be varied.
! Caution
When using enPuls lotion or other lubricants, the applicator head must be covered with a silicone cap to protect it.
Note:
Despite high internal damping as a result of the weight and design of the handpiece, vibrations may cause strain to the user's hand. Recommended protective measure: - Limit the duration of exposure
Note:
The patient should be carefully monitored throughout the treatment.
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enPuls briefly 1.4.
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Handpiece
The handpiece (7) contains the pulse generator, a fan to dissipate heat and the slot for the different applicator heads. It is connected to the control unit (1). Note:
The pulse generator in the handpiece is an expendable part and has to be replaced after a specific period of use, as its functionality decreases over time. Zimmer MedizinSystems guarantees unrestricted use of at least 2 million pulses per pulse generator. Wear on the pulse generator varies. Depending on performance and frequency, sometimes far more than 2 million pulses can be delivered. For more information on the need to replace the pulse generator, see chapter 10. To work with the handpiece on a patient, it is essential that one of the applicator heads is screwed tightly onto the handpiece as far as it will go. The cable should not be stretched beyond its maximum length and must be protected against pinching or any other mechanical damage. To avoid heat accumulating in the handpiece, it is essential to ensure that the hand holding it or anything else does not block the air vents at the top, and particularly, on the base of the handpiece.
Standby mode on device The fan in the handpiece is started by depressing the footswitch and stops and handpiece automatically after reaching a certain temperature.
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enPuls briefly 1.5.
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Applicator heads
There are 3 different applicator heads available for treatment. Changing applicator heads
To change the various applicator heads, hold the handpiece in one hand and unscrew the applicator head from the handpiece with the other hand (anticlockwise). Screw the required head tightly onto the handpiece (clockwise), until the black outside ring of the applicator head rests on the handpiece (there should no longer be any thread visible).
Note:
Applicator heads are expendable parts and must be replaced after a certain period of use. Minor / slight deformation or shortening of the rear impact dome does not affect functionality. In cases of greater deformation or stronger shortening of the rear impact dome the applicator head must be replaced. A test template is supplied with the device that enables the user to test if the wear limit has been reached (see diagram).
Test template
Air gap applicator OK
Test template
Template makes contact or air gap at the tip Wear limit has been reached
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enPuls briefly 1.6.
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Footswitch
Place the footswitch so that it can be reached easily during treatment. The footswitch control unit is multi-directional so it is not necessary to align the footswitch exactly. To avoid damage, please note that only slight pressure needs to be exerted on the switch. Use the front part of your foot, not the heel to operate the footswitch. The switch does not have a locking device, which means that it only remains actuated as long as pressure is applied to it.
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Installation 2.1.
Fitting the cables, starting the system
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Note:
Before starting up the system, remove enPuls from its transport case. Do not operate the device while it is in the case. Ensure that enPuls is placed on a stable surface.
Note:
Make sure that the main switch on the device is set to '0'.
Connecting the mains cable
Connect the mains cable to the designated port (17) of the device and then plug into the mains.
Connecting the handpiece
Plug the handpiece into the appropriate socket (18) of the device and place it on the table.
Note:
Ensure that an applicator head is inserted into the handpiece and that it is properly screwed in as far as it will go.
Connecting the footswitch
Plug the footswitch into the appropriate socket (19) of the device and then place it on the floor.
Switching on the device
Switch on the device using the main switch (15).
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Installation 2.2.
Note:
2
Settings
Changes to the default settings can only be made from the start screen. Press button “Settings” to open the Settings screen
Figure 1
Language
Press this button to open the menu to select the language. The language is selected by pressing on the appropriate row in the pull down menu.
Start settings Start screen
Option to choose between 5 start screens. Press the button to open the pull down menu to select the start screen. The start screen is selected by pressing on the appropriate row.
Start display
Option to choose between 2 start displays: Press the button to open the menu to select the start display. The start display is selected by pressing on the appropriate row.
Welcome message
Option to configure an individual welcome message. Activate the welcome message field to open the keyboard in order to enter a welcome message.
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Installation 2.2.
2
Settings
Audio / graphic settings Brightness
Option to adjust the brightness of the screen lighting. Adjust the volume using the two arrow keys.
Volume
Option to adjust the volume of the signals when activating the control fields.
Handpiece counter status
The counter status for the handpiece that is currently connected, is shown in this display field.
Version
Press the version button to open the window with information about the current software version of the device.
Default settings
Press the default button to reset the factory default settings.
Touch calibration
Press the “Touch Calibration” button to open the screen to carry out the touch calibration. This can be done to improve the touch input if it is not sufficiently accurate.
First press the + symbol in the top left corner. A + symbol appears then in the lower right corner. Then precisely press the + symbol in the lower right corner. Repeat the procedure to complete the touch calibration.
Alternative language
The option “Alternative language” is inactive.
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SD-Card
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User-defined settings are saved on the SD card.
Note:
If the SD card is not inserted, the message ‘SD card not found’ appears when the 'Favorites' and 'Memory' buttons are pressed. Deactivate the message by pressing the button “OK” and continue.
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Treatment screen
4
Title bar
The title bar shows the name of the current program.
Status bar
The status bar shows the information about the current status of the treatment. If the treatment is not active, it shows the word ‘Ready' and if treatment is running the text 'Active' appears.
Mode
Shows the selected operational mode (continuous in this case). Press the 'Mode' button to open the 'Input' window and select the operational mode (continuous, Burst 4 Pulses, Burst 8 Pulses, Burst 12 Pulses)
Frequency
Shows the selected frequency. Change the frequency using the right controller. Frequency range: 1 Hz – 16 Hz, adjustable using the right controller in 1 Hz steps.
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Treatment screen
4
Energy/ Bar graph
Shows the selected pulse energy. When treatment is active the bar graph is filled in. Setting the pulse energy can be done either before or during pulse delivery. The pulse energy can be set at the levels 60, 90, 120 or 185 mJ.
Save
After changing the parameters, based on individual needs, press the button “Save” for saving the settings either in the Favourites list or the Memory list.
Count direction
Press to set the count direction (increasing or decreasing) of the number of pulses set.
Number of pulses
Shows the pre-selected pulse numbers as well as the current number of pulses delivered to the patient. Also the count direction (increasing in this case) is shown. Pressing the “Number of pulses” field opens the Input window, defining pre-selection.
Note:
enPuls offers two options for pulse delivery:
Pulse delivery without pre-selecting the pulse number
For pulse delivery with no pre-selected number of pulses, the device does not end the treatment. As long as the footswitch is activated, pulses will be delivered. For pulse delivery with no pre-selected number of pulses, only the upward count direction is active.
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Treatment screen
Pulse delivery with pre-selection of the number of pulses
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For pulse delivery with a pre-selected pulse number, the device ends the treatment once the pre-selected number of pulses has been reached. The footswitch is deactivated and pulse delivery is no longer possible. The treatment can be continued by resetting the current number of pulses or by adjusting the pre-selection. When the number of pulses is pre-selected the count direction is automatically set to decreasing. By pressing the 'Count direction' button on the treatment screen the increasing count direction button can be selected.
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