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Summary of Contents for Globus DIACARE 8000 PRO
- Page 1 User Manual DIACARE 8000 PRO 0476...
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Page 2: Table Of Contents
TABLE OF CONTENTS TECHNICAL FEATURES ............................4 DEVICE ..................................4 OUTPUT WAVEFORM ............................4 POWER SUPPLY ..............................5 USE CONDITIONS ............................... 5 STORAGE AND TRANSPORTATION CONDITIONS (ORIGINAL PACKAGING) ......5 DISPOSAL ................................5 INTENDED USE ................................ 6 DEVICE CLASSIFICATION ........................... 6 DEVICE COMPLIANCE ............................ - Page 3 OPTIONAL ACCESSORIES ..........................25 CONNECTIONS ..............................26 CONNECTION TO THE DEVICE ........................26 CABLE CONNECTION ............................. 26 DEVICE USE ................................27 START MENU ............................... 27 GENERAL SETTINGS ............................28 "SUGGESTED PROTOCOL" AREA ........................29 ATLAS ..................................29 SPORTS .................................. 30 SUGGESTED PROTOCOL ..........................
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Page 4: Technical Features
TECHNICAL FEATURES Device Frequency: 448, 470 kHz (medical frequencies) 400, 700, 1000, 1200 kHz (frequencies not covered by medical CE) Case: Protection level of the case: IP 20 Dimensions: 16.5x12.5x7.2 in Weight: 25.35 lbs Power: 160 W [RMS] +/-10% in continuous mode/100 Ω 250 W [RMS] +/-10% in non-continuous mode/100 Ω... -
Page 5: Power Supply
Power supply Voltage: 220/230V 50/60Hz 3.7A max 110/127V 50/60Hz 7.4A max Absorbed power: 730W Fuses: 2x F 10A L 250V 5x20mm RTC battery (optional): Internal battery for clock maintenance, type CR2032 3V Use Conditions Temperature: from 32°F to 82.4°F Maximum relative humidity: from 30% to 75% Atmospheric pressure: from 700 hPa to 1060 hPa Transportation conditions (original packaging) Temperature: from 14°F to 113°F... -
Page 6: Intended Use
INTENDED USE Tecar therapy is designed for the following purposes in men and women over the age of 14: 1. Pain Management: Diacare is utilized to alleviate pain stemming from various sources, including musculoskeletal disorders, injuries, and chronic pain conditions. 2. -
Page 7: Device Compliance
- Device for continuous operation. - Device not suitable for outdoor use. - Sound and acoustic signals are in compliance with the 60601-1-8 directive. DEVICE COMPLIANCE The device has been manufactured in compliance with applicable technical standards and has been certified, in compliance with Directive 93/42/EEC as amended by directive 2007/47 on medical devices, by the Notified Body Kiwa Cermet Italia, Via Cadriano 23, 40057 Granarolo Dell’Emilia (BO) Italy (n. -
Page 8: Warranty Conditions
N.B. Before returning the device for repairs, we suggest reviewing the user manual and consulting the Globus website. If you must return the product for repair, please contact your dealer or the Globus customer service. Rev.02 / 10-2023... -
Page 9: Labeling And Symbols
LABELING AND SYMBOLS Warning. Indicates that the device can emit from the electrodes a current above 10mA and a voltage above 10V. This symbol on the device indicates that it complies with the requirements of the directives on medical devices (93/42/EEC 47/2007EEC). - Page 10 Power: indicates the power absorbed by the power-supply of the device. Power Fuse Fuse: indicates the features of the fuses assembled on the device. Weight Weight: indicates the mass of the device. Out power Output power: it indicates the maximum power emitted by the device. Output voltage: it indicates the maximum output voltage of the device.
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Page 11: Device
(for example, if the code is *** 2123 *****, it means that the device was manufactured in week 21 of 2023). Accessories Globus conductive cream Indicates that the cream complies with the requirements of regulations... -
Page 12: Display And Interface
DISPLAY AND INTERFACE The device displays the user interface by means of a touch screen and three physical buttons placed under the screen. Below are descriptions of the functions and features for each command. Physical buttons The central knob turns to increase or decrease the output power of the device. The button on the left of the knob has a "skip phase"... -
Page 13: Pre-Start Screen
In the menu that has program and user lists with more than 5 elements, this button indicates that the list continues on the following page. By pressing the icon, the user moves directly on to the next screen. In the menu that has program and user lists with more than 5 elements, this button indicates that the list continues in the previous page. - Page 14 Display screen Set parameters of the treatment. Indicates the instantaneous current value expressed in mA. The histogram graph displays the instantaneous current output expressed in mA. The histograms have different colors depending on the current output. This way the user can always check the graphical indication that allows to understand in real time if the current output is low or high for the treated tissue, depending on the green-yellow-red-purple color progression.
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Page 15: Home Screen Touchscreen Buttons
Setting menu. By entering the settings menu from the display screen, in addition to all the different functions, it is also possible to carry out the calibration. 13 Indication of the selected user. Execution screen touchscreen buttons This section allows the operator to manage the treatment in the most appropriate way. Example: STOP button will interrupt the treatment definitively. -
Page 16: Home Screen
of the delivered power takes on more intense colors than in regular mode. “Square” button, only available in the programs contained in the Atlas section. This allows the user to view all the information of a program in detail during the treatment, offering greater support to the user through images and descriptions of the treatment. - Page 17 >901 In capacitive mode, colors change as follows: Current [mA] COLOR >501 Standard-mode power graph (without boost activation) The color triangle shows in real time the percentage of power being used and its colors can vary from green to yellow depending on the percentage of power that is being used. From 0 to 30% of the power, the graph is green, 31% to 60% - yellow and over 60% is red.
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Page 18: Alarms
From 0 to 30% From 0 to 30% of the power, the graph is orange, from 31% to 60% red, and over 60% is purple. The shifts from a power percentage to another are managed with color shades. ALARMS The operator should place the device so that "functioning during emission" and "functioning with suspended emission"... -
Page 19: Volume
circuited handpieces alarm by pressing the menu button during the program and choosing the option that disables the alarm. The short-circuit alarm can be disabled also from the general settings. In both cases the disabling is activated until the device is turned off. The next time it is turned on, the short-circuit alarms will return to ON. -
Page 20: Safety Precaution (Patient And Operator)
Using the device near short wave or microwave appliances can generate an instability of the device outputs. The simultaneous use of other high-frequency medical devices can cause a burn hazard in near the electrodes and possible device failure. Do not use flammable materials while using the device. It is absolutely forbidden, during the treatment, to place the mobile electrode upon the counter electrode. -
Page 21: Preparation To Use The Device
PREPARATION TO THE USE OF THE DEVICE One the device is turned on, make sure that the software version and the model of the device appear on the screen, which means that the device is working and ready to be used. If it is not, switch it off and on again. - Page 22 REF G5129 Resistive monopolar handpiece Ergonomic handpiece for resistive treatments. The handpiece is designed for a plug-in connection which facilitates the insertion of the resistive electrode. The handpiece is fully equipped with three flat resistive Ø 70-50-30 mm electrodes. REF G5130 Capacitive monopolar handpiece Ergonomic handpiece for capacitive treatments.
- Page 23 The kit consists of a handpiece and a non-insulated Ø 50 mm electrode. REF G3369 Tecar therapy cream Bottle of Globus conductive cream, 1000 ml. REF G5976 Hands-Free Kit The kit is composed of a series of accessories to carry out treatments in automatic mode with the "Hands-free"...
- Page 24 Resistive and Neutral cable (called "A") with Ø 4 mm DIN connection. 2 cables with crocodile clips to connect cable "A" and the adhesive electrode. Resistive and Neutral. Splitter that enables the connection to the "A" cable of two small adapting cables with Ø 4 mm connection.
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Page 25: Optional Accessories
Optional accessories REF G5651 Kit Fascia tools The Globus Fascia Tools are special ergonomic Resistive electrodes designed for the mobilization and the advanced treatment of soft tissue disorders. Fascia tools allow for the integration of the technology with manual application to enhance patient outcomes and comfort. -
Page 26: Connections
Optional Convex Capacitive and Resistive Electrodes Ø 30 Ø 50 Ø 70 mm CONNECTIONS Power Connection Plug the power supply into the indicated inlet behind the device, then connect to the wall electrical outlet. Ensure that the cable can be easily unplugged from the socket. Cable connection The connection port plugs of the Neutral plate, the Resistive and the Capacitive handpiece are located in the front of the device below the 3 buttons. -
Page 27: Device Use
DEVICE USE Turning on/off The Diacare 8000 PRO device is supplied with a start button on the back panel. Press the button to the ON position to turn the device on. Start menu At the start, the touch screen displays 11 buttons and one icon to enter the setting menu. - Page 28 By pressing the icons, the following areas can be accessed: 1. LANGUAGE SETTINGS To select the language of Diacare 8000 PRO, just press the corresponding flag. 2. ALARM SETTINGS This section allows to activate or disable short-circuit alarms. When the icon is dark gray, it means that the corresponding option is on.
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Page 29: Suggested Protocol" Area
Suggested Protocols Areas Atlas The "Atlas" area offers the option to select the program based on the pathology to treat. The pathological conditions to be treated are divided according to Anatomy indicated by a dot. To view the programs, press the corresponding dot, then select the pathology and confirm with Ok. -
Page 30: Sports
then it is not possible to see the corresponding descriptions and images. To modify parameters, press the cell that corresponds to the relevant parameters and switch the option using the directional arrows. The user can administer the modified program directly or store it in his/her personal area by pressing "Save as". Sports The Sports Section contains a library of preset programs divided by type of Sport. -
Page 31: Suggested Protocol
Suggested Protocols The Suggested Protocols area contains a library of preset programs listed by type of pathology. Unlike the Atlas section, the operator can choose the program to use by browsing by type of pathology to be treated. The macro pathological areas are divided as follows: - bones and articulations - tendon and ligament... -
Page 32: Hands-Free Program
The parameters of the programs included in the default area can be modified and saved in the personal area. To modify, select the cell that corresponds to the parameters to be modified and change the option by using the directional arrows. The user can start the modified program directly or store it in the personal area by pressing "Save as"... -
Page 33: Athermic Program
Athermic program This program is characterized by a duty cycle that allows to administer a treatment without producing diathermic effects. This mode allows to use TECAR and its bio- stimulating effect at an acute stage of the pathology/injury when the presence of heat may be inappropriate. -
Page 34: Transdermal Program
Special programs consist of three different ways of applying TECAR therapy, once the Specials icon has been selected, the following list of programs will appear: - Transdermal - Pulsed - Multi Frequency Transdermal Program The Transdermal program allows to perform a Tecartherapy treatment and facilitate the absorption of therapeutic pharmacological substances within the tissues. -
Page 35: Multifrequency
Multi Frequency This Multi Frequency program is characterized by the application of 1 or 2 phases of treatment with 3 different frequencies, instead of a fixed frequency. The emission is continuous. The program offers 6 different possibilities according to the goals. This program allows the user to involve in tissues with varying depth and composition. -
Page 36: Free Program
Free program Phase 3 programming Phase 2 programming Save by pressing the "save as" button. Type the name of the program and press the Enter button. The program saving appears in the My Programs menu of the user. The Free program area allows professionals who are more expert in the use of TECAR to start a program quickly and the ability to customize all of the treatment parameters. - Page 37 By selecting "New program" the user can add up to three work phases and save the program in "My Programs" or start the program. To add parameters, press any of the cells in the first column, next the "Save as" button appears.
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Page 38: User Menu
User menu Enter the list of users Press the add-user button. Type the name and last name of The new user has been saved. the user and press ENTER on the keyboard. How to delete a user select the Confirm the deletion by name, press the trash button and pressing the green symbol or confirm with the OK button. -
Page 39: Application Method
Before starting the treatment, clean the skin accurately and make sure that there are no traces of soaps or other products. Start the desired program. Diacare 8000 PRO can transfer energy in two different modes: Capacitive and Resistive. Depending on the system that is being used, a shift and concentration of electric charges develops on tissues at different depths, allowing the user to focus treatment of bones, tendons, ligaments, muscles, or more superficial tissues. -
Page 40: Contraindications And Side Effects
the electrodes must be covered with cream to allow a uniform electrical conduction. The alternating electrical field causes the movement and the concentration of electrical charges within the tissues. With the resistive mode, the current produces a temperature increase especially in correspondence of the tissue with higher impedance, generating a thermal increase at a deeper level first. -
Page 41: Side Effects
suffer from one of the following diseases: - neoplasia - serious cardiovascular failure - hemorrhages - local or systemic infections - active dermatological pathologies - ischemic tissues - fever - alteration of coagulation. Attention should be paid in the following cases: - body areas with little sensitivity (hypoesthesia) - seriously obese patients - inflammatory diseases in the acute phase. -
Page 42: Maintenance And Cleaning
To monitor the patient during the treatment and receive feedback on the perceived temperature, it is recommended to use a temperature scale with values ranging from 0 to 10, where zero means there is no heat sensation, while 10 corresponds to an excessive temperature. -
Page 43: Transportation
For the choice of the temperature to be induced in the tissues, it is necessary to follow the appropriate clinical training (Globus Academy). The temperature can be monitored by means of a laser thermometer, of the therapist's touch and of the patient's subjective perception reported on a VAS scale, which must never cause discomfort or pain. - Page 44 (For further information, follow the Globus Academy courses.) What are the recommended power levels? The perception of heat must never be excessive.
- Page 45 How do I select the correct size of the electrode to use? The smaller electrode is specific for smaller areas and for the trigger points. The medium electrode for areas such as the shoulder, the ankle, the hand or the neck. The large electrode for larger areas like the thigh, the arm, the leg, the gluteus or the lumbar/dorsal muscles.
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Page 46: Emc Accompanying Documents
EMC Accompanying Documents Essential performance PERFORMANCE CONDITION RISK ACCEPTED EVENT Heat treatment Disturbance Display information no The machine must stop the emission. by Tecar outside the longer readable. The machine must maintain the emission Therapy. electronic circuit. unvaried and accept the commands. It must be possible to stop the emission safely using the controls. - Page 47 Overheating of the Damage to the device, The device must monitor the temperature of electronic board. incorrect radio the electronic board, if a threshold is frequency emission. exceeded it must reduce the emission power or interrupt the treatment by signaling the anomalous condition with visual warnings on the display or acoustic warnings.
- Page 48 Warning: Radiofrequency communication devices (including accessories like antennas or antenna cables) must be used at least 3 meters away from every part (including cables and accessories) of DIACARE 8000 PRO. Otherwise the performance of DIACARE 8000 PRO may be affected.
- Page 49 Globus USA 15807 Biscayne Blvd. Suite 109 North Miami Beach, FL 33160 Phone: (855) 456-2875 www.tecarglobususa.com...
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