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400-Series Symbols on the equipment Points to laser aperture Attention, read the and shows direction of manual beam Manufacturer Abbreviations Accomodation Quotient Constant Current Combination therapy Courte Période Constant Voltage Diphasé Fixe Electrode Electromagnetic Compatibility Electrostatic Discharge Electrotherapy Hospital Antiseptic Concentrate Laser therapy Longue Période Medium Frequency: with unidirectional and interferential...
400-Series AFETY Purpose The 400-Series is intended solely for medical applications. A trained professional can use the 400-Series for electro therapy, ultrasound therapy, combination therapy and laser therapy. The device is suited for continuous use. Safety instructions 1.2.1 General • Only qualified people who are trained in the application of the therapies may use the appliance.
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400-Series 1.2.2 Electrical safety • Only use the equipment in an area with facilities that meet the applicable legal regulations. • Connect the equipment to an outlet with an earth terminal. The outlet must meet the locally applicable requirements for medical areas. The device is Class II with a functional earth for EMC purposes 1.2.3 Prevention of explosion...
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400-Series 1.2.5 Electro therapy • Do not use the equipment simultaneously with high frequency surgical equipment. This combination can cause burning of the skin under the electrodes. • Patients with electrical implants (e.g. a pacemaker) may only be treated after obtaining specialist medical opinion. •...
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400-Series 1.2.7 Laser therapy The laser is a class 3B laser product which emits invisible infrared light. • Make sure the laser warning sign is clearly visible outside the entrance to the therapy room. • The radiation of a laser probe can cause a physiological effect.
400-Series 1.2.8 Vacuum accessories • Check the electrode cables and the electrodes at least once a month. Check whether the insulation is still intact. See §5.1 • Always use slightly salinated demineralized water to moisturize the vacuum sponges to prevent lime deposits in the watertank, hoses, cups and sponges.
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400-Series Specific for relative biphasic pulses • Skin infections • Thrombosis, thrombophlebitis • Heart disease, rhythm disorder • Decreased sensibility • Locat. near sinus caroticus • Pregnancy 1.3.2 Ultrasound therapy General • High fever • Severe cardiovascular problems • Psychological problems •...
400-Series 1.3.4 Laser therapy General • High fever • Severe cardiovascular problems • Psychological problems • Cancer with tumor metastasis • Generalised tuberculosis Specific absolute • Looking into the laser beam • Thyroid gland (local applications) • Increased connective tissue production •...
2. Connect the 6-pin connection cable (5). Use in combination with another device The Vaco 400 can only be used in combination with: • The Combi 400 • The Duo 400 Performing the functional test 1. Switch the equipment on with the switch at the rear of the equipment.
400-Series Setting language, time and preferences 1. Press on the home screen. The System settings menu appears. See §4.10.1. 2. Select Touch panel calibration. 3. Press Start and follow the instructions on the screen. 4. Select Language and select the language with which the read-out must work.
400-Series ESCRIPTION OF THE EQUIPMENT Combi 400 with standard accessories 1. Combi 400. See §3.5. 9. Elastic fixation straps (4 2. Touchscreen pen pieces) 3. CD-ROM User manual 10. EL sponges for rubber 4. Safety instructions electrode (4 pieces) 5. Power cord 11.
400-Series Duo 400 with standard accessories 1. Duo 400. See §3.5. 8. Elastic fixation straps (4 2. Touchscreen pen pieces) 3. CD-ROM User manual 9. EL sponges for rubber 4. Safety instructions electrode (4 pieces) 5. Power cord 10. Rubber electrodes (4 pieces) 6.
400-Series Pulson 400 with standard accessories 1. Pulson 400. See §3.5. 6. US head small with holder 2. Touchscreen pen 7. US head large with holder 3. CD-ROM User manual 8. VAS score card 4. Power cord 9. Safety instructions 5.
400-Series Components of 400-Series 10 9 15 14 1. Display. See §3.6. 11. Power and communication 2. Intensity of channel A cable between main unit and 3. Intensity of channel B Vaco 400 option 4. Connectors for US head 12. Electro therapy cable between 5.
400-Series Display 3.6.1 Home menu 1. Home button 6. Vacuum settings button 2. Title of the screen 7. Contraindications button 3. Therapy selection 8. System settings button 4. Window channel B parameters 9. On screen menu. Submenus 5. Window channel A parameters may appear next to this menu.
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400-Series 3.6.2 Therapy display Biphasic surge 0 - 100 s Treatment time 15:00 Pulse time µs Pulse frequency 50 Hz Expert times (s) Pulse shape Expert modes Rest Expert times Polarity CC / CV Program 13 Biphasic surge Conventional TENS 15:48 08:00 140 mA...
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400-Series 3.6.3 Therapy set parameters display Biphasic surge 0 - 100 s Treatment time 15:00 µs Pulse time Pulse frequency 50 Hz Expert times (s) Pulse shape Expert modes Rest Expert times Polarity CC / CV Program 13 Biphasic surge 15:48 140 mA 1.
400-Series Frequency sweep mode 12s/12s 1s/5s -1s/5s 6s/6s 1s/1s 3.8.2 Ultrasound therapy US duty cycle 10% US head, ERA 4 cm 10ms US duty cycle 20% US head, ERA 1 cm 10ms US duty cycle 30% Set US intensity 10ms Unit of the set US US duty cycle 40% intensity...
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400-Series TENS burst TENS random frequency 3.9.5 NMES currents Rectangular surge Triangular surge Biphasic surge Intra pulse interval surge 2-pole MF surge Dipole vector field Russian stimulation Han stim 3.9.6 Microcurrents Microcurrent Microcurrent surge 3.9.7 High voltage currrents High voltage High voltage surge...
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400-Series 3.9.8 Current shapes combination therapy Ultrasound + conventional TENS Ultrasound + brief/intense TENS Ultrasound + low frequency TENS Ultrasound + burst TENS Ultrasound + random frequency TENS Ultrasound + 2-pole MF...
400-Series PERATION Therapy selection You can select a therapy in different ways, via the menu entries or via the direct therapy keys. • Objectives: Select a therapy on the basis of an objective. See §4.1.2. • Indications: Select a therapy on the basis of a medical indication. See §4.1.3.
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400-Series 4.1.2 Therapy selection via objectives 1. Press Objectives in the home menu. 2. Select the objective. 3. Select the therapy method. 4. Follow the on screen options to select the desired treatment. 4.1.3 Therapy selection via indication list 1. Press Indications in the home menu.
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400-Series 4.1.5 Diagnostic program selection With the diagnostic programs, you can investigate the state of the electrical sensitivity of the neuro-muscular system. 1. Press Diagnostics in the home menu. 2. Select the desired diagnosis. See §4.8. 4.1.6 Memory selection 1. Press Memory in the home menu.
400-Series Performing therapy 4.2.1 Set and start therapy 1. Select the desired menu until the treatment appears. 2. Change the value of the parameter with . The setting range of the parameter is shown at the top of the screen. You can change the parameter as long as the parameter is highlighted.
400-Series 4.2.3 Immediately stop treatment 1. Press . All active treatments are stopped immediately. The parameter settings are retained. 2. Set the intensity of the channel again to continue the treatment. 4.2.4 Therapy and help information Therapy information 1. Check if the button is available.
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400-Series Placing the rubber electrodes 1. Moisten two EL sponges with water. 2. Slide a rubber electrode into each sponge. 3. Place the sponges on the part of the body that must be treated. 4. Fasten the sponges to the part of the body with the elastic fixation straps.
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400-Series 4.3.2 Perform electro therapy with vaginal, anal or rectal stimulation probe • Considering the very personal and intimate character of these treatments, a probe may only be used for one patient. • Never disinfect the probes in an autoclave. The probes can be damaged by the extreme temperature.
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400-Series Set new intensity between sequential steps The intensity determines the peak value during the treatment. When changing to a following step, the intensity is retained if safety allows. Sometimes, it is necessary to increase the intensity for the following step.
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400-Series 1. Apply the medicine on a sterile gauze. See §8.1. 2. Place the gauze on the electrode. Make sure that the polarity corresponds with the medicament used. 3. Place the electrodes. 4. Select an Iontophoresis program. 5. Set the intensity between 0.1 and 0.2 mÂ/cm .
400-Series Ultrasound therapy 4.4.1 Performing ultrasound therapy 1. Connect the US head into one of the two connectors of the 400- Series. You can connect two different US heads, but only one US head can be in operation at one time. The device detects which type of US head is connected to the connector.
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400-Series Contact of the US head The contact of the US head with the skin: Bad contact, US head switched off (0 W). Bad contact. Sufficient contact. Good contact. Very good contact. Test the US head if its conduction is bad. See §5.1.2. Î...
400-Series Combination therapy 4.5.1 Performing combination therapy • With combination therapy, the US head is always the negative pole. The electrode is the positive pole. Notice that the polarity can be flipped in the electro therapy menu. • With combination therapy, a maximum current density of 2.0 mA is advised.
400-Series Laser therapy 4.6.1 Laser safety Start a laser therapy only when all persons in the room wear laser goggles for eye protection. 4.6.2 Performing laser therapy 1. Make sure all persons wear laser goggles. 2. Plug the connector of the laser probe into the connector the 400-Series.
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400-Series 4.6.3 Read-out values 1. Channel select button 2. Laser test symbol; visible if the laser detector detects laser emission. Laser 3. E 1:30 4. Remaining treatment time 35 mW 5. E (during therapy) or E 3.15 (during laser energy measurement) 6.
400-Series Accessing the anatomical library You can access the anatomical library for anatomical information on the musculoskeletal system. 1. Press 2. Select Anatomical Library. 3. Select the body part you want to display information of. 4. Select an item from the list. 5.
400-Series Information is also available during the therapy. Go to the home menu and select the anatomical library. Diagnostics With the diagnostic programs, you can investigate the state of the electrical sensitivity of the neuro-muscular system: • Rheobase and chronaxie. See §4.8.1. •...
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400-Series 5. Select Confirm amplitude. The measured rheobase (in mÂ) is saved. 6. The equipment now doubles the rheobase (mÂ). The pulse time changes to 0.1 ms. Increase the pulse time by , until you observe a a minimal muscle twitch.
400-Series Auto mode 1. Rotate intensity knob A to start the treatment. 2. Increase the intensity in steps of 0.1 mÂ, until you observe a tangible or visible contraction 3. Select Confirm Amplitude. The measurement result is directly shown on the graph. In auto mode, a new pulse value and shape is selected.
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400-Series 4.9.1 Saving a program or diagnostic result 1. Press from a therapy or diagnostic. 2. From the save program menu: • Select to save as own program. • Select to save as favourite. • Select to save a diagnostic result. 3.
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400-Series 4.9.2 Use a saved program Select a saved program 1. Access the memory: • Select to show the own program list. • Select to show the diagnostic result list. • Select to show the favourite list again. 2. Select to sort the list in alphabetical order or to sort...
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400-Series When a diagnostic was selected, the diagnostic information appears. Diagnostic information is read-only. When a program was selected, a therapy program appears. If desired, start the therapy. Delete a program or diagnostic 1. Press . The text “Delete this program?”...
400-Series 4.10 System settings With the system settings, you can adapt the Standard settings of the equipment. You can not change the system settings during a therapy. 4.10.1 Changing the system settings 1. Press for system settings 2. Select the desired system setting.
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400-Series System information System information of the equipment. Always have this information available when you contact the technical service department. Error history The total number of error reports that the equipment has had and details about the last 10 error reports. Always have this information available when you contact the technical service department.
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400-Series 4.10.3 Set text for start up screen You can set your own text for the start up screen. For example, you can put your name or address information here. 1. Press 2. Select Start up info. 3. follow the on screen instructions to enter the desired start up information.
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400-Series 4.10.7 Suction cup test 1. Press 2. Select Accessories test. 3. Select Suction Cup test. 4. Connect two suction cups with the vacuum hoses to channel A of the vacuum module. 5. Switch on the vacuum. 6. Place the cups against each other, with moisturised sponges. Make sure that the sponges make contact over the whole surface.
400-Series Test the clusterprobe 1. Place the laser probe output perpendicular over the laser test eye . with the first laser diode. 2. Press and hold the black button on the laser probe during the laser test. The laser test symbol appears on the read-out screen.
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400-Series 2. Connect the four vacuum hoses. Select two cables with the same hose colour for each channel. Connect the red connectors from the vacuum hoses to the output connectors with the red dot. Connect the black connectors from the vacuum hoses to the output connectors with the black dot.
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400-Series 4.11.4 Vacuum treatment Start treatment 1. Place the vacuum electrodes on the part of the body that must be treated. The vacuum electrodes stay in place due to underpressure. Too high suction cause patient discomfort, change the working pressure if necessary. See §4.11.3. 2.
400-Series NSPECTIONS AND MAINTENANCE Inspections Component Check Frequency Electrode cables Damage At least 1x per month and electrodes Insulation intact Electrode cables, Conductivity At least 1x per week electrodes, See §4.10.4. to §4.10.7. suction cups and vacuum hoses Vacuum Cleaning. See §5.2.3. After every treatment electrodes Vacuum sponges Cleaning.
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400-Series 4. Select from the starting screen and start the vacuum pump. 5. Suck the liquid up until the “Water reservoir full” warning appears. 6. Stop the vacuum pump 7. Empty the water reservoir. 8. Repeat steps 3 until 7 with pure water. 5.1.2 US head test Test the US head if its conduction is bad.
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400-Series Inspection result 1. A registration must be maintained of the technical safety inspections. Use the inspection report in the appendix for this purpose. See §8.5.. 2. Copy this appendix. 3. Complete the copied appendix. 4. Keep the inspection reports for at least 10 years. The inspection is successful if all inspection items are passed.
400-Series Maintenance Component Check Frequency Main unit Cleaning. See §5.2.1. As required Electrodes Cleaning. See §5.2.3. After every treatment (Rubber, metal and suction cups) Sponges and Cleaning. See §5.2.4. After every treatment sponge bags Fixating bandages Cleaning. See §5.2.5. If necessary Vaginal, anal and Cleaning and After each use...
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400-Series 5.2.2 Cleaning the touch screen Use of incorrect cleaners can result in optical impairment of touch panel and/or damage to functionality. • Cleaner must be neither acid nor alkali (neutral pH) • Do not use abrasive cleaners • Do not use organic chemicals such as: paint thinner, acetone, toluene, xylene, propyl or isopropyl alcohol, or kerosene.
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400-Series 5.2.6 Cleaning and disinfecting vaginal, anal and rectal stimulation probes • Considering the very personal and intimate character of these treatments, a probe may only be used for one patient. • Never disinfect the probes in an autoclave. The probes can be damaged by the extreme temperature.
400-Series ALFUNCTIONS SERVICE AND GUARANTEE Malfunctions Component Problem Solution 400-Series Equipment cannot be See §6.1.1. switched on Equipment does not react to See §6.1.2. commands or a fault report appears Foreign language on the Change the language. screen See §4.10.1. Vacuum Contamination by ionization See §6.1.3...
400-Series Service • Only a technician authorised by GymnaUniphy N.V. may open the equipment or the accessories to perform repairs. The equipment does not contain any components that may be replaced by the user. • If possible, open the screen with the system settings before you contact the technical service department.
400-Series This guarantee does not apply to the repair of defects that are caused: • by incorrect use of the equipment, • by an incorrect interpretation or not accurately following these user instructions, • by carelessness or misuse, • as a consequence of maintenance or repairs performed by people or organisations that are not authorised to do so by the manufacturer.
400-Series ECHNICAL INFORMATION General Dimensions 400-Series (w x h x d) 360 x 285 x 260 mm Weight 400-Series 5 kg Weight including accessories6 kg Mains voltage 100 - 240 VAC, 50-60 Hz Maximum power, in operation 85 VA Safety class Class II with functional earth (earthed socket required) Electro therapy...
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400-Series 7.2.2 Current shapes Unidirectional currents • Direct current • Rectangular pulse • 2 - 5 current (Ultra Reiz) • Triangular pulse • Medium frequency constant • Iontophoresis - Medium frequency constant • Iontophoresis - Direct current Pulse time 0,1 ms - 6 s Pulse pause 1 ms - 6 s Intensity of CC...
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400-Series NMES currents • Monophasic rectangular surge • Monophasic triangular surge Pulse time 0,1 - 5 ms Pulse frequency 1 - 150 Hz Intensity of CC 0 - 80 m at 300 to 1000 Ω Intensity of CV 0 - 80 V peak •...
400-Series • Dipole vector field See 2-pole medium frequency and isoplanar vector field Rotation mode 0 - 20 s Rotation angle 0 - 355° Segment angle 0 - ±30° Segment time 0 - 10 s Microcurrents • Microcurrent continuous • Microcurrent surge Intensity of CC 0,1 μA - 1 mA at 300 to 1000 Ω...
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400-Series 7.4.2 Modulation and pulse duration Modulation duty cycle ∞ Pulse time Ratio of p 2,50 3,33 7.4.3 US heads US head, model US404 Acoustic operating frequency Output power Effective intensity of W/cm output voltage Effective Radiating Area (ERA) Beam Non-uniform Ratio (BNR) Maximum intensity of beam 14,0...
400-Series Laser therapy 7.5.1 General Insulation classification Type B Laser classification Class 3B 7.5.2 Monoprobe: Mono400 Number of laser diodes Nominal ocular hazard 214 mm distance Wave length 905 nm Energy per pulse 2,35 μJ Pulse peak power 13,5 W Maximum average power 70,5 mW Pulse frequency...
115.684 Touch screen pen Gymna 316.151 Safety instructions 115.684 Quick start manual Gymna 400 340.494 CD-ROM User manual Gymna 400- 311.872 Series multi language 1 This power cord has a CEE 7/7 type plug. For countries with other outlets, a different...
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Quantity Description Art. no. US head, 1/3 MHz - ERA 4 cm incl. 340.204 holder Contact gel, 500 ml 114.827 US head, multi-frequency,1/3 MHz - 340.201 ERA 1 cm , incl. holder 1 Standard for Pulson 400, optional for Combi 400.
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Optional accessories ultrasound therapy Quantity Description Art. no. US head, multi-frequency,1/3 MHz - 323.595 ERA 1 cm , incl. holder Contact gel, can 5 l 100.019 Pump for can, 5 l 100.020 1 Standard for Pulson 400, optional for Combi 400.
400-Series Diagnostic S-D curve Physiotherapist: Date of investigation: Name of patient: Date of birth: Anamnesis: Evaluation (neuro-muscular): Accommodation Quotient: Rheobase: Chronaxie: Conclusion: Treatment: 1000 T (ms) Electrode, US head and laser probe placements Select the therapy via indication list to get information about the placement.
400-Series The description next to the illustration gives information to the precise anatomic location. The description of the location is often explained with the abbreviations: peripheral nerve point skin nerve point mnp motor nerve point mtp myofascial trigger point nerve nervi muscle musculi...
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400-Series 8.4.1 Guidance and declarations Guidance and manufacturer’s declaration - electromagnetic emissions The 400-Series devices are intended for use in the electromagnetic environment specified below. The customer or the user of a 400-Series device should assure that it is used in such an environment. Emission test Compliance Electromagnetic environment -...
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400-Series Guidance and manufacturer’s declaration - electromagnetic immunity The 400-Series devices are intended for use in the electromagnetic environment specified below. The customer or the user of a 400-Series device should assure that it is used in such an environment. Immunity IEC 60601 Compliance level...
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400-Series Guidance and manufacturer’s declaration - electromagnetic immunity The 400-Series devices are intended for use in the electromagnetic environment specified below. The customer or the user of a 400-Series device should assure that it is used in such an environment. Immunity IEC 60601 Compliance level...
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400-Series Guidance and manufacturer’s declaration - electromagnetic immunity The 400-Series devices are intended for use in the electromagnetic environment specified below. The customer or the user of a 400-Series device should assure that it is used in such an environment. Immunity IEC 60601 Compliance level...
400-Series Technical safety inspection 400-Series with serial number ..... is / is not in good working order Inspection performed by: Owner: Location: Name: Name: Date: Initials: Initials: 1 Cross out what does not apply. If a specific test does not apply to this equipment, place a mark in the NA (not applicable) column.
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400-Series 8.5.2 Test 2: Electro therapy Yes No Connect loads of 500 Ω to both normal electrode pairs. Connect an oscilloscope to these pairs (black to ground). Select channel A, program 138: galvanic, CC. At maximum intensity, the output currents corresponds within 10% with the values on the display.
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400-Series Yes No 21. The polarity changes to negative if RED(-) is selected. 22. The warning "Insufficient contact with the patient" is given if the load is disconnected. Figure 1 Figure 2 Figure 3...
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400-Series 8.5.3 Test 3: Ultrasound Yes No Connect the treatment head and place it in an ultrasound measurement device. Select an ultrasound therapy. Select 1 MHz, continuous (duty cycle 100%), 2 W/cm The measured value is within ±20% of the P value in the channel window.
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400-Series Test A: The monoprobe Yes No Press the black knob on the laser probe. The yellow indicator light lights up and the green indicator light goes out. Release the black knob. The green indicator light lights up and the yellow indicator light goes out. Start the laser therapy to measure the E value with the laser radiation measurement device.
400-Series Test C: Calibration of the laser test eye Yes No Place the laser probe output perpendicular on the laser test eye . Start the laser energy measurement. Move the probe a bit to-and-fro to obtain the maximum value. The measured E value is ......μJ.
400-Series EFERENCE Literature A literature list can be sent on request. Please contact GymnaUniphy. Terminology absolute muscle power: The maximum total tension that a muscle can produce. accomodation: The ability of the nerve tissue to protect itself against stimulations that slowly increase in strength. Pulse time Delay in action potential of Accomodation...
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400-Series HAC®: Hospital Antiseptic Concentrate (0,5% chlorhexidine, 0,5% cetrimide). hyperalgesia: An increased sensitiveness for pain. Apply a modified dosage in the case of acute hyperalgesia. injury current: A small unidirectional current between the epidermis and the corium, which occurs after a wound. This current activates the recovery process.
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400-Series responsiveness: The degree to which a tissue or organ reacts to a stimulation. With a high responsiveness, a mild treatment is desired. With a low responsiveness, a more intensive treatment can be desired. Make a good estimate of the responsiveness to determine the correct dosage.
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400-Series NMES parameter type I type II Series duration and Short Long series pause Treatment time Long VAS score: Score on the Visual Analogue Scale (VAS). Tool for evaluating a clinical complaint from the patient. This usually concerns the degree to which pain is felt. With a high VAS score, a mild treatment is usually adequate.
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400-Series Index Date & Time 54 Denervation 97 Diadynamic currents 29 Abbreviations 5 Absolute muscle power 97 Diagnostic perform 48 Accessories 79 program selection 35 optional 79 Display 24 optional electrotherapy 80 symbols 27 optional laser therapy 82 Disposal 95 optional ultrasound therapy 81 Durability 97 standard 77...
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400-Series Muscle tissue HAC( 98 type I and type II 99 High voltage currents 30 Myofascial Trigger Point 98 Hyperalgesia 98 NMES 98 Indication list 34 currents 30 Injury current 98 Innervation 98 Input Panel 54 Objectives 34 Inspections 61 Installation 17 Interferential currents 29 Pain threshold 98...
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400-Series Responsiveness 99 Therapy Restore all programs 55 direct selection 33 Rheobase 48, 49, 99 program selection 35 selection via indication list 34 selection via objectives 34 Safety 9 set 36 instructions 9 start 36 technical inspection 62, 90 Tone 99 Sclerolysis 99 Touch screen cleaning 65 Transport 18...
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