Enraf Nonius 1600905 Page 103 User Manual Download

Page: 103 / 106

101

1600751-4D

14.3 Vacuum unit (Vacotron)

Vacuum pressure

: 10- 90 (0

–

600 mbar), continuously adjustable

Pulsed vacuum via vacuum range: adjustable from 10

–

80%

Hold time

: 0

–

2,5 seconds in steps of 0,5 second

14.4 EMG

E.M.G. Channels

: 2

Sensitivity

: 0,5 µV

–

10.000 µV

Raw EMG signal

: 1.500 Hz

Sample frequency

: 160 Hz

Bandwidth

: 5

–

1.500 Hz

Filtering

: digital

Pressure

: 1 channel via internal sensor

Range

: 0

–

360 hPa

14.5 Safety and Performance standards

IEC 60601-1

: General requirements for the safety of electrical medical

systems

Safety class according to IEC 60601-1: class I type BF

IEC 60601-2-5

: Particular requirements for the safety of ultrasonic

therapy equipment.

IEC 60601-2-10

: Particular requirements for the safety of nerve and

muscle stimulators.

IEC 60601-2-40

: Particular requirements for the safety of

electromyographs and evoked response equipment.

Summary of Contents for 1600905

Page 1: ...6 series User Manual ...

Page 2: ...opyright Enraf Nonius B V Vareseweg 127 3047 AT Rotterdam The Netherlands Tel 31 0 10 20 30 600 Fax 31 0 10 20 30 699 info enraf nonius nl www enraf nonius com Part number 1600 751_4D November 27th 2019 ...

Page 3: ...6 series User Manual ...

Page 4: ......

Page 5: ...3 1600751 4D ...

Page 6: ...ntial Currents 17 4 3 1 a Classical Interferential 17 4 3 1 b Isoplanar Vector 18 4 3 1 c Dipole Vector Manual 18 4 3 1 d Dipole Vector Automatic 18 4 3 2 Biphasic Pulsed Currents TENS 19 4 3 2 a Asymmetrical and Alternating Asymmetrical 19 4 3 2 b Burst Asymmetrical and Burst Alternating Asymmetrical 20 4 3 2 c Symmetrical 20 4 3 2 d Burst Symmetrical 21 4 3 3 Premodulated 21 4 3 4 Russian Stimul...

Page 7: ...asound 690 692 32 8 4 Standard Accessories Vacuum 682V 692V 632V 32 8 5 Standard Accessories Vacuum 684V 33 8 6 Standard Accessories StatUS 33 8 7 Standard Accessories EMG 632 33 8 8 Optional Accessories 33 9 INSTALLATION 34 9 1 Units without a Vacotron module 34 9 2 Units with a Vacotron module 34 9 3 Connection to mains supply 34 10 APPLICATION NOTES 35 10 1 Electrotherapy 35 10 1 1 Before treat...

Page 8: ... e Exercise Rest 63 11 2 10 f Template 64 11 2 10 g Shift 65 11 2 10 h Myofeedback Stimulation 65 11 2 10 i Alternating 66 11 2 10 j Stimulation above Threshold 68 11 2 10 k Stimulation below Threshold 70 11 2 10 l Pressure 72 11 2 10 m EMG feedback with 2 channels 74 11 2 10 n Analyze 74 11 2 10 o Report 76 11 2 11 System Settings 77 11 2 11 a Change Language 77 11 2 11 b Backup and restore perso...

Page 9: ...id 90 13 7 IG Pulsed Currents 91 13 7 1 IG30 Monophasic 91 13 7 2 IG30 Biphasic 91 13 7 3 IG50 Monophasic 91 13 7 4 IG50 Biphasic 92 13 7 5 IG100 Monophasic 92 13 7 6 IG100 Biphasic 92 13 7 7 IG150 Monophasic 93 13 7 8 IG150 Biphasic 93 13 8 Faradic Pulsed Current 94 13 8 1 Triangular Pulsed Current 94 13 8 2 Triangular alternating current 94 13 8 3 Rectangular Pulsed current 94 13 8 4 Rectangular...

Page 10: ...4 SPECIFICATIONS 96 14 1 Ultrasound parameters 96 14 2 Stimulator output parameters 97 14 3 Vacuum unit Vacotron 101 14 4 EMG 101 14 5 Safety and Performance standards 101 14 6 EMC details 102 14 7 Technical Data 104 ...

Page 11: ...or the 6 series provide both 1 and 3 MHz operation The ultrasound treatment heads can be used with both large and small treatment surfaces and are suitable for subsequent treatments Contact control suspends the application of ultrasonic energy when acoustical contact with the treatment area becomes insufficient The user can connect two ultrasound treatment heads These can be activated from the ult...

Page 12: ...urface electrodes vaginal and anal electrodes The pressure sensor can be used in combination with vaginal and anal pressure probes Several measure methods are applicable via de EMG channels and these channels can be used in combination with the stimulation current wave forms from the electrotherapy module Myofeedback or EMG Feedback is a method whereby the electrical activity of a muscle is regist...

Page 13: ...s of the product To the maximum extent permitted by applicable law in no event will Enraf Nonius or its suppliers or resellers be liable for any indirect special incidental or consequential damages arising from the use of or inability to use the product including without limitation damages for loss of goodwill work and productivity computer failure or malfunction or any and all other commercial da...

Page 14: ...e of at least 1 meter from the device during ultrasound therapy treatment 3 2 CAUTION Read understand and practice the precautionary and operating instructions Know the limitations and hazards associated with using any electrical stimulation device Observe the precautionary and operational decals placed on the unit Use of controls or adjustments or performance of procedures other than those specif...

Page 15: ...13 1600751 4D contraindications warnings and precautions Consult other resources for additional information regarding the application of electrotherapy ...

Page 16: ...east 1 meter from the device during ultrasound therapy treatment Type BF applied part Temperature Range Indicates acceptable temperature range Humidity Limits Indicates acceptable relative humidity Atmospheric Pressure Indicates the range of atmospheric pressure to which the medical device can be safely exposed Keep the device dry Manufacturer name address and date of manufacture Reference Number ...

Page 17: ... is to be used as a symptomatic treatment for pain and has no curative value Patients should be cautioned and their activities regulated if pain that would otherwise serve as a protective mechanism is suppressed The long term effects of chronic electrical stimulation are unknown Safety has not been established for the use of therapeutic electrical stimulation during pregnancy Stimulation should no...

Page 18: ...ction of electrical current into the heart may cause cardiac arrhythmias must be avoided Warnings The long term effects of chronic electrical stimulation are unknown Safety has not been established for the use of therapeutic electrical stimulation during pregnancy Stimulation should not be applied over swollen infected or inflamed areas of skin eruptions e g phlebitis thrombophlebitis varicose vei...

Page 19: ...ier frequency contributes to the patient comfort that is often associated with this current type Interferential currents are all AC currents without any residual DC components Several variations of the interferential current type are known the following of which are available in the 600 series 4 3 1 a Classical Interferential With this therapy method four electrodes are used and two non modulated ...

Page 20: ...urrents from the two electrode pairs are vectorially summed in the tissue The effect is that stimulation only occurs into the direction of the resulting vector which can be adjusted over a range of 360º Amplitude modulation occurs in the equipment and the modulation depth is 100 Stimulation with 100 modulation depth only occurs into the direction of the vector The advantage of this method is that ...

Page 21: ...in TENS Transcutaneous Electrical Nerve Stimulation applications This waveform is characterized by variable phase duration and variable pulse frequency Its typical amplitude duration and rate of rise and decay are unequal for each phase with respect to the baseline The waveform is fully balanced i e the phase charges of each phase are equal See fig 13 1 for a graphical representation A variation t...

Page 22: ...e See fig 13 1 3 for details 4 3 2 c Symmetrical TENS current pulses can also be used for muscle stimulation applications Often the symmetrical biphasic pulsed current waveform is used See fig 13 1 5 for a graphical representation The specified phase duration applies to both pulse phases which doubles the amount of available energy with respect to the asymmetrical pulsed current waveform This wave...

Page 23: ... 4 3 3 Premodulated As with Interferential currents a medium carrier frequency is used to pass the low frequency stimulation beat frequency through the skin See fig 13 2 for the current waveform Premodulated implies that amplitude modulation occurs in the equipment allowing it to be applied with a single electrode pair The Premodulated alternating current is often used where the objective is to st...

Page 24: ...ncreased until a powerful contraction is produced from the motor stimulation level up to the limit of tolerance As with all muscle stimulation applications a Surge program can be used allowing the muscles to rest between exercise cycles Parameters Carrier Frequency expressed in kHz is the base frequency of the alternating current Burst Frequency expressed in Hz defines the repetition rate of the b...

Page 25: ...the final frequency will vary from 40 80 Hz Modulation Program defines the time and sequence in which the frequency will sweep through the Frequency modulation range See for the available Modulation programs fig 13 11 13 11 3 Alternation Mode defines whether the polarity of the pulses is automatically alternating or not Alternation Sequence expressed in seconds defines the polarity reversal timing...

Page 26: ...paragraph 11 2 11 a for details Surge programs are only available with MF and DF 4 3 8 IG Pulsed Currents IG currents are triangular pulsed currents Monophasic and biphasic versions are available The monophasic IG30 current consists of a single pulse with a rising slope of 30ms followed by falling slope of 10ms See fig 12 7 for details The biphasic version fig 13 7 2 1 has two such phases with opp...

Page 27: ...on of the degree of denervation of the muscle tissue With this technique the relationship between the current amplitude and phase duration of a rectangular and triangular pulse is plotted in a strength duration curve The strength duration curve is recorded by observing the current amplitude required at various phase duration values ranging from 0 01 to 1000ms that produce a just perceptible i e ju...

Page 28: ...th amplitude an de duration ON time of the applied current since a relation exist between the strength and the duration necessary to elicit a threshold response from nerve and muscle By varying the strength and duration of the electrical stimulus it is possible to plot a curve called the strength duration SD curve that gives a graphic illustration of the excitability of nerve and muscle The streng...

Page 29: ...to follow the increase in metabolic demand and tissue necrosis might result In the presence of metal implants of any type Patients with sensory loss on the area to be treated The gonads or to the developing fetus The heart The brains The testicles The eyes Ultrasound should not be used on unconscious patients Precautions and Warnings Precaution should be taken when using therapeutic ultrasound on ...

Page 30: ...splay can be toggled between W and W cm In pulsed mode the Amplitude during the pulse is displayed The time averaged Amplitude can be obtained by multiplying this value with the Duty Cycle 5 2 Combination Therapy Combination therapy is the combined application of ultrasound and electrical stimulation With combination therapy the metal surface of the ultrasound treatment head becomes the negative e...

Page 31: ...ying the ultra sound intensity This form of modulation is also characterised by a rhythmic period of 12 seconds The intensity W cm2 is set at 100 The intensity will gradually drop from 100 to 85 in the first 6 seconds after which it will increase back up to 100 in the next 6 seconds Amplitude Modulation with text example of the modulation when intensity is set at 1 0 W cm2 Both forms of modulation...

Page 32: ...of a muscle such as the activation of the muscle the muscle s capacity for relaxation coordination between muscles the tiredness of a muscle the capacity of a muscle to lengthen This makes Myofeedback especially suitable as a measuring instrument for charting our locomotive operations Figure 1 7 1 Parameters Sensitivity allows changing the sensitivity from the measurement range For surface EMG the...

Page 33: ...erapy does not do anything to the body few contraindications exist Myofeedback therapy is not recommended for persons with severe psychosis depression or obsessional neurosis nor for debilitated patients or those with psychopathic personalities However because resulting functional improvements can require strenuous physical effort individuals interested in Myofeedback may need to be aerobically fi...

Page 34: ...0 x 3 cm 1 pc 3444021 Fixation strap 250 x 3 cm 1 pc 1600751 User manual 6 series 3444290 Power cord 8 2 Standard Accessories electrotherapy 684 4 x 3444211 Patient cable 2 core 2 mm male plugs black with coloured clips 4 x 3444129 Flexible rubber electrode 6 x 8 cm set of 2 pc 1460266 Sponges 6 x 8 cm 2 sets of 4 pc 2 x 3444020 Fixation strap 100 x 3 cm 2 x 3444021 Fixation strap 250 x 3 cm 16007...

Page 35: ...et 2 pc 1460273 Sponges for rubber electrode 4 x 6 cm set 4 pc 1460275 Sponges for rubber electrode 8 x 12 cm set 4 pc 3444056 Self adhesive electrodes size 32mm Ø 1 pack 10 sheets of 4 pc 3444135 Self adhesive electrodes size 50mm Ø 1 pack 10 sheets of 4 pc 3444057 Self adhesive electrodes size 50x50mm 1 pack 10 sheets of 4 pc 3444058 Self adhesive electrodes size 50x90mm 1 pack 10 sheets of 4 pc...

Page 36: ...on to mains supply Insert the mains cable into socket 20 and connect it to a wall socket Status indicator LED 14 indicates that the unit is connected to the mains supply CAUTION Do not place the unit in a location where the power cord could be tripped over or pulled out during treatment Do not attempt to use the unit if it is not properly grounded Make certain that the unit is electrically grounde...

Page 37: ...ap water In areas with soft tap water use a saline solution instead This will improve electrical conduction The supplied sponge pads have three layers With AC currents apply one sponge layer between the skin and the electrode for minimum resistance With DC currents apply two sponge layers between the skin and the electrode Two layers provide more absorbing capacity for electrolysis by products Fix...

Page 38: ...of the supplied sponges to keep the effects to a minimum Make sure that the sponges are kept well moistened and place the thick side of the sponge between the flexible rubber electrodes and the patient 10 1 6 Current density In the particular standard for Electrical Nerve and Muscle Stimulators IEC 60601 2 10 it is recommended not to exceed a current density of 2 mA r m s cm otherwise skin irritat...

Page 39: ...transfer of ultrasound energy is a gel The gel should be applied to the part of the body to be treated and then spread out with the ultrasound treatment head Never apply the gel to the ultrasound treatment head The treatment head will register this as acoustical contact and may emit ultrasound energy which could damage the treatment head If the body surface is very irregular making it difficult to...

Page 40: ...n circulation and mobility Ask the patient to inform the therapist of any reactions 10 3 StatUS 10 3 1 Connecting the StatUS StatUS applicator ultrasound treatment head Make sure that the logo of the ATUS controller is pointing upward Plug in the left plug of the ATUS controller in connection B of the UG module 1 Connect the right plug to the StatUS module 2 A special gel cushion gel pad is placed...

Page 41: ...uctions are supplied with the gel pads Read these carefully You are also referred to chapter 10 3 for instructions on operating the device Warning only use the original Enraf Nonius gel pads Do not use liquid gel as this will be sucked into the vacuum tubes and pump causing malfunction Any warranty claim will be rejected if liquid gel residue if found in any of these components Warning since the S...

Page 42: ... the unit for the raw EMG signal The connection with the MyoComBox is wireless via Bluetooth This is only possible if the X module is integrated CAUTION Connection of accessories other than the ones specified by the manufacturer can adversely affect the safety of the patient and correct functioning of the equipment and is therefore not permitted ...

Page 43: ...iew or adjust all parameters of electrotherapy channel 2 3 Selection button for Ultrasound channel Push the button to view or adjust all parameters of the ultrasound channel 4 Selection button for Optional module 5 Central controller Use this controller to select menu items and to adjust all parameters including current amplitude and ultrasound intensity 6 Confirmation button for Confirmation of a...

Page 44: ...g of the equipment and is therefore not permitted The selection for activating the output is in the ultrasound menu 14 Status LED This lamp can indicate one of the following device states Off Not connected to power line Yellow blinking Initializing Yellow continuous Standby Green blinking Performing self test Green continuous Ready for use 15 Connections Vacuum Cables Electrotherapy channel 1 16 C...

Page 45: ...rameter list For some applications such as interferential therapy and combination therapy two adjacent channels can be linked Linked channels are indicated by a combined tab The tab halves show the output amplitude of each channel while the parameters on the remainder of the sheet apply to both channels When you turn on the unit you will first enter the Home menu In the Home menu none of the chann...

Page 46: ...ush the assist button 7 and select Home menu Select the treatment with the central controller 5 and enter with the confirmation button 6 Select the current channels in the Channel Selection 1 2 channels are linked 1 independent channel 2 independent channel Therapy Wizard Body Part Applications Protocol List Personal Protocols Therapy Wizard Body Part Shoulder Upper Arm Elbow Forearm Hand Hip Thig...

Page 47: ...here you can find all Current Waveforms for pain management o Muscle stimulation here you can find all Current Waveforms for muscle stimulation o Quick access to all Current Waveforms o Diagnostics here you enter the diagnostic part to generate S D curves Select the desired choice with the central controller 5 and enter with the confirmation button 6 Pain Management 1 2 Sub luxation acromioclavicu...

Page 48: ... up screen Push the confirmation button 6 to return Select other parameter or start the therapy with the intensity Home Electrotherapy Pain Management Muscle Stimulation All Current Waveforms Diagnostics Therapy Wizard Pain Management Premodulated 4 Polar Interferential Biphasic Pulsed Current TENS Faradic Current Diadynamic Current Galvanic Current High Voltage Electrotherapy 1 2 Pain Management ...

Page 49: ...l 2 Select Search Probe with the central controller 5 and enter with the confirmation button 6 Select On or Off Read the information on in the pop up screen concerning the return electrode use the negative electrode as return electrode Electrotherapy Pain Management Muscle Stimulation All Current Waveforms Diagnostics Electrotherapy Diagnostics New Session Stored Session Electrotherapy 2 New Sessi...

Page 50: ...ton 6 Repeat by pushing the confirmation button 6 again Select Chronaxie with the central controller 5 and confirm with the confirmation button 6 The retrieved intensity in the Rheobase will be doubled automatic Adjust the Phase duration with the central controller 5 until the muscle contract Electrotherapy 2 Diagnostics Electrode selection Phase Interval 5 s Rheobase Chronaxie S D Curve Rectangul...

Page 51: ...er 5 to adjust the intensity Every push on the special probe or every beep will generate one pulse Confirm the value by pushing the confirmation button 6 Select the second the next phase duration with the central controller in the list To receive a correct calculation you need to select minimum 10 different phase durations always include 500 ms Select left corner to return to the previous menu Dia...

Page 52: ... special probe or every beep will generate one pulse Confirm the value by pushing the confirmation button 6 Select the second the next phase duration with the central controller in the list To receive a correct calculation you need to select minimum 10 different phase durations always include 500 ms Select left corner to return to the previous menu Electrotherapy 2 Diagnostics Type Electrode Beep ...

Page 53: ...al settings with the central controller 5 and enter with the confirmation button 6 Under personal protocols we offer you a range of treatment suggestions Under manual settings you can adjust all parameters Diagnostics 2 Report Rheobase 1 6 mA Chronaxie 10 ms Effective Phase Duration 1000 ms Accommodation Threshold 4 2 mA Accommodation Quotient 2 6 Optimal Phase Duration 30 0 ms Amplitude 2 8 mA So...

Page 54: ...e main menu Enter the selection with the confirmation button 6 Select personal protocols or manual settings with the central controller 5 and enter with the confirmation button 6 Under personal protocols you can retrieve your stored protocols Under manual settings you can adjust all parameters Ultrasound 3 Treatment Time 06 00 min Applicator Ultrasound Frequency 1 MHz Duty Cycle 100 Pulse Frequenc...

Page 55: ... personal protocols or manual settings with the central controller 5 and enter with the confirmation button 6 Under personal protocols you can retrieve your stored protocols Under manual settings you can adjust all parameters Combination Therapy 2 Premodulated Treatment Time 7 00 Carrier Frequency 4 0 kHz Beat Frequency 80 Hz Frequency Modulation 0 Hz Modulation Program 1 1 s Output Mode CV 07 00 ...

Page 56: ...p causing malfunction Any warranty claim will be rejected if liquid gel residue if found in any of these components Warning since the StatUS applicator ultrasound treatment head transfers ultrasound energy into the tissue at a most efficient and effective way we advise you to use lower intensity settings than the usual intensity settings for traditional semi stationary or dynamic ultrasound StatUS...

Page 57: ...p up with the central controller 5 Vacuum pressure To start the vacuum unit adjust the pressure with the central controller 5 Push the confirmation button to return Electrotherapy Assist Stop Unlink Channels Home Store Vacuum 15 00 0 0 mA 0 0 mA Electrotherapy 1 2 Vacuum Vacuum Pressure 0 Range 0 Hold Time 0 0 s 15 00 0 0 mA 0 0 mA Electrotherapy 1 2 Vacuum Pressure 15 00 0 0 mA 0 0 mA 25 100 0 ...

Page 58: ...sure under the cup will rhythmically pulse between the vacuum setting and the selected range The rhythm cycle can be adjusted with the parameter Hold time and can be adjusted from 0 to 2 5 seconds in steps of 0 5 seconds The hold time setting is applied when the lower vacuum limit is reached Please see par 12 13 11 2 9 b Vacuum electrode selection Using the central controller 5 select electrode se...

Page 59: ...nd connect these with the unit CAUTION Connection of accessories other than the ones specified by the manufacturer can adversely affect the safety of the patient and correct functioning of the equipment and is therefore not permitted Using the central controller 5 select Feedback Therapy in the main menu Enter the selection with the confirmation button 6 Select manual settings using the central re...

Page 60: ...e with the central controller Go to Record to start treatment and registration Feedback Therapy Myofeedback Myofeedback Stimulation Pressure Pressure Myofeedback Stored Sessions 0 00 0 00 E1 10 00 0 0 mA 0 0 mA Feedback Therapy 4 Myofeedback Continuous Exercise Rest Template Continuous 1 2 Exercise Rest 1 2 Template 1 2 0 00 0 00 E1 10 00 0 0 mA 0 0 mA Myofeedback 4 Continuous Settings Treatment T...

Page 61: ...ttings 1 Turn on the MyoComBox make sure that the Bluetooth antenna is in one of the USB connections of the MyoComBox 2 Go to the System Settings via the Home menu Select the MyoComBox and then select Search The device will show the serial numbers of the available MyoComBox es in a list Connect the device to the MyoComBox of your choice by selecting the serial number from the list Check that the s...

Page 62: ...ysis screen press on the orange Assist key and select Save Then select the file from which you want to write the data to the USB memory stick When you then insert this USB memory stick into your computer you can open the data files You can import them as a txt file text file with tab separated data or create a report from the data with the aid of the MyoComBox Data Viewer by Enraf Nonius article n...

Page 63: ...change the value with the central controller 5 and push the confirmation button 6 again to return 11 2 10 d Threshold Setting Using the central controller 5 to select Threshold and push the confirmation button 6 Myofeedback 4 Continuous Settings 0 00 0 00 E1 09 45 0 0 mA 0 0 mA 85 µV Myofeedback 4 Continuous Record 0 00 0 00 E1 09 45 0 0 mA 0 0 mA 85 µV Myofeedback 4 Continuous Settings Treatment ...

Page 64: ...g the treatment Threshold setting during treatment Select the Threshold icon with the central controller 5 Push the confirmation button 6 and change the value with the central controller 5 and push the confirmation button 6 again to return Myofeedback 4 Continuous Settings 0 00 0 00 E1 09 45 0 0 mA 0 0 mA 85 µV Myofeedback 4 Continuous Record 0 00 0 00 E1 09 45 0 0 mA 0 0 mA 85 µV Myofeedback 4 Co...

Page 65: ...se time Green area is the Rest time Note Stop the treatment via the assist button Use the pause under the assist button to interrupt the treatment Use the same button to start again Feedback Therapy 4 Myofeedback Continuous Exercise Rest Template Continuous 1 2 Exercise Rest 1 2 Template 1 2 0 00 0 00 E1 10 00 0 0 mA 0 0 mA Myofeedback 4 Exercise Rest Settings Exercise Time 0 10 Rest Time 0 05 Cyc...

Page 66: ...orm is displayed in orange as the guide line for the patient to follow Note Stop the treatment via the assist button Use the pause under the assist button to interrupt the treatment Use the same button to start again Feedback Therapy 4 Myofeedback Continuous Exercise Rest Template Continuous 1 2 Exercise Rest 1 2 Template 1 2 0 00 0 00 E1 10 00 0 0 mA 0 0 mA Myofeedback 4 Template Settings Templat...

Page 67: ...ing menu and select Shift Scroll with the shift until the signal is back on the screen The sensitivity range is much lower and only for a limited range Note The shift range is linked to the Sensitivity setting 11 2 10 h Myofeedback Stimulation 1 Place the reference electrode on the skin and connect it with the unit 2 Place the EMG electrodes on the skin and connect these with the unit CAUTION Conn...

Page 68: ...onfirmation button 6 Sonopuls 692 M Home Therapy Wizard Electrotherapy Ultrasound Therapy Combination Therapy Feedback Therapy System Settings 0 00 0 00 E1 10 00 0 0 mA 0 0 mA Feedback Therapy Myofeedback Myofeedback Stimulation Pressure Pressure Myofeedback Stored Sessions 0 00 0 00 E1 10 00 0 0 mA 0 0 mA Feedback Therapy 4 Myofeedback Stimulation Alternating Stimulation above Threshold Stimulati...

Page 69: ...ion setting for channel 1 and adjust with the central controller 5 The current indications for the EMG channels will be displayed as usual in current channel 1 and 2 The electrode indication will change to E1 for channel 1 end E2 for channel 2 Go to record to start the treatment Feedback Therapy 4 Myofeedback Stimulation Premodulated Russian Stimulation Biphasic Pulsed Current TENS Faradic Current...

Page 70: ...s mode the stimulation will be activated automatically when the contraction is above the threshold during the exercise time The stimulation time will be followed by a rest time Select Stimulation above Threshold with the central controller 5 and enter with the confirmation button 6 Myofeedback Stimualtion 4 Alternating Record E1 0 00 E1 01 05 0 0 mA 0 0 mA 65 µV Feedback Therapy 4 Myofeedback Stim...

Page 71: ...se to adjust the stimulation level first Push the button xx to activate the stimulation setting for channel 1 and adjust with the central controller 5 Go to record to start the treatment Feedback Therapy 4 Stimulation above Threshold Premodulated Russian Stimulation Biphasic Pulsed Current TENS Faradic Current Diadynamic Current High Voltage E1 0 00 E1 10 00 0 0 mA 0 0 mA Myofeedback Stimulation 4...

Page 72: ...lation will be activated automatically when the contraction is below the threshold during the exercise time The stimulation session will always be followed by a rest time Select Stimulation below Threshold with the central controller 5 and enter with the confirmation button 6 Myofeedback Stimualtion 4 Stimulation above Threshold Record E1 0 00 E1 01 05 7 0 mA 0 0 mA 65 µV Feedback Therapy 4 Myofee...

Page 73: ... to adjust the stimulation level first Push the button xx to activate the stimulation setting for channel 1 and adjust with the central controller 5 Go to record to start the treatment Feedback Therapy 4 Stimulation below Threshold Premodulated Russian Stimulation Biphasic Pulsed Current TENS Faradic Current Diadynamic Current High Voltage 0 00 0 00 E1 10 00 0 0 mA 0 0 mA Myofeedback Stimulation 4...

Page 74: ...nnection of accessories other than the ones specified by the manufacturer can adversely affect the safety of the patient and correct functioning of the equipment and is therefore not permitted Using the central controller 5 select Feedback Therapy in the main menu Enter the selection with the confirmation button 6 Myofeedback Stimualtion 4 Stimulation below Threshold Record E1 0 00 E1 01 05 10 0 m...

Page 75: ...off value is to high or not wanted use the Zero setting to reset the value to zero Push the confirmation button reset Go to Record to start treatment and registration Feedback Therapy Myofeedback Myofeedback Stimulation Pressure Pressure Myofeedback Stored Sessions 0 00 0 00 E1 10 00 0 0 mA 0 0 mA Feedback Therapy 4 Pressure Continuous Exercise Rest Template 0 00 0 00 E1 10 00 0 0 mA 0 0 mA Pressu...

Page 76: ... showing in de display in the right tab as follow E1 is for channel 1 E2 is for channel 2 To change the read out value in the display between EMG channel 1 and 2 Push the button 4 and change the read out with the central controller 5 between E1 and E2 11 2 10 n Analyze At the end of the treatment go to Analyze with the central controller 5 and push the confirmation button 6 Myofeedback 4 Continuou...

Page 77: ...pe with the central controller 6 and push the confirmation button 6 Change the timeline with the central controller to zoom in on the area Go back to the previous screen to select report Pressure 4 Continuous Analysis 0 00 0 00 P 00 00 0 0 mA 0 0 mA Pressure 4 Continuous Analysis 0 00 0 00 P 00 00 0 0 mA 0 0 mA Pressure 4 Continuous Analysis 0 00 0 00 P 00 00 0 0 mA 0 0 mA ...

Page 78: ...the complete session To transfer these parameters you need to have the X module and the MyoComBox Pressure 4 Continuous R Zero Threshold P 0 0 hPa Graph Sound Record Analyze Report 0 00 0 00 P 0 00 0 0 mA 0 0 mA Pressure 4 Continuous Report Minimum 0 0 hPa Maximum 122 6 hPa Average Total execution time 0 30 s 0 00 0 00 P 0 00 0 0 mA 0 0 mA ...

Page 79: ...ired Language in the list with the central controller 5 Confirm the new language by pushing the confirmation button 6 The unit will reboot automatically 11 2 11 b Backup and restore personal data Go to System Settings in the Home menu Push the confirmation button 6 and select Service with the central controller 5 Insert a SD card in the card sleeve 2 Select Backup personal data with the central co...

Page 80: ...n button 6 Parameters Ramp up time expressed in s defines the time in a surge program during which the current is increased from 0 to the adjusted level See fig 13 122 for details The ramp up time can be adjusted in increments of 0 1s Hold time expressed in s defines the time in a surge program during which the current is kept at the adjusted level See fig 13 122 for details The hold time can be a...

Page 81: ...ameter menu During treatment the displayed ultrasound Amplitude can vary around the set value caused by fluctuations in acoustical coupling A blinking display indicates insufficient acoustical coupling 11 3 Memory functions The 600 series is equipped with a memory to store protocols Push the Assist button 7 and select store in the pop up with the central controller 5 Follow the instruction on the ...

Page 82: ...layed in the channel tab When the selected protocol consists of only one treatment step both times displayed are identical Each treatment step is terminated with a short beep When the end of the protocol has been reached a standard end of treatment beep is given 11 3 1 b Storing a protocol Prior to the execution of a modified protocol it can be saved for later use under Personal protocols Push ass...

Page 83: ...with the central controller 5 to the desired position Push the confirmation button 6 to modify the first character Note Store the settings before starting the treatment Electrotherapy 1 2 Store D E N 0 0 0 4 F 12 45 15 00 mA 14 30 mA ...

Page 84: ...o be stained but this does not affect the operation of the electrodes Between patient uses the sponge pads should be washed in warm water using a household cleaner After washing they must be rinsed with clear water thoroughly drained and then dried Damaged sponge pads should be replaced 12 1 4 Patient cable Clean the patient cable with a damp cloth Use lukewarm water and a non abrasive household c...

Page 85: ...r other cleaning liquids For proper cleaning of the StatUS applicator ultrasound treatment head s contact surface the rubber cuff may be folded back on one movement see Figure A If necessary you can push up the StatUS applicator ultrasound treatment head a bit from beneath see Figure B ATTENTION Never fold the entire cuff See Figure C Note In order to guarantee good transmission of the ultrasound ...

Page 86: ...ly It is recommended to keep sponges and a spare electrode in stock Calcium scale can be deposited on the metal surfaces of the electrodes This has an insulating effect In order to maintain optimum conductivity these surfaces should be regularly cleaned and polished Electrode cables Check the cables regularly for damage and or poor contacts It is recommended to keep a spare electrode cable in stoc...

Page 87: ...d sponges If necessary use a saline solution to improve the electrical conductivity of the water Too high current amplitude with self adhesive electrodes Try to continue the treatment with flexible rubber electrodes If the problem occurs in CC mode the current amplitude will ramp down to 0 and will have to be readjusted when the problem has been removed If none of the above scenarios appear to be ...

Page 88: ... manufacturer will not be held responsible for the results of maintenance or repairs by unauthorized persons 12 4 End of life The 6 series contains materials that can be recycled and or are noxious to the environment Specialized companies can dissemble the unit and sort out these materials When you dispose of the unit find out about local regulations concerning waste management ...

Page 89: ...p Pulse frequency 13 1 2 Asymmetrical Alternating t Phase duration fp Pulse frequency 13 1 3 Burst Asymmetrical fB Burst frequency 13 1 4 Burst Asymmetrical Alternating fB Burst frequency 13 1 5 Symmetrical t Phase duration ti Phase interval fp Pulse frequency 13 1 6 Burst Symmetrical fB Burst frequency ...

Page 90: ...88 1600751 4D ...

Page 91: ...ole vector fc Carrier frequency fb Beat frequency 13 3 Russian Stimulation fc Carrier frequency fB Burst frequency 13 4 Micro Current f Frequency 13 5 High Voltage t Peak interval 64 µs fixed fp Pulse frequency 13 6 Diadynamic Current 13 6 1 MF 13 6 2 DF ...

Page 92: ...90 1600751 4D 13 6 3 LP 13 6 4 CP 13 6 5 CPid ...

Page 93: ...91 1600751 4D 13 7 IG Pulsed Currents 13 7 1 IG30 Monophasic 13 7 2 IG30 Biphasic 13 7 3 IG50 Monophasic Envelope ...

Page 94: ...92 1600751 4D 13 7 4 IG50 Biphasic Envelope 13 7 5 IG100 Monophasic Envelope 13 7 6 IG100 Biphasic Envelope ...

Page 95: ...93 1600751 4D 13 7 7 IG150 Monophasic Envelope 13 7 8 IG150 Biphasic Envelope ...

Page 96: ...se interval 13 8 3 Rectangular Pulsed current tp Phase duration ti Phase interval 13 8 4 Rectangular alternating current tp Phase duration ti Phase interval I 13 9 Träbert 2 5 Current tp Phase duration 2 ms ti Phase interval 5 ms 13 10 Galvanic Current 13 10 1 Direct Current 13 10 2 MF medium frequency Interrupted Current f Carrier frequency 8 kHz fixed Duty cycle 90 fixed ...

Page 97: ...ncy modulation 13 11 2 Modulation program 6 6 or 12 12 6 6 or 12 12 fp Pulse frequency fm Frequency modulation 13 11 3 Modulation program 1 30 1 30 fp Pulse frequency fm Frequency modulation 13 12 Surge program parameters tr Ramp up time th Hold time tf Ramp down time ti Interval time td Delay time ...

Page 98: ... output power for 5 cm applicator Duty cycle 5 50 0 15 W Duty cycle 80 0 12 W Duty cycle 100 0 10 W continuous wave Peak output power for 0 8 cm applicator Duty cycle 5 50 0 2 4 W Duty cycle 80 0 2 W Duty cycle 100 0 1 6 W continuous wave Output meter uncertainty 20 for any output above 10 of maximum Pulse frequency 100 Hz 1 fixed Duty cycle 5 80 and 100 100 is continuous wave Pulse duration 0 5 8...

Page 99: ...by the Effective Radiation Area ERA and the Beam Non uniformity Ratio BNR The Effective Radiation Area is the cross sectional area of the ultrasound beam Its value depends on the ultrasound standard used International IEC 60601 2 5 2000 USA 21 CFR 1050 10 The Beam Non uniformity Ratio is the ratio of the maximum ultrasound Amplitude to the average ultrasound Amplitude measured at the Effective Rad...

Page 100: ...rrier Frequency 2 2 5 3 3 5 4 5 6 7 8 9 10 kHz Beat Frequency AMF 0 200 Hz in steps of 1 Hz Frequency Modulation spectrum 0 180 Hz in steps of 1 Hz Modulation Program 1 1 6 6 12 12 1 30 1 30 s Amplitude 0 100 mA Resolution vector 2 25 per step 160 steps over 360 Current mode CC Asymmetrical Phase Duration 10 400 µs in steps of 5 µs Pulse Frequency 1 200 Hz in steps of 1 Hz Frequency Modulation 0 1...

Page 101: ... 5 6 7 8 9 10 kHz Burstfrequency 0 100 Hz in steps of 1 Hz Burst Pause 1 1 1 2 1 3 1 4 1 5 Surge Program Yes Amplitude 0 100 mA High Voltage Twin Pulse Frequency 1 200 Hz in steps of 1 Hz Frequency Modulation spectrum 0 180 Hz in steps of 1 Hz sum of Pulse frequency and Frequency Modulation can not exceed 200 Hz Modulation Program 1 1 6 6 12 12 1 30 1 30 s Surge Program Yes Polarity Positive or Ne...

Page 102: ...ect Galvanic current Polarity Positive or Negative Amplitude 0 40 mA Faradic Rectangular Pulsed Current Phase Duration 0 02 1000 ms Phase Interval 5 15000 ms Surge Program Yes Polarity Positive or Negative Amplitude 0 80 mA Faradic Triangular Pulsed Current Phase duration 0 1 1000 ms Phase interval 5 15000 ms Surge program Yes Polarity Positive or Negative Amplitude 0 80 mA Träbert 2 5 Rectangular...

Page 103: ...Hz Filtering digital Pressure 1 channel via internal sensor Range 0 360 hPa 14 5 Safety and Performance standards IEC 60601 1 General requirements for the safety of electrical medical systems Safety class according to IEC 60601 1 class I type BF IEC 60601 2 5 Particular requirements for the safety of ultrasonic therapy equipment IEC 60601 2 10 Particular requirements for the safety of nerve and mu...

Page 104: ...1 test level Compliance level Electromagnetic environment guidance Electrostatic discharge ESD IEC 61000 4 2 6 kV contact 8 kV air 6 kV contact 8 kV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Electrical fast transient burst IEC 61000 4 4 2 kV for power supply lines 1 kV for input output lines 1 kV for...

Page 105: ...ed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and r...

Page 106: ...wer not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply i...

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