Nu-Tek ComboRehab2 Bio Скачать руководство пользователя страница 3

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Declaration of conformity:

Shenzhen Dongdixin Technology Co.,LTD.declares that the ComboRehab-Series,

StimRehab-Series and UltraRehab-Series complies with following normative documents:

IEC60601-1,IEC60601-1-2,IEC60601-2-10,IEC60601-2-5,ISO7010

IEC61689,ISO14971,ISO10993-1,ISO10993-5,ISO10993-10

Complies with MDD 93/42/EEC and Amended by

directive 2007/47/EC requirements

Rehab-Series

Содержание ComboRehab2 Bio

Страница 1: ...otherapy Nu Tek Stim Rehab2 MT2200 Features Benefits Provided with the most common currents 4 pole IF 2 pole IF Premode NMS Russian Biphasic TENS Hi Voltage HV Microcurrent MCR DC Galvanic Faradic Dia...

Страница 2: ...0197 Rehab Series USER MANUAL www nutekmedical com...

Страница 3: ...StimRehab Series and UltraRehab Series complies with following normative documents IEC60601 1 IEC60601 1 2 IEC60601 2 10 IEC60601 2 5 ISO7010 IEC61689 ISO14971 ISO10993 1 ISO10993 5 ISO10993 10 Compli...

Страница 4: ...continued supervision of a physician or licensed practitioner Specifications put forth in this manual were in effect at the time of publication However owing to manufacturer her policy of continual im...

Страница 5: ...y 3 MHz thus the practitioner can decide which frequency to use according to the condition and depth to be treated Contact control sus pends the application of ultrasonic energy when acoustical contac...

Страница 6: ...ystem No additional Software is required for the Module as the System automatically recognizes its presence and activates all necessary software inherent in the System CT2200 two channels electrothera...

Страница 7: ...nd and combo battery module EMG module CT2400 four channels electrotherapy ultrasound and combo Name ComboRehab VB ComboRehab Vac Plus ComboRehab Bio Plus Model Mainframe Vacuum module VAM200 EMG modu...

Страница 8: ...MT2200 MT2201 two channels electrotherapy vacuum module MT2202 two channels electrotherapy EMG module MT2203 two channels electrotherapy battery module MT2204 two channels electrotherapy vacuum module...

Страница 9: ...KHVH PRGXOH Model Mainframe Vacuum module VAM200 EMG module EMG200 Battery module BTM200 Mainframe UT2200 Mainframe UT2200 MT2402 four channels electrotherapy EMG module MT2403 four channels electroth...

Страница 10: ...ields of surrounding devices diathermy X rays mobile phones and other radio frequence equipment to prevent unwanted interference If unwanted interference occurs place the device farther from the sourc...

Страница 11: ...104 F with a Relative Humidity ranging from 30 85 non condensing Do not expose the unit to direct sunlight heat radiated from a heat radiator excessive amounts of dust moisture vibrations and mechanic...

Страница 12: ...eck because this could cause severe muscle spasms resulting in closure of the airway difficulty in breathing or adverse effects on heart rhythm or blood pressure Do not apply stimulation across the pa...

Страница 13: ...s not a substitute for pain medications and other pain management therapies TENS devices have no curative value TENS is a symptomatic treatment and as such suppresses the sensation of pain that would...

Страница 14: ...cation of electrical stimulation near the eyes and to the head and face Patients should stop using the device and should consult with their physicians if they experience adverse reactions from the dev...

Страница 15: ...sor rashes or over swollen red infected or inflamed areas or skin eruptions e g phlebitis thrombophlebitis varicose veins Do not apply stimulation over or in proximity to cancerous lesions Do not appl...

Страница 16: ...you should follow precautions recommended by your physician If you have suspected or diagnosed epilepsy you should follow precautions recom mended by your physician Use caution if you have a tendency...

Страница 17: ...stimulation alternates between agonists and antago nists This is accomplished through asynchronous stimulation over two current chan nels with an appropriate delay between the two channels Co contract...

Страница 18: ...Pole Parameters Carrier frequency Carrier frequency is the base frequency of the alternating current Beat Frequency The frequency at which the amplitude is modulated This is the effective therapeutic...

Страница 19: ...Hz defines a variable frequency range that is summed to the Pulse frequency i e when the Pulse frequency is set to 80 Hz and the Frequency modu lation is set to 40 Hz the final frequency will vary fro...

Страница 20: ...connect the lead wire to the active electrode Cycle Time refers to the time that the current is On and Off in seconds Example for a Cycle Time of 10 50 the current will be flowing for 10 seconds and...

Страница 21: ...es that occur in a one second period of time and is denoted as in Hz or Pulses Per Second pps Phase Duration expressed in s is the elapsed time from the beginning to the end of the initial pulse phase...

Страница 22: ...e electrode Cycle Time refers to the time that the current is On and Off in seconds Example for a Cycle Time of 10 50 the current will be flowing for 10 seconds and resting for 50 seconds Ramp The tim...

Страница 23: ...Phase duration f Pulse frequency t Phase duration f Pulse frequency f Burst frequency f Burst frequency Asymmetrical Alternating Symmetrical Burst Asymmetrical Burst Symmetrical 22 200mA max 1 f 200mA...

Страница 24: ...tion f Pulse frequency tp Phase duration f Pulse frequency t Phase duration f Pulse frequency Burst Alternating Tr bert 2 5 Current Rectangular Pulsed current Triangular Pulsed Current NMS 200mA max 1...

Страница 25: ...quency 8 kHz fixed Duty cycle 90 fixed t Peak interval 100 s fixed f Pulse frequency f Frequency NMS Burst Galvanic Interrupted Galvanic Continuous High Voltage Micro Current 200mA max 1 f 80mA max 1...

Страница 26: ...Diadynamic Current Modulation program CPid Surge program parameters CP LP DF MF 25 70mA max 70mA max 70mA max 1s 1s 1s 70mA max 1s 1s 1s 70mA max Reset Time Ramp Up Ramp Dowm Rehab Series...

Страница 27: ...Frequence Modulation IPC 4P Premod Channel Mode Co Cont Both ON 10 OFF 10 Reciprocal ON 10 OFF 10 TENS 1 Freq Mod Frequency 1 Frequency Beat Low Beat High CH1 CH2 10s 10s CH1 CH2 10s 10s 10s Rehab Ser...

Страница 28: ...ous patients 27 Ultrasound is a mechanical energy consisting of high frequency vibrations applied by means of an ultrasound applicator These vibrations pass through the tissue of the body and are grad...

Страница 29: ...sts qualified by training knowledge and experience to admin ister such treatments such application carries with it recognized hazards of applying heat to the eyes Treatment of the facial sinus exposes...

Страница 30: ...he underlying musculature we must be acquainted with the develop ment of the EMG signal and the construction and function of the motor mechanism Thus properties and mutations in the musculature the jo...

Страница 31: ...rompted to relax their pelvic muscle Wide Narrow Above Below Continue OFF Above the threshold Below the threshold Continue full scale OFF no bar graph sound 2 99 sec Auto Manual Number of work rest re...

Страница 32: ...gs Biofeedback is dangerous for diabetics and others with endocrine disorders as it can change the need for insulin and other medications Please check with the doctor to see whether this is an appropr...

Страница 33: ...User manual 1 Serial No Name Quantity 1093294 MT2200 mainframe 1 1183323 Patient Interrupt Switch 1 7160132830 Mains Power cable 1 7100100001 Rubber electrodes 60x90mm 2 7100100000 Rubber electrodes...

Страница 34: ...223317 MTM200 mainframe 1 1183323 Patient Interrupt Switch 1 7100100001 Rubber electrodes 60x90mm 2 7100100000 Rubber electrodes 70x110mm 2 9051650011 Electrode Sponges 70x100mm 2 9051650010 Electrode...

Страница 35: ...4 7130033300 Vacuum Lead Hose Red 2 7130033310 Vacuum Lead Hose Black 2 Serial No Name Quantity 1223316 EMG200 mainframe 1 7100000081 Self adhesive Electrodes 50x50mm 8 10260041 Intravaginal Probe 26...

Страница 36: ...have occurred during shipment Place the main device on top of the functional module Carefully lift the main device at the front and insert flat cable into connector 6 1 3 Rehab series with two modules...

Страница 37: ...on from mains supply Systems without a battery When you have finished treatments turn the device off by setting the power line switch to Off 0 The device is now disconnected from the mains supply Syst...

Страница 38: ...p water to remove the impregnating agent Before application saturate the sponge pads with tap water In areas with soft tap water use a saline solution instead This will improve electrical conduction T...

Страница 39: ...continue the treatment with flexible rubber electrodes com bined with properly moistened sponge pads Self adhesive electrodes are not recommended for use with currents that contain a DC com ponent CAU...

Страница 40: ...contact over the entire elec trode surface 7 1 7 Connection and disconnection reactions Constant Current CC output characteristics may cause unpleasant connection and discon nection reactions if the e...

Страница 41: ...al method The water should be degassed by previous boiling in order to prevent air bubbles arising on the ultrasound applicator and the body 7 2 3 Before treatment Check the patient for contra indicat...

Страница 42: ...ng from the pulsed vacuum ensures a good blood flow through the skin under the electrodes This reduces the resistance of the skin and increases he effectiveness of the stimulation current See paragrap...

Страница 43: ...ash the probe gently in mild soapy water rinse and make sure the probe is completely dry before returning to storage in the plastic bag Read carefully the probe instruction of use originally attached...

Страница 44: ...logy 7 Patient interrupt switch 8 Electrotherapy Therapy button Combo Rebah Stim Rehab Treatment button Ultra Rehab 9 LED indicator 10 Combination Therapy button Combo Rehab Favorites button StimRehab...

Страница 45: ...Cable Electrotherapy channel 3 20 BTM200 21 VAM200 module 22 Connections Vacuum Cables Electrotherapy channel 1 23 Connections Vacuum Cables Electrotherapy channel 2 24 EMG200 module 25 Reference Elec...

Страница 46: ...ust therefore be avoided CAUTION RQQHFWLRQV DUH LQWHQGHG IRU WKH connection of type BF applied parts complying with the leakage current requirements of IEC 60601 1 8 2 Symbol Symbol Symbol Meaning Mea...

Страница 47: ...when the sheet is not selected A Device model B Navigation level Shows where you reside in the navigation C Battery indicator only visible when operating from the battery D Navigation bar Provides scr...

Страница 48: ...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 channels are selected The Home menu...

Страница 49: ...l Tab Illustration Of Ultrasound Remaining treatment time When a sequential protocol has been loaded the value indicates the total remaining treatment time of the sequential protocol Output value Unit...

Страница 50: ...ation I J K L Channel Tab Illustration Of Combination Output Indicator Output Indicator Standard electrodes Ultrasound Applicator Remaining treatment time When a sequential protocol has been loaded th...

Страница 51: ...tral controller to scroll through the list and select the clinical protocol by touching the button The channel selection screen appears For therapy information touch the info button on the left side o...

Страница 52: ...s Only the intensity can be set differently Parameter screen therapy screen In this screen the user can adjust the intensity or change the parameter by touching the button and changing the value with...

Страница 53: ...otherapy Manual Operation The electrotherapy menu gives access to functions OLQLFDO 3URWRFROV DYRULWHV 0DQXDO 2SHUDWLRQ Select Manual Operation by touching the button The next screen appears Select fr...

Страница 54: ...y can be set differently Parameter screen Adjust the parameters by touching the button DQG FKDQJH WKH YDOXH ZLWK WKH FHQWUDO FRQWUROOHU Note some parameters are grouped and in the next screen the sett...

Страница 55: ...6723 button in the navigation bar The Home menu gives access to all functions of the unit Select in the Home menu ultrasound therapy by touching the button Ultrasound The next screen appears Ultrasoun...

Страница 56: ...button left of the protocol and the therapy info will appear Therapy information 8VH WKH FHQWUDO FRQWUROOHU WR VFUROO WKURXJK the pages in most cases the first page is text followed by one or more ill...

Страница 57: ...screen appears Combination Therapy Clinical Protocols The Combination menu gives access to functions OLQLFDO 3URWRFROV DYRULWHV 0DQXDO 2SHUDWLRQ Select Manual Operation by touching the button The next...

Страница 58: ...W WKH ultrasound parameters 7RXFK WKH HOHFWURWKHUDS EXWWRQ WR UHWXUQ WR the previous screen 7RXFK WKH XOWUDVRXQG UHDG RXW DQG DGMXVW WKH LQWHQVLW ZLWK WKH FHQWUDO FRQWUROOHU 7RXFK WKH FXUUHQW UHDG RXW...

Страница 59: ...WKH EXWWRQ DQG DGMXVW WKH SUHVVXUH XVLQJ WKH FHQWUDO FRQWUROOHU 7KH YDFXXP cups are automatically selected when the pump starts to run The Home menu gives access to all functions of the unit Select in...

Страница 60: ...ed channel 2 3 and 4 are still available for another therapy When Channel 1 2 or 3 4 is selected both channels have the same parameters Only the intensity can be set differently Touch the botton the s...

Страница 61: ...EMG menu gives access to functions OLQLFDO 3URWRFROV DYRULWHV 0DQXDO 2SHUDWLRQ Select Manual Operation by touching the button The next screen appears Select from the list a current waveform 6FUROO WR...

Страница 62: ...n and changing the value with the central controller Touch the timer button the color changes into orange and adjust the treatment time with the FHQWUDO FRQWUROOHU Touch the E Stim button to switch to...

Страница 63: ...Vacuum settings are not saved When a treatment screen is completely set as required its settings can be stored in a favorite for later use V ORQJ DV WKH WUHDWPHQW KDV QRW EHHQ VWDUWHG a Store button...

Страница 64: ...Treatment screen which is selected last time Favorites button Pressing this button can enter Favorites screen which is selected last time Clinical Protocols button Pressing this button can enter Clini...

Страница 65: ...djusting the current amplitude unless a surge program has been selected To start a surge program touch the Start Continue button in the navigation bar 8 2 6 3 CC CV mode Depending on the selected curr...

Страница 66: ...oft and dry cotton cloth or micro fiber tissue to clean the panel To remove fingerprints or grease use a non abrasive glass cleaning agent Apply a small amount of the cleaning agent to a soft cotton c...

Страница 67: ...ter The applicator can be disinfected using a cloth moist ened with a 70 alcohol solution Check the applicator and cable regularly for damage 9 1 6 Vacuum electrodes and sponges The vacuum electrodes...

Страница 68: ...with the cleaning liquid until the water reservoir is full 9 2 Warning Messages Error Messages 9 2 1 Prompt tone 001 002 003 004 005 006 reason Ultrasound applicar is without load Parameters is sett u...

Страница 69: ...res Bad contact quality on channel 2 Check pads and lead wires Bad contact quality on channel 3 Check pads and lead wires Bad contact quality on channel 4 Check pads and lead wires Attempting to save...

Страница 70: ...tone Warning tone Warning tone System Stop Ultrasound treatment output Ultrasound Applicator is too hot Overcurrent on channel 1 Check pads and lead wires Overcurrent on channel 2 Check pads and lead...

Страница 71: ...0 10 standard this unit should be adjusted and safety tested once each year Procedures laid down in the service manual should be followed This may be carried out by your supplier or by another agency...

Страница 72: ...the electrodes varies depending on skin conditions skin preparation storage and climate Replace electrodes that no longer stick NOTE If the following measures fail to alleviate the problem please call...

Страница 73: ...e management Stimulation is uncomfortable Stimulation is ineffective Intensity is too high Electrodes are too close together Damaged or worn electrodes or lead wires Electrode active area size is too...

Страница 74: ...0W XW IDFWRU IRU FP 0 1W 2 0W Output accuracy 20 for any level above 10 of maximum Peak out Amplitude Duty XW IDFWRU FP XW IDFWRU FP Treatment timer 0 30 min 0 1 min 5 cm Applicator ERA Effective Rad...

Страница 75: ...L 200 Hz stepping 1Hz Beat Low 1 Beat H Hz stepping 1Hz Intensity CC 0 100mA stepping 0 5mA CV 0 100V stepping 0 5V Treatment Time 1 60 minutes 10 2 2 IF 2P IFC Interferential Premodulated 2 Pole Prem...

Страница 76: ...1Hz cycle 16s P Dur 20us 1000us stepping 5us Intensity CC 0 200mA stepping 0 5mA CV 0 100V stepping 0 5V Channel mode Single channel Mode Reciprocal Mode Co Contraction Mode Treatment Time 1 60 minut...

Страница 77: ...9 10 2 3 4 TENS Alternating Rec Frequency 1 250Hz stepping 1Hz F M 0 250Hz stepping 1Hz P Dur 20us 1000us stepping 5us Intensity CC 0 200mA stepping 0 5mA CV 0 200V stepping 0 5V Channel mode Single c...

Страница 78: ...form of very low intensity The literature reports benefi cial effects of this waveform in the treatment of wounds The physiological working mecha nism of this effect is as yet not clearly understood I...

Страница 79: ...equency 0 2Hz 200Hz stepping 0 1Hz 1Hz Polarity Positive negative P Dur 20 10000us steping 100us 1000us Intensity CC 0 80mA stepping 0 5mA CV 0 80V stepping 0 5V Channel mode Single channel Mode Recip...

Страница 80: ...500V stepping 5V Channel mode Single channel Mode Reciprocal Mode Co Contraction Mode Treatment Time 1 60 minutes Cycle Time continues 10 10 10 20 10 30 10 50 custom 0 60 Ramp 0 0 1 1 2 2 5 5 8 8 cust...

Страница 81: ...ons 256x180x124mm LxWxH Operating Environmental Temperature 10 C 50 F to 40 C 104 F Relative humidity 30 85 Atmosphere pressure 700hPa 1060hPa Storage Environmental Temperature 10 C 14 F to 55 C 131 F...

Страница 82: ...al device classification IIa 21 CFR 1050 10 This equipment complies with all requirements of 21 CFR1050 10 Performance Standard for Ultrasonic Therapy devices 21 CFR 898 This equipment complies with a...

Страница 83: ...ic environment as indicated below The customer or user of the REHAB SERIES unit should ensure that it is operated in such an environment Interference tests Conformity Electromagnetic environment guide...

Страница 84: ...for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 seconds 6 kV contact 8 kV air IEC 60601 test level Compliance level Electromagnetic environment Guidance Power frequency 50 60 Hz...

Страница 85: ...on in situa the field strength of stationary radio transmitters should be less than the compliance level at all frequencies Interference may occur in the vicinity of REHAB SERIES devices which is mark...

Страница 86: ...radios amateur radio stations AM and FM radio and TV broadcasting To determine the electromagnetic environment in rela tion to the fixed transmitters an electromagnetic site survey should be consider...

Страница 87: ...um rated output of the transmitter in Watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the higher frequency range is applicable Separation distance according to frequency...

Страница 88: ...0001 Rubber electrodes 60x90mm 2 7100100000 Rubber electrodes 70x110mm 2 9051650011 Electrode Sponges 70x100mm 2 9051650010 Electrode Sponges 80x120mm 2 7100000081 Self adhesive Electrodes 50x50mm 4 7...

Страница 89: ...Sponges 80x120mm 2 7100000081 Self adhesive Electrodes 50x50mm 4 7100000152 Self adhesive Electrodes 50x100mm 4 7200300010 Fixation strap 75x1200mm 1 7200300050 Fixation strap 75x600mm 1 7101000016 S...

Страница 90: ...2 9051650010 Electrode Sponges 80x120mm 2 7100000081 Self adhesive Electrodes 50x50mm 4 7100000152 Self adhesive Electrodes 50x100mm 4 7200300010 Fixation strap 75x1200mm 1 7200300050 Fixation strap...

Страница 91: ...es Optional Accessories 11 8 Cart Serial No Name Quantity 1223316 EMG200 mainframe 1 7100000081 Self adhesive Electrodes 50x50mm 8 10260041 Intravaginal Probe 26 5mm 1 7101000016 Stim Lead Wires 2 710...

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