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InTENSity Twin Stim IV

 

Roscoe Medical

- 36 -

10. ELECTROMAGNETIC COMPATIBILITY 

(EMC) TABLES

Information for accompanying documents in the scope of  

IEC60601-1-2:2007

Important information regarding Electro Magnetic Compatibility (EMC)

With the increased number of electronic devices such as PC’s and mobile 
(cellular) telephones, medical devices in use may be susceptible to  
electromagnetic interference from other devices. Electromagnetic  
interference may result in incorrect operation of the medical device and  
create a potentially unsafe situation. Medical devices should also not  
interfere with other devices.
In order to regulate the requirements for EMC (Electro Magnetic  
Compatibility) with the aim to prevent unsafe product situations,  
the EN60601-1-2 standard has been implemented. This standard  
defines the levels of immunity to electromagnetic interferences as well as 
maximum levels of electromagnetic emissions for medical devices.

Medical devices manufactured for Roscoe Medical Inc. conform to this 
EN60601-1-2:2007 standard for both immunity and emissions.
Nevertheless, special precautions need to be observed:
•   The use of accessories and cables other than those specified by  

Roscoe Medical, with the exception of cables sold by Roscoe Medical  
as replacement parts for internal components, may result in increased  
emission or decreased immunity of the device.

•   The medical devices should not be used adjacent to or stacked with  

other equipment. In case adjacent or stacked use is necessary, the  
medical device should be observed to verify normal operation in the  
configuration in which it will be used.

•   Refer to further guidance below regarding the EMC environment in  

which the device should be used.

Summary of Contents for InTENSity Twin Stim IV

Page 1: ...Twin Stim IV INSTRUCTION MANUAL www roscoemedical com...

Page 2: ...ents may however be published in new editions of this manual All Rights Reserved Rev V1 0 2015 20150211 United States Federal Law restricts this device to sale by or on the order of a physician or lic...

Page 3: ...20 5 1 Battery 5 2 Connecting Electrodes 5 3 Connecting Lead Wires 5 4 Turn On The Device 5 5 Setting a New Program 5 6 Start Treatment 5 7 Other Important Functions Safety Lock Feature Low Battery In...

Page 4: ...anation of pain Pain is an unpleasant sensation that can serve a useful purpose by alerting us to a possible injury or disease When the body is functioning normally pain serves as a warning system tha...

Page 5: ...y of treating muscular injuries It works by sending electronic pulses to the muscle needing treatment this causes the muscle to exercise passively This device is low frequency and in conjunction with...

Page 6: ...Stim IV Stimulator may be used for the following conditions 1 Symptomatic relief of chronic intractable pain 2 Post traumatic pain 3 Post surgical pain For Neuromuscular Electrical Stimulation Therape...

Page 7: ...ch use could cause electric shock burns electrical interference or death Together with a life supporting medical electronic device such as an artificial heart or lung or respirator In the presence of...

Page 8: ...wrong Therefore if you suffer from any serious illness consult your physician in order to confirm that it is advisable for you to use this TENS Stimulator WARNINGS AND PRECAUTIONS REGARDING THE PADS A...

Page 9: ...e pads at least 1 inch apart on your skin The pads should never touch each other Make sure the components are connected well and the pads are fixed on the part of the body you wish to treat or the the...

Page 10: ...s may damage the device Do not use near a cell phone as this may cause the stimulator to malfunction Do not bend or pull the end of the cord When pulling out the cord from the device hold the plug and...

Page 11: ...ctive medium gel If you have suspected or diagnosed heart disease you should follow precautions recommended by your physician If you have suspected or diagnosed epilepsy you should follow precautions...

Page 12: ...use to treat one region for extended periods of time more than 30 minutes a session up to 2 times day or muscles in that region may become exhausted and sore You may experience skin irritation and bu...

Page 13: ...s follow the operating instructions prescribed by your healthcare provider QUICK REFERENCE GUIDE PAGE 1 1 2 Top Side Front Back 3 4 5 6 7 8 9 10 11 Channel 1 and 2 sockets AC DC adapter receptacle T t...

Page 14: ...setting status 5 Power Button Press once to turn on Press and hold for 3 seconds to turn off 6 Channel 2 Intensity Buttons Increase or decrease the output intensity of channel 2 7 Pause Mode Button P...

Page 15: ...Contraction Relaxation Ramp 7 Displays output intensity of channel 1 pulse width and pulse rate 8 Displays therapeutic body part hand foot shoulder arm leg and back 9 Displays therapeutic mode TENS NM...

Page 16: ...Without battery Electrode Detection Function The amplitude level will be reset to 0mA when the amplitude level is 10mA or greater and an open circuit at either channel is detected Technical Specifica...

Page 17: ...2 20 Min 10Hz 220 260 s 20 Sec Hand P1 20 Min 100Hz 100 s Fixed P2 20 Min 1 10Hz 200 s 20 Sec Low back P1 20 Min 80 100Hz 100 s 10 Sec P2 20 Min 4Hz 200 260 s 20 Sec Knee P1 20 Min 120Hz 100 120 s 10...

Page 18: ...Hand P1 20 Min 10Hz 300 s 12 Sec 20 Sec 2 Sec P2 20 Min 5Hz 300 s 12 Sec 30 Sec 2 Sec Low back P1 20 Min 60Hz 300 s 12 Sec 20 Sec 2 Sec P2 20 Min 70Hz 300 s 12 Sec 30 Sec 2 Sec Knee P1 20 Min 20Hz 30...

Page 19: ...im IV 19 4 3 Waveform Information TENS Continuous Pulse Width Modulation Pulse Rate Modulation Modulation Pulse rate and width modulation Waveform Information NMES Synchronous Cycle time Cycle time Cy...

Page 20: ...s according to the your federal state and local regulations As a consumer you are obligated by law to return depleted batteries CAUTION 1 Keep the battery and the product out of the range of children...

Page 21: ...ng the insulated portion of the connector push the plug end of the wire into one of the sockets see drawing one or two sets of wires may be used 4 This device has two output receptacles controlled by...

Page 22: ...s powerful equipment is neither a toy nor a gadget 5 5 Setting a New Program There are 6 therapeutic body part buttons available neck shoulder hand low back knee and foot Each therapeutic part has 3 p...

Page 23: ...he body part which you want to treat Press the body part button until the LCD displays program U1 B Set Pulse Rate Press S button to enter the pulse rate and the Hz will flash Press or button to adjus...

Page 24: ...ich you want to treat Press the body part button until the LCD displays program P1 or P2 B Set Treatment Time Press S button to enter the treatment time and the Min will flash Press or button to adjus...

Page 25: ...like the following B Set Treatment Time Press S button to enter treatment time and the min will flash Then press or button to adjust the treatment time C Set Pulse Rate Press S button to enter the pu...

Page 26: ...n press or button to adjust the treatment time F Set Contraction Time Press S button to set the contraction time and the sec will flash along with the symbol circled in red below Then press or button...

Page 27: ...t Press the M II button to choose NMES mode Then select the body part which you want to treat Press the body part button until the LCD displays program P1 or P2 B Set Treatment Time Press S button to...

Page 28: ...isplay on the LCD Press it again to continue treatment or press button to stop treatment and the device will return to the home screen 5 7 Turn OFF Device Press and hold button until the device turns...

Page 29: ...After the battery has been recharged disconnect the cable from the wall outlet or USB port and the device is ready to be used again The life of a rechargeable battery depends on the number of rechargi...

Page 30: ...how the number of records and treatment time as shown in the below picture Press or buttons to check each record To delete a record press S button and hold for 3 seconds B Check and Delete Accumulativ...

Page 31: ...not require sterilization 6 2 Cleaning the Electrode Pads 1 Turn the power off and remove the lead wires from the electrodes 2 Wash the electrodes when the adhesive surface becomes dirty and or the e...

Page 32: ...ct of the stimulation Use of electrodes that are much smaller than the electrodes provided with the Twin Stim IV may increase the chance of skin irritation or electrode burns occurring under the elect...

Page 33: ...d worn damaged Replace with new lead wires Stimulation is uncomfortable Intensity is too high Decrease intensity Electrodes are too close together Reposition the electrodes at least 1 1 2 apart Electr...

Page 34: ...Clean the electrodes according to description in this manual or replace with new electrodes The surface of the electrode was scratched Replace with a new electrode Output current stops during therapy...

Page 35: ...evice in accordance with the legal obligation 9 GLOSSARY OF SYMBOLS Electrical devices are recyclable material and should not be disposed of with household waste after their useful life Help us to pro...

Page 36: ...tandard has been implemented This standard defines the levels of immunity to electromagnetic interferences as well as maximum levels of electromagnetic emissions for medical devices Medical devices ma...

Page 37: ...ions CISPR 11 Group 1 The device uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF em...

Page 38: ...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 Not applicab...

Page 39: ...from the equation appropriate to the frequency of the transmitter Recommend separation distance d 1 2 P d 1 2 P 80 MHz to 800 MHz d 2 3 P 800 MHz to 2 5 GHz Where P is the maximum output power rating...

Page 40: ...le radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site surve...

Page 41: ...tion distance according to frequency of transmitter in meter 150 kHz to 80 MHz d 1 2 P 80 MHz to 800 MHz d 1 2 P 800 MHz to 2 5GHz d 2 3 P 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 78 1 1 2 1 2 2 3 10 3 8 3...

Page 42: ...warranty do not extend the warranty period either for the device or for the replacement parts 3 The following is excluded under the warranty All damage which has arisen due to improper treatment e g n...

Page 43: ......

Page 44: ...Manufactured for Roscoe Medical 21973 Commerce Parkway Strongsville Ohio 44149 Ph 800 3 ROSCOE 376 7263 www roscoemedical com...

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