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TENSPros

1. Safety information

1.1 General

InTENSity

IF Combo stimulator is a portable electrotherapy device

featuring two therapeutic modes: Transcutaneous Electrical Nerve

Stimulation (TENS) and Interferential (IF), which are used for pain

relief. The stimulator sends gentle electrical current to underlying

nerves and muscle group via electrodes applied on the skin. The

parameters of device are controlled by the buttons on the front panel.

The intensity level is adjustable according to the needs of patients.

1.2 Medical background

EXPLANATION OF PAIN

Pain is a warning system and the body’s method of telling us that

something is wrong. Pain is important; without it abnormal conditions

may go undetected, causing damage or injury to vital parts of our

bodies. Even though pain is a necessary warning signal of trauma or

malfunction in the body, nature may have gone too far in its design.

Aside from its value in diagnosis, long-lasting persistent pain serves

no useful purpose. Pain does not begin until coded message travels

to the brain where it is decoded, analyzed, and then reacted to. The

pain message travels from the injured area along the small nerves

leading to the spinal cord. Here the message is switched to different

nerves that travel up the spinal cord to the brain. The pain message

is then interpreted, referred back and the pain is felt.

EXPLANATION OF TENS

HOW TENS WORKS

Transcutaneous Electrical Nerve Stimulation (TENS) is a non-

invasive, drug free method of controlling pain. TENS uses tiny

electrical impulses sent through the skin to nerves to modify your

pain perception. TENS does not cure any physiological problem; it

only helps control the pain. TENS does not work for everyone;

however, in most patients it is effective in reducing or eliminating the

pain, allowing for a return to normal activity.

There is nothing “magic” about Transcutaneous Electrical Nerve

Stimulation (TENS). TENS is intended to be used to relieve pain.

The TENS unit sends comfortable impulses through the skin that

stimulate the nerve (or nerves) in the treatment area. In many cases,

Содержание IF COMBO DI4738

Страница 1: ...T E N S P r o s if combo INSTRUCTION MANUAL ...

Страница 2: ...any time without prior notice Amendments may however be published in new editions of this manual All Rights Reserved Rev V1 1 2010 United States Federal Law restricts this device to sale by or on the order of a physician or licensed practitioner Conformity to safety standards Current Solutions LLC declares that the device complies with following normative document IEC60601 1 IEC60601 1 2 IEC60601 ...

Страница 3: ...lation programs 4 INSTRUCTION FOR U 4 1 Battery 4 2 Connect electrodes to lead wires 4 3 Connect lead wires to device 4 4 Electrodes 4 5 Turn ON 4 6 Select the Therapeutic Mode 4 7 Steps to set a new program 4 8 Adjust Channel Intensity 4 9 Safety Lock Feature 4 10 Stop the treatment 4 11 Turn OFF 4 12 Low battery indicator 5 PROGRAM 23 6 24 6 1 Tips for skin care 6 2 Cleaning the device 6 3 Elect...

Страница 4: ...ting persistent pain serves no useful purpose Pain does not begin until coded message travels to the brain where it is decoded analyzed and then reacted to The pain message travels from the injured area along the small nerves leading to the spinal cord Here the message is switched to different nerves that travel up the spinal cord to the brain The pain message is then interpreted referred back and...

Страница 5: ...o stimulate muscle nerves to achieve the symptomatic relief of chronic intractable pain post traumatic pain and post surgical pain 1 3 Indication for use InTENSityT M IF Combo Stimulator may be used for the Symptomatic relief of chronic intractable pain acute post traumatic pain or acute post surgical pain IMPORTANT SAFETY INFORMATION Read instruction manual before operation Be sure to comply with...

Страница 6: ...nancy Do not use during pregnancy unless directed by your physician 5 Electrical stimulation is not effective for pain of central origin 6 Electronic monitoring equipment such as ECG monitors and ECG alarms may not operate properly when electrical stimulation is in use 7 Stimulation should not be applied over the carotid sinus nerves particularly in patients with a known sensitivity to the carotid...

Страница 7: ...T E N S P r o s CAUTIONS 1 Federal law USA restricts this device to sale by or on the order of a physician 2 For single patient use only 3 Keep yourself informed of the contraindications ...

Страница 8: ...T E N S P r o s ...

Страница 9: ...electrode cables and contacts with your headphones or other devices and do not connect the electrodes to other devices 24 Do not use sharp objects such as pencil point or ballpoint pen to operate the buttons on the control panel 25 Inspect Applicator cables and associated connectors before each use 26 Turn the device off before applying or removing electrodes 27 Electrical stimulators should be us...

Страница 10: ...etting mode to the user interface 4 Increasing the output intensity of channel 1 To set the application program and the parameter of the waveform in the setting state 5 Decreasing the output intensity of channel 1 To set the application program and the parameter of the waveform in the setting state To unlock the current treatment program 6 LCD display Shows the operating state of the device 7 Para...

Страница 11: ...T E N S P r o s To set the button and hold for To set the 2 2 LCD display ...

Страница 12: ... C to 40 C 41 to 104 with a relative humidity of 30 75 atmospheric pressure from 700 to 1060 Hpa Storage conditions 10 C to 50 C 14 to 122 with a relative humidity of 10 90 atmospheric pressure from 700 to 1060 Hpa Dimensions 4 5 2 55 0 9 inches L W H Weight 0 28 lbs With battery Tolerance There may be a 5 tolerance of all setting and 10 tolerance of output of intensity Electrode Detection Functio...

Страница 13: ...ed on the setting value Pulse Width Modulation P3 The pulse width is automatically varied in a cycle time The pulse width is decreased from its original setting to 60 in setting cycle time and then increased from 60 to its original setting in nest setting cycle time In this program pulse rate 1 to 150Hz pulse width 50 to 300us and cycle time 5 to 30 sec are fully adjustable Pulse Rate Modulation P...

Страница 14: ...z to 10Hz cycle time 5 to 30 sec is fully adjustable CH 2 pulse rate 4000Hz Interference frequency P2 The pulse rate of the CH1 is fixed in 4000Hz CH2 pulse rate is increased from 4001Hz to 4150Hz in a cycle time and then decreased from 4150Hz to 4001Hz in nest setting cycle time In this program CH2 interference frequency is varied from 1Hz to 150Hz cycle time 5 to 30 sec is fully adjustable CH 2 ...

Страница 15: ... its original setting to 60 in setting cycle time and then decreased from 60 to its original setting in nest setting cycle time In this program CH2 interference frequency 2 to 150Hz and cycle time 5 to 30 sec are fully adjustable CH 2 pulse rate 4000Hz Interference frequency 3 3 The waveforms of the stimulation programs Burst Normal Pulse Width Modulation 15 ...

Страница 16: ...re you are installing the battery properly Be sure to match the positive and negative ends of the battery to the marking in the battery compartment of the device 4 Press and pull down following the direction of the arrow indicated on the photo 5 Replace the battery compartment cover and press to close 6 If replace the battery you should slide the battery compartment cover and open Pull up the batt...

Страница 17: ...ged dismantled thrown into fire or short circuited 4 Protect battery from excess heat Take the battery out of the product if they are spent or in case you no longer use the article This prevents damage caused by leaking battery 5 Always replace the same type battery 4 2 Connect electrodes to lead wires Insert the lead wire connector into electrodes connector standard 0 08 inch female connection Ma...

Страница 18: ...rode 4 4 1 Electrode options The electrodes are disposable and should be routinely replaced when they start to lose their adhesive nature If you are unsure of your electrode adhesive properties order replacement electrodes Replacement electrodes should be re ordered through or on the advice of your physician to ensure proper quality Follow application procedures outlined in electrode packing to ma...

Страница 19: ...eds of the individual patient Every patient responds to electrical stimulation differently and their needs may vary from the conventional settings suggested here If the initial results are not positive speak to your physician about alternative stimulation settings and or electrode placements Once an acceptable placement has been achieved mark down the electrodes sites and the settings so the patie...

Страница 20: ...o 30 seconds Only modulation has this parameter setting Press S button cycle to enter this menu and then press the and button to adjusting the setting 3 Set Timer Press S button cycle to enter this setting The treatment time is adjustable from 1 to 60 minut control to adjust setting You can set the timer to Continuous mode by pressing the control when it shows 60 minutes Its output will be shut of...

Страница 21: ...es or Continuous Press or control to adjust setting You can set the timer to Continuous mode by pressing the button when it shows 60 minutes Its output will be shut off when time is up 3 Set Interference frequency optional Channel 1 has 4000 Hz fixed Fundamental frequency Channel has selectable frequency from 4001 to 4150 Hz Interference frequency is adjustable form 1 Hz to 150 Hz Only P4 has this...

Страница 22: ...the stimulator s output intensity surpasses 12mA the intensity will enulls automatically reset to 0mA 4 9 Safety Lock Feature The Safety Lock Feature automatically activates after there is no operation in the panel for 30 seconds by locking out the ability to press the buttons This is a safety feature to prevent accidental changes to your settings and to prevent accidental increases to the intensi...

Страница 23: ...y you can continue the treatment When stimulation feels weaker than usual or the stimulator turns off it is time to replace the new battery 5 Program Mode Program Modulation Method Frequency Pulse Width Treat time TENS P1 Burst 0 5 5Hz 50 300us 1 60min continous P2 Continuous 1 150Hz 50 300us 1 60min continous P3 Pulse width modulation 1 150Hz 50 300us 1 60min continous P4 Frequency modulation 1 1...

Страница 24: ... that are excessively stretched across the skin during application To prevent this apply electrodes from centre outward avoid stretching over the skin 5 To minimize pulling stress tape extra lengths of lead wires to the skin in a loop to prevent tugging on electrodes 6 When removing electrodes always remove by pulling in the direction of hair growth 7 It may be helpful to rub skin lotion on electr...

Страница 25: ... to the lead wire 2 Remove the protective backing from the electrode surface Do not throw away the protective backing because it is reused after the treatment session has been completed 3 Place the tacky surface to the prescribed skin area by pressing the electrode firmly against the skin To remove your electrodes 1 Lift the corner of the electrode and gently remove it from the skin 2 Apply the pr...

Страница 26: ...0601 1 2 such as with CE mark or are legally marketed in the US under 510 K procedure 6 4 Cleaning the Electrode s cords Clean the electrode cords by wiping them with a damp cloth Coating them lightly with talcum powder will reduce tangles and prolong the life 6 5 Maintenance Maintenance and all repairs should only be carried out by an authorized agency The manufacturer will not be held responsibl...

Страница 27: ... Electrodes are too close together Damaged or worn electrodes or lead wires Electrode active area size is too small Decrease intensity Reposition the electrodes Replace Replace electrodes with ones that have an active area no less than 16 0cm2 4cm 4cm Intermittent output Lead wires Program option in use 1 Verify connection is secure Insure firmly 2 Turn down the intensity Rotate lead wires in sock...

Страница 28: ...ll ventilated place 3 Never place any heavy objects on the device 9 Disposal Used fully discharged batteries must be disposed of in a specially labeled collection container at toxic waste collection points or through an electrical retailer You are under legal obligation to dispose of batteries correctly Please dispose of the device in accordance with the legal obligation 28 ...

Страница 29: ...stablishments other than domestic and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Harmonic emissions lEC 61000 3 2 Not applicable Voltage fluctuations flicker emissions lEC 61000 3 3 Not applicable Guidance and manufacturer s declaration electromagnetic immunity The device is intended for use in the electromagnetic envi...

Страница 30: ...stance Conducted RF lEC 61000 4 6 3 Vrms 150 kHz to 80 MHz 3 Vrms Radiated RF lEC 61000 4 3 3 V m80 MHz to 2 5 GHz 3 V m 80MHz to 800MHz 800MHz to 2 5MHz Where P is the maximum output power rating of the transmitter In watts W according to the Transmitter manufacturer and d Is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagn...

Страница 31: ...ted RF disturbances are controlled The customer or the user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the as recommended below according to the maximum output power of the communications equipment Rated maximum output power of transmitter W Separation distance according to f...

Страница 32: ...ing warranty terms apply 1 The warranty period for device is one year from date of purchase In case of a warranty claim the date of purchase has to be proven by means of the sales receipt or invoice 2 Repairs under 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 ...

Страница 33: ...T E N S P r o s ...

Страница 34: ...T E N S P r o s ...

Страница 35: ...T E N S P r o s ...

Страница 36: ...SPros Manufactured for Current Solutions TM LLC 3814 Woodbury Drive Austin TX 78704 Ph 800 871 7858 www currentsolutionsnow com ...

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