Fortress Technologies Tens Professional Digital Owner's Manual

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Fortress Tens

Professional Digital

www.fortressequipment.com

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Summary of Contents for Fortress Technologies Tens Professional Digital

Page 1 Fortress Tens Professional Digital www.fortressequipment.com...
Page 2: Chapter 1: Introduction
Chapter 1: Introduction 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.
Page 3: Chapter 2: Cautions
Chapter 2: Cautions Do not use this device for undiagnosed pain syndromes until consulting a physician. Patients with an implanted electronic device, such as a cardiac pacemaker, implanted defibrillator, or any other metallic or electronic device should not undergo TENS treatment without first consulting a doctor.
Page 4 Chapter 3: Warnings TENS devices should be used only under the continued supervision of a physician. TENS devices have no curative value. TENS is a symptomatic treatment and as such suppresses the sensation of pain, which would otherwise serve as a protective mechanism. TENS is not effective for pain of central origin.
Page 5: Chapter 5: Adverse Reactions
Chapter 5: Adverse Reactions Skin irritation and electrode burns are potential adverse reactions. If skin irritation occurs, discontinue use and consult your physician. Chapter 6: General Description The Fortress TENS is a battery operated pulse generator that sends electrical impulses ®...
Page 6 Chapter 7: Construction FRONT BACK Lead Connector Battery Strip Intensity Control (On/Off Battery Case Switch) Belt Clip Panel Cover Liquid Crystal Display SIDE Mode Control Protective Cover Set Control Increment Control Decrement Control www.fortressequipment.com...
Page 7: Chapter 8: Technical Specifications
Chapter 8: Technical Specifications The technical specification details of Fortress TENS are as follows: ® Mechanism Technical Description Channel Dual, isolated between channels Pulse Amplitude Adjustable, 0-100 mA peak into 500 ohm load each channel Wave Form Asymmetrical Bi-Phasic Square Pulse Voltage 0 - 50V (Load: 500 ohm) Power source...
Page 8 increasing while the pulse width is decreasing and vice versa. The intensity is decreased by 40% while the pulse width is increased by 40% in 5 seconds. In the next 5 seconds, the intensity is increased by 40% while the pulse width is decreased by 40%. Total cycle time is 10 seconds.Pulse rate (2~150Hz) and pulse width (50~300µs) are fully adjustable The SD2(Strength-Duration) mode consists of automatic modulation...
Page 9: Chapter 9: Replaceable Parts
Chapter 9: Replaceable Parts The replaceable parts and accessories of Fortress TENS devices are as given below – ® Except leads, electrodes, battery and battery case cover, please do not try to replace the other parts of a device. Parts Lead Wires Electrodes 9V Battery, Type 6F22...
Page 10: Chapter 10: Graphic Symbols
REF No. Description Quantity KB - 24 Electrodes Leads 2 pieces GC - 01 9 V Battery, type 6F22 1 piece Instruction Manual 1 piece Carrying Case 1 piece Label The label attached to the back of device contains important information about this device - model name, serial number (started with manufacturing year and week of the device), supply voltage, name of the manufacturer, CE number and classification.
Page 11: Chapter 12: Operating Instructions
Chapter 12: Operating Instructions Insert the 9V battery into the device’s battery compartment. Make sure to remove the plastic seal on the 9V battery. Line up the positive and negative terminals on the battery with their corresponding terminals in the device. Make sure that both Intensity control (ON/OFF Switch) knobs are in the off position.
Page 12 The choice of which pulse duration to use is partially dependent upon the Treatment Mode and Protocol selected (refer to the appropriate section). Pulse Rate The Pulse Rate (hertz or pulses per second) chosen depends greatly upon the type of electrode placement given to the patient.
Page 13: Chapter 14: Attachment Of Electrode Lead Wires
Time Duration The onset of pain relief should occur shortly after the intensity setting has been determined. However, in some cases, pain relief may take as long as 30 minutes to achieve. TENS units are typically operated for long periods of time, with a minimum of 20 – 30 minutes and in some post-operation protocols, as long as 36 hours.
Page 14 Caution Do not insert the plug of the patient lead wire into any AC power supply socket. Chapter 15: Lead Wire Maintenance Clean the wires by wiping with a damp cloth. Coating them lightly with talcum powder will reduce tangling and prolong life. Chapter 16: Electrode Options The electrodes are disposable and should be routinely replaced when they start to lose their adhesive nature.
Page 15: Chapter 18: Tips For Skin Care
Contiguous Placement This is the most common placement technique. It involves placing the electrodes alongside the area of localized pain site, in such away as to direct the flow of current through or around the area of pain. In a single channel application, this would involve placing each pad on either side of the pain site if the pain is localized on a limb and deep within the tissue.
Page 16: Chapter 19: Application Of Reusable Self Adhesive Electrodes
It may be helpful to rub skin lotion on electrode placement area when not wearing electrodes. Never apply electrodes over irritated or broken skin. Chapter 19: Application of Reusable Self Adhesive Electrodes Application Clean and dry the skin at the prescribed area thoroughly with soap and water prior to application of electrodes.
Page 17: Chapter 20: Adjusting The Controls
Care and Storage Between uses, store the electrodes in the resealable bag in cool dry place. It may be helpful to improve repeated application by spreading a few drops of cold water over the adhesive and turn the surface up to air dry. Over Saturation with water will reduce the adhesive properties.
Page 18 Power On/Off Switch and Intensity Controls: If both controls are in the off-position, the device is switched off. By turning the controls clockwise, the appropriate channel is switched on and the indicator of power (CH1 or CH2) will reveal on the LCD. The current strength of the impulses transmitted to the electrodes increases further when the control is turned clockwise.
Page 19 Set Control By pressing the “SET” control, you may enter the setting you intend to make adjustment. You may start to set the value by pressing the “Increment” and “Decrement” controls when the value is flashing. Increment Control This button controls the increase of settings. When pressing this button, the parameter will increase.
Page 20 Select a Mode Select a mode by pressing the “MODE” control. The mode you select will show up on the top of liquid crystal display. There are 5 modes of your option, including Burst, Normal, Modulation, SD1 and SD2. Set Pulse Width Pulse Width is adjustable from 50 s to 300 s.
Page 21 Set Timer Press “SET” to enter this setting. The treatment time is adjust- able from 1 to 60 minutes or Continue. Press “Increment” or “Decrement” control to adjust setting. Your settings will be stored in this unit eternally unless they are adjusted again. You can set the timer to “Continuous”...
Page 22: Chapter 21: Battery Information
Check and Delete Accumulative Record At the individual records menu, press “Mode” control to switch to accumulative record menu. Press the “SET” control first, then press the “MODE” control simultaneously for 3 seconds and all of the records will be deleted followed by a beeper sound. Check/Replace the Battery: Over time, in order to ensure the functional safety of TENS, changing the battery is necessary.
Page 23 Remove battery if equipment is not likely to be used for some time. Please recycle the used battery in accordance with domestic regulation. Do not throw the used battery into fire. If you use rechargeable batteries, please follow the instructions. Rechargeable Batteries (Not Included) Prior to the use of a new unit, the rechargeable battery should be charged according to the battery manufacturer’s instructions.
Page 24 Do not short the terminals of the battery. This will cause the battery to get hot and can cause permanent damage. Avoid storing the batteries in your pocket or purse where the terminals may accidentally come into contact with coins, keys or any metal objects. WARNINGS: Do not attempt to charge any other types of batteries in your charger, other than rechargeable batteries made for your charger.
Page 25: Chapter 23: Safety - Technical Controls
Chapter 23: Safety - Technical Controls For safety reasons, review the following checklist before using your Fortress TENS ® Check the device for external damage. - deformation of the housing. - damaged or defective output sockets. Check the device for defective operating elements. - legibility of inscriptions and labels.
Page 26: Chapter 25: Conformity To Safety Standards
Chapter 25: Conformity to Safety Standards The Fortress TENS devices are in compliance with the following standards: ® EN 60601-1-2: 2014 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance Collateral standard: Electromagnetic compatibility Requirements and tests EN 60601-1:2006 Medical electrical equipment Part 1: General requirements for basic safety and essential performance Chapter 26: Warranty...
Page 27: Chapter 27: Electromagnetic Compatibility Information
Chapter 27: Electromagnetic Compatibility Information The device complies with current specifications with regard to electromagnetic compatibility and is suitable for use in all premises, including those designated for private residential purposes. The radio frequency emissions of the device are extremely low and in all probability do not cause any interference with other devices in the proximity.
Page 28 Electromagnetic IMMUNITY test IEC 60601 test level Compliance level environment - guidance Electrical fast Mains power quality should be ± 2 kV for power ± 2 kV for power transient/burst IEC that of a typical commercial or supply lines supply lines 61000-4-4 hospital environment.
Page 29 Guidance and manufacturer’s declaration - electromagnetic immunity The unit is intended for use in the electromagnetic environment specified below. The customer or the user of the unit should assure that it is used in such an environment. IEC 60601 test IMMUNITY test Compliance level Electromagnetic environment - guidance...
Page 30 Recommended separation distances between portable and mobile RF communications equipment and the unit The unit is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the unit can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the unit as recommended below, according to the maximum output power of the communications equipment.
Page 31 (Appendix I) Test Environment www.fortressequipment.com...
Page 32 (Appendix II) Waveform of EV-804 Digital TENS Burst Mode Load: 500 ohm Pulse Rate: 150Hz Pulse Width: 300 s Scope A: VERT: 10.0V/DIV HORIZ: 2mS OUTPUT: 57.1875Vpk-pk Pulse Rate: 100Hz Scope B: VERT: 10.0V/DIV HORIZ: 50mS Pulse Rate: 5.000Hz www.fortressequipment.com...
Page 33 Normal Mode: Load: 500 ohm Pulse Rate: 150Hz Pulse Width: 300 s Scope A: VERT: 10.0V/DIV HORIZ: 2ms OUTPUT: 59.1825V pk-pk Pulse Rate: 148.8Hz Scope B: VERT:10.0V/DIV HORIZ:100 s OUTPUT:59.1825V pk-pk www.fortressequipment.com...
Page 34 Modulation Mode (-50% Pulse Width & Rate Modulation): Load : 500 ohm Pulse Rate : 150Hz Pulse Width : 300 s Scope A: VERT:1 0.0V/DIV HORIZ: 100 s OUTPUT: 54.9975Vpk-pk Pulse width: 300 s Scope B: VERT:10.0V/DIV HORIZ:100 s OUTPUT:49.5000V pk-pk Pulse width:150 s Scope C: Modulation:-50%...
Page 35 SD1 MODE (-40% Pulse Width & Intensity Modulation): Load : 500 ohm Pulse Rate : 150Hz Pulse Width : 300 s Scope A: VERT: 10.0V/DIV HORIZ: 100 s OUTPUT: 51.0000V pk-pk Pulse width: 190 s Scope B: VERT:10.0V/DIV HORIZ:100 s OUTPUT:35.0025V pk-pk Pulse width:300 s www.fortressequipment.com...
Page 36 SD2 MODE (-70% Pulse Width & Intensity Modulation): Load : 500 ohm Pulse Rate : 150Hz Pulse Width : 300 s Scope A: VERT: 10.0V/DIV HORIZ: 100 s OUTPUT: 48.9975Vpk-pk Pulse width: 90 s Scope B: VERT:10.0V/DIV HORIZ:100 s OUTPUT:21.9957V pk-pk Pulse width:300 s www.fortressequipment.com...