EMSI Flex-MI Instruction Manual
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EMSI Flex-MI Instruction Manual

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  • Page 2 3504 Cragmont Dr. Suite #100 | Tampa, FL 33619 P: 800.588.8383 | 813.931.2369 | F: 800.588.9282 | E: customerservice@wecontrolpain.com...

  • Page 5: Intended Use

    1.0 | Intended Use e Flex-MI is design for the following: Interferential Stimulation > Symptomatic relief of chronic intractable pain > Adjunctive treatment for the management of post-traumatic or post-surgical pain EMS- Electrical Muscle Stimulation > Relaxation of muscle spasm >...
  • Page 6 3.0 | Contraindications 1. Any electrode placement that applies current to the carotid sinus (front of neck) region. 2. Any electrode placement that causes current to flow transcerebrally (through the head). 3. Any use of this device on patients who have a demand-type cardiac pacemaker. 4.0 | Warnings 2.
  • Page 7 7. For external use only. 8. Do not use device on the eye area. 10. Safety for use during pregnancy or delivery has not been established. 11. Electronic equipment such as ECG monitors and ECG alarms may not operate properly when the device is in use.
  • Page 8 5.0 | Precautions 1. Caution should be used for patients with suspected or diagnosed heart problems. 2. Caution should be used for patients with suspected or diagnosed epilepsy. 3. Caution should be used in the presence of the following: ( a ) When there is a tendency to hemorrhage following acute trauma or fracture; (b) Following recent surgical procedures when muscle contraction may disrupt the healing process.

  • Page 9: Adverse Reactions

    In unusual circumstances, unintended functions of the Flex-MI could be initiated, possibly giving rise to undesirable risks for the patient or user such as a surge in energy level or ineffective treatment parameters.

  • Page 10: Unit Description

    7.0 | Unit Description ON/OFF Button: Turns the unit ON and OFF. Amplitude Controls: Controls the “INTENSITY” level of stimulating pulses. MODE Button: Choose the IFC or EMS stimulation modes. SET Button: Set the pulse width, pulse rate, ramp time, on time and off time. TIMER Button: Sets the timer.
  • Page 12 Electrode Leadwires: Two sets of electrode leadwires which Flex-MI is recommended for use with the are compatible with commercially available electrodes EMSI self adhesive electrodes. (Re-order informa- (standard 0.08 inch female connection) are provided with tion on page 26) Flex-MI Battery Charger: .
  • Page 14 8.0 | Specifications continued LCD display, 10 sections of each section with 2 adjustments 0~±23V(Loading: 1000 ) Output 0~±23mA(Loading: 1000 ) Output Current Level 1: ±2.1V Levels Level 2: level 20 Each level increases ±1.1V (Loading: 1000 ) Pulse Width µs for each phase, Fixed 4000Hz, Fixed Carrier Rate...
  • Page 15 EMS Mode MODE Descriptions e pulses of CHANNEL 1 and CHANNEL 2 are synchronous. While Synchronous Channel 1 is activated, Channel 2 will be activated simultaneously. pulses active and inactive duration is. controlled by ON TIME and OFF TIME. Both CHANNEL 1 and CHANNEL 2 are continuous pulses under an adjustable pulse Constant rate and pulse width.
  • Page 18 MAKE SURE THAT NO BARE METAL OF THE PINS IS EXPOSED Caution: e Flex-MI is compatible and recommended for use with EMSI electrodes. Always use electrodes and leadwires that came with the unit. Using other electrodes and leadwires may render the unit non-operable, ineffective, and void the warranty.

  • Page 20: Turn Unit Off

    NOTE: is device is capable of “locking” out either IFC or EMS features. To isolate device into a specific treatment (EMS or IFC) mode, ensure device is not providing any stimulation and is on the desired treatment mode. Press and hold Channel 1 and Channel 2 negative (-) amplitude button for 5-7 sec until audible beep is heard.
  • Page 21 SPECIAL CARES IN OPERATING • Clean and dry the skin surface of the body area to be treated. • Inspect the electrode cords and electrode pads for wear. If they are not in good condition, they should be replaced. If they are acceptable, then insert the cord pins into each electrode pad. Electrodes are for single patient use, and are to be used in accordance with the labeling provided with the electrodes.
  • Page 25 4 . D e v i c e S t o r a g e a n d D i s p o s a l I f t h e d e v i c e w i l l b e s t o r e d f o r a n e x t e n d e d p e r i o d o f t i m e , r e m o v e t h e b a t t e r y f r o m t h e d e v i c e a n d s t o r e a l l c o m p o n e n t s i n a c o o l , d r y l o c a t i o n .
  • Page 28 Guidance and manufacturer’s declaration-electromagnetic immunity e device is intended for use in the electromagnetic environment specified below, and should be only used in such an environment. IEC 60601 Compliance Electromagnetic Immunity test test level level environment-guidance Electrostatic ±8 kV contact discharge ±8 kV contact discharge Floors should be wood, concrete or discharge(ESD)

  • Page 29: Immunity Test

    Guidance and manufacturer’s declaration-electromagnetic immunity continued IEC 60601 Compliance Electromagnetic Immunity test test level level environment-guidance Mains power quality should be that Surge IEC ±2kV Power lines ±2kV Power lines of a typical commercial or hospital 61000-4-5 environment. Mains power quality should be that 0% UT;...
  • Page 31 Recommended separation distance between portable and mobile RF communications equipment and the device. e device is intended for use in an electromagnetic environment in which radiated RF disturbances are under control. User can help prevent electromagnetic interference by keeping the device at a minimum distance from portable and mobile RF communications equipment (transmitters).
  • Page 33 Synchronous Symmetric, Multi Pulse Waveform Symmetric, Single Pulse Waveform Asymmetric, Single Pulse Waveform Asymmetric, Multi Pulse Waveform...
  • Page 34 Constant Symmetric, Multi Pulse Waveform Symmetric, Single Pulse Waveform Asymmetric, Single Pulse Waveform Asymmetric, Multi Pulse Waveform...
  • Page 35 IFC (500 Loading) Symmetric,Multi Pulse Waveform (CH1) Symmetric, Single Pulse Waveform (CH1) Symmetric, Single Pulse Waveform (CH2) Symmetric,Multi Pulse Waveform (CH2)
  • Page 36 EMSI reserves the right to honor/dishonor product warranty as it sees fit. CAUTION: Federal law requires a prescription from your physician before use of this product.
  • Page 37 C o p y r i g h t 2 0 2 4 b y E MS I . A l l R i g h t s R e s e r v e d . R E V B...

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