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SaeboStim Pro
Saebo
INSTRUCTION MANUAL

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Summary of Contents for Saebo SaeboStim Pro

  • Page 1 SaeboStim Pro Saebo INSTRUCTION MANUAL...
  • Page 3: Introduction

    This manual contains important information for both the person who will use the SaeboStim Pro and the clinician who may provide and setup the device. Please consult your physician prior to starting treatment with the SaeboStim Pro.
  • Page 4: Table Of Contents

    Installing Batteries ..................25 Clean Skin ..................... 26 Plug in Electrode Wires ................26, 27 Powering the SaeboStim Pro ................ 28 Select and Start a Program ..............29 - 35 Sensory Electrical Stimulation (SES) Program ..........36, 37 Usage of Electrical Pads ................38 Care and Maintenance ................
  • Page 5: List Of Symbols

    List of Symbols Contraindications, that may cause danger Mandatory requirement or may cause an injury or physical discomfort Type BF Equipment Use with Caution List of Symbols Contraindications, that may cause danger Non-Ionizing Radiation List of Symbols Mandatory requirement or may cause an injury or physical Contraindications, that may cause danger discomfort Date of Manufacture...
  • Page 6: Contraindications

    List of Symbols (continued) Fragile Keep upward List of Symbols Keep dry Contraindications, that may cause danger List of Symbols Mandatory requirement or may cause an injury or physical The protection level against water is IP22 IP22 Contraindications, that may cause danger discomfort List of Symbols Mandatory requirement or may cause an injury or physical...
  • Page 7 Contraindications (continued) • Do not apply stimulation over, or in proximity to, cancerous lesions. • Do not apply stimulation over metal implants. • Do not apply stimulation in the presence of electronic monitoring equipment (e.g., cardiac monitors, ECG alarms), which may not operate properly when the electrical stimulation device is in use.
  • Page 8: Warnings

    Contraindications (continued) • Stimulation should not be applied over the carotid sinus nerves, particularly in patients with a known sensitivity to the carotid sinus reflex. • Stimulation should not be applied over the neck or mouth. Severe spasm of the laryngeal and pharyngeal muscles may occur and the contractions may be strong enough to close the airway or cause difficulty in breathing.
  • Page 9: Adverse Reactions

    • You should always take rests between therapy sessions. If the reddening does not disappear after a couple hours, discontinue use of the system, and contact www.saebo.com. • There is a small percentage of people that may have allergic reactions to gel and...
  • Page 10: Emc, Caution

    • If any skin irritation or allergy occurs, please stop using the stimulator immediately and follow doctor’s instructions. • Do not position on allergic area. Electromagnetic Compatibility (EMC) This equipment generates, uses, and radiates radio frequency energy. The equipment may cause radio frequency interference to other medical or non-medical devices and to radio communications.
  • Page 11: Guidance And Manufacture's Declaration

    Table 1 Guidance and Manufacture’s Declaration – Electromagnetic Emission This equipment is intended for use in the electromagnetic environment specified below. User should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment - guidance RF emissions Group 1 This equipment uses RF energy only for its internal function. CISPR 11 Its RF emissions are very low and are not likely to cause any interference in nearby electronic.
  • Page 12 Table 2 Guidance and Manufacture’s Declaration – Electromagnetic Immunity This equipment is intended for use in the electromagnetic environment specified below. User should assure that it is used in such an environment. Immunity test IEC60601 test Compliance Electromagnetic environment - level level guidance Electrostatic ±8kV contact ±8kV contact Floors should be wood, concrete discharge or ceramic tile. Humidity should ±2kV, ±4kV, ±2kV, ±4kV, (ESD)
  • Page 13 Table 2 (Continued) Voltage dips 0 % UT; 0.5 0 % UT; 0.5 cycle Mains power quality should cycle At 0°, 45°, 90°, be typical commercial or IEC 61000-4-11 At 0°, 45°, 90°, 135°, 180°, 225°, hospital environment. UPS 135°, 180°, 270° and 315° power is recommended if 225°, 270°...
  • Page 14 Table 3 Guidance and Manufacture’s Declaration – Electromagnetic Immunity This equipment should be used in the electromagnetic environment specified below. User should assure that it is used in such an environment. Immunity IEC60601 test Compliance Electromagnetic environment - test level level guidance Conducted 3Vrms 3Vrms Portable and mobile RF communications equipment should 150 kHz to 80 be used no closer to any parts than IEC 61000- the recommended separation distance...
  • Page 15 Table 3 (Continued) (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the device). Where “P” is the maximum output power rating of the transmitter in watts according to transmitter manufacturer and “d”...
  • Page 16 Table 3 (Continued) a) T he ISM (industrial, scientific and medical) bands between 0.15 MHz and 80 MHz are 6.765 MHz to6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz. The amateur radio bands between 0.15 MHz and 80 MHz are 1.8 MHz to 2.0 MHz, 3.5 MHz to 4.0 MHz, 5.3 MHz to 5.4 MHz, 7 MHz to 7.3 MHz, 10.1 MHz to 10.15 MHz, 14 MHz to 14.2 MHz, 18.07 MHz to 18.17 MHz,21.0 MHz to 21.4 MHz, 24.89 MHz to 24.99 MHz, 28.0 MHz to 29.7 MHz and 50.0 MHz to 54.0 MHz.
  • Page 17 Table 4 Test Specifications for ENCLOSURE PORT IMMUNITY to RF Wireless Communications Equipment. Test Band Service Modulation Maximum Distance mmunIty Frequency Power TEST LEVEL (MHz) (MHz) (V/m) Paulse modulation 380 - 390 TETRA 400 18 Hz GMRS 460, ± 5 kHz 430 - 470 FRS 460 deviation 1 kHz sine Pulse LTE Band 13, modulation...
  • Page 18 Table 4 (Continued) Bluetooth, Pulse 2 400 - WLAN, modulation 2 450 2 570 802.11 b/g/n. 217 Hz LTE Band 7 5 240 Pulse 5 100 - WLAN 802.11 modulation 5 500 5 800 217 Hz 5 785 NOTE: If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting antenna and the ME EQUIPMENT or ME SYSTEM may be reduced to 1 m test distance to permitted by IEC 61000-4-3.
  • Page 19 Table 5 (Continued) This device can be used under the environment that radiated RF disturbances are controlled. User should maintain a minimum distance between portable and mobile RF communications equipment to prevent electromagnetic interference. Following recommended distance is calculated according to the maximum output power of the communication equipment.
  • Page 21: Intended Use

    Intended Use The SaeboStim Pro device delivers muscle and nerve stimulation using the principles of both Neuromuscular Electrical Stimulation (NMES) and Transcutaneous Electrical Nerve Stimulation (TENS). The indications for use include relaxation of muscle spasms, prevention or retar- dation of disuse atrophy, increasing local blood circulation, muscle re-education, immediate post-surgical stimulation of calf muscles to prevent venous thrombosis and maintaining or increasing range of motion.
  • Page 22: Description Of Device And Controls

    Description of Device and Controls 1. On/Off Switch: Slide the switch to turn the device on/off. 2. Channel Key: Press the Channel Key (CH) to switch between the 2 channels. If icon A is flashing on the screen, the user can set the Intensity level or activate the Trigger Mode in Channel A. If icon B is flashing on the screen, the user can set the Intensity level or activate the Trigger Mode in Channel B. The flashing will stop following 10 seconds of no operation. 3. Pause/Trigger Key: The Pause/Trigger Key (T) serves both functions. - Pause: When the stimulator is running a treatment program, press the Pause/Trigger Key once to pause the treatment.
  • Page 23 - Trigger Mode: Once the desired Channel Key is pressed and flashing, press and hold the Pause/Trigger Key for 3 seconds to activate the Trigger Mode. An “arrow” symbol will appear below the corresponding Channel. The stimulator enters a contraction period for as long as the Key is pressed. When the Key is released the stimulator enters the relaxation period (stimulation is not on).
  • Page 24: Display Screen Symbols And Description

    7. Output Ports: Channel A/B cables supplied are inserted into the ports on the top portion of the device. 8. DC Jack: The stimulator can be powered though the USB cord. For USA shipments only, an AC adaptor will also be provided. Connect one end to a power source and other to the connector on the left side of the unit.
  • Page 25 Description of Display Screen Symbols Battery – remaining battery power. Lock – prevents unwanted changes to the intensity level. Warning – indicates poor Electrode Wires to Electrode Pads or Electrode Pads to skin connection. A – Channel A. B – Channel B. Intensity Bar – when activated the intensity bar will increase and decrease corresponding to the contraction and relaxation cycle on each Channel. P1 – indicates the current treatment program. Time – length of time remaining. Arrow – when Trigger Mode is activated, an arrow symbol will appear below the corresponding Channel. FWSRT – custom icons appear when pressing the Program Key for 3 seconds.
  • Page 26: Getting Started

    Getting Started Unpacking the Device Remove the SaeboStim Pro and all of the components from the packaging. Verify that all parts are present. See Figure 3. Parts Included: • SaeboStim Pro Device: 2 Channel Stimulator. • Electrode Wires: The Electrode...
  • Page 27: Installing Batteries

    Installing Batteries The unit is powered by three disposable, standard AAA alkaline (non rechargeable) batteries available in all consumer electrical stores. The battery compartment is located on the rear of the device. In order to open, unscrew and place your thumb onto the symbol shown on the battery compartment and slide firmly to remove.
  • Page 28: Clean Skin

    Clean Skin Remove all jewelry and clean skin thoroughly with soap and water. Rinse and dry. Electrodes do not work well if any lotion, oil, dirt is on the skin. Plug in Electrode Wires The Electrode Wires provided with the unit are inserted into the Output Ports (OUT A / OUT B) located at the top of the Stimulator.
  • Page 29 Connect Electrode Pads and Position on Skin Connect the Electrode Pads provided to the Electrode Wires. No metal should be visible. See Figure 8. Figure 8 Remove the Electrode Pads from the film by grasping the edge of the Electrode and peeling it off. See Figure 9. Figure 9...
  • Page 30: Powering The Saebostim Pro

    Place the Electrode Pads on the precise skin location by applying the center of the Electrode first and smoothing down the edges. The complete surface of the Electrodes should be in contact with the skin. See Figure 10. Powering the Device Figure 10 Slide the toggle switch on the right side of the device to turn on the stimulator.
  • Page 31: Select And Start A Program

    Select and Start a Program Step 1 Press the Channel Key (CH) once and icon A will flash. Then, press the Program Key (P) to select the appropriate treatment program. See Figures 13 & 14. Displayed on the screen will be “ P ” followed by the number corresponding Channel Key with the Program (i.e., P1 ).
  • Page 32 Select and Start a Program Step 2 Intensity Key Once the program is selected, and while Channel A icon is still flashing, press Intensity Keys (-/+) to adjust the intensity to the desired level in Channel A. Pressing (+) button during treatment increases the intensity level by a factor of one for that channel. Pressing (-) button during treatment decreases the intensity level by a factor of one.
  • Page 33 Note: To utilize both channels (4 electrodes instead of 2), press the Channel Key again so icon B is flashing. While Channel B icon is still flashing, press Intensity Keys to adjust the intensity to the desired level in Channel B. Step 3 Lock Key Once the desired intensity level(s) are reached, the user can press and hold the Lock Key for 2 seconds to avoid unwanted Figure 19 changes to the intensity level.
  • Page 34 Trigger Mode The Trigger Mode is possible in Programs 1, 2, 4, 6, 7, and 9. To activate, select the desired Channel by pressing the Channel Key (i.e., Ch A or Ch B), so “A” or “B” is flashing. See Figure 21. When the selected Channel is flashing, press the Pause/Trigger Key (T) and hold for 3 seconds to activate Channel Key...
  • Page 35 To return to the programmed contraction/ relaxation cycle, press the intensity key of the appropriate Channel. See Figure 24. The corresponding Channel will stop flashing after approximately 5 seconds and the arrow symbol will turn off. Caution: In Trigger Mode, where stimulation is held constant for several continuous Intensity Key seconds, muscle fatigue could occur.
  • Page 36 Icon/Range F – Frequency, range: 1~125Hz (below 5Hz: with steps of 1Hz; above 5Hz: with steps of 5Hz) W – Pulse Width, range: 100~350μs (±10%, with steps of 50μs) S – Contraction time, range: 1~10s (with steps of 1s) R – Relaxation time, range: 1~10s (with steps of 1s) T – Treatment time, range: 5-60 minutes (with Figure 27 intervals of 5 minutes) Press the Program Key again to select icon F...
  • Page 37 After the Frequency is set, press the Program Key again to switch to Pulse Width. See Figure 29. The icon W is on, and the other 4 icons are off. Press the Intensity Keys to adjust the Pulse Width. To set the other parameters, repeat the above steps. Program Key Once finished, Press the Pause/Trigger Key Figure 29...
  • Page 38: Sensory Electrical Stimulation (Ses) Program

    SaeboStim Pro offers a Sensory Electrical Stimulation program. Program 14 provides SES to the arm and hand using a specialized Electro-Mesh garment technology (sold separately). The Electro-Mesh garments consist of an elbow sleeve (arm stimulation) and glove (hand stimulation). The material is highly conductive and is made of silver treated nylon fibers blended with Dacron®...
  • Page 39 They are NOT included with this device. To purchase, contact your Saebo representative for details. Loose Electrode Indication The SaeboStim Pro monitors the connection between the Electrode Pads and the user. When the Electrodes Pads exhibit a poor connection, the treatment will be paused and an audible beep will emit from the unit.
  • Page 40: Usage Of Electrical Pads

    Usage of Electrode Pads • It is advisable to consult a physician before or after use to avoid any complications. • Remove body hair for better electrical conductivity. An electric razor or a pair of scissors is recommended. • Please retain the film of the Electrode Pads when using it and cover after use. •...
  • Page 41: Care And Maintenance

    Care and Maintenance Device Storage • Do not store in direct sunlight, high temperature, moist, dusty, or corrosive gas. • Store where children cannot reach. • Use a wet cloth with mild detergent or alcohol to clean the surface of the device.
  • Page 42 Parameters • Waveform Type - Symmetrical Biphasic • Pulse Width - 100-350μs (±10%), (with steps of 50μs) • Pulse Rate - 1-125 Hz (±10%), (below 5Hz: with steps of 1Hz; above 5Hz: with steps of 5Hz) • Intensity: 0-60mA (±10% or±2mA, whichever is greater, 500Ω load) Performance Parameters Power: 3* LR03 4.5V; or Power adapter, input AC 100-240V 50/60Hz 0.3A, output DC 5V /1.2A Protection against electric shock: Class II Safety class: BF type Protection Grade: IP22 Shutdown current: ≤0.1mA Operating current: ≤1200mA Environmental Specifications Working Condition...
  • Page 44: Program Information

    Program Information NOTE: Contraction time includes Ramp up and Ramp down times. Prescription Frequency Pulse Contraction Relaxation Ramp Up Ramp Trigger Treat (Hz) Width (sec) (sec) (sec) Down Time (μs) (sec) (mins) Upper Extremity - Short Contraction Upper Extremity - Long Contraction Upper Extremity...
  • Page 45 Program Information (Continued) Prescription Frequency Pulse Contraction Relaxation Ramp Up Ramp Trigger Treat (Hz) Width (sec) (sec) (sec) Down Time (μs) (sec) (mins) Lower Extremity - Long Contraction Lower Extremity - Alternating Note 2 Lower Extremity - Advanced Edema Pain 1 Pain 2 Pain 3 (Alternating)
  • Page 46 Program Information (Continued) Note 1 (Program 3): Channel A stimulates for 9 seconds (including Ramp up/down) and Channel B is off. Then, Channel B stimulates for 9 seconds (including Ramp up/down) and Channel A is off. Repeat. Note 2 (Program 8): Channel A stimulates for 9 seconds (including Ramp up/down) and Channel B is off. Then, Channel B stimulates for 9 seconds (including Ramp up/down) and Channel A is off.
  • Page 47 Program Information (Continued) Note 3 (Program 13): Constant stimulation for 45 minutes. In 12 seconds cycle, it remains at 125Hz, 150μs for the first 6 seconds, and 4Hz, 250μs for the second 6 seconds. See below illustration...
  • Page 48 Program 14 provides SES to the arm and hand using a specialized Electro-Mesh garment technology (sold separately). The Electro-Mesh garments consist of an elbow sleeve (arm stimulation) and glove (hand stimulation). For optimum effectiveness, conductive garments and lotion will be required. To purchase, contact your Saebo representative for ordering details.
  • Page 49: Troubleshooting

    Troubleshooting Problem Possible Solution The display does not come Battery discharged Replace battery on & there is no signal from Battery was incorrectly Remove battery, replace the unit positioned correctly Battery symbol flashing, and The battery is low Replace the battery the stimulator beeps for 10 seconds Stimulation received Faulty electrode wire...
  • Page 50: Technical Support, Warranty

    Email: sales@saebo.com Phone: 888-284-5433 Warranty SaeboStim Pro carries a one year warranty, starting at the date of purchase. Saebo will not provide free repair for the malfunctions caused by the following behaviors: • Disassemble or modify the product without authorization.
  • Page 51 #14 Jinhui Road, Pingshan New District Shenzhen, China Post Code: 518118 Tel: 86-755-29888818 Fax: 86-755-28312625 Hotline: 400-830-0991 E-mail: xft@xft.cn Website: http://www.xft-china.com Authorized Distributor Saebo, Inc. 2459 Wilkinson Blvd. Suite 120-B Charlotte, NC 28208 Phone: (888) 284-5433 Fax: (855) 414-0037 Website: https://www.saebo.com/ US Agent Yang Lingyun...
  • Page 52 Saebo www.saebo.com rev 1/20...

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