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Summary of Contents for SOLIS 1100
- Page 1 User Manual Model 1100 US Pat. #9,037,269 Canada Pat. #2,824,697 EU Pat. # EP 2 837 405 B1 India Pat. Pending...
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Page 4: Table Of Contents
TABLE OF CONTENTS A Introduction Page 3 General Information B Important Use Information Page 3 Indications for use Contraindications Usage Warnings Precautions Adverse Reactions C Operation Page 8 Battery Information Conductor Information Skin Preparation Use of Controls D Getting Started Page 11 E Additional Information Page 11 Storage Maintenance Troubleshooting Warranty Information Environmental and Technical Information Regarding Electromagnetic Compatibility (EMC) Guidance and Manufacturers Declaration – Electromagnetic Immunity F Glossary... -
Page 5: A Introduction
A Introduction General Information The Solis Pain Relief System is a handheld Neuro-Modulator with advanced technology for deep lasting relief of pain. It is portable and designed to be easy to use. The advanced design of SOLIS allows you to apply penetrating pressure directly to the area of pain. When pressed against the skin, precise gentle electric pulses trigger natural body responses to relieve pain. B Important Use Information Indications For Use To be used for temporary relief associated with sore and aching muscles due to strain from exercise or normal household and work activities. To be used for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis. Contraindications Do not use this device if you have a pacemaker, implanted defibrillator, or other implanted metallic or electronic device. Such use could cause shock, burns, electrical interference, or death. Do not use this device if your pain syndrome is undiagnosed. -
Page 6: Usage
Usage Refer to the Operation section of this document or the Solis Pain Relief System Quick Start Guide for set up and treatment instructions. Warnings • If you are in the care of a physician, consult your physician before using this device. • If you have had medical treatment for your pain, consult with your physician before using this device. • If the pain does not improve or becomes more acute, stop using the device and consult with your physician. • Do not use or place this device on your head. • Do not apply stimulation over the front (throat area) and the sides of your neck because this could cause severe muscle spasms resulting in closure of the airway, difficulty in breathing, or adverse effects on heart rhythm or blood pressure. • Do not use over the carotid sinus area (along the side of your neck below your jaw). Stimulation of the carotid sinus may be hazardous • Do not apply stimulation across your chest or place both hands, arms, or fingers on Conductors at the same time, because the introduction of electrical current into the chest may cause rhythm disturbances to your heart, which could be lethal. - Page 7 • This device can affect the operation of demand type cardiac pacemakers and is not recommended for those with known heart disease without consulting physician. • Do not apply stimulation over open wounds or open rashes, or over swollen, red, infected, or inflamed areas or skin eruptions (e.g., phlebitis, thrombophlebitis, varicose veins). • Do not apply stimulation over, or in proximity to, cancerous lesions. • 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. • Do not apply stimulation when you are in the bath, shower or water in general. • Do not apply stimulation while sleeping; or while driving, operating machinery, or during any activity in which electrical stimulation can put you at risk of injury. • Apply stimulation only to normal, intact, clean, healthy skin. • Conductors should not be placed over the eyes, in the mouth, or internally. • Do not use this device during pregnancy. • Do not use this device if the device housing has been damaged. • Do not use this device if the source of your pain is not known.
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Page 8: Precautions
• Keep out of reach of children. • Do not use this device in the presence of strong electromagnetic fields. Precautions • Neuro-Modulation is not effective for pain of central origin, including headache. • Neuro-Modulation is not a substitute for pain medications and other pain management therapies. • Neuro-Modulation has no curative value. • Neuro-Modulation is a symptomatic treatment and, as such, suppresses the sensation of pain that would otherwise serve as a protective mechanism. • The long-term effects of electrical stimulation are unknown. • Since the effects of stimulation of the brain are unknown, the unit’s Conductors should not be applied anywhere on the head. • The safety of electrical stimulation during pregnancy has not been established. • Some users may experience skin irritation or hypersensitivity due to the electrical stimulation or electrical conductive gel. • Users with suspected or diagnosed heart disease and epilepsy should follow precautions recommended by their physicians. • Use caution if you have a tendency to bleed internally, such as following an injury or fracture. -
Page 9: Adverse Reactions
• Do not use after recent surgical procedures when stimulation may disrupt the healing process. • Use caution if stimulation is applied over the menstruating uterus. • Use caution if stimulation is applied over areas of skin that lack normal sensation. • Keep this device out of the reach of children. • Use this device in accordance with this instruction manual. • Use this device only with the conductors and accessories recommended by the manufacturer. Adverse Reactions • Users with sensitive skin may experience skin irritation beneath the stimulation conductors. • You should stop using the device and should consult with your physicians if you experience any adverse reactions from the device. • You may experience headache and other painful sensations during or following the application of electrical stimulation near the eyes and to the head and face. -
Page 10: C Operation
C Operation Battery Information Your new Solis is shipped with a fresh 9 Volt Duracell Alkaline Battery installed. BEFORE USING, open the battery compartment by sliding the latch with fingers and remove the plastic insulating tab. With normal use, the battery in your Solis Pain Relief System should last for up to 70 hours of operation and give you long lasting service. We recommend that the battery be replaced with a fresh battery at regular intervals to reduce the possibility of battery leakage. The battery is located in the handle and can be accessed by removing the battery compartment door. Remove the battery during long term storage to prevent damage caused by leakage from the battery. Always turn the Power Switch to “Off” before removing the battery. Replace with a fresh 9V Duracell alkaline battery and be careful to observe the polarity when installing a new battery. Conductor Information The Solis Pain Relief System has self-contained stainless-steel conductors. With long term use, it is normal for the stainless-steel conductors to tarnish. This will not affect the operation of your Solis Pain Relief System. If desired, any tarnish can be removed... -
Page 11: Skin Preparation
Clean and moisten the skin area with a damp towel and then firmly press the Solis Pain Relief System conductor end against the skin. If conduction is insufficient and the user doesn’t feel the therapy, rub a small amount of the Parker Spectra 360 Salt Free Hypoallergenic gel supplied with the unit onto the skin as needed and reapply moisture using a damp towel. Do not use any other type of gel but salt free. Skin Preparation By properly caring for skin prior to using the Solis Pain Relief System, you will allow more stimulation to reach the targeted nerves. If skin irritation develops, discontinue using your Solis Pain Relief System, and consult with your physician. To properly care for your skin: • Wash all skin area sites that will be in contact with the conductors with mild soap and water before using the Solis Pain Relief System. • Moisten the skin prior to each use. • Trim excess body hair from conductor site for comfort as needed. • Do not use on cut, broken or irritated skin. -
Page 12: Use Of Controls
Use of Controls The Solis Pain Relief System controls are designed to be simple and easy to operate. Refer to the diagram below for the location of the controls. Intensity: A thumb dial located on the side provides continuous adjustment of the intensity of therapy during treatment and is labeled 0-8. Preset the Intensity to no more than ”0” prior to placing conductors against the skin. After use, reduce the Intensity to zero. On-Off: Main power switch. Pulse Width: The Pulse Width Switch selects either 150 or 230 microsecond (µS) pulse width. The 230 microsecond setting usually produces a more intense treatment experience and can lower the total treatment time needed. Polarity: The Polarity Switch allows you to choose the polarity of the conductors for best results. Occasionally during use, there may... -
Page 13: D Getting Started
D Getting Started Please refer to the Quick Start Guide Additional Information Storage When your Solis Pain Relief System is not in use, store it in a safe dry place away from children. For long term storage, remove the battery and keep in dry storage area away from sunlight at normal room temperature. Remove battery before storing Maintenance • Never immerse this device in water, alcohol or other fluids, since this could seriously damage the internal electronics. • Avoid using cleaning fluids or solvents to remove stains or dirt. Such liquids may damage the plastic. • Clean conductors with an alcohol wipe or Sanizide Pro depending on user needs. - Page 14 • Use only fresh batteries and replace as necessary. • There are no replaceable parts inside the Solis Pain Relief System. Troubleshooting Guide Problem Possible Cause Corrective Action Low or no stimulation felt ▪ Low Battery ▪ Add moisture to skin ▪ Low Intensity setting ▪ Add Spectra 360 gel ▪ Dry skin ▪ Increase Intensity ▪ Reposition electrodes ▪ Replace battery Intermittent ▪ Poor battery contact ▪ Add moisture to skin Stimulation ▪ Low Intensity setting ▪ Add Spectra 360 gel ▪ Dry skin ▪ Increase Intensity ▪ Reposition electrodes ▪ Replace battery Stimulation not ▪ Low Battery ▪ Add moisture to skin powerful enough ▪ Low Intensity setting ▪ Add Spectra 360 gel ▪ Dry skin ▪ Increase Intensity ▪ Reposition electrodes ▪ Replace battery Stimulation ineffective against ▪ Electrode placement ▪ Add moisture to skin...
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Page 15: Warranty Information
Do not try to repair a defective device. There are no serviceable parts in the Solis Pain Relief System. The factory warranty will be voided if there is evidence of disassembly. Warranty Information The Solis Pain Relief System carries a one year manufacturer’s warranty from the date of purchase. The warranty covers both parts and labor for any problems that arise from defects or faults in manufacturing. The warranty does not apply to damage resulting from failure to follow the operating instructions, accidents, abuse, alteration or disassembly by unauthorized personnel. When returning under warranty, you will need to obtain a Return Material Authorization from the manufacturer. Keep your purchase receipt showing the date of purchase. -
Page 16: Environmental And Technical
Environmental and Technical For use in normal office or home environment Dimensions 6 X 3.875 inches Weight 3.4 oz. Waveform Asymmetrical Bi-phase Square Pulse Pulse Rate 40 Hz Pulse Width 150 or 230 microseconds (selectable) Peak Current 0-80 milliamps (500 ohms) Peak Voltage 0-40 V (500 ohm) Maximum Charge per 20 Microcoulombs Pulse Power Supply 9 Volt Alkaline Battery Conductors Stainless Steel Complies with IEC60601-1, IEC60601- Safety tests 1-2, and IEC60601-2-10 Draft Guidance for Industry and Staff: Class II Special Control Guidance Document: Transcutaneous Electrical Nerve Stimulator for Pain Relief (April 5, 2010) -
Page 17: Information Regarding Electromagnetic Compatibility (Emc)
Information Regarding Electromagnetic Compatibility (EMC) • Medical Electrical Equipment needs special precautions regarding EMC and needs to be used and put into service according to EMC information provided in this manual. • Portable and mobile Radio Frequency (RF) communications equipment can affect Medical Electrical Equipment. • The use of accessories, transducers, and cables other than those specified by the manufacturer may result in increased emissions or decreased immunity of the Solis Pain Relief System. • The Solis Pain Relief System should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the Solis Pain Relief System should be observed to verify normal operation in the configuration in which it will be used. Do not use near microwave equipment. -
Page 18: Guidance And Manufacturers Declaration - Electromagnetic
Guidance and Manufacturers Declaration – Electromagnetic Immunity The Solis Pain Relief System is intended for use in the electromagnetic environment specified below. The customer or user of the Solis Pain Relief System should assure that it is used in such an environment. Table 1: Guidance and Manufacturers Declarations - Electromagnetic Emissions The Solis Pain Relief System is designed to produce very low levels of radio frequency (RF) emissions (interference), to be immune to the effects of interference produced by other equipment operating in the vicinity, and to be immune to damage due from electrostatic discharge, all when operating in a domestic or clinical environment. For more information, please refer to the tables below. Emissions Compliance Electromagnetic Environment Guidance Test The Solis Pain Relief System uses RF energy only for its internal function. Emissions Group 1 Therefore its RF emissions are very low CISPR 11 and are not likely to cause any interfer- ence in nearby electronic equipment. The Solis Pain Relief System is suitable for use in all establishments including domestic establishments and those di- Emissions Class B rectly connected to the public low volt- CISPR 11 age power supply network that supplies buildings used for domestic purposes. -
Page 19: Immunity
Table 2: Guidance and manufacturer’s declaration - electromagnetic immunity The Solis Pain Relief System is intended for use in the electromagnetic environment specified below. The customer or the user should assure that it is used in such environment Electromagnetic Immunity IEC 60601 Compliance Environment test test level level guidance Floors should be wood, ± 6 KV ± 6 KV Electrostatic concrete, or ceramic tile. Contact Contact Discharge If floors are covered with (ESD) IEC synthetic material, the ± 8 KV ± 8 KV 61000-4-2 relative humidity should be at least 30% Power frequency mag- Power Frequency netic fields should be at (50/60 Hz) levels characteristic of a Magnetic 3 A/m 3 A/m typical location in a typical... - Page 20 Table 3: Guidance and manufacturer’s declaration - electromagnetic immunity The Solis Pain Relief System is intended for use in the electromagnetic environment specified below. The customer or user should assure that it is used in such an environment. Immunity IEC 60501 Compliance Electromagnetic environment guidance test Test level level Portable and mobile RF Communications equipment should be used no closer to any part of the device, including cables, than the recommended distance calculated from the equation applicable to the frequency of the transmitter’s recommended separation distance 80 MHz to 800 MHz Radiated 3 V/m d = 1.2 √P RF IEC 80 MHz to 3 V/m 61000-4-3 2.5 GHz 800 MHz to 2.5 GHz d = 2.3 √P 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 strength from fixed RF transmitters as determined by the electromagnetic site survey, a. should be less than the compliance level in each frequency range. b. interference may occur in the vicinity of equipment marked with the following symbol: NOTE 1: At 80 MHz to 800 MHz, the higher frequency range applies.
- Page 21 Table 4: Recommended separation distances between portable and mobile RF communication equipment and the Solis Pain Relief System. The Solis Pain Relief System is intended to be used in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) as recommended below, according to the maximum output power of the communications equipment. Separation distance (m) according to frequency of transmitter Rated maximum output power 80 MHz to 800 MHz 800 MHz to 2.5 GHz of transmitter (W) d = 1.2 √P d = 2.3 √P 0.01 0.12 0.23 0.38 0.73 For transmitters not listed above, the recommended separation distance (d) in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power of the transmitter in Watts (W) according to the manufacturer. NOTE 1: At 80 MHz to 800 MHz, the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
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Page 22: F Glossary
Glossary μS Microseconds Hertz Caution Type BF Applied Part... - Page 24 Manufactured by Interplex Medical, LLC for: Mid-America Medical Innovations, LLC Jefferson City, MO Rev. August 2020 Made In the USA...
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