ELITONE CAD-1114 User Manual

Regain control – regain confidence

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Regain Control – Regain Confidence

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Summary of Contents for ELITONE CAD-1114

Page 1 ® Regain Control – Regain Confidence User Manual Visit elitone.com/start/ for additional information and videos about getting started with ELITONE. ...
Page 2 Overview of User Interface. See Page 11 for Detailed Operation Intensity Lights Treatment Light Battery Light Charged Solid Orange Contract Constant Green Charging No Light Relax Blinking Green Low Battery Blinking Orange Paused Blinking Red Constant Red Error Tap to Decrease Intensity Tap to Increase Intensity Either Button ON – Tap Once (from off) OFF – Hold 2 Seconds USB Charging Cable Port Pause – Tap Once (during treatment) (lift blue cover) ...
Page 3 Overview The ELITONE® Device (ELITONE) allows comfortable, convenient, and non‐invasive treatment of stress urinary incontinence by delivering electrical muscle stimulation to the pelvic floor muscles and surrounding tissues. This manual provides comprehensive instruction regarding use of the device. Please read it thoroughly and contact Elidah if you have additional questions. Restoring continence can often be achieved through strengthening weakened pelvic floor muscles and calming overactive bladder muscles. Electrical muscle stimulation is a therapy that delivers a small electric current to the pelvic floor muscles. Electrical muscle stimulation has been used for more than forty years; however, it is traditionally delivered through a vaginal probe. Elidah understands that women prefer non‐invasive therapies and has developed ELITONE as a discreet, wearable solution that allows at‐home treatment and doesn’t interfere with women’s busy schedules. Because incontinence often gets worse with age, starting and continuing treatment is important for both your current and long term health. We hope that you find the treatment effective and that it allows you to get back to a fully active lifestyle. ‐ The Elidah Team 3 ...
Page 4 Therapy Typical use consists of 20 minute treatment sessions, 4‐5 times per week, during which the pelvic floor muscles undergo comfortable contract and relax cycles. After 6‐12 weeks of regular use, incontinence symptoms should reduce; however, every woman’s body is different and not everyone will respond to treatment in the same way. Consult your healthcare provider regarding the best treatment regimen for you. For best results, the sessions should be spaced throughout the week and the intensity should be at the highest level that is comfortably tolerable. In time, as you become familiar with the treatment, you should strive to increase the intensity level. The pelvic floor muscles, like other muscles, will atrophy if not used. After completing 6‐12 weeks of treatment, some women benefit from occasional maintenance sessions with ELITONE. Indications, Contraindications, Warnings & Precautions Indication for use: ELITONE is a non‐implanted muscle stimulator designed to treat stress urinary incontinence in women. It applies stimulation to the pelvic floor muscles and surrounding tissues. 4 ...
Page 5 Contraindications: Do NOT use if you have/are:  Pregnant or attempting to become pregnant. The safety of electronic muscle stimulators during pregnancy has not been established.  An electronic implant (e.g. cardiac pacemaker, implanted defibrillator) or suffer from heart problems.  Cancer, epilepsy, or cognitive dysfunction.  Pelvic floor surgery within the last six weeks.  Complete denervation of the pelvic floor.  History or symptoms of urinary retention, extra‐urethral incontinence, or overflow incontinence.  Conductive intra‐uterine devices (IUD/Coil) or metal implants in the abdominal or pelvic area, including the hip and lumbar spine. Warnings / Precautions / Adverse Reactions / Notes:  Read all instructions prior to use. Failure to follow these directions may result in personal discomfort or injury, or damage to the device.  The long‐term effects of chronic muscle stimulation are unknown.  The device is intended for indoor use only.  Exposure of the Controller to liquids may result in personal injury or damage to the device. Do not use while bathing, swimming, or otherwise submerged. 5 ...
Page 6  Discontinue treatment and consult a healthcare provider if you feel light‐headed or faint while using the device.  Use of equipment should be discontinued upon signs of treatment‐related stress or discomfort.  The device should not be used while driving, operating machinery, or any other activity in which involuntary muscle contraction may put the user at risk.  Use only with ELITONE GelPads.  Use only with ELITONE GelPad Cable. Use with other cables could result in increased electromagnetic emissions or decreased electromagnetic immunity and result in improper operation.  The GelPad is for single person use. Reuse of the GelPad by another user could cause cross‐infection of skin disease.  Only apply the GelPad as instructed. Applying the GelPad to or in proximity of the chest, neck, head, face, or eyes could result in serious injury.  Do not power on the device prior to applying the GelPad and connecting it to the Controller.  Only apply the GelPad to normal, intact, clean, healthy skin. ...
Page 7  Do not place the GelPad over or in proximity to cancerous lesions, open wounds, rashes, recent scars, swollen, red infected or inflamed tissue, or skin that is susceptible to acne, thrombosis or other vascular problems.  Use caution if GelPad application area lacks normal sensation.  Replace the GelPad if it no longer sticks firmly to the skin.  Do not use GelPads or the GelPad Cable if they have visible damage.  Do not connect the GelPads or GelPad Cable to other objects.  Do not modify or attempt to repair this device.  Do not touch the gel, metal studs, or snaps with your fingers while the Controller is on.  Do not use more than once per day or at an intensity that exceeds your comfort level. Treatment should not cause undue discomfort or muscle fatigue.  Turn the Controller off before removing GelPad.  Keep device out of reach of children and pets. ELITONE is for use by adults only.  Do not attempt to use the device while it is charging or connected to the charging cable.  Do not use the product while sleeping.  Use the toilet before starting a treatment session.  Best results may be achieved by removing/trimming hair from the application site.  Do not use the device with any other product which delivers electrical current to the body (e.g. muscle stimulators, high frequency surgical equipment) as this could result in burns or other injury. 7 ...
Page 8  Do not apply stimulation in the presence of electronic monitoring equipment (e.g. cardiac monitors, ECG alarms), which may not operate properly when the device is in use.  Do not use in close proximity (e.g. 1 meter) to shortwave or microwave therapy equipment, as this may produce instability in the Controller’s output.  Wireless communication equipment such as wireless home network devices, mobile phones, cordless telephones, base stations, and walkie‐talkies can affect this device. See the EMC Information section of this User Manual for additional information.  Consult your healthcare provider before using the device if: o You have any serious illness or injury not mentioned in this guide. o You have an underlying neurological condition (e.g. Multiple Sclerosis or Parkinson’s disease). o You have a tendency to hemorrhage, following acute trauma or fracture. o You take insulin for diabetes. o You suffer from muscle or joint problems, including pelvic pain or a paravaginal defect. o You suffer with suspected or diagnosed heart disease. o You underwent a recent surgical procedure and where muscle contraction may disrupt the healing process. ...
Page 9: What's In The Box
What’s in the Box 1. Controller (EC‐1003) The Controller generates a treatment signal that is sent into your body, causing your muscles to contract and relax. It includes intensity adjustment buttons, a user display, a rechargeable battery, and connection points for the GelPad Cable and Charging Cable. 2. GelPad (EE‐1002, Packaged Separately) The patented GelPad lightly adheres to the skin and allows the treatment signal to comfortably pass through your muscles. The GelPad is thin, flexible and shaped to ...
Page 10 3. GelPad Cable (EC‐1005, also called Patient Cable) This reusable cable connects the GelPad to the Controller. It is long enough to allow the Controller to be worn at your waist or in your pocket. 4. USB Charging Cable (EA‐1007) This cable is used to recharge the Controller battery. The small end of the cable is a micro USB‐B connector, which fits into the side of the Controller. The other end is a USB Type A connector, which fits into a standard 5 volt USB jack. 5. Storage Case (EA‐1004, Accessory) The collapsible case provides an elegant and convenient way to store the Controller, Belt Clip, cables, and tear‐ off Quick Reference Guide. Pull the side flaps outward to keep the case open. 6. User Manual This User Manual provides comprehensive instructions regarding the use and maintenance of the device. Please read it thoroughly. The tear‐off Quick Reference Guide within the box (not shown) provides abbreviated instruction on device operation. Belt Clip (EA‐1008, Accessory, Not visible, attached to Controller) The removable Belt Clip allows easy attachment to clothing. 10 ...
Page 11 Controller User Interface Overview Either Button ON – Tap Once (from off) Intensity OFF – Hold 2 Seconds Lights Pause – Tap Once (during treatment) Battery Light Treatment Light Constant Green Charged Solid Orange Contract Blinking Green Charging No Light Relax Blinking Orange Blinking Red Paused Low Battery Constant Red Error Tap to Decrease Intensity Tap to Increase Intensity USB Charging Cable Port (lift blue cover) Patient Cable Port ...
Page 12: Operation
Operation 1. Ensure Battery is Charged Press either button to check the battery status. If Constant Green – Fully Charged Blinking Green – Charging battery outline blinks red or does not light, charge the Blinking Red – Low Battery battery prior to use. Lift the blue flap and connect the USB Charging Cable to the side of Controller and a USB power supply. The battery light will blink green while charging and turn solid green when fully charged. The device cannot be used when the battery is low or while charging. Remove the USB Charging Cable prior to use. The fully charged device can deliver at least two Snap GelPad Cable treatment sessions, depending on the selected to GelPad ...
Page 13 3. Position the GelPad Peel the liner from gel surface and save for later use. Place the sticky gel surface on skin as shown in the figures. The top portion should be low on the pubic bone area. Firmly press and ensure that all four sticky regions are adhered to the skin. Note: initially, you may need to readjust to understand the best placement for strongest contractions on your body. Wearing underwear over the GelPad may help keep it adhered to the skin. 13 ...
Page 14 4. Connect GelPad Cable to Controller Connect the cylindrical end of the GelPad Cable to the bottom of the Controller. 5. Begin Treatment Session / Turn ON  Turn device on by tapping either button. The solid green light indicates that the device is on.  Keep tapping the increase [+] and decrease [‐] buttons to adjust the intensity level until you feel strong tolerable muscle contractions. There are 35 intensity Decrease levels. Increase  The blue light changes with every 5 intensity levels. Intensity Intensity The first light corresponds to levels 0‐4, the second ...
Page 15  [Optional] Secure the Controller to underwear or clothing using the Belt Clip and resume normal activity. Note: some women feel Beltclip stronger contractions if they sit down due to the electrode being Faces out pressed against the body. Pause or Adjust Treatment  During treatment tap either [+] or [‐] to pause treatment. The orange treatment light will blink. Wait  Tap [+] or [‐] again to resume treatment and/or adjust intensity. For Adjust comfort, the treatment automatically resumes at a lower intensity. Treat  The device will turn off after 30 seconds in pause mode if no additional buttons are pressed. Pause Finish Treatment / Turn OFF  The device will automatically turn off after the 20 minute treatment session. Three short bursts signal the end of treatment.  Alternately, turn off the device by holding either [+] or [‐] for two Constant Orange – Contract ...
Page 16: Frequently Asked Questions
 Disconnect the GelPad Cable.  Gently peel off GelPad.  Place the GelPad on the correct side of the liner Pull Flaps and reseal it in the storage bag to prevent it from Outward drying out.  Store Controller and cables in the storage case. Frequently Asked Questions Q: What does the therapy feel like? A: Women report a tingling sensation where the GelPad contacts the skin. Internally you will feel tightening, and possibly a raising of the pelvic floor muscles. You control the intensity with the Controller, so set it to a tolerable level. The treatment should never be painful (see “Troubleshooting”). Q: Should treatment feel like Kegel exercises? A: Some women report similarities to Kegel exercises, but not all do. To get a strong muscle contraction try moving the GelPad slightly forward or backward. Also try sitting during treatment, which forces the GelPad into more direct contact with the skin. 16 ...
Page 17 (see “Caring for the Product”). Q: Can I use ELITONE while on my period? A: You may use the device with a tampon, or you may want to wait until a lighter flow day. Q: Can I use this while using other electronic devices like a mobile phone? A: You can operate common electronic devices like phones and computers while wearing ELITONE. See “Indications, Contraindications, Warnings & Precautions” for specific use limitations. 17 ...
Page 18 Q: Can I use ELITONE if I have a metal implant? A: See “Indications, Contraindications, Warnings & Precautions” and consult your healthcare provider before using ELITONE. Q: How soon after childbirth can I use ELITONE? A: See “Indications, Contraindications, Warnings & Precautions” and consult your healthcare provider. Q: My muscles are tired/weak after use. Is this normal? A: Yes. As with any exercise, your muscles may be weak/tired for a day after use, and you may leak more immediately afterwards. If you are new to ELITONE we recommend starting use at a relatively low level of muscle contraction. Then, as you become familiar with the treatment, increase the treatment intensity. We also recommend spacing apart your treatments throughout the week to allow adequate recovery time. Q: My skin is numb after use. Is this normal? A: Some numbing of the application site is normal. If numbness persists consult your healthcare provider. Q: Can I adjust the intensity mid‐treatment? A: Yes, increasing or decreasing the intensity is at your control, but at no time should the device cause pain. Some women report minor numbing at the application site after a few minutes and that this allows them to increase the intensity during treatment. 18 ...
Page 19 Q: If I use the device more often will I get better faster? A: Typical treatment regimens consists of a single 20 minute session, 4‐5 times per week. More use may provide faster improvement, but overuse may fatigue the pelvic floor muscles and reduce the treatment benefits. Consult your healthcare provider before adding additional treatment sessions or increasing the treatment length. Q: Why is there such a wide range in recommended treatment duration (6‐12 weeks)? A: How quickly you respond to the treatment, and therefore how long you should continue, depends on factors including your symptom severity, the treatment intensity (higher is better), your compliance with the recommended 4‐5 sessions per week, and your physiology. ...
Page 20 Q: I feel a tightening in my butt/anus. Is this normal? A: Some tightening in the butt/anus is normal. More important is that you are feeling muscle contraction around the urethra. If not, shift the GelPad forward. Q: Does ELITONE stimulate the clitoris? A: No. The GelPad is not designed to contact the clitoris and should not provide clitoral stimulation. Q: What is the two second of pulsing I feel at the end of each 6 seconds of stimulation? A: That part of the stimulation is intended to relax the bladder and may treat urge incontinence symptoms. Q: How is this different from a general use TENS or electrical stimulation device? A: The ELITONE GelPad is specifically designed to allow easy and accurate placement that targets the pelvic floor muscles through a single electrode. Also, the Controller outputs a “modulated” stimulation that allows stimulation to comfortably pass through the skin and effectively contract the pelvic floor muscles. See elitone.com/faqs/ for responses to additional questions 20 ...
Page 21: Troubleshooting
Troubleshooting Problem Possible Cause Solution I feel sharp Poor contact with skin Turn off the device and reposition the electrode and pain under all ensure that all four gel areas are fully contacting the or a portion of skin. the GelPad For best results clean the skin site prior to application. GelPad dried out or damaged Replace GelPad I don’t feel GelPad dried out or damaged Replace GelPad anything when GelPad not positioned Turn off the device, shift the GelPad forward or I increase the properly backward one inch, and check intensity. intensity Poor contact with skin Clean and dry the application area. Trim or shave hair to improve contact. Intensity too low Continue pressing the increase intensity button [+]. Some women don’t feel sensation until the third blue light is lit. Cable connections are loose Confirm that the GelPad Cable is fully inserted into the Controller and that both snaps are connected to the GelPad. 21 ...
Page 22: Caring For The Product
Unit will not Charging Cable not connected See “Battery, Charging, Discharging” charge to a suitable power source Charging Cable may not be Check that blue cable port cover is not in the way. Fully fully inserted press cable end until a “click” is felt. Unit damaged Contact Elidah Customer Service Solid Red LED An internal error has occurred After a minute, the device should reboot. Contact within the device Elidah Customer Service if the problem persists. Caring for the Product Controller, Cables, and Belt Clip  Do not allow the Controller or cables to get wet or be left in excessive sunlight.  Wipe with slightly dampened cloth. Do not allow water to enter the Controller. Use of aggressive cleaners, solvents or alcohol may damage the product.  The battery is not accessible or replaceable. Do not attempt to remove the battery.  Do not attempt to repair a damaged or malfunctioning device.  The Controller contains a lithium polymer battery and other electrical components that should be disposed of in accordance with local regulation. 22 ...
Page 23: Description Of Symbols
GelPads  Always store the GelPads in the provided resealable pouch to prevent drying out.  Store GelPads in a cool, dry place until next use.  The GelPads are for single person use only.  When the GelPad loses adhesiveness, dries out, or becomes less effective replace it with a new GelPad.  Do not fold GelPad. Reordering and Replacing Parts You will likely need more GelPads over time. Only use ELITONE GelPads with the device. To order replacement GelPads visit www.elitone.com or call 1‐978‐435‐4324. If you lose or damage one of the other parts or accessories contact customer service to obtain a replacement. Description of Symbols Caution! Consult User Manual Storage Temperature Limits 23 ...
Page 24 Follow instructions for use. Use by (YYYY‐MM) Type BF applied part. Do not use if package is damaged Class II medical equipment Manufacturer according to IEC 60601‐1 Ingress Protection Rating. Protected Recycle the device according to against access to hazardous parts local regulation. IP22 with a finger and against vertically falling water drops when enclosure is tilted up to 15 degrees. Batch or lot code Product reference number / catalog number 24 ...
Page 25: Technical Specifications
Technical Specifications Intended Use  Pelvic floor muscle stimulator Classification  Internally powered equipment, Type BF applied parts.  This product is intended for continuous operation, i.e. operation in normal use, for an unlimited period of time, without the specified limits of temperature being exceeded.  This product is not suitable for use in an oxygen rich environment.  This product is not suitable for sterilization.  Protected against ingress, as per IP22. Output The 20 minute treatment session comprises alternating 6 seconds of stimulation and 6 seconds of rest. A 1 second ramp‐up is delivered prior to the 6 second stimulation. The stimulation waveform and output specifications are described below. 25 ...
Page 26 Parameter 500Ω 1000Ω Symmetric, amplitude modulated Waveform Type sinusoidal , voltage controlled Peak Output Voltage (user adjustable) 0‐50V 0‐75V Peak Output Current (rms) 0‐30mA 0‐20mA Output Frequency 10 & 50 Hz with 2000 Hz carrier wave DC Component None None Environmental Conditions Operating Storage and Transportation Temperature +5 to +27°C (+41 to +80°F) +5 to +27°C (+41 to +80°F) Humidity 15‐95% RH, non‐condensing 10‐95% RH, non‐condensing Atmospheric Pressure 50‐106 kPa 50‐106 kPa Battery, Charging and Discharging The Controller contains a 3.7V nominal rechargeable Li‐Po battery. Charging takes approximately one hour. When fully charged the battery will provide one or two 20 minute treatments. The battery can be charged hundreds of times, but will eventually wear out. To achieve maximum battery life: 26 ...
Page 27: Expected Service Life
 Use the device regularly.  Disconnect the Charging Cable from the Controller when fully charged.  Avoid storing the device in hot or cold temperatures. Charge the device by connecting it to a power supply with the following outputs:  Output Voltage: 5V DC nominal  Output Current: 0.5A (500 mA)  Output Connector (Micro‐B USB Connector) Expected Service Life  Controller and Cables: 3 years  GelPads: 3 treatment sessions Product Warranty Elidah offers a 30‐day warranty on this device for defects in workmanship. Contact Customer Service for details. Do not attempt to service the device. 27 ...
Page 28: Customer Service
Warning: Use of this device near other equipment should be avoided because it could result in improper operation. If such use is necessary, this device and the other equipment should be observed to verify that they are operating normally. Warning: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the ELITONE device. Otherwise, degradation of the performance of this equipment could result. 28 ...
Page 29 Table 1: Guidance and Manufacturer’s Declaration – Electromagnetic Emissions ELITONE is intended for use in the electromagnetic environment specified below. The customer or the user should assure that it is used in such an environment. Emissions Test Compliance Electromagnetic Environment ‐ Guidance ELITONE uses RF energy only for its internal function. Therefore, RF emissions CISPR 11 Group 1 its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. ELITONE is suitable for use in all establishments including RF emissions CISPR 11 Class B domestic and those directly connected to the public supply network that supplies buildings used for domestic purposes. Table 2: Guidance and Manufacturer’s Declaration – Electromagnetic Immunity – for all equipment ELITONE is intended for use in the electromagnetic environment specified below. The customer or the user should assure that it is used in such an environment. Immunity Test Test Level Compliance Electromagnetic Environment ‐ Guidance Floors should be wood, concrete or ceramic Electrostatic Discharge ± 8kV Contact ± 8kV Contact tile. If floors are covered with synthetic (ESD) IEC 61000‐4‐2 ± 15kV Air ± 15kV Air material, the relative humidity should be at least 30%.
Page 30 Table 3: Guidance and Manufacturer’s Declaration – Electromagnetic Immunity – for equipment and systems that are not life‐supporting ELITONE is intended for use in the electromagnetic environment specified below. The customer or the user should assure that it is used in such an environment. Immunity IEC 60601 Compliance Electromagnetic Environment ‐ Guidance Test Test Level Portable and mobile RF communications equipment should be used no closer to any part of ELITONE, including cables, than the recommended separation distance calculated from the equation application to the frequency of the transmitter. 10 V/m 10 V/m Recommended separation distance Radiated RF 80 MHz to 80 MHz to d = 1.2 √P IEC 61000‐4‐3 2.7 GHz 2.7 GHz d = 1.2 √P 80 MHz to 800 MHz d = 2.3 √P 800 MHz to 2.7 GHz Where P is the maximum output power rating of the transmitter in watts (W) and d is the recommended separation distance in meters (m). 30 ...
Page 31 Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey , should be less than the compliance level in each frequency range. Interference may occur in the vicinity of equipment marked with the following symbol: NOTE 1: At 80 MHz and 800 MHz, the higher frequency applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a) Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which ELITONE is used exceeds the applicable RF compliance level above, ELITONE should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re‐orienting or relocating ELITONE. 31 ...
Page 32 ® www.elitone.com customercare@elitone.com USA: 1‐978‐435‐4324 Made in the USA Manufactured and Distributed by: Elidah, Inc., 810 Main St., Monroe, CT, USA Copyright © 2020 Elidah, Inc. All rights reserved ELITONE is a trademark of Elidah, Inc. US Pats 9,623,231 & 10,035,016. Patents Pending Kit Number: EK‐1006 EL‐1007 REV 2 Date: 5/2020 32 ...