Athena Feminine Technologies E03946001 Remote Control for Medical Device User Manual Patient inst compiled pmd

Athena Feminine Technologies, Inc Remote Control for Medical Device Patient inst compiled pmd

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Patient Manual Revised

Athena Pelvic Muscle Trainer™PATIENTINSTRUCTIONS FOR USECAUTION: Federal law (USA) restricts this device to sale by or on theorder of a physician
ATHENA Pelvic Muscle Trainer™ (PMT)Athena Pelvic Muscle Trainer™Table of ContentsCAUTION: Federal law (USA) restricts this device to sale by or on the order ofa physician.2.Introduction 3Pelvic Muscle Stimulation 4Indications for Use 5Product Description 6Instructions for UseDiagram/ Warnings 7Initial Treatment 8Overview of PMT Use 9Precautions 10Cleaning the PMT 10Directions for Home Use 11PATIENT DIARY/LOG 12Recommended Treatment Protocol 13Product Specifications 14Warranty and Disclaimer 15References 16
ATHENA Pelvic Muscle Trainer™ (PMT)The Athena Pelvic Muscle Trainer™ (PMT) is a mild electrical vaginalstimulator that treats urinary incontinence in females. It has beenshown to be effective in strengthening the pelvic muscles that cancontrol incontinence. This is a single-user device and should not beshared.This manual discusses how the Athena PMT treats incontinence,shows you the parts of the PMT, and explains how to use and care foryour new Athena PMT.Why Incontinence OccursINTRODUCTION3.Incontinence can occur for many reasons. One of the most commoncauses is the weakening of the pelvic muscle. The pelvic muscle islike a hammock that holds up the bladder and other organs.When this muscle is weak it may not hold up the bladder correctly andmay allow urine to leak. Strengthening the pelvic muscle can often helpcontrol incontinence.ATHENA Pelvic Muscle Trainer™ (PMT)
ATHENA Pelvic Muscle Trainer™ (PMT)4.Pelvic Muscle StimulationMany studies have shown that one way to strengthen weakenedmuscles is to apply mild myostimulation to them. This causes themuscles to contract, making them stronger in the same way physicalexercise does.Contracting the muscles in the floor of the pelvis voluntarily is calledthe Kegel exercise. The Athena PMT causes the pelvic floormuscles to contract, similar to the way they are contracted whendoing the Kegel exercise. The difference between the two is that theAthena PMT causes the muscles to contract for you, by applyinggentle myostimulation to them. You can then lie back and exercisewith little voluntary effort.Studies of other devices during the last 20 years have shown thatintra-vaginal myostimulation of weakened muscles in the pelvic floorcan lead to control of the most common forms of incontinence infemales up to 60% to 90% of the time. Because of its effectivenessand lack of side effects, intravaginal myostimulation is an ideal firstchoice of treatment for urinary incontinence in women.What will the stimulation feel like?The stimulation will feel like a gentle pulsating contraction of themuscles. It may feel like a flutter at lower settings. Each time youuse the Athena PMT you should try to use it at a high enoughintensity to feel contractions. As your muscles get stronger you maywant to gradually increase the intensity so that you use the strongeststimulation that is comfortable for you. NEVER turn it up to anintensity that is uncomfortable or painful.ATHENA Pelvic Muscle Trainer™ (PMT)P/D 1700Rev.3/01/0417.Federal Communications Commision (FCC) Compliance Notices:Pelvic Muscle Trainer (Wireless Control Unit)FCC ID: RMLE03946001This device complies with Part 15 of the FCC Rules. Operation is subjectto the following two conditions: (1) This device may not cause harmfulinterference, and (2) this device must accept any interference received,including interference that may cause undesired operation.Warning - Any changes or modifications not expressly approved by theparty responsible for compliance (i.e. Athena Feminine Technologies) couldvoid the user's authority to operate this equipment.This unit was authorized under the FCC Certification ProcedurePelvic Muscle Trainer (Trainer Unit)This device complies with Part 15 of the FCC Rules. Operation is subjectto the following two conditions: (1) This device may not cause harmfulinterference, and (2) this device must accept any interference received,including interference that may cause undesired operation.Warning - Any changes or modifications not expressly approved by theparty responsible for compliance (i.e. Athena Feminine Technologies) couldvoid the user's authority to operate this equipment.This unit was authorized under the FCC Declaration of ConformityProcedure.Responsible Party:Athena Feminine Technologies179 Moraga WayOrinda, CA 94563(925) 254-2121Athena Feminine TechnologiesATHENA PMT-II
ATHENA Pelvic Muscle Trainer™ (PMT)5.This therapy may be appropriate if you:•experience incontinence due to weak pelvic floor muscles.•are willing to comply with the therapy program on a consis-tent basis.•understand how to use the Athena PMT as described in thisinstruction booklet.•are generally in good health.This therapy is not appropriate if you:•have a neurological deficiency that does not permit propersensory perception or stimulation (have areas of numb-ness that might interfere with your feeling thestimulation).•are currently pregnant or attempting to get pregnant.•have a cardiac pacemaker or a history of heart rate orconductive disturbance.•have irregular menstrual cycles.•have urinary or vaginal infections.•have a history of urinary retention, or current symptoms.Your physician will determine if this device is appropriatefor your use.Contraindications (When you should not use the device)Indications for UseThe Athena Pelvic Muscle Trainer is intended to providemyostimulation and neuromuscular reeducation for the pur-pose of rehabilitation of weak pelvic floor muscles for thetreatment of stress, urge and mixed urinary incontinence inwomen.ATHENA Pelvic Muscle Trainer™ (PMT)REFERENCES16.• Berghmans LCM, Hendriks HJM, Bo K et al. (1998). Conservativetreatment of stress urinary incontinence in women: a systematic review ofrandomized clinical trials. Br J Urol, 82:181-191.• Blaivas JG, Appell RA, Fantl JA et al. (1997). Standards of efficacy forevaluation of treatment outcomes in urinary incontinence: recommendations ofthe Urodynamic Society. Neurourol Urodyn, 16(3):145-7• Bo K, Talseth T, Holme I. (1999). Single blind, randomised controlled trial ofpelvic floor exercises, electrical stimulation, vaginal cones, and no treatment inmanagement of genuine stress incontinence. Br Med J, 318:487-493.• Dumoulin C, Seaborne DE, DeGirardi CQ et al. (1995). Pelvic-floorrehabilitation, Part 2: Pelvic-floor reeducation with interferential currents andexercise in the treatment of genuine stress incontinence in postpartumwomen—a cohort study. Phys Ther, 75(12):1075-1081.• Gallo M, Sasso KC. (1997). Key components of patient education for pelvicfloor electrical stimulation in the treatment of urinary incontinence. Urol Nurs,17(1):10-16.• Luber KM, Wolde-Tsadik G. (1997). Efficacy of functional electricalstimulation in treating genuine stress incontinence: a randomized clinical trial.Neurourol Urodyn, 16:543-551.• Sand PK, Richardson DA, Staskin DR et al. (1995). Pelvic floor electricalstimulation in the treatment of genuine stress incontinence: a multicenter,placebo-controlled trial. Am J Obstet Gynecol, 173:72-79.• Siegel SW, Richardson DA, Miller KL et al. (1997). Pelvic floor electricalstimulation for the treatment of urge and mixed urinary incontinence in women.Urology, 50(6):934-940.• Shumaker SA, Wyman JF, Uebersax JS et al. (1994). Health-relatedquality of life measures for women with urinary incontinence: the IncontinenceImpact Questionnaire and the Urogenital Distress Inventory. ContinenceProgram in Women (CPW) Research Group. Qual Life Res, 3(5):291-306.• Stuart N, Elixhauser A. (1998). Review of the Clinical Literature on Pelvicfloor electrical stimulation for Urinary Incontinence. MEDTAP International,Inc.• Yamanishi T, Yasuda K, Sakakibara R et al. (1997). Pelvic floor electricalstimulation in the treatment of stress incontinence: an investigational studyand a placebo controlled double-blind trial. J Urol, 158:2127-2131.
ATHENA Pelvic Muscle Trainer™ (PMT)6.The Athena Pelvic Muscle Trainer™ (PMT) is an intravaginal pelvicfloor exerciser that strengthens the pelvic muscles to aid in thecontrol of urinary incontinence (UI) in women. This is a single-userdevice and should be used by one person only.Description of the Pelvic Muscle Trainer™•The Athena Pelvic Muscle Trainer™ is an intravaginal exerciserconstructed of medical-grade plastic and has one electrode pair.•The probe is not tethered and is controlled through a radio frequency (RF) signal from the wireless controller.•The electrodes are designed to deliver myostimulation to the pelvicfloor muscles to induce Kegel-like contractions.•The exerciser is only reusable by a single person and isergonomically designed.PRODUCT DESCRIPTIONThe Athena Pelvic Muscle Trainer has two parts:1. Wireless Controller with PMT trainer storage cradle2. PMT TrainerATHENA Pelvic Muscle Trainer™ (PMT)15.Contact Athena Customer Support at 1-866-308-4436 or visit us at ourwebsite www.athenaft.comIn the event the purchaser makes any modifications or alterations to theproduct, the foregoing warranties shall be void and of no future force oreffect.WARRANTY AND DISCLAIMERAthena Feminine Technologies warrants the Athena Pelvic MuscleTrainer for a period of one year from the date of purchase to be freefrom defects in workmanship and material and in material compliancewith all published product specifications in effect on the date of ship-ment. During the warranty period, Athena Feminine Technologies shall,at its option, replace any products shown to Athena Feminine Technolo-gies to be defective at no expense to the purchaser. The foregoingremedies shall be the purchaser’s sole and exclusive remedies underthis warranty.BatteriesThe Athena PMT Trainer contains a sealed battery compartment foryour safety. The battery has a life of about two years. When it needs areplacement mail the PMT Trainer to:BATTERY REPLACEMENTAthena Feminine Technologies179 Moraga WayOrinda, CA 94563The Athena PMT Wireless Controller runs on four AAA batteries. Toreplace the batteries, loosen the small screw on the back of remote,remove the cover and replace the batteries.
ATHENA Pelvic Muscle Trainer™ (PMT)7.PMT TrainerEyelet to insert dental floss for easy removalWireless ControllerStop Button(Turns off device)ElectrodesDo not use in water or while bathing.Keep out of the reach of children.Do not use simultaneously with high frequency hospital equip-ment (e.g. diathermy equipment). It may result in burns at thesite of the electrodes and possible damage to the trainer.WarningsFrequencyAdjustmentSwitch(12.5Hz or 50Hz)PMT Trainer StorageCradleSet Level Dial:ATHENA Pelvic Muscle Trainer™ (PMT)PRODUCT SPECIFICATIONSElectrical PropertiesOutput Current: 0-70mAPulse Width: 200uS at 1%Frequency: 12.5Hz and 50 HzPower Source: PMT trainer: One- 3.6 volt lithium batteryWireless controller: Four- AAA batteriesOutput Type: Constant voltage over range of 100 to 1000 OhmsOutput Isolation:>100 meg OhmsSpecificationsComplies with IEC-601-1Mode of Operations: IntermittentEquipment not suitable for use in the presence of a flammable anaestheticmixture with air or oxygen or nitrous oxide.IPX7 rating (protected from dust and liquid ingress)Transportation and StorageAmbient temperature range: -40 degrees C to 70 degrees C.(-40 degrees F to 158 degrees F)Relative Humidity range: 10% to 100% including condensationAtmospheric pressure range: 500hPa to 1060hPa. (7.25 PSI to15.36 PSI)14.EnvironmentalPlease dispose of according to local regulatory standards in your area. ATTENTION TYPE BF EQUIPMENT NON-IONIZED RADIATION
ATHENA Pelvic Muscle Trainer™ (PMT)8.Note: The stimulation should always be at a comfortablelevel. If you feel any discomfort, turn the intensity downslightly until comfortable. It is not necessary or benefi-cial to stimulate at levels higher than are comfortable.Initial TreatmentThe initial treatment with the Athena PMT will be done undermedical supervision. You will then be sent home to use the AthenaPMT on your own for a period of two to 14 weeks. It is veryimportant that you follow the instructions as directed by yourphysician. Much like medication, if you don’t do the treatments,you will not experience improvement.If you miss one or two treatments don’t be alarmed. But if youmiss several in a row, call the physician or clinic for a possiblerevision in your treatment regimen. They will review how far youhave progressed in your treatment regimen and whether there havebeen any changes in your bladder activity to determine what wouldbe best for you.Note: Using the Athena PMT every day, as directed, is like doingexercise on a regular basis. It will produce the best and most rapidresults.INSTRUCTIONS FOR USEATHENA Pelvic Muscle Trainer™ (PMT)13.It is important to establish goals and guidelines with your physician fordetermining success. Frequently a patient’s perception of successdoes not correlate with what is actually happening. By setting reason-able and mutually agreeable goals for “significant improvement,” youwill establish an acceptable measure for success.When used for the recommended sessions, typically most patientssuffering from urge incontinence will see improvement in three to fourweeks. Patients with stress incontinence, or incontinence associatedwith sphincter weakness usually see significant improvement in six toeight weeks. A standard treatment program for pelvic floor stimulationis 12 to 14 weeks.If the problem is not resolved in the treatment period and you continueto show improvement, your physician may recommend that you con-tinue the therapy until there is no further improvement.It is recommended that you continue to use the Athena PMT on aperiodic basis even after the goal is reached. This will ensure thatthe pelvic muscle stays strong and will help to eliminate any furtherproblems.Achieving SuccessAssessing SuccessTo assess treatment success, you might keep a one week voiding diaryprior to treatment and immediately following treatment. You mightalso want to make milestones on your chart, i.e. fewer pads used, dryday, etc.RECOMMENDED TREATMENT PROTOCOLContinuing Success
ATHENA Pelvic Muscle Trainer™ (PMT)9.•The Athena PMT is inserted into the vagina for 15-minutesessions. It is best used when lying down or in a recliningchair.•The device starts to work when you press the ON button.•It will automatically adjust to the level of your previoussession.•If you want to lessen or strengthen the contractions, use thedial on the PMT wireless controller to adjust the strength asappropriate.•The PMT will automatically turn off after a 15-minutesession.• If you need to take the PMT trainer out before the endof the session, use the STOP button. Then remove thePMT trainer.•Wash the PMT trainer with warm water and soap, then dry.•Return the PMT trainer to its spot in the controller cradle.•THE PMT TRAINER MUST BE RETURNED TO THECRADLE TO FUNCTION PROPERLY.•To increase the effectiveness of the contractions, physicallycontract your pelvic muscles when you feel the PMT trainercontraction.Overview of PMT UseATHENA Pelvic Muscle Trainer™ (PMT)12.To receive maximum benefits you should use the Athena PMT as prescribedby your physician. Regular use of the PMT is necessary for improvement tooccur. Take an active part in the treatment and try to be as consistent aspossible. DoneMissedP Menstral CyclePATIENT DIARY/LOG
ATHENA Pelvic Muscle Trainer™ (PMT)10.The PMT trainer should not remain inserted when the unit is not in use. The PMT should not be used while you:•are sleeping.•have anything else in your vagina such as a tampon, dia-phragm or are engaging in sexual intercourse.•are engaging in any activity that could place the PMT incontact with water e.g. swimming, bathing•are driving a motor vehicle.•are having your menstrual period. Discontinue treatments and contact your physician if you:•feel any pain.•notice abnormal vaginal discharge, irritation to the tissues, orvaginal bleeding not associated with your usual menstrualcycle•experience burning when you urinate or other symptomsassociated with a urinary infection.•develop any lesions on your perineum (any bumps or soresappear around the area where you insert the Athena PMT).PrecautionsCLEANING THE PMT1. Wash the PMT trainer prior to initial use and after every use.Use a mild water and soap. Soap that is free of deodorants, fra-grance and dyes is recommended. Do not immerse in water.2. The PMT trainer can be air-dried or wiped off with a lint-freecloth.3. Be sure that the PMT trainer is clean and dry before replacingin the cradle.4. Should the PMT trainer develop an odor, wear out, or becomediscolored, it should be replaced.ATHENA Pelvic Muscle Trainer™ (PMT)11.♦Remove the PMT trainer from the cradle and thread a piece ofdental floss through the eyelet. Tie floss together to form a loop.This loop allows for easy removal.♦Place the PMT trainer back into the cradle (this is important forproper PMT functioning).♦Empty your bladder before beginning a session.♦Find a comfortable place to lie or recline for the 15-minute session.♦Set the switch on the wireless controller to either 12.5Hz or 50Hz,as directed by your physician.♦Remove the PMT trainer from the cradle and insert it like youwould a tampon.♦Lie back and relax. Push the ON button. The PMT will automati-cally slowly adjust to the level set by your physician.♦You will begin to feel a sensation and then small contractions.♦ If you do not feel any contractions within 2 or 3 minutes, gently takethe tip of your finger and reposition the PMT trainer slightly untilyou feel the muscle contracting.♦If you want to change the contraction level, use the dial on thewireless controller. Increase the level slowly to avoid over-stimulat-ing the muscle.♦If at any time during the cycle you need to remove the PMT trainer,press the STOP button and then remove it. .♦After 15 minutes the contractions will stop.♦Use the floss to remove the PMT trainer. You may also removethe trainer by standing up and gently squeezing your pelvic muscle.♦Wash the PMT trainer with warm water and soap. DO NOTIMMERSE IN WATER♦Return the PMT trainer to its proper place in the cradle. IF THEPMT TRAINER IS NOT RETURNED TO THE CRADLE, ITWILL NOT WORK THE NEXT TIME.♦Once replaced in the cradle, it is now ready for your next use.DIRECTIONS FOR HOME USE

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