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

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

Contents

Physician Manual Revised

Athena Pelvic Muscle Trainer™PHYSICIANINSTRUCTIONS 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 3Product Description 4Diagram 5Clinical Information 6Directions for Use 7Initial Fitting and Treatment 8Initial Treatment Checklist 10Recommended Treatment Protocol 11Assessing and Achieving Success 12Cleaning the PMT 13Product Specifications 14Warranty and Disclaimer 15References 16
ATHENA Pelvic Muscle Trainer™ (PMT)INTRODUCTIONThe Athena Pelvic Muscle Trainer™ (PMT) is a vaginal myostimulatorthat induces the pelvic muscles to contract and relax, similar to Kegelexercises. The system consists of a vaginal trainer (PMT trainer) with asealed battery and a wireless controller to adjust the strength of thecontractions while the PMT trainer is in use. The PMT trainer is housedin a cradle in the wireless controller. It is necessary for the patient toreturn the PMT trainer to the cradle in the wireless controller after eachuse in order for the system to function correctly.Studies of other devices over the past 20 years have shown that pelvicfloor myostimulation and neuromuscular reeducation can be up to 60% to90 % effective in reducing or eliminating urinary incontinence. Thismanual provides an overview of pelvic floor stimulation and complete useinstructions for the Athena Pelvic Muscle Trainer (PMT).Pelvic Floor Stimulation is a treatment for incontinence.Pelvic floor stimulation is a simple, low-risk treatment for incontinenceresulting from lax pelvic floor muscles or a hyperactive bladder. Anelectrical current activates sensory nerve fibers that can facilitate orinhibit a sensory-motor response.When used consistently, pelvic floor myostimulation has been clinicallydocumented to have the following prolonged therapeutic effects:1. Strengthening of the pelvic floor muscles.2. Inhibiting the detrusor muscle through reflexive mechanisms.For best results, the Athena Pelvic Muscle Trainer™ should be usedtwice a day. Other regimes may be appropriate for some patients.3.ATHENA Pelvic Muscle Trainer™ (PMT)
ATHENA Pelvic Muscle Trainer™ (PMT)The Athena Pelvic Muscle Trainer™ (PMT) is an intravaginal pelvic floorexerciser that provides myostimulation and neuromuscular reeducationfor the purpose of rehabilitation of weak pelvic floor muscles to aid in thecontrol of urinary incontinence (UI) in women. This is a single-userdevice and should be used by one patient 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 trainer is not tethered and is controlled through a radio frequency (RF) signal from the wireless controller.•The electrodes are designed to deliver current to stimulate the pelvic floor muscles to perform Kegel-like contractions.•The exerciser is reusable and ergonomically designed.PRODUCT DESCRIPTIONThe Athena Pelvic Muscle Trainer has two parts:1. Wireless Remote Control with PMT trainer storage cradle2. PMT Trainer4.ATHENA Pelvic Muscle Trainer™ (PMT)P/D 1700Rev.3/01/04Federal 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) 254-212117.Athena Feminine TechnologiesATHENA PMT-II
ATHENA Pelvic Muscle Trainer™ (PMT)Eyelet to insert dental floss for easy removalWireless ControllerSet Level Dial:Stop ButtonTurns offdeviceElectrodes5.FrequencyAdjustmentSwitch12.5Hz or 50HzON ButtonPMT Trainer Storage CradlePMT TrainerATHENA 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)CLINICAL INFORMATIONThe Athena Pelvic Muscle Trainer is intended to provideelectrical stimulation and neuromuscular reeducation for thepurpose of rehabilitation of weak pelvic floor muscles forthe treatment of stress, urge, and mixed urinary inconti-nence in women.This therapy is not appropriate if a patient:•has a neurological deficiency that does not permit proper sen-sory perception or stimulation.•is currently pregnant or attempting to get pregnant.•has a cardiac pacemaker or a history of heart rate or conduc-tivedisturbance.•has an anatomical vaginal structure that does not permit properand complete placement of the trainer.•has irregular menstrual cycles.•has urinary or vaginal infections, localized lesions, or otherundiagnosed symptoms.•has a history or symptoms of urinary retention.WarningsReview the following warnings with your patient:Do not use in water or while bathing.Keep out of the reach of children.Do not use simultaneously with high-frequency hospitalequipment (e.g. diathermy equipment). It may result in burnsat the site of the electrodes and possible damage to the trainer.Indications for UseContraindications6.ATHENA Pelvic Muscle Trainer™ (PMT)Contact Athena Customer Support at 1-866-308-4436 or visit us online atwww.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 shipment.During the warranty period, Athena Feminine Technologies shall, at itsoption, replace any products shown to Athena Feminine Technologies tobe defective at no expense to the purchaser. The foregoing remediesshall be the purchaser’s sole and exclusive remedies under this warranty.15.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 PMTTrainer 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)DIRECTIONS FOR USEPrecautionsReview the following precautions with your patient:1. The PMT trainer should not remain inserted when the unit is not inuse.2. The PMT should not be used while patient:•is sleeping.•has anything else in her vagina such as a tampon, diaphragmor is engaging in sexual intercourse.•is engaging in any activity that could place the PMT incontact with water (e.g. swimming, bathing).•is driving a motor vehicle.•is having her menstrual period.3. The patient should discontinue treatments and contact physician ifpatient:•feels any pain .•notices abnormal vaginal discharge, irritation to the tissues,or vaginal bleeding not associated with the usual menstrualcycle.•experiences burning when she urinate or other symptomsassociated with a urinary infection.•develops any lesions on her perineum .7.For Best ResultsFor best results, the patient should use the PMT twice a day during thetreatment period. If this is not possible, the stimulation can still beeffective, but improvement may take longer.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) Initial Fitting and Treatment1. Instruct the patient to clean the exerciser per “Cleaningthe PMT” instructions ( page 13) prior to initial place-ment.2. The patient should be placed in standard lithotomy position.3. If the patient does not have sufficient lubrication of herown, apply water or a water-based lubricant such as K-YJelly to the PMT trainer. Do not use a petroleum-basedproduct as it will have a deleterious effect on the exerciserand will limit the flow of stimulating current.4. Remove the PMT trainer from the cradle and show thepatient how to thread a piece of dental floss through theeyelet in the PMT trainer. The patient should tie the flossto create a loop. This will allow for easy removal.5. Instruct the patient to set switch to either12.5Hz (urge) or50 Hz (stress) incontinence.8.(For mixed incontinence,vary the level by session)6. SHOW THE PATIENT HOW TO PLACE THE UNIT BACKINTO THE CRADLE. The PMT trainer is controlledthrough a magnet in the cradle. Putting it back into thecradle will set the unit to the start position.ATHENA Pelvic Muscle Trainer™ (PMT)CLEANING THE PMTReview the cleaning instructions with the patient:1. Wash the PMT trainer prior to initial use and after every use. Usewater and a mild soap. Soap that is free of deodorants, fragranceand 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 replacing inthe cradle.4. Should the PMT trainer develop an odor, wear out, or becomediscolored, it should be replaced.•The Athena PMT is most effective when used twice every day.•If the contractions seem to stop during a session, the patientshould gently use her fingertip to reposition the PMT trainer.Notes on Use13.
ATHENA Pelvic Muscle Trainer™ (PMT)7. Remove the PMT trainer from the cradle. Insert the PMTtrainer into the patient‘s vagina until it meets resistance fromthe cervix or cul-de-sac. Make sure the dial is initially set to 0.8. When the correct position is reached, press the ON button tostart the session. Slowly rotate the dial to increase the strengthof the stimulation until it is comfortable for the patient. Futuresessions will automatically go to the setting last used by thepatient.9. The patient should be asked to contract her pelvic musclestightly in order to prevent the PMT trainer from being easilyremoved from the vagina. Concurrently, you should requestthe patient to place her finger(s) on the end tip of the PMTtrainer and gently move or rotate until she feels a muscle con-traction. In most cases, she will feel a slight pushing forwardon the PMT trainer. If no contraction is felt and the exerciseris easily dislocated, perform a pelvic exam in order to locatethe appropriate muscles; once identified, position the exerciser.10. If the patient has difficulty holding the exerciser within thevagina, treatment should be prescribed for a supine position.11. Have the patient practice inserting the PMT trainer on her ownto make sure she does it correctly.Note: The stimulation should always be at a comfortable level. Ifthe patient expresses discomfort, turn the intensity down slightlyuntil comfortable. It is not necessary or beneficial to stimulateat levels higher than those determined above.9.ATHENA Pelvic Muscle Trainer™ (PMT)It is important to establish goals and guidelines for determining successwith the patient. Frequently a patient’s perception of success does notcorrelate with objective findings. By setting reasonable and mutuallyagreeable goals for “significant improvement,” you will establish anacceptable measure for success.When used for the recommended twice-daily, 15-minute sessions,typically most patients suffering from urge incontinence will seeimprovement in three to four weeks. Patients with stress incontinence,or incontinence associated with sphincter weakness, usually seesignificant improvement in six to eight weeks. A standard treatmentprogram for pelvic floor stimulation is 12 to14 weeks.If the problem is not resolved in the treatment period and the patientcontinues to show improvement, continue the therapy twice a day untilthere is no further improvement.Achieving Success12.To assess treatment success, we recommend that the patient keep aone week voiding diary prior to treatment and immediately followingtreatment. We also recommend a follow-up visit at week two oftreatment to verify compliance and to address any concerns. You maywish to have the patient complete a voiding diary midway throughtreatment and evaluate progress with a patient visit between weeks sixand eight of treatment.Assessing SuccessIt is recommended that patients continue to use the Athena PMT on aperiodic basis even after the goal is reached. This will ensure that thepelvic muscles stay strong and will help to eliminate any furtherproblems.
ATHENA Pelvic Muscle Trainer™ (PMT)INITIAL TREATMENT CHECKLIST1. Show patient how to clean PMT trainer.2. Show patient how to insert floss for PMT trainer removal string.3. Set the controller to either 12.5Hz or 50Hz and the dial to 0. Return the PMTtrainer to cradle.4. Have the patient lie down.5. If needed, use vaginal lubricant to allow for easier insertion.6. Remove the PMTtrainer from the cradle and insert it into the vagina.7. When the PMT trainer is in the right position, push the ON button and thesession will begin.8. Slowly increase the intensity dial until the patient feels a comfortable sensa-tion. Once the level is set it will automatically increase to that level in futuresessions. Therefore, the patient will not have to set the level each time it isused.9. The PMT will begin to stimulate with an on/off cycle of 2.5 seconds on and2.5 seconds off, thus inducing pelvic muscle contractions.10. If necessary, further adjust the level to meet the patient’s needs. More sensi-tive patients may need a lower setting. Older patients may require a muchhigher setting.11. The Athena PMTtrainer will automatically shut off after 15 minutes of use. Ifa shorter treatment is desired, the PMT may be turned off at any time bypressing the STOP button on the wireless controller.12. Remove the PMT trainer. Clean as per the “Cleaning the Athena PMT”instructions (page 13).13. After the PMT trainer is dry, store the probe in the storage cradle on thewireless controller.10.ATHENA Pelvic Muscle Trainer™ (PMT)RECOMMENDED TREATMENT PROTOCOLYou may prefer to prescribe the use of 12.5 Hz for patients with urge inconti-nence, as some studies support the use of lower frequency for optimal inhibitionof bladder contractions. Similarly, you may prefer to prescribe 50 Hz for patientswith pure stress incontinence. Patients with mixed incontinence can alternatebetween the two channels from session to session. ( For example, 12.5 Hz in themorning and 50 Hz in the evening.)To receive maximum benefits, most patients should use the Athena PMT for 15minutes, twice a day. Regular use of the PMT is necessary for improvement tooccur. Encourage the patient to take an active part in the treatment and to try tobe as consistent as possible in use.When used consistently, patients with urge incontinence should show improve-ment in three to four weeks. Those with stress incontinence should showimprovement in 12 to 14 weeks.The following chart is also provided in the patient instructions. It may help thepatient towards the consistency needed for improvement. There are spaces onthe patient’s page to write the goal of treatment, as well as any special instruc-tions that you might have.11. Done MissedP Menstrual Cycle

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