RMLE03946001Remote Control for Medical Device

Athena Pelvic Muscle Trainer ™ PATIENT INSTRUCTIONS FOR USE CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician ATHENA Pelvic Muscle Trainer ™ (PMT) Athena Pelvic Muscle Trainer ™ Table of Contents CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. 2. Introduction 3 Pelvic Muscle Stimulation 4 Indications for Use 5 Product Description 6 Instructions for UseDiagram/ Warnings 7 Initial Treatment 8 Overview of PMT Use 9 Precautions 10 Cleaning the PMT 10 Directions for Home Use 11 PATIENT DIARY/LOG 12 Recommended Treatment Protocol 13 Product Specifications 14 Warranty and Disclaimer 15 References 16 ATHENA Pelvic Muscle Trainer ™ (PMT) The Athena Pelvic Muscle Trainer ™ (PMT) is a mild electrical vaginal stimulator 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 Occurs INTRODUCTION 3. 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 Stimulation Many 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.3/01/04 17. Federal Communications Commision (FCC) Compliance Notices: Pelvic Muscle Trainer (Wireless Control Unit)FCC ID: RMLE03946001 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 Certification Procedure Pelvic 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) 254-2121 Athena 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 appropriate for your use. Contraindications (When you should not use the device)Indications for Use The 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) REFERENCES 16. • Berghmans LCM, Hendriks HJM, Bo K et al. (1998) . Conservative treatment of stress urinary incontinence in women: a systematic review ofrandomized clinical trials. Br J Urol , 82:181-191. • Blaivas J…

Text truncated - open the document above for the full version.

Athena Pelvic Muscle Trainer ™ PHYSICIAN INSTRUCTIONS FOR USE CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician ATHENA Pelvic Muscle Trainer ™ (PMT) Athena Pelvic Muscle Trainer ™ Table of Contents CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. 2. Introduction 3 Product Description 4 Diagram 5 Clinical Information 6 Directions for Use 7 Initial Fitting and Treatment 8 Initial Treatment Checklist 10 Recommended Treatment Protocol 11 Assessing and Achieving Success 12 Cleaning the PMT 13 Product Specifications 14 Warranty and Disclaimer 15 References 16 ATHENA Pelvic Muscle Trainer ™ (PMT) INTRODUCTION The Athena Pelvic Muscle Trainer ™ (PMT) is a vaginal myostimulator that 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% to 90 % 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 clinically documented 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 used twice 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 floor exerciser 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 exerciser constructed 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 DESCRIPTION The Athena Pelvic Muscle Trainer has two parts:1. Wireless Remote Control with PMT trainer storage cradle 2. PMT Trainer 4. ATHENA Pelvic Muscle Trainer ™ (PMT) P/D 1700Rev.3/01/04 Federal Communications Commision (FCC) Compliance Notices: Pelvic Muscle Trainer (Wireless Control Unit)FCC ID: RMLE03946001 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 Certification Procedure Pelvic 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) 254-2121 17. Athena Feminine TechnologiesATHENA PMT-II ATHENA Pelvic Muscle Trainer ™ (PMT) Eyelet to insert dental floss for easy removal Wireless ControllerSet Level Dial: Stop ButtonTurns offdevice Electrodes 5. FrequencyAdjustmentSwitch12.5Hz or 50Hz ON Button PMT Trainer Storage Cradle PMT T rainer ATHENA Pelvic Muscle Trainer ™ (PMT) REFERENCES 16. • Berghmans LCM, Hendriks HJM, Bo K et al. (1998) . Conservative treatment 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 for evaluation 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 of pelvic 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-floor rehabilitation, 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 pelvic floor electrical st…

Text truncated - open the document above for the full version.

Dear Tim, Thank you for the comments. This is a partial reply to the comments and questions that you raised on the Athena Feminine Technologies Wireless Control Unit (i.e. Remote), and on the Athena Trainer Unit (i.e. Probe) in your letter dated 11 February 2004 for FCC ID: RMLE03946001. Your comments/questions are listed below, followed by our responses. Question 1: 1) Photographs were provided for both the probe and remote. Note that the application being reviewed will only cover the remote TX portion of the system. Various items provide specific to the probe (Internal photographs, schematics, etc) are not being reviewed. Assuming the probe is strictly a RX, the probe should be approved as a RX under a separate DoC or Certification application as desired by the manufacturer. Answer 1: We thought that it was clear from the text of Section 1.2 and Annex A of the Test Report that the Probe (which is a receive-only device) is being approved by Acme Testing Co. under the DoC Procedure. The DoC Procedure information on the Probe was provided to you in the Test Report because it is FCC Policy that a standalone TX cannot be approved unless there is an accompanying Test Report for the Receiver that is to be used with the TX. Please note that we do NOT wish for the Probe to be submitted for Certification Procedure Approval by ATCB. Question 2: 2) It appears that a DoC is being applied as for the probe as a RX. However, the manual does not include the appropriate DoC information per 2.1077. See below: COMPLIANCE INFORMATION FOR DoC AUTHORIZATIONS (47CFR 2.1077) If a product is tested and authorized under a Declaration of Conformity, a compliance information statement shall be supplied with the product at the time of marketing or importation, containing the following information on a single page (in the users manual or as a separate sheet): (1) Identification of the product, i.e. name and model number. (2) A statement similar to that contained in Section 15.19(a)(3) that the product complies with Part 15 of the regulations. (3) The identification, by name, address and telephone number, of the responsible party. The responsible party is defined as either the manufacturer, or if the equipment is imported, the importer. The responsible party for a Declaration of Conformity must be located within the United States. To: "Timothy R. Johnson" <[email protected]> Subject: RE: Review of Athena Feminine Technologies, Inc., FCC ID: RMLE03946001 Page 1 of 4In 2/24/2004Printed for "Timothy R. Johnson" <[email protected]> Answer 2: The probe is indeed is going for a DoC Procedure approval by Acme Testing Co. We will contact the manufacturer to have the manual corrected to include the information required in Section 2.1077 and Section 15.19(a)(3). Question 3: 3) Please confirm if the remote is a transmitter or a transceiver. Answer 3: The "remote" (formally called the Wireless Control Unit) is a Transmitter. It is not a Transceiver. (Please see Section 4.1 of the Test Report, which states this clearly). Question 4: 4) Please provide external photographs of the back of the remote. Answer 4: Acme Testing will take new photos, and will upload them soon. Question 5: 5) Please provide a clearer/closer photograph of the top of the main board in the remote. Answer 5: Acme Testing will take new photos, and will upload them soon. Question 6: 6) Please note that a detailed technical operational description referenced in the confidentiality request letter does not appear to have been provided. The product brochure provided is not confidential information, therefore confidentiality can not be granted on this item. Is there another file provided that confidentiality was referencing? If not, please remove the request for confidentiality from the request letter. Answer 6: The Detailed (2-page) Technical Operational Description will be uploaded. (We apologize for this omission). Question 7: 7) The label provided shows "FCC ID: E03946001". However, from the 731 form, it is expected that the label would state "FCC ID: RMLE03946001". Please review and correct as necessary. Answer 7: The manufacturer will be contacted for the label revisions. The revised label artwork will be uploaded as soon as it is available. Question 8: 8) Please justify the use of the DoC labeling information (FCC Logo and associated text) on the remote. This labeling is reserved for particular Page 2 of 4In 2/24/2004Printed for "Timothy R. Johnson" <[email protected]> approvals that do not appear to apply to this device (PC Peripheral, Stand alone RX, etc.). Answer 8: It has been decided by the manufacturer that the placing the DoC labeling applicable to for a standalone RX on the Probe would be impossible, because the probe is inserted into a body cavity, and Mylar type labels would be destroyed during use and subsequent cleaning. Metal and/or molded-in labeling would create rough surfaces which could cause internal damage to the user. Consequently, it was decided to place the labeling for the Probe on the Remote. That said, after reviewing the label again it is clear that some words should be added to the label to clarify that the FCC ID applies to the Wireless Remote Transmitter and that the FCC logo and 15.19(a)(3) text applies to the Trainer (i.e. the Probe). The manufacturer will be advised to modify the label accordingly. Please note if this approach is NOT acceptable, we need to be notified immediately because label artwork is both expensive and a long-lead item. Question 9: 9) The label should include the 2 part statement specified in 15.19 (a)(3). Please correct. Answer 9: Please see answer to question 8. Question 10: 10) Please correct the spelling to the word "modifications" given in the FCC statements in the users manual on page 14. Answer 10: The manufacturer will contacted to correct this. We will upload the revised manual as soon as it is available. Question 11: 11) Please confirm that all testing was performed with "fresh…

Text truncated - open the document above for the full version.

American Telecommunications Certification Body Inc. 6731 Whittier Ave, McLean, VA 22101 February 11, 2004 RE: Athena Feminine Technologies FCC ID: RMLE03946001 I have a few comments on the above referenced Application. 1) Photographs were provided for both the probe and remote. Note that the application being reviewed will only cover the remote TX portion of the system. Various items provide specific to the probe (Internal photographs, schematics, etc) are not being reviewed. Assuming the probe is strictly a RX, the probe should be approved as a RX under a separate DoC or Certification application as desired by the manufacturer. 2) It appears that a DoC is being applied as for the probe as a RX. However, the manual does not include the appropriate DoC information per 2.1077. See below: COMPLIANCE INFORMATION FOR DoC AUTHORIZATIONS (47CFR 2.1077) If a product is tested and authorized under a Declaration of Conformity, a compliance information statement shall be supplied with the product at the time of marketing or importation, containing the following information on a single page (in the users manual or as a separate sheet): (1) Identification of the product, i.e. name and model number. (2) A statement similar to that contained in Section 15.19(a)(3) that the product complies with Part 15 of the regulations. (3) The identification, by name, address and telephone number, of the responsible party. The responsible party is defined as either the manufacturer, or if the equipment is imported, the importer. The responsible party for a Declaration of Conformity must be located within the United States. 3) Please confirm if the remote is a transmitter or a transceiver. 4) Please provide external photographs of the back of the remote. 5) Please provide a clearer/closer photograph of the top of the main board in the remote. 6) Please note that a detailed technical operational description referenced in the confidentiality request letter does not appear to have been provided. The product brochure provided is not confidential information, therefore confidentiality can not be granted on this item. Is there another file provided that confidentiality was referencing? If not, please remove the request for confidentiality from the request letter. 7) The label provided shows "FCC ID: E03946001". However, from the 731 form, it is expected that the label would state "FCC ID: RMLE03946001". Please review and correct as necessary. 8) Please justify the use of the DoC labeling information (FCC Logo and associated text) on the remote. This labeling is reserved for particular approvals that do not appear to apply to this device (PC Peripheral, Stand alone RX, etc.). 9) The label should include the 2 part statement specified in 15.19 (a)(3). Please correct. 10) Please correct the spelling to the word "modifications" given in the FCC statements in the users manual on page 14. 11) Please confirm that all testing was performed with "fresh/brand new" batteries during the testing. --- Continued on Next Page --- z Page 2February 11, 2004 12) Please explain the use of the 15.209 limit to the 868 MHz reading. It appears only the 15.231 limit should be applied to this. Timothy R. Johnson Examining Engineer mailto: [email protected] The items indicated above must be submitted before processing can continue on the above referenced application. Failure to provide the requested information may result in application termination. Correspondence should be considered part of the permanent submission and may be viewed from the Internet after a Grant of Equipment Authorization is issued. Please do not respond to this correspondence using the email reply button. In order for your response to be processed expeditiously, you must submit your documents through the AmericanTCB.com website. Also, please note that partial responses increase processing time and should not be submitted. Any questions about the content of this correspondence should be directed to the sender.

American Telecommunications Certification Body Inc. 6731 Whittier Ave, McLean, VA 22101 February 24, 2004 RE: Athena Feminine Technologies FCC ID: RMLE03946001 I have a few comments on the above referenced Application. 1) Please provide an updated users manual that includes the DoC information previously mentioned in comment 2. 2) Please provide a clearer/closer photograph of the top of the main board in the remote (main component side). 3) The operational description provided does not necessarily appear to the be the detailed technical operational description referenced in the confidentiality request letter but simply a portion of the users instructions. The operational description recent uploaded does not appear to contain any confidential information and therefore confidentiality can not be granted on this item. Is there another file provided that confidentiality was referencing? If so, please provide or alternatively please remove the request for confidentiality from the request letter. 4) The label provided shows "FCC ID: E03946001". However, from the 731 form, it is expected that the label would state "FCC ID: RMLE03946001". Please provide an updated label as referenced in your previous response. 5) The TX label (not RX label as referenced in the response) should include the 2 part statement specified in 15.19 (a)(3). Please provide a corrected copy as referenced in your response. 6) Please provide a corrected users manual that corrects the spelling to the word "modifications" given on page 14. 7) The proposed labeling appears to be a good idea, but is not consistent with past FCC interpretations (such as devices that are swallowed) which have stipulated that the FCC information be placed in the manual and product packaging. To be consistent with this, it is recommended that for the receiver the FCC logo and 2 phrases ("Tested to Comply...." and "For Home or Office Use") be placed in the users manual and packaging. See attached interpretation. Note that the interpretation is for a Certification, however the same subsection relating to this issue appears for both Certifications and DoC's (15.19(a)(5) and 15.19(b)(3)). While the proposed labeling seems viable, it would be best to obtain a response from the FCC regarding this issue prior to implementing. Please let us know how you wish to proceed with this issue. Timothy R. Johnson Examining Engineer mailto: [email protected] The items indicated above must be submitted before processing can continue on the above referenced application. Failure to provide the requested information may result in application termination. Correspondence should be considered part of the permanent submission and may be viewed from the Internet after a Grant of Equipment Authorization is issued. Please do not respond to this correspondence using the email reply button. In order for your response to be processed expeditiously, you must submit your documents through the AmericanTCB.com website. Also, please note that partial responses increase processing time and should not be submitted. Any questions about the content of this correspondence should be directed to the sender.

Hannah, I received a call from Harry regarding the email below that was sent earlier. Based on the size of the device, placing of the 2 part statement in the users manual should be sufficient. I was under the impression that the device was larger. Additionally, we expect to receive the remaining information for review (manual) shortly. Thank You, Tim Date: Wed, 03 Mar 2004 14:34:17 -0500 To: (Acme) Hannah Rood From: "Timothy R. Johnson" <[email protected]> Subject: Fwd: MESSAGE attached to RMLE03946001_ATCB000915 by acmetest Hannah, Review of the FCC Label FCC ID now looks good....... The 2 part statement referenced in our last set of comments, item #5 does not appear on the label. Note that if the device is larger than the palm of your hand, this is expected to be on the label. If the device is smaller that the palm of your hand, then the statements may be placed in the manual. It is also assumed that the DoC information previously discussed will be placed in the manual/box since this information was not present. Please let us know when you expect to address the last remaining items 5-7? Thank You, Tim Date: Tue, 2 Mar 2004 4:57:59 PM, -0500 From: [email protected] <[email protected]> To: <[email protected]> Cc: <[email protected]>, <[email protected]> Subject: MESSAGE attached to RMLE03946001_ATCB000915 by acmetest X-OriginalArrivalTime: 02 Mar 2004 21:57:59.0937 (UTC) FILETIME= [6D758710:01C400A1] To: (Acme) Hannah Rood Subject: Fwd: MESSAGE attached to RMLE03946001_ATCB000915 by acmetest 3/8/2004file://C:\DOCUME~1\TIMOTH~1.JOH\LOCALS~1\Temp\eud18F.htm From: Hannah Rood (acmetest) Tim, Please review and approve the label that was just uploaded. Hannah Timothy R. Johnson, NARTE Certified EMC Engineer (No. EMC-002205-NE) Examining Engineer American TCB, Inc. 6731 Whittier Ave. McLean, VA 22101 email: [email protected] alternate email: [email protected] direct number: 404-414-8071 corporate phone: 703-847-4700 corporate fax: 703-847-6888 Timothy R. Johnson, NARTE Certified EMC Engineer (No. EMC-002205-NE) Examining Engineer American TCB, Inc. 6731 Whittier Ave. McLean, VA 22101 email: [email protected] alternate email: [email protected] direct number: 404-414-8071 corporate phone: 703-847-4700 corporate fax: 703-847-6888 3/8/2004file://C:\DOCUME~1\TIMOTH~1.JOH\LOCALS~1\Temp\eud18F.htm













  
 

INTERNAL PICTURES FOR REMOTE CONTROL

One in three women in the U.S., and an estimated 200 million women worldwide suffer from the debilitating and often rarely discussed problem of urinary incontinence. Most women are reticent to discuss their own urinary incontinence, and many women incorrectly believe that there is nothing that can be done to alleviate or correct this problem. The new, patented Athena PMT TM is a discreet, easy to use, and effective way to treat urge and stress incontinence in women. THE WIRELESS ATHENA PMT TM SOLUTION Perfect Kegels Every Time! The Wireless Control •Dual mode operation for urge incontinence (12.5Hz) and stress incontinence (50Hz) •Patient-adjustable intensity •15-minute preset cycles and automatic shutoff •Memory function (eliminates need to set level each time) The PMT gently stimulates the pelvic muscles to contract (performing kegel exercises) properly and effectively every time. The PMT, used for 15 minutes twice a day, results in increasing continence. The PMT works to: •Strengthen the pelvic floor muscles •Inhibit the detrusor muscle through reflexive mechanisms •Stimulate nerves and increase blood flow to enhance vaginal sensation April 15, 2002 Patient: 67-year-old female Incontinence history: Stress incontinence since youth Medical history: Hysterectomy, kidney transplant Previous treatments: Medication, absorbent pads Athena PMT TM treatment: Twice daily Result: Patient is now continent! Case Study URINARY INCONTINENCE The Athena PMT TM has many advantages over voluntary kegel exercises. It is simple to use and it works! The new, patented Athena Pelvic Muscle Trainer TM (PMT) is a simple, elegant, and effective solution for the debilitating problems associated with the weakening of the pelvic floor muscles. Never before has any pelvic floor exerciser been able to provide this level of superior performance in combination with the convenience and portability of a cordless design. The PMT is comfortable, easy to use, affordable and enables women to perform kegels correctly, anytime and anywhere. •FDA APPROVED •BY PRESCRIPTION ONLY •MEDICARE REIMBURSABLE “I think the new wireless Athena pelvic floor trainer gives today’s active women the freedom that they demand, and as such it has enormous potential for impacting our patients’ quality of life.” S. Abbas Shobeiri M.D. Director, The Female Pelvic & Bladder Health Clinic Center for Research in Women’s H…

Text truncated - open the document above for the full version.