VED® User Manual
Contents
1. 17 PROBLEM SOLVING Problem No Erection Partial Erection Rapid Loss of Erection in less than 5 minutes Delayed Loss of Erection after 5 to 10 minutes Pulling of the Skin on the Scrotum Discomfort or Pain During Pumping Discomfort or Pain from Constriction Ring Discomfort or Pain During Intercourse Discomfort or Pain During Ejaculation Burning Sensation Irritation or Bruising Penis Feels Cold to you or your partner Penis Pivots at its Base 18 Likely Cause No vacuum due to air leak caused by a poor seal inadequate lubrication or excessive pubic hair Incorrect cylinder size incorrect sizing insert not enough practice sessions Vacuum lost because of air leak from faulty equipment poor seal inadequate lu brication or excessive pubic hair Insufficient tension from constriction rings Lubricant on scrotum improper pumping technique inexperience with system cylinder opening too large cylinder not positioned properly against underside of the penis Too rapid pumping Pulling scrotal tissue Constriction ring too small User anxiety Inadequate lubrication Pressure on a sensitive area Long period of abstinence Infection or inflammation of the prostate gland Too rapid pumping or over pumping Constriction of blood flow to penis lubrication Constriction of blood flow to penis PROBLEM SOLVING continued If you need assistance call customer service at 817 473 742. Continue use of the VED If painor Problem usually resolves as you continue to discomfort persists consult a physician use the VED If pain or discomfort persists consult a physician Slower pumping fewer pumps Consult a physician if this problem persists past the first few practice sessions Wash off lubricant or warm the lubricant Partners can use a water soluble warming before use lubricant for added benefit Call our office for suggestions If manageable apply the device after you have a partial erection 19 WARRANTY AND RETURNS One Year Limited Warranty for Over the Counter VED Firma Medical guarantees the VED CLASSIC ULTRA from mechanical failure resulting from defective parts and or workmanship for one year from the date of purchase The warranty includes the major components of the product VED CLASSIC ULTRA vacuum pump and cylinder Should any of the components listed fail to function properly return the damaged part s and Firma will replace the part s free ofcharge The following restrictions apply Items such as the SofTouch Constriction Seal Constriction Rings VED Personal Lubricant and batteries are not included in this warranty The warranty does not cover damage due to improper handling cleaning or misuse of the product or failure to follow the instructions in the Directions for Use Products tampered with or altered in any way are not covered in the warranty This wa
3. 1 When using the VED ULTRA AXIS Battery Powered Vacuum Pump insert the battery powered vacuum pump into the wide end of the cylinder 2 Make sure it 1s seated firmly to prevent air leakage Now the VED ULTRA AXIS is ready to be used to achieve an erection When beginning it is best to use the VEDO while in a standing position 3 After coating the inside of the cylinder and your penis with lubricant insert the penis into the cylinder so that it is lying along the bottom Lubrication helps obtain the seal necessary to create a vacuum and allows the penis to slide easily inside the cylinder Use only water based lubricant 4 Position the cylinder over the penis and place it firmly against the body to begin In order to get an air tight seal do not allow air to enter the end of the cylinder pressed against your body 5 Hold the cylinder in place and begin the pumping action by depressing the gray switch on the top of the pump The pump will stop automatically when no pressure is applied to the switch 6 Operate the pump slowly Press down the switch and slowly count for 3 5 seconds Next let up on the button the motor will stop and again count for 3 5 seconds It is this procedure that draws blood from your body filling your penis creating an erection Repeat DO NOT RUSH THIS PART OF THE PROCEDURE 7 As blood is drawn into the penis a stretching sensation will be felt as the penis enlarges Discomfort can be expected during th
4. and rented or sold from beneficiaries 16 A supplier must disclose these supplier standards to each beneficiary to whom it supplies a Medicare covered item 17 A supplier must disclose to the government any person having ownership finan cial or control interest in the supplier 18 A supplier must not convey or reassign a supplier number i e the supplier may not sell or allow another entity to use its Medicare Supplier Billing Number 19 A supplier must have a complaint resolution protocol established to address ben eficiary complaints that relate to these standards A record of these complaints must be maintained at the physical facility 20 Complaint records must include the name address telephone number and health insurance claim number of the beneficiary a summary of the complaint and any ac tions taken to resolve it 2 A supplier must agree to furnish CMS any information required by the Medicare statute and implementing regulations PATIENT RIGHTS AND RESPONSIBILITIES As a client patient of Firma Medical you may exercise the following rights regardless of age gender economic status race color national origin religion ethnicity disability educational background marital status sexual orientation or source of payment for care These rights also apply to the person who has legal responsibility for decisions concerning your care if you are unable to make decisions yourself I The Right to information You have
5. fax or by letter a resolution will be made as quickly as the concern requires but no more than 14 calendar days after the receipt of the grievance IMPORTANT CONTACT INFORMATION Our Organization Firma Medical LP 99 Regency Pkwy Ste 203 Mansfield TX 76063 Toll Free 800 771 9263 Direct 817 473 7473 Fax 817 473 9639 www firmamedical com Accreditation Company The Compliance Team INC P O Box 160 905 Sheble Ln Ste 102 Spring House PA 19477 Toll Free Complaint Line 888 291 5353 Phone 215 654 9110 20 State Agency Office for Civil Rights U S DHHS 1301 Young St Ste 1169 Dallas TX 75202 Phone 214 767 4056 www hhs gov ocr discrimhowtofile pdf Federal Agencies Office of Inspector General Dept of Health amp Human Services Attn Hotline 330 Independence Ave SW Washington DC 20201 Toll Free 800 447 8477 Fax 800 223 8164 Email HHSTips oig hhs gov Medicare 1 800 MEDICARE www cms hhs gov CMS MEDICARE DMEPOS SUPPLIER STANDARDS Note This list is an abbreviated version of the application certification standards that every Medicare DMEPOS supplier must meet in order to obtain and retain their billing privileges These standards in their entirety are listed in 42 C F R pt 424 sec 424 577 c and were effective on December 11 2000 1 A supplier must be in compliance with all applicable Federal and State licensure and regulatory requirements 2 A supplier must provide complete and
6. in a local directory or a toll free number available through directory assis tance The exclusive use of a beeper answering machine or cell phone is prohibited 10 A supplier must have comprehensive liability insurance in the amount of at least 300 000 that covers both the supplier s place of business and all customers and employees of the supplier If the supplier manufactures its own items this insur ance must also cover product liability and completed operations Failure to maintain required insurance at all times will result in revocation of the supplier s billing privileges retroactive to the date the insurance lapsed 11 A supplier must agree not to initiate telephone contact with beneficiaries with a few exceptions allowed This standard prohibits suppliers from calling beneficiaries in order to solicit new business 12 A supplier is responsible for delivery and must instruct beneficiaries on use of Medicare covered items and maintain proof of delivery 13 A supplier must answer questions and respond to complaints of beneficiaries and maintain documentation of such contacts 14 A supplier must maintain and replace at no charge or repair directly or through a service contract with another company Medicare covered items it has rented to beneficiaries 15 A supplier must accept returns of substandard less than full quality for the par ticular item or unsuitable items inappropriate for the beneficiary at the time it was fitted
7. the right to receive accurate and easily understood information con cerning our product and service to include the to charges out of pocket cost and possible third party payment II The Right to Choose You have the right to a choice of medical equipment providers and healthcare providers that are sufficient to provide you with access to appropriate high quality health care III Access to Emergency Services You have the right to access emergency health services when and where the need arises IV Participation in Treatment Decisions You have the right to know all your treatment options and to participate in decisions about your care You have the right to refuse service care after the consequences of refusing are fully presented V Service without Discrimination You have the right to be treated with respect consideration and recognition of dignity and individuality VI The Right to Privacy You have the right to talk in confidence with Firma Medical s identifiable representatives and to have your private health care information protected You have the right to be advised of our policies regarding the disclosure of clinical records VII Complaints and Appeals You have the right to voice grievances complaints regarding the service product and to have a fast fair and objective review of any complaint you have against Firma Medical Just as Firma Medical has responsibilities to its staff and clientele so too does the patient have responsi
8. with an alcohol solution Never put components in a microwave REPLACEMENT PARTS There are three ways to order replacement parts and accessories 1 Mail or fax the enclosed order form to Firma Medical 2 Call our Customer Service at 1 800 771 9263 3 Visit our online store at www firmamedical com coming soon 14 CONIRAINDICATIONS Do not use VED CLASSIC ULTRA if 1 You are under the influence of alcohol or drugs 2 You experience persistent pain in the penis 3 There are sores or ulcers on the penis 4 There are black or blue areas ecchymosis on the penis 5 There 1s any unusual swelling of the penis Medical conditions that may affect use of VED CLASSIC ULTRA ar 1 History of sickle cell trait or other bleeding disorders History of priapism prolonged erection Coagulation defects Tumors of the penis Removed penile implant Physical conditions that make sexual intercourse inadvisable QS a a Consult a physician if you have questions regarding your medical history and how it may affect your use of the VED External penile rigidity devices are over the counter OTC devices however they are often used in consultation with a physician Manufac turers may elect to restrict distribution of their devices through professional channels and healthcare providers may actually prescribe these devices to patients External penile rigidity devices used in consultation with a physician rely on the medical exper
9. 73 or 800 771 9263 Remedy Comments Use more lubricant apply firm pressure Problem is most often associated with in to the body Trim pubic hair Check the experience it resolves as you become more VED CLASSIC ULTRA for air leaks adept at using the device Mare nractice ueinothe VENe Problem most often improves with gt More practice using the VED t mn T y pe a Ape ker l CLASSIC ULTR ATM rige inued use ot the VED CLASSIC UL Same as No Erection Also use sizing Requires that you experiment with varying insert Use smaller constriction ring or use sizes of constriction rings See a physician multiple rings Transfer constriction ring if you need help or support to persevere very carefully Trim pubic hair Use smaller constriction ring or a Call Firma Medical to order constriction combination of constriction rings and SofT rings in more sizes Rings are offered in Ouch TM sizes 3 through 10 Remove lubricant from the scrotum Problem may disappear as you become Use sizing insert Use double pump more adept at using the VED procedure as noted in the instructions An CLASSIC ULTRA gle cylinder downward during pumping Continue practice sessions Slower pumping Angle cylinder Problem usually resolves as you become downward during pumping more adept at using the VED Use larger constriction ring Problem usually resolves as you continue to _ use the device Apply more lubrication Change positions
10. _ FIRMA MEDICAL TABLE OF CONTENTS Biel or Gio elec Tp 1 Product Descriptions VED 2 Intended Use and Indications acccssconaaceseecernemarnae 4 The Instructional DVD 5 Directions for Use Ultra Axis sss 6 Directions for Use Classic queste sssntoo suite tetra ness 7 Directions for VED Therapy op carassovssnecummmetueconwe 8 New Technology Sensation Seal 9 Use with Constriction Rings esses 10 Use with Soft Touch Seal suus 12 Constriction Device Nemi yalbu os emeret etate 13 Maintaining Device Effectiveness 14 Cleaning the VED Device eese 14 ISepIGCcOmenE PUES soreer niei E EE 14 reote borea COINS EC 15 POCU TON c 15 Sici cic ey eee rom nee ee ene ne eee 15 TONES BO KNOW cece 16 Frequently Asked Questions sessssuaenasateseecemaspenoseeteons 16 Popen DON e T a M e E 18 Warranty Returns Complaints 20 Medicare Po rz dta AEC 6 MIR M 21 Patient Rights amp Responsibilities 21 The user should read all instructions before using the device PRODUCT DESCRIPTIONS VED 1 Cylinder The cylinder serves as a vacuum chamber to allow for increased blood i flow to the penis 2 VED ULTRA Battery Powered Pump with 2 AA Batteries This is the vacuum source with a built in sa
11. accurate information on the DMEPOS sup plier application Any changes to this information must be reported to the National Supplier Clearinghouse within 30 days 3 An authorized individual one whose signature is binding must sign the applica tion for billing privileges 4 A supplier must fill orders from its own inventory or must contract with other companies for the purchase of items necessary to fill the order A supplier may not contract with any entity that is currently excluded from the Medicare program any State health care programs or from any other Federal procurement or non procure ment programs 5 A supplier must advise beneficiaries that they may rent or purchase inexpensive or routinely purchased durable medical equipment and of the purchase option for capped rental equipment 6 A supplier must notify beneficiaries of warranty coverage and honor all warranties under applicable State law and repair or replace free of charge Medicare covered items that are under warranty 7 A supplier must maintain a physical facility on an appropriate site 8 A supplier must permit CMS or its agents to conduct on site inspections to ascer tain the supplier s compliance with these standards The supplier location must be accessible to beneficiaries during reasonable business hours and must maintain a visible sign and posted hours of operation 9 A supplier must maintain a primary business telephone listed under the name of the business
12. and distributed by FIRMA MEDICAL L 99 Regency Parkway Suite 203 Mansfield TX 76063 Office 817 473 7473 Toll Free 800 771 9263 Fax 817 473 9639 www firmamedical com email sales firmamedical com 24
13. bilities when under the care of Firma Medi cal These include the following I Participation in Care and Accurate Information a You have the responsibility to provide accurate and current health information and follow the instructions outlined for the proper use of the equipment device b You are responsible for your actions if you do not follow the out lined instructions II Financial Obligations a You have the responsibility to provide accurate information with regards to your health insurance coverage b You have the responsibility to give accurate financial information and to pay your bill promptly III Appropriate Conduct You have the responsibility to be considerate and cooperative of others and avoid discrimination against health care providers because of race color gender ethnicity national origin religious affliction or sexual orientation If you believe that any of your rights have been violated please call the State Health Insurance Assistance Program in your State 2 NOTES 22 VED REGISTRY CHECKLIST Please remember to send in your VED Registry Questionnaires e Baseline Questionnaire Date Sent Very important to have a baseline or starting point e 3 Month Questionnaire Date Sent e 6 Month Questionnaire Date Sent 12 Month Questionnaire Date Sent 23 DIRECTIONS FOR USE ULTRA Battery powered Vacuum Pump CLASSIC Manual Vacuum Pump Vacuum Erection Device Manufactured
14. constriction ring for daily VED therapy 1 Maintain a comfortable erection in the cylinder with an air tight seal for 1 minute i 2 After the minute is up press the valve release located on your pump which will release the vacuum seal This will cause the blood to flow out of your penis and back into your body 3 Repeat steps 1 amp 2 until you have achieved a total of 3 5 erections in a ten minute period Continue until you experience regular night time erections or spontaneous daytime erections For comfort and protection the vacuum pump has a built in safety limiter valve to prevent excessive vacuum build up We recommend that men practice using the VED to achieve a firm erection daily for at least two weeks before using it for intercourse With continued practice the length of time needed to achieve an erection will decrease and the firmness of the erection will improve This will also give your penis time to adjust to being filled with blood again USE WITH CONSIRICTION RINGS Using The Constriction Devices Using the Constriction Rings with the Loading Cone The Loading Cone is not available in all Systems but can be purchased as an accessory separately 1 To use the constriction ring start out selecting the constriction ring with the largest number from the kit 2 Remove the sizing insert from the end of the cylinder putting it aside Fig I 3 Place the adaptor ring into the end of the cylinde
15. dysfunction 1 e inability to achieve an erection that is sufficient for sexual intercourse consult a physician prior to using this device to avoid a potentially harmful delay in diagnosin any of the common causes of this condition such as diabetes multiple sclerosis cirrhosis of the liver chronic renal failure or alcoholism Do not use the device if you have decreased sensation of pain in the area of the penis Use of petroleum based lubricants with your VED may result in damage to the device REFERENCES FDA Draft Guidance For the Content of Premarket Notification For External Penile Rigidity Devices dated March 21 1995 Patient Handout for vacuum devices and constriction rings December 1991 Contemporary Urology 15 IHINGS TO KNOW For some men one or more of the following differences may be noted The penis may feel slightly cool This 1s because the constriction decreases the amount of blood flowing into the penis The penis is bigger around larger girth than during a normal erection This 1s because all the tissues of the penis beyond the constriction are filled with blood The penis may appear darker and the veins will stand out This is because blood is trapped in the penis by the constriction The penis will pivot at its base The penis is rigid only beyond the constriction During a normal erection the hardness extends back into the body The semen may not come out when you reach an orga
16. e first few uses Once the penis fills with as much blood as it can hold STOP Some men find that with the erection obtained using the VED the penis is wider feels slightly cool may appear darker has promi nent veins and or pivots at the base These are all normal responses when using vacuum constriction DIRECTIONS FOR USE CLASSIC Using the VED CLASSIC 1 When using the VED CLASSIC Manual Vacuum Pump make sure the end cap 1s seated firmly in the cylinder 2 Attach one end of the connecting tube to the vacuum pump and the other end to the nipple on the cylinder end cap Both ends on the connecting tube are the same fittings Be sure the fittings are snug to prevent air leakage E hes Now the VED CLASSIC is ready to be used to achieve an erection When beginning it is best to use the VEDO while in a standing position 3 After coating the inside of the cylinder and your penis with lubricant insert the penis into the cylinder so that it is lying along the bottom Lubrication helps obtain the seal necessary to create a vacuum and allows the penis to slide easily inside the cylinder Use only water based lubricant 4 Position the cylinder over the penis and place it firmly against the body to begin In order to get an air tight seal do not allow air to enter the end of the cylinder pressed against your body 5 Hold the cylinder in place and begin the pumping action by squeezing the handle on the pump Th
17. e pump will stop automatically when no pressure 1s applied tot he handle 6 Operate the pump slowly Squeeze the handle and slowly count for 3 5 seconds Next stop squeezing the vacuum will stop and again count for 3 5 seconds It 1s this procedure that draws blood from your body filling your penis creating an erection Repeat DO NOT RUSH THIS PART OF THE PROCEDURE 7 As blood is drawn into the penis a stretching sensation will be felt as the penis enlarges Discomfort can be expected during the first few uses Once the penis fills with as much blood as it can hold STOP Some men find that with the erection obtained using the VEDS the penis is wider feels slightly cool may appear darker has prominent veins and or pivots at the base These are all normal responses when using vacuum constriction NEW TECHNOLOGY Sensation Seal Installing the Sensation Seal Penis Opening Rolled End Bid 1 D Line up the rolled end of the Sensation Seal with the smaller end of the cylinder 2 Using your fingers stretch the rolled end of the Seal over the outside rim of the cylinder opening Step 2 3 Pull the Sensation Seal over the cylinder about 1 2 inches over the outside of the cylinder Push the re maining Sensation Seal material into the cylinder with the penis opening facing down into the cylinder SIDE 4 4 To make the length of the seal shorter pull the rolled end of the seal down Saat about further o
18. fety limiter and vacuum release button The VED ULTRA consists of a vacuum cylinder that fits over the penis and a bat tery operated vacuum pump that is attached to the cylinder The cylinder and vacuum pump create a vacuum to draw enough blood into the penis to make it rigid 3 VED CLASSIC Manual Vacuum Pump Vacuum source with built in safety limiter and vacuum release mechanism The VED CLASSIC consists of a vac uum cylinder that fits over the penis a vacuum pump that is attached to the cylinder with a connecting tube and end cap The cylinder and vacuum pump create a vacuum to draw enough blood into the penis to make it rigid C vD 4 Cylinder with removable End Cap to be used with the CLASSIC Ss The cylinder serves as a vacuum chamber to allow for increased blood flow to the penis 5 Connecting Tube The connecting tube is used to connect the cylinder with end cap to the manual vacuum pump End fittings are universal and may be attached to either component 6 Sizing Insert The sizing insert is used to adjust the size of the cylinder open ing to fit a man s personal needs Its use 1s optional 7 Sensation Seal The Sensation Seal is to be used on the end of the cylinder to create a seal around the penis while using the vacuum device The Seal comes in four sizes 3 5 7 and 9 to adjust to your needs See page 14 for ordering details PRODUCT DESCRIPTIONS VED 8 Personal Lubricant This water based lubrican
19. he pump to make sure the batteries are functioning properly 5 Refit the pump cover on the pump and turn the cover to the left until it is locked i firmly in place The pump is now ready for use CLEANING THE VED ULTRA AXIS CLASSIC VED ULTRA with Battery Powered Vacuum Pump motorized vacuum pump model After using the VED ULTRA clean all components except the battery powered vacuum pump in warm soapy water and allow to air dry Be sure to remove the battery powered vacuum pump from the cylinder before cleaning To remove the battery pump from the cylinder grasp the cylinder firmly and gently twist the pump upward in a clockwise direction Wipe the outside of the battery powered vacuum pump with a dry cloth but do not immerse it in any type of fluid or it will be damaged beyond repair Never wash any VED ULTRA component in a dishwasher nor clean them with an alcohol solution Never put components n a microwave VED CLASSIC Manual Vacuum Pump hand powered manual vacuum pump model After using the VED CLASSIC clean all components except the pump and connecting tube in warm soapy water and allow to air dry Remove the cylinder end cap for ease in cleaning Wipe the VED CLASSIC vacuum pump with a dry cloth but do not immerse it in any type of fluid or it will be damaged beyond repair Never wash any VED CLASSIC component in a dishwasher nor clean them
20. iction may be left safely in place for up to 30 minutes Constriction Rings To remove the constriction ring s place the fingers in the outer loops and carefully pull them away from the body allowing the blood flow to return After several seconds slide the constriction ring s off the penis Sof Touch Seal Carefully remove the SofTouch Seal by gripping the raised edges on both sides and slide it off the penis The penis will return to its normal non erect state once the constriction has been removed Warnings do not fall asleep while wearing the constriction ring since prolonged use of the constriction ring may cause permanent injury to the penis allow at least 60 minutes between uses as more frequent use may increase the risk of injury to the penis do not use constriction rings under the influence of alcohol or drugs since such use may impair the user s judgment and increase the risk of injury to the penis misuse of a constriction ring may cause bruising painful injury or permanent damage to the penis constriction rings do not prevent pregnancy do not use constriction devices with penile implants unless otherwise instructed by your physician Precautions use of a constriction ring may aggravate already existing medical conditions such as Peyronie s disease the formation of hardened tissue in the penis that causes pain curvature and distortion usually during erection priapism persistent
21. ience and knowledge of the physician in performing an evaluation of the patient determining whether an external penile rigidity device is appropriate for the patient and thoroughly discussing any instructions unique to that patient s circumstances PRECAUTIONS Consult a physician should any complications present and discontinue use of the device 1f such conditions persist Alternative treatments such as counseling drug therapy hormonal therapy vascular surgery and implanted prosthetic devices also exist Contact your physician for more information regarding these alter native treatments The user should apply the minimum amount of vacuum pressure necessary to achieve an erection The user should stop using the vacuum pump if pain occurs Vacuum pumps should not be used under the influence of alcohol or drugs Use of the vacuum pump may bruise or rupture the blood vessels either immediately below the surface of the skin or within the deep structures of the penis or scrotum resulting in hemorrhage and or the formation of a hemorrhage Misuse of a vacuum pump may aggravate already existing medical conditions such as Peyronie s disease pria pism and urethral strictures Misuse of the vacuum pump could result in swelling of the penis and or serious permanent injury to the penis Do not use an electrically powered vacuum pump in or near water Warnings and Cautionary Statements when using VED e f you have symptoms of erectile
22. it We usually recommend two weeks of practice 16 FREQUENTLY ASKED QUESTIONS cont Why are my erections not hard The degree of firmness depends on many factors and the firmness of the erections created with the VED may increase with use and practice Remember that the goal of the VED is to create an erection sufficiently firm to penetrate your partner Will I always need to use a ring or the Soft Touch Seal in order to have intercourse This 1s different for every man but some men find that using the VED without the constriction ring can help create an erection sufficient for penetration The constriction devices are used only if the blood is not staying in the penis after the vacuum is turned off Why do I need to use the lubricant that Firma Medical sells The lubricant we provide was created to be used with our VED Many over the counter lubricants are petroleum based or too thin to hold up under the pressure created by the vacuum It s possible for particles of these to be pulled into the vacuum head which could decrease the life of the motor Why do the rings hurt The rings may cause some discomfort but if it causes pain you probably need a larger size The rings come in various sizes Call 1 800 771 9263 or visit www firmamedical com to order larger constriction rings Why does my penis hurt when I push the vacuum button If the count of 1 2 3 causes discomfort try counting just to two or even one to see if tha
23. ith erec tile dysfunction by means of an applied vacuum to the penis which draws blood into the penile corpora cavernosa causing the penis to become erect and rigid The two corpora cavernosa and corpus spongiosum are three expandable erectile tissues along the length of the penis which fill with blood during penile erection The two corpora cavernosa lie along the penis shaft from the pubic bones to the head of the penis where they join See diagram below Constriction Device The Soft Touch seal and Constriction Rings are used to maintain penile rigidity in men with erectile dysfunction by restricting penile venous outflow after the patient has obtained an erection with the aid of a vacuum pump The VED is designed to help create an erection sufficient to penetrate the vagina and have sexual intercourse It 1s intended for use by men who have full or partial impotence Note The VED is not a contraceptive Penis Anatom Urethra Corpus Spongiosum INSIRUCTIONAL DVD Watch the Instructional DVD WEN 3 2 22 9 FIRMA MEDICAL We recommend watching the Instructional DVD and reading the User Manual before using the VEDO The instructional DVD will show the steps for using the constriction devices included in your system It is recommended that men practice achieving an erection several times using the VEDO for sexual intercourse DIRECTIONS FOR USE ULTRA AXIS Using the VED ULTRA AXIS
24. n it will provide Start with the largest numbered ring provided and move to a lower numbered ring only if maintaining an erection is a problem Do not leave a constriction ring on longer than 30 minutes Constriction rings are not contraceptive devices 11 Once an erection is achieved transfer the constriction ring s from the end of the cylinder to the base of the penis Pull the constriction ring s from the underside of the cylinder being careful not to lose vacuum If more than one constriction ring is used you may transfer the constriction rings either one at a time or together N 12 Release the vacuum and remove the cylinder from the penis leaving the constriction ring in place Fig 17 The erection should be suitable for intercourse 13 If after removing the cylinder the erection 1s not adequate use a smaller ring multiple rings or combine the Soft Touch with one or more constriction rings Call your Education Specialist for more information an Some men find the erection obtained using the VED the penis is wider feels slightly cool may appear darker has prominent veins and or pivots at the base These are all normal responses when using vacuum constriction USE WITH SOFT TOUCH SEAL Using the Soft Touch M Seal 1 Insert the cone onto the top of the applicator and place it on a flat surface Fig 7 2 Apply a generous amount of Personal Lubricant to the cone T and to the inside opening of the Soft To
25. r where you removed the sizing insert Fig 2 4 Insert the cone into T adaptor sleeve Now you are ready to apply the Figure 2 constriction ring Fig 3 5 Next apply lubricant around the cone Fig 5 6 Place the center of the constriction ring over the cone head and slowly start sliding the ring over the cone toward the cylinder Fig 6 amp 7 7 Completely slide the ring over the inima Figure 3 Figure 4 Fig 8 amp 9 Figure 5 Figure 6 Figure 7 Figure 8 Figure 9 Ring over the end to apply it to the cylinder Note If you do not have the Loading Cone System you may still stretch the Constriction zi USE WITH CONSTRICTION RINGS CON T 8 Remove the cone and adaptor sleeve from the cylinder and replace the sizing insert you took off in the beginning Fig 10 amp 11 9 Seat the ring as close to the cylinder edge as possible Fig 12 Now the pump cylinder and constriction ring are ready for use to achieve and sustain an erection as instructed in the previ ous steps two and three Figure 10 Figure 11 Figure 12 10 Position the cylinder over the penis and place it firmly against the body to create a seal NOTE For ease it may be necessary to stretch it or soak the constriction ring in warm water before attempting to place it onto the cylinder The constriction rings are available in sizes 3 through 9 A 4 and 6 are usually standard with your VED The larger the number the less constrictio
26. rranty is in lieu of any other warranties either expressed or implied Five Year Limited Warranty for Rx VED Medicare Beneficiaries Every Rx VED system sold by Firma Medical carries a 5 year manufacturer s warranty This warranty will cover the pump manual and battery operated and the cylinder against manufacturer defects for 5 years Firma Medical will notify all Medicare beneficiaries of the warranty coverage and we will honor all warran ties under applicable law All warranted Medicare and Rx equipment will be replaced free of charge under this warranty provided your account is in good standing Customer Return Policy Contact Firma Medical for full details and restrictions which apply to a Return Authorization You must contact the main office and acquire an RA Number before returning the product In many instances a problem can be corrected by adjusting the manner in which the product 1s used Our clinical specialists can provide user tips which often overcome mechanical difficulties encountered by the user this may prevent unnecessary inconvenience The products Firma Medical manufactures are considered sanitary and are for single person use Products are never refurbished and for that reason items purchased such as replacement parts constriction rings SofTouch Constriction Seals and constriction bands are not returnable COMPLAINT PROCESS Once Firma Medical receives a complaint either verbally electronically by
27. sm The urethra may be blocked by the pressure of constriction or in most instances if you had prostate surgery you will not ejaculate NOTE The VED CLASSIC ULTRA is not a contraceptive FREQUENTLY ASKED QUESTIONS Why do I count I 2 3 holding the button and then I 2 3 without holding the button The first count pulls blood into the penis while the second count without using the button allows time for the skin of the penis to expand allowing room for the blood This process continues with each count When do I stop counting 1 2 3 What size should my penis be when I stop counting Each time you use the device you will reach a point where you feel the vacuum will no longer increase the penis size You will likely know this more by feel than by sight This is when you should stop Note that this might not be the size of full erections you have had previously but as you continue to use the device the maximum size may increase to that of your full erection Why does my penis immediately become small again when I remove the cylinder Because the blood has been drawn into the penis through the pressure of the vacuum and returns once the vacuum is released Why didn t the rings work for me to have intercourse the first night that I used the system This is probably just a matter of comfort and practice Many men find it helpful to try the device by themselves to get used to it before attempting intercourse with
28. t is more comfortable You can also lengthen the time in between activating the device when the device is not running If this doesn t help and you are still experiencing pain contact your physician Why did the Soft Touch Seal tear when I barely pulled on it The Soft Touch Seal is very thin It needs to be thin in order to perform as designed After liberal lubrication we suggest that it be pulled over the head of the cone by placing each thumb on the raised edges and gently pull downward with equal stretching on both sides until you reach the base of the applicator The Soft Touch Seals can be replaced by calling 1 800 771 9263 or visiting www firmamedical com How much lubricant should I use Use enough to generously cover an area about the size of a quarter Place this on your longest finger and coat the inside of the cylinder each time before use Additional lubricant can be used to coat the rim of the cylinder where it comes in contact with the body to provide a tighter seal Do I need to pay for something if it breaks The cylinder and the vacuum head are covered under warranty and can be replaced if they break within the warranted time frame The other pieces may require replacement To order replacement parts call 1 800 771 9263 or visit www firmamedical com Is my pubic hair supposed to be pulled into the cylinder too Men should groom their pubic area for a better seal and comfort This can be done by trimming or shaving
29. t is required for proper function of the device See page 14 for ordering information for additional lubricant the SoftTouch Constriction Seal to the base of the penis The adaptor and cone are used for ease of loading the constriction rings onto the cylinder If your kit does not sleeve cone adaptor come with a loading cone you may purchase one as an accessory n Y 9 Loading Cone System The sleeve and cone are needed for the applying 10 Soft Touch Constriction Seal The Soft Touch Constriction Seal is used to maintain an erection Soft Touch provides maximum comfort and efficiency This product must be used with the Loading Cone System 2 5 11 Constriction Rings Constriction Rings are used to maintain an erection 9 Jj Sizes are available in 3 4 5 6 7 and 8 Experiment until the constriction needed to ud maintain an erection is found See page 14 for information about ordering additional constriction rings as replacement parts AD FIRMA MEDICAL B 12 Instruction Manual Reading the manual will increase satisfaction and make the VED easier to use DIRECTIONSFORUSE Tm 13 Instructional DVD This DVD demonstrates proper use of the VED for the purpose of intercourse and therapy INTENDED USE AND INDICATIONS The VED The Vacuum Erection Device consists of two main parts the pump and constriction device Vacuum Pump ULTRA CLASSIC AXIS This is used to create an erection in men w
30. uch Seal n 3 Place the flat end of the thumbs on the raised edges of the Soft H Touch Seal and position it over the cone Fig 8 d 4 With one smooth motion slide the Soft Touch all the way down to the bottom of the applicator Fig 9 5 Remove the cone from the sleeve Fig 10 b 1 Apply Lube 6 Place some lubrication around the base of the penis Position the applicator onto the penis as close to the base as possible after removing the cone Fig 11 7 By holding the Soft Touch tightly against the body at the base of the penis and removing the applicator with the other hand you will be able to transfer the Soft Touch from the applicator onto the penis smoothly Fig 12 n E 1 t Fig 9 Fig 10 Now the pump cylinder and Soft Touch are ready for use to achieve and sustain an erection as instructed in the previous page 8 Position the cylinder over the penis and place it firmly against the Soft Touch Seal Fig 15 9 Once an erection 1s achieved release the vacuum and remove the cylinder from the penis leaving the Soft Touch in place Fig 14 Fig 11 Fig 14 Some men find that with the erection obtained using the VEDO the penis is wider feels slightly cool may appear darker has prominent veins and or pivots at the base These are all normal responses when using vacuum constriction 12 CONSTRICTION DEVICE REMOVAL Removing the Constriction Devices After Use Constr
31. usually painful erection of the penis as a consequence of disease and not related to sexual arousal and urethral strictures urethral stricture is an area of hardened tissue which narrows the urethra sometimes making it difficult to urinate limit use of the constriction ring to no longer than 30 minutes per use prolonged use of the constriction ring 1 e without removal may cause permanent injury to the penis device use may bruise or rupture the blood vessels within the penis or scrotum resulting in petechiae a small purplish spot on a body surface such as the skin or a mucous membrane caused by a minute hemorrhage flow of blood from ruptured blood vessels or the formation of a hematoma localized swelling filled with blood resulting from a break in a blood vessel use the least constrictive ring size that maintains an erection since excessive constriction could injure the penis 13 MAINTAINING DEVICE EFFECTIVENESS Instructions for changing the batteries in your VED ULTRA Battery Powered Vacuum Pump The pump operates on two AA batteries Periodically these batteries will need to be replaced The procedure to replace the batteries 1s as follows m 1 Remove the pump cover by twisting it one half turn to the right 2 Locate the batteries and remove them from the battery holder 3 Place new batteries in the battery holder Be sure the batteries are connected properly 4 Depress the button located at the top of t
32. ver the outside rim ipd 65 Connect the pump to the end of the cylinder wu O The battery operated pump is shown but the Classic can be connected as well Using Sensation Seal to Create an Erection Step 2 Step 1 f Once the Sensation Seal is loaded onto the end of the cylinder place the tip of the flaccid penis against the opening at the center of the Sensation Seal 2 At the beginning gently push the cylinder against your body to help facilitate the seal The penis will be drawn through the Sensation Seal into the cylinder and an erection will form An air tight seal is created at the penis opening located at the center of the Sensation Seal Step 3 Step 4 KE As the vacuum is created within the cylinder and the penis expands in length and girth the seal stretches allowing the penis to pass though the opening l A J To remove the penis from the VED stop pumping press the release valve and gently pull the penis out of the Sensation Seal The Seal should remain on the cylinder You may find the penis slides easier when placing VED lubricant on the inside opening of the Sensation Seal Note the expandable penis opening is available in four different sizes DIRECTIONS FOR VED THERAPY VED Therapy is a daily exercise to pull blood into the penis It s designed to replace lost nocturnal or night time erections Follow these instructions or your physician s advice for therapy Do not use a
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