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Viberect-X3 Penile Vibratory Stimulation System USER`S GUIDE

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Contents

1. ccceeccceeeeeeeeseeeeeeneeeneeas 12 Viberect Product Specifications uu kk 13 al C eens eee ete E meen etre eer anne ne Menten nt cn cer om er ea Pee 13 Customer Service and Contact Information iEEEEE 15 Step by Step NSIRUGHONS s ees ee eee las aken a bek DE l banek Kan awa nenn kik Kil kab 16 Z NWARNING Spinal Cord Injury use carries risk of Autonomic Dysreflexia j B bi case READ THIS USER MANUAL IN ITS ENTIRETY FOR CORRECT USE AND OPTIMAL RESULTS Reflexonic Viberect Page 2 of 16 VIBERECT X3 User Guide 2014 Rev 0 2216682 A indd 2 10 24 14 5 52 AM PG 2 Your INTRODUCTION Watch us on YouTube under Viberect Viberect penile vibratory stimulation device is a US manufactured hand held therapeutic vibrator intended to provoke penile erection for erectile dysfunction and to provoke ejaculation Penile vibratory stimulation is an easy and non invasive nerve stimulation method similar to sexual intercourse or manual stimulation that helps to activate nerve receptors nerve antennas that are located on the skin surface of the penis These nerves communicate with sexual centers of the brain and spinal cord Activation and initiation of sexual reflexes by the Viberect device helps to initiate penile erection rigidity ejaculation and orgasm This device is designed by urologists specializing in ejaculation and sexual medicine to help men benefit from this
2. Viberect Starting a family has never been easier Reflexonic Viberect Page 9 of 16 VIBERECT X3 User Guide 2014 Rev 0 2216682 A indd 9 10 24 14 5 52 AM TIPS FOR EJACULATION SUCCESS IN MEN WITH SCI Written by David Buck Tennis Champion SCI advocate I ve been using PVS Penile vibratory stimulation to ejaculate for over 16 years When using PVS as a spinal cord injury brain injury stoke patient MS or any man we need to understand the way we respond to vibratory stimulation We can typically only have successful ejaculation using the Viberect X 3 or the Ferticare personal using PVS on a once or twice a week basis The reflex arch can become exhausted if we stimulate with high amplitude vibration more then 1 2 times every 7 10 days or for more then 3 5 minutes without resting between each attempt And when using PVS for the purpose of conceiving children or to collect sperm for future fertility always recommend taking a full 10 days off from any vibratory stimulation to help insure a positive result the day your spouse is in ovulation or the day the doctors are collecting your sperm Prior to using PVS you should always be in a relaxed state of mind And ina physical position that triggers spasticity in your lower extremities If you can t ambulate and your using a wheelchair on a daily basis The best position to have success is typically lying flat on your back allowing the hip flexor to stretch to a flat position
3. Toll Free Fax 800 886 1470 Reflexonic LLC Innovative Urological Solutions 915 Toll House Avenue suite 205 Frederick MD 21701 This User Guide is also available in Spanish German French Portuguese Italian Dutch Chinese Polish www reflexonic com Reflexonic Viberect Page 15 of 16 VIBERECT X3 User Guide 2014 Rev 0 2216682 A indd 15 10 24 14 5 52 AM PG 15 STEP BY STEP REFLEXONIC PRE VIBERECT STRETCH EXERCISES AND FROPER APPLICATION OF THE VIBERECT FOR OPTIMAL SEXUAL RESPONSE 1 Lie on your back or sit comfortably Grasp the head of penis as demonstrated 2 Squeeze the head and stretch the penis straight in the air until its natural limit You should feel a gentle reflex tightening of your pelvis and 3 Release the stretch back to normal length Do not release your grip 4 Repeat steps 2 and 3 every 2 3 seconds for 2 3 minutes The penis gradually becomes engorged with arterial blood and gets increment ally rigid exposing nerve antennas for Viberect stimulation Reflexonic Viberect 2216682 A indd 16 PG 16 5 Hold the Viberect close to the vibrating end and bring the medical Softpads toward the head of the penis Attempt different positions position with penis located below the heart 6 As you close your grip the Viberect automatically activates Apply pressure You can move the Viberect to find the most sensitive area 7 Now st
4. 61000 4 11 95 dip 5 sec Reflexonic Viberect Page 12 of 16 VIBERECT X3 User Guide 2014 Rev 0 2216682 A indd 12 10 24 14 5 52 AM PG 12 VIBERECT PENILE VIBRATORY STIMULATION SYSTEM PRODUCT SPECIFICATIONS Power Suppy SL Power AULT MENB1010A0903F01 Frequency range with fully charged battery 70 110 Hz Amplitude peak to p ak ccccccccseccecesececeeeeeeaeeeesaueeeeaeeeeeseneetaneees 3 0 mm EA TO ae ane dex N k e ua yena chore nde T T Ni MH rechargeable 4 AA Temperature Avoid Viberect use in temperatures exceeding 35 C or 95 F 2 2 a oe a ee ee eee Ambient temperature 68 77 F 20 25 C Symbols Table Batch Z N Caution Catalogue Do Not Use if Number Package is damaged Consult Manufacturer Instructions for Use and Date of Manufacture against electrical shock Fragile Type B applied part Device provides protection Do not discard device improperly Reflexonic Viberect Page 13 of 16 VIBERECT X3 User Guide 2014 Rev 0 2216682 A indd 13 10 24 14 5 52 AM PG 13 Notes Reflexonic Viberect Page 14 of 16 VIBERECT X3 User Guide 2014 Rev 0 2216682 A indd 14 10 24 14 5 52 AM PG 14 Contact Information Customer Service Customerservice reflexonic com recommended amp most efficient method Tel 001 301 378 8433 9 00 am 3 00 pm M F US Eastern time
5. Reflexonic Viberect Page 7 of 16 VIBERECT X3 User Guide 2014 Rev 0 2216682 A indd 7 10 24 14 5 52 AM Pie DIRECTIONS FOR USE FOR EJACULATION SPINAL CORD INJURED CAUTION If your lesion is above T6 spinal Continue vibration until cord level you must follow your ejaculation occurs or for a physician s instructions carefully to maximum of 3 minutes followed prevent autonomic dysreflexia by a pause of 1 minute Speak to your physician for further setting Autonomic dysreflexia is recommendations experienced as a sudden pounding headache and a rapid increase in the blood pressure due to excessive activation of the autonomic nervous system If your spinal cord injury is above the T6 level your body may have lost ability to automatically control the blood pressure It is recommended that at least two vibration procedures are performed in a Clinical setting before using the The reflex arch can Viberect at home become exhausted if you stimulate with high The following initial setting is amplitude vibration more recommended then 1 2 times every 7 10 days or for more then 3 5 Frequency 100 Hz minutes without resting Amplitude 3 mm constant between each attempt Place yourself comfortably before turning on the Viberect device Try lying on a firm mattress massage table or even the floor Reflexonic Viberect Page 8 of 16 VIBERECT X3 User Guide 2014 Rev O 2216682 A indd 8 10 24 14 5 52 AM PG
6. modality with ease in the comfort of their home This User s Guide provides information and instructions which must be followed to ensure safe performance of the Viberect device This User s Guide also contains warnings and precautions which must be observed at all times CAUTION ALL STATEMENTS IN THIS GUIDE SHOULD BE FOLLOWED AT ALL TIMES Read the instruction carefully before use WARRANTY Manufacturer guarantees the Viberect Device from mechanical and electrical failure resulting from defective parts and or workmanship for 12 months from the date of purchase The warranty does not cover damage caused by accidents tampering or alterations of product in any way or due to improper handling cleaning or misuse of the product or failure to follow the instructions in the User s Guide Manufacturer s liability is limited to the replacement of a defective product The Reflexonic company shall not be liable for any incidental or consequential damages whether direct or indirect Reflexonic Viberect Page 3 of 16 VIBERECT X3 User Guide 2014 Rev 0 2216682 A indd 3 10 24 14 5 52 AM PG 3 BATTERY The battery in your Viberect Disposal of the battery has not been charged prior to delivery The rechargeable battery in the vibrator contains Nickel Metal A completely discharged Hydride NiMH battery will take approximately 6 8 hours to fully charge The Like other batteries of this type if Red charge indicator wi
7. with an erection After successful ejaculation we can have as much as 1 teaspoon of ejaculate that can remain inside the urethra canal And with normal intercourse we can actually conceive a child Or with vaginal or oral sex our spouse can trigger continued ejaculation Reflexonic Viberect Page 10 of 16 VIBERECT X3 User Guide 2014 Rev 0 2216682 A indd 10 10 24 14 5 52 AM PG 10 CLEANING To ensure that your Viberect device is always ready for use it is recommended to clean both vibrating pads and the entire surface and to recharge the battery after each use Wipe the outside of the vibrator with a dry or alcohol dampened cloth Do not immerse the Viberect in any type of fluid It is important to wipe off any lotion or moisture off the pads and body of the device after each use with a clean dry cloth and to wipe them with alcohol pads Removal and Replacement of Viberect Soft Pads If the Viberect Soft Pads start showing any signs of wear and or degradation replace them immediately Specifically check the surface of the pad over mold for any signs of wear degradation and replace if needed and check the integrity of the pad pad over mold assembly Simply pull each pad in the direction directly away from the body of the device see image Place new pads by easily snapping them into the pad attachment Make sure device is in the OFF position when replacing the pads Dispose old pads in a closed trash container Vib
8. If you have your spouse stimulate the hip flexor with massage while using PVS it can also help trigger the spasticity and help you become more reactive to PVS You can also have your spouse flex the heel cord Achilles tendon while performing PVS to also help trigger spasticity If you are using any medications to reduce spasticity it can directly interfere with your ability to have successful ejaculation as well So whatever time of day your body is the least affected by these medication will always be the best time to perform PVS In some cases the level of medication can be too high to get results at any time of the day or night You should always consult with your doctor first and if they clear you to reduce your dosage or skip a dose of your medication it can be the difference in having successful ejaculation In clinical studies spasticity can be reduced or eliminated for 2 hours all the way up to 24 hours after each use And this is why we need adequate rest between each attempt to ejaculate with PVS If you re still not having success the surface you re lying on may be too soft Try lying on a firm mattress massage table or even the floor Or you can place something like a stiff foam wedge or anything under your gluteus Maximus rear end to stretch the hip flexor beyond 180 degrees to help make the body even more spastic PVS will work with a completely flaccid penis soft penis and can in some cases work better flaccid then
9. MEDICAL PENILE VIBRATORY STIMULATION SYSTEM PHYSIOLOGICAL EFFECTIVE reflexonic usa Manufactured for Reflexonic LLC 915 Toll House Avenue Suite 205 Frederick MD 21701 Phone 1 301 378 8433 Fax 1 800 886 1470 Email customerservice reflexonic com www Reflexonic com Reflexonic a le Urological Solutions Viberect X3 Penile Vibratory Stimulation System USER S GUIDE Made in USA EMERGO EUROPE Molenstraat 15 F 2513 BH The Hague The Netherlands Phone 31 70 345 8570 Fax 31 70 346 7299 Indications for Use Viberect X3 Penile Vibratory Stimulation Device is a hand held medical device indicated to provoke ejaculation in men with spinal cord injury Prescription use in the US Over the counter in all other countries Page 1 of 16 OTC VIBERECT User Guide 2014 Rev 2 2216682 A indd 1 10 24 14 5 52 AM PG 1 TABLE OF CONTENTS desl UON eee E E HH 3 KAETI Y AEI E E AS AATE E EE A AA 3 BN A E A E E EE E A E S A S EA 4 Precautions for safe USC c ccccceccssseceecceeeeceecceseeecseueeeceseceeseeeesssneneeseees 5 Viberect Operating Instructions kk 6 7 Directions for Use Ejaculation 0 c ccc cccseceeeeseeeeeesaeeeeessseeeesssaeeeessaes 8 9 Tips tor Ejaculation in SCI men i kk 10 ehla Mza ONS DD _ _ _ _ _ _ _ _ mera mm 11 Pad Removal and replacemen tl L k kK 11 Electromagnetic emission statement
10. RECT Penile Vibratory Stimulation Device Operating Instructions Accessories and detachable parts 1 Soft Pads included are detachable and replaceable Soft Pads replacements order 1680024BkK provided in pairs 2 Battery Charger Reflexonic Viberect Page 6 of 16 VIBERECT X3 User Guide 2014 Rev 0 2216682 A indd 6 10 24 14 5 52 AM PG 6 Touch Pad 4 Pad mode button and indicator The device may be turned on and off by pressing the button on the touch pad a m Hold the on off button for 3 seconds to ai x AW ha a Wera wr n basis inin ii on j T ion r i i op surface of the penis Dorsal 2 e AUEN E ONIROE Vibrating only the bottom surface of the penis Ventral or 3 Both surfaces recommended for s maximal sexual response The modes can be switched easily while the device is active by Pressing on the or buttons on the touch pad will increase the frequency pressing on the pads button once from hr a all E u CER twice or three times to the desired desired The ee Ale areye Ua mode The LED lights will indicate increments of 5 Hz as visible with red LED lights which progressively turn on from right to left the modes 3 CHARGING INDICATOR 5 Charging Socket Single red LED light indicates that the Viberect device requires charging If no red LED light is visible the device has adequate power for application The charging Socket is located in the back of the device
11. arging WARNING No modification of this equipment is allowed If this equipment is modified appropriate inspection and testing must be conducted to ensure continued safe use of equipment Reflexonic Viberect Page 4 of 16 VIBERECT X3 User Guide 2014 Rev 0 2216682 A indd 4 10 24 14 5 52 AM PG4 PRECAUTIONS FOR SAFE USE WARNING Each Viberect device is intended for use by one person only It should never be shared by another person as this will increase risk of communicable or sexually transmitted diseases Treat your device like a personal toothbrush or other personal hygienic products WARNING This device should not be used over swollen or inflamed areas or skin eruptions Do not use in presence of unexplained calf pain Consult your physician WARNING This device should not be used for more than 10 minutes a day to avoid skin injury Excessive vibratory stimulation can increase risk of skin irritation and temporary numbness Vibratory stimulation may cause superficial trauma to the skin resulting in bruising bleeding or superficial ulceration If any such condition occurs refrain from vibrating and consult your physician Do not immerse the vibrator in any type of fluid Do not operate the vibrator in bathrooms or elsewhere under wet conditions If the user is spinal cord injured an episode of autonomic dysreflexia may develop as a result of vibratory stimulation If so vibration should be stopped imme
12. diately Consult your physician Reflexonic Viberect Autonomic dysreflexia increase in blood pressure sweating headaches may be caused by various factors such as for instance an over distended bowel or urinary bladder Procedures which involve triggering of orgasm or including vibratory stimulation may precipitate an acute episode of autonomic dysreflexia If the user has spinal cord lesion and is above the T6 level the user should obtain careful instructions from your physician concerning autonomic dyreflexia its potential consequences and whether vibratory stimulation is acceptable form of treatment If the user is at risk of experiencing autonomic dysreflexia it is recommended to use nifedipine a calcium channel blocker 10 20 mg orally 10 15 minutes before vibration is initiated and to stop vibration immediately at onset of ejaculation WARNING If the user develops penile erection after use of the Viberect device that lasts for more than four hours consult your physician or go the emergency room immediately as the user may have developed Priapism which is a medical emergency Priapism is a medical condition in which poorly oxygenated red blood cells are entrapped in your penis This requires urgent medical or surgical attention WARNING Avoid Viberect use in temperatures exceeding 35 C or 959 F Page 5 of 16 VIBERECT X3 User Guide 2014 Rev O 2216682 A indd 5 10 24 14 5 52 AM PG 5 VIBE
13. el Electrostatic discharge Ha 6kV Contact Floors should be wood concrete or ceramic tile If 8kV Air Complies floors are covered with synthetic material the relative IEC 61000 4 2 humidity should be at least 30 Field strengths outside the shielded location from fix Radiated RF 3 V m 80MHz to a zz cee ned lee oe Complies RF transmitters as determined by an electromagnetic IEC 61000 4 3 2 5GHz sit survey should be less than 3 V m Interference may occur in the vicinity of equipment marked with the following symbol Conducted RF 3Vrms 150kHz to a IEC 61000 4 6 80MHz Compter c Electrical fast transient 2kV power line Complies KE RCN ee Mains power quality should be that of a typical 1kV differential gill commercial or hospital environment IEC 61000 4 5 2kV common pale Power frequency Power frequency magnetic fields should be at levels magnetic field 3 A m Complies characteristic of a typical location in a typical IEC 61000 4 8 commercial or hospital environment WA gi ease diy 0 Su yela Mains power quality should be that of a typical commercial or hospital environment If the user of the Viberect device requires continued operation during power mains interruptions it is recommended that the Viberect device be powered from an uninterruptible power supply or battery Voltage dips short interrupts and voltage 60 dip 5 cycles variations on power Complies supply input lines 70 dip 25 cycles IEC
14. erect Soft Pads or Pad Over Molds m c Direction of pull to remove touch pads Additional pads can be purchased from www reflexonic com Reflexonic Viberect Page 11 of 16 VIBERECT X3 User Guide 2014 Rev 0 2216682 A indd 11 10 24 14 5 52 AM PG 11 Guidance and manufacturer s declaration electromagnetic emissions The Viberect device is intended for use in the electromagnetic environment specified below The customer or the user of the Viberect device Should assure that it is used in such an environment Emissions Test Electromagnetic environment guidance The Viberect device uses RF energy only for its internal function RF Emissions CISPR 11 Group Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equi RF Emissions CISPR 11 Saronic entlanons TRL The Viberect device is suitable for use in all establishments including 61000 3 2 Class B domestic and those directly connected to the public low voltage power Voltage fluctuations supply iin power supply that supplies buildings used for domestic r Complies purposes flicker emissions Guidance and manufacturer s declaration electromagnetic immunit The Viberect device is intended for use in the electromagnetic environment specified below The customer or the user of the Viberect device should assure that it is used in such an environment a Te Electromagnetic environment guidance level lev
15. ll burned or punctured it could extinguish once the charge release toxic material which could cycle has completed Cause injury To ensure that your Viberect Device has no replaceable internal is always ready for use it is power source Batteries cannot be recommended to recharge the replaced by the end user If you battery after use Do not wish to dispose of the device do leave the device on charger not disassemble components mode for more than 8 hours Discard in its entirety A fully charged battery will Check with local solid waste allow about 30 minutes of officials for details concerning vibration at medium frequency recycling options and proper setting disposal In the United States call toll free 1 800 8 BATTERY or visit When completely discharged the Battery Recycling Corporation allow 6 8 hours to recharge website at Ensure that the vibrator is http Awww call2recycle org turned off before recharging The life of NiMH batteries is Use only the charger supplied strongly influenced by the care that with the vibrator Charge the they receive If properly maintained Viberect while laying it on its the battery is capable of more than side so the two arms are not 500 charge discharge cycles before brought together by gravity dropping to 80 of capacity Do not which may turn the device on exceed the allowable ambient temperatures during charging DO NOT ATTEMPT to use operating or storage the device while ch
16. retch your penis while stimulating with the Viberect and hold for several minutes 5 10 minutes 8 As you stimulate focus on sexual thoughts and intense past memories or actual sexual encounters in your life Let both your penis and the brain stimulate sexual centers in your spinal cord Relax Avoid impatience and anxiety Warning use these instructions at your own risk Never perform pre Viberect amp Viberect stimulation if you have sores or tears on your penis Viberect use in men with spinal cord injury carries risk of autonomic dysreflexia Page 16 of 16 VIBERECT X3 User Guide 2014 Rev 0 10 24 14 5 52 AM

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