4 - Kegel8
Contents
1. Kegel8 products are designed to produce very low levels of radio frequency RF emissions interference to be immune from effects of interference produced by other equipment operating in their vicinity and damage due to electrostatic discharge all when operating in a typical domestic and or clinical environment They are certified to meet the international EMC standard EN60601 1 2 Table 201 Guidance and manufacturer s declaration electromagnetic emissions The Kegel8 product is intended for use in the electromagnetic environment specified below The customer or the user of the Kegel8 product should ensure that it is used in such an environment i Electromagnetic environment __Emisstons test Compliance Feeroma nerie environment RF emissions round The Kegel8 product uses RF energy CISPR 11 H only for its internal function Therefore its RF emissions are very low and are not likely to Cause any interference in RF emissions nearby electronic equipment CISPR 11 mad i uu The Kegel8 product is suitable for use Harmonic emissions i in all establishments including domes IEC 61000 3 2 Not applicable tic establishments and those directly IEC 61000 3 2 connected to the public low voltage power supply network that supplies Voltage fluctuations Not applicable buildings used for domestic purposes flicker emissions IEC 61000 3 3 Table 202 Guidance and manufacturer declaration electromagnetic immunity The Ke2. When driving a vehicle or operating potentially dangerous equipment Use the Kegel8 ULTRA only as directed Do not immerse the unit in water or any other liquid Keep unit out of reach of children If in doubt about the use of the Kegel8 ULTRA unit call your distributor for advice Doctor or Healthcare professional Only use CE approved skin electrodes Only use CE approved vaginal or rectal probes Do not place electrodes X Over carotid sinus nerves Over larynx or trachea Inside mouth Over the area of the heart unless so advised by your Doctor Kegel8 ULTRA User Guide Description amp Functions of the Kegel8 ULTRA Pelvic Health Device Fo Connect Probe to Channel A or B Channel A Channel B LCD Display Lead Wire and Pin Select Programme SET Front Rear PRG button Selects the desired set programme from PO1 P11 or customised programme PC1 PC3 Pauses reducing the intensity MA to zero and escapes from a running programme SET button Reduces the intensity MA to zero and pauses the programme if a programme is running and moves the phase one step forward Displays the menu for programmes PC1 PC3 and allows the parameters for Time Work Rest Ramp up time CH A CH B Synchronous or Alternating and delay to be set 7 Kegel8 ULTRA User Guide Frequency amp Lock Current phase pulse width of phase symbol phase indic
3. User Guide If the lubricant does not help your Doctor can prescribe a course of oestrogen cream use this for the recommended time and then re commence using the Kegel8 Remember the pelvic floor needs to be exercised do not be put off by vaginal atrophy there are easy solutions for all women to overcome this painful condition Q Why are there two channels Channel A left hand side is generally used for a vaginal probe Channel B on the right hand side is generally used for an anal probe If you have suffered from an anal prolapse please telephone us and we can help you with a customised programme for your condition a selection of anal probes are also available online at StressNoMore co uk Q How do I clean my probe Simply rinse the insertable part under the tap keeping the wires dry at all times Do not boil the probe It can be sterilized using a mild sterilizing solution If you want to use the same probe vaginally and anally this is fine but always clean the probe thoroughly Q Why can I only feel stimulation on one side You do not have proper connectivity with the probe you need to adjust your position ensuring the probe touches both sides of the vagina muscle wall If your vagina has been stretched through childbirth and you are not feeling the probe on both sides you need to sit with your legs tightly together squeezing your pelvic floor as much as you can against the probe Don t forget the lubricant to a
4. These guidelines may not apply in all situations Electro magnetic propagation is affected by absorption and reflection from structures objects and people 31 Kegel8 ULTRA User Guide Warranty Savantini Limited Medical Dep provides a warranty to the original purchaser that this product will be free from defects in the material components and workmanship for a period of 2 years from the date of purchase invoice date If Savantini Limited is satisfied that the product s is defective the purchaser may return this unit s to Savantini Limited Medical Dep or the appointed distributor for repair or replacement with a new unit All returns must first be authorised by Savantini Limited Medical Dep in ad vance The liability of Savantini Limited Medical Dep under this limited product warranty does not extend to any misuse or abuse such as dropping or immersing the unit in water or other liquid substance or tampering with the unit or normal wear and tear Any evidence of tampering will nullify this warranty Manufactured by Verity Medical Ltd Unit 7 Upper Slackstead Farm Farley Lane Braishfield Romsey Hampshire SO51 OQL This product is manufactured in compliance with the European Union Medical Device Directive MDD93 42 EEC under the supervision of SGS Notified Body number 0120 C 0120 Verity Medical Ltd is certified by SGS to the following Quality Standards ISO 9001 2008 ISO13485 2003 32 Ke
5. of rain X Do not dispose in normal dustbin see page 23 for the disposal instructions Kegel8 ULTRA User Guide Warnings Do not insert lead wires into a mains power supply Do not immerse unit into water or any other substance Type BF equipment Continuous Operation Do not use the Kegel8 Ultra unit in the presence of a flam mable anaesthetic gas mixture and air or with Oxygen or Nitrous Oxide The unit is not protected from the ingress of water droplets from a shower of rain if used outside the carrying case If using rechargeable 9 Volt PP3 Nickel Metal Hydride bat teries be sure to use a CE approved battery charger Never connect the Kegel8 Ultra directly to a battery charger or to any other mains powered equipment We advise not to use Ni Cad rechargeable batteries Patient Probes and or Electrodes are for single patient use only Keep out of reach of children Do not use this stimulator on your facial area unless you are under strict guidance from a qualified Clinician Operation in close proximity e g 1m to a shortwave or mi crowave therapy equipment may produce instability in the stimulator output Simultaneous connection of a patient to a high frequency surgical equipment may result in burns at the site of the stimulator electrodes and possible damage to the stimulator This unit must be used with the guidance of a Physiothera pist or Doctor No modification of this equipment is allowe
6. Kegel8 either lying down or sitting with your legs elevated This will help you to get used to the kegel8 sensation but also to stop the probe being displaced It is important that the probe maintains contact with the muscle to contract and exercise it properly Conductivity is also improved by using the lubricant provided it is water based and body friendly and you ll get better results Q How far do I put the probe in The vaginal probe needs to be inserted just 2 inches 5 5 cm this is the optimum level to stimulate the pelvic floor muscle Q I have an IUD or Mirena Coil can I use the Kegel8 Yes The Mirena is plastic so not problems there An IUD contains copper which is unaffected by the Kegel8 and STIM so no problems there either Q Can I use my Kegel8 when I have my period There are no problems with this however if you are at the peak of your period and flow is heavy you may prefer not to Many users have reported it helps with menstrual cramps too Here in the office we tend to use it on lighter flow days Rinse the probe in warm water and towel dry the probe can be sterilized using a mild sterilizing solution if necessary do not immerse the connectors at the ends of the leads in water do not boil it will cause the plastic to crack 24 Kegel8 ULTRA User Guide Q Can I use it whilst pregnant Clinical guidelines advise against using any STIM machines vaginally during pregnancy Q I aim to hav
7. Programme PO1 Pain Relief es Phasetime mn mode com Frequency work me 03 150 ses 10 Ramp down time ses 0 Resttime ses 0 Alternating __ Synchronous Overalltime 20min Programme P02 Urge Prolapse mn 39 WR Te 250 Pulse duration L3 uS 250 Ramp downtime secs o remang synchronous overalt time 3mm Kegel8 ULTRA User Guide Programme P03 Mode JJ Alternating Synchronous moe ses alternating Synchronous Programme P04 Kegel8 ULTRA User Guide Frequency Programme P05 Urge 1 New Mothers Mode LL WR Ramp down time se 0 Alternating _ __ Synchronous vera time 20mm Mode pf Cot gt Frequencywork HS 10 Pulse duration us 200 __ Ramp uptime ses 10 Ramp down time ses 0 Alternating gt Synchronous gt 5 0 0 0 Frequency P PO6 1 20 i 1 Kegel8 ULTRA User Guide hase time Mode requency work Pulse duration Ramp up time Ramp down time EE _ Overall time 20min 1 1 _ This programme works continuously with no rest period It is used in some countries where they have found continuous stimulation can work effectively Programme Lack of Phase POS Sensitivity 4 Mode JW R W R W R W R J W R Fr
8. athic detrusor instability and urge incontinence Neurourol Urodynam 8 219 230 Miller K Richardson D A Siegel S W Karram M M Blackwood N B Sand P K 1998 Pelvic Floor electrical stimulation for genuine stress incontinence who will benefit and when Int Urogynecol J Pelvic Floor Dysfunction 9 5 265 270 Osterberg Graf W Eeg Olofsson K Hallden M Pahlman L 1999 Is electrostimulation of the pelvic floor an effective treat ment for neurogenic faecal incontinence Scan J Gastroenterology 34 3 319 24 34 Kegel8 ULTRA User Guide Notes 35 Customer Service and Distribution Kegeld Helpline 44 0 1482 496 932 Call us We re here to help you Monday Friday 8am 5pm Address Savantini Ltd 14D iPark Innovation Drive Hull HUS 1SG England Email Sales Kegel8 co uk Web www Kegel8 co uk Manufactured by Verity Medical Ltd Unit 7 Upper Slackstead Farm Farley Lane Braishfield Romsey Hampshire SO51 OQL This product is manufactured by Verity Medical Ltd in compliance with the European Union Medical Device Directive MDD93 42 EEC under supervision of SGS Notified Body number 0120 C 0120 Verity Medical Ltd is certified by SGS to the following Quality Standards ISO 9001 2008 ISO 13485 2003
9. ator Phase mode Programme Total Number of phases rogramme 9 n Time of current phase Low battery indicator Channel A Channel B miliamps milliamps Example of preset programme Phase being set Programme Phase mode Number of phases Total Current setting programme being altered time adds work in this cumulatively example as time added to phases Set Work Rest Ramp Delay seconds Example of custom programme Kegel8 ULTRA User Guide Lock Button Frequency amp pulse Lock symbol width of phase flashes when being unlocked Phase mode Programme Number of phases Hours and minutes unit was used in the locked mode Minutes Average millamps Average milliamps for CH A CH B An optional concealed lock button is included in the Kegel8 ULTRA which allows to accurately record the time the device was used and the average intensity MA It also locks the customised programmes stopping them from being altered To Lock the Unit 1 Select the pre set or customised programme required In the case of a customised programme make sure that the pulse width frequency time etc are set up correctly see page 20 2 Remove the battery cover and using a thin rod gently press on the lock button as shown in the diagram on page 7 until you hear a double beep The unit is now locked and cannot be altered until unlocked Note The lock symbol will appear on the LCD when
10. be observed to verify normal operation If abnormal performance is observed additional measures may be neces sary such as reorienting or relocating the Kegel8 product b Over the frequency range 150 KHz to 80 MHz field strengths should be less than 3V m 30 Kegel8 ULTRA User Guide Table 206 Recommended separation distances between por table and mobile RF communications equipment and Kegel8 product The Kegel8 product is intended for use in an electromagnetic envi ronment in which radiated RF disturbances are controlled The cus tomer or the user of the Kegel8 product can help prevent electro magnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Kegel8 product as recommended below according to the maximum output power of the communications equipment Separation distance according to frequen cy of transmitter Rated maximum 150k Hz to 80 800 MHz to output power of MHz 2 5 GHz transmitter W d 1 2vP d 1 2vP d 2 3vP For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2
11. d Contents Warnings What is STIM Contra Indications amp Precautions Description amp Functions of the Kegel8 ULTRA Pelvic Health Device Lock Button Quick Start Instructions Pre set Kegel8 ULTRA Pelvic Health Programmes Which Programme to select Custom programme setting Applications Care amp Maintenance of your Kegel8 ULTRA Frequently Asked Questions Specifications Information regarding Electromagnetic compatibility and interference EMC Warranty Customer Service Clinical References Kegel8 ULTRA User Guide 10 12 18 20 21 22 24 28 29 32 33 34 Kegel8 ULTRA User Guide What is STIM The Kegel8Y ULTRA Pelvic Health Device is one of a new breed of modern Neuromuscular Stimulators STIM developed with the aim of achieving optimum pelvic health for women Our principle aim was to design a product to give women the opportunity to tone and exercise their PC muscles strengthen weak muscles and nerve fibres in a compact easy to use device we also wanted the device to be able to be versatile enough so that as a woman achieved greater muscle control with high levels of functional use are sensibly priced compact and user friendly Neuromuscular Stimulation has been used for many years to stimulate muscle and nerve fibres to treat a number of muscle and nerve related conditions Over the last 30 years numerous clinical trials and papers have been written you can v
12. dd greater conductivity 26 Kegel8 ULTRA User Guide Q How long will the battery last If you use the Kegel8 daily it should last about 3 months You can get replacements from us or at your local supermarket please choose a quality 9v battery that will not leak You will know when your battery is low because a battery icon will flash on your Kegel8 screen Q How long will my probe last With normal use your probe should last between 12 18 months We recommend you replace it after this time to keep getting the maximum results from your Kegel8 We recommend you take care with the leads and wires of the probe don t bend them in two or tie them up this could cause wire damage and stop the probe working effectively When inserting and removing the probe always hold the base of the probe not the wires especially when removing the probe If you pull the wires instead of the probe base you can damage the wires We always offer a range of different probes for all uses please check online or telephone us for more information Q I can t find the answer to my question Give us a call we have personal experience of the Kegel8 and if we can t answer it the medical manufactures will 27 Kegel8 ULTRA User Guide Specifications STIM 1 Dual channel individually isolated circuits 2 Amplitude 0 90 mA into 500 Ohm load indication only Actual mA will tend to be less than indicated due to electrode impedance a
13. e lead wires carefully after each use Lead wires Disposal please return to the distributor Vaginal Rectal Probes Check the connectors have not become separated from the probe Before use the probe can be washed in warm soapy water the probe may also be cleaned with our antibacterial cleanser HiGenie Vaginal Rectal Probe Disposal please return it to the distributor Caution Static electricity may damage this product NOTE Only our appointed distributors importers are approved to undertake servicing Responsible Recycling Initiative In compliance with Waste Electrical and Electronic Equipment WEEE Regulations 2006 we aim to reduce the amount of electrical waste being sent to landfill sites Electronic devices contain toxic materials which seep into the ground when dumped irresponsibly causing serious health and environmental problems To recycle responsibly all you need to do is return your device to us We will Carefully and correctly dispose of your old Kegel8 product Ensure as much of it is recycled as possible Address WEEE Recycling Savantini Limited 14D iPark Innovation Drive Kingston upon Hull HU5 1SG Great Britain 23 Kegel8 ULTRA User Guide Frequently Asked Questions Q I can t get the mA s past 6 7 or 8 If you do not get an effective contact with the probe you will find that you cannot increase the mA s past level 6 7 or 8 Initially we recommend you use the
14. e my mA s at 40 but on some programmes it drops to 30 why is that While the programme goes through its preset routine the pulse width and pulse length varies when the pulse rate and length increase the mA s drop so that the intensity does not take you by surprise the mA s can again be increased So if you feel a decrease in intensity increase the mA s back up to a comfortable level Q How soon after the birth of my baby can I start with my Kegel8 ULTRA Consult with your Midwife or Doctor Generally women feel happy to start after a successful six week check up Q I have had pelvic surgery how soon can I start using my Kegel89 ULTRA Consult with your Doctor or Consultant every case is different but the Kegel8 could help to speed recovery Stress Incontinence and prolapse is usually a sign of a weak pelvic floor so if you have had an operation to help with either of these conditions you will still need to strengthen it The Kegel8 is ideal but check with your Doctor or physiotherapist Q I find it painful inserting the probe Use the lubricant this isn t supplied just to help make insertion easier it also helps with the conductivity The better conductivity the more the muscle will be exercised and the more mA s you ll be able to achieve If you are menopausal you could be suffering from vaginal atrophy this causes vaginal dryness thinning of the vaginal membrane and great discomfort 25 Kegel8 ULTRA
15. equency work Fequenyret Hz J Pulse duration Modulation time Ramp up time Ramp down time Work time Rest time Alternating Synchronous Overall time e N x O Kegel8 ULTRA User Guide Programme Pelvic Floor ro CFFE E Phase time 1 mn f4 8 Me TS qw Se E E amp op ume me ss os ws Ramp down time ses o o o Work time ses 5 Rest time Les 35 J Kom Ez EZ ERE Programme Phase P10 Phase time mn 20 gt E ST L EE Frequency work Hz 20 Pulse duration ps 250 Ramp uptime ses fos Ramp down time ses o r Work time ses 5 J Rest time ses 5 J Alternating JP o Synchronous Jr I _ Overall time 20mm EE UO OE Kegel8 ULTRA User Guide Programme P11 Relaxing the Pelvic Muscles Morte 9 Wenn j S z oeme mm meus mm Je 5 5 vede wi ws ex Frequency werk Tw as eo 9 o pos pee xm 29 O gt 52 j 2 Pa lt lt amp 8 lela amp 13 amp amp 2 3 3 8 91212 J5 1212 J O ets IS io ls 3 53J 0 Ln A O 3 D W R INTERMITTENT WORK REST CONT CONTINUOUS Kegel8 ULTRA User Guide Which Programme to select PO1 Pain Relief Vulvodynia is a chronic pain conditio
16. gel8 ULTRA User Guide Customer Service Any queries should be addressed to Helpline 44 0 1482 888 785 Call us We re here to help you Monday Friday 8am 5pm Address Savantini LTD 14D iPark Innovation Drive Hull HU5 1SG England Email Sales Kegel8 co uk Web www Kegel8 co uk 33 Kegel8 ULTRA User Guide Clinical References Neuromuscular Stimulation Knight S Laycock J Naylor D 1998 Evaluation of neuromuscular electrical stimulation in the treatment of genuine stress incontinence Physiotherapy 84 No 2 61 71 Gibson J N Smith K Rennie MJ 1988 Prevention of disuse mus cle atrophy by means of electrical stimulation Maintenance of protein synthesis The Lancet 2 8614 767 70 Lindstrom S Fall M Carlson C A Erlandson BE 1983 The neu rophysiological basis of bladder inhibition in response to intravaginal electrical stimulation Fall M Ahlstrom K Carlsson C Ek A Erlandson BE Franken berg AS Mattiasson A 1986 Contelle Pelvic floor stimulator for female stress urge incontinence A multicentre study Urology 27 282 287 Berghmans L C Hendriks H J Bo K Hay Smith E J deBie R A van Waalwijk Van Doorn E S 1998 Conservative treatment of stress urinary incontinence in women a systematic review of ran domised clinical trials Br J Urol 82 2 181 191 Eriksen B C Bergmanm S Eik Nes S H 1989 Maximal Electros timulation of the pelvic floor in female idiop
17. gel8 product is intended for use in the electromagnetic environment specified below The customer or the user of the Kegel8 product should ensure that it is used in such an environment and that precautions regarding that environment are heeded Immunity IEC 60601 Compliance Electromagnetic environment test test level level guidance Electrostatic 6 kV 6 kV Floors should be wood concrete discharge or ceramic tile If floors are ESD contact contact covered with synthetic material IEC 61000 4 2 the relative humidity should be 0 8 KV air xs ar at least 30 Power Power frequency magnetic fields frequency should be at levels characteristic 50 60 Hz of a typical location in a typical magnetic commercial or hospital ebviron field ment IEC 61000 4 2 29 Kegel8 ULTRA User Guide Table 204 Guidance and manufacturer s declaration electromagnetic immunity The Kegel8 product is intended for use in the electromagnetic environment specified below The customer or the user of the Kegel8 product should ensure that it is used in such an environment Immunity test IEC 60601 Compliance Electromagnetic environment guidance test level level Portable and mobile RF communications equipment should be used no closer to any part of the Kegel8 product including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation dis
18. i User Guide Tight for life Kegel ULTRA Web www Kegel8 co uk Symbols on the unit and case Follow operating instructions Failure to do so could place the patient or operator at risk afgafadf Neuromuscular Stimulation STIM and EMG Triggered Stimulation ETS should not be used by Patients fitted with demand style cardiac pacemakers Please seek advice from your health supervisor Patient s shock protection type BF Body Floated Equipment This equipment is not earthed but con tains a battery within an insulated unit Indicates the manufacturer s catalogue number so that the medical device can be identified Manufacturer s LOT Batch number Present it together with SN number when you report a technical fault or claim a warranty return Manufacturer s serial number of the unit Present it together with LOT number when you report a technical fault or claim a warranty Name and address of Manufacturer Date of manufacture Conformity indication with the essential health and safety requirements set out in European Directives body identification SGS This product should be kept dry This is an indication for protection against ingress of water and particulate matter The mark IP20 on your unit means your unit is protected against solid for eign objects of 12 5mm dia and greater Not protected against water IPO2 on the carrying case means Protected from the ingress of water droplets from a shower
19. iew our Clinical References on page 34 of this users guide The Kegel8 ULTRA Pelvic Health Device is a dual channel device combining several treatment programmes into one unit Neuromuscular Stimulation is increasingly understood by Therapists and Doctors There is a better understanding of the mechanisms which exist between nerves and muscles that makes it possible to stimulate the neuromuscular system with precise electrical signals The Kegel8 ULTRA Pelvic Health Device offers precision giving full control of Pulse Widths Rates Ramp up times Work Rest cycles as well as alternating or synchronous application if two channels are being applied Customer Care We welcome constructive comments regarding our equipment particularly those that might help us to improve existing features add new ones or develop new products for the future Kegel8 ULTRA User Guide Contra Indications amp Precautions Please read this Kegel8 ULTRA users guide before using this Stimulation device STIM should not be used X By patients fitted with a demand style cardiac pacemakers unless so advised by their Doctor During pregnancy unless medically advised By patients with undiagnosed pain conditions By patients with undiagnosed skin vaginal or rectal conditions With patients who have diminished mental capacity or physical competence who cannot handle the device properly On anaesthetised or desensitised skin
20. n characterized by burning stinging irritation and or rawness in the female genital area this programme is designed to help It also helps in cases where unknown pelvic pain has been diagnosed by a health care professional PO2 Urge Prolapse Urge in this programme refers to a woman who does not have leakage problems just the urge to pass urine This programme is suitable for women suffering from bladder and vaginal prolapse We can programme your K8 to help with anal prolapse please telephone for more details PO3 Stress 1 Stress incontinence is due to leakage of the bladder in particular when people jump up and down and when exercising or during lovemaking This programme is set at a rate of 40Hz the level favoured by UK physiotherapists PO4 Stress 2 Stress incontinence is due to leakage of the bladder in particular when people jump up and down and when exercising or during lovemaking This programme is set at a rate of 30Hz the level favoured by Scandinavian physiotherapists PO5 Frequency Urge New Mothers When a woman has the urge and frequency to actually pass urine several times during the day and night This programme is recommended for new mothers who want to get back in shape after childbirth start after your 6 week check up when you health care professional says it is OK to do so After 12 weeks you can progress onto PO8 the thorough Pelvic Floor Workout a couple of times a week Kegel8 ULTRA U
21. r you and your partner during intimacy Kegel8 ULTRA User Guide Custom Programme Setting up the Customised Programmes PC1 PC2 or PC3 First if a programme is running press the PRG button twice to return to the home screen Refer to the example of custom programme diagram on page 7 1 2 10 11 12 13 Press the PRG button until PC1 PC2 or PC3 is selected Press and hold the SET button for three seconds the phase indicator arrow and Hz symbol will flash on and off Press CH B to set the fequency between 2 Hz and 100 Hz Press CH A the uS symbol will flash press CH B to set the pulse duration between 50 uS and 330 jS Press CH A the MIN symbol will flash press CH B to set the length of the phase time between 1 and 99 minutes Set the time to zero to end the programme on this phase Press CH A the WORK REST or the CONT symbols will flash press the CH B to select WORK REST or CONT continuous Note if continuous is selected the menu will loop back to step 2 Press CH A WK will appear and flash press CH B to set the work seconds between 2 and 99 seconds Press CH A RT will appear and flash press CH B to set the rest seconds between 2 and 99 seconds Press CH A RP will appear and flash press CH B to set the ramp seconds between 0 1 and 9 9 seconds Press CH A AL or SY will appear and flash press CH B to select alternating or synchrono
22. sed with an anal probe please see online for more information or call our helpline 5 Press the on button on the Kegel8 ULTRA control unit the screen will illuminate In the top left hand corner of the screen is displayed the programme setting Click the PRG button under the on off button to select your chosen programme 6 To start the programme press the button on Channel A on the left hand side you will see the mA change to 1 this will start your exercise programme The timer min sec will count down through the routine and switch the unit off when your exercise is complete Kegel8 ULTRA User Guide 7 Please remember the higher the mA s the better the programme will be more MAS more eventual pelvic power The mA s can reach a maximum of 99 however you must choose a level of mA s that is comfortable not painful Increase the mA s using the button on the A side or decreased by using the button on the B side 8 At the end of the programme your Kegel8 will automatically switch off Remove the probe by its base do not pull on the wires Rinse the probe under running water to clean ensuring the connectors do not get wet Dry and store WARNING Do not immerse the probe in boiling water the probe can be sterilized in a mild solution such as Milton Sterilizing fluid if required but we find a simple rinse in warm water is adequate Kegel8 ULTRA User Guide Pre set Kegel8 ULTRA Pelvic Health Programmes
23. ser Guide PO6 and PO7 Frequency Urge When a woman has the urge and frequency to actually pass urine several times during the day and night This programme is used primarily in Scandinavian countries It offers continuous stimulation They prefer continuous stimulation whereas here in the UK we prefer a work rest programme to allow the muscle to rest and recuperate PO8 Lack of Sensitivity In some women following childbirth although they have good muscle control they have a lack of sensitivity This could mean nerve damage and this programme helps to recondition the muscle and to facilitate nerve sprouting to regain sensitivity PO9 Pelvic Floor Workout An excellent overall pelvic floor workout Good for women entering or out of the menopause but not suffering vaginal atrophy see our FAQ s P10 Endurance This programme is ideal if you feel your muscle tone is reasonable and you can contract the muscle but you can t hold the contraction for long P11 Relaxing the Pelvic Muscles This programme is to help relax the pelvic muscle after the excercises when the pelvic muscle has been working hard and some fatigue may have resulted The very low 2 Hz frequency will help to relax the muscle PC2 Vitality We recommned this programme if you lack intimate sensation and want to tighten up your vaginal muscles This programme can reinvigorate your pelvic floor to make it easier to reach orgasnm and increase sensation fo
24. t 1000 Ohms load Electrodes in poor condition the maximum will be limited to 70 mA at 1500 Ohms load the maximum will be limited to 65 mA 3 Type Constant Current maximum output voltage 180 Volts 10 30 Volts 4 Waveform Asymmetrical rectangular bi phasic with zero DC current 5 Selectable pulse width 50 uS 330 uS 2 accuracy Pulse Rate selection in the continuous mode 2 Hz 100 Hz 2 accuracy 7 Time duration of the treatment selectable 1 minute to 90 minutes 8 Low Battery Indicator If the battery goes below 6 9 volts 0 2 volts the battery symbol will flash on off once every second 9 Open Electrode Detect If an open circuit is detected at the output of channel A or B the output current will be reset at Zero 10 Ramp up time 0 3 9 9 seconds 11 If the battery voltage is below 6 6 0 2 volts the unit will not turn on Expected average battery set life of standard 800 mAh alkaline 19h Expected service life 5 years Careful use and maintenance extends the life of the unit over the service life limit Physical dimensions 108 x 62 x 23 mm Weight 70g without battery 100g with battery Environmental Conditions for use 5 to 40 degrees Centigrade 15 93 Humidity Environmental conditions for storage amp transport 10 to 50 degrees Centigrade 0 90 Humidity 28 Kegel8 ULTRA User Guide Information regarding Electromagnetic compatibility and interference EMC
25. tance d 1 2VP 150 KHz to 80 MHz d 1 2VP 80 MHz to 800 MHz d 2 3VP 800 MHz to 2 5 GHz where P is the maximum output power rating Conducted RF IEC 61000 4 6 Radiated RF IEC 61000 4 3 3 Vrms 150 KHz to 80 MHz 3V m 80 MHz to 2 5 GHz 3 Vrms 150 KHz to 80 MHz 3V m 80 MHz to 2 5 GHz of the transmitter in watts W acording to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b interference may occur in the vicinity of equipment marked with the following Co NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidlines may not apply in all situations Electromagnetic propagation is af fected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cord less telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast connot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be consid ered If the measured field strength in the location in which Kegel8 product is used exceeds the applicable RF compliance level above the Kegel8 product should
26. the unit is locked To Unlock the Unit Remove the battery cover and press the concealed switch with a thin rod until a single beep is heard Now the LCD will dis play the average mA used on each channel A B and the total hours and minutes the unit has been in use when locked as shown in the above diagram To return to normal unlocked operation simply press SET Kegel8 ULTRA User Guide Quick Start Instructions Lets Get Started 1 Insert the battery into the Kegel8 ULTRA control panel slide off the cover slot in the battery aligning the and accordingly The red material strip goes under the battery and should be pulled to remove the battery to avoid damage to your Kegel8 controller Slide the battery cover back on 2 Take one of the control leads you have two of these and they have the black and red connectors at one end Insert the white ended connector into the Kegel8 control unit at the top left This is called the A side Push the lead tightly into the socket so it is fully connected 3 Hold the probe at its base and insert it into the vagina the base part remains outside the vagina We recommend you use the lubricant supplied this is not just to facilitate easy insertion it also helps improve the level of conductivity of the stimulation to the muscle 4 Plug the probe wire into the top left hand side of the controller this is the A side used mainly for vaginal probes and the B side can be u
27. us current Note if alternating is selected the menu will loop back to step 2 Press CH A DY will appear and flash press CH B to set the delay of channel B starting between 0 and 4 seconds after channel A The menu will now loop back to step 2 and the Hz symbol will flash To set the next phase press the set button The phase symbol will flash over the next phase continue with step 2 to set this phase 20 Kegel8 ULTRA User Guide 14 When finished setting the phases press the PRG button to save the settings and return to the home screen The programme will be saved permanently Setting the phase time of phase 2 3 4 or 5 to zero will cause the programme to end at that phase Following procedures 1 to 12 can reprogramme a customised programme Applications Why every woman should use the Kegel ULTRA Pelvic Health Device The Kegel8 promotes continence The Kegel8 increases and improves muscle strength The Kegel8 maintains or improves range of movement The Kegel8 increases and improves the blood supply to the muscle The Kegel8 reduces pain The Kegel8 strengthens the pubococcygeus PC muscles in order to prevent or reduce pelvic floor problems and to increase sexual satisfaction The Kegel8 can be used to treat Vaginal and Uterine prolapses depending on the severity of symptoms The Kegel8 can strengthen the levator muscles weakened by damage or lost nerve inp
28. ut from childbirth especially in the case of c sections operations for hernia and hysterectomy 21 Kegel8 ULTRA User Guide Care amp Maintenance of your Kegel8 ULTRA WARNING Only medically approved accessories should be used Control Unit x Wipe the surface once a week with a damp cloth or antiseptic wipe Do not use cleaning sprays or alcohol based cleaning solutions Control unit disposal please return to the distributor Battery To change the battery open the battery door on the rear of the control unit by pressing down on the raised rib pattern just below the belt clip Lift the battery out of the compartment This is very easy and can be done by the user Check periodically for any discharge from the battery Remove battery completely from unit if not in use for any extended period of time typically one week Low battery indicator of 6 9 volts shown on LCD display When flashing change battery for a new one Preferably use a GP Alkaline Pro 9v battery these can be ordered separately Battery disposal please return to the distributor Lead Wires The lead wires should be handled carefully and never stretched as this can cause the stimulation to function below normal standards or not at all Examine lead wires before each treatment for loose connections or damage 22 Kegel8 ULTRA User Guide Avoid stretching and twisting the lead wires Store th
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