Booklet IntelliSTIM BE
Contents
1. 10 50 250 2 4 0 0 5 4 10 P14 PAIN MANAGEMENT PAIN 80 50 6 3 1 1 64 4 25 P15 PROPRIOCEPTION SEXO 195 250 25 0 6 0 3 0 3 03 15 32 11 Available programs Manual programs F n arles eres ie oon Free program 0 without IntelliSTIM control 10 300 10 0 3 0 0 iT 5 Free program 1 under IntelliSTIM control 35 250 4 5 1 0 5 4 15 Free program 2 under IntelliSTIM control 50 250 3 6 0 0 4 15 Free program 3 under IntelliSTIM control 70 250 3 8 0 0 4 4 15 PRESET programs a Fee eee Fo P5 URGE incontinence 5 250 15 0 2 2 0 4 20 P6 URGE 1 incontinence 10 250 30 0 2 2 0 20 P7 URGE 2 incontinence 31 IntelliSTIM BE 28 UG User manual Rev 4 10 03 2006 For urge incontinence most people start noticing an improvement after 7 10 20 minute treatments and a majority are cured after 15 20 treatments Stress incontinence requires the rebuilding of muscle strength and endurance so results take longer The IntelliS TIM function There is a relationship between FREQUENCY WORK time and REST times as regards the physiological effect If the frequency is changed then work and rest tim2. PROG button for more than 2 sec opens the to the menu of P05 P12 PRESET programs To again switch to the manual programs simply press the PROG again for 2 seconds When the PROG button is pressed the output stops Hz Hz buttons AzA These buttons are pressed to modify the operating Hz frequency It is also possible to change the frequency while the unit is in use for example to select more comfortable parameters 18 4 The Ta T Y buttons can be used to change the Pulse width The FUNCTION button is used to sequentially select and show on the display any time based parameters used in the stimulation program e Treatment time e Synchronisation 3 S e ACTION time O7 Or N e REST time e REST time Ch2 only if ALT S synchronisation has been selected e RAMP UP time 7 e RAMP DOWN time Any selected parameter can be easily modified using the buttons Ta TY The symbol identifying the selected parameter is seen blinking on the display should the parameter not be modified within 6 seconds using the key buttons Ta TY the device will return to the original function 19 IntelliSTIM BE 28 UG User manual Rev 4 10 03 2006 The channels Ch1 and Ch2 are always synchronised which means the times of work and rest are the same for both channels The alternating mode of Ch1 and Ch2 3 5 is possible only in the program MO
3. Selecting and modifying the Synchronisation parameter is done using the FUNCTION key as explained above A The buttons intensity CH1 av and intensity CH2 ay Increase or decrease stimulation level of Channel 1 and Channel 2 respectively The button Wave shape can be used for changing the Ain wave shape for example to simultaneously stimulate just one or two similar muscles contra lateral with the same channel 20
4. original function pulse width For MANUAL programs changes will be saved In PRESET programs changes will be lost when the device is switched off To change the SYNChronisation between Ch1 and Ch2 Possible only for the MO program The possible selections will be 3 or S simultaneous or alternating 22 9 Starting a session When the unit is switched ON the program used during the last session is ready to use again Simply set the intensity level for each channel To select a different program Press the PROG button to select one of the other programs in memory PO5 to P12 or MO M1 M2 M3 To switch between MANUAL programs M and PRESET Programs P the PROG key must be held down for at least 2 seconds see section 8 To change the FREQUENCY Use the Hz Hz buttons to change the frequency of the selected program The frequency can be changed at any time even during the preset programs To change the Pulse WIDTH Use the Ta TY buttons to change the Pulse WIDTH of the selected program The Pulse WIDTH can be changed at any time even while the preset programs are running 21 IntelliSTIM BE 28 UG User manual Rev 4 10 03 2006 relationships automatically preserved by IntelliSTIM M O completely free without the automatic Intellistim adjustment and 8 PRESET Programs Pressing PROG button successively selects programs from MOO to M03 then back to MOO Pressing and holding
5. appropriate for recovery or elimination Please contact the BEAC local distributor for detailed information on the collection and processing of this product 38 USER name write in CAPITALS USER address write in CAPITALS Other USER data Phone Fax E Mail Data of the PURCHASE Details of any complaint in CAPITALS Model IntelliSTIM BE 28 UG Serial Moo cece cceccceeeceeeeeeeeeaeeeeeeeeaeess Date of purchase 1 Introducing PFS perineal re education through electrical stimulation Pelvic floor or perineal stimulation is a popular method for treating incontinence Pelvic floor electrostimulation successfully restores continence especially in female patients Pelvic floor electrostimulation is normally applied using vaginal electrodes probes characterised by at least two electrodes often in the form of rings The object is to stimulate the group of perineal muscles especially the pubococcygeal muscle 2 Effects of PFS Pelvic Floor Stimulation The different effects of electrostimulation have been observed and demonstrated by many researchers Strengthening the pelvic floor Electrostimulation improves muscle activity When the Oxford score pubococcygeal test gives a value of 1 or 2 1 just perceptible contraction 2 weak contraction endo vaginal electrostimulation has been found to be very effective quic
6. of explosion if the batteries are fitted incorrectly Replace with AA Alkaline 1 5 volt batteries LR6 Do not mix old and new batteries Do not dispose of the batteries in a fire and keep them out of reach of children The 14 batteries must be removed from the device before it is scrapped and they should be disposed of safely STEP 2 LEADS Decide whether you wish to use the unit with one lead or two Unravel one or both leads and insert the plug s into either of the sockets at the top of the unit If only using one lead insert into the ch1 socket as marked on the unit STEP 3 PROBE Remove the probe from the bag and connect it to the leads Before using on a patient test the stimulation by holding the probe in the hand Increase the intensity only while stimulation is taking place STEP 4 POSITION OF PROBE Insert the probe as described in the Section 5 STEP 5 Read the next section on Operation of the IntelliSTIM UG Unit and decide how to use the unit for the treatment 15 IntelliSTIM BE 28 UG User manual Rev 4 10 03 2006 FUNCTION key within 6 seconds The symbol of the parameter ready to be set will be seen blinking on the display Make changes using the Ta Ty buttons 6 seconds after these keys are used the setting will return to the original pulse width function To change the REST time After having set the WORK time press the FUNCTION button within 6 seconds and the RES
7. 16 Function of the buttons The ON OFF gt button gt D Switches the unit ON OFF and PAUSES the activity as required Press once to switch ON when the unit is OFF When the unit is ON and the intensity of both channels is 0 press the same button once more to switch OFF When the unit is ON and the intensity of at least one channel is above O pressing the same button once more will PAUSE the unit the output level of both channels go to zero and the symbol gt II will be displayed To exit from the PAUSE state push the same button once more The level of intensity level before pausing will be restored on both channels in 2 seconds To switch the unit OFF while it is stimulating push and hold down the ON OFF button for at least 2 seconds PROG button This is for selecting Programs 3 Manual ze Programs M 1 M 2 M 3 Prog with the Frequency Work and Rest time 17 IntelliSTIM BE 28 UG User manual Rev 4 10 03 2006 Either the Frequency or the Pulse width can be changed and the difference will be immediately felt by the user With the FUNCTION button it is possible to sequentially select some other parameters which can be then modified using the buttons Ta TY For example To change the TREATMENT time Press the FUNCTION button once to select the TREATMENT time Then change it within 6 seconds by using the Ta TY buttons After 6 seconds the buttons Ta TY will return to the
8. CONTENTS 1 Introducing PFS 2 2 EffectsofPFS 3 3 Indications forPFS 5 4 Product description T The IntelliSTIM function 8 5 Perineal stimulation techniques 9 6 Contraindications 11 T Preparing the unit 13 8 Operation 16 9 Starting a session 21 10 Specifications 27 11 Available programs 31 12 Connection of probes 33 13 General Information 34 14 Warranty 36 15 Information for disposal of the product 38 1 IntelliSTIM BE 28 UG User manual Rev 4 10 03 2006 15 Information for disposal of the product This symbol indicates that the product as Electric or Electronic product must be disposed of separately from normal waste at the end of its operational lifetime Please dispose of this product by taking it to your local collection point or recycling centre for such equipment This will help to protect the environment in which we all live This obligation is set out in directive 2002 96 CE accepted in law by the government of every European community member country The product contains parts that can be recovered or eliminated safely contributing to the environmental improvement The product contains substances which if incorrectly disposed of can have harmful effects on the environment and human health The Manufacturer is available to dispose the product at the end of its useful life as
9. STIM BE 28 UG User manual Rev 4 10 03 2006 down as the contraction lifts the pelvic floor and the patient feels a muscle contraction a tightening of the pelvic floor When the current is increased a pins and needles sensation is felt and this becomes more and more intense but when the muscles contract the stimulation feels more comfortable Stimulation should never be too uncomfortable It is impossible to cause damage with the Intellistim When using a low frequency program for URGE incontinence the object is not a muscle contraction so we do not look for any probe movement one must rely on patient feedback on the position of the probe and the intensity of stimulation The higher the intensity the more therapeutic is the stimulation so ask the patient to make themselves as uncomfortable as possible During stimulation the discomfort diminishes with time and the current can be turned up further 10 6 CONTRAINDICATIONS BEFORE USE PLEASE READ THE FOLLOWING General contraindications of electrical stimulation Do not use IntelliSTIM BE 28UG unit under the following circumstances e For 3 months after labour or at anytime during pregnancy e If a heart pacemaker is used or in the case of a serious heart rhythm problem e While driving or operating machinery Be cautious using IntelliSTIM BE 28UG unit under the following circumstances 1 In case of epilepsy consult your doctor before using any e
10. T time symbol will be seen blinking on the display Using Ta TY buttons change the time Then after 6 seconds the original pulse width function setting will return The Ch2 REST time Normally the REST time is the same for both channels Ch1 and Ch2 The only exception is in MO program In this case after selecting the 24 stimulation Once the TREATMENT time is set again press the FUNCTION key and see the symbol 3 will blinking on the display Using the Ta TY buttons change the synchronisation between SIMULTANEOUS 3 and ALTERNATING 5 If a button is not pressed within 6 seconds the buttons Ta TY will return to their original function pulse width To change the WORK time The WORK time of any program is preset automatically by the InteliSTIM system if this is acceptable there is then no need to modify it A change is possible temporarily in the preset programs permanently in the manual programs Once synchronization is set WORK time can be set by again pressing the 23 IntelliSTIM BE 28 UG User manual Rev 4 10 03 2006 8 OPERATION Operation of the IntelliSTIM BE 28UG unit is controlled by buttons on the keyboard and the LCD display shows what is happening The display CH1 CH2 DOSS Aus S SO PROGRAM URGE II PAIN ana O STRESS II MIX RELAX SEXO I 1H AG Cas Ome AE Abie The keyboard Om Gn GO Prog D A D A
11. des the red connector should be connected to the proximal electrode ring in the middle of the probe The symmetrical biphasic wave shape should be used 3 When using probes with electrodes along the two sides it would be better to use the symmetrical alternating wave shape 4 The second channel can be used for example for special double circuit probes for simultaneous vaginal and anal stimulation 33 IntelliSTIM BE 28 UG User manual Rev 4 10 03 2006 Urge incontinence caused by detrusor instability Here the most appropriate frequency is between 5 and 10 Hz with a pulse width of between 250 and 400 microseconds The treatment is best performed on daily basis for the first week then 2 to 3 sessions per week for the next 3 or 4 weeks The therapy may be conducted at home Mixed Incontinence This accounts for about 40 of all cases of incontinence and is characterised by episodes of incontinence when straining along with or alternating with episodes of incontinence due to detrusor instability causing urgency Depending on the predominance of the first or the second kind of incontinence one can decide to use a relatively high frequency e g 75 Hz for greater effect on the muscle 6 tone or lower frequencies to give greatest effect on detrusor inihibition Urge incontinence usually responds more quickly than stress so this is usually treated first Alternatively two treatments per day
12. es should also be adjusted to achieve the best results For Manual Programs M1 M3 the IntelliSTIM system automatically adjusts work and rest times when frequency is changed This unique feature makes it very easy to set programs without having to consider the optimum relationship between frequency work and rest times 5 Pelvic floor stimulation techniques The stimulation level and the position of the electrodes play a key role in the success of PFS The patient should be placed in the modified gynaecological position and be relaxed Once the probe has been correctly inserted ask the patient to straighten the legs perhaps placing a pillow under the knees to allow the legs to remain slightly flexed The session will proceed with the patient in the chosen position reclining sitting or standing How does one know that the probe is in the right position It is quite easy Insert the probe as far as it will go comfortably When using a program for obtaining pelvic floor contractions Stress incontinence during the contraction phase we MUST observe that the external portion of the probe tilts 9 IntelliSTIM BE 28 UG User manual Rev 4 10 03 2006 minute Once it reaches zero the unit will automatically shut off Auto switch OFF When the unit intensity levels are 0 on both channels and it has not been in use for 5 minutes the unit will automatically switch off Open circuit detection When
13. h relatively short work periods and gradually building up endurance by increasing the contraction time as the muscles strengthen Pulse widths may be selected between 100 to 400 microseconds depending on the patient 5 IntelliSTIM BE 28 UG User manual Rev 4 10 03 2006 13 GENERAL INFORMATION Statement This unit is CE Marked according to C the 93 42 CEE MDD 0051 Directive and it is classified a Medical Device class lla PRECAUTIONS A 1 Do not immerse the unit in water 2 Do not place the unit close to excessive heat 3 Use only the specified batteries 2x 1 5volt AA Alkaline LR6 Using of any other battery could damage the unit 4 Do not use the unit while asleep 5 Remove the batteries from the unit when it is not used for long time 6 Keep the unit away from sources of high magnetic fields such as TV S microwave ovens and hi fi speakers as these may affect the LCD screen 6 Temperature amp Relative Humidity during storage and transport 20 C to 80 C 8 to 80 R H 34 12 CONNECTION OF PROBES Cables and Polarity management Each channel output is connected to the probe vaginal or anal through a pair of cables terminating with male 2mm colored connection one red one black General principles 1 Using the symmetrical biphasic wave shape the strongest effect will be felt under the positive electrode red 2 When using probes with two ring shaped electro
14. kly producing an improvement by at least 2 points This improvement is the result of the electrostimulation providing two separate but concurrent effects the excito motor action that increases muscle tone and the vascular effect improving local circulation Effect on the urethral closure pressure A significant increase of the urethral closure pressure has been reported by some researchers Dr PIGNE BOURCIER 3 IntelliSTIM BE 28 UG User manual Rev 4 10 03 2006 14 WARRANTY In addition to your statutory rights the Manufacturer agrees that if any defect in materials or workmanship appears in this product within two years after the original date of consumer purchase it will repair or at it s option replace the product in question free of charge This applies only if the product has been used for domestic purposes and has not been damaged through misuse accident or neglect and has not been modified or repaired by anyone other than the Manufacturer or its authorized agents If a defect appears please check that the article is being used in accordance with instructions if so return it with this warranty and the Certificate of Purchase or some other proof of purchase to your nearest IntelliSTIM supplier Note only our authorized service agents should carry out Repairs of the IntelliSTIM BE 28UG units Exclusions The batteries must be considered excluded by this warranty due to their exhaust du
15. lectrical stimulation unit 2 For children under 12 apply only under medical supervision 11 IntelliSTIM BE 28 UG User manual Rev 4 10 03 2006 Other features The LOCK function prevents patients from changing parameters Simultaneously push and hold for at least 4 seconds the CH1 intensity v and Ta buttons the unit will then lock The user will be only allowed to e Set the intensity e Set the session time The locked state will be unaffected by switching off the unit or by removing the batteries When the unit is locked a small symbol of a key will appear on the right lower corner of the display The Program LOCK function Simultaneously push and hold for at least 4 seconds the CH2 intensity v and Ta keys only the program in use will be locked In such state the user will be unable to change any parameters of the locked program however one may e Select another program manual or preset 28 10 Specifications Ch1 intensity settings in 20 steps of 5mA from 5mA to 100mA on a 1KQ load peak to peak value by using a pulse width of 200us Ch2 intensity settings in 20 steps of 5mA from 5mA to 100mA on a 1KQ load peak to peak value by using a pulse width of 200us Frequency Hz 1 2 3 4 5 6 7 8 9 10 12 14 16 18 20 25 30 35 40 45 50 60 70 80 90 100 110 120 130 140 150 Hz Pulse width 50 400us in steps of 50us Wave forms Rectangular bipha
16. one for urge and the other for stress may be carried out 4 Product description IntelliSTIM BE 28UG is a dual channel perineal stimulator suitable for professional or personal use Fifteen pre set programs are available in the memory ready for use They can be modified by the therapist but any changes will be lost when the unit is switched off unless the program is locked For stress incontinence treatment consists of periods of stimulation through a vaginal or anal probe causing pelvic floor muscle contractions these are followed by rest periods The objective is to improve the voluntary control of the pelvic floor muscles for stress incontinence or to strengthen the reflex inhibition of the detrusor muscle for urge incontinence 7 IntelliSTIM BE 28 UG User manual Rev 3 13 08 2005 PRESET programs 20 250 30 10 3 0 0 20 a r or oclo lev Fe P8 STRESS incontinence STRESS 35 250 3 6 0 0 3 20 P9 STRESS incontinence 1 STRESS 1 50 250 2 4 0 0 3 4 20 P10 STRESS incontinence 2 STRESS 2 60 250 2 4 0 0 3 4 20 P11 MIXED incontinence MIX 35 250 3 6 0 O 10 4 2 20 P12 MIORELAXING RLX 2 400 30 0 2 2 0 4 8 cating ACB daske ater CIDR 10 250 5 1 3 3 0 4
17. one or both of the electrodes do not touch the skin or contact is broken the output level of the corresponding channel will immediately drop to zero Cumulative time recording By simultaneously pushing and holding for at least 4 seconds the keys Ch2 v and Prog the display will show the cumulative time the device was used since the last resetting It is possible reset this value by simply pushing and holding down the Prog and Wave Shape keys for at least 4 seconds To return to the normal operating mode push again and hold down the keys Ch2v and Prog 30 e Set the intensity e Set the session time The program lock state will be unaffected by switching off the unit or by removing the batteries When the unit is program locked and the locked program is selected a small symbol of a key will blink on the right lower corner of the display To Unlock a locked program repeat the same steps made to lock it Parameter retention Should during the session one or more parameters of a manual program MO M3 except the intensity and the session time be modified the new values will be retained even after switching OFF the unit or removing the batteries On the contrary in the case of pre set programs any parameter change will be lost when the unit is switched OFF Session time When the treatment timer is set it will begin to count down one minute by one 29 Intelli
18. ress the FUNCTION button to bring up the blinking RAMP DOWN symbol and set the time using the Ta TY buttons as before 26 alternating synchronisation S and after having set the REST time on Chi again press the FUNCTION button and adjust the REST time on Ch2 by using the Ta TY buttons as before After 6 seconds the original pulse width function returns WARNING The REST time of Ch2 can NEVER be set lower that the WORK time If the setting is incorrect the ATTENTION Symbol A will blink on the display and the REST time on Ch2 will be shown again ready to be changed To change the RAMP UP time After having set the REST time or the REST Ch2 time by again pressing the FUNCTION button the Ta TY buttons set the RISE time which will be seen blinking After 6 seconds 25 IntelliSTIM BE 28 UG User manual Rev 4 10 03 2006 To assemble the unit Assembly of the IntelliSTIM BE 28UG unit is very easy and requires only five steps STEP 1 BATTERIES Remove the battery cover and insert two batteries as shown on the diagram inside the battery compartment Re apply the battery cover Note Your unit will not function if the batteries are inserted incorrectly Pull down the front cover to expose the buttons Press the Om ON OFF button once and the LCD display will light if the batteries have been correctly inserted Press the button again to switch the unit off CAUTION There is a risk
19. ring normal usage 36 ORIGINAL ACCESSORIES The unit must be used only with the original accessories supplied by the manufacturer Since the unit is used with internal special electrodes for perineal stimulation therapy they must be the original type supplied or suggested by the manufacturer in any case they must have CE mark as Class lla medical device according to the 93 42 CEE Directive The instructions for use and cleaning of accessories included in their original package must be read and followed 35 IntelliSTIM BE 28 UG User manual Rev 4 10 03 2006 Effect on the vesical tone A significant improvement of vesical compliance has been observed along with a considerable reduction of the non inhibited contractions of the detrusor An improvement of the cystometric capacity has also been observed 3 Indications for PFS Pelvic Floor stimulation Stress incontinence frequently due to sphincter deficiency Symptoms include leaking of urine caused by a strain such as coughing rising from a chair etc in absence of detrusor activity Stress incontinence is usually treated with relatively high frequency electrical pulses from 35 to 100 pulses per sec p p s depending on patients and therapist preference this exercises the phasic components of the muscle fibres which provide strong but short contractions The treatment should be performed for about 20 minutes daily starting wit
20. sic symmetrical Rectangular alternating biphasic RISE FALL times 0 5s in steps of 1s ACTION time 1 60s in steps of 1s REST time 0 60s in steps of 1s TREATMENT time Continuous 10 20 30 45 60 90 minutes 27 IntelliSTIM BE 28 UG User manual Rev 4 10 03 2006 Contraindications of perineal electrostimulation Absolute contraindications pregnancy nephropathies infections of the lower urinary tract tumours In situ post micturition residual above 100 ml vesico ureteral reflux total denervation vaginal bleeding outside the time of menstruation Relative contraindications Hyper sensitivity to the electrostimulation menses psychological contraindications IF IN DOUBT CONSULT YOUR THERAPIST 12 7 PREPARING THE UNIT The IntelliSTIM BE 28UG unit has been designed to be simple and easy to use yet highly effective Before use please read all the instructions and ensure that CONTRAINDICATIONS do not apply CONTENTS Your IntelliSTIM pack should contain the following e 1 IntelliSTIM UG Unit e 2 Leads e 2 Alkaline AA1 54v LR6 Batteries e 1 Instruction Booklet which you are reading e 1 carry bag Having checked that all the contents are correct please proceed to assemble the unit 13 IntelliSTIM BE 28 UG User manual Rev 4 10 03 2006 the original pulse width function will return To change the RAMP DOWN time After having set the RAMP UP time p
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