DVP1000 Tap Water Iontophoresis (TWI) System User Manual
Contents
1. 04 01 2015 IMPORTANT EMI INFORMATION 1 20 volts per meter V m is a generally achievable and useful immunity level against interference from radio wave sources as of May 1994 the higher the level the greater the protection 2 This device has an immunity level of 20V m with no accessories con nected to the device HIDREX tap water iontophoresis devices should be used in an electro magnetic environment as listed below The client or user should ensure that it is used in an appropriate environ ment Table 1 Electromagnetic Emissions Conformity EMC environment Guide The test unit generates RF energy only for internal RF emission following CISPR Group 1 use Radiation thus is low 11 and it seems unlikely that adjacent medical appa ratus is perturbed af emission following CISPR HIDREX tap water ionto phoresis devices are suit Mains harmonics following abla forse inal esiab IEC61000 3 2 lishments including do mestic establishments and those directly connected to Emission of voltage dips flicker Compliant a public low voltage power following IEC61000 3 3 supply network that sup plies buildings used for domestic purposes Table 4 Electromagnetic Immunity Life Support Equipment Susceptibility IEC 60601 test level Actual level Conducted RF 3V ort 3 V IEC 61000 4 6 150 kHz to 80 MHz Radiated RF 3V ort IEC 61000 4 3 80 MHz to 2 5 GHz Rev 1 0 04 01 2015 DVP1000 Tap Water lontophoresis Syst2. H DREAX GREAT POWER II GREAT OUTCOMES DVP1000 Tap Water lontophoresis TWI System User Manual DVP1000 HiDREX Accessories not shown Table of Contents Table of Contents Read Before Use Your Safety is Important eie ee RR ee ER ee ee ee ee ER ee ee ee ee ee Ee ee ee ee ee ee ee Contraindications ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee Additional Important Safety Considerations ccccccccsscccceeesssssseeeeeeesssssseeeeeeeeeeeas Intended Use Mechanism of Action Treatment Fundamentals 0cccccccccccccccccceeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeseeseceeeeeeeeeeeeseesesensess Polarity Reversal and the Efficacy of Treatment iese ee ee ee EE ee ee ee ee Types of Current a es eee Ee DE N eee EG De System Components Standard Accessories ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee ee Optional Accessories EER Ee ER RR RR RR EG Gee Gee Ee RA RR RR RE EE Ee Gee Gee RR RR RR RE EE EE Control Unit Side amp Rear Panel Element see ees ee ee RR ee ee RR ee GR RR Re e RR Re ee GER EK ee Control Unit Front Panel Elements esse ees ee ee ke ee ee RR ee RR ee RR ee RR ee ee RR ee RR Re ee RR Ke ee Ee Installation Treatment Setup Setup for Hands and Feet Treatment ee Setup for Axillary Armpits Treatment eie ee ee ER ee ee ee ee ee ee ee Conducting Treatments Primary Param
3. Profile Button Dose Setup confirm settings and exit Programming Mode Lower dose Setup Mode Confirm settings and exit to then enter Programming Mode Programming Mode Increase dose Setup Mode Select pulse width and type of current Programming Mode Decrease time Setup Mode Select Profile Programming Mode Increase time Setup Mode and during treatment Switch display during treatment only between voltage and current milliamps Indicates selected user profiles for specified treatment areas 3 LEDs Indicates display shows measured current in amperes during treatment Indicates Pulsed or Variable Pulsed Current has been selected Active indicates that circuit is complete and device is active DVP1000 Tap Water lontophoresis System User Manual Rev 1 0 04 01 2015 Installation Treatment Setup The following steps describe how you set up your therapy system for a treatment session Please note that the setup for treating hands or feet is slightly different from the setup required for treating hands and feet simultaneously or for treating the underarms Setup for Hands and Feet Treatment 1 Place the device on a firm level surface Make sure an electrical outlet is within reach 2 Insert the AC adapter cable into jack on the rear panel and plug the adapter into an AC wall outlet 3 Plug the color coded connectors of the cable set into the jacks on the back panel to their matchin
4. by new ones e The control unit must be purified and disinfected A technical check and safety inspection must be completed and docu mented The medical device may be reconditioned up to 10 times Troubleshooting If prior to during or after a treatment session the device does not operate in accordance with this manual please go through the following checklist and perform the operational check before you send the device for repair This can save you considerable cost and inconvenience Thank you Error Checklist Please go through this checklist as the first step in troubleshooting B gt Verify that the AC power adapter is properly connected to the control unit and to the wall outlet B gt Verify that the connectors on the cable set are pushed far enough onto the receptacles of the treatment electrodes for establishing a re liable connection B gt Verify that the device works properly on another person If it does over treatment protection is on and you will need to wait until your skin needs treatment before using again Hint In rare cases tap water conductance may be inadequate e g when tap water deionizing equipment is in use In that case try non carbonated mineral or table water instead to raise the current 22 DVP1000 Tap Water lontophoresis System User Manual Rev 1 0 04 01 2015 Operational Check Proceed with the following steps for an operational check of your system 1 Setup the therap
5. by or on the order of a physician Contraindications A Under none of the following circumstances should you use iontophoresis Patient with a cardiac pacemaker Patient with an ICD implantable cardioverter defibrillator Pregnancy Patient with a metal containing intrauterine device IUD Metallic implants within the current path arm or leg oo 2 amp Large skin defects wounds that cannot be covered with petroleum jelly Rev 1 0 04 01 2015 DVP1000 Tap Water lontophoresis System User Manual 3 Patients with impaired sensibility in their hands or feet e g patients with polyneuropathies Potentially malignant lesions acute localized infections skin eruptions or swollen broken or inflamed areas Any area where sensation is absent or impaired Apply electrical current through or across the chest brain or sinuses Patients with suspected or diagnosed heart problems or epilepsy Side Effects Possible side effects or results of using this device include Mild dysesthesia tingling or burning Short term skin irritation reddening after treatment A Erythema skin redness transient vesicles or blisters Skin irritation or burns at the areas of electrode contact have been re ported with the use of electrical stimulators BOY O D oo 20 Additional Important Safety Considerations DO Place the device on a firm level surface lt gt Make sure that the device is at room temperature befo
6. current used during treatment DC Direct Current standard PC Pulsed Current VPC Variable Pulsed Current 6 DVP1000 Tap Water lontophoresis System User Manual Rev 1 0 04 01 2015 PC and VPC are recommended as options for treatment of underarms or treat ments where the skin is more sensitive or for the treatment of children Pulse width is a measurement or metric used to define the type of current The pulse width directly corresponds to the percent of time the current is being transmitted within the current cycle for example a pulse width of 60 means that the current is transmitting 60 of the time during one cycle Direct Current DC In DC the current voltage is being transmitted 100 of the time equivalent to a pulse width of 100 DC is the standard current of the device and is the most efficient method of tap water iontophoresis treatment available Due to user comfort preferences this device gives the user the option to choose PC or VPC as alternatives Pulsed Current PC In PC the current alternates its transmission between ON the pulse and OFF the pause for equal lengths of time The pulse and the pause are the same duration equivalent to a pulse width of 50 PC can be practically imperceptible at certain voltages and allows a better com fort level but is typically slightly less effective Variable Pulsed Current VPC VPC is a type of hybrid current between DC and traditional PC
7. influence on the completion of the session and protects you only against burns 1 This does not relate to the surface skin layer but to the moisture content of the deeper skin layers an indicator of the extent of hyperhidrosis DVP1000 Tap Water lontophoresis System User Manual Rev 1 0 04 01 2015 During the course of further treatments higher dose values are gradually reached as perspiration decreases the electric resistance of the skin in creases so higher doses are necessary for effectiveness The protection circuit may appear to react faster when using pulsed current mode but this is not the actual case In PC or VPC mode the average dose value is displayed but the device monitors the maximum current not the average Safety circuit The DVP1000 has a safety circuit which stops the treatment in the case the current exceeds 35 mA In this case the display will show StOP and all LEDs will blink Please turn it off unplug the power supply from the wall and send the device with all electrical accessories back to us if this occurs Please refer to section Shipping the Device for Repair or Maintenance Care and Maintenance This section contains important instructions about your HIDREX system Special Remarks Our responsibility for system safety functionality and reliability applies only if any maintenance and servicing is exclusively performed by an authorized HIDREX repair center Our warranty ceas
8. of the treatment area for example right hand then it is advisable to reverse polarity and contin ue the initial phase without changing polarity up to normal or acceptable dryness has occurred in the other side of the treatment area for example left hand Once normal or acceptable dryness has occurred in both sides of the treatment area for example both hands then it is advisable to reverse polarity for each treatment during the maintenance phase Phase 2 Polarity is reversed simply by changing which side of the treatment area is treat ed by the anode or cathode the electrodes with the red or black cable respec tively For example on the first treatment in the maintenance phase if the right hand was treated with the anode and the left hand was treated with the cathode then on the next treatment the right hand would be treated with the cathode and the left hand would be treated with the anode This sequence would continue for every treatment Remark Failure to do this does not cause any harm or side effects rather results in only a slight loss of efficacy Long term treatment re sults do not depend on the direction of current flow Only in the beginning of the initial phase Phase 1 the anode red cable is slightly more effective than the cathode black cable Hint It is recommended NOT to reverse polarity within any given treat ment session Types of Current The DVP1000 has several options for the type of
9. take home and clean themselves and then bring them back to subsequent sessions DVP1000 Tap Water lontophoresis System User Manual Rev 1 0 04 01 2015 e Hand wash the axillary pads with 140 195 F 60 90 C water and common detergent Rinse thoroughly with clean water squeeze dry rig orously and let the pads air dry e Hand or machine wash the towels with 140 F 60 C water and a com mon detergent Dry the towels by dryer or air dry Important Calcifications on the electrodes can hinder the treatment current This deposit can be removed with a common descaler or even vinegar or citric acid A discoloration of the electrode metal after the first treatment ses sions is normal Maintenance HIDREX tap water iontophoresis devices are basically maintenance free Nevertheless for safety reasons we recommend a technical check and safety inspection by an authorized HIDREX repair every 2 years Suitable measuring and test equipment is mandatory for the technical safety inspections which cover at least the following Visual check of medical device and accessories Protective conductor test in accordance with EN 60601 1 2007 Leakage current test in accordance with EN 60601 1 2007 Operational check of the medical device Because exclusively unscathed skin will be treated the HIDREX tap water ionto phoresis devices are classified as non critical concerning disinfection As a communal device for multi pat
10. than normal the dose cannot be increased protection against over treatment Your HIDREX system automatically checks your specific skin conductance If your skin conductance is beyond the preset threshold the protection circuit is activated and locks the system The ACTIVE LED does not light up even when the treatment current path is closed Hint To double check if over treatment protection has been activated for you and that it is not a fault of the device you can run a quick opera tional check of the device to confirm that it is your skin conductance and not the device Simply take one cable red OR black and insert each end into a jack on the module AFTER the device is in Program ming Mode This closes the circuit the ACTIVE LED will light up if the device is working properly If over treatment protection is activated you should interrupt your treatment course for at least one week until excessive perspiration returns Please contact us if the OTP feature has been activated AND you still have excessive perspiration which is a situation that may arise in very rare cir cumstances Current Limitation In cases of very heavy sweating which indicates a low electric resistance of the skin and easier current flow the maximum treatment current can be reached before the specified dose volt value is achieved A protection cir cuit current limitation intervenes in this case and stops the device This doesn t have any
11. your DVP1000 is pre set as follows Perret Pulse width 90 preset for Time 15 minutes hand Dose 20 Volts PROFILE 2 Pulse width 100 DC preset for Time 15 minutes feet Dose 30 Volts PROFILE 3 Pulse width 70 preset for Time 15 minutes axillary Dose 8 Volts The settings provided in the table above are also the recommended initial values for treating in manual mode In order to avoid skin irritation by excessive dose settings in pulsed mode where current flow is practically imperceptible we recommend that you assess your individual direct current thresh olds for hands feet or armpits before you start the first treatment session To conduct axillary treatments as a rule the dose should not be raised above 15 volts because the sensitive skin may otherwise get burnt Begin Treatment Programming Mode After completion of the initial setup the unit will automatically switch to Pro gramming Mode after about 6 seconds or when the ENTER button is pressed Depending on Profile selection the intended treatment time and dose will be displayed Before you start the actual treatment session you need to check and or set the time and dose treatment parameters Rev 1 0 04 01 2015 DVP1000 Tap Water lontophoresis System User Manual 15 1 Setting treatment parameters If a Profile presets for hands feet or axillary has been selected the device uses the corresponding saved treatme
12. REX repair center DO Wash the supplied towels on a regular basis together with your regular laundry make sure to comply with the laundry instructions on the tag Intended Use Mechanism of Action Intended Use This tap water iontophoresis device is intended to treat hyperhidrosis excessive sweating affecting hands feet and A underarms Any other use or usage beyond this scope is considered un intended use and may have dangerous consequences Mechanism of Action During the HIDREX treatment a current flows through the body regions that are being treated The water in the trays or pads mediates this current flow The skin areas in contact with the water will thereby secrete less sweat Although treatment success has been validated in numerous medical stud les there is still no completely satisfactory scientific explanation for the mechanism of action Medical researchers believe that the electrical current irritates the synapses between sweat inducing nerves and sweat glands to such an extent that sweat glands can no longer be stimulated In other words the treatment does not affect the sweat glands directly it only affects the nervous input to these glands This effect explains why the original condition returns relatively quick ly when the treatment is discontinued The treatment current can be adjusted according to your individual sensitivity There is no risk involved as the current cannot exceed certain maximum
13. ability System setup is easy and the device is simple to operate This manual is intended to guide you through setup and programming familiarize you with the system s features and offer hints on the use of your new therapy system A Your Safety is Important This treatment system may only be powered by the HIDREX AC power adapter which can be identified by a HIDREX nameplate with Serial No This power supply is especially designed for this device In order to prevent burns during treatment make sure the supplied tow els or pads cover the treatment electrodes at all times Avoid direct con tact with the metallic surface Two devices may not be simultaneously used by one patient Prior to treatment remove any metallic jewelry wedding bands etc which would otherwise come in contact with the water source trays or pads Keeping such accessories on would lead to localized minor elec trical burns that are secondary to increased current densities Avoid application of current in excess of that which can be safely and comfortably tolerated by the patient Always treat carefully and observe patient reaction As a rule avoid current intensity greater than 0 5 1 0 milliamperes per square inch of active electrode area The long term effects of chronic electrical stimulation have not been es tablished Keep this device out of the reach of children Caution U S Federal law restricts this device to sale
14. and allows for the ON part of the cycle the pulse to run longer than the OFF part of the cycle the pause This device allows you to change the pulse width in 10 increments for example ON Variable Pulse Width 60 and OFF 40 or ON 70 and OFF 30 High efficiency combined with minimal sensitivity etc This allows for more effective treatment AND a better comfort level It is customizable for your preferences and tolerance levels With increasing percentages of the pulse width the length of the pulse is increased and the length of the pause is decreased accord ingly Due to the shorter pause more current is applied than in PC The chart to the right shows how treatment efficiency increases as gus pulse width increases G vo he i 12 Y o v 10C100 Extensive trials showed that the efficiency of pulsed current can be increased dramatically When the pulse width is 90 the effectiveness is almost the same when compared to direct current for example 50 microseconds ON and then 50 microseconds OFF and then the cycle repeats Rev 1 0 04 01 2015 DVP1000 Tap Water lontophoresis System User Manual 7 In summary the following chart defines what is DC PC or VPC based on pulse width EE HE Variable Pulse Current VPC 60 70 80 90 Hint Once selected for the treatment session the pulse width will remain the same throughout the session If the user desires to change the pulse wi
15. d of repair or replacement parts or additional accessories are needed the patient can contact customer service at 1 8HIDREXUSA 1 844 373 9872 or customer service hidrexusa com Care and Purification For flawless and long lasting function of your HIDREX tap water iontophoresis device we recommend the following steps after each use Care after each treatment Wash out towels 4 or axillary cushions thoroughly with clean water without addition of detergents or cleaning agents e Squeeze dry the towels or axillary pads rigorously to remove excess moisture e Let the towelsA or axillary pads air dry do not store in the closed hardcase due to humidity e Dry the electrodes 4 with a soft cloth to prevent calcium deposits on the sheet metal Please make sure to remove any moisture from the treat ment electrodes after each treatment e Dry the treatment trays hard case trays or ergonomic trays with a soft cloth and let them air dry do not close the hard case tray due to humidity Purification Cleaning every 5 sessions or whenever necessary Warning Before cleaning make sure the device is turned off and separated from the power line Never use kero sene thinner or other solvents e The control unit the treatment trays hard case trays or ergonomic trays and electrodes4 should be cleaned with a moistened cloth or with a common detergent 1 It is suggested that the consumables are given to the patient to
16. dth for better comfort or more efficiency then the treatment must be stopped Power must be cycled on the device to return to Setup Mode to change the pulse width System Components Your HIDREX therapy system is com prised of a control unit and the accessories explained in the following sections Fig DVP1000 S tandard Accessories lt AC adapter Hard Shell Case Cable Set A 2 treatment electrodes covered in the picture A 2 towels DVP1000 Tap Water lontophoresis System User Manual Rev 1 0 04 01 2015 Optional Accessories Ergonomic treatment trays Axillary Treatment Kit Control Unit Side amp Rear Panel Elements Control unit main ON OFF switch main power switch Jacks for connecting the cable set to the treatment electrodes Connector for AC adapter 12V DC 1 Axillary Treatment Kit includes a pair of small electrodes AX electrodes and a pair of pads each pad consists of a sponge cushion with a leather cover Rev 1 0 04 01 2015 DVP1000 Tap Water lontophoresis System User Manual 9 Control Unit Front Panel Elements a LED Profile 1 b LED Profle2 L T c LED Profile 3 LED Milliamps LED Pulsed Current LED Active Button Time Switch Display mA V DVP1000 H DREX Main Display MINUTES VOLT mA Button Dose Setup select pulse width Button Time Setup select
17. em User Manual 25 Table 2Electromagnetic Immunity 8kV ad 8kV ad 2kV mains 2kV mains IEC 61000 4 4 1kV I O 1kV VO Surges 1kV dm 1kV dm IEC 61000 4 5 2kV cm 2kV cm Voltage drops etc Reduction to Reduction to 5 for 10 ms 5 for 10 ms positive IEC 61000 4 1 1 positive amplitude amplitude 5 for 10 ms 5 for 10 ms negativee negative amplitude amplitude 40 for 100 ms 40 for 100 ms 30 for 500 ms 30 for 500 ms O for 5000 ms O for 5000 ms H field at 50 60 Hz TR 3 Alm IEC 61000 4 8 Table 6 Recommended Separation Distances W 80 MHz 800MHz 2 9 GHz 11 67 m 11 67 m 23 34 Waste Management and Packaging of Electronic Devices Our packages and the transportation protection parts were LAY produced out of non polluting salvageable materials The form parts are from PS foamed Polystyrol free of FCKW amp amp foils and bags are from PE Polyathylen and outside package are of cardboard Dispose all package parts in an environ mentally acceptable way If the device can no longer be used please dispose of it proper ordinances are to be heeded regarding any other parts Appliances that are marked with the marginal symbol cannot be disposed with the house garbage You are a indebted to dispose of such electro and electronics garbage separately DVP1000 Tap Water lontophoresis System User Manual Rev 1 0 04 01 2015 Please inform yourself about the possibil
18. ent session you can change treatment time and dose settings by pressing the respective push buttons If you interrupt the treatment by removing the treatment area from the water source the ACTIVE LED goes off and the treatment timer is paused The display shows the remaining treatment time and the selected dose in volts When you continue the treatment the ACTIVE LED will light up again and the dose display changes to zero before it slowly increases to the desired value in milliamps or volts as previously selected 4 Ending a treatment session When the treatment time is up the treatment dose is automatically lowered to zero Please keep your hands and feet in the trays or the axillary pads in place respectively until the dose display reads End Remove the treatment area from the water source trays or pads and THEN switch the device off Rev 1 0 04 01 2015 DVP1000 Tap Water lontophoresis System User Manual 17 Important Advice for Conducting Treatments For your safety your HIDREX treatment system comes equipped with sev eral protective circuits Immersion monitoring Immersion monitoring is a built in feature that detects when the treatment electrical current circuit is closed due to immersion of the palms or feet or placement of the pads under the arms The ACTIVE LED will light up when the circuit is closed and treatment is active Over Treatment Protection OTP Feature If your skin is dryer
19. erator Hint Individuals who only use the device privately usually do not have to comply with special requirements Symbol Legend Connector for treatment electrodes 0633 Anode red cable Cathode black cable Device identification Serial No YY X X zzz yy Year of manufacture A Type BF device X X internal product type ID ZZZ consecutive number Prescription use only 1 Device leakage currents comply with standards the system provides protection against electrical shock Type B device is insulated floating Type F Caution Federal law restricts this device to sale by or on the order of a physician Rev 1 0 04 01 2015 DVP1000 Tap Water lontophoresis System User Manual 23 Manufacturer HIDREX GmbH Otto Hahn Strake 12 42579 Heiligenhaus Germany Phone 49 2056 98110 Fax 49 2056 981131 E Mail info hidrex de www hidrex de Legal reasons limit the lifespan of this medical device to 4 years The manufac turer must recondition the medical device no later than by the end of this term Each successful reconditioning by the manufacturer extends the lifespan of the medical device by 2 years If the HIDREX tap water iontophoresis system is reconditioned for the same patient the treatment trays or carrying case depend ing on their condition do not necessarily have to be replaced Electromagnetic Compatibility HIDREX devices are developed and manufactured after the stipulated gu
20. es and we assume no liability if any manipula tion or service is performed by unauthorized personnel The regulations valid in the respective operator s country e g infection preven tion technical servicing or registration and documentation regulations are to be kept in connection with the location of use e g medical institution in any case by the operator Multi Patient Use The device is suitable for the use by several patients at the prescribing physi cian s office or hospital to conduct the initial or maintenance phases of the treatment under a doctor s supervision 1 For example if PC 50 pulse width is used the displayed value has to be doubled to calculate the current limit Rev 1 0 04 01 2015 DVP1000 Tap Water lontophoresis System User Manual As a communal device for multi patient use the following protocols should be obeyed e Each patient will be provided with own consumables for HIDREX ionto phoresis treatment pair of towels or axillary pads which can be re used to every session e Between treatments the electrodes4 and trays hard case trays or ergonomic trays must always be cleaned dried and disinfected final ly as described in the following section Remark It is at the physician s discretion whether to issue sell either the actual device used during in office treatments or a brand new de vice to any given patient In either case if the device issued sold is ever in nee
21. eter Setup Setup Mode RA ee Re RA ee ee ee ee Begin Treatment Programming Mode ee RE RA ee ee ee EE ee ee ee ee Important Advice for Conducting Treatments iie ee ee Re Ee ee ee Care and Maintenance Special REMAMK ccccccccccccccccccsssssssssseneeeeeeeeseeeeeeessseseseeeeeeeeeeeeeeeeeesesseeseesaaaeeeeeeeeeeeeees MM ET dd ON ce eeecesessssessssssssssssssssssseessssssssssssesssesessssessssessseessssseagagagsaes Care and Purification ee ee ee ee ee ee EE ER Re ee ee ee ee ER RR Re Re ee ee ee ee ee Bi iste EE EE EE N RE N N EE FROG eke hei ER N aait Troubleshooting EriorChnecklist sisie gl en ee ee os oe ee OK do ve si ee eek ene in ea ee Operational Check ee ee ee ee Shipping the Device for Repair or MaintenanCe eie ee ee ER RR Re ee ee ee ee ee Applicable Regulations and Legal Reduirements Symbol Es je RE NE EE EE OR EE EE OE EE AN N NE Manufacturef ee ee ee ee ER Re ee ER ee ee ee ee ee ee ee ee ee EE ee ee ee ee ee Ee ee ee ee ee E A RE OE N OO OE OO N N OE N Electromagnetic Compatibilty ee ee EE RE RR ee ee ee Ee ee ee ee ee Waste Management and Packaging of Electronic Devices sesse esse se ee ee ee Technical Data 2 DVP1000 Tap Water lontophoresis System User Manual Rev 1 0 04 01 2015 Read Before Use Your HIDREX tap water iontophoresis device was designed to maximize functionality and us
22. g colors 4 Push the red and black terminals of the cable set firmly onto the respec tive connectors on the treatment electrodes 4 Make absolutely sure to forcefully push the connectors all the way onto the necks of the treatment electrodes 5 Place one treatment electrode 4 in each hard shell case or in each er gonomic treatment trayx respectively When using the ergonomic treat ment tays make sure the sloping rims point toward you this will facili tate hand immersion and increase comfort 6 Completely cover the long part of each treatment electrode with a tow eld ESE EES 7 Now fill both hard shell cases and or treatment trays with towelA hand warm tap water so that the skin areas to be treated can be easily immersed the backs of the hands and backs of the feet should not be covered with water electrode 4 case tray f N i The two basins of the case can easily be separated by pushing the left side away from you while pulling the right side toward you The case must be completely open lying flat before attempting to separate the sides Rev 1 0 04 01 2015 DVP1000 Tap Water lontophoresis System User Manual 11 Setup for Axillary Armpits Treatment The setup for axillary treatment is similar to the setup for hand or feet treat ment except that axillary treatment requires the Axillary Treatment Kit instead of trays g 5 aban K Assembled Axillary Treatment Kit Proceed wit
23. h steps 1 to 4 of the instructions on the previous page Thoroughly soak the axillary pads Sponges with leather covers with hand warm tap water At this time insert the AX electrodes Hint Do not squeeze any water from the pads Subdivide every axillary treatment into two sessions of 7 minutes each in order to re soak the axillary pads Conducting Treatments For your comfort please observe the following two instructions before you begin a treatment session 1 BEFORE you start a treatment session and close the electrical current circuit with your hands feet or underarms make sure to FIRST turn ON the main power switch If this sequence is reversed there is also a chance that you receive a completely harmless but uncomfortable electric shock 2 When conducting a treatment avoid removing your hands or feet from the water or removing the Axillary Treatment Kit from your underarms If you ignore this advice you run a very small risk of feeling a complete ly harmless but uncomfortable electric shock Although the HIDREX system comes equipped with a feature called Anti Shock Electronics ASE designed to permit current flow interruption there is a very small chance of this shock occurring due to various other circumstanc es 12 DVP1000 Tap Water lontophoresis System User Manual Rev 1 0 04 01 2015 Primary Parameter Setup Setup Mode Before you initiate a treatment session you can choose between various opt
24. idelines for electromagnetic compatibility EMC Medical Electric devices are subject to particular EMC precautions Please note the following comments and warnings ELECTROMAGNETIC INTERFERENCE EMI WARNING RADIO WAVE SOURCES MAY AFFECT DEVICE CONTROL Radio wave source such as radio stations TV stations amateur radio HAM transmitters two way radios and cellular phones can affect powered devices Following the warning listed below should reduce the chance of incidents which could result in serious injury 1 Do not turn ON hand held personal communication devices such as citizens band CB radios and cellular phones while the device is turned ON 2 Be aware of nearby transmitters such as radio or TV stations and try to avoid coming close to them 3 If unexpected events occurs remove treated area from the water and turn the powered device OFF 4 Be aware that adding accessories or components or modifying the powered device may make it more susceptible to interference from ra dio wave sources Note There is no easy way to evaluate their effect on the overall immunity to the powered device and 5 Report all incidents of unexpected events to the powered device manu facturer and note whether there is a radio wave source nearby 6 Wearable and mobile HF Communication facilities as portable phones or pagers can influence medical electric appliances DVP1000 Tap Water lontophoresis System User Manual Rev 1 0
25. ient use the following protocol should be obeyed e Spray a surface disinfectant on the electrodes and treatment trays hard case trays or ergonomic trays so that the entire surfaces are completely moistened e Let the disinfectant remain on the surface as directed by its instructions and then wipe it dry with a clean cloth e The consumables should be replaced by new or patient owned towels 4 or axillary pads 1 For single patient use in home therapy the care and purification according to the preceding chapter is sufficient In this case a regular disinfection is not strictly necessary Henkel Incidin Extra 1 Incidin Plus 0 5 Incidur 0 5 Minutil 0 5 Dr Trippen desomed Biguamed Bbraun Melesept SF 0 5 5 Hexaquart S 1 5 5 Meliseptol undeluted Rev 1 0 04 01 2015 DVP1000 Tap Water lontophoresis System User Manual 21 Reconditioning HIDREX tapwater iontophoresis devices are reusable medical devices and can be reconditioned after use of a customer The reconditioning of the devices is classified as non critical The reconditioning should be done only by an authorized HIDREX repair center If a device is to be reconditioned the following actions will also be taken e The consumables towels or axillary pads need to be disposed of and replaced by new ones e The accessories treatment trays hard case trays or ergonomic trays and electrodes 4 need to be disposed of and replaced
26. ions depending on the area you want to treat The following describes how to select and store these parameters 1 After setting up your HIDREX therapy system in accordance with the instructions in the Installation chapter turn on the control unit by pushing the main power switch First the main display will briefly show three moving bars for about 5 seconds self test of the device MINUTES Next the following text SEt is shown and indicates the device is in Setup Mode The selected options are indi cated by the LED a c to LED during Setup Mode and dur MINUTES VOLT mA ing treatment also Important If no button is pressed within 6 seconds the device will automatically switch from Setup Mode to Programming Mode Hint When the device automatically switches to Programming Mode the settings that were used on the last treatment session or factory presets if the device was never used before will automatically be used For example if the last treatment was on the hand profile and the hand profile had been customized to a pulse width of 80 a dosage of 18 volts and a duration of 10 minutes then these settings would be stored and used again until changed if the user did not make any changes be fore the device automatically switched from setup to Programming Mode Rev 1 0 04 01 2015 DVP1000 Tap Water lontophoresis System User Manual 13 2 While in Setup Mode activate or deacti
27. ity of regular waste disposal within your community With separate waste disposal you supply the garbage to the recy cling center Please help prevent incriminating materials from going into the envi ronment ElektroG WEEE Reg Nr DE 42510094 Manufacturer Duales System Interseroh 134502 VerpackV Technical Data Controller DVP1000 Display Tolerance Treatment Voltage Dose 2 V Treatment current 1 mA Treatment Time 1 190 x 49 x 137 mm WxHxD 0 5kg 12 V 500 mA max 6 VA Power input Input voltage Max input current Input power Environmental tempera 10 C to 30 C ture Direct current output Treatment voltage Treatment current 35 mA max into a 1 KO load Effective treatment current 30 mA max 5 mA reserved for the de vice Max output power 225 mW Pulsed current output Treatment voltage Treatment current 35 mA max into a 1 KO load Effective treatment current 30 mA max 5 mA reserved for the de vice Pulse repetition frequency 9 9 kHz Rev 1 0 04 01 2015 DVP1000 Tap Water lontophoresis System User Manual 27 AC Power Adapter Type Friwo FW 7662M 12 Input voltage 100 240 V 50 60 Hz Nominal output voltage Distribution Trading H DREAX GREAT POWER II GREAT OUTCOMES HIDREX USA LLG P O BOX 28612 SUGAR LAND TX 77487 TOLLFREE 1 SHIDREXUSA EMAIL CUSTOMER SERVICE OHIDREXUSA COM WWW HIDREXUSA GOM DVP1000 Tap Water lonto
28. nt parameters If no preset has been selected none of the three LEDs is lit The numbers in the TIME DOSE left window show the selected treatment duration in minutes and the numbers in the right window show the selected treatment dose in volts If mA LED is ON the display i show mA s ONLY during MINUTES VOLT mA treatment NOT during Pro gramming Mode n Select the desired treatment dose with buttons and OIGOFMN YSTER and the desired treat ment duration with buttons 5 O and Each time you push one of these buttons the corresponding treatment pa rameter is increased or decreased by one minute or one volt respectively Hint By holding one of the push buttons down you can continuously in crease or decrease the corresponding treatment parameter Hint The system saves these settings for each of the three profiles preset for hand feet axillary even if you adjust parameters dur ing a treatment The device will automatically suggest these pa rameters when a new treatment session is started 2 Startind the Treatment When treating hands or feet place each hand or foot onto one towel 4 each that are covering the electrodes in the carrying case trays or ergonomic treatment trays that are sufficiently filled with tap water according to the installation in structions noted previously Make sure that your skin does not touch the elec trodes directly Do not forget to rem
29. ove any jewelry Avoid direct contact between skin and the metal electrode 1 pulse width time and dose Select the dose in accordance with your doctor s orders or use the table of factory pre set treatment parameters for guidance DVP1000 Tap Water lontophoresis System User Manual Rev 1 0 04 01 2015 To conduct an axillary treatment place the pre soaked axillary pads into your underarms Make sure the pads fit well and apply even pressure to maximize the contact area When the built in immersion monitoring sys HT active tem recognizes that the circuit is closed the ACTIVE LED lights up to indicate that the treatment is active When treatment is active ACTIVE LED light is ON the actual dose being currently administered is displayed on the right of the dis play Upon immersion or start of a treatment the dosage always starts at zero and then slowly in NATE VOLLE creases to the desired dose previ ously set Note The dose measurement can be in milliamps or volts depending on your selection in the Setup Mode it can also be toggled during an active treatment but NOT during Programming Mode Important If you experience any localized pain during a treatment you need to interrupt the session and cover the painful area with petroleum jelly Pressing any button will stop the automatic in crease of the treatment dose 3 Adjusting treatment parameters At any time throughout the treatm
30. phoresis System User Manual Rev 1 0 04 01 2015
31. re you power it Up DO You may remove the treatment area from the water source at any time but it is advisable to lower the dose to zero before you do so In rare cases safe but uncomfortable electric shocks may result if the dose is not reduced The system should not be operated in the vicinity of shortwave or microwave medical diathermy devices A minimum distance of 2 meters should be kept at all times v Prior to using AC wall power check that your outlet meets the system s requirements of 110 230 V and 50 60 Hz Unplug the AC power adapter if a thunderstorm approaches or if you do not intend to use the system for an extended period of time This device should only be used indoors Do not expose the device to rain or excessive moisture Do not use kerosene thinner alcohol wax remover or any other solvents Y Yy Y Y K Prior to cleaning the device turn the device off and unplug all connectors For cleaning use a soft cloth moistened with a mild cleaning agent 1 These electric shocks are definitely uncomfortable but harmless 4 DVP1000 Tap Water lontophoresis System User Manual Rev 1 0 04 01 2015 DO Prevent kinking of the cable and do not expose the cable to heat or chemicals If the cable is damaged unplug it from the device and have it checked by an authorized HIDREX repair center DO Never open the device there are no control elements inside The system may only be serviced by an authorized HID
32. values Treatment Fundamentals The HIDREX treatment concept comprises two treatment phases Phase 1 The initial phase therapy initiation is sometimes conducted under a doctor s supervision During this stage patients learn to administer treatments For therapy initiation at least three weekly treatments of approximately 15 minutes each should be scheduled not more than one treatment per day Sweat secretion will normalize after approximately 10 treatments 1 Additional indications include Dyshidrotic dermatitis palmoplantar pustolosis and acrocynosis Rev 1 0 04 01 2015 DVP1000 Tap Water lontophoresis System User Manual 5 Phase 2 Long term treatment maintenance therapy is necessary because the HIDREX treatment effect is reversible Depending on the severity of the condition maintenance therapy involves one to three weekly sessions of approximately 15 minutes each Polarity Reversal and the Efficacy of Treatments It has been clinically documented that the area being treated with the anode the electrode that is attached to the red positive cable will produce slightly better results initially than the area being treated with the cathode the electrode that is attached to the black positive cable It is recommended to conduct all treatments in the initial treatment phase Phase 1 without changing polarity until one side reaches an acceptable dryness level Once normal or acceptable dryness has occurred in one side
33. vate the options as desired Profiles presets Button Allows you to choose a preset treatment option for hands un derarms or feet or save the cur rent pulse width time and dos age to memory for the selected treatment area Display Option LED ON shows current Allows you to choose between mA instead of voltage V having voltage V or current MAY shown in the right side of Om the main display during active treatment Pulse Width LED ON pulsed current Changes pulse width during Set with 50 90 pulse width up Mode toggles in 10 incre LED OFF direct current ments P100 100 pulse width 50 90 is pulsed current and 100 is direct current arr aot ENE Is used to go directly into Program ming Mode without waiting for 6 seconds Important The Setup Mode is accessible only directly after switching on the device If you leave the Setup Mode you must turn off the device briefly and then turn it on again in order to access Setup Mode and alter the above treatment options 1 Adjust the system in accordance with your doctor s instructions Note You can only control the value of voltage treatment dose The current value will be deter mined automatically based on body resistance The changes in display of voltage or current cannot exceed the pre determined dose at any time DVP1000 Tap Water lontophoresis System User Manual Rev 1 0 04 01 2015 In the factory
34. y system as you would for a treatment 2 Activate the main power switch to turn the control unit ON Dose and treatment time settings should appear on the main display 3 Take one cable red OR black and insert each end into a jack on the mod ule AFTER the device is in Programming Mode This closes the circuit 4 The ACTIVE LED wil light up if the device is working properly If the ACTIVE LED does not light under this test although the items on the error checklist have been followed please contact us or our distributor to coordinate the required steps Shipping the Device for Repair or Maintenance The device should only be shipped in the supplied carrying case If possible use the original packaging material for shipping Make sure the device is protected against impact inside the case and that packaging is suitable for shipping Prior to shipping do not forget to clean and dry the system and the acces sories Please do not ship towels axillary pads or any other pads Please send all electrical accessories AC power adapter electrodes 4 AX electrodes and cable set together with the HIDREX control unit Applicable Regulations and Legal Requirements The regulations valid in the respective operator s country e g infection preven tion technical servicing or registration and documentation regulations are to be kept in connection with the location of use e g medical institution in any case by the op
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