Hidrex PSP1000 User Manual
Contents
1. snennnennnnnn nee 10 Setup for Axillary Treatment Armpits 00 0 nn n ern nn nanna 11 Treatment Setup for Special Applicators nn nnnnnnnnnnnnnnnnnnnnznnnnnnn 11 Conducting Treatments l cccccssssssecessessessesessessesscsecsessesacsassesscsacsessesaceess 12 Primary Parameter Setup Setup Mode ccccccccccceeeeeeeeeeeeeeeeeeees 12 Begin Treatment Treatment Mode nn nnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn ntiza 14 important Advice for Conducting Treatments nnnnnznnnnnnnn 17 SIde ENGG one ee eee ee eee eee ee 18 General Information l eee eae eee rea ee 18 Special REMAK rikki ee 18 Care and Maintenance Lssss sse snnnnnnnnnnnnnnnnnnnnnnnnnrnnnttnnnnnnnnnnnnnntttnnzzEEEAAEEEnnEEEEAAE NI 18 Operational G ECK i eee eee eee 19 Symbol CIN ccc ee secs secs eg sees wesc ve snoe ests os tensed nie oe ee carer seoesieees 20 EMOF CGHECKIS L iii ia rt 20 Shipping the Device for Repair or Maintenance sess nnnnznnnnnnnnzznni 21 Applicable Regulations and Legal Requirements 9 24 Reconditioning and Disinfection nn enennnnnnnnnnnnnnnnnnnnnnn nanna ann 21 Technical Safety Inspection 0 0 eee nnnnn nn nnnnnnnnna 22 li c i ATO 22 Electric Magnetic Compatibilitv nn nnnennnnnnnnnnnnnnnnnnnnnnnnnn ann n tna 22 Entsorgung von Verpackung und Elektro Altger ten 23 Technical Data ec ccccscscsescsesscsesscsesuesessesesuesesuc2. New Health Experience MED z lt HIDREX PSP1000 IF gt lt Kull x OOOO AKE fe NA sft tiSe m4 f WHY User Manual Tap Water Iontophoresis System HIDREX PSP1000 T A ala 020202020202020202 e Eh E Table of Contents Table of Contents l cccssccssssssescsecsessececsssesscsucsessesarsucsessesacsussesaceacsacsesacsess 2 Read Before Use l cccsssssssssssescsssessesucsussesscsucssesesacsucsessesacsacsesacsacennseeaceaess 3 Your safety is important Contraindications ss nnnnnnnnnnnnnnnnnnnnnn 3 Additional important safety considerations ss nnnnnnnnnnnnnnnnnnnnnnnnn 4 Intended Use Mechanism of Action anna nee 5 Treatment Fundamentals ses nnnnnnnnnnnnnnnnnnnennnnnnnnnnnnnnnnrnnnnnnn tna nnnnnnna ta 5 IDREX PSPT000 A meaa a ERA 6 System Components nemmen nanna nanna nanna 7 Standard Accessories 00 sse seennnnnnnnnnnnnnnnnnnnnnnnttnnnnnnnnnnnnEnntEnnnnzzEENAAEEANEEENNNZEEZZAEEE 7 Optional Accessories sess ss ssnnnnnnnnnnnnnnnnnnnnnnnnnrnnn tna nrnnnnnKEEnntnnnnEEENANEEENEEENNEEEZZEENE T Controls on the Casing Panels nn nnnnnnnnnnnnnnnnnnnnnnnnnnnnn nn nnn nn nn nn nn 8 Front Panel Controls eee eennnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnrnnnnnnnnnnttnnnznnznnnnAnnnnnnA EE na 9 Installation Treatment Setup l ccccsssssssessessecessessessesecsessesecsersucserecees 10 Setup for Treating Hands and Feet
3. a safety circuit which stops the therapy in the case the current exceeds 50mA In this case the display will show STOP and all LEDs will blink Is this the case please turn it off unplug the power supply from the wall and send the complete device back to us Mild dysesthesia tingling or burning can occur under therapy as well as short term skin irritation reddening after treatment Important Make absolutely sure to pay attention to the list of contraindica tions Excessive dose settings can lead to burns General Information This chapter contains important instructions about your HIDREX system Special Remark Our responsibility for system safety functionality and reliability applies only if any maintenance and servicing is exclusively performed by ourselves or by personnel authorized by us Our warrantee ceases and we assume no liability if any manipulation or service is performed by unauthorized person nel Care and Maintenance HIDREX iontophoresis systems are basically maintenance free Squeeze the towels and axillary applicators dry rigorously after use To prevent cal cium deposits on the sheet metal please make absolutely sure to re move any moisture from the treatment electrodes after each treat ment User Manual Tap Water lontophoresis System PSP1000 Rev 1 0 2011 07 20 Ces p gt P lt Pq os 1 ee ee 08 p lt gt 0 0 0 0 0 0 0 0 0 0 Important Calcifications at the electrodes can hinde
4. facilitate hand immersion 7 Completely cover all treatment electrodes with a towel each 8 Now fill both hard shell cases and or treatment trays with 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 wa terl User Manual Tap Water lontophoresis Svstem PSP1000 Rev 1 0 2011 07 20 am AA lt PK ax GI P lt lt lt talk poeta 0 0 0 0 0 0 0 0 0 0 Setup for Axillary Treatment Armpits The setup for axillary treatment is mostly identical to the setup for hand or feet treatment although axillary treatment requires special axillary ap plicators instead of water baths trays 2r 7 Axillary applicators 1 Proceed with steps 1 to 4 of the instructions on the previous page 2 Thoroughly soak the sponge cushions AX equipped with integral leather pouches or the sponge pouches AX II with hand warm tap water At this time insert the AX electrodes Do not squeeze any water from the sponge cushions or sponge pouches Hint Subdivide every treatment of the axillar or the special applicators in two sessions of 7 minutes each in order to soak the applicators once again Treatment Setup for Special Applicators The AX electrodes are also used for conducting treatments with the face mask or the nape or back applicator Treatment setup is identical to the setup for axil
5. is a pulsed width current therapy A pulse width of Display Taste 100 is direct current therapy ey P 50 50 pulse width P 60 60 pulse width P100 100 pulse width direct current LED off Enter and safe for basic parameters during setup Taste Important The Setup Mode is generally activated only direct after switching on the device If you left the Setup mode you must turn off the device shortly and then again must be switched on in order to alter the above treatment options Adjust the system in accordance with your doctor s instructions Rev 1 0 2011 07 20 User Manual Tap Water lontophoresis System PSP1000 13 User Manual Tap Water lontophoresis Svstem PSP1000 p lt P lt L gt a b lt p lt P lt oe tt oe p lt gt 02020202020202020202 Begin Treatment Treatment Mode After completion of the initial setup the unit will automatically switch to treatment mode after about 8 seconds or when the ENTER button is pressed Depending on memory 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 parame ters 1 Setting treatment parameters If no user has been selected none of the three LEDs is lit the main displav will show the following On the left the displav indicates the scheduled treatment duration in mi l nutes and on th
6. 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 accessories Please do not ship towels sponge cushions or the facial mask Please send all electrical accessories safety wall adapter treatment and AX electrodes and dual connecting cable set together with the HIDREX control unit Applicable Regulations and Legal Requirements In accordance with addendum l and Il of the MPBetreibV Medical Device Vigilance System the operator of a medical device is required to maintain a Medical Device Log and to document completion of the safety inspections listed below Important Private persons who use the device only privately do not have to comply with these requirements Nevertheless we recom mend periodic safety inspections in accordance with the regula tions Reconditioning and Disinfection HIDREX iontophoresis systems are reusable medical devices recondition ing is classified as non critical The applicable joint recommendations of the Kommission fur Krankenhaushygiene und Infektionspravention am Ro bert Koch Institut RKI Robert Koch Institute Division of Applied Infection and Hospital Hvgienef and the Bundesinstitut fur Arzneimittel und Medi zinprodukte BfArM Federal Institute for Drugs and Medical Devicesf on Anforderungen an die Hvgiene bei der Aufbereitung von Med
7. tapes used with the AX elec trodes User Manual Tap Water lontophoresis System PSP1000 7 Scala Qal aa NS ne lt lt gt lt gt lt gt lt gt KO KOKORO Controls on the Casing Panels Therapy system main ON OFF switch main power switch Jacks for connecting the dual connecting cable set treatment electrodes Connector for safety wall adapter 12V DC includes 2 additional electrodes each towels and a dedicated cable set User Manual Tap Water lontophoresis System PSP1000 Rev 1 0 2011 07 20 FS SE GNF Oo INS L DO Di lt lt gt lt gt lt gt lt gt lt gt lt D gt DKK ox Front Panel Controls LED User pspjooo 4 IX ME 039307 LED Ampere LED Pulsed LED Dive e lower dose Setup confirm primarv settings increase dose Setup select pulsewidth and type of current decrease time Setup select memory increase time during therapy switch between Voltage and current ndicating selected user 3 LEDs o indicating view of measured dose in Ampere indicating pulsed current active Immersion monitoring Dive 6 Rev 1 0 2011 07 20 User Manual Tap Water lontophoresis System PSP1000 p lt P lt L gt a b lt p lt P lt oe tt oe p lt gt 0 0 0 0 0 0 0 0 0 0 Installation Treatment Setup The following steps describe how you set up your therapy system for a treatment session Please note that the setup for tr
8. ably and the therapy would start automatically User Manual Tap Water lontophoresis System PSP1000 15 BOAO ASOD OS DS ho Owe ei 0 0 0 0 0 0 0 0 0 0 When the integral immersion monitoring system recognizes that the circuit is closed the Dive LED SA lights up to indicate that treatment has started with face mask nonstop The colon expires during the Treatment eae On the display the dose setting changes L l from the desired setting to zero before it L Il slowly increases to the desired value Important If you perceive much localized pain during a treatment you need to interrupt the session and cover the painful area with petrolatum By pressing an arbitrary button the automatic ris ing of the treatment dose can be interrupted 3 Adjusting treatment parameters At any time throughout the treatment session you can change treatment time and dose settings by pressing the respective push buttons If you interrupt the treatment by removing your hands or feet from the bath the Dive LED goes off and the treatment timer is halted The display shows the remaining treatment time and the selected dose When you continue the treatment the Dive LED will light up again and the dose display changes to zero before it slowly increases to the de sired value 4 Ending a treatment session When the treatment time is up the treatment dose is automatically lowered to zero Please keep your
9. al please go through the following checklist before you send the device for repair Working through the checklist as the first step can save you considerable cost and inconve nience Thank you D gt Verify that the safety wall adapter is properly connected to the con trol unit and to the wall outlet gt Verify that the connectors on the dual connector cables are pushed far enough onto the receptacles of the treatment electrodes for es tablishing a reliable connection lt gt The dose will only be increased to the selected setting after the time display shows a value of greater than 1 minute and the skin has closed the treatment current path Dive LED 9 is lit Device leakage currents comply with standards the system provides protection against electrical shock Type B device is insulated floating Type F Rev 1 0 2011 07 20 Rev 1 0 2011 07 20 a b p lt P lt a Te 4 talk p lt gt 02020202020202020202 D gt Verify that the device works properly on another person over treatment protection B gt Complete the operational check described below 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 Shipping the Device for Repair or Maintenance The device should only be shipped in the supplied carrying case If at all possible use the original packaging material for
10. direct contact with the metallic surface Two devices may not be simultaneously used by one patient Prior to treatment remove any metallic jewellery wedding bands etc which would otherwise be immersed in the water bath Keeping such accessories on would lead to localized minor electrical burns sec ondary to increased current densities Rev 1 0 2011 07 20 User Manual Tap Water lontophoresis System PSP1000 3 ey e KI e ax P lt je os IE p lt gt 0 0 0 0 0 0 0 0 0 0 Additional important safetv considerations Place the treatment device on a firm level surface Make sure that the treatment device is at room temperature before you power it up Vou mav remove vour hands or feet from the treatment water bath at any time but it is advisable to lower the dose to zero before you do so In rare cases uncomfortable electric shocks may result if the dose is not reduced The system may 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 Prior to using wall power check that your outlet power meets the sys tem s requirements of 110 230 V and 50 60 Hz Unplug the wall power adapter if a thunderstorm approaches or if you do not intend to use the treatment system for an extended period of time This treatment device may only be used indoors Do not expose the system to rain or excessive moisture Prior to cleaning the sys
11. ds 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 quickly 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 values Remark In general HIDREX treatment results do not depend on the direction of current flow The anode red however is slightly more effective than the cathode black Current direction should therefore be reversed on a regular basis but not with in one treatment session Important The HIDREX iontophoresis unit PSP7000 is intended to treat hyperhidrosis affecting hands feet face necks back and arm pits Any other use or usage beyond this scope is considered unintended use and may have dangerous con sequences Treatment Fundamentals HIDREX iontophoresis devices are primarily intended for treating hyperhidrosis excessive sweating of hands and or feet Provided the optional axillary applicators are utilized the system can also be used for treating axillary hyperhidrosis The HIDREX treatment concept comprises two treatment phases Additional indications include Dyshidrotic dermatitis palmoplantar pustolosis and acro cynosis User Manual Tap Water lontophoresis System PSP1000 5 p l
12. e right the pre selected treatment dose in Volts L e l The colon blinks during this phase Select the desired treatment dose with buttons 8 and 8 and the de sired treatment duration with buttons and Each time you push one of these buttons the corresponding treatment parameter is increased or decreased by one Volt or one minute respectively Hint By holding one of the push buttons down you can continuously in or decrease the corresponding treatment parameter Memories HAND FOOT AXE lf a user has been selected the de vice proposes the corresponding saved treatment parameters time and dose You can adjust these to your needs by pushing the respec tive buttons The system saves these settings When another treatment session is started the device will automatically suggest the latest settings If you adjust treatment parameters during a treatment session the sys tem will automatically save these changes as well 1 Select the dose in accordance with your doctor s orders or use the table of factory preset treatment parameters for guidance see page 14 in this manual Rev 1 0 2011 07 20 Rev 1 0 2011 07 20 p gt P lt L gt gt P lt b lt p lt P lt oe tt oe p lt gt 02020202020202020202 Hint The PSP 1000 saves pulse width dose and time for each of the three memories Hand Feet Axes These are the settings the device will propose when a new trea
13. eating hands or feet is slightly different from the setup required for treating hands and feet simulta neously and for treating the armpits Setup for Treating Hands and Feet 1 Place the therapy device on a firm level surface Make sure an electric outlet is within reach 2 Insert the safety wall adapter cable into jack on the rear panel and plug the adapter into a wall outlet 3 Plug the color coded connectors of the dual cable set into the jacks on the back panel matching colors 4 Push the red and black terminals of the dual connecting cable set D firmly onto the respective connectors on the treatment electrodes Make absolutely sure to forcefully push the connectors all the way onto the necks of the treatment electrodes 5 For simultaneous treatment of hands and feet use the optional DUO accessory set and the hard shell cases for your feet and the ergo nomic blue treatment trays for your hands Connect the two elec trodes in the hard shell cases and the electrodes in the treatment trays each to the respective cables from the DUO set Now connect the black and red connecting cable with one electrode of the hard shell case and one electrode of the treatment tray 6 Place one treatment electrode in each hard shell case W or in each treatment tray respectively When using the ergonomic treatment trays make sure the sloping rims point toward yourself drainage groove away from you this will
14. hands and feet in the water bath or the axillary applicators in place respectively until the dose display reads End Switch the device off Heed to this also the hint about current limitation on the next sides User Manual Tap Water lontophoresis System PSP1000 Rev 1 0 2011 07 20 Rev 1 0 2011 07 20 A A a lt q A d p lt gt 02020202020202020202 Important Advice for Conducting Treatments For your safety your HIDREX treatment system comes equipped with several protective circuits Immersion monitorin Until the treatment current path is closed immersion monitoring by im mersion of the palms the dose cannot be increased to any value above zero The Dive LED will light up when immersion is complete Over treatment protection If vour skin is drver than normal the dose cannot be increased protec tion against over treatment Vour HIDREX svstem automaticallv checks your specific skin conductance If your skin conductance is beyond the preset threshold the protection circuit is activated and locks the system The Dive 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 simply ask another person to close the current path this can be done without starting an actual treatment If the Dive LED lights up when the other person closes the current path the system Is in good working order If over
15. ional Check Proceed with the following steps for an operational check of your HIDREX system 1 Set up the therapy 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 0 3 Now close the treatment current path by placing one electrode onto the towel that covers the other electrode but do not let the electrodes touch Rev 1 0 2011 07 20 User Manual Tap Water lontophoresis System PSP1000 User Manual Tap Water lontophoresis Svstem PSP1000 am AA lt PK ax GI P lt b ej r 4 talk are ec 0 0 0 0 0 0 0 0 0 0 Both electrodes are now immersed in a water filled tray and lie on top of each other remaining separated by a towel When testing the system with AX electrodes directly press both water soaked sponge cushions together 4 The unit s Dive LED should now be lit If the Dive LED does not lit under this test although the items on the error checklist have been followed please contact us so that we can coordinate the required steps Symbol Legend Connector for treatment electrodes C 0 633 N Anode red cable Cathode black cable gy Type BF device Device identification Serial No yy x x zzZ yy Year of manufacture X X Internal product type ID zzz consecutive number If prior to during or after a treatment session the device does not oper ate in accordance with this manu
16. ironmental temperature e fe 225 mW 35 mA max into a 1 KO load See supplementary sheet for guidelines and factory declarations in accordance with DIN EN 60601 1 2 2001 EMC Safety Wall Adapter Type Friwo FW 7662M 12 Input voltage 100 240 V 50 60 Hz MM mr Distribution Trading United Kingdom Avanor Healthcare Ltd Unit 19 Mahoney Green Rackheath Norwich NR13 6JY UK Phone 0845 643 9545 www avanor co uk LS EID NCS ad NA NS NA OCI 0A000000 lt lt eae jaa Rev 1 0 2011 07 20
17. izinprodukten User Manual Tap Water lontophoresis Svstem PSP1000 21 e Pes e OY o Cd OY a 0 0 0 0 0 0 0 0 0 0 Reconditioning of Medical Devices Hygiene Requirements published on August 25 2001 need to be complied with For reconditioning the device has to be cleaned and disinfected in accor dance with the instructions provided in the chapter on Care and Mainten ance The accessories towels treatment electrodes and treatment trays carrying case need to be disposed of and have to be replaced by new ones In addition a technical safety inspection has to be completed and do cumented The medical device may be reconditioned up to 10 times Technical Safety Inspection Only competent technicians trained by the HIDREX GmbH may be con tracted for technical safety inspections Suitable measuring and test equip ment is mandatory The medical device may only be operated with the ac cessories listed in the instruction manual In accordance with MPBetreibv HIDREX iontophoresis units require tech nical safety inspections every 2 years in addition to inspections after each repair or reconditioning Technical safety inspections have to cover at least the following items Visual check of medical device and accessories Protective conductor test in accordance with DIN EN 60601 1 1990 Leakage current test in accordance with EN 60601 1 1990 Operational check of the medical device in accordance with the instruc ti
18. lary treatments except for the requirement to insert the AX electrodes into the pouches sewn onto the respective applicators Please ascertain that the sponge material is completely soaked do not Squeeze Now secure the applicator with the hook and loop fasteners Rev 1 0 2011 07 20 User Manual Tap Water lontophoresis System PSP1000 11 p lt P lt b ax P lt a et a p lt gt 0 0 0 0 0 0 0 0 0 0 Conducting Treatments Please observe the following two items before you begin a treatment session 1 When conducting a treatment avoid removing your hands or feet from the water bath or removing the axillary applicators from your armpits If you ignore this advice you run a slight risk of feeling a completely harmless yet quite uncomfortable electric shock This shock may occur although the HIDREX system comes equipped with a protection circuit designed to permit current flow interruption 2 Before you start a treatment session and close the current path with your armpits hands or feet make sure to first turn on the main pow er switch If this sequence is reversed there is also a chance that you receive a completely harmless yet quite uncomfortable elec tric shock Primary Parameter Setup Setup Mode Depending on the specific HIDREX system you own you can choose be tween various options before you initiate a treatment How you select and store these parameters is described in the follo
19. length of the pulse is in 90 90 creasing and the length of the pause is decreased accordingly Due to this much shorter pause times much more energy 80 than with the standard time gt pulsed current is applied A pulse width of 100 no pause is therefore cor responding to the classical direct current method The variable pulse widths allow an individual and continuous adjustment between the more sensitive pulsed current and the more effective direct cur rent 50 50 im rrent 6 User Manual Tap Water lontophoresis Svstem PSP1000 Rev 1 0 2011 07 20 Rev 1 0 2011 07 20 ien AGO ga f d a ZOZOZOZOZOZOZOZOZOzOx Svstem Components HIDREX PSP1000 D Your HIDREX therapy system compris es a control unit and the accessories d i explained in the following chapters l met OOGG Fig Hidrex PSP1000 Hard Shell Case Treatment electrode covered in the picture Towel Dual connecting cable set Safety wall adapter Fig similar Optional Accessories Ergonomic treatment tray Axillary applicators Fig Model AX 1 Face mask Nape or back applicator not shown Set DUO allows simultaneous treatment of hands and feet not shown 1 includes a pair of sponge cushions with leather covers respectively a pair of sponge pouches and special small electrodes AX electrodes made of foam and come equipped with hook and loop
20. on manual The operator is responsible to rectify any faults detected during the technical safety inspections i e the user has to make arrangements for repair Legal reasons limit the lifespan of this medical device to 4 years The manu facturer has to recondition the medical device not 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 iontophoresis sys tem is reconditioned for the same patient the treatment trays or carrying case depending on their condition do not necessarily have to be replaced Electric Magnetic Compatibility Of course the HIDREX Devices are developed after the stipulated guide lines for electromagnetic compatibilitv EMV and been manufactured 22 User Manual Tap Water lontophoresis System PSP1000 Rev 1 0 2011 07 20 p lt P lt p gt P lt is 1 ee lt 1 ee p lt gt 0 0 0 0 0 0 0 0 0 0 Caution Medical Electric Appliances are subject to medical electric appliances The EMV particular precautions and must install in accordance with the EMV Hints contained in the accompanying papers and in operation is taken Wearable and mobile HF Communication facilities as portable phones or Pager can influ ence medical electric appliances Please heed the broad guidance and manufacturer declarations in this con text relating to DIN EN 60601 1 2 2001 which you can consult at www hidrex de or order
21. r the treatment current This deposit can be taken away with customary descaler as well as through putting the electrodes in vinegar or citric acid A discoloration of the electrode metal after the first therapy sessions is regular Store only quite dry accessories in the suitcase Purification Cleaning execute with demand The control unit treatment trays and electrodes should be cleaned with a moistened cloth or with a common detergent Surface disinfectants may also be used The AX sponge cushions can be washed at 90 C alternatively they may be steam sterilized or immersed in a disinfectant solution If disinfectant is used the sponges should be thoroughly rinsed with water before they are reused The towels can be washed in the washer with your regular laundry follow the specific instructions Common disinfectant supplements for laundry detergents may be used Calcium deposits on the electrodes can impair current flow Use a house hold calcium deposit remover or immerse the electrodes in vinegar Expect discoloration of the electrode metal after the first therapy sessions Warning Before cleaning make sure the device is turned off and sepa rated from the power line Never use kerosene thinner or other solvents l Henkel Incidin Extra 1 Incidin Plus 0 5 Incidur 0 5 Minutil 0 5 Dr Trippen desomed Biguamed B Braun Melesept SF 0 5 5 Hexaquart S 1 5 5 Meliseptol undiluted Operat
22. sesuesesucsesuesceussesatseeaeseeaeseees 24 Distribution TFRAMNQ sisien ee 24 2 User Manual Tap Water lontophoresis System PSP1000 Rev 1 0 2011 07 20 p lt P lt L gt a b lt p lt P lt oe tt oe p lt gt 0 0 0 0 0 0 0 0 0 0 Read Before Use Your HIDREX iontophoresis device was designed to maximize functionality and usability System setup is easy and the device is simple to operate This manual is intended to guide you through the setup procedure familiarize you with the system s features and will offer hints on the use of your new therapy system Your safety is important Contraindications Important Under no circumstances should you use iontophoresis if any of the following conditions apply 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 Large skin defects wounds that cannot be covered with petrolatum Patients with impaired sensibility in their hands or feet e g patients with polyneuropathies 90909000009 Warning The treatment system may only be powered by the HIDREX wall adapter to recognize at 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 towels cover the treatment electrodes at all times Avoid
23. t P lt L gt a b lt p lt P lt oe tt oe p lt gt 02020202020202020202 Phase 1 The initial phase therapy initiation is conducted under a doctor s supervision During this stage patients learn to administer treatments For therapy initiation 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 Phase 2 Long term treatment maintenance therapy is indicated because the HIDREX treatment effect is reversible Patients should conduct maintenance therapy sessions by themselves at home and with their own unit Depending on the severity of the condition maintenance therapy involves one to three weekly sessions of approximately 15 minutes each HIDREX PSP1000 The new lontophoresis device with changeable pulse width allows the innovative adjustment of the pulse intensity Extensive trials showed that the efficiency of pulsed current could be increased dramatically There fore pulsed current is now usable for feet and severe cases also without losing the advantage of less sensitivity of the patient for EE pucewiatn Pause current This is not reduced even with a pulse width of 90 direct current o gt o Le A pulse width of 50 is equivalent to the actual pulsed current operation In this case the pause is as long as the pulse With increasing percentages for the pulse width the
24. tem turn the device off and unplug all connectors For cleaning use a soft cloth moistened with a mild cleaning agent Do not use kerosene thinner alcohol wax remover or any other solvents 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 the HIDREX Company Never open the device there are no control elements inside The system may only be serviced by the HIDREX Company Wash the supplied towels on a regular basis together with your regular laundry make sure to comply with the laundry instructions on the tag These electric shocks are definitely uncomfortable but absolutely harmless 4 User Manual Tap Water lontophoresis System PSP1000 Rev 1 0 2011 07 20 Rev 1 0 2011 07 20 A lt gt a b lt p lt P lt oe tt oe p lt gt 0 0 0 0 0 0 0 0 0 0 Intended Use Mechanism of Action During HIDREX treatment a current flows through the body regions un der treatment The water bath mediates this current flow The skin areas inside the treatment water will thereby secrete less sweat Although treatment success has been validated in numerous medical studies 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 glan
25. tment session begins In the factory your HIDREX system is preset as follows pulse width 90 dose 20 Volts time 15 minutes pulse width 100 Gleichstrom dose 30 Volts time 15 minutes pulse width 70 dose 8 Volts time 15 minutes 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 nearly completely imperceptible we recommend that you assess your individual direct current thresholds for hands feet or armpits before you start the first treatment session To conduct axillary treatments the dose should not be raised above 15 because the sensi tive skin may otherwise get burnt 2 Treatment start When treating hands or feet place each hand or foot onto the towels lav ing in the tap water filled hard shell cases carrying case W or ergonomic treatment trays Make sure that your skin does not touch the electrodes directly Do not forget to remove any jewellery To conduct an axillary treatment pack the soaked axillary applicators into your armpits The well soaked face mask and special applicators are secured with hook and loop fasteners Make sure the applicators fit well and apply even pressure to maximize the contact area Important choose manual mode Because of the leading conjunction across the mask itself the Dive LED shines dur
26. treatment protection is activated you should interrupt your treat ment course for at least one week until excessive perspiration returns Please contact us if the over treatment circuit triggers although you still have excessive perspiration a situation that may arise in rare circums tances Current Limitation In case of very heavy sweating therefore a low electric resistance of the skin the maximum treatment current can be reached before the discon tinued dose volt value is gained A protection circuit current limitation intervenes in this case and stops the appliance This doesn t have any influence on the treatment success but pro tects you only before burns In course of further treatments slowly higher dose values are gained by the abatement of the perspiration the electric resistance of the skin rises Up This does not relate to the water bath but to the moisture content of the deeper skin layers an indicator of the extent of hyperhidrosis User Manual Tap Water lontophoresis System PSP1000 17 A ES OOD Po f a 4 0 0 0 0 0 0 0 0 0 0 This protection circuit seems to especially use fast by using pulsed cur rent However this is not applicable In the pulse mode an average dose value that you would have to double for example in the compari son to the direct current is generally shown However the appliance watches the maximum current and not the average Safety circuit The PSP 1000 has
27. wing paragraphs 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 Next the following text is shown for about 8 seconds Setup Mode indication l Various treatment options can be selected as long as this text re mains visible Important If no button is pressed within approximately 8 seconds the device will automatically switch from setup to treat ment mode Hint By pressing the ENTER key you can directly switch to treatment mode without having to wait 12 User Manual Tap Water lontophoresis System PSP1000 Rev 1 0 2011 07 20 ESOS ONS OS OO SS Oe EI 0 0 0 0 0 0 0 0 0 0 2 Once in Setup Mode activate or deactivate the options as desired Option Function symboe SETUP the devices safes for 3 LED on active different treatments the parame ter pulse width time and dose ws lf no LED is on manual use is active changing memories by Taste pressing the key During therapy you can switch LED on measured between voltage V and current Current mA is displayed mA in the display on the right side instead of voltage V This key allows the change of LED on pulsed cur the pulse width during setup rent multiple pressing A pulse With 50 90 pulse width of 50 90
28. with us Entsorgung von Verpackung und Elektro Altgeraten 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 foils and es bags are from PE Polvathvlen and outside package are of cardboard Dispose all package parts in an environmentally acceptable wav If the appliance can become use no more vou please dispose expertiv of it In the remainder the national ordinances are to be heeded Appliances that are marked with the marginal svmbol can not be disposed with the house garbage You are indebted to dispose of such electro and electronics garbage sepa rately Please inform yourself about the possibility of the regular waste disposal with your commune With the sepa rate waste disposal you supply the garbage to the recy cling You help to avoid with it that incriminating materials reach into the environment ElektroG WEEE Reg Nr DE 42510094 Maufacturer Duales System Interseroh 134502 VerpackV Manufacturer HIDREX GmbH Otto Hahn Strafe 12 D 42579 Heiligenhaus Germany Phone 49 2056 98110 Fax 49 2056 981131 e mail info hidrex de www hidrex de Rev 1 0 2011 07 20 User Manual Tap Water lontophoresis System PSP1000 23 User Manual Tap Water lontophoresis Svstem PSP1000 A 8 MM a aa LOO GOED EOD BEG EDD EN 0 Technical Data Controller PSP1000 oe S S O Env
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