User Manual
Contents
1. Maintenance VV 19 Applicable Regulations and Legal Requirements ss 19 T chnieal Sat nee BEE 20 Waste disposal of package and Electro Garbage nni 20 FeCONGITIONING and DISIMTECHOM ys RER MURS Rue a 20 Se 21 Electric Magnetic Compatibility 4 21 Broadputlines and Manufacturer Declaration cc csccecscsecececeeeeeeeeeeesessssessnesnaeaeens 21 el e WR RS a D nana a 24 ManUractuninG and tu e te A EE 24 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 systems 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 0909000009 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 Warning The treatment system may only be powered by the HIDREX wall adapter to recognize at HIDREX namep2. and factory declarations in accordance with DIN EN 60601 1 2 2001 EMC Safety Wall Adapter Typ Egston P2xFMW3 6W Input Input voltage 100 240 V 50 60 Hz Nominal output voltage Manufacturing and Distribution HIDREX GmbH l D R EX Biomedizinische Technik Otto Hahn Str 12 BI MEDIZINISCHE TECHNIK D 42579 Heiligenhaus Tel 49 0 1805 98 11 00 Internet www hidrex com Fax 49 0 1805 98 11 33 Email info hidrex de 24
3. checklist have been followed or if dose selection fails please contact us so that we can coordinate the required steps 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 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 and II 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 recommend periodic safety inspections in accordance with the regulations 19 Technical Safety Inspection Only competent technicians trained by the HIDREX GmbH may be contracted for technical safety inspections Suitable measuring and test equipment is mandatory The medical device may only be operated with the accessorie
4. frequency energy exclusively for his its internal function His its HF therefore is end program very low and it is unlikely that neighbouring electronic appliances are disturbed The appliance is for the use in all facilities including residential areas and such certain that is Overtone after Class A connected directly at a public supply net which IEC 61000 3 2 looks after also buildings that are used for Voltage swing patcher after IEC 61000 3 3 residential purposes HF Emission after CISPR 11 21 RECOMMEND DEFENCE DISTANCE BETWEEN ACCEPTABLE AND MOBILE HF TELE COMMUNICATION DEVICE AND THERAPY DEVICE OF THE COMPANY HIDREX GMBH DIN EN 60601 1 2 6 8 3 201 Table 206 The device is meant for the business in a electromagnetic surrounding where are HF sturgeon sizes are controlled The user of the device can help due the fact to avoid electric magnetic disturbulece by keeping the minimum distance between acceptable and mobile HF Tele communication device transmitter and the device dependent on the power output of the Communication device like specified below Fo Defence distance dependent on the transmit frequency in m 150 kHz to 80 MHz Wattage rating of the transmitter W 3 5 ju 80 MHz to 800 MHz 3 5 E V 800 MHz to 2 5 GHz d 7 E V P For transmitters that maximum wattage rating is not specified in table above the advice defence distance d can be ascertained in meters m under dispo
5. special applicators are made of foam and come equipped with hook and loop tapes These applicators are also used with the AX electrodes Controls on the Side Panel Therapy system main ON OFF switch main power switch Controls on the Back Panel Jacks for connecting the dual connecting cable set treatment electrodes Connector for safety wall adapter 12V DC 7 Front Panel Controls HIDREX PS 500 1 NTOPHORESE 4 Main Display 3 LEDs indicating selected user LED j Sensitive S mode active PO Wan LED Pulsed current active LED Immersion monitoring Pushbutton Pushbutton E Pushbutton lower dose increase EEE decrease time Se ea confirm primary hes H select sensitive due of settings select user EE current HIDREX GS 400 1 NTOPHORESE met ee vs OD LED Memory function active LED Immersion monitoring AA Pushbutton lower dose confirm primary settings Pushbutton increase time memory function Pushbutton decrease time Pushbutton increase dose 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 f
6. HAND FOOT AXE If the memory function is active or when a user has been selected the device proposes the corresponding saved treatment parameters time and dose You can adjust these to your needs by pushing the respective 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 system will automatically save these changes as well 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 13 Hint In addition to storing HAND FOOT and AXE for each user model PS 500 also saves the respective treatment dose and time plus the selected primary settings SENSE and PULSE These are the settings the device will propose when a new treatment session begins In the factor our HIDREX system is preset as follows GS 400 SENSE not available not available 0 Volt 15 minutes deactivated activated 20 Volt 15 minutes deactivated deactivated 30 Volt 15 minutes activated activated 18 Volt 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
7. HIDREX BI MEDIZINISCHE TECHNIK HIDREX GMBH e Otto Hahn Str 12 e D 42579 Heiligenhaus e Germany User Manual Tap Water lontophoresis Systems HIDREX GS 400 HIDREX PS 500 Wily by z Ge Ou Rev 1 2 Sep 9 2007 Table of Contents rer KEE RE RE RER RE A ER scrote 2 Sr lee d Your safety is important COntralndiCations ccccccecsecsecececeeeessseeeaeceseseessseseaeaeeeeeees 3 Additional important safety Considerahonme 3 Intended Use Mechanism of Action ccccscssssesseseecesessensnsesenceeeeseseenenenees 4 chuu lieren Saige ae alte see wt eh ewes en ln ra a At a a Date 5 DVSICIN EE EE EE EE 6 CONTOUR ne a a a 6 Standard ee teen ne E vanne che ee selle ne ns 6 ODOM al ACCCSSO NCS SR nan era tem ee cui 6 Controlsontine Sid E 7 Controls Gn the Back Panel WE 7 FROME AMek COPUEOIS SR eat teeta 8 Installation Treatment Setup a a n a 9 Setup for Treating Hands and Feet 9 Setup for Axillary Treatment Armpits isin a 10 Treatment Setup for Special Appicatore 10 Conducting Treatments aren a a 11 Primary Parameter Setup Setup Mode 11 Begin Treatment Treatment Mode LS 13 Important Advise for Conducting Treatment cccccsccsccceceeeseseesseseseesesessseneaeanes 16 LS EE 16 Generali edu le EE 17 PEC Fe AE MAR ue nn ed ne none 17 Care and Maintenance E 17 NS FAO TS CNG PR 18 Srel g nt ES en Re nn Se nd ne 18 eegen Ee 19 Shipping the Device for Repair or
8. and cover the painful area with petrolatum By pressing an arbitrary button the automatic rising of the treatment dose can be interrupted 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 desired value Hint You can use your fingers to operate the controls even if your hands are inside the hard shell cases To accomplish this the device needs to be positioned directly in front of one of the hard shell cases Make sure that the palm of the hand you intend to operate the controls with stays under water and on the towel so that the current path remains closed After dose adjustment pull the entire hand into the water bath making sure palm and towel remain in contact at all times 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 water bath or the axillary applicators in place respectively until the dose display reads End Switch the device off DER Important Advise for Conducting Treatments For your safety your HIDREX treatment system comes equipped with several protective circuits Immersion monitoring Until the treatmen
9. 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 not even in SENSE mode because the sensitive skin may otherwise get burnt 2 Treatment start When treating hands or feet place only one hand or foot onto the towels laying in the tap water filled hard shell cases Kofferschalen or treatment trays Make sure that your skin does not touch the electrodes directly Do not forget to remove any jewellery 14 To conduct an axillary treatment pack the soaked axillary applicators into your armpits Make sure the applicators fit well and apply even pressure to maximize the contact area in your armpit The well soaked face mask and special applicators are secured with hook and loop fasteners When the integral immersion monitoring system 4 recognizes that the circuit is closed the Dive LED lights up to indicate that treatment has started The colon expires during the Treatment On the display the dose setting changes from the desired setting to zero before it slowly increases to the desired value 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 Important If you perceive very localized pain during a treatment you need to interrupt the session
10. e Now secure the applicator with the hook and loop fasteners 10 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 power switch If this sequence is reversed there is also a chance that you receive a completely harmless yet quite uncomfortable electric shock Primary Parameter Setup Setup Mode Depending on the specific HIDREX system you own you can choose between various options before you initiate a treatment How you select and store these parameters is described in the following 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 Various treatment o
11. e the treatment system for an extended period of time gt This treatment device may only be used indoors Do not expose the system to rain or excessive moisture gt Prior to cleaning the system turn the device off and unplug all connectors For cleaning use a soft cloth moistened with a mild cleaning agent gt Do not use kerosene thinner alcohol wax remover or any other solvents gt 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 gt Never open the device there are no control elements inside The system may only be serviced by the HIDREX Company gt 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 During HIDREX treatment a current flows through the body regions under 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 glands can no longer be stimulated In other words T
12. eet is Slightly different from the setup required for treating hands and feet simultaneously 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 O 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 ergonomic blue treatment trays for your hands Connect the two electrodes 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 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 facilitate hand immer
13. etup mode you must turn off the device shortly and then again must switch on in order to alter the above treatment options Adjust the system in accordance with your doctor s instructions 12 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 user selection or memory function 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 1 Setting treatment parameters lf you have deactivated the memory function LED is not lit or if no user has been selected none of the three LEDs is lit the main display will show the following On the left the display indicates the scheduled treatment duration in minutes and on the right the pre selected treatment dose in Volts The colon blinks during this phase Select the desired treatment dose with buttons and and the desired treatment duration with buttons and 6 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 Special functions MEMO respectively
14. fter the time display shows a value of greater than 1 minute and the skin has closed the treatment current path Dive LED is lit gt Verify that the device works properly on another person over treatment protection 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 If that case try non carbonated mineral or table water instead Device leakage currents comply with standards the system provides protection against electrical shock Type B device is insulated floating Type F 18 Operational 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 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 Both electrodes a 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 units Dive LED should now be lit and the dose should rise to the preset value If the dose does not increase under this test although the items on the error
15. he 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 4 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 within one treatment session Important The HIDREX iontophoresis units GS 400 and PS 500 are 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 consequences 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 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 appro
16. igher frequency area near 80 MHz and 800 MHz is valid NOTE 2 These broad outlines may not be applicable in all cases The spread of electromagnetic sizes is influenced by absorptions and reflections of the buildings objects and people The field strength of stationary stations like Z B Basis stations of radio telephones and mobile country radio equipments amateur radio stations AT THE and FM radio and TV stations cannot be predetermined exactly theoretically In order to determine the electromagnetic surroundings regarding the stationary stations a study of the location should be considered If the measured field strength in the location at which the appliance is used exceeds the above accordance levels the appliance should be observed in order to prove the due functions If uncommon features are observed additional measures can be necessary like i e a changed alignment or another location of the appliance Over the frequency area of 150 KHz of 80 MHz the field strength should be more inferior than 3 V m 23 Technical Data Control Unit GS 400 and PS 500 Display Tolerance Treatment Voltage Dose 2 V Treatment Time 1 190 x 49 x 137 mm W x Hx D Dimensions ms CTC Power input 12V max 6 VA Direct current output 60 V max 35 mA max into a 1 KO load 225 mW Pulsed current output 60 V max 35 mA max into a 1 KO load Pulse repetition frequency 9 9 kHz See supplementary sheet for guidelines
17. l business or hospital surroundings The quality of the supply tension should correspond to that of atypical business or hospital surroundings There was been by the power adapter the test The power adapter has an independent decrease 22 The device engendered a magnetic therapy field Cancelled the measuring ELECTROMAGNETIC STURGEON SOLIDIT Y DIN EN 60601 1 2 6 8 3 201 table 204 Sturgeon strength test Sec Accordance levels Elektromagnetic surroundings broad outlines Wearable and mobile radio equipments should be used in no more inferior distance between the appliances including the managements as the recommended protection distance that is calculated after the equation applying to the transmitting frequency recommended protection distance d 3 5 V V P d 35 E JVP for 80MHz to 3 Va HF led sturgeon sizes after IEC 61000 4 6 150 KHz to 80 Mhz d 7 E VP for 800 MHz to with P as nominal performance of the station in watt W in accordance with statements of the Beamed HF sturgeon 3 V m E 3 V m station manufacturer and d as recommended sizes of IEC 61000 4 3 80 MHz to 2 5 GHz protection distance in meters m The field strength of stationary radio stations should be more inferior than the accordance level with all frequencies in accordance with an examination on the spot In the surroundings of appliances that carries the following picture sign disturbances are E Dol NOTE 1 The h
18. late 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 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 secondary to increased current densities Additional important safety considerations x gt x gt x gt Place the treatment device on a firm level surface Make sure that the treatment device is at room temperature before you power it up You may remove your 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 These electric shocks are definitely uncomfortable but absolutely harmless 7 gt The system may not be operated in the vicinity of shortwave or microwave medical diathermy devices minimum distance of 2 meters should be kept at all times gt Prior to using wall power check that your outlet power meets the system s requirements of 110 230 V and 50 60 Hz lt gt Unplug the wall power adapter if a thunderstorm approaches or if you do not intend to us
19. list of contraindications Excessive dose settings can lead to burns 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 16 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 personnel Care and Maintenance HIDREX iontophoresis systems are basically maintenance free To prevent calcium deposits on the sheet metal please make absolutely sure to remove any moisture from the treatment electrodes after each treatment 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 elect
20. posal with your commune With the separate waste disposal you supply the garbage to the recycling You help to avoid with it that incriminating materials reach into the environment ElektroG Reconditioning and Disinfection HIDREX iontophoresis systems are reusable medical devices reconditioning is classified as non critical The applicable joint recommendations of the Kommission f r Krankenhaushygiene und Infektionspravention am Robert Koch Institut RKI Robert Koch Institute Division of Applied Infection and Hospital Hygiene and the Bundesinstitut f r Arzneimittel und Medizinprodukte BfArM Federal Institute for Drugs and Medical Devices on Anforderungen an die Hygiene bei der Aufbereitung von Medizinprodukten Reconditioning of Medical Devices Hygiene Requirements published on August 25 2001 need to be complied with 20 For reconditioning the device has to be cleaned and disinfected in accordance with the instructions provided in the chapter on Care and Maintenance 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 documented The medical device may be reconditioned up to 10 times Legal reasons limit the lifespan of this medical device to 4 years The manufacturer has to recondition the medical device not later than by the end of this
21. ptions can be selected as long as this text remains visible Important If no button is pressed within approximately 8 seconds the device will automatically switch from setup to treatment mode Hint By pressing the ENTER key you can directly switch to treatment mode without having to wait 11 2 Once in Setup Mode activate or deactivate the options as desired Option Model Function sym Memory GS 400 If Memory is activated Active if LED is lit d si the unit will always save the most recent time and dose treatment settings otherwise the system runs in manual mode PS 500 In addition to the primary settings pulse and sense the unit saves the time and dose treat ment parameters for 3 users If no LED is lit the unit is in manual mode User change by pressing the button several times SENSE PS 500 When SENSE is active Active if LED is lit i fy decreased setting apply to power output maximum ER current and current slope WW This function was de Key signed for sensitve patients children and for treating armpits and face PULSE PS 500 When PULSE is active a Active if LED is lit ef pulsatile treatment current is used PULSE minimizes the uncomfortable tingling S Se sensation when current is Key flowing Important The Setup Mode is generally activated only direct after switching on the device If you left the S
22. rodes can impair current flow Use a household 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 separated from the power line Never use kerosene thinner or other solvents 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 17 Symbol Legend Connector for treatment electrodes C 0197 Anode red cable Gathode black cable Type BF device Device identification Serial No yy x x zzz yy Year of manufacture X X internal product type ID ZZZ consecutive number Error Checklist lf prior to during or after a treatment session the device does not operate in accordance with this manual 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 inconvenience Thank you gt Verify that the safety wall adapter is properly connected to the control 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 establishing a reliable connection lt gt The dose will only be increased to the selected setting a
23. s listed in the instruction manual In accordance with MPBetreibV HIDREX iontophoresis units require technical 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 e Operational check of the medical device in accordance with the instruction 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 Waste disposal of package and Electro Garbage wm Our packages and the transportation protection parts were produced out of non polluting salvageable materials The form parts are from PS KL AN foamed Polystyrol free of FCKW foils and bags are from PE ow Polyathylen and outside package are of cardboard Dispose all package parts in an environmentally acceptable way lf the appliance can become use no more you please dispose expertly of it In the remainder the national ordinances are to be heeded Appliances that are marked with the marginal symbol cannot be disposed with the house garbage You are indebted to dispose of such electro and electronics garbage separately Please inform yourself about the possibility of the regular waste dis
24. sion 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 water 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 applicators instead of water baths trays Axillary applicators 1 Proceed with steps 1 to 3 of the instructions on the previous page 2 Firmly push both plugs of the dual connecting cable onto the jacks of the AX electrodes 3 Thoroughly soak the sponge cushions AX I equipped with integral leather pouches or the sponge pouches AX Il with hand warm tap water At this time insert the AX electrodes Do not squeeze any water from the sponge cushions or sponge pouches 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 axillary 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 squeez
25. sition of the equation that belongs to the respectively chasm which according the specification of the transmitter producer the maximum wattage rating of the Transmitter in watt W is P NOTE 1 The higher frequency area near 80 MHz and 800 MHz is valid NOTE 2 These broad outlines may not be applicable in all cases The spread of electromagnetic sizes is influenced by absorptions and reflections of the buildings objects and people ELECTROMAGNETIC STABILITY DIN EN 60601 1 2 6 8 3 201 table 202 Electromagnetic S ae IEC 60601 Conformity r Stability verification Verification gauge gauge es ment broad Discharge static Electricity ESD after IEC 61000 4 2 Fast transient electric sturgeon sizes Bursts of IEC 61000 4 4 Withstanding Surges after IEC 6100 4 5 Tension break ins shortly in the time of interruptions and with fluctuations of the supply voltage after IEC 61000 4 1 1 Magnetic field at the supply frequency 50 60 Hz after IEC 61000 4 8 6 kV Contact discharge 8 KV Air discharge 2 kV for main connection 1 KV f r in and 1 kV out connection Not applicable 1 KV scanning tension 2 kV common mode tension Floors should consist of wood or concrete or with ceramics flow is equipped If the floor with synthetic material is equipped the relative humidity must amount at least 30 percent The quality of the supply tension should correspond to that of atypica
26. t current path is closed immersion monitoring by immersion 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 your skin is dryer 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 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 treatment protection is activated you should interrupt your treatment 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 circumstances In that case we would readjust the sensitivity settings to your needs Side Effects 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
27. term Each successful reconditioning by the manufacturer extends the lifespan of the medical device by 2 years If the HIDREX iontophoresis system 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 guidelines for electromagnetic compatibility EMV and been manufactured 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 influence medical electric appliances Broadputlines and Manufacturer Declaration The following tables include the broad outlines and manufacturer explanations after DIN EN 60601 1 2 2001 of all magnet field therapy appliances of the company Hidrex GmbH Otto Hahn Str 12 D 42579 Heiligenhaus ELECTROMAGNETIC RADIATIONS DIN EN 60601 1 2 6 8 3 201 Table 201 The Therapy Appliances of the company Hidrex GmbH is certain for the business in the below stated electromagnetic surroundings The user of the respective appliance should guarantee that it is used in such a surrounding Emission measurement Conformity Electromagnetic environment broad outlines The appliance uses high
28. ximately 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 Additional indications include Dyshidrotic dermatitis palmoplantar pustolosis and acrocynosis 5 System Components Your HIDREX therapy system comprises a control unit and the accessories explained in the following chapters Control Unit Model GS 400 Standard Accessories Hard Shell Case Kofferschale Treatment electrode Towel Dual connecting cable set Safety wall adapter Ergonomic treatment tray Axillary applicators Set AX or AX II 6 Face mask D Nape or back applicator not depicted Set DUO not depicted includes 2 additional electrodes each towels and a dedicated cable set allows simultaneous treatment of hands and feet Also refer to chapter Treatment Setup und installation Two types of axillary applicators are available a pair of sponge cushions with leather covers and a pair of soonge pouches with special small electrodes AX electrodes The
Download Pdf Manuals
Related Search