HiToP 191 - gbo Medizintechnik
Contents
1. Recommended separation distances to portable and mobile RF communication equipment The equipment is intended to be operated in an electromagnetic environment where radiated RF interference is controlled The user can help in avoiding interferences by means of meeting minimum separation distances between portable and mobile RF communication equipment transmitters according to the maximum output power of the communication equipment Rated power of the transmitter W 150 kHz to 80 80 MHz to 800 800 MHz to 2 5 GHz MHz MHz d 2 3 P d 1 2 P gbo Medizintechnik AG 2008 2011 Version 2 2 28 12 Index A Assembly of the device 10 C Care 20 Cleaning 20 Control panel 7 D Description of the unit 5 Device Connection and switch on 10 Disinfection 20 Display 7 G Graphic display 7 H High Tone Therapy 6 gbo Medizintechnik AG 2008 2011 HiToP 191 Hinweis 15 19 I Intensity regulator 7 N Note 19 S Safety controls 19 Supply voltage 10 Switch on the device 10 T Transport of the device 10 W Warning 10 14 18 20 Warnings 10 Version 2 2 HiToP 191 29 Personal notes gbo Medizintechnik AG 2008 2011 Version 2 2 30 HiToP 191 Art No 017 7 0138 gbo Medizintechnik AG 2008 2011 Version 2 22. 3 4 1 Treatment time The treatment time can be set in steps of 5 minutes between 30 and 60 minutes Treatment time 55 min With the Intensity regulator you can modify the treatment time to the requested value By pressing the Intensity regulator you store the value to the non volatile memory gbo Medizintechnik AG 2008 2011 Version 2 2 HiToP 191 13 3 4 2 Language In the language setting you can select between german english spanish italian czech portuguese russian and polish language Language deutsch cesky english portugu s espanol pycckun italiano polski With the Intensity regulator you can choose the language By pressing the Intensity regulator you store the value to the non volatile memory 3 4 3 Service menu The service menu is only used by service agents 3 4 4 Exit menu With the Exit menu setting you can choose the therapy mode by pressing the button of the Intensity regulator and start the therapy program by adjusting the intensity see chapter 4 2 treatment details gbo Medizintechnik AG 2008 2011 Version 2 2 14 HiToP 191 3 5 Important notes and safety precautions Warning It is imperative to comply with the notes and safety precautions in this user manual The unit should only be used for the treatment described in this user manual e In case of patients with an implanted electronic device please carry out high tone therapy only after having checked whether there is a
3. V R 75V A This shown display is only for example I 160 mA Figures may differ in your therapy P 2062 mW 9 The treatment stops after the treatment timer reaches zero You can also stop or interrupt the treatment by decreasing the intensity to zero 4 3 Display details In the detailed view the following values are shown gt Ur released voltage SS R patients resistance OOS I released current S P released power S O swelling active inactive Table 1 Information in the detailed view Some information on the detailed view In the detailed view you can recall treatment values like shown 1n the table above The time shown is the treatment time and it is decreased in steps of seconds When the treatment timer reaches zero the unit stops the treatment and the intensity 1s set to zero The values for voltage U and current I can be used as an indicator for the following therapies We are not able to give information about the absolute values of voltage and current because each patient reacts differently sensible to the current A common value for muscle contraction is between 150 200 mA This setting should result in a contraction of both thights visible and noticable by the patient gbo Medizintechnik AG 2008 2011 Version 2 2 HiToP 191 17 The patient s resistance R gives information about the electric conductivity of the system The resistance should fit to the area of 30 200 Ohms T
4. assure that it is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Electrostatic discharge ESD IEC61000 4 2 Electrical fast transient burst IEC 61000 4 4 Surge IEC 61000 4 5 Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 Power frequency 50 60 Hz magnetic field IEC 61000 4 8 6 kV contact 8 kV air 2 kV for power supply lines 1 kV for input output lines 1 kV differential mode 2 kV common mode lt 5 U for 2 cycle gt 95 dip 40 U for 5 cycles 60 dip 70 U for 25 cycles 30 dip lt 95 U for 5s gt 5 dip 6 kV contact 8 kV air 2 kV for power supply lines 1 kV for input output lines 1 kV differential mode 2 kV common mode lt 5 U for 2 cycle gt 95 dip 40 U for 5 cycles 60 dip 70 U for 25 cycles 30 dip lt 95 U for 5s gt 5 dip Note U is the a c mains voltage prior to application of the test level gbo Medizintechnik AG 2008 2011 Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be tha
5. biochemistry and involves their sub disciplines Put briefly and simply High Tone Therapy takes the fact that electrical changes in the tissue are always associated with biochemical changes and vice versa and puts it to use for therapeutic purposes In doing so it provides an alternative to medicinal physical and operative therapies that have so far proven unsatisfactory risky associated with side effects or even unsuccessful and planned surgical treatment 1 4 Operating the HiToP unit You purchased a HiToP 191 The unit is dedicated for private use If you use the unit commercially it 1s subjected to the Medical Devices Operator Ordinance In this case you as the user are legally obligated to execute safety controls as described in Chapter 6 1 gbo Medizintechnik AG 2008 2011 Version 2 2 HiToP 191 7 2 Operating concept 2 1 Control panel Box for accessories Display Main switch Figure 1 Front view Output plug for Intensity and connector to the modification patient cable regulator 2 1 1 Ergonomic control panel The control panel possesses a display the main switch the plug for the connector of the patient cable and the intensity regulator These elements are easy to recognize and to operate and their functions are described in detail in the following chapters 2 1 2 to 2 1 3 2 1 2 Display The device is equipped with a Graphic display There clear notes are provided to start the therapy the
6. Medical Devices Operator Ordinance is not valid for countries outside EU gbo Medizintechnik AG 2008 2011 Version 2 2 20 HiToP 191 6 2 Cleaning disinfection and care 6 2 1 Cleaning the device For cleaning the device for High Tone Therapy and its accessories do use only a soft fluffless cleaning tissue or common cleaner for plastic material Do not use any abrasive cleaner Warning Do not clean the device under running water and do not use even liquid abrasive cleaner Prior to cleaning or disinfection unplug the mains plug out of the socket The device is suited for wiping disinfection No liquids should penetrate the device Plugs or sockets must never get wet For cleaning or disinfection the device may not be sprayed on 6 2 2 Cleaning Electrodes You can clean the electrodes after a treatment by using some warm water Wash off the rest of the contact spray Dry the electrodes with a cleaning tissue or let them air dry Note The conductivity of the electrodes is optimized by using a big part of graphite Therefore while using and also while cleaning the electrodes black color may come off gbo Medizintechnik AG 2008 2011 Version 2 2 HiToP 191 21 7 Explanation of the used signs C 4 0123 CE Conformity sign Caution Observe the instructions for use Application part ungrounded safety degree type BF This product complies with WEEE Directive 2002 96 EG waste electrical and electron
7. afety Precautions of this manual as well as in the Technical Information on the next two pages gbo Medizintechnik AG 2008 2011 Version 2 2 26 HiToP 191 In accordance with the EMC regulations for medical products we are obliged by law to provide the following information Guidance and manufacturer s declaration electromagnetic emissions The equipment is intended for use in the electromagnetic environment specified below The customer or the user of the equipment should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance The equipment uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 RF emissions Class B The equipment is suitable for use in all establishments including CISPR 11 domestic establishments and those directly connected to the public Harmonic emissions Class A low voltage power supply network that supplies buildings used for IEC 61000 3 2 ae domestic purposes Voltage fluctuation flicker emissions IEC 61000 3 3 Note For devices with a power consumption between 75 W and 1000 W only Guidance and manufacturer s declaration electromagnetic immunity The equipment is intended for use in the electromagnetic environment specified below The customer or the user of the equipment should
8. always be carried out in a comfortable and relaxed position The joints shall be placed in an angular position so that they are placed in a relaxed position from which both the flexor as well as the extensor muscles can be stimulated In general the preparation and application of the electrodes is carried out as follows 1 Connect the electrodes to the patient cable 2 Connect the patient cable connector to the output plug on the frontside of the device 3 Wet the conductive rubber electrodes with contact spray to avoid current sensations on the skin Push the spray button for one or two times and disperse the fluid on the black side of the electrodes with your fingers 4 Remove oil and creme of the skin with a cleaning tissue Apply the electrodes as shown on page 8 6 Apply the Velcro strap in a way that the electrode fits completely ma Warning e Do not apply the electrodes on skin injuries Even minor abrasions can cause a burning Also you may not be able to judge the current intensity objectively If this cannot be avoided apply zinc ointment or vaseline to cover the affected parts of the skin e The electrodes must adhere completely to the skin in order to avoid excessive local current density Otherwise there can occur erythemas and sometimes even burns gbo Medizintechnik AG 2008 2011 Version 2 2 HiToP 191 19 6 Maintenance Efficiency reliability and safety characteristics of the device for High Tone The
9. equencies The current is applied by rubber electrodes which are moistured with contact spray During the treatment the muscle is contracted in intervals An interval consists of a 3 seconds rise time intensity increases a 3 seconds hold time intensity is constant on the maximum setted before and a 3 seconds break time Intensity 0 f Note If you like to interrupt or stop the treatment decrease the intensity to zero by turning the Intensity regulator counterclockwise 4 2 Treatment details 1 Switch on the unit 2 You see the start display 3 On the display the following message appears HiToP 191 Adjust the intensity until you get a muscle contraction 4 Increase the intensity clockwise by turning the Intensity regulator until you see a visible muscle movement 5 On the display the following message appears Time 28 21 OO C_C S This shown display is only for example Int 160 mA Figures may differ in your therapy oa L L gbo Medizintechnik AG 2008 2011 Version 2 2 16 HiToP 191 6 The therapy starts The therapy timer is shown on the display and decreases in steps of seconds Above the timer the intensity of the released voltage is shown on the display 7 By pressing the Intensity regulator you can select between the overview display and the detailed view as shown in chapter 4 3 Display in Detail 8 In the detailed view you see some additional informations Time 59 22 U 12 1
10. ers or services authorized by the manufacturer The product s life scheduled by the manufacturer is 10 years The HiToP 191 is an electronic device For its disposal the respective regulations for electronic devices must be observed Incidentals have to be disposed with residual waste On request the manufacturer will provide further technical descriptions for all repairable parts of the device such as circuit diagrams spare parts lists and adjustment instructions as far as these are of use for the qualified technical staff of the operator Comments on electromagnetic compatibility EMC Medical electrical devices are subject to special precautions concerning the EMC They must be installed and operated according to the EMC advice given in the accompanying documents In particular medical electrical devices may be influenced by portable and mobile RF communication devices The manufacturer guarantees the conformity of the unit with the EMC requirements only when accessories which are listed in the EC declaration of conformity are used The use of other accessories may cause an increased emission of electromagnetic disturbances or may lead to a reduced electromagnetic immunity The unit must not be placed physically close to other devices or stacked on them If such an order is necessary nevertheless the unit must be observed in order to check it for the intentional operation You find more EMC comments in the Chapter Warnings and S
11. he reason for a resistance greater than 200 Ohms may be e No contact spray was used to moisten the electrodes e Bad contact because of oil and or creme on the skin e No contact of the distribution cable to one of the electrodes The released power P is the product of voltage and current and gives some information about the released energy for one treatment 4 4 Duration and frequency of treatment The duration of treatment is pre set to 60 minutes In the basic settings see chapter 3 4 1 Treatment time the treatment time can be set from 30 to 60 minutes The frequency of the treatments depends on the intensity of the polyneuropathic pain In the beginning of the therapy first 2 4 weeks the treatment should be done daily Later on the treatment interval of 3 days was very effective for many patients For the treatment of your polyneuropathic pain you should find your personal treatment interval Please treat your polyneuropathic pain every day to prove the HiToP therapy If you experience less pain or no pain you can increase the interval of treatment Evaluate when the pain between the treatment comes back and increase the treatment interval With this method you can evaluate your personal optimum treatment interval gbo Medizintechnik AG 2008 2011 Version 2 2 18 HiToP 191 5 Electrodes The standard accessories for HiToP 191 include rubber electrodes of 120 x 80 mm 5 1 Electrode application The therapy shall
12. ic equipment Separate collection for electrical and electronic equipment gbo Medizintechnik AG 2008 2011 Version 2 2 22 HiToP 191 Technical data frequency Current consumption With 115 V max 1080 mA Omo oonamton faim a0 V ma Sma Output voltage max 50 V eff Admissible loaded 30 Q 5 KQ impedance Safety class II in accordance with IEC 601 Safety degree BF in accordance with IEC 601 Protection against ingress of IP X1 water Dimensions 13 5 cm x 23 cm x 23 cm H x Dx W Height at opened case 17 5 cm 1 4 kg without accessories Display LCD backlighted 128 x 64 dots full graphic Surrounding conditions Operation Temperature range 15 C 40 C Relative air humidity 30 75 Temperature range 10 C 50 C Relative air humidity lt 90 none condensing Types of current Sinusoidal currents of 4096 32768 Hz gbo Medizintechnik AG reserves the right to modify design and specification without prior notice gbo Medizintechnik AG 2008 2011 Version 2 2 HiToP 191 23 9 Accessories Connection cable 191 017 0 0191 Easy Fix electrode 80 x 120 Velcro straps Contact spray User s manual HiToP 191 in english Short form instruction 191 in english Following accessories can be ordered additional or for replacement Distribution cable 191 017 0 0067 Easy Fix electrode 80 x 120 mm with fixation slot package of 2 017 0 0062 Easy Fix electrode 80 x 120 mm
13. izontal surface The device must not be placed in front of radiators and should not be covered with pillows or blankets during the therapy Also the ventilation slots on the bottom of the unit should not be covered gbo Medizintechnik AG 2008 2011 Version 2 2 HiToP 191 25 11 Appendix Notes in accordance with the EC Directive and Medical Device Directive The HiToP 191 is a line powered device for High Tone Power Therapy of safety class II The device is in accordance with the EC directive for Medical devices 93 42 EWG and therefore carries the CE sign with the Notified Body s number The corresponding graphical symbol is placed on the type plate According to the Medical Device Directive HiToP 191 is a device of class Ia The manufacturer is only responsible for the safety operational reliability and functionality of the device if e the device is used in accordance with the instructions for use e the electrical installation of the location where the device will be used corresponds to the respective current requirements of electrical safety e the device is not used in hazardous environments and humid locations e the mounting amplifications readjustments modifications or repair works are carried out only by personnel authorized by the manufacturer e the operator regulation of this EC directive is observed within the scope of the Medical Device Directive You may obtain technical support by the manufacturer deal
14. nnected with the black connectors of the patient cable The electrodes below the groin must be connected with the white connectors of the patient cable Start the unit with the main switch on the front of the device Adjust the intensity until you get a muscle contraction appears on the display Increase the intensity until you can see a visible muscle contraction on the thigh Maybe some rotations clockwise 5 is a normal value A typical value for the current is about 160 mA However intensities from 80 up to more than 250 mA are common practice The chosen intensity should be comfortable for the patient The therapy is now started During therapy the intensity may decrease about 10 20 mA If required the intensity can be changed It is recommendable to do the adjustment in the active phase during the contraction At the end of the therapy the current to the patient will be automatically reduced to zero If you want interrupt or stop the therapy you can decrease the intensity to 0 by turning the Intensity regulator counterclockwise After use the electrodes can be cleaned with a wet cloth gbo Medizintechnik AG 2008 2011 Version 2 2 HiToP 191 9 D N DY SRAN Figure 3 therapy with the HiToP 191 gbo Medizintechnik AG 2008 2011 Version 2 2 10 HiToP 191 3 Start of operation 3 1 Transport and installation The device for High Tone Therapy is a portable unit The unit may be placed on any plane h
15. ny risk e Turn off cell phones or place them at a distance of 2 3 m from the device e Cardiac pacemakers can extremely be disturbed In these cases the therapy should be only carried out under continuous pulse and ECG control Take regards to the right electrode placement on the thighs In this case the treatment may be performed without control e If the patient and or the patient cable is in direct range of high frequency short wave or micro wave therapeutic devices a damage to the device or an injury of the patient cannot be excluded Please keep a distance of at least 2 to 3 meters e A simultaneous connection of the patient to a high frequency surgery device can lead to burns under the electrical stimulus electrodes e The device is not meant for use in non explosion proof places If it is used in dangerous anethesia areas an explosion is possible e Do not use the unit while taking a bath e Apply the electrodes only to those parts of the body which are described in the user manual e Do not connect other persons with the electrodes e Keep the unit away from children In case of all recognizable failures immediately contact gbo Medizintechnik AG or one of the service agencies authorized by gbo Medizintechnik AG gbo Medizintechnik AG 2008 2011 Version 2 2 HiToP 191 15 4 Therapy 4 1 General notes about the therapy For the therapy we use a muscle stimulation The muscle stimulation is generated with HiToP fr
16. obo High Tone Power Therapy Device HiToP 191 User Manual 2 HiToP 191 gbo Medizintechnik AG has taken care in the preparation of this manual However the company does not give any expressed or implied warranty nor do we assume any responsibility for errors or omissions All rights reserved No part of this manual may be reproduced in any form or by any means electronic mechanical or otherwise without the prior written permission of gbo Medizintechnik AG gbo Medizintechnik AG 2008 gbo Medizintechnik AG Kleiststrasse 6 DE 64668 Rimbach Telefon 06 25 3 808 0 Telefax 06 25 3 808 245 E Mail info gbo med de Internet http www gbo med de Version 22 Date of issue November 30th 2011 gbo Medizintechnik AG 2008 2011 Version 2 2 HiToP 191 3 Contents INTRODUCTION cestcescccaecaccstiucosnscadeuwensaudcansedeweatensauddandeasaubenkaugousietencetaneas 5 a di 1g 216 BLS cl gt pete ee een eee eee ee Oe ne ee ee nD 5 12 WCSCNDUOM ONS UNI sarisin bead nsec ted etiiedeuictedabedoiscctaec nica dedaie beaded 5 1 38 What is High Tone Power Therapy cccccccseeeseeeeseeeeeeeeseeeeaeeeseeees 6 1 4 Operating the HiToP UNit viscsccecsvoacsccvessssevesetedeverwesseavnseessaserereivvoostvenss 6 2 OPERATING CONCEPT sacveccevneneeniwsncnisecsanvevceruesteeudeenteueeensnesnnsaveuxecsnenen 7 BW COTM OL AN EE EEEE 7 2hr Ergonomie CONIC DAN Cl isctccwaestuciuscevmniuetuieienanebamiventuaraianuu
17. on range predestines this device for the use at home in modern and well equipped hospitals or medical practices Thus the HiToP HighTone Power 191 is well suited for e Symptomatic treatment with polyneuropatic aliments like 1 E pain burning prickling numbness e muscle stimulation Through external muscle stimulation the metabolism is activated which again results in an improvement of the sensibility to insulin Also patients with varicose veins metal implants endoprothesis and open wounds ulcus cruris may be treated Since the electrodes are placed at this Polyneuropathy treatment exclusively on the legs also patients with cardiac pacemakers may be treated The HighTone Power Therapy device HiToP provides a therapy with middle frequency sine waves The therapy is absolutely free of d c components The frequency range used comprehends 3 octaves the range of 4096 32768 Hz The therapy frequency is scanned with a defined frequency This method is called SimulFAM for Simultanous Frequency Amplitude Modulation gbo Medizintechnik AG 2008 2011 Version 2 2 6 HiToP 191 1 3 What is High Tone Power Therapy High Tone Power Therapy is a specific new development based on scientific knowledge from a number of different disciplines 1 e it is an inter disciplinary new development The specialist knowledge involved is derived from medicine physics mathematics physiology histology cytology chemistry
18. open the cover you can put the accessories electrodes velcro band and patient cable in this box gbo Medizintechnik AG 2008 2011 Version 2 2 HiToP 191 11 Figure 4 device with opened accessory box 3 3 Preparing the electrodes The 4 white velcro bands must be thread in the electrodes as shown on this picture Figure 5 velcro bands with threaded electrodes The side of the velcro band where the washing instructions are seen must face upwards and be placed 5 10 cm over the edge of the electrodes The velcro fastener has to face upwards on this side gbo Medizintechnik AG 2008 2011 Version 2 2 12 HiToP 191 3 4 Basic settings In the basic setting you can do modifications which will be stored in the non volatile memory Do the following steps to modify the parameters of HiToP 191 Switch off the unit Switch on the unit while pressing the Intensity regulator On the display you will see the selectable settings Menu Language Treatment time Service menu Exit menu You can select between the settings with the Intensity regulator After selection confirm your choice by pressing the button of the Intensity regulator and you can modify the values When you have taken your choice you can switch off the unit Your modifications will be stored in the nonvolatile memory If you want to start the therapy immediately afterwards you can select the Exit menu to get into the therapy mode
19. orizontal surface The distance between device and wall must be at least 20 cm The device for High Tone Therapy corresponds to the regulations DIN VDE 0750 EN 60601 It is a device of safety class II Within the scope of the Medical Device Directive the device for High Tone Therapy belongs to class Ila see also Chapter 3 5 and safety precautions Warning Note for use in clinical practice The unit is not designed to be used at non explosion proof places If it is used in dangerous areas of anesthesia departments the possibility of an explosion cannot be excluded If the patient and or the patient cable is directly exposed to a radiator of a medical device for high frequency heat therapy a damage of the device or a threat to the patient cannot be excluded As a rule a safety clearance of 2 to 3 mis enough 3 2 Connection and switch on The device for High Tone Power Therapy was set to be connected to a supply voltage of 100 V up to 240 V and will be switched automatically to the right supply voltage by the unit Irrespective of the supply voltage the device is appropriate for power frequencies of 48 to 62 Hz Connect the device for High Tone Therapy with the mains cable to a shockproof socket The device is switched on by the main switch at the front of the device This inhibits erroneous unintended disconnection of the device during normal operation On the top of the device you find an integrated box for the accessory When you
20. parameters of the selected type of current are indicated 2 1 3 Intensity regulator Modification regulator With the Intensity regulator you can switch through the menu of the program Push on the button of the regulator if you want to choose the function indicated on the display During the therapy you can set the output voltage with the Intensity regulator It is furnished in the form of a rotor pulse generator The current increases by turning right in direction and is reduced by turning left in direction The numerical value is shown on the display in mA To find the wanted intensity you may possibly turn the regulator clockwise for more than one rotation The Intensity regulator is also used as modification regulator for the basic settings chapter 3 4 gbo Medizintechnik AG 2008 2011 Version 2 2 8 HiToP 191 2 2 Short instructions Apply the electrodes to both thights like shown on these two pictures White connector Black connector Figure 2 Electrode placement First wet the black side of the conductive rubber electrodes with contact spray Push the spray button for one or two times and disperse the fluid on the black side with your fingers Apply one electrode 80 x 120 each to the thigh just above the knee and fix each electrode with a velcro band Apply one electrode 80 x 120 each to the thigh just below the groin and fix each electrode with a velcro band The electrodes above the knee must be co
21. rapy are only guaranteed in case of proper use in accordance with the operating instructions Safety control maintenance work repair work and modifications shall be carried out only by the manufacturer or the service agents authorized by him In case of a failure parts which influence the safety of the device shall be only replaced by original spare parts of the manufacturer The electric installation shall be carried out in accordance with the requirements of VDE IEC The device does not contain any parts which need maintenance work done by the user 6 1 Safety controls Commercial users are obligated to keep the Medical Device Directive and documentation of the safety controls The safety controls have to be carried out on the basis of this directive Here the operator regulation has to be especially observed Irrespective of the legal rules or beyond the scope of the Medical Device Directive it is recommended to have the device checked at 12 months intervals by the manufacturer or by an authorized service agency The check shall consist of at least the following e Electrical safety check in accordance with the check plan of the manufacturer Check of the device in regard to external integrity Check of all display and operating elements in regard to damage Check of all inscriptions in regard to legibility Check of all functions according to the user manual Note f e Private users do not obligate to the duties mentioned above The
22. t of a typical commercial or hospital environment If the user of the equipment requires continued operation during power mains interruptions it is recommended that the equipment be powered by an uninterruptible power supply or a battery Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment Version 2 2 HiToP 191 27 Guidance and manufacturer s declaration electromagnetic immunity The equipment is intended for use in the electromagnetic environment specified below The customer or the user of the equipment should assure that it is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Portable and mobile RF communications equipment should be used no closer to any part of the equipment including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended ae distance Conducted RF 3 Ve IEC 61000 4 6 150 kHz to 80 MHz Radiated RF 3 V m paaa IEC 61000 4 3 80 MHz to 2 5 GHz for 80 MHz to 800 MHz d 2 3VP for 800 MHz to 2 5 GHz Where P is the maximum output power rating of the transmitter in watts according to the transmitter manufacturer and d is the recommended separation distance in meters m Interference may occur in the vicinity of equipment marked with the following
23. uusdieanantecualeaial 7 Ne DIODI se rersceacttesyh e Gate hatin Ge von E O AOA 7 2 1 3 Intensity regulator Modification regulator cccceecccseeeeeeseeceeeeseeeeeseeeeeas 7 Ze OPOMIN WCU ONS sctaraeticaet tun tracin saan ataaaiea A 8 3 SUEART OF OPERATION rcunaoniansan setanesneeanunees 10 oi EFAS DON ana INSTANT GAOM seceeec cic cite tee eenect seh cehceceiceeneacetepedc sect ohideseaed 10 3 2 Connection and switch on sagens te cnteatrecanntbans yeadentleneyadatavaadnmaameeboneumeteinns 10 3 3 Preparing the electrodes sisisi aani 11 3e BASIC SCHINGS ease EEO 12 eA eatment UME crre R EA 12 942 Langu onen E E daadeaeaaaedi 13 oS or Wk DONC 0 2 a A E N EAEI AEA 13 AA EXET a a eave A E A E AAA 13 3 5 Important notes and safety PreCautiONS cccceecceeeceeeseeeeeeseeeseeeees 14 IASI Users Se cine su aeenn rapewenpce cn te waste nceanaaaas nua wenens denon sesmeseecanaoehens 15 4 1 General notes about the therapy ccccccccceeccceeceeceeeeseeeesseeeeeeeeees 15 4 2 Treatment detalls assan e A 15 eS mm C 9 Fe Ve 2 t2 See te en ee en ner ene ne een mene eters 16 4 4 Duration and frequency of treatment ccccceeeceeeeceeeseeeseeeneeeseeenees 17 9 ELECTRODES iad seeentcatwetaicea enews eneestndaesscnane cdcwatoican EE 18 51 EICCITOOS QDDNGCANOM siisii a EASi 18 6 MAINTENANCE iiinn seas Sie maataenueeea ta veemadeen teens eeeeeees 19 Bal OECO O Snaecatencetsatetnaaneeneqse bi eiancaie
24. wee O 19 6 2 Cleaning disinfection and CALE cccccceecceeceeeeeeeeeceeteeeteeteeeeeeeeeeeeas 20 6 2 1 CIGANING ING GCVICE vcccicvesececevasscavsqeseecenvarscexdyessecteverscacsueseectverscersxeseansaens 20 6 2 2 Cleaning Elec rodes xis hacag oe ese ees tei elas ate rd ee asda De Gated See eer tadad 20 7 EXPLANATION OF THE USED SIGNG cc ceccseseeeeseeeneeeeeeeeeeeeneeees 21 8 TECHINIGAL DATA cscstcctecssvecutenantaccaatedevestotacteiesinestenancaieanvernvesnestecteness 22 9 ACCESSORIES arredonar aeiia 23 10 ERROR MESSAGES wacsicccaiasccecssecarsicccnecevecaccasnsctiesnevscecacssasssecerscstaces 24 10 1 Error messages on the display ccccecceccseeceeceeeeeeeeeeeeeeeeeeeaees 24 gbo Medizintechnik AG 2008 2011 Version 2 2 4 HiToP 191 10 2 Further errors 2 0 c cece cc ccccccccccccccccccccccccecceccecacencectecueeauesnecuueaueseesaes 24 11 od od od BD Qe 25 12 INDEX ot ol ee ec ee on a ae ee en ae 28 Warnings and safety precautions Warning Warnings which have to be observed by all means Caution Observe the instructions for use Note Information that will facilitate your work gbo Medizintechnik AG 2008 2011 Version 2 2 HiToP 191 5 1 Introduction 1 1 Intended Use Electrotherapy with sinusoidal alternating currents 1 2 Description of the unit The HiToP 191 is a microprocessor controlled HighTone Therapy device for electrotherapy Its applicati
25. with fixation slot package of 4 017 0 0070 ee Contact spray a ee e a Note Use gbo original accessories only to guarantee the safe function of the unit gbo Medizintechnik AG 2008 2011 Version 2 2 24 HiToP 191 10 Error messages 10 1 Error messages on the display Error 1 current limit This error message appears when a short circuit of the electrodes causes a current which exceeds the maximum valid value Error 3 current monitoring This error message appears when contact problems in the cable system causes a strong fluctuation of the current Error 4 open circuit This error message appears when there is no current flow This can be caused by a cable defect or an error in the electrode placement Error 5 Unduly high temperature This error message appears when the temperature of the unit increases unduly high Please switch off the device and let it cool down Don t switch on the device until you are sure it has cooled enough down If the error message appears frequently please contact your service agents or the manufacturer 10 2 Further errors symptom cause and action Device can not be switched on no display Please check the main plugs and sockets Contact if necessary your service agents or the manufacturer Please contact your service agent or the manufacturer if the problems cannot be solved by the measures mentioned above Please note that the unit may be placed on plane hor
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