QRS®-101.4 QRS®-101 PROFESSIONAL
Contents
1. Pressing the key confirms the current selection leaves this menu and starts the device and its standard functionality NOTE You may leave the menu to set the language at any time by pressing the der key The currently made incorrect setting will then not be effective 3 1 6 RESTORE BASIC SETTINGS Through a certain hot key you may restore the factory made basic device settings You may restore these basic settings by turning the device off On Off J pressing both O and x keys simultaneously keeping them pressed while the device stays turned off and now e turning the device on via the key ORS 101 4 and QRS 101 P will now reset to the following basic settings display light OFF speaker ON language DE German Basic settings only for QRS 101 4 therapy program relax therapy intensity medium e therapy duration 8 min e timer 1 OFF and 06 00 o clock vital medium 8 min e timer 2 OFF and 22 00 o clock relax medium 8 min 3 2 HOME THERAPY The home therapy describes a mode of operation where a QRS 101 4 and OQRS 101 P therapy is performed via simple key programming The operation is quite simple For each therapy 3 parameters have to be defined e the therapy program relax basis or vital e the therapy intensity sensitive medium or intensive and e the therapy duration 8 16 or 24 minutes You may select the s2. No applicator has been connected or the connected applicator does not correspond to the one selected in a chip card therapy W Please connect an applicator respectively the one prescribed on the chip card The chip card may not contain a therapy credit may be inserted the wrong way or may be mechanically damaged W Please check if the chip card has been inserted correctly see label otherwise please contact your physician therapist service partner or distributor The applicator does not conduct current The applicator or its connection cable may be defect usually caused by rough or inappropriate handling W Please check if the applicator has been connected and tightened correctly If available test another applicator on the device s corresponding connection In case of visible mechanical defects please contact your service partner or distributor The control unit has detected an error during its self test W Turn the control unit off and back on after a few seconds If this is a permanent or recurring error please contact your service partner Please note the error code fil and forward it to your service partner Fe 6 1 1 ERROR CODES DURING TIMER THERAPY If a timer therapy activated by the user through a chip card or via timer programming could not be performed a fault report will appear on the display the next time the device is started This report must be acknowledged by pressing the Start Stop
3. 1 kV differential mode 2 kV common mode lt 5 U for cycle gt 95 dip 40 Ufor 5 cycles 60 dip 70 U for 25 cycles 30 dip lt 95 U for 5s gt 5 dip 3 A m Note U is the a c mains voltage prior to application of the test level Electromagnetic environment guidance Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative h umidity 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 that 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 from 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 NOTE NA AND MEDICAL DEVICE DIRECTIVE MDD Guidance and manufacturer s declaration electromagnetic immunity A 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 Conducted RF oY IEC 61000 4 6 150 kHz
4. 5060 Hz ANN and power consumption Power consumption in stand by mode maximum 800 mW 315 mA slow blow Output signal MDD device class Ila Safety class Protection against ingress of water na Display DOT matrix 16 characters Operation of the device Environmental conditions Transport and storage As a maximum 3 V 170 mA 40 uT Temperature range 10 C up to 40 C Relative humidity 30 up to 75 Temperature range 5 C up to 50 C Relative humidity lt 90 none condensing Magnovit International Produktions und Handels AG reserves the right to modify the design and speci fication without prior notice Item Order Number ORS 101 4 Scope of delivery ORS 101 PROFESSIONAL Scope of delivery Mat applicator M1 Pillow applicator K1 Magnetic field pen MFS1 Carrying bag User manual Applicator glasses Applicator ear phone Control Unit Operating Instructions Power Cord Mat applicator Pillow applicator Carrying bag Control Unit Operating Instructions Power Cord Mat applicator Pillow applicator Carrying bag 033 0 0030 033 0 0030 033 5 0010 033 5 001 1 033 5 0013 033 8 0005 033 7 0013 033 5 0020 033 5 0021 Allergic Reactions Anesthesia rooms Applicator Attention Automode Baby Backlight Bacteroidosis Basic settings Basis program Beeper Burnout syndrome Cancer Cardiac Dysrhythmia Care Cell Met
5. B ead OK key The key confirms the current value and goes to the next position After confirming the last time digit you automatically reach the menu to set the date The corresponding display may look as follows Please proceed accordingly to set the date By confirming the last date digit the menu is closed and the device will be started with its standard functionality NOTE e You may leave the menus to set time and date at any time by pressing the The currently made incorrect settings will then not be effective e Only the German format for time and date are available exclusively 3 1 5 SETTING THE NATIONAL LANGUAGE You may operate QRS 101 4 and QRS 101 P in different languages To set the standard language the device s user interface offers you convenient menu guidance You may reach the corresponding menu by turning the device off pressing the key and keeping this key pressed while the device stays turned off and e turning the device on via the key You are now positioned in the menu to set the national language and see the display You may now move the cursor or abbreviation of the currently selected language is marked between brackets and NA through the menu to chose among various languages The The following languages are available DE German e EN English e FR French e T Italian e ES Spanish e SE Swedish
6. HZ 750 HZ 1000 HZ The Relax program Indications Relaxation immune system stimulation reduction of sleep disorders To achieve these effects special frequencies for the circulatory system were reinforced in the Relax program compared to the Basis program It can be used with the settings sensitive and medium The intensity intensive is not sensible and therefore prohibited The Vital program Indications Increase of vitality and attention also of elderly people reduction of sensitivity to weather changes Also in the Vital program in comparison to the Basis program and Relax program special frequencies are reinforced whilst others have been eliminated ORS 101 4 and QRS 101 P may recognize error situations by its own and show the corresponding messages on display Some of these errors may be corrected by the user himself without outside help The following description classifies errors roughly as those which may be shown on display with a comprehensive message and others which may not be described if only incomprehensibly For all errors the symptoms and if possible also the cause and the remedy are described ATTENTION In case of any doubt please contact the manufacturer an authorized service partner or your distributor e For all actions reaching beyond the measures as described in chapters 2 and 3 the mains cord has to removed from the socket or the device s jack 6 1 ERROR MESSAGES ON THE DISPLAY
7. Medical Devices an ordinance connected with Medical Device Directive 93 42 EEC Please let us point out clearly that e the Medical Device Directive is not valid outside the EC e the Ordinance on Operators of Medical Devices is not valid for medical devices which serve neither commercial nor economic purposes and in whose danger zone no employees are required to work 7 1 2 DURCHFUHRUNG SICHERHEITSTECHNISCHER KONTROLLEN Irrespective of the legal rules or beyond the scope of the Medical Device Directive it is recommended to have the device checked by the manufacturer or by a service agency authorized by him at 24 months intervals The check shall consist of at least the following criteria e Electrical safety check in accordance with the test plan of the manufacturer Check of the device in respect of external integrity Check of all display and operating elements in respect of damages Check of all inscriptions in respect of legibility 7 2 CLEANING DISINFECTION AND CARE For cleaning and disinfection ofthe device and its accessories there should not be used any agents containing higher portions of phenol derivatives alcohol compounds of chlorine or peracetic acid It is recommended to use disinfectants on aldehyde basis We recommend to clean the device with a soft damp cloth For tenacious stains you may also apply mild detergent used for delicate plastic surfaces The device is not suited for heat sterilizat
8. e g 16 MIN By pressing the key the time decreases in 1 minute steps and by pressing the key the time increases in 1 minute steps The intensity can be adjusted starting from any of the intensity keys sensitive medium intensive Press the key for 2 sec until the intensity in the display changes and shows e g INT 05 By pressing the key the intensity decreases and by pressing the key the intensity increases The intensity range starts from SE sensitive up to 1 10 The therapy program relax allows only values up to 5 After having reached the desired setting press the confirmation key OK and continue with normal operation 3 3 CHIP CARD MODE A chip card contains an electronic prescription and will be given to you by your physician or therapist The chip card may include up to 4 different therapies All required parameters have been saved on the corresponding chip card To perform a therapy through chip card please insert it into the card reader At this point it is irrelevant whether or not QRS 101 4 resp QRS 101 P have already been turned on NOTES e The chip card depicts the direction in which it has to be inserted into the card reader All other possible directions 3 out of 4 will cause the following error e If a chip card is inserted in the control unit all pressing of control keys to perform a home therapy will be ignored After inserting a valid chip card you w
9. medium Use the Relax program to avoid negative influence on sleep Therapy duration per day Up to 2 hours is safe according to a study by Prof Dr Dr A Varga Heidelberg The pain memory The learnt pain memory works in steps up and down After every improvement a slight pain can start again until the pain level is brought down to 0 The learning The learning tableau steps 5 1 THREE RELIABLE PROGRAMS BASIS VITAL AND RELAX PROGRAMS Experience with the reliable and internationally patented QRS signal has lead to the QRS 101 4 and ORS 101 P magnetic field therapy device with 3 programs with intensities selectable from sensitive to intensive The following programs can be chosen The Basis program The Basis program is the traditional and effective QRS program and is applied using the Treatment Advice recommendations It covers the frequency spectrum from 0 1 to over 1000 Hz This Basis program is described in the international patent Device for transporting ions especially protons Extract of the patent text As the experiments showed basically every biological organism can be treated especially organisms with a blood or lymph circulation The device is recommended for treating humans in the medical and sporting fields above all in cases of bone fractures Relax Stimulation of Transport Biochemical reactions circulatory system of ions muscle activity IN 3 HZ 20 HZ 250 HZ 500
10. rising blood pressure which sometimes occurs in the beginning of a QRS therapy please lower the field strength until the patient has grown accustomed to the QRS therapy It may also be useful to reduce the therapy duration to 2 minutes and to increase it gradually In case of vertigo which may also occur in the beginning please lower the field strength and or reduce the application to once a day In chronic illnesses initial aggravations may occur as they are known from homeopathic medicines The therapy should not be ended though Biological initial aggravations namely indicate the beginning reaction and or loosening of blockades within the body A secondary aggravation may occur after several weeks of QRS application Then you should also reduce duration and field strength of the respective application and increase them slowly Should the patient be on medication according to indication it may be assumed that these can must be reduced after a certain time 4 EXPLANATION OF THE SIGNS USED 0123 CE Conformity sign with the identifying number of the notified body for medical productse Attention Observe the instructions for use Application part ungrounded protection degree Type BF Appliance or safety class Il This product complies with WEEE Directive 2002 96 EG waste electrical and electronic equipment Separate collection for electrical and electronic equipment Mains voltage frequency 15 220
11. 0 minutes Treatment with the QRS magnetic field triggers positive effects on the human organism which continue for up to 8 hours To vitalize and stabilize good health in healthy people we recommend 2 treatments per day about 8 hours apart The QRS system has several applicators at its disposal These guarantee the most effective therapy results even at the large variety of different indications One of the applicator specific characteristics is the corresponding magnetic flux density especially regarding the setting of a definite intensity on the control unit For your information the following table states the magnetic flux density in micro Tesla uT measured directly at the applicator 10 tolerance for the three most common applicators Level Mat pT Pillow pT Pen 7 21 28 10 5 9 27 36 10 intensive 30 40 15 During therapy the appliance ensures that electro smog cannot pollute the body and therefore degrades the therapy Only ORS has this ability a process that is patented internationally EU Pat 0 621 795 PCT WO 94 11062 4 1 THE COIL PILLOW K1 The pillow is applied purposefully for individual parts of the body without influencing other regions with the pulsating magnetic field e Coil Pillow K1 ATTENTION The magnetic field effectively spreads up to 0 3 meters sideways and up to 1 2 meters vertically which means that people in the immediate proximity during treatment will r
12. 3 DESCRIPTION OF THE KEYS ORS 101 4 AND QRS 101 PROFESSIONAL 101 PROFESSIONAL On Off timer 1 key timer 1 key key key timer 2 timer 2 key und Taste gt key gt applicator selection and confirmation key Es intensity and fine tuning program A key NI display backlight speaker On Off On Off therapy duration Start speaker and fine tuning Stop Taste backliaht On Off On Off 1 4 DESCRIPTION OF THE DISPLAY ORS 101 4 and QRS 101 P have a 16 digit display Their contents depend on the current device function For detailed information please refer to chapter 3 Functional Characteristics Example 17 34 current time THERAPY 2 selected therapy program e g the 274 program on a chip card 2 1 TRANSPORT AND ASSEMBLY The image above shows supply and fuse on the device s upper quoin power inlet fuse carrier applicator B applicator A ORS 101 4 and QRS 101 P are mobile mains powered appliances that shall not be moved during intended operation Any location on a level surface is suitable The devices should not be placed in front of a heater or radiator leave approx 1 m clearance There are no further requirements concerning wall distance or ventilation The device meets the requirements DIN VDE 0750 EN 60601 1 EN 60601 1 2 and belongs to the protection class Il It is part of class Ila within the scope of the Medical
13. Device Directive ATTENTION The unit is not designed to be operated in places with the inherent risk of explosions If it is used in dangerous areas of anaesthesia departments the possibility of an explosion cannot be excluded If the patient and or an applicator cable is directly exposed to a radiator of a medical device for high fre quency heat therapy the damage of the device or danger to the patient cannot be excluded As a rule a distance of 3 m is sufficient 2 2 POWER SUPPLY ORS 101 4 and QRS 101 P are intended to be connected to mains voltages of 115 V or 230 V and a mains frequency of 50 or 60 Hz Within this range there is no need for further change or alteration on the devices Connect the device s power jack to a grounded socket by means of the attached power cord NOTE ORS 101 4 and ORS 101 P allow time controlled operation Timer Mode In this case the device starts automatically at a predefined time selected either via key programming see 3 4 Timer Mode or via chip card see 3 3 Chip Card Mode This functionality is available since the control unit permanently surveys its time controlled routines in the so called stand by mode even if it has been turned off via the on off switch It is thus mandatory that the control unit is continuously connected to the power supply through its mains cord Please do not remove the mains cord from the device and never connect the device to the power supply vi
14. G FL 9492 Eschen www magnovit ch Produktion Deutschland gbo Medizintechnik AG D 64668 Rimbach ORS Produktion Deutschland N N En af x ING N N gr ER 4 s ur v gt 3 A ou goer sires p a Sees La ml ae te Bu
15. ORS 101 4 ORS 101 PROFESSIONAL OPERATING INSTRUCTIONS The Magnovit International Produktions und Handels AG has taken care in preparation of this manual but makes no expressed or implied warranty of any kind and assumes no 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 the Magnovit International Produktions und Handels AG Magnovit International Produktions und Handels AG 2007 Sales and production Magnovit International Produktions und Handels AG Industriestrasse 651 FL 9492 Eschen Telefon 41 0 817406783 Telefax 41 0 817406784 E Mail info magnovit ch Manufacturer gbo Medizintechnik AG Kleiststra e 6 D 64668 Rimbach NOTE NA ORDAN A E DIR AND MEDICAL DEVICE DIRECTIVE MDD ORS 101 4 and QRS 101 PROFESSIONAL are mains powered magnetic field therapy devices of protection class I The devices are in accordance with the EC directive for medical devices 93 42 EWG and therefore carry the CE sign with the registration number of the notified body for medical devices The according graphical symbol is placed on the type plate According to the MDD QRS 101 4 and QRS 101 PROFESSIONAL are class Illa devices The manufacturer is only responsible for the safety operational reliability and functionality of t
16. S 101 PROFESSIONAL work with magnetic field intensities up to 40 micro Tesla and thus lies below the WHO limit For comparison Highest ORS 101 4 QRS 101 PROFESSIONAL intensity 40 pT Terrestrial magnetic field 50 pT WHO limit 100 pT On this scale the therapy s intensity may be adapted to the current patient s state of health manually The treatment time can be perfectly adapted to each person s individual needs After an individually set time 1 60 minutes the control unit automatically switches the magnetic field off The positive physiological effects which are started through the use of the QRS magnetic field usually take place within 8 hours healthy organism The regular recommendation is a treatment in the morning in the midday and in the evening Bei dem QRS 101 4 handelt es sich um das Home Ger t Mit diesem Ger t ist es m glich Therapien mit den Programmen Basis Vital und Relax ohne Chipkarte durchzuf hren Zus tzlich kann eine in der Arztpraxis erstellte Chipkarte als elektronisches Rezept verwendet werden Kapitel 3 Punkt 3 Bei dem ORS 101 PROFESSIONAL handelt es sich um das Profiger t Mit diesem Ger t ist nur der Chipkartenbetrieb m glich Kap 3 3 Es kann in der Praxis als zus tzliches Therapieger t benutzt werden In den folgenden Kapiteln wird dieses Ger t QRS 101 P genannt 1 2 VIEW OF QRS 101 4 AND QRS 101 PROFESSIONAL ORS 101 4 OQRS 101 PROFESSIONAL 1
17. YP 0 23 0 73 23 7 3 23 NOTES IN ACCORDANCE WITH EC DIRECTIVE AND MEDICAL DEVICE DIRECTIVE A OVERVIEW 8 1 INTRODUCTION 9 1 1 Intended use 7 1 2 View of QRS 101 4 and QRS 101 PROFESSIONAL 10 1 3 Description of the Keys 11 1 4 Description of the Display 11 2 START OF OPERATION 12 2 1 Transport and Assembly 12 2 2 Power Supply 12 2 2 1 Mains Fuses 13 2 3 Connecting the Applicator 13 2 4 Turning on the Device 14 3 FUNCTIONAL CHARACTERISTICS 15 3 1 Basic Functions 15 3 1 1 Selecting the Applicator Jack 15 3 1 2 Turning the Display Light On Off 15 3 1 3 Turning the Speaker On Off 16 3 1 4 Setting the Time 16 3 1 5 Setting the National Language 17 3 1 6 Restore Basic Settings 18 3 2 Home Therapy 18 3 2 1 Fine tuning of Intensity and Therapy Duration 19 3 3 Chip Card Mode 20 3 4 Timer Mode 21 4 APPLICATORS 23 4 1 The Coil Pillow K1 24 4 1 1 Dosage Guidelines for the Pillow Applicator 25 4 2 The Coil Mat M1 25 4 2 1 Application of Coil Mat M1 25 4 3 The Magnetic Field Bar MFS1 Pen Applicator 26 5 THE QRS MAGNETIC FIELD THERAPY 27 5 1 Three Reliable Programs Basis Vital and Relax Programs 28 6 TROUBLESHOOTING 29 6 1 Error Messages on the Display 23 6 1 1 Error Codes During Timer Therapy 30 6 2 Further Error Situations 31 7 MAINTENANCE 32 7 1 Safety Controls 232 7 1 1 Gesetzliche Auflagen und Bestimmungen 32 7 1 2 Durchf hrung sicherheitstechnischer Kontrollen 32 7 2 Cleanin
18. a a switched supply power strip 2 2 1 MAINS FUSES Mains fuses serve to protect the device from further damage in case of a serious error Mains fuses are not subject to aging or wear Thus a defect mains fuse always indicates an internal device error If the device does not show any function after being switched on display stays dark first make sure that the socket and mains cord conduct line voltage Should this be futile please check the mains fuse and replace it by a new fuse with the same values if it is defect The mains fuse is located in the fuse carrier as shown in the image above The fuse is accessible by gently pressing the fuse carrier toward the device and turning it about 1 8 turn counter clockwise ATTENTION Please contact an authorized service partner in case of doubt after a defect fuse or after multiple defects 2 3 CONNECTING THE APPLICATOR Please connect the applicator s pillow mat pen to the 15 pole jack s submin D ATTENTION The applicator s 15 pole jacks are provided with 2 thumb screws for attachment Always hand screw these into the stud bolts of the device s jacks Never apply tools to tighten these screws 2 4 TURNING ON THE DEVICE e To switch on the device please press the The illuminated display shows the following text V1 1 is the current software version s label and may change during the device s development cycle e The device now performs an autom
19. abolism Cell Phones Cell Regeneration Cell Vitalization CE sign Child Chip Card Cleaners Coil Mat Coil Pillow Contraindications Credit Disinfection Display light EC directive Electro sensitivity Electro smog Electromagnetic sensitivity Epilepsy 12 13 29 27 33 35 2 34 22 33 19 23 23 34 Fine tuning Heater HF Device Hyperthyroidism Hypo and Hypertension Implantations Initial Aggravation lon Transport Language Local Application Loss of Blood Magnetic Acupuncture Magnetic Field Bar Magnetic Flux Density Mains Frequency Mains Voltage Mattress Medical Device Directive Medication Metal Parts Jewelry Mycosis Notified body Operating Staff Security Ordinance on Operators of Medical Devices 12 34 34 34 35 17 34 35 34 oe Pace Makers 34 Pain memory 2 Pregnancy 34 Protection degree 38 Radiator 12 Relax program 28 Rising Blood Pressure 35 Safety controls 32 Safety Precautions 34 Secondary Aggravation 35 Sedation 26 Side Effects 9 Stand By Mode 13 38 Sterilization 33 Therapy Description 20 21 Therapy Duration 26 Therapy Intensity 18 19 22 Therapy Program 11 18 19 21 22 Time 9 11 13 14 15 16 17 18 10 1 Time Out 14 Timer 11 13 18 21 22 30 Toning 26 Transport 9 Ventilation 12 Vertigo 35 Vital program 28 Wall Distance 12 WEEE 35 Wiping disinfection 33 Magnovit International Produktions und Handels A
20. andled identically Activation and deactivation of both timers start on a switched off device To program the timer 1 please press Zz the RL key keeping it pressed Now turn the device on via key The display will then show gt EN To activate the timer apply the ore to deactivate the timer apply the Bod cy The display will change accordingly This command must be confirmed via the key If the timer is deactivated the device will now start with the standard operating mode If the timer is activated you may now start with its programming As its first programming step you will set the time at which the therapy shall be started automatically The display will show the following menu exemplary time The blinking cursor is positioned on the time s first digit 2 as shown above You may now change the time PN by increasing the digit positioned below the cursor by pressing the key or to lessen it via the key The key confirms the current value and goes to the next position After confirming the last time digit you automatically reach the menu to set the therapy parameters Alterna tely you can now see the settings programmed for this timer regarding therapy program therapy intensity therapy duration and applicator To change one or several of these settings you may press the corresponding control key in any given order Should 2 applicators be connected to the control unit you may a
21. atic function test The display shows e In case of grave errors the display shows an error code see chapter 6 Troubleshooting e If everything works properly The display will show If required please adapt application specific settings see chapter 3 1 e The device is now ready for operation it displays the last operating state and waits for your input NOTE ORS 101 4 and ORS 101 P come with a time out turning the device off 8 minutes after not having been used 8 minutes after the end of therapy or 8 minutes after the last key click After this shutdown the device has to be restarted as described above 3 1 BASIC FUNCTIONS 3 1 1 SELECTING THE APPLICATOR JACK ORS 101 4 and QRS 101 P are equipped with jacks for 2 applicators see image in chapter 2 Start of Operation The physical identification for those 2 jacks are A more to the side of the case and B almost quoin center Some QRS System s applicators may be attached to these two jacks If 2 applicators are connected which have not already been predefined by an electronic prescription see 3 3 Chip Card Mode you may chose the applicator to be applied for the next therapy on the device The display of the selected applicator ensues by pressing the key All of the QRS System s applicators are coded thus QRS 101 4 and QRS 101 P may identify the connected applicator s type Therefore the display will not show th
22. called beeper in the following This beeper signalizes a key click an error or the end of therapy with different sounds each The key click s acoustical echo as well as the error signal may not be turned off contrary to the acoustic signal at the end of therapy since the latter disturbed some patients The end of therapy s signal status may be checked by simply pressing the status one of the following displays will appear key Depending on its vo These are always visible for 1 5 seconds before returning to the previous status If the A d key is being pressed while the display shown above is visible the end of therapy signal s status will be changed i e the switched on signal will be turned off and vice versa 3 1 4 SETTING THE TIME ORS 101 4 and QRS 101 P possess a clock battery backed RTC To set the time the device s user interface offers you convenient menu guidance You may reach the corresponding menu by turning the device off pressing the A key and keeping this key pressed while the device stays turned off and e turning the device on via the key You are now positioned in the menu to set the time and see the display exemplary time The blinking cursor is positioned on the time s first digit 1 as shown above You may now change the time by increasing the digit positioned below the cursor by pressing the NA key or to lessen it via the A
23. e applicator s physical identification A or B but the descriptive logical identification mat pillow or pen You may for example see the following display This display will be shown for 1 5 seconds before returning to the display of the operating mode A JE AJID AID NK OK You may switch to the respective other applicator by pressing the key a second time while the above stated display is still visible NOTE You may only switch to another applicator if 2 applicators are actually connected to the device If only one applicator has been connected it may be displayed but the cursor symbol will not appear on the display 3 1 2 TURNING THE DISPLAY LIGHT ON OFF The display s backlight may be turned on or off If it is turned on it stays active during the whole operation If it is turned off the display will light up for every operation keys but shuts down independently after one minute The backlight status may be checked by simply pressing the O key Depending on its status one of the following displays will appear These are always visible for 1 5 seconds before returning to the previous status If the O key is being pressed while the display shown above is visible the display light s status will be changed i e the switched on display light will be turned off and vice versa 3 1 3 TURNING THE SPEAKER ON OFF ORS 101 4 and QRS 101 P contain a speaker
24. eceive a gentle stimulation People not requiring treatment should remain outside the above mentioned range 4 1 1 DOSAGE GUIDELINES FOR THE PILLOW APPLICATOR Following are some setting examples for the pillow applicator Carvcial spine 1 Shoulder level 1 Thoraic spine level 2 3 Elbow level 2 3 Lumbar spine level 4 5 Hip level 4 5 Hand level 5 6 cold hands level 1 Knee level 7 8 Foot level 5 6 cold feet level 1 4 2 THE COIL MAT M1 The coil mat M1 creates a magnetic field of different strength depending on the control unit settings For the Sensitive setting the magnetic field strength lies at about 0 3 uT for level intensive the magnetic field strength increases up to 30 pT The magnetic field is distributed over the whole coil mat uniformly Its impact ranges 0 5 meters beyond the mat and approx 1 2 meters above and below the mat The body is embedded into the magnetic field and penetrated uniformly 4 2 1 APPLICATION OF COIL MAT M1 Nachfolgend abgebildet sind einige Einstellbeispiele f r das Spulenkissen gegeben e Coil Mat M1 4 3 THE MAGNETIC FIELD BAR MFS1 PEN APPLICATOR The magnetic field bar creates a magnetic field from a punctiform source The magnetic field disperses conically the highest strength being at the top of the rod Magnetic field bar MFS1 Local Application Preferred for small joints fingers jaw elbow for specific pain e g tenn
25. g Disinfection and Care gt 8 CONTRAINDICATIONS AND SAFETY PRECAUTIONS 34 8 1 Operating Staff Security 34 8 2 Application for Baby and Child 25 8 3 Further Additional Reactions in the Application 35 8 4 Explanation of the Signs used 35 9 TECHNICAL DATA 36 10 ACCESSORIES 37 11 INDEX 38 Chapter 1 Chapter 2 Chapter 3 Chapter 4 Chapter 5 Chapter 6 Chapter 7 Chapter 8 Chapter 9 Chapter 10 Chapter 11 describes the devices basic characteristics and offers a brief introduction into its operation explains the device s setup and initiation Essential settings are described describes all of the device s functions and their operation states indications about the use of applicators and accessories explains how to carry out the therapies lists possible failures their indication as well as their possible causes states indications of safety related checks according to the MDD as well as routine maintenance lists possible contraindications of QRS Therapy in addition to advices for avoiding hazards states all of the device s relevant technical data depicts the device s scope of supply and further accessories including the corresponding part numbers Index 1 1 INTENDED USE The Quantron Resonance System is the result of more than 20 years of fundamental research by leading international scientists A qualitative breakthrough has been achieved with thi
26. he device if e the device is used in accordance with the operating instructions e the electrical installation of the location where the device will be used meets the respective current requirements of electrical safety e the device is not used in hazardous environments and humid locations mountings enhancements re adjustments 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 MDD Technical support may be obtained by the manufacturer dealers or service authorized by the manufacturer The product s duration of life as scheduled by the manufacturer is 10 years ORS 101 4 and QRS 101 PROFESSIONAL are electronic devices For their disposal the according regulations for electronic devices have to be observed Incidentals have to be disposed with residual waste On request the manufacturer will provide you with 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 necessary 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
27. heck if the socket and mains cord conduct line voltage if necessary check the mains fuse see chapter 2 2 1 If necessary please contact your service partner The control unit s program memory has the wrong content Please contact your service partner The control unit s clock is powered by a battery its regular life span averages at more than 5 years The battery is empty and must be replaced Please contact your service partner Functionality reliability and safety characteristics of the device 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 by 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 must correspond to the requirements in accordance with VDE IEC The device does not contain any parts which need maintenance work done by the user 7 1 SAFETY CONTROLS 7 1 1 GESETZLICHE AUFLAGEN UND BESTIMMUNGEN The device is subject to the provisions of the Medical Device Directive The safety controls have to be carried out on the basis of this directive Thereby the Ordinance on Operators of Medical Devices has to be especially observed NOTES Safety controls have to be made on a basis of the Ordinance on Operators of
28. ill alternately see one of the following 3 typical displays Here the display s left side shows the current time its right side displays the chip card s therapy index therapy 1 2 3 or 4 If several therapies max 4 have been prescribed on the chip card you may page within those with the keys and Following the therapy number the plain text therapy description will be displayed for example This plain text has been chosen by your physician or therapist and serves solely as mnemonical description to identify the therapy If this text is longer than 16 characters they will be displayed as a sort of ticker as running text Following the therapy description the respective applicator jack will be displayed finally This is either the HPLC TOR H or HPLC TU Ey After starting the therapy the display will show the following typical contents On the display s left side the current therapy number and therapy description plain text will be shown alternately on its right side you can see the remaining time until the end of therapy The time of day the corresponding applicator jack as well as the preselected therapy duration are not displayed during the therapy NOTES e In making a chip card the maximum number of therapies to be performed by the patient will be prescribed This credit of therapy units will be deduced by one after performing each therapy As soon as this credit has been exhau
29. influenced by portable and mobile RF communication devices The manufacturer guarantees the conformity of the unit with the EMC requirements only when using accessories which are listed in the EC declaration of conformity The usage of other accessories my cause an increased emission of electromagnetic disturbances or may lead to a reduced electromagnetic immunity The unit must not be arranged physically close to other devices or stacked with other devices 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 Safety Precautions of this manual as well as in the Technical Information on the next two pages NOTE A _ JIKUAN AND MEDICAL DEVICE DIRECTIVE M A a DD 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 RF emissions CISPR 11 RF emissions CISPR 11 Harmonic emissions IEC 61000 3 2 Voltage fluctuation flicker emissions IEC 61000 3 3 Compliance Group 1 Class B Class A Complies purposes Electromagnetic enviro
30. ion or for sterilization with gases ATTENTION Before cleaning or disinfection unplug the power supply out of the socket The device 15 suited for wiping disinfection It has 1 be observed that no liquids enter the device In no case shall the plug or socket get wet For cleaning or disinfection the device may not be drizzled Control Unit Pillow Applicator Do not immerse in water Use normal household cleaners for synthetic materials Only wipe with a damp cloth Be sure to keep sharp pointed objects away from mat applicator and pillow applicator Do not expose the system to direct sunlight and protect it from frost Placing Mat under a Mattress The mat can be placed under a mattress A woolen blanket should be placed between the mattress and the mat in order to avoid undesirable bacteria or fungi caused by sweat ATTENTION With the following contraindications the QRS application should be done under medical survey pregnancy epilepsy hyperthyroidism cardiac dysrhythmia loss of blood cancer severe hypo and hypertension burnout syndrome severe mycosis and bacteroidosis e The QRS application is unobjectionable for metal implantation or pace makers which comply with the standards or EN 60601 2 31 For patients with other implanted electronical devices a risk assessment must be performed and if required a therapy under surveillance e Jewelry and glasses must be taken off du
31. is elbow or for indications regarding the head eyes ears jaws and paranasal sinuses The selection of intensity and duration ensues the same as for the coil pillow Magnetic Acupuncture Especially recommended for children and Magnetic proportions at adults who are afraid of pinpricks Also level intensive applicable for acupuncture massage Toning one minute for each acupuncture point level intensive basic program Sedation three minutes for each acupuncture point level medium basic program Maximum Therapy Duration Unlimited Recommended Time of Day none except for the head only low intensity in the evening Provisions for the ideal impact of the QRS therapy are to drink sufficiently 1 glass of water before and after each application support through vitamins minerals trace elements mainly magnesia regular sensible and balanced nutrition refrain from radical diets no abrupt discontinuation of medication regular application of the QRS therapy stable placement of applicator as well as patients position improved results with additional light thermal or kinesitherapy start QRS therapy at low intensity increasing slowly Information regarding the magnetic field strength settings is given in the preceding chapter Treatment times Possible treatments per day 3 times morning midday and evening After 6 PM the setting of the Basis program should not be higher than setting
32. key For each possible time controlled therapy timer 1 and timer 2 therapy 1 through 4 chip card the display will show the following messages code meaning the following E101 No applicator has been connected or the applicator does not correspond to the applicator selected in a chip card therapy W Please connect an applicator respectively the one prescribed on the chip card E102 The applicator does not conduct current The applicator or its connection cable may be defect usually caused by rough or inappropriate handling W Please check if the applicator has been connected and tightened correctly If available test another applicator on the device s corresponding connection In case of visible mechanical defects please contact your service partner or distributor E103 The therapy could not be started since the device was already in operation ulteriorly at the programmed starting time W Please check the starting times correct them if required and repeat the therapy if necessary E104 The therapy could not be started due to an error within the device Communication problem W Please contact your service partner 6 2 FURTHER ERROR SITUATIONS Symptom Cause Remedy The device cannot be turned on the display stays dark and empty A permanent alarm signal resounds after connecting the device to the mains power supply The menu to set the time appears every time the device is turned on Please c
33. lso change the respective applicator via key After the first click on this key the programmed applicator will be displayed for 1 5 seconds The respective applicator will be changed by pressing the visible i e no later than 1 5 seconds after the first click key a second time while the display is still On Off J Programming the timer is concluded by pressing the Mk key In both cases all previously set values will be saved for this timer By pressing the Start Stop key the device will be set to the standard operating mode The on off key will turn the device off NOTE If a ORS 101 4 control unit with activated timer is taken out of the power supply and reconnected later the device will switch on independently display the text AUTOMODE and switch off again The patented control unit generates in the mat or pillow applicator a pulsating magnetic field of the body s own frequency pattern with an exactly defined waveform The field strength corresponds to the biological windows of humans To achieve an optimal effect the field strength was designed to be variable because the electro sensitivity is subject to variations depending on the health of users and the acidity of the blood The field strength or intensity of the magnetic field can be chosen in 3 steps Sensitive Medium and Intensive The control unit automatically switches off after 8 minutes unless it has been individually programmed from 1 to 6
34. nment 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 The equipment is suitable for use in all establishments establishments and those directly connected to including domestic the public low voltage power supply network that supplies buildings used for domestic 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 assure that it is used in such an environment Immunity test Electrostatic discharge ESD IECE1000 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 IEC 60601 test level 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 cycle gt 95 dip 40 U for 5 cycles 60 dip 70 U for 25 cycles 30 dip lt 95 U for5s gt 5 dip 3 A m Compliance level 6 kV contact 8 kV air 2 kV for power supply lines 1 kV for input output lines
35. ring the therapy Cell phones must be turned off or placed at a three meter distance from the device Ifthe patient and or applicator or its connecting lead be located in the immediate sphere of a high frequency short wave or microwave therapy device the possible damage of device or patient may not be excluded Please keep a distance of at least 3 m e The device is not intended to be used in areas with the risk of an explosion If it is used in anesthesia rooms in an endangered area a possible explosion cannot be ruled out e For all recognizable malfunctions please contact your distributor or an authorized service partner 8 1 OPERATING STAFF SECURITY The pulsating magnetic field is distributed up to 0 3 m beyond the mat pillow applicator and up to 1 2 meters above and below Persons who are not being treated should stay beyond the stated range during an ongoing therapy 8 2 APPLICATION FOR BABY AND CHILD Children tend to react exuberantly Therefore the device may not be applied on children below the age of 10 without surveillance 8 3 00 nn MI For babies you should only apply the field strength sensitive with the pillow applicator For children aged two to 10 the intensity setting medium should be selected as a maximum FURTHER ADDITIONAL REACTIONS IN THE APPLICATION In case of allergic reactions always cover the applicator with a bio compatible cloth or paper In case of
36. s system in the domain of magnetic field therapy placing this therapy on a sound scientific basis which will ensure its place in medicine The Quantron Resonance System in short QRS serves for pain therapy and has proven successful in many indications even without further pharmaceutical therapies It supports the cell vitalization as well as the cell metabolism through precise ion transport This process activates the whole metabolism stabilizes the immune defense and improves the cell regeneration thus naturally strengthening weakened body functions According to intense international investigation and users journals no harmful side effects could be located to date since 1993 about 200 000 devices of ORS patent have been field tested The method is internationally patented patent no EP 0594 655 Through the applicators the control unit QRS 101 4 and QRS 101 PROFESSIONAL create a low frequency variable vibrant magnetic field of the body s frequency pattern with a precisely defined wave shape The intensity frequency is adapted according to the vital parameters and specific to the biological frames of the cell structures to be treated as indicated Since the individual electromagnetic hypersensitivity varies depending on the patient s health and his blood s acidity the magnetic field intensity may be altered to achieve the ideal effect The magnetic field intensity must be explicitly chosen via operation ORS 101 4 and OR
37. sted the corresponding therapy may no longer be selected from this chip card Please contact your physician or therapist as soon as possible e If a ORS 101 4 or QRS 101 P control unit containing a chip card with automatical time controlled start of therapy autostart option is taken out of the power supply and reconnected later the device will switch on independently display the text AUTOMODE and switch off again The same display appears if a chip card is inserted into a switched off control unit 3 4 TIMER MODE ORS 101 4 and QRS 101 P contain 2 independent timers These programmable timing circuits serve to automatically start a therapy Here you are free to choose the starting time as well as all therapy parameters therapy program intensity duration and applicator The timers have to be programmed and activated before their first use Afterwards the timers will start the selected therapy every 24 hours unless they have been deactivated explicitly NOTES e To perform a therapy in timer mode the device may be turned off but must be connected to a live power supply see chapter 2 2 Power Supply the first use of the timers they are set as described in chapter 3 1 6 Restore Basic Settings Both of the QRS 101 4 and QRS 101 P timers are equal and will be activated and programmed the identical commands The following example shows the commands for timer 1 Timer 2 is to be h
38. tated parameters via control keys on the keyboard arbitrarily The therapy will be started after setting these parameters by pressing the key Before starting the therapy you may typically see the following display Here the current time is shown on the display s left side the right side will alternately display the selected parameters for the therapy program the therapy intensity or the therapy duration e g therapy intensity as depicted above After starting the therapy the display will change to the following typical view On the display s left side the current therapy program and selected therapy intensity are shown alternately the right side displays the remaining time until the end of therapy The time of day and the pre defined therapy duration are not displayed during the therapy NOTES e The home therapy may not be performed if a chip card has been inserted into the card reader Please remove the chip card first e The therapy intensity intensive is not available for the therapy program relax The intensity medium will always be chosen whenever the intensity intensive is being selected 3 2 1 FINE TUNING OF INTENSITY AND THERAPY DURATION When necessary the intensity and duration of the home therapy can be fine tuned The therapy duration can be adjusted starting from any time key 8 min 16 min 24 min Press the key for 2 sec until the time in the display flashes and shows
39. to 80 MHz Radiated RF 3 V m IEC 61000 4 3 80 MHz to 2 5 GHz 3V eff Compliance level 3 V m Electromagnetic environment guidance Portable and mobile RF com munications 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 separation distance d 1 2YP d 1 2VP 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 recom mended separation distance in meters m Interference may occur in the vicinity of equipment marked with the following symbol 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 Separation distance according to the tranmission frequency m 80 MHz to 800 MHz 800 MHz to 2 5 GHz transmitter W 150 kHz to 80 MHz 91 24 0 01 0 12 0 1 0 38 1 2 10 3 8 100 12 d 1 2 P OZ 0 38 12 36 12 d 2 3
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