vasotrain - Harmony Medical
Contents
1. 0220022022002002n0 nen nnnnnnnnnsnnennnnnnennennnnnnennnnnnenne nennen 9 SOC EEC eraa ee ee 5 A DEVICE OPEFAUON sisina E an na rac ra 5 SWIICHING ON ans Daten ae a ea a Be Ra et ee se Eee ehe 5 SWICNING OR ee ee 6 PRU ORR a NREEEERRERRERTERANERER 6 Battery REDIACEMEN wcsiesssvevsenbscousuesdiateoseendivebcusiwsdauauceumleeueeebieeusesetduueeemieewsveloomesnioemies 6 Connection plugs at the upper case SICE ccc cecceccsecceeeeeeeeteceeeeeeeeeeeseeeeeeeeeeeeeaeeseeees 6 IS DIAY Qelalls un ses euere ee T 5 Operation of Vasolrain u22u0220ssuessennnsenennennnsnnennennnnnnennnnnnnnennnnenennennnnnennensnennenn 8 First steps before training CAL Mode u2220222022202000 000 onnn ann nenn nano nnn nenn nnne nennen 8 Start Of training mode MEA Mode nahen 9 Running training phase MEA Mode ccccssccseecececeeeseeseeeceeeceeeseeceeeseeecaeeseesaeesaees 9 THE USE OF NEAADNONES sasira EEO 9 Fade out INIOTMAUON sevisinsidionivntisoninendnensncaimenimontnans sentcaduadanntanscaaaterntsentareanedaraiaanterararntarts 9 SWIC OFF IE COV ICC ee ee 9 Sal 17 1010 Cape Mee er et eee neat ee ere Cee ee ne et eee eee ee eee eee eee eee eee 10 Setting Mode Calibration Mode CAL ccccceccsecceecceceeeeeeeeeeeeceeeseeeeeceeeseeeseeeseeeaess 10 Training Mode Measurement Mode MEA cccceccseeceeeceeeceeeeeeeeeeeeeeseeseeeeeeesaeees 10 SEO IVI OCS se as hoot bet arth a AN 10 RE2. Serious Obsessive Compulsive Disorders Serious depression Therapy resistant seizure disorder epilepsy The treatment effect can also be significantly compromised at State of disorientation and confusedness irrepressible state of anxiety Side Effects Amplification and aggravation of present discomforts 4 Device Operation Several operating elements of the VasoTrain are displayed in the following Function key P Function key E Volume Parameter Setting Sensitivity ON OFF all oe ae Switching ON Switch ON the VasoTrain with If the device switches OFF again with an acoustic signal the batteries are too low and have to be replaced VasoTrain Instruction Manual Switching OFF Switch OFF the VasoTrain with All display details shall disappear Auto OFF The VasoTrain switches OFF automatically with a signal tone if not used for more than 5 minutes Battery Replacement In case the battery status is too low the device switches OFF automatically with a signal tone Attention Never use new and old batteries together or batteries of different types Always replace all batteries at once Dispose the batteries in accordance to the regulations of your country In case of ignoring these pieces of advice the batteries function can be compromised 1 Slide back the battery compartment cover at the device backside The cover shall open after sliding 2 Take out the three empty Mignon batter
3. the patient as circle symbols and with acoustic tone pitches with the help of the VasoTrain Hereby the circles display the width of the vessel more circles wide vessel dilatation few circles constriction 2 Intended use Vasolrain is a biofeedback device used in migraine therapy for prevention of migraine attacks VasoTrain is especially indicated to be used by patients who feel certain auguries prior to a migraine attack and for patients who suffer from a circulating migraine in the vicinity of the temples The device Vaso Train can help to improve the technique of conscious change of blood circulation around the temple arterials Vasoconstriction to minimize the migraine attacks VasoTrain Instruction Manual 3 Safety Instructions Precautions Do not use the equipment when it has reached contact with water or other liquids Remove the batteries and let the equipment dry completely prior to reuse Attention The VasoTrain must only be used with the original BVP sensor Never put a plug of another device into the sensor plug connection The BVP sensor emits low infrared light which cannot be recognized by the human eye and also is of low intensity and not harmful to the human eye VasoTrain is a battery run device with low voltage which is not emitting electric shocks Relative Contraindications Psychic disorders and other diseases that may be amplified through the treatment such as Psychoses Serious neuroses
4. pulse signal no clear signal tone is audible or only unstable Possible Reason One or more batteries are inserted incorrectly wrong poles Many reasons can be taken into consideration Please check these possibilities Infrared radiation or strong light falls on the device through the patient s skin Suggestion for solution Insert the batteries correctly with right poles Make sure that the sensor has contact with the skin at the touch side Stay still for 8 10 seconds before checking again Do not move your head clench your teeth or speak Make sure that no hair lies between skin and sensor Remove all creme and makeup Check if the sensor is clean Raise or lessen the pressure onto the arterial by adjusting the headband At the beginning the correct sensor positioning at the temples and the finding of the pulse takes time and some experience Changes of 1 mm position can already result in value variations for the signal amplitude Switch OFF all light sources avoid direct sunshine 94 VasoTrain Instruction Manual 9 Delivery content VasoTrain device 507102 1 piece BVP Sensor 507103 1 piece Stand 507108 1 piece Flexible headband 507104 1 piece User manual 507131 1 piece 1 5 V AA Battery 450780 6 pieces 10 Technical Data VasoTrain unit Highest heart rate recognizable by device Lowest heart rate recognizable by device 150 beats per minute 35 beats per minute Required batteries 3x
5. AA 1 5V Current consumption without acoustic signal 6 mA Current consumption with acoustic signal 10 60 mA Impedance headphones 16 Ohm Dimensions Weight without batteries BVP Sensor Temperature Drift BVP Sensor Infrared radiation wavelength Axial Radiation intensity of pulse Average Axial Radiation intensity Sensor Frequency VasoTrain Instruction Manual 15 13 2 x 8 6 x 4 7 cm 140 g 0 5 per C 880 nm max 10 mW sr max 0 3 mW sr 1 kHz Manufacturer Pierenkemper GmbH Hoernsheimer Eck 19 35578 Wetzlar Germany Distributor schwa medico GmbH Wetzlarer Str 41 43 35630 Ehringshausen Germany Tel 49 64438333113 www schwa medico com export schwa medico de MEDICAL EQUIPMENT
6. DOC MOJE nein 11 TeS MOE vinia AT 11 C Gener AVC oaea E E E O 12 Description of graphical symbols used on the type label onnannnnennnnonnnnennensnnensnrennn 12 Interaction With OMMeEnrdeViCeS rii R NO 13 Guarantee and REDA Serry aaa EANES NSE eE 13 Dalely related Checks ineeieensihenrihenzihe 13 Gare and CIE AMING socictezotezsieiensesiaastouaeeveiecavetebardvaveldcomwewiceuweevioeuementeumeowinemcesinemmumtiel 13 1272 US U SSSPPERPRENEFENELEBEREORERGEFRURTESETERRTRUEREUETENELTORIEURTETRIFTEFRCRTESELFURTTER N ERUEORISURLEFRUFERORTECRETEENERSRERE 13 COMM GB esse state tate sete Eee soli tats caleba Basen ee aaae a aiceaet aac tries cine al 14 Product CaS SINE AO Wa een ee 14 O Trouble SOONG Eee ee Metelen 14 9 DOVE COMEM eek 15 1O Feco Ca BB Ale Birke RE EEE EEE 15 VasoTrain Instruction Manual Eu 1 Introduction VasoTrain is a biofeedback training device for the treatment of migraine attacks The device helps to perform a conscious training during a migraine attack whereby the widened skull brain surface vascular structures are narrowed Vasoconstriction If a proper technique for this training is applied the typical migraine attacks may be diminished significantly What is biofeedback Biofeedback is a self regulation technique which can be learned and practised with the help of a physiological device The device helps to display a body process for the patient such as the activity of a muscle or the width of a vascula
7. VASOTRAIN PORTABLE BIOFEEDBACK EQUIPMENT Instruction Manual 507131 Abbreviated Instructions 1 Insert batteries and plug sensor into the VasoTrain 2 Position the sensor with the help of the headband onto the arterial temporalis temple if necessary seek the pulse at the temple with the finger and place the equipment on this point Attention Put sensor area on the skin during this procedure make sure that the skin is clean and no hair falls between skin and sensor 3 Switch ON the VasoTrain with The device starts in the automatic Setting Mode CAL Check the pulse intensity and heart rate on the right display bars after some seconds If the display shows a low intensity with less than 4 bar segments renew the sensor s position at the temple and press P 4 Start the first phase calibration with calm and easy breathing until the preset CAL Setting Mode is changed to MEA in the display 5 The VasoTrain now runs in Training Mode MEA Start the training now On the left bottom display side you see the running time visible for your orientation 6 Switch OFF the VasoTrain with after finishing the training take off the headband and the sensor We recommend storing the equipment in the original delivered suitcase 2 VasoTrain Instruction Manual Contents 1 INITOQUCUON 2 55 ee een 4 Z 2 a0 278 RO ol e en ne eae eee ae eee 4 I SANS UCUN S eena 5 PFECAUNONS za an 5 Relative Contraindications
8. e volume The range is between 0 and 8 whereby 0 is signal OFF and 8 the highest volume Setting the automatic start time The left bottom side of the display shows the automatic start time Within this variable time period the device remains in the Setting Mode before switching to the Training Mode Press the right W key to choose a shorter starting time period and the right A key to choose a longer start time period The adjustable range is between 5 and 20 seconds The automatic start time can also be switched OFF if the value 5 is reached press the right W key again The display will show OFF and the patient shall switch to the Training Mode with P An automatic switch is now shut down By pressing the right A key the automatic start time can be switched ON again 90 VasoTrain Instruction Manual Adjustment of Sensitivity On the right bottom side the display shows the range of the device s sensitivity toward measure variations and external disturbances but also the reaction factor of the BVP amplitude sensor By pressing the E key three levels of intensity 1 3 can be selected whereby 1 represents the fastest reaction and highest sensitivity and 3 the slowest In level 3 the BVP amplitude reaction takes time but the sensitivity toward external disturbances is the slowest Report Mode While switching ON the device press simultaneously the E and the right A key to switch into the Report Mode Ea Report mode T R Numbe
9. f graphical symbols used on the type label Attention Read accompanying documents especially the user manual With the labelling of the CE certificate the manufacturer approves that the device meets all necessary requirements from EU directives and that a conformity evaluation process has been successfully completed Application unit of Type BF Warranty for protection against electric shock at adequate leakage current This symbol is followed by the product s year of manufacturing This symbol is followed by the product s serial number This symbol is followed by the product s article respectively order number This symbol is followed by the product s LOT charge description This product is labelled with the Recycling symbol in accordance with the EU directive 2002 96 EG This means that the product at the end of its working life must be disposed freely at a communal recycling location Do not dispose it in the household waste It is an active deed for the benefit of the environment D4 g a eit ea amp 92 vasoTrain Instruction Manual Interaction with other devices Compromising other devices At appropriate use the VasoTrain has no influence on other medical equipment or electrical devices Compromising by other devices The VasoTrain is high sensitive equipment The operation of the VasoTrain may be disturbed when used in the vicinity of infrared light direct light influence or intensive electromagnetic radiation in lo
10. g phase Start of training mode MEA Mode The lock symbol disappears if the device receives proper values and the Training Mode MEA begins standard time 5 seconds may be set in the Setup Mode resp Edit Mode To skip the 5 seconds pause and to start the training manually you can also press the key Running training phase MEA Mode During the training the ring display shows you the status and alteration of the blood vessel width in comparison to the starting width via circles The display starts with showing 15 rings A rising number of rings is equal to a widening vessel a declining number the narrowing In case of very big variations independent of patients movements the display shall be adjusted less sensitive The display scale can be adjusted or equalized within 7 levels Start of the adjustment level is 3 A higher adjustment is equal to lower device sensitivity lower adjustments results in a higher sensitivity Regulate the sensitivity with the right V and A keys The use of headphones The acoustic signal can also be heard via usual headphones with standard 3 5 mm plugs The volume is regulated via the left WV and A keys If the volume is set to V O the acoustic feedback is switched OFF and is confirmed by the symbol beside Attention Do not set the volume too loud at the start many headphones are set quite high from the beginning and may harm the hearing Volume Regulation Fade out Informa
11. ies and insert three new ones properly as shown on the device Check the polarity of the batteries The VasoTrain does not operate if batteries are inserted incorrectly 3 Slide back to close the battery cover Connection plugs at the upper case side Headphone connection BVP sensor connection VasoTrain Instruction Manual Connecting the BVP Sensor Plug in the cable and connection of the BVP sensor into the regarding device slot until you feel an interlock The connection is completed the cable does not have to be removed after the treatment To remove the BVP sensor always pull the plug connection not the cable as it may be damaged and fall lose from the actual plug Connecting headphones Headphones not included in the delivery amount shall have a 3 5 mm standard stereo connection Insert the plug properly into the regarding connection slot Display details Automatic Setting Mode Calibration Mode CAL Battery level Lock symbol Amplifying factor Training Mode Measurement MEA Response via circle display Signal intensity Therapy duration VasoTrain Instruction Manual 5 Operation of VasoTrain If not directed differently by the practitioner or therapist a usual training unit to Vasoconstriction is performed as follows The patient starts with a relaxation phase of 3 5 minutes after which he concentrates on narrowing the temple vessels for 3 minutes constrict
12. ion as small display circles as possible and 1 minute afterwards as relaxation again dilatation bigger display circles This cycle shall be repeated 6 times and be finished with a relaxation phase of 5 minutes at the end The display circles and hence the vessel width hereby is only influenced with relation to certain images and concentration training Please take care to relax all facial muscles and breath calmly during the therapy Further advice regarding the manipulation of the display circles shall be required from the practitioner or therapist A short manual cannot teach mental training or clinical background methods We therefore recommend gaining extra information with practitioners specially trained in Vasoconstriction and Biofeedback Learning with the help of written material or by experiment on oneself can surely help but does not often assure success First steps before training CAL Mode Neckband Connect the device to the sensor Adjust the headband and the hook and pile fastener to a tight halt Go beneath the headband and search with the finger for a tactile pulse Place the sensor under the headband at the point of a tactile pulse see application point in the picture Attention Hair and birth marks moles between skin and sensor may compromise the measured values of the device The skin at and near the application area shall be clean Switch ON the VasoStrain with the key The device is now i
13. n the automatic setting mode At the start CAL is shown on the left top display side Take a relaxing and comfortable position during therapy We recommend sitting in a comfortable armchair Attention The BVP sensor is very sensitive Even small movements like change of pressure clenching the teeth talking swallowing turning of the head etc may compromise the device s given values Wait a few seconds until the pulse is visible which is confirmed by a stable signal tone If the sensor is placed properly the device can quickly recognize a tactile pulse and the BVP amplitude The device emits a stable signal tone equal to the beating pulse The pulse is shown in the numeric display on the bottom right display side It is normal that a stable signal appears after some moments of unstable values If however no pulse is visible after 8 10 seconds possibly the signal is too low In this case try to place the sensor at a position more suitable or change the pressure of the headband If this also does not help see trouble shooting VasoTrain Instruction Manual Attention To find a proper pulse position takes practice and can take a while Even position differences of 1 mm can be effective After every new positioning the sensor needs some time to search a clear signal The lock symbol signifies that the device is still setting whereby the device checks the sensor values for exactness The lock symbol disappears after the settin
14. r of Total therapy therapy The first details of the Report Mode on the left bottom side show the total therapy time of all sessions in hours and minutes On the right bottom side the user can see the number of sessions By pressing the E key the patient reaches the second part of the Report Mode Here one can see the average time per session in minutes and seconds On the right bottom side the amount of sessions is displayed By pressing E again all data can be deleted By pressing the P key the Setting Mode is reached again Test Mode Reach the Test Mode by switching ON the device and simultaneously press the the E and left V key Battery level Ring display Bar display Fi Ru aoe at of a ar Display field 2 oo Display field 3 VasoTrain Instruction Manual Showing all display symbols Within the first test all possible graphical symbols are displayed so they can be checked Advanced technical device check By pressing the E key the second part of the Test Mode is reached Hereby the signal transducer the ring and bar display can be checked On the left top side the actual software version and during the editing the volume is shown The circle symbols may be faded out or in by pressing the right arrow keys The left arrow keys can fade in and out the bar display at the same time also adjustment for the volume The Setting Mode can be reached again by pressing the P key 7 General Advice Description o
15. r structure As soon as the patient has required a certain routine with the technique he or she is often in the position to regulate processes alone without the help of the device Biofeedback therapy is a part method of Cognitive Behavioural Therapy In contrast to medication the patient hereby plays an active essential role in the therapy and thus also controls great parts of the success What application areas can be treated with the VasoTrain Vasoconstriction is a well proven clinical non medication method to treat migraine attacks with biofeedback therapy that often results in diminished pain symptoms Consult your practitioner or therapist prior to the therapy Before starting the biofeedback therapy for Vasoconstriction your therapist or practitioner shall definitely have diagnosed migraine in your case At the moment Vasoconstriction may only make sense for treating migraine attacks Clinical tests have not clearly shown so far where other application fields might lay for instance within other types of headache etc Your therapist shall also advise and instruct you in the Vasoconstriction Indication Migraine How does the Vasoconstriction work within the migraine therapy A trick is used to display the relative vascular arterial width A special sensor Plethysmograph helps to measure the blood volume of the surface blood vessel beneath the sensor From this blood volume pulse BVP the relative vessel width is reckoned and shown to
16. tion All information excluding battery status and ring display can be faded out with the E key if they irritate Press E once more to fade in the information again Switch OFF the device The device VasoTrain can be switched OFF at any time with the key VasoTrain Instruction Manual 9 6 Modes The VasoTrain has 5 working modes Setting Mode or Calibration Mode CAL Training Mode or Measurement Mode MEA Setup Mode Report Mode Test Mode for technicians Setting Mode Calibration Mode CAL By switching ON the device with the key the VasoTrain is put into Setting Mode This mode can also be reached with the P key The amplifying factor shown on the display s left bottom side is chosen by the device and cannot be changed manually Training Mode Measurement Mode MEA The Training Mode is reached after the usual start of the setting phase This also happens after pressing the P key if the lock symbol is faded out or after a normal start time Setup Mode Enter the setup mode by simultaneously press and hold the E and the right W key while switching ON the unit with the key The mode can also be reached from the Setting Mode by pressing the E key D A time OOS Volume Adjustment in Setup Mode The volume set for the acoustic feedback is shown on the left display side The volume can be adjusted with the left V and A keys Press the left W key to regulate less volume and the left A key to raise th
17. to high humidity dust direct sunshine or strong infrared radiation Clean the cable and device with a moist lint free cloth Make sure that no liquid enters the device If however liquid shall enter the device take out the batteries and let the device dry completely before reuse Batteries Use with 3 AA Mignon batteries with the VasoTrain The lowest agreeable voltage is 1 2 V Battery type Volt Recommendation Normal Carbon Zink 1 5 V For non frequent use Alkaline 1 5 V Recommended Accu Alkaline 1 5 V For non frequent use Accu NiCd 1 2 V For frequent use Accu NiMH 1 2 V For frequent use Extension of battery life Do not leave the device at hot places like in the car at high temperatures Batteries may get leaky and lose a lot of power at high temperatures via self discharge Use the acoustic feedback only when needed The energy consumption can be 2 10 times higher depending on the adjusted volume A lower volume setting is needed with headphones VasoTrain Instruction Manual Storing For perfect use the equipment shall be stored in the suitcase under the following conditions Temperature 10 30 C Humidity Avoid direct light direct sunshine and infrared light Product Classification 20 90 The VasoTrain is classified as medical product of class due to the European Directive 93 42 EWG 8 Trouble Shooting Problem The device cannot be switched ON after battery change The device finds no
18. wer frequency range To avoid value variations please do not use the VasoTrain near the following devices Infrared devices therapy lamps radiant heaters Heat sources electric heaters flames or fire places strong and radiating light sources fluorescent lamps Running engines ventilator washing machines Running devices with strong electromagnetic radiation Guarantee and Repairs The manufacturer affords one year guarantee from date of purchase for the device plus accessories of VasoTrain The VasoTrain equipment shall only be used with the original BVP sensor The manufacturer will not assume responsibility for any damage resulting from connecting the BVP sensor and the VasoTrain to other electric equipment The equipment is delivered without exchange parts Repairs must only be performed by the manufacturer or persons authorized by the manufacturer Contact addresses can be found at the end or back of the user manual The manufacturer will only assume responsibility regarding security and operation safety if the VasoTrain is repaired newly set or changed by authorized personnel and used in accordance with the user manual Safety related Checks With economical and commercial use the VasoTrain shall undergo safety related checks every 24 months due to 6 MPBetreibV Care and Cleaning Do not expose the device to high temperatures such as leaving it in the car at high temperatures Also do not expose device and sensor
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