User Manual - PATH medical Solutions
Contents
1. You can use the demo mode to evaluate the need for additional modules for your device see section 5 4 From the distributor you will receive a new license key to be installed on your device Before installing a new license key please make sure to have the former license key available in written e g on delivery note for potential reinstallation if needed Install a new license Press the Enter license key button enter your new license key and confirm the input by pressing the ENTER key 2a 5 First steps 5 6 Other errors and their possible reasons Error descrip tion Recommendation Action Black display No feed back black display No feed back display stalled 5 7 Possible error messages Test MAGIC PTA SUN 5 8 Cleaning Senti The display is automatically deactivated after 2 minutes without user activity in order to increase use time without recharging Please touch the display in order to leave the power saving mode After 5 minutes without user activity the device auto matically powers down completely Please start the device by pressing the on switch If the device does not respond to user action you might need to restart the device by pressing the reset switch see Fig 3 Please charge the battery if necessary If the error is still present please contact your distributor and describe which circumstances resulted in this behaviour during the meas2. 16 17 With the MIRA PC software see Chapter 4 you are able to de activate user management and to create different user profiles with or without password which can be uploaded to the device If you need further information please use the context sensitive help on the device 1 e press the info icon in the footer Note It is assumed that one user will usually login and work with the device until turning off the device Hence changing a user is possible by turning off and on the device n 2 7 a za Global parameters device settings cb Gh u O a O es O O a O e O Fig 16 Initial screen if Fig 17 Patient list if no password was assi patient data had been gned or after login generated 5 5 First steps 5 2 Device settings The following settings can be changed on the device see Fig 17 global parameters Date Time including date and time format e g DD MM YYYY or MM DD YYYY Language selection out of several languages dependent on the installed lan guage pack 1 g E D I ESP F Sound Brightness Hardware tests Delete data data will be removed from device to restore data do not delete before transferring data to the PC see Chapter 4 System information 5 3 Hardware test and possible error messages Device Error Recommendation self message Action test Battery Please contact your distribu Core vol xX tor tage Codec Please contact you
3. F S I M R L b R b L Stimulus information is listed coded within the header This can be deselected hidden stimulus information in the settings menu Active stimulus conditions are displayed on the left whereas infor mation about the last recording patient input is displayed on the right For further information please refer to the How To Manual Frequency modulated tone sine tone Instruction phase Measurement phase Current stimulation at__ ear R right ear L left ear b R Right ear measurement of both ears selec ted b L Left ear measurement of both ears selected Indication of current stimulus level 40 dB HL Indication of a test with a muted stimulus Information about previous patient response last stimulus level in dB HL e g 40 patient input tone was heard Information about previous patient response last stimulus level in dB HL e g 60 patient input tone was not heard Patient indicated to hear a sound after presenta tion of a muted stimulus Low attentiveness could be the reason for this behavior For these responses the respective test frequency is marked in the audiogram with a question mark MAGIC audiogram mode only together with the total of such events mute heard Not heard patient response after presentation of a muted stimulus Symbols footer Meaning Footer struc Back home diverse info ture turn off symbols 10 Turn of
4. locked mode Shift sine level Shift masking noise level Simultaneously shift level of sine tone and mask ing noise locked mode Symbols and structure of the graphical user interface Symbols footer Meaning 9 SUN Training Symbols in the main screen Stimulus output on right ear red Stimulus output on left ear blue Special symbol during SUN Training test The training phase can be switched to test mode immediately The symbol is in the hidden footer which can be shown by pressing the on off switch of the instrument see Fig 2 In test mode all log atomes are presented with increasing noise level in order to test soeech understanding in noise Meaning Image based self controlled pure tone audiometry for children from 3 years on There are two test types MAGIC Audio and MAGIC Screen The footer will be removed when using MAGIC see 3 1 Advices of how to instruct children to per form the test as well as more details of the measuring procedure can be found in the How To Manual Chapter 2 MAGIC MAGIC audiometry mode Frequencies from 250 Hz to 8 kHz initial stimulus level and stimulus type can be chosen MAGIC screening mode Frequencies from 250 Hz to 8 kHz screening level and stimulus type can be chosen Conventional pure tone audiometry following ISO 60645 1 Class 4 screening up to 70 dB HL or class 3 diagnostic up to 100 dB HL for air and bone c
5. sein Die Ausbreitung elektromagnetischer Gro en wird durch Absorptionen und Reflexionen der Geb ude Gegenstande und Menschen beeinflusst Nennleistung des Senders W Schutzabstand abh ngig von der Sendefrequenz 150 kHz bis 80 MHz 80 MHz bis 800 MHz 800 MHz bis 2 5 GHz d 3 5 3 Wurzel P d 3 5 3 Wurzel P d 7 3 Wurzel P 0 01 0 1 0 1 02 0 1 04 04 07 1 12 13 23 10 37 37 74 Fig 21 Copy of electromagnetic compatibility detail report distance to radiator sender depen dant on frequency This is a blank page due to production process Take your notes here 39 Made in Germany by PATH medical GmbH PATH medical GmbH Landsberger Stra e 63 82110 Germering Germany Tel 49 89 800 76 502 Fax 49 89 800 76 503 http www pathme de 0124
6. 1210 a gt EIERN I EEE woe A E EE E S E T E RING ane EIERN SEELEN a Electromagnetic compatibility report EMC report 2 0 0 0 cee 36 Made in Germany by PATH medical GmbH zu a 40 1 Scope of application Senti is especially designed for audiological examination of children from 3 years on for preschool and schoolscreening for pedaudiological diagnosis and for screen ing of speech understanding for school children and adults Before starting the measurement make sure to eliminate disturbing noise or distrac tion in the test room Background noise can affect the concentration of the patient and thus compromises the test results A separate room with no or not much background noise is ideal for tests with Senti 1 Scope of application 2 Remarks used symbols 2 1 Notes on safety AN This manual includes notes on safety which need to be followed in order to allow the correct usage of Senti The connector sockets are intended for connecting to the proper plugs of the origi nal acessories as decribed in section 3 3 Other devices must not be connected During measuremens with Senti the serial transfer cable or the label printer cable must not be connected Strong electromagnetic radiation may affect the operability of the instrument Do not use Senti nearby devices with strong electromagnetic radiation Please refer to the suggestions in section 8 5 Cleaning instructions are described in chapter 5 8 an
7. MEDICAL SOLUTIONS User Manual Senti Software Revision 1 3 Manual Senti Produced by PATH medical GmbH Germering Germany Printed on paper which was produced without chlorine bleaching Revision 7 Valid since Firmware Version 1 3 April 2011 Copyright 2011 PATH medical GmbH Reprint even partially only allowed with written notice from PATH medical GmbH Article number 100240 Contact info pathme de 49 89 8007 6502 All mentioned items products brands and trademarks are registered owned by the mentioned companies This manual and mentioned technical details are subject to change Errors and omissions excepted Contact information from your distributor contact information from your service partner Table of contents 1 Scope of application 2 Remarks used symbols 2 NOSSO Sale Peer er ee 232 NOS ON Operallonal eonceHt zierte au Eaa units 2 3 About this manual and further sources of information 0000 nn 2 4 Symbols and structure of the graphical user interface 2 22cceesceeen 3 Start reset charging and connecting sockets 3 1 On off switch special function for showing footer 220 3 2 Hardwar reset devices stalled 2 2 2 0 nr 3 3 Connecting to the sockets of the device an an ee Die SOS E EEEN E E E EA T a cas A ke EE nen E E EEA E AE ee GLEN Socket nee eier a a aa Deriabintetiiee Cable anak ecewt sn aa seen a ee een 3 4 Charging the
8. able and are to be paid by the customer Please send the device in its original packaging to your distributor Warranty is not applicable in cases of breakage malfunction due to manipulation or unintended usage negligence nonobservance of cleaning instructions crashes or accidents damages due to shipment Warranty is also not applicable when the device is not used according to manufacturer s instructions 6 2 Repair In case Senti is defect or differs in any way from its original setup an authorized distributor will repair re calibrate or exchange the device Service features and repairs of the device and its electro medical accessories must only be conducted by the manufacturer or its authorized service partners The manufacturer reserves the right to decline any responsibility for the safety in operation reliability and capability of the device if any service features or repairs were conducted by a non authorized body If in doubt please contact the manufacturer before making your service part ner repair the device 29 6 Warranty repair and service 6 3 Service routine maintenance 30 Calibration For all device types of the Senti device group an annual metrological inspection following 11 Clause 2 of the medical device operator act must be conducted by a service partner which is authorized by the manufacturer Note For the PTA module an annual inspection period is stipulated by the European standa
9. available modules in the How To manual Frequencies 0 25 0 5 1 2 3 4 6 8 kHz Stimulus levels 5 to 70 dB HL in steps of 5 dB Screening audiometer class 4 according to EN 60645 1 Frequencies 0 25 0 5 1 2 3 4 6 kHz Stimulus levels 0 to 70 dB HL in steps of 5 dB PTA4 Extended PTA3 SUN Screening audiometer class 4 according to EN 60645 1 with extended frequency level range Frequencies 0 25 0 5 1 2 3 4 6 8 kHz Stimulus levels 10 to max 100 dB HL in steps of 5 dB Audiometer class 3 according to EN 60645 1 Frequencies 0 25 0 5 1 2 3 4 6 8 kHz Stimulus levels 10 to max 100 dB HL in steps of 5 dB Speech understanding in noise Speech level 50 70 dB HL in steps of 5 dB HL Optional free field loudspeaker calibration via CCITT noise 8 4 Accessories Accessories like e g headphones or insert earphones include separate manuals data sheets which contain important information 35 8 Technical specifications standards manufacturer data 8 5 Electromagnetic compatibility report EMC report 36 m Labor f r die T der elektromagnetischen Vertr glichkeit Electromagnetic G ty Testing Laboratory ELEKTRONIK SCHWILLE ELEKTRONIK Benzstrasse 1A 85551 Kirchheim Germany EMV Pr fbericht EMC Testreport Gegenstand Audiologisches Handgerat Equipment EUT Hersteller PATH medical GmbH Manufacturer 82110 Germering Typ Senti Sentiero Type Auftragge
10. ber PATH medical GmbH Customer 82110 Germering Anforderung DIN EN 60601 1 2 VDE 0750 1 2 2007 12 Medizinische elekinsche Ger te Requirement Teil 1 2 Allgemeine Festlegungen f r die Sicherheit einschlie lich der wesentlichen Leistungsmerkmale Erganzungsnomm Elektromagnetische Vertr glichkeit Anforderungen und Pr fungen IEC 8080 1 1 2 3007 modifiz EN 60601 1 22007 DIN EN 60645 1 Norm 2002 08 Akustik Audiometer Teil 1 Reinton Audi IEC 60645 1 2001 Deutsche Fassung EN 60645 1 2001 Result The compliance with the requirements is fulfilled Gesamt 50 Seiten Total 50 pages Genehmigung des ausstellenden Laboratonums Prufbenchte ohne Unterschrift und Stempel haben kein Die Pr fergebnisse beziehen sich ausschlie lich auf den Prufgegenstand Die Messgr en und di Kalibnerungen sindruckf hrbar auf nationale DKD Einheiten This test report may not be reproduced other than in full except with the permission of the issuing labo and annual cakbraton is traceable to national DKD normals Fig 19 Copy of the electromagnetic compatibility EMC report bilingual Ger man English Electromagnetic compatibility report EMC report The EMC report certifies the conformity with respect to the mentioned require ments Senti can be used in an environment with electromagnetical radiation as spe cified in the detail report see fig 20 The user shall take care that the device is used in an environment with minimum distances
11. d 5 9 Acessories cleaning instructions are described on the respective data sheets Following art 1 18 and Art 2 of the law concerning the rearrangement of waste legislation product stewardship for batteries and rechargeable batteries from June 25 2009 The device includes a NiMH rechargeable battery pack In case the rechargeable battery pack cannot be charged anymore the rechargeable battery pack must be replaced by an authorized distributor The distributor is responsible for the correct disposal and storage In case of disposal of the device the device is not intended for consumer waste but for special waste A fully charged and completely functional battery pack will allow for measurements of up to 6 to 8 hours dependent on usage 2 Remarks used symbols 2 2 Notes on operational concept After turning on the device Senti can be operated via a touch sensitive display touch screen providing several menus and functions Context sensitive help screens which explain the currently available symbols and their functions allow an intuitive handling of the hand held device The context sensitive help screens are available via the blue information icons which are displayed on each screen in the footer at the right hand side At some screens there is an additional information icon which will provide further information for the user 2 3 About this manual and further sources of information In this manual you will fi
12. der Versorgungsspannung elektrische St rgr en 1 kV f r Gngangs und 1 kV f r Bngangs und sollte der einer typischen Gesch fts oder Bursts nach Ausgangsleitungen Ausgangsleitungen Krankenhausumpebung entsprechen EC 61000 4 4 Stohspannungen Surges 1 kv Spannung 1 kV Spannung Die Qualit t der Versorgungss pannung nach Au enleiter Au enleiter Au enleiter Au enleker sollte der einer typischen Gesch fts oder IEC 61000 4 5 Krankenhausumgebung entsprechen Spannungseinbroche o MU SIR U Die Qualit t dar Versorgungsspannung Kurzzeiunterbrechungen gt 95 Einbruch der LL gt 95 Einbruch der UL solte der einer typischen Gesch fts oder und Schw ankungen der fOr 1 2 Periode f r 1 2 Periode Krankenhausumgebung entsprechen Versorgungsspannung 40 U 40 U Wenn der Anwender des MBS fortgesetzte nach IEC 61000 4 11 50 Einbruch der lL 60 Einbruch der U Funktion auch beim Auftreten von f r 5 Penoden f r 5 Perioden Unterbrechung der Energeversongung 70 U TO U fordert wird empfohlen das BUT aus einer 30 Einbruch der LL 130 Einbruch der U Junterbrechungsfreen Stromversorgung f r 25 Perioden f r 25 Penoden oder einer Batterie zu speisen lt 9 LL lt o LL gt 95 Einbruch der U gt 95 Einbruch der UL f r 55 f r 55 Magnetfeld bei der 3 Alm 3 Alm Magnetialder bei der Netzfrequenz sollten Versorgungstreguenz den typischen Werten w ie sie in der 50 Hz 60 Hz nach Gesch fts und Kra
13. device and and connecting to the label printer POWER SUP Een rn ME SE ren Concerto abel printer zusenden 4 MIRA PC software and updates 4 1 Range of functions of the MIRA PC software 0 e eee eee 4 2 Dow CO St IVI sense A 5 HOV O0 UO DGALCS ee an centered esas are near 5 First steps bl User padent selection ses Ber aan 3 2 Device settings aao eae ee E EAS 5 3 Hardware test and possible error messages users ee 3 4 System INlormatlonand deme mode unser iin 539 license manasement and uper des nes 3 6 Other errors atic their possible reasons ns nern 5 7 Possible error messages during the measurement of ni sc Deo Be 0 Sri nihal O E aT NR TRENNEN NEE TON O 59 Gleaming Ol headphone ACCESO air OE 6 Warranty repair and service Ol N AE EER EA ee EA een ee 0 2 REPA nie De Ha einer 0 9 Service Toutne ANENA zus e a a A Rnge 7 Accessories 8 Technical specifications standards manufacturer s data 8 1 Device classification and applied standards 0 c eee eee 8 2 8 3 8 4 8 5 NIC VICS OLAV e LA Doreen ee eta teases eee heer el 34 PDO VACE ya rar ee riesen Meere 34 Power supply techatceable battery ae ee user 34 SDA ANG ASPO re ee E N E 34 Modules somarea ann E a E O ERA E E E OS 35 MIC ee E E RR RESTE 35 PTAA en eyes en es 35 PIERRE ENO AAEN AEEA A OOA ee 35 A se EEI EEE AEE E EAA EEEE GEN E SEEE E EEE 35 Se ee ot eee ee en acts 35 INC CE
14. f the device Context sensitive help info Symbols and structure of the graphical user interface Symbols footer Meaning q y J Cy Specific information available slideshow on selec ted topics Parameter settings global or test specific Previ ously entered settings are stored for further meas urements under same test conditions individual protocols possible Search patient last name Add a new patient Measurement with anonymous patient please note that data is not stored after measurement Back to previous menu Cancel data entry Scroll through pages e g patient list help screen Confirm data entry Enter space character Backspace Delete character The content of the edit window can be selected red Changing between numerics letters or special characters 11 2 Remarks used symbols Symbols footer Meaning MAGIC Test L PTA Test r A Fa Ah A uid f 12 Date input increase number decrease number Back to patient list Back to main menu i e test selection Print test results from the test view menu PRIN TER module needed Special symbols during MAGIC test Refill animal rack Undo previous patient response Special symbols during PTA test Configure level shift control shift sine level only shift masking noise level only or simultaneously shift sine and masking noise level
15. frequen cies If a muted stimulus was heard this might be an indicator for reduced attentiveness The num ber of these wrong responses is shown in audio gram mode at the respective frequency beside the question mark symbol The measurement at these frequencies should be repeated Special symbols during PTA test Pure Tone Audiometry The stimulus is presented as long as the loudspea ker button is pressed Decrease Increase level Stimulus Noise indicator Lights highlighted as long as the stimulus orange light or noise green light is presented Symbols and structure of the graphical user interface Symbols in the main Screen Meaning Patient response indicator if the patient response button is pressed the indicator is highlighted green light The threshold at the crosshairs can be set by clicking on the audiogram Use continuous sine tone as stimulus Use pulsed sine tone as stimulus Use warble tone as stimulus Use air conduction Use bone conduction placed at the forehead Use bone conduction placed at the mastoid 17 2 Remarks used symbols 18 3 Start reset charging and connecting sockets 3 1 On off switch special function for showing footer Special function during MAGIC and SUN module on off when pressing the ff switch th turn off device press switch for j el 10 seconds or touch the off shown Otherwise sy
16. he MIRA PC software Irrespective of the installed licenses 1 e modules on the device with the MIRA PC software you are able to update your device firmware For updating your device firm wate please connect the device via RS232 cable to your PC Devices which have the SW COM module enabled license additionally can transfer data between the device and the PC MIRA PC software simplifies data analysis enables user configuration and allows adding comments to patient and test data Various report options simplify documentation office printer Please note that MIRA does not provide any additional diagnostic function 4 2 How to get MIRA The latest MIRA PC software and its corresponding manual are available via down load on the PATH medical homepage Url http www pathme de su 4 3 How to get updates New device firmware and PC software updates will be posted each April and Octo ber on the PATH medical homepage Url http www pathme de su If any additional updates are available the distributors will be informed The distrib utors are supposed to inform the end customers 23 4 MIRA PC software and updates 24 5 First steps 5 1 User patient selection After turning on the device you will be asked either to select a user or to select an existing patient or create a new patient data set Dependent on your application situ ation it may be useful to activate or deactivate the user management sce Fig
17. mbol on the display footer eier disappears Fig 2 On off switch on the right hand side of the device special functionality during MAGIC and SUN module 19 3 Start reset charging and connecting sockets 3 2 Hardware reset device is stalled Push the reset button below the rubber casing on the back side of the device with a pen Afterwards the device can be turned on with the on switch Fig 3 Black reset but ton on the back side of the device below the red rubber casing 3 3 Connecting to the sockets of the device Blue socket Headphone for audiometry plug with blue tension relief Fig 4 Blue and grey socket w Fig 5 Free field Fig 6 GNotome Fig 7 Head Fig 8 Head Fig 9 Head loudspeakers JBL trics insert earpho phone Interacou phone Holmco phone Sennheiser Control 2 nes stics DD 45 PD 81 HDA 280 20 Connecting to the sockets of the device Grey socket Patient response switch bone conductor or charger plug with grey tension relief and labelprinter are to be connected to the grey socket Fig 10 Power supply and charging cable with grey ten sion relief Fig 11 Fig 12 Patient response Fig 13 power plug Fig 14 Labelprin Patient switch combined with bone ter response conductor switch Serial interface cable Fig 15 left serial interface cable RS232 wi
18. nd information about the handling of the device as well as information about the operation and cleaning Further information and details about the measurement modules potential clinical applications and recommendations for combining several test procedutes are explained in the guide for practical application How To Manual You can download this manual from http www pathme de support Symbols and structure of the graphical user interface 2 4 Symbols and structure of the graphical user interface All screens contain three basic elements the header the main screen and the footer header main screen footer Fig 1 Screen lay out The following table will provide an overview of all symbols and their corresponding function The symbols are sorted by their appearance in one of the above elements header main screen and footer The functions are also explained in the context sens itive help on the device Symbols header Meaning header Current time menu patient battery level structure name indicator e g 11 44 settings charging symbol Battery level indicator green sufficient power available Battery is charged Fi red charging needed ir Patient search pattern is active Search pattern filter can be changed deleted via magnifying glass symbol footer 2 Remarks used symbols Symbols header Meaning Special sym bols for MAGIC
19. nkenhausurgebung IEC 6 1000 4 8 vorzufinden sind entsprechen Anmerkung U st die Netzw achselspannung vor der Anw andung der Pr fpegel Fig 20 Copy of electromagnetic compatibility detail report 37 8 Technical specifications standards manufacturer s data 38 St rfestigkeit IEC 60601 Ubereinstimmungs Blektromagnetische Umgebung Leitlinien s Pr fungen Prufpegel Pegel Geleitete HF 3V 3V eff Tragbare und mobile Funkger te sollten in keinem St rgr en Efektivw ert geringeren Abstand zum HJTeinschlie lich der Leitungen nach 150kHz bis verw endet w erden als dem empfohlenen Schutzabstand IEC 61000 4 6 80MHz der nach der f r die Sendefrequenz zutreffenden Gleichung berechnet w ird Empfohlener Schutzabstand d 3 5 3 Wurzel F Gestrahlte HF 3 V m 3 V m d 3 5 3 Wurzel P von 80 MHz bis 800 MHz St rgr e 80MHz bis d 7 3 Wurzel F von 800 MHz bis 2500 MHz nach 2 9GHZ IEC 61000 4 3 mit Pals der Nennleistung des Senders in Watt W gem Angaben des Senderherstellers und d als empfohlenem Schutzabstand in Metern m Die Feldst rke station rer Funksender sollte bei allen Frequenzen gem einer Untersuchung vor Ort geringer als der bereinstimmungspegel sein In der Umgebung von Geraten die das Bildzeichen tragen sind St rungen m glich Ko Anmerkung 1 Bel 80 MHz und 800 MHz gilt der h here Frequenzbereich Anmerkung 2 Diese Leitlinien m gen nicht in allen F llen anw endbar
20. on 33 8 Technical specifications standards manufacturer s data 8 2 Device storage transport Device Device dimensions 209 3 x 98 0 x 34 8 mm Weight incl Rechargeable battery pack and ear probe 660 g Real time clock Rechargeable battery pack duration of life gt 2 years Interfaces RS232 up to 115 kbps Display 240 x 320 pixel graphic LCD 3 5 Resistive touch screen Up to five selectable languages per language pack Power consumption max 2 W 400 mA Power supply rechargeable battery Power supply auto backlight control automatic shutoff double voltage control Maximum operating time with fully charged batteries 6 hours Rechargeable battery pack 4 8 V NiMH Input voltage 100 240 V AC 47 63 Hz 0 16 0 29 A Output voltage 8 11 V DC 12 W max Maximum charging cycles 500 1000 Maximum charging time 2 hours Storage and transport 34 Please keep the device in the provided carrying case in order to protect the device and its accessories against external forces and environment impacts Extreme storage and operating conditions may result in breakage of the touch screen display extremely low temperature or in impairment of the device s calibration Storage temperature 0 40 C 32 104 F Operating temperature 10 40 C 50 104 F Air humidity 20 80 rel Air pressure 900 1030 hPa Modules 8 3 Modules MAGIC PTA4 You will find further information with respect to the
21. onduction insert sound probes patient response switch contralateral masking stimulus selection For more details about measuring proced ures see How To Manual Chapter 3 PTA 13 2 Remarks used symbols Symbols in the main Screen SUN View Results Symbols of result view Test names and layout 14 Meaning Screening test for assessing speech intelligibility in noise in school children and adults Vocal Conson ant Vocal logatoms are used The test is available for different languages I D E F The screening level can be chosen between 50 and 70 dB HL Sound presentation is available via headphones insert earphones or free field loudspeakers For more details about the measuring pro cedure see How To Manual Chapter 5 SUN In training mode all logatomes are presented without noise This is intended for instructional purposes In test mode all logatomes are presented with increasing noise level in order to test speech understanding in noise View results of stored measurements of the selec ted patient The test results shall always be interpreted by an expert The following symbols are only meant as visual indicators and thus do not imply any dia gnostic recommendation Test result OK Test result not OK Test result needs to be seen in detail to decide if OK e g aborted measurement Result might be in between OK and not OK The following abbreviations are used f
22. or the diffe rent test results MAGIC Audiogram mode PTA Audiogram SUN Score result Screening tests modes are given with a 3 letter abbreviation and the stimulus level MAG45 MAGIC Screening at 45 dB HL Additionally the tested ear right left the date and time of the measurement and a visual indica tor of the test result is given Symbols and structure of the graphical user interface Symbols in the main Screen Additional symbols wo DO ee MAGIC Test Meaning To start a measurement change settings Start test with right ear Start test with left ear Start test for both ears binaural or serial pro cessing right and left ear Decrease value e g frequency level Increase value e g frequency level Check box multiple selections possible Radio button single selection from the radio but ton group possible Special symbols used in MAGIC test Restart instruction phase Hide stimulus information in header button toggles between hide and show Show audiogram intermediate result 15 2 Remarks used symbols Symbols in the main Screen 16 Meaning Different animals in the MAGIC test represent dif ferent frequencies Tone on while button is pressed Animal with scarf response symbol for tone not heard Animal without scarf response symbol for tone heard Repeat MAGIC audiogram test at selected
23. r distribu x tor SDRAM Please contact your distribu x tor All tests Selftest was successful Sta Jf tus o k 26 System information and demo mode 5 4 System information and demo mode 9 34 System info ET Firmware release PN 1 3 build 2872 Release date 28 04 2011 Serial number 100045 Next service date 20 12 2011 Connected transducers HDA280 50032 SER_CABL 00000 Next calibration date 20 12 2011 Memory usage 2 Fig 18 System inform ation with license man agement and demo mode Demo Mode In the system information general information about the device and firmware ver sion is displayed Information about connected transducers are also displayed con nected before menu is entered When contacting your distributor error message module update this data should be at hand You can activate the demo mode 10 times In demo mode you are able to use all modules of your platform until the end of the day If you are interested in upgrading your device with a specific module please contact your distributor 5 5 License management and upgrades In order to update your license key e g after buying a new module you need to press the License No button on the System Information screen see Fig 18 The already entered license key and all currently licensed modules are displayed If you would like to add other modules to your device please contact your distributor
24. rd EN 60645 1 Order Nr 100 119 100 214 100 083 100 251 100 297 100 117 100 118 100 282 100 273 100 199 100 189 100 169 100 088 100 162 Accessories Article alphabetical order Bone conductor Set Bone conductor Patient response switch Firmeware PTA 3 Bone conductor with patient response switch BC RE1 available for PTA class 3 and PTA class 4 extended only Charger CH1 Free field cable Free field loudspeaker Set JBL Control 2 loudspeaker cable Headphone HPO1 Sennheiser HDA 280 Headphone HPO2 Holmco PD81 circumaural Headphone HPO3 DD 45 similar to TD39 Insert earphones GN otometrics Label printer cable Label printer with printer cable Patient response switch Serial interface cable SC1 Serial USB converter 31 7 Accessories 32 8 Technical specifications standards manufacturer s data 8 1 Device classification and applied standards Device class Ha according to Directive 93 42 EWG Appendix IX Application part BF Directive 93 42 EWG concerning medical products 1993 modified by 2007 47 EG German Medical Devices Act Medizinproduktegesetz MPG 2002 EN ISO 9001 2008 EN ISO 13485 2010 EN ISO 14971 2009 EN ISO 10993 1 2010 EN 60601 1 2007 EN 60601 1 2 2007 EN 60601 1 4 2001 EN 60601 1 6 2010 EN 1041 2008 EN 980 2008 EN 60645 1 2002 PTA module All laws directives and standards apply in their latest versi
25. th grey tension relief right USB converter Connect the handheld device via a serial interface cable RS 232 to your PC see Fig 15 left in order to update the device firmware or to exchange measurement data with the MIRA PC software see Chapter 4 If necessary use a serial to USB converter in order to get connected to your PC Fig 15 right Please refer to the manufacturer s informtion on the USB convertor s driver installation 21 3 Start reset charging and connecting sockets 3 4 Charging the device and and connecting to the label printer Power supply Connect the charging cable as seen in Fig 10 to the device For charging the device connect the power plug to a power socket with appropriate output voltage and fre quency see data on charger The charging process starts automatically and is fin ished within 2 hours Connect to label printer 22 When using the PRINTER module see license management section 5 5 you are able to print the test results directly from the device View test menu Therefore you need the Seiko Smart Label Printer 440 or 450 as well as a special connector cable to the device Art nr 100 189 Please connect the cable to the device as pictured in Fig 10 The label printer must be connected to the device only with this special connector cable in order to maintain patient safety and integrity of the medical device 4 MIRA PC software and updates 4 1 Range of functions of t
26. to potential radiators as mentioned in fig 21 table with Nennleistung effective power and Abstand distance dependant on frequency of radiator sender St raussendungs Messungen bereinstimmung Blektromagnetische Um gebung Leitlinie HF Aussendung nach Gruppe 1 Das MES verw endet HF Energie ausschle lich zu seiner CISPR 11 internen Funktion Daher ist seine HF Aussendung sehr gering und es ist unw ahrscheinlich dass benachbarte elektronische Ger te gest rt w erden HF Aussendung nach Klasse B Das MEG ist f r den Gebrauch in alen Einrichtungen CISPR 11 einschlie lich denen im Wohnbereich und solchen geeignet die unmittelbar an ein ffentliches Versorgungsnetz angeschlossen sind das auch Geb ude versorgt die zu Wohnzw ecken benutzt werden Aussendung von Oberschw ingungen Klasse A nach IEC 61000 3 2 Aussandungen von Stimmt Uberein Spannungschw ankungen Flic ker nach EC 61000 3 3 St rfe stigke its IEC 60601 Pr fpegel Ubereinstimmungs Bektromagnetische Umgebung Fr fungen Pegel Leitlinien Entladung state cher 6KV Kontaktentladung 6kV Kontaktentladung Fu b den sollten aus Holz oder Beton Bektrizit t ESD 8 kV Luftentladung 3 kV Luftentladung bestehen oder mit Keramkfliesen versehen nach EC 61000 4 2 sein Wenn der Fu boden mit synthetischem Material versehen ist muss die relative Luftfeuchte mndestens 30 betragen Schnelle transiente 2 kW f r Netzleilungen 2 kV f r Netleitungen Die Qualit t
27. urement of Error Recommendation descrip Action tion Please make Please connect a headphone Sure to have to the blue socket and if exactly one applicable a bone conductor transducer to the grey socket type connec ted to the proper con nector Before cleaning Senti the device must be turned off and removed from all connec ted devices Make sure that no liquids get to the interior of the device Do not dunk the device into anv liquid e g water or cleaning agents y liquid g g ag Only use wiping disinfection cleaners Ethanol 70 80 Propanol 70 80 or Alde hyde 2 4 Use a moistened cloth Please adhere to the local regulations and laws 5 9 Cleaning of headphone accessory Please follow the instructions of the manufacturer see special data sheet of access ory 28 6 Warranty repair and service 6 1 Warranty After the date of shipment of Senti you are guarenteed the implied warranty for the statutory period Warranty includes material and labor costs and has to be in accordance with the manufacturer specifications For the rechargeable battery pack the touch screen and wearing parts a six months period of warranty is provided The warranty is only valid for devices purchased from an authorized distributor Warranty procedure Inform your distributor about the defect Send the device together with an error description to your distributor Mailing expenses are not refund
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