User Manual - PATH medical Solutions
Contents
1. anmleistung des Senders W Schutz abstand abh ngig von der Sendefraquenz 150 kHz bis 80 MHz 80 MHz bis 800 MHz 800 MHz bis 2 5 GH d 3 5 3 Wurzel P d 3 53 Wurzel P d 7 3 Wurzel F Fig 27 Copy of electromagnetic compatibility detail report distance to radiator sender dependant on frequency 50 This s a blank page due to production process Take your notes here 51 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 01242. 100 032 Ear tip for probe tip S Lamella 4 6 7 mm 100 369 Probe Cable Clip Clip for Ear Probe 100 160 Test cavity for probe tip S Test cavity for EP DP and EP TE with Ear Probe Tip S blue 100 207 Accessory Box E Accessory Box Sentiero ECO fully filled with all ear tip sizes type A 100 261 Accessory Box P Accessory Box Sentiero fully fil led with all ear tip sizes type A S for Pedaudio logy 100 269 Headphone SE Sennheiser HDA 200 calibrated incl EEPROM for high frequency audiometry 100 286 Ear tip Soft tip for insert Phone Small 100 285 Ear tip Soft tip for insert Phone Standard 100 287 Ear tip Soft tip for insert Phone Jumbo 100 343 Patient button Sentiero Advanced 100 344 Bone conductor Radio Ear B71 Sentiero Advanced 100 341 Label Printer cable cable for Senti Sentiero to Label Printer for Sentiero Advanced 100 307 ABR Electrode cable 3 lead shielded 100 335 Electrodes Foam ECG electrode with carbon snap 43 x 45 mm gel pad 100 334 Electrodes Disposible Ag AgCl EEG EMG electro des with clear adhesive gel 100 368 Electrodes Blue Sensor P single patient use 9 Technical specifications standards manufacturer s data 9 1 Device classification and applied standards Device class lla 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
3. Pegel 6 kv Kontaktentladundg 8 KV Luftentladung 2 kw f r Metzleitungen 1 kw f r Bngangs und Ausgangsleitungen 1 4 Spannung Au enleter Au enleker o a LL gt 95 Enbruch der U fur 1 2 Periode 40 U 60 Enbroc h der U fur 5 Perioden TO U 30 BGnbruch der U f r 25 Perioden lt 5 U gt 95 So Embruch der U far 5s 3 Alm Hektromagnetische Umg Leitlinien Fu b den sollten aus Holz a bestehen oder mt Keramkfl sein Wenn der Fu boden m synthetischem Material vers die relative Luftfeuchte mmd betragen Die Qualit t der vYersorgqung sollte der einer typischen Ge Krankenhausumgebung ents De Qualt t der Versorgung sollte der einer typischen Ge Krankenhausumgebung enis Die Qualit t der Versorgung sollte der emer typischen Ge Krankenhausumgebung ents Wenn der Anwender des Mi Funktion auch beim Auf tree Unterbrechung der Energew fordert wird empfohlen das unterbrechungsfraen Strom oder einer Batterie zu Speise Magnetfielder bei der Netzfre den typischen Werten wie Gesch fts und Krankenhau vorzufinden sind entsprech 1 LL st die Netzw echselspannung vor der Anwendung der Pr fpeael Fig 26 Copy of electromagnetic compatibility detail report 49 st rfestigkeit IEC 60601 acturer s data Ubereinstimmungs Elektromagnetische Umgebung Leitlinien Pr fungen Prufpegel Fegel saleslete HF 3w av eff Tragbare und mobile Funkger te s
4. Speech under Noise screeningtest MAUS Auditory processing disorder screening test MATCH Image based speech test for children TEDIAG TEOAE Diagnostic DPDIAG DPOAE Quick Test with multiple test levels DPTHRES DPOAE Threshold SUN Score result Screening tests modes are given with a 3 letter abbreviation and the stimulus level MAG45 MAGIC Screening at 45 dB HL DPQ35 DPOAE Quick Test at 35 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 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 17 2 Remarks used symbols Symbols in the main Screen 0 MAGIC Test 18 Meaning 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 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 t
5. The test is avail able for different languages Il D E F The screening level can be chosen between 50 and 70 dB HL Sound presentation is avallable via head phones insert earphones or free field loudspeak ers 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 Additional speech tests are avallable on this instrument Symbols and structure of the graphical user interface Symbols in the main Screen MATCH vaus Meaning Image based speech test for children In German language adaptation to other languages after request Screeningtest for auditory processing disorders MAUS Validated in German language adapta tion to other languages after request Otoacoustic emissions are elicited with clicks TEOAEs or tones DPOAEs Measurements have to be performed in a quiet environment Correct probe placement is checked by calibration phase before measurement phase Three DPOAE measurement types are available in two separate modules For more details about the measuring pro cedures see How To Manual Chapter 4 OAE Automated hearing threshold estimation is done by using extrapolated DPOAE I O functions This patented method use
6. ing function The symbols are sorted by their appearance n one of the above ele ments header main screen and footer The functions are also explained n the context sensitive 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 red charging needed 7 _ Battery is charged Ex Battery is fully charged mains operation E 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 F S I M R L b R b L 40 dB mute USB connected 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
7. K tor SDRAM Please contact your distribu x tor All tests Selftest was successful Sta Jf tus o k Probe test 32 In order to conduct a probe test use either the red test cavity test cavity for probe tip A Article nr 100 129 for testing the big probe tip OR the blue test cavity test cavity for probe tip S Article nr 100 160 for testing the small probe tip Connect the probe WITH probe tip but WITHOUT ear tip into the test cavity Please verify correct placement Press Probe Test to start the test Please use only the big probe tip together with the red big cavity Please use the small probe tip together with the small blue cavity Please use only the big ear tips together with the big probe tip during measurem nts and the small ear tips together with the small probe tip Wrong combination of ear tip and probe tip will deteriorate your results See also advice in the accessory box If in doubt about what combination is correct please contact your service partner Hardware tests and possible error messages Probe test Error message Recommendation Action No probe found Probe failed Please check if the probe is connected to the device If it is connected properly Probe could not be re cognized hardware error Please contact your dis tributor 1 Is the probe placed inside the red calibration cavity gt If not please use the cal ibration cavity 2 Are there one or t
8. 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 60601 2 40 1998 EN 1041 2008 EN 980 2008 EN 60645 1 2002 Audiometry EN 60645 6 2010 EN 60645 7 2010 EN 389 1 2000 2 1996 3 1999 4 1999 EN 62304 2007 All laws directives and standards apply n the r latest version 43 9 Technical specifications standards manufacturer s data 9 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 USB 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 44 Please keep the device in the provided carrying case in order to protect the device and its accessories against externa
9. 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 Back home diverse info structure turn off symbols 10 Turn off the device Symbols and structure of the graphical user interface Meaning Symbols footer Context sensitive help info Specific information available slideshow on selected 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 De
10. and Abstand distance dependant on frequency of radiator sender 47 9 Technical specifications standards manufacturer s data Labor f r die Pr fung der elektramagnetischen Vertr glichkeit un dorar 48 ELEKTRENIK SCHWILLE ELEKTRONIK Produktions und Vertnebs GmbH Benzstrasse 1 A 85551 Kirchheim Germany EMC Testreport Gegenstand Audiologisches Handger t Equipment EUT Hersteller PATH medical GmbH Manufacturer 82110 Germering Typ senti Sentiero Type Aufiraggeber PATH medical GmbH Customer 82110 Germering Anforderung DIN EN 60601 1 2 VDE 0750 1 2 2007 1 2 Medizinische elekinsche Ger te Requirement Teil 1 2 Allgemeine Festlegungen f r die Sicherheit einschlie lich der wesentlichen Leistungsmerkmale Erganzungsnorm Elektromagnetische Vertr glichkeit Anforderungen und Pr fungen IEC 60601 1 2 2007 modifiz EN 60601 1 22007 DIN EN 60645 1 Norm 2002 00 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 Unterschnitund Stempel haben kein Die Pr fergebnisse beziehen sich ausschlie lich auf den Prufgegenstand Die Messgrofen und di Kalibnerungen sind ruckfuhrbar auf nationale DKD Einheiten This test report may not be reproduced other than in full except with the permission of the issuing labo
11. 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 speech understanding in noise 13 2 Remarks used symbols Symbols in the main Screen 14 SW 4 Speech 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 willbe 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 conduction insert sound probes patient response switch contralateral masking stimulus selection For more details about measuring proced ures see How To Manual Chapter 3 PTA Screening test for assessing speech intelligibility in noise in school children and adults Vocal Con sonant Vocal logatoms are used
12. yess 24 E nan ee Aaa a 24 BIGESOCKED rante sata 25 Gey SOCKET e 25 USB SOCKEL es ne tens etic ee nice REES een 26 SA ne aetna AAE ee a Nie 27 Blue white and red socket o 21 3 4 Charging the device and and connecting to the label printer 21 One LE U an E re ee ae eee 21 Connect to label O sacs ee a en en ER er 28 4 MIRA PC software and updates 29 4 1 Range of functions of the MIRA PC software cceneeneennan 29 AS sun ea En ae 29 AO OO SC LUNES 2er iris 29 I ISO ee ads 30 5 First steps 31 3 1 USE Pallent SeICCU OM tas 31 PP e E A 32 5 3 Hardware tests and possible error Messages ooooooccocoocooconconconnonrn rro 32 5 4 System information and demo mode cccceeeeeeeeseeeeeeeeeeeeeneenenn 34 5 5 License management and upgrades 00 cece ccc teen een een eens 34 5 6 Other errors and their possible reasons 0 000 c ccc ccc ccc n een ees 35 5 7 Possible error messages during the measurement of 0 0 00 cece cece eee 35 6 Cleaning 37 6 1 eanne SENEO ee sale er EOE EAN 37 6 2 Cleaning of ear probe headphone accessory 2ccccceeeeeeeeeeeeeeeenennn 37 6 3 Cleaning and disinfection of the ear probe calibration cavity 38 7 Warranty repair and service 39 A A O e ae irl aS E A 39 ESA REPO EA NEE RENNEN A Tee ee 39 1 3 Service Toutine Maintenance ii ae nn 40 8 Accessories 41 9 Technical s
13. 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 tur ning off the device Hence changing a user is possible by turning off and on the device 10 28 Select Patient lt lt Mr 10 31 Select Patient lt lt WI is Bm SB Global parameters device settings D S Qa O w O 21 Initial screen if Fig 22 Patient list if no password was assi patient data had been gned or after login generated 31 5 First steps 5 2 Device settings The following settings can be changed on the device see Fig 22 global parame ters Date Time including date and time format e g DD MM YYYY or MM DD Y Y Y Y Language selection out of several languages dependent on the installed language pack 1 8 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 tests and possible error messages Device self Error message Recommendation Action test Battery Please contact your distribu Core vol K tor tage Codec Please contact your distribu
14. 4 kHz TE Diag Window of analysis 5 13 ms post stimulus Stimulus type Click broadband chirp Polarity positive negative alternating Level 5 dB nHL 90 dB nHL Single or multiple selection up to 5 Level per test sequence Modules Rate 10 0 Hz bis 89 9 Hz Jitter Parameter Masking Jitter Auto Proceed Auto Stop 5 editable Presets Recording processing storage Window size up to 30 ms 1 000 20 000 averages Weighted averaging algorithm for artefact rejection Continuous monitoring of electrode impedance Display and storage of waveform impendance residual noise averages peak marker editable Stimuli Insert earphones headphones Future options Bone conductor Ear probe Frequency specific stimulus Hi Mid Low Chirp 9 4 Accessories Accessories like e g headphones or insert earphones or electrode cables include separate manuals data sheets which contain important information 9 5 Electromagnetic compatibility report EMC report The EMC report certifies the conformity with respect to the mentioned require ments Two reports have been issued by independent laboratories in 2009 and 2011 Sentiero can be used in an environment with electromagnetical radiation as specified in the detail report see fig 26 The user shall take care that the device is used in an environment with minimum distances to potential radiators as mentioned n fig 27 table with Nennleistung effective power
15. Declaration The measurement principle of otoacoustic emissions 1s not explicitly described in 11 of the medical device operator act Germany EU Therefore the manufac turer is obliged to define metrological inspection instructions Calibration For all device types of the Sentiero 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 standard EN 60645 1 Explanation In the Sentiero device group including its accessories e g ear probe there are parts which are exposed to pressure moisture temperature and contamination In order to ensure accurate measurement operability the fault tolerance provided by the manufacturer needs to be controlled by specificly designed instrumentation and defined procedures Therefore the metrological inspection must be conducted by authorized service partners who were instructed and trained by the manufac turer The annual metrological inspection is established following the regulations for audiometers see EN 60645 1 8 Accessories Order Nr Articles selected 100 135 Accesory box Adult big probe tip and big ear tips 100 296 Acoustic earmuffs Peltor 100 119 Bone conductor Set Bone conductor Patient response switch Firmeware PTA 3 100 214 Bone conductor with p
16. User Manual Sentiero Software Revision 1 4 Manual Sentiero Produced by PATH medical GmbH Germering Germany Printed on paper which was produced without chlorine bleaching Revision 8 Valid since Firmware Version 1 4 November 2011 Copyright 2011 PATH medical GmbH Reprint even partially only allowed with written notice from PATH medical GmbH Article number 100158 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 The latest information and revision is available online www pathme de support Errors and omissions excepted Contact information from your distributor contact information from your service partner Table of contents 1 Scope of application 5 2 Remarks used symbols 7 2 1 NOES ONSA uses esse 7 2 2 INOS OD OPTOMA CONCEDE neuere 8 2 3 About this manual and further sources of information 0 0 0c eee 8 2 4 Symbols and structure of the graphical user interface 0 0 0 0 cece eee 9 3 Start reset charging and connecting sockets 23 3 1 On off switch special function for showing footer cccccenncen 23 3 2 Hardware reset device is stalled 2 2 02 ccc cence ence een eens 24 3 3 Connecting to the sockets of the device 0 0 ccc e cence eens 24 a SA A antenna enn
17. and annual calibration is traceable to national DKD normals Fig 25 Copy of the electromagnetic compatibility EMC report bilingual Ger man English issued 2009 endungs Messungen ndung nach auna nach ng won Oberschw ingungen 1000 3 2 Ingen won Gruppe 1 Klasse E Klasse A bereinstimmung Blektromagnetische Umgebung Leitlir Das MEG versendet HF Energie ausschlie l internen Funktion Daher ist seine HF Ausse gering und es ist unwahrscheinlich dass be elektronische Ger te gest rt w erden Das MES ist f r den Gebrauch in allen Einriel alnschlieSkch denen im Wohnbereich und so geeignet die unmittelbar an ein ffentliches Versorgungsnet2 angeschlossen sind des versorgt de zu Wohnzw ecken benutzt wer Stimmt berein schw ankungen Plic ker 1000 3 3 keits n statischer ESD 1000 42 ansiente St rgr en A 4 4 ungen Surges 4 5 ssinbroche terbrechungen ankungen der JSSPpannunmg 1000 4 11 bai der gstrequenz Hz nach 4 8 IEC 60601 Pr fpegel 6 kw Kontaktentiadung 9 k Luftentladung 42 kV f r Met leitungen 1 kW f r Enganas und Ausgangsleitungen 1 kV Spannung Au enleiter Au enleiter lt 3 a U gt 95 Enbruch der LL f r 1 2 Periode 40 U 60 Enbruch der LL fur 5 Penoden 70 UL 30 Einbruch der LL f r 25 Perioden lt 556 U gt 95 Enbruch der U f r 5s 3 Alm Ubereinstimm ungs
18. atient response switch BC RE1 available for PTA class 3 and PTA class 4 extended only 100 083 Charger Senti Sentiero 100 268 Charger Sentiero Advanced 100 028 Ear probe EP DP 100 120 Ear Probe EP TE 100 063 Ear tip ET 03 5 0 mm 100 064 Ear tip ET 10 with fins 6 10mm 100 125 Ear tip ET 11 with fins 12 16 mm 100 058 Ear tip ET 12 soft tip 14 mm 100 144 Ear tip ET 13 10 12 mm 100 230 Ear tip ET 14 soft tip 18 mm 100 251 Free field cable 100 297 Free field loudspeaker Set JBL Control 2 loudspeaker cable 100 117 Headphone HPO1 Sennheiser HDA 280 100 118 Headphone HPO2 Holmco PD81 circumaural 100 282 Headphone HPO3 DD 45 similar to TD39 100 273 Insert earphones GN otometrics 100 199 Label printer cable Senti Sentiero 100 189 Label printer with printer cable 100 169 Patient response switch 100 013 Probe tip A for children and adults PT A 41 8 Accessories 42 Order Nr Articles selected 100 014 Probe tip S for newborns PT S 100 089 Sentiero USB cable 100 088 Serial interface cable SC1 for Senti 100 162 Serial USB converter 100 129 Test coupler calibration cavity 100 151 Visual inspection tool for probe tip cleaning tool 100 347 Pure Tone Audiometer Class 3 incl bone conductor pat Button for Sentiero Advanced 100 342 Label Printer Seiko incl cable label printing SW 100 030 Ear tip for probe tip S 4 5 mm 100 031 Ear tip for probe tip S 5 0 mm
19. ding grounding During usage of HF surgery devices Sentiero must not be used During usage of defibrillators Sentiero must not be used 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 Sentiero 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 Sentiero nearby devices with strong electromagnetic radiation Please refer to the suggestions in section 9 5 Cleaning instructions are described in chapter 6 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 dis 2 Remarks used symbols tributor s responsible for the correct disposal and storage In case of disposal of the device the device 1s not intended for consumer waste but for special waste A fully charged and completely functional battery pack w ll allow for measure ments of up to 6 to 8 hours dependent on usage 2 2 Notes on
20. erman valida ted French English in validation additional languages after request 45 9 Technical specifications standards manufacturer s data MATCH Mainzer 1a MAUS Image based speech test for children from 2 5 yrs on via headphone freefield insert earphones Stimulus level 0 65 dB HL step 1 dB Threshold estimation SRT Speech recognition threshold with adaptive algo rithm or discrimination loss estimation with fixed level Copyright Westra Elektroakustik GmbH 2003 2004 Details in separate manual Author A Nikisch et al DPOAE Quick mode Sample rate 24 kHz Frequency ratio fz fi 1 2 Level ratio Ly L scissor paradigm Measurement interval 512 samples Frequencies f gt 1 5 2 3 4 6 8 kHz single and multiple selections possible Stimulus levels L2 35 to 65 dB HL in steps of 5 dB single and multiple selecti ons possible DPOAE Threshold mode TEOAE ABR 46 Sample rate 24 kHz Frequency ratio fz fi 1 2 Measurement interval 512 samples Frequencies f gt 1 5 2 3 4 6 8 kHz single and multiple selections possible Stimulus level L2 65 to 20 dB HL Level ratio Ly L scissor paradigm with automatic level optimization of L Sample rate 16 kHz Stimulus level ca 80 dB SPL peak Stimulus type nonlinear click Statistical stop criterion TE Quick or user defined stop criterion SNR 3 6 or 9 dB in 3 4 or 5 out of 5 frequency bands 1 1 5 2 3
21. ing to the sockets of the device Headphone for Blue socket audiometry plug with blue tension relief u E a E Fig 6 Blue grey and red socket Fig 7 Free field Fig 8 GNotome Fig 9 Head loudspeakers JBL trics insert earpho phone Interacou Control 2 nes stics DD 45 Fig 10 Head Fig 11 Head phone Holmco phone Sennheiser PD 81 HDA 280 Fig 12 Sennhei ser HDA 200 HF Audiometry 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 13 Power supply and charging cable with grey ten sion relief 25 3 Start reset charging and connecting sockets Fig 14 Fig 15 Patient response Fig 16 power plug Fig 17 Labelprin Patient switch combined with bone ter response conductor switch USB socket The USB socket is located at the bottom part of the device Fig 18 USB socket Connect the handheld device via a USB cable to your PC n order to update the device firmware or to exchange measurement data with the MIRA PC software see Chapter 4 26 Connecting to the sockets of the device 3 3 2 Sentiero A Blue white and red socket Patient response Headphones inserts switch ABR and freefield cable are electrode cable label connected to the blue printer or power are to socket as
22. l forces and environment impacts Extreme stor age 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 9 3 Modules MAGIC PTA4 You will find further information with respect to the 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 O to 70 dB HL in steps of 5 dB PTA4 Extended PTA3 PTA HF 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 110 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 110 dB HL in steps of 5 dB Only in connection with headphone Sennheiser HDA 200 extends PTA3 with frequencies 9 10 11 2 12 5 14 16 kHz Stimulus levels max 70 dB HL Speech understanding in noise Speech level 50 70 dB HL in steps of 5 dB HL Optional free field loudspeaker calibration via CCITT noise Different languages pronounciations of VCV selectable Italian G
23. lete character The content of the edit window can be selected red 11 2 Remarks used symbols Symbols footer Meaning 123 gt pi IF gt F MAGIC Test ron pe de es A PTA Test 12 Changing between numerics letters or special characters 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 View results of stored measurements of the selec ted patient Special symbols during MAGIC test Refill animal rack Undo previous patient response Special symbols during PTA test Stimulus output on right ear red Stimulus output on left ear blue Symbols and structure of the graphical user interface Symbols footer Meaning Configure level shift control shift sine level only shift masking noise level only or simultaneously shift sine and masking noise level locked mode Shift sine level Shift masking noise level Simultaneously shift level of sine tone and mask ing noise locked mode Special symbols during OAE tests Abort test Resume paused test Pause test Skip measurement at current stimulus setting and proceed with the measurement at the next stimu lus setting Activates edit mode for ABR result Peak Markers Jewett I Ill V can be set Special symbol during SUN Training test The
24. liding 50 oe A down zooms out sliding up zooms in The scale is tec ma PL eV adjusted accordingly does Tipping onto the result view area latencies chan ges the displayed information from latencies gt parameters used gt impedances and residual noise 21 2 Remarks used symbols 22 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 on off switch turn off device press switch for 2 are al 2 10 seconds or touch the off oe symbol on the display footer he Tooter disappears Fig 2 On off switch on the right hand side of the device special functionality during MAGIC and SUN module 23 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 ofthe 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 3 3 1 Sentiero Red socket i Fig 5 OAE probe TE grey and DP red with red tension relief 24 Ear probe for OAE measurements plug with red tension relief Fig 4 Blue grey and red socket Connect
25. od see How To Manual Chapter 8 OAE Valid response Invalid response The test at this stimulus setting was skipped No result available The cochlear threshold is calculated from DPOAE growth functions using a patented algorithm The following symbols are used Complete threshold estimation for the right red circle or left blue cross ear based on patented algorithm Threshold estimation is performed via analysis of the lowest stimulus level which produced a valid DPOAE right ear red left ear blue No valid DPOAE available at this frequency the threshold is likely to be above 50 dB HL right ear red left ear blue Grey symbols indicate that at one or more stimu lus settings the measurement was skipped 20 Symbols and structure of the graphical user interface Symbols in the Meaning main screen Edit preset name 50 Select a waveform here level 30 is chosen in order to navigate the peak marker u B 30 B B The Jewett I Ill oder V can be selected and set manually by direct navigation tip on peak of curve or by using the navigation arrows The marker can be validated by the green o k symbol it will change color from black to green Latencies are calculated and displayed table in result view Result view for ABR The scaling of the waves can be changed by sli ding with one finger over the graphic area S
26. olten in keinem Htorgro en Efektiv ert geringeren Abstand zum AUT eins chkeGlich der Le tach 150kHz bis venw endet werden as dem empfohlenen Schutz OL 61000 46 SOME der nach der fur die Sendefrequenz zutreffender Glelichung berechnet w ird Empfohlener Schu abstand d 3 03 Wurzel P strahlte HF 13 Wim 3 W m d 3 5 3 Wurzel P von 80 MH bes 800 NHz vorgroke BOM bis d 7 3 Wurzel P von 600 MHz bs 2500 MHz tach 2 OH AL 61000 4434 mt Pals der Nennlestung des Senders in Watt Wi gena Angaben des Senderhersteders und d als Hrtpfohlenem Sc hutzabstand in Metern m Die Peldst rke station rer Funksender sole bei al Fequenzen qemal emer Untersuchung vor Orte als der bereinstimmungspegel sean in der Umgebung von Geraien die das Bildzeiche tragen sind St rungen m glich SO inmerkung 1 Bei 80 MHz und 800 MHz git der h here Frequenzbereich inmerkung 2 Dese Leitlimmen m gen nicht in allen F llen anw endbar sem De Ausbreitung elektromagnet Gro en wird durch Absorptionen und Reflexionen der Geb ude Gegenstande und Wense beeinflusst antero ist f r den Betrieb in einer elektromagnetischen Umgebung bestimmt in der die HF St rg ntrolliert sind r Kunde oder der Anwender kann dadurch helfen elektromagnetische St rungen zu vermeiden i an Mindestabstand zwischen tragbaren und mobilen HF Telekommunikationsger ten Sendern ur antero abh ngig von der Ausgangsleistung des Kommunikationsger tes wie unten angegeben
27. omain or in table format Artefact ratio and stability of the stimulus are displayed as well as the chosen detection criteria Auditory Brainstem Responses ABR evoked potentials are elicited by click or chirp stimuli They are recorded with electrodes see accessory electrode cable When starting the measurement the impedance of the electrodes is measured and monitored dur ing measurement For more details about the measuring pro cedures see How To Manual Chapter 5 ABR Five individual different protocols can be con figured and maintained on the instrument The preset name can be edited for each setting Parameters are Click chirp polarity frequency jitter masking auto proceed auto stop stimulus level up to 5 traces from 5 to 90 dB nHL rate averages recording window age group norm values 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 Symbols and structure of the graphical user interface Symbols in the main Screen Test names and layout Additional symbols It BEBE Meaning The following abbreviations are used for the diffe rent test results MAGIC Audiogram mode PTA Audiogram SUN
28. one heard Repeat MAGIC audiogram test at selected frequen cies lf 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 Symbols and structure of the graphical user interface Symbols in the main Screen PTA Test Y Meaning 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 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 19 2 Remarks used symbols Symbols in the Meaning main screen Use bone conduction placed at the mastoid The following symbols are only meant as visual indicators and thus do not imply any diagnostic recommendation Please note that the results are subject to the inherent accuracy of the test meth
29. operational concept After turning on the device Sentiero can be operated via a touch sensitive dis play 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 fur ther information for the user 2 3 About this manual and further sources of information In this manual you will find 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 recommenda tions for combining several test procedures 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 correspond
30. pecifications standards manufacturer s data 43 9 1 Device classification and applied standards oooooccccccoccccccccccoccnncnrcnrnnos 43 9 2 DEVICE Storage Tans POr ae ee 44 Device A A 44 Power supply rechargeable battery 2 0 0 0 occ cece cece eee e beeen ene e eee eens eens 44 Storage and transport 0 0 0 c ence cece bebe bebe bebe EERE 44 Dd INIGOUICS ee 45 E O II tne E e tam E E EEO 45 PA ea hh take E A Dinca leat tach ae ET Saal N Eure 45 PTA4 Extended 2 4 ia bis 45 PEN E A A IN II II II dni cel tach ose eee 45 A ae Ra II a a ea ee ee 45 SUN a Eee ee ae ee a ee ea een 45 MATCH Mainzer 1a at nen di ae ein 46 A RE A ER SORERIRETERE 46 DPOAE Quick mode 0 00 0 cece cece cece cece cece eee e bebe beet ernennen e nennen 46 DPOAE Ihreshold mode u a ee enges sel 46 A ee he rn MO ae RS a ae A ee ee ar 46 O E E E AN 46 DAs ACCESS OT ee ee ee fet eds lspci distin ts lada 47 9 5 Electromagnetic compatibility report EMC report 00 0 0 ccc ence 47 Made in Germany by PATH medical GmbH 52 1 Scope of application Sentiero offers both psycho acoustical and physiological test procedures This includes conventional and image based pure tone audiometry speech logatome intelligibility auditory brainstem responses ABR and otoacoustic emissions The usage of Sentiero should be supervised by qualified personnel Sentiero is designed for l Diagnostics moni
31. rge the battery if necessary If the error is still present please contact your distributor and describe which circumstances resulted in this behaviour Multiple language groups are offered Within each language group several languages can be selected and changed dur ing operation In order to changing the language group please contact your distributor 5 7 Possible error messages during the measurement of Test Error descrip tion Recommendation Action OAE MAGIC PTA SUN Wrong probe for test No probe found Remove cable Incomplete Please make sure to have exactly one transducer type con nected to the proper connector Please check if a valid ear probe EP DP or EP TE is properly connected to the device Please check if a valid ear probe is properly connected to the device Please remove the connector cable of the label printer or the RS232 cable Ear probe calibration is invalid Please replace the ear probe in the patient s ear When necessary check if the probe tip is blocked e g ceru men and eventually replace it Con duct a probe test Settings Hard ware tests Please connect a headphone to the blue socket and if applicable a bone conductor to the grey socket 35 5 First steps 36 6 Cleaning 6 1 Cleaning Sentiero Before cleaning Sentiero the device must be turned off and removed from all connected devices Make sure that no liquids get to
32. s a special stimulus setting for eliciting DPOAEs and presents cochlear func tion in the form of an audiogram Test frequencies can be chosen between 1 5 kHz and 8 kHz User defined DPOAE measurement at frequencies between 1 5 kHz and 8 kHz at different levels from 25 dB HL to 50 dB HL in steps of 5 dB Single and multiple selection of stimulus parameters enable 2 different types of protocols screening and indi vidual diagnostic measurements TEOAE are analyzed in a time window of 5 to 13 ms There are two TEOAE measurement types avallable in one combined module TEOAE Quick and TEOAE Diag For more details about the measuring proce dures see How To Manual Chapter 4 OAE TEOAE measurement is done by using an auto mated statistical algorithm for response detection valid invalid TEOAEs are shown in time and fre quency domain Artefact ratio and stability of the stimulus are displayed If two ear probes are connected to red socket and blue socket the measurement can be conducted simultaneously in both ears binaural 15 2 Remarks used symbols Symbols in the main Screen ABR Symbols of result view 16 Meaning TEOAE measurement is done by using user defined criteria for response detection in 3 5 4 5 and 5 5 different frequency bands 1 1 5 2 3 und 4 kHz For each frequency band different min imum SNRs 3 6 and 9 dB can be chosen Res ults are presented in time and frequency d
33. ter 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 the 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 firmware please connect the device via USB 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 download on the PATH medical homepage Url http www pathme de support 4 3 How to get updates New device firmware and PC software updates will be posted each April and October on the PATH medical homepage Url http www pathme de support If any additional updates are available the distributors will be informed The dis tributors are supposed to inform the end customers 29 4 MIRA PC software and updates 4 4 MIRA FAQ Question Answer How to disable USER Login into MIRA 30 MANAGEMENT on the instr
34. the interior of the device Do not dunk the device into any liquid e g water or cleaning agents Only use wiping disinfection cleaners Ethanol 70 80 Propanol 70 80 or Aldehyde 2 4 Use a moistened cloth Please adhere to the local regulations and laws 6 2 Cleaning of ear probe headphone accessory Please follow the instructions of the manufacturer see special data sheet of accessory Fig 24 Test coupler right probe with mounted probe tip ear tips accesso ries 37 6 Cleaning 6 3 Cleaning and disinfection of the ear probe calibration cavity 38 The calibration cavity see Fig 24 for the ear probe test must be used with a desinfected and clean new probe tip In case of contamination with pathological material or suspected dirt inside the cavity do not reuse the calibration cavity Do not use cleaning liquors or vapour sterilization For external cleaning please use a sterile alcohol wipe typically containing isopropyl alcohol 70 Please refer to the manufacturer s data sheet for the minimum time period in which the wipe has to be in direct contact with the surface to ensure the effectiveness of the cleaning Warranty repair and service 7 1 Warranty After the date of shipment of Sentiero a warranty period of one year is provided for the device Warranty includes material and labor costs and has to be n accord ance with the manufacturer specifications For the rechargeable battery pack
35. the touch screen and wearing parts a six months period of warranty is provided The warranty is only valid for devices pur chased 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 refundable and are to be paid by the customer Please send the device in its ori ginal packaging to your distributor Warranty is not applicable in cases of breakage malfunction due to manipula tion or unintended usage negligence nonobservance of cleaning instructions crashes or accidents damages due to shipment Warranty s also not applicable when the device is not used according to manufacturer s instructions 7 2 Repair In case Sentiero is defect or differs in any way from its original setup an autho rized distributor will repair re calibrate or exchange the device Service features and repairs of the device and its electro medical accessories must only be conduc ted by the manufacturer or 1ts authorized service partners The manufacturer reser ves the right to decline any responsibility for the safety in operation reliability and capability of the device 1f any service features or repairs were conducted by a non authorized body If in doubt please contact the manufacturer before making your service partner repair the device 39 7 Warranty repair and service 7 3 Service routine maintenance 40
36. toring and follow up after newborn hearing screening 2 Pre school school and adult hearing screening pure tone threshold and speech intelligibility 3 ENT diagnostics Confirmation of a cochlear hearing loss or a neural hearing loss Topological diagnostics Monitoring of cochlear function after noise exposure or ototoxic drug adminis tration Identifying patients who are simulating a hearing loss Proof of a noise induced hearing loss for medical opinions Pediatric audiology OAEs are not present in ears with sound conductive hearing loss since both the stimulus and the response amplitude are reduced due to the damping of the middle ear Before starting the measurements please make sure that any noise or other distracting factors are eliminated A separate room with little ambient noise should be available for measurements with Sentiero Criterion of exclusion Sentiero must not be used in cases of external otitis outer ear canal infec tion or in any case which yields to pain when inserting the ear probe 1 Scope of application 2 Remarks used symbols 2 1 Notes on safety MN This manual includes notes on safety which need to be followed in order to allow the correct usage of Sentiero Warning The following situations may cause harm or may be dangereous for patient or user If Sentiero is used during a surgery the ear probe and all connectors must not have contact to any conductible objects inclu
37. tton on the System Information screen see Fig 23 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 distrib utor 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 Other errors and their possible reasons 5 6 Other errors and their possible reasons Error descrip tion Recommendation Action Black display No feedback black display No feedback display stalled My language is not avallable 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 automatic ally 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 cha
38. ument How to update the instrument s firmware using MIRA All users are deselec ted including ADMIN user No login possible What s the initial pass word How to get more infor mation and help on MIRA Section system setting user management on instrument uncheck Login into MIRA and import latest firmware available on PATH Homepage Url http www pathme de support by pressing Firmware button gt select folder and con firm Alternatively download latest version of MIRA which has the latest frmware already included After that connect instrument with PC USB and press Update button The instrument and the PC shall not be dis connected see display of instrument The instrument must have enough energy full battery or must be connected to mains Reset the Admin account by starting the Recovery Console This program is installed in the same program folder as Mira Password Stargate 1234 MIRA contains an online help function Additional information can be found in the MIRA manual on the PATH support page Url http www pathme de support 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 situation it may be useful to activate or deactivate the user management see Fig 21 22 With the MIRA PC software see Chapter 4
39. well as the be connected to the second ear probe for white socket binaural TE Quick measurement Ear probe for OAE measurement or bone conductor are to be connected to the red socket Fig 20 ABR electrode cable Sentiero A can be used for ABR measurements module ABR see license management Basing on the security concept for ABR measurement minor differences can be found in the accessories in comparison to Sentiero s acessories ABR electrode cable power plug patient response switch bone conductor and label printer cable All the other accessories can also be used in Sentiero 3 4 Charging the device and and connecting to the label printer Power supply Connect the charging cable as seen in Fig 13 or Fig 19 to the device For char ging the device connect the power plug to a power socket with appropriate output voltage and frequency see data on charger The charging process starts automat ically and is finished within 2 hours 21 3 Start reset charging and connecting sockets Connect to label printer 28 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 n Fig 13 or Fig 19 The label prin
40. wo Smooth lines red and blue and are these lines outside the limit markers Please contact your dis tributor 3 Are there jagged lines and are these lines below the limit markers Please check if the probe tip is clogged Change the probe tip and conduct the probe test once again If there is still no valid result please contact your dis tributor 33 5 First steps 5 4 System information and demo mode 10 46 System info lt 1 ET Firmware release ERBEN NER 1 3BETA build 2675 Release date 02 03 2011 Serial number 200052 Next service date 22 07 2011 Connected transducers EP DP 40004 Next calibration date 17 11 2011 Memory usage 0 Fig 23 System information with license management and demo mode Demo Mode In the system information general information about the device and firmware ver sion 1s displayed Information about connected transducers are also displayed connected before menu s entered When contacting your distributor error mes sage module update this data should be at hand You can activate the demo mode 15 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 upgra ding your device with a specific module please contact your distributor 5 5 License management and upgrades 34 In order to update your license key e g after buying a new module you need to press the License No bu
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