User Manual - PATH medical Solutions
Contents
1. option Page 16 40 The device self test examines several device properties as internal power supply codec la function and memory integrity If a device property is correctly working a green checkmark icon V is shown Otherwise a red x icon x is shown If not all device properties are tested successfully i e not only green checkmarks please contact your distributor The probe test examines ear probe functionality Please use either the red test cavity test li cavity for probe tip A for testing the large probe tip or the blue test cavity test cavity for probe tip S for testing the small probe tip Do not use other combinations The probe test either results in a pass probe OK or in one of the error messages shown in Table 3 Please follow the recommended actions for troubleshooting mentioned in Table 3 Error message Recommended actions for troubleshooting No probe found Check ifthe ear probe is properly connected to the device gt If not connect the ear probe to the device Probe failed 1 Check if the ear probe is placed in the correct test cavity gt If not use the correct test cavity provided with the ear probe 2 Check ifthe calibration curves are within the upper and lower tolerance limit markers or if both of the calibration curves are smooth lines gt If not make sure to use the correct test cavity and check if one or both channels of the probe tip are clogged If so change or cl2. 9 3 Power Supply 2W For medical applications the following power supply units are exclusively allowed when used with Senti and Sentiero devices Sinpro MPU12C 104 Sinpro MPU16C 104 Friwo FW7662M 12 GPP6 for desktop devices only Page 33 40 When using the power supply unit Sinpro MPU16C 104 protection class I in order to avoid For Sentiero do not use any power supply unit other than the ones mentioned above Failure to do so may reduce electrical safety and may damage the device risk of electrical shock the power supply unit must only be connected to a supply mains with protective earth Input rating of power supply units Sinpro MPU12C 104 100 240 V AC 47 63 Hz 0 16 0 29 A Sinpro MPU16C 104 100 240 V AC 47 63 Hz 0 18 0 33 A Friwo FW7662M 12 100 240 V AC 50 60 Hz 0 15 A Output rating of power supply units Handheld 9V 1 2 A Desktop 9 12 V 0 4 A Rechargeable battery pack Handheld 4 8 V NiMH Desktop 3 7 V Li lon Maximum operating time with fully charged batteries ca 6 8 hours dependent on usage Maximum charging cycles 500 1000 life time gt 2 years for normal usage Maximum charging time Handheld ca 2 hours Desktop ca 8 hours 9 4 Storage Transport and Operating Conditions For storage and transport please keep the device and its accessories in the provided carrying case in order to protect all components against external fo
3. Dry the device with a lint free cloth immediately after cleaning Disposable accessories e g ear tips and other accessories marked for single use only on the package label or data sheet must be replaced between patients or ears of the same patient to avoid cross infection The ear probe test cavity must be used with a disinfected and clean new probe tip In case of contamination with pathological material or suspected dirt inside the cavity please discontinue the use of the test cavity For external cleaning please use a sterile alcohol wipe typically containing 70 isopropyl alcohol It is recommended that parts which are in direct contact with the patient e g headphone cushions are subject to standard disinfecting procedures between patients This includes physical cleaning and use of recognized disinfectants For further information about cleaning instructions for accessories e g ear probe please refer to the respective manual or data sheet of the accessory When using a cleaning agent please refer to the manufacturer s data sheet of the cleaning agent for the minimum time period in which the wipe has to be in direct contact with the surface of the device or accessory to ensure effectiveness of cleaning The device and its accessories if not stated otherwise on the respective package label or data sheet are provided non sterile and are not intended to be sterilized Page 23 40 Page 24 40 6 Accessories Avail
4. Please follow your local regulations for proper disposal of the device and its accessories Page 32 40 9 Technical Specifications This section provides a summary of the most important technical specifications Further technical details are described in a separate Technical Specification document which can be downloaded from www pathme de support 9 1 General Device Information Device classification 93 42 EEC MDR Canada Class Il a Class II Application part classification Application parts Type BF body floating Headphones insert earphones ear probe bone conductor electrode cable patient response button Ingress protection rating IP code Handheld IP30 Desktop IP40 Applied standards 9 2 Device Characteristics Device dimension ISO 389 1 ISO 389 2 ISO 389 3 ISO 389 4 ISO 389 5 ISO 389 8 transducer calibration ISO 10993 1 biocompatibility ISO 15223 1 manual IEC 60601 1 electrical safety IEC 60601 1 2 EMC IEC 60601 1 4 PEMS IEC 60601 1 6 usability IEC 60601 2 40 AEP equipment IEC 60645 1 PTA IEC 60645 5 tympanometry IEC 60645 6 OAE IEC 60645 7 ABR IEC 62304 software lifecycle Handheld ca 209 x 98 x 52 mm Desktop ca 150 x 210 x 45 mm Device weight including battery pack Handheld ca 500 g Desktop ca 475 g Display properties 240 x 320 pixel graphic LCD Handheld 3 5 Desktop 5 0 Maximum power consumption
5. d Auditory Steady State Responses Sentiero must not be used in cases of external otitis outer ear canal infection or in any case which yields to pain when inserting the ear probe or applying any other transducer Page 6 40 Please note that the intended use depends on your individual combination of licensed modules and may be a subset of the above mentioned use cases Sentiero is intended for indoor use only and must be operated at defined environmental conditions See also operating conditions in section 9 Technical Specifications and information about environmental conditions regarding electromagnetic disturbances in section 10 li Electromagnetic Compatibility Information Sentiero is not intended for use in oxygen rich environments Sentiero is intended for use by audiologists ear nose throat ENT doctors pediatricians and other hearing health care professionals and audiologically trained technicians Please consider local regulations regarding the qualification requirements for performing measurements with a specific test module Sentiero is not intended for operational use by the general public All test procedures must be supervised or conducted by qualified personnel In the United States of America Federal law restricts this device to sale by or on the order of a licensed physician CONTRAINDICATIONS Ear probes or insert earphones must not be used in cases of external otitis outer ear canal infection or in any case w
6. 10 Watt 3 7m 3 7m 7 4m Table 8 Examples of minimum distances to potential radiators report nr 3917 translated from German Page 37 40 Page 38 40 Page 39 40 Contact information from distributor service partner Made in Germany nn PATH medical GmbH Landsberger Stra e 63 82110 Germering Germany Tel 49 89 800 76 502 Fax 49 89 800 76 503 Internet www pathme de ce 0124
7. GHz d 7 3 sqrt P Page 36 40 Note P is the the nominal output of the sender in Watt W according to specifications from the manufacturer of the sender d is the recommended protection distance in meter m Corresponding to an on site investigation the field strength of stationary radio units shall be lower than the concurrent level at all frequencies In vicinity to devices which bear the antenna symbol disturbances are possible At 80 MHz and 800 MHz the higher frequency range is applicable These guidelines may not be applicable in all cases The spread of electromagnetic properties is influenced by absorptions and reflections of buildings objects and humans Table 7 Minimum distance to potential radiators report nr 3917 translated from German The device is intended for use in an environment in which high frequency disturbances are controlled The user of the device can help avoid electromagnetic disturbances by complying with Ba minimum distances between the device including its connected cables and portable and mobile high frequency telecommunication devices and other radio transmitters The minimum distance is dependent on the output power of the radio transmitting device see Table 8 T site ofthe Minimum distance dependent on frequency E oe 150 kHz 80 MHz 80MHz 800MHz 800 MHz 2 5 GHz 0 01 Watt 0 1m 0 1m 0 2 m 0 1 Watt 0 4 m 0 4 m 0 7 m 1 Watt 1 2m 1 2m 2 3m
8. electromyographs and evoked response equipment was certified by an accredited laboratory with report number 4963 Additional information on the full report is available from PATH medical upon request li The user must take care that the device is used in an environment with electromagnetic radiation as specified in Table 5 and in Table 6 Emitted interference x F Compliance Electromagnetic environment measurement High frequency emission Group 1 The medical electric device uses high frequency according to CISPR11 HF energy only for internal operation Hence its HF emissions are very low and it is unlikely that adjacent electronic devices are disturbed Class B The medical electric device may be used in all establishments including those in residential environments and those that are directly connected to a public power network that also supplies buildings used for residential purposes Emission of harmonic Class A components according to IEC 61000 3 2 Emission of voltage fluctuation Compliant flicker according to IEC 61000 3 3 Table 5 Compliance with electromagnetic emission guidelines and resulting requirements for electromagnetic environment report nr 3917 translated from German Tests for immunity to interference IEC 60601 test level Concurrent level Electromagnetic environment Electrostatic discharge ESD according to IEC 61000 4 2 6 kV contact discharg
9. not immerse the device in fluids as e g cleaning agents Dust particles may corrupt the touch pad Please make sure to keep the touch pad clear of dust particles Do not put excessive pressure on the device display or allow any item to puncture the device display Do not place the device next to a radiator or any other heat source 8 3 Electrical Safety A The power supply is specified as a part of the device Do not use any power supply other than the ones defined in section 9 Technical Specifications Other power supplies made for other electronic devices such as notebook computers or printers may cause damage to the device Likewise using the Sentiero power supply on other types of devices may cause damage to those devices Avoid accidental contact between connected but unused applied parts and other conductive parts including those connected to protective earth Conductive parts of electrodes and their connectors including the neutral electrode are not allowed to contact other conductive parts and earth Do not use the device during the application of high frequency surgical devices cardiac pacemakers defibrillators or other electrical stimulators If the device is used during surgery the connectors must not touch conductive items including ground When using the power supply unit Sinpro MPU16C 104 protection class in order to avoid risk of electrical shock the power supply unit must only be conne
10. not place Sentiero close to other electronic devices If this cannot be avoided the correct operation according to the intended use of Sentiero must be supervised Please also refer to the suggestions provided in section 10 Electromagnetic Compatibility Information Use of other accessories than the ones provided by PATH medical or use of extension cables may result in higher transmission or reduced immunity to interference of the device 8 5 Accessories A The probe tip of the ear probe must not be inserted into an ear without a disposable ear tip properly affixed to the probe tip Make sure that the ear tip size corresponds to the patient s ear canal size Ear probes or insert earphones must not be used in cases of external otitis outer ear canal infection or in any case which yields to pain for the patient when inserting the ear probe or insert earphone Disposable accessories e g ear tips and other accessories marked for single use only on the package label or data sheet must be replaced between patients or ears of the same patient to avoid cross infection Do not clean or reuse these items Do not connect any accessories other than those provided by PATH medical Other accessories are not compatible with the device and may result in device damage or improper functionality of the device If connecting accessories which do not comply with the same safety requirements as this product this may lead to a reduction in th
11. patient can be added selected from the list of patients or the test module selection can be called in Anonymous mode i e without adding a patient It is also possible to delete a single patient or all patients Device Settings gt Data Management In Anonymous mode tests can be conducted and saved to a session The session can li later be renamed with the appropriate patient data This may be helpful e g for quickly testing a sleeping child if there is no time to enter the patient data in advance When conducting data in Anonymous mode always make sure that you are able to assign the test data later to the correct patient For further information about patient management please see device online help see section 3 2 Online Help on the Select Patient screen 3 5 3 Device Settings There are multiple options to configure the device to your needs The device settings can be reached with the tools button A from the main patient selection screen The following device settings are available Date and time Date and time format Language Sound key click result sound Display brightness Preferences e g BC symbol representation speech calibration For further information about device settings please see device online help see section 3 2 Online Help on the Device Settings screen and its submenus 3 5 4 Hardware Tests The main device functions can be tested with the Hardware Tests
12. shown if USB cable is connected to a PC Battery status fully charged EZF charging EE Er EEE status indicator from empty to full Page 11 40 D Main screen including screen related elements e g test module list patient list test data result view Footer including control elements e g for browsing to different screens and online help see section 3 2 Online Help For explanation of symbols please refer to the device online help see section 3 2 Online Help 3 2 Online Help Context sensitive help screens allow an intuitive handling of the device Automatically generated message boxes may additionally present context sensitive warnings or information The context sensitive help screens are available via the blue information icon which is displayed in the footer The help screens explain the currently available symbols and their functions 3 eae p At some screens there is an additional information icon which will provide further information for the user e g recommendations for measuring DPOAESs in a noisy environment explanation of free field calibration 3 3 Test Result Status Icons In the test history list test results are shown with an overall test result status icon The icons correspond to the following definitions Test result OK Screening test valid result Diagnostic test result within expected range of normal hearing Test result incomplete in between OK and not OK furt
13. welcome screen appears For switching off the device press the switch for about 10 seconds Alternatively the device can be switched off via the off switch icon O in the footer of the device display In addition the on off switch can be used in some test modules to show the footer which may be hidden in these modules during the test Please refer to the online information provided in the context sensitive help screens Figure 2 On off switch for handheld left and desktop device right marked with blue circle 3 4 2 Device Reset If the device is stalled i e no reaction when pressing the touch screen the device can be reset After reset the device can be started again with the on off switch The reset button does not reset any device or test module settings or any other data on the device In order to reset the device for handheld devices press the reset button on the back side of the device below the rubber casing see Figure 3 For desktop devices press the on off switch for several seconds Figure 3 Device reset button for handheld device Page 13 40 3 4 3 Device Sockets Multiple accessories can be connected to the device This includes transducers e g headphones ear probe electrode cable patient response button label printer communication cable RS232 USB and power supply unit For further information see section 6 Accessories Desktop devices When printing via label printer please make s
14. NCEPTO e izers essnee eee a dt ds 11 3 1 SCHEENILAYOUL ae ee ee ee ee T E AE 11 3 2 A AR EETEER EN 12 3 3 Test Result Status ICONS un ee nen na 12 3 4 Device Hardware eek 13 3 4 1 ONO SS Witt era ee E AA 13 3 4 2 Device Reset nassen erinnere 13 3 4 3 Device Sockets ios 14 3 4 4 Charging the DeviC ccccoconococcconcnononononnnnnnnonononenononnonnnnnnon non a EAEE EREET REEERE 15 3 5 Device FUNCUONS ur as ee en eae da ines dani 15 3 5 1 User Management In seuddes 16 3 5 2 Patient Management aa 16 3 5 3 DEVICE id 16 3 5 4 Hardware Testi o ne 16 3 5 5 License Management ae a a 17 3 5 6 Demo Meios en E RI 18 3 5 7 Systemilnformation s ses esse eE Ea EaR E re AEREE SERRES 18 3 5 8 Test Module Information ococonccnnnccnnnonanonnnnnncnnnncncnnne cnn recrean 18 3 5 9 Error Handling ateei UE 19 3 6 Mira PE SOWAN eseesega e aE REEE nE aE a EERE EES 19 3 7 PATH Service Tool een EE E EEE EAE E 20 4 Serviceand Maintenance u un a 21 4 1 General Service Information ooooocccnnccononanononcnoncconnnnnnnnnnnnnn cono n nr non n cnn rra nro nn nr nn nn n ranma cnn 21 4 2 Routine Maintenance and Calibration ooonocccnncccnonccnnonnnnnoncnnnocononn nono nnnnna cnn cnn rn nennen nennen 21 4 3 E O 22 A O eee er 23 6 ACTOS Meco AAA at 25 7 NN AO VA 27 8 Notes ON diran a td Sa Tal ba Ba A cee A cba Bs AA ad ee er 29 8 1 GeneralUs gesr area te sense ee ee nes 29 8 2 Handling Transport and SOIRE reniir ari
15. able accessories for Sentiero devices include headphones e g Sennheiser HDA 280 Sennheiser HDA 300 Interacoustics DD 45 Holmco PD 81 GN Otometrics ME 70 insert earphones ear coupler cable e g PATH ECC bone conductor e g RadioEar B 71 free field loudspeaker e g JBL Control 2P and related accessories o loudspeaker connection cable ear probe e g PATH EP TE PATH EP DP and related accessories probe tips adult and baby size ear tips multiple sizes and types test cavity corresponding to adult and baby size probe tip calibration volume cavities for middle ear analyzer 0 5 2 5 ml Oo 0 amp inspection cleaning tool o fixation clip electrode cable and related accessories o electrode testing device o electrodes multiple brands label printer e g Seiko SLP 650 SE and related accessories o label printer connection cable o printout paper rolls patient response button sound insulation headphone e g Peltor Optime III communication cable USB RS232 and related accessories o RS232 to USB converter transportation bag case power supply unit Sinpro MPU12C 104 Sinpro MPU16C 104 Friwo FW7662M 12 The above list of accessories may be subject to change Accessories may be available only upon request may be replaced by comparable equipment or may be discontinued without prior notice Please contact your distributor for an up to date list of available accessories Please note that the same accessory may b
16. accidents damages by external causes e g flood fire or damages due to shipment see also disclaimer of warranty This warranty is not valid for normal deterioration of wearing parts and cosmetic damages e g scratches Opening the device case or any accessory housing voids this warranty as well as modifications or changes in the device or accessory not approved in writing by PATH medical This warranty includes material and labor costs and has to be in accordance with the manufacturer specifications PATH medical reserves the right to credit repair or replace with a new or refurbished product an in warranty device or accessory at its sole option When suspecting a warranty case please inform your distributor about the defect Send the device or accessory 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 or accessory in its original packaging to your distributor See also section 4 1 General Service Information Page 27 40 DISCLAIMER OF WARRANTY The warranty contained herein is exclusive PATH medical disclaims all other warranties Ba expressed or implied including but not limited to any implied warranty of merchantability or fitness for a particular purpose or application PATH medical shall not be liable for any incidental indirect special or consequential damages whether resulting from the purchase use misuse or i
17. activities or repairs were conducted by a non authorized service partner see also section 7 Warranty If in doubt please contact PATH medical service pathme de before commissioning a service activity or repair Please send the device or accessory in its original packaging to your distributor 4 2 Routine Maintenance and Calibration To ensure safe operations and to keep measurements valid it is stipulated by PATH medical AN to check the device and calibrate its transducers at least once a year or more frequently if required by local regulations or if there is any doubt about correct system function A warning message is shown on the device if the device service date or a transducer calibration date has expired Please return the device or accessory immediately to your distributor or service partner Free field loudspeakers need to be calibrated regularly by the user according to device instructions Hence free field loudspeakers are exempt from the above mentioned annual calibration procedure li Please note that for all Sentiero devices it is easy to exchange transducers individually and recalibrate them separately This will help you to increase uptime and availability of your device Page 21 40 REGULATORY BACKGROUND For the device and all transducers an annual metrological inspection following 811 Clause 2 of the medical device operator act MPBetreibV Germany must be conducted by a service partner who is authorized by PATH
18. cted to a supply mains with protective earth Do not connect the label printer cable or RS232 cable to the device during testing If a connection is established from the device to a standard PC which is powered through the mains network special precautions must be taken in order to maintain medical safety A standard USB cable can only be used if the connected PC is outside the patient s close range or if the PC is running on battery is medically approved or is powered via a medically approved safety transformer In all other cases a galvanic separator must be inserted in the USB connection Page 30 40 8 4 Electromagnetic Compatibility BH The radio frequency emissions of the device are very low and are not likely to cause any interference in nearby electronic equipment However negative effects or loss of functionality of other electronic devices may occur if they are placed in close vicinity to Sentiero It may be necessary to implement suitable corrective measures e g new orientation or positioning of Sentiero or shielding Please also refer to the suggestions provided in section 10 Electromagnetic Compatibility Information Strong electromagnetic radio frequency emissions may affect the operability of the device e g occurrence of unwanted noise PATH medical recommends restricting the use of other electronic devices with strong electromagnetic radiation e g mobile phones pagers in close vicinity to Sentiero Do
19. device via Mira Please follow the speech file installation instructions that you receive together with the speech license file 3 5 6 Demo Mode You can activate the demo mode a limited number of times In demo mode you are able to use all modules that are available for your device until the end of the day Please note that after activating the demo mode you cannot change your device date and time until the end of the day If you are interested in upgrading your device permanently with a specific module please contact your distributor 3 5 7 System Information On the system information screen general information about the device and firmware li version is displayed Information about connected transducers is also displayed if the respective transducer has been connected before the system information screen is entered When contacting your distributor regarding any service request e g error message or module update this data should be at hand 3 5 8 Test Module Information Multiple test modules are available for each device Please contact your distributor or check the PATH medical homepage for an up to date list of available modules and features When conducting a measurement please consider the following aspects If necessary for appropriate test performance Audiometry DPOAE the device must be li used in a quiet environment e g soundproof cabin room with low ambient noise For measurements with ear probes e g OAE al
20. e 8 kV air discharge 6 kV contact discharge 8 kV air discharge The ground floor shall consist of wood concrete or ceramic tiles If the ground floor consists of synthetic material the relative air humidity must be gt 30 Fast transient electric disturbance bursts according to IEC 61000 4 4 2 kV for power lines 1 kV for input and output lines 2 kV for power lines 1 kV for input and output lines The quality of supply voltage shall correspond to typical hospital or commercial environment Page 35 40 Impulse voltage surges according to IEC 61000 4 5 1kV voltage outer conductor outer conductor 1kV voltage outer conductor outer conductor The quality of supply voltage shall correspond to typical hospital or commercial environment Voltage drop short interruption and fluctuation of supply voltage according to IEC 61000 4 11 lt 5 Ur gt 95 Ur drop for period 40 Ux 60 Ur drop for 5 periods 70 U 30 U drop for 25 periods lt 5 Ur gt 95 Ur drop for 5 seconds lt 5 Ur gt 95 Ur drop for period 40 Ur 60 Ur drop for 5 periods 70 U 30 Ur drop for 25 periods lt 5 Ur gt 95 Ur drop for 5 seconds The quality of supply voltage shall correspond to typical hospital or commercial environment If the user of the medical electric device also demands continued proper functioning of th
21. e sockets For correct connections see section 3 4 3 Device Sockets Do not try to insert any plug into a device socket with excessive force A plug fits only into a device socket if the mechanical coding of the plug is corresponding to the device socket Color codes help finding the correct device socket For desktop devices please also check the icons on the back panel of the device for correct insertion See section 3 4 3 Device Sockets When pulling a plug out of a socket always pull at the plug and not at the cable to avoid cable break Do not expose the label printout to sunlight or heat Printing on thermal paper fades with exposure to light or heat 8 6 Waste Disposal BH The device includes a NiMH handheld or Li lon desktop rechargeable battery pack In case the battery pack cannot be charged anymore or in case of any other suspected defect of the battery pack the battery pack must be replaced by an authorized service partner The service partner is responsible for the correct disposal and storage of the battery pack Do not dispose of the batteries in your normal household waste bin Please follow your local regulations for proper disposal Within the European Union the device must not be disposed of in your normal household waste bin since electronic waste may contain hazardous substances The device is electronic equipment covered by the Directive 2002 96 EC on waste electrical and electronic equipment WEEE
22. e available with different connectors and therefore different article numbers for different devices see section 3 4 3 Device Sockets When asking your distributor about accessories please always refer to your device Sentiero Sentiero Advanced and Sentiero Desktop Page 25 40 Page 26 40 7 Warranty PATH medical warrants that the supplied device and its accessories are free from defects in material and workmanship and when properly used will perform in accordance with applicable specifications during the defined warranty period Please note that the warranty between the end user and the distributor cannot be managed by PATH medical as it is not under PATH medical s responsibility Nevertheless PATH medical encourages all regional distributors to provide at least the warranty stated by law or stated by the following rules For the device a one year warranty period is provided For the rechargeable battery pack the touch screen and wearing parts a six months warranty period is provided The warranty period starts at the date of shipment In case longer warranty periods are defined by law these warranty periods take precedence This warranty is only valid for devices and accessories purchased from an authorized distributor This warranty is not valid in cases of breakage malfunction due to manipulation or unintended usage negligence non observance of manufacturer s instructions including cleaning instructions crashes or
23. e device during an interruption of energy supply the connection of the device to an uninterrupted power supply UPS or battery is recommended Magnetic field at mains frequency 50 60 Hz according to IEC 6000 4 8 3 A m 3 A m Magnetic fields at the mains frequency shall correspond to typical hospital or commercial environment Note U is the mains AC voltage before applying the test level Table 6 Compliance with immunity to interference tests and resulting requirements for electromagnetic environment report nr 3917 translated from German BH to potential radiators as described in Table 7 and Table 8 The user must take care that the device is used in an environment with minimum distances Tests for immunity to interference IEC 60601 test level Concurrent level Electromagnetic environment Conducted high frequency disturbance according to IEC 61000 4 6 3 Veffective 150 kHz 80 MHz 3 Veffective Portable and mobile radio units shall not be used closer to the device and its components i e connected cables than defined by the recommended protection distance which is calculated with the following formula dependent on the radio emitting frequency d 3 5 3 sqrt P Radiated high frequency disturbance according to IEC 61000 4 3 3 V m 80 MHz 2 5 GHz 3 V m For 80 MHz 800 MHz d 3 5 3 sqrt P For 800 MHz 2 5
24. e latest Mira PC software is available via download from the PATH medical homepage see www pathme de support Mira includes the latest firmware and speech files for updating the device Mira comes with an online help for further information about correct handling Mira can be used for administering users downloading data from the device uploading and downloading patient information to and from the device reviewing and archiving test data printing test data to a standard PC printer and exporting test data in various formats e g GDT Excel Page 19 40 Some of the functionality only works with a communication license installed on the device e g data download from device You do not need a communication license installed for the following activities with MIRA updating your device to a new firmware updating a speech license or speech files updating user management on the device uploading patients to the device Information about Mira error handling can be found at www pathme de support faq 3 7 PATH Service Tool The PATH Service Tool is only available for authorized distributors and service partners The latest PATH Service Tool software is available via download from the PATH medical homepage via restricted area login The PATH Service Tool is needed for servicing devices and for calibrating transducers Additional hardware e g CaliPro device loopback cable and training from PATH medical is required For further inf
25. e overall system safety level Cleaning the device and its accessories is very important for compliance with hygienic requirements and to avoid any cross infection For further information please refer to section 5 Cleaning Always handle cables and transducers with care Do not excessively bend or twist any cable The cable may break and hence deteriorate overall device functionality or reduce the overall system safety level Do not drop throw or hit any transducer on a hard object Sensitive parts e g ear probe microphone and loudspeakers may get damaged and deteriorate measurement performance Do not use a cable or transducer if any damage is suspected Keep small parts e g ear tips out of patient s range especially children in order to prevent accidental swallowing Page 31 40 No parts may be eaten burnt or in any other way used for purposes other than audiometry Inspect the transducer channels of the insert earphone and or ear probe including probe tip and ear tip before use A blocked loudspeaker channel may yield lower stimulus levels or prevent successful calibration A blocked microphone channel may yield lower response levels or prevent successful calibration If in doubt conduct a probe test see section 3 5 4 Hardware Tests The sockets are intended to connect to the respective accessories e g transducer electrode cable power supply unit label printer Do not connect any other item to thes
26. ean EE NERE AEA E AETR ANE 29 8 3 Electrical sr 30 8 4 Electromagnetic Compatibility ocoooococccnononononannnnnnncnnnanonononnnnnnnnnonononnnnnnnnnnnonononnnnncnnnns 31 8 5 ACCESSO OS nn Risiken 31 8 6 Waste Dis posal iii 32 9 Technical Speeifie tionsz ar nen heh oesecieavaa seein seer adda haus eens eae af eh 33 9 1 General Device Information Mernis aii ea a aiaia da aean ii ieaiai 33 9 2 Device Characteristics 33 9 3 POWErSUPP VE O 33 9 4 Storage Transport and Operating Conditions cccococcoconnnncnonononannnnnnnnnonanononnnnncnnonnnnnnnnnoss 34 10 Electromagnetic Compatibility Information oocococccncncconononaannononnnnnonanonnnnnonnnnnnnonnnnnnncnnnnnnnns 35 1 Overview 1 1 Introduction Thank you for purchasing a Sentiero This manual is your guide for safely operating and maintaining your device Please read this manual carefully before using Sentiero the first time We recommend li taking particular note of the safety see section 8 Notes on Safety intended use see section 1 3 Intended Use cleaning see section 5 Cleaning and maintenance see section 4 Service and Maintenance instructions Sentiero is reliable easy to use and a mobile medical device All devices provide easy navigation via touch screen and are intended for hearing examinations see section 1 3 Intended Use Some of the mentioned firmware modules in this manual may not be included with your license Please contact
27. ean the probe tip For EP TE ear probes only one channel is available and hence only one curve is shown Table 3 Probe test error messages and recommended actions If the recommended actions in Table 3 or in the online FAQ www pathme de support faq do not help in solving the problem please contact your distributor li The pump unit test examines the functionality of the pneumatic system of Sentiero Desktop Ifthe pump unit test fails red icon please contact your distributor 3 5 5 License Management If you would like to add modules to your device please contact your distributor You can also use the demo mode to evaluate the need for additional modules see section 3 5 6 Demo Mode When upgrading your license from the distributor you will receive a new license key that needs to be entered on your device Before entering a new license key on the device please make sure that you keep a written note of the former license key details for potential reinstallation if needed In order to update your license key you need to go to the License Management screen Device Settings gt Device Configuration The existing license key and all currently licensed modules are displayed When correctly entering and confirming the new license key the additional modules will be available on the device Page 17 40 If you order a speech license you will additionally receive a speech license file which needs to be installed on the
28. en or service the device and its components yourself Return the device to the authorized service partner for all service Do not operate the device if its power supply is connected to the device and shows a damaged cord or plug Likewise this is true for any accessory with a separate power supply e g label printer The device is capable of producing high stimulus levels for diagnostic purposes Always make sure to use only stimulus levels which will be acceptable for the patient Do not present high stimulus levels to a patient if it could cause a hearing damage The patient is allowed to operate the device during self controlled tests e g MAGIC according to instructions from qualified personnel Do not allow children handicapped persons e g mentally handicapped subjects or other persons who may need assistance to operate the device without adequate supervision Supervision by qualified personnel is recommended for all subjects at all times The device needs to be operated in a quiet environment so that measurements are not influenced by ambient noises This may be determined by an appropriately skilled person trained in acoustics ISO 8253 1 section 11 defines maximum ambient noise levels for audiometric hearing testing If not followed measurement data may not reliably represent the actual hearing status See also section 3 5 8 Test Module Information There are no device parts which can be serviced during use w
29. her test interpretation needed Test with hearing threshold result e g PTA MAGIC Audio and DPOAE Threshold result within expected range of mild hearing loss Test result not OK Screening test invalid result Diagnostic test result within expected range of moderate to severe hearing loss The test result status icon is meant as a rough hearing status estimator It is not to be interpreted as a binding result A green status icon is not necessarily an indication that the full auditory system is normal A full audiologic evaluation should be administered if concerns about hearing sensitivity persist A yellow or red status icon should not be assumed to be an indicator of a lack of auditory function or the presence of pathology However it should be followed with full audiologic diagnostic testing as appropriate In all cases the examiner needs to check and interpret result data within the context of the patient s case history considering results from other measurements and additional influencing factors as appropriate e g environmental conditions during the test patient cooperativeness Page 12 40 3 4 Device Hardware 3 4 1 On Off Switch The on off switch is located at the right side of the device housing for handheld devices and at the rear panel of the device housing for desktop devices see Figure 2 The on off switch can be used to switch on or off the device For switching on the device press the switch briefly The
30. hich yields to pain when inserting the ear probe or insert earphone See also section 8 Notes on Safety Page 7 40 Page 8 40 2 Explanation of Symbols This section explains all symbols used within this manual and on the device label Symbols within this manual Symbol Explanation BE Important notice please read for important information A Warning please read for safety relevant information which may cause risk of danger to persons and or device if not followed Symbols on the device label Symbol Explanation Consult instruction for use e this manual Serial number Manufacturer name and address production date Compliance with applied part type BF body floating requirements according to IEC 60601 1 Device with safety class Il according to IEC 60601 1 Direct current input 105 The device is electronic equipment covered by the directive 2002 96 EC on waste electrical and electronic equipment WEEE When discarded the item must be sent to separate collection facilities for recovery and recycling Mm CE mark to declare conformity with medical device directive 93 42 EEC The number below the CE mark refers to the identifier of the notified body For further symbols e g on accessory labels please refer to the respective manual or data sheet of the accessory Important symbols may include Symbol Explana
31. ith a patient There are no device parts which can be serviced by the patient when the patient is an intended operator e g MAGIC See also section 4 Service and Maintenance 8 2 Handling Transport and Storage A Do not drop or otherwise cause undue impact to the device or any accessory lf any damage is suspected e g loose parts inside device do not use the device or accessory anymore and return it to your local service partner for repair and or calibration Do not modify the device and its components in any way without written consent of the manufacturer Failure to do so may result in a reduced level of safety of the system Page 29 40 and or degradation of functionality Do not transport store or operate the device at environmental conditions exceeding those stated in section 9 Technical Specifications f the device is moved from a cold location to a warmer one there will be a risk of condensation If condensation occurs the device must be allowed to achieve normal temperature before it is switched on Make sure that any platform table cart or other surface used during the operation transport or temporary or permanent storage of the device and its components is adequate sturdy and safe PATH medical is not responsible for any injury or damage that may result from inadequate poorly constructed or unapproved transports carts or operating surfaces Do not allow any fluid to infiltrate the device Do
32. marras DATE g FA FAR MEDICAL ha SOLUTIONS Sentiero Manufacturer PATH medical GmbH Landsberger Str 63 D 82110 Germering Germany Email info pathme de Telephone 49 800 765 02 Fax 49 800 765 03 Manual Information Article number 100570 Release date 2014 01 27 Revision 0802_MA_Sentiero_Manual_EN_03 Valid from Firmware Rev 1 7 Mira PC Software Rev 1 5 Printed on paper without chlorine bleaching All mentioned items products brands and trademarks are registered or owned by the mentioned companies All information illustrations and specifications provided within this manual are based on the latest product information available at the time of publication PATH medical reserves the right to make changes at any time without notice The latest revision of the user manual is available online at www pathme de support Errors and omissions excepted Copyright Notice No part of this manual may be reproduced translated stored or transmitted in any form or by any means electronic mechanical photocopying recording or otherwise without the prior written consent of PATH medical GmbH Copyright 2014 PATH medical GmbH CE 0124 Table of Contents SN A thoatneseaeactied yoacaeusacahes soncaeveaeachesuy Sacaevsseadnes A 5 1 1 Introducci tad 5 1 2 Device versions 222 4228 0 ers 5 1 3 IntendediUser santas E 6 2 Explanation Ot SyMDOls macro ad dro 9 3 Operational CO
33. medical Regarding the PTA module an annual inspection period is stipulated by ISO 8253 1 and by MPBetreibV annex 2 The measurement principle of otoacoustic emissions OAE or acoustically evoked potentials AEP is not explicitly described in MPBetreibV Therefore the manufacturer is obliged to define metrological inspection instructions IEC 60645 6 OAE and IEC 60645 7 AEP both suggest an annual inspection interval EXPLANATION The device and its accessories contain parts which are exposed to environmental impacts and contamination In order to ensure an accurate measurement function the fault tolerance provided by the manufacturer or defined by applicable standards needs to be controlled by specifically designed instrumentation and defined procedures Therefore metrological inspection must be conducted by authorized service partners instructed and trained by PATH medical In addition to the annual metrological inspection a regular visual inspection and a regular Ba check for correct operation of the device and its accessories is recommended Guidelines for routine inspections are provided e g in ISO 8253 1 for pure tone audiometry Before using the middle ear analyzer module each day use the calibration volume cavities provided with your device to check the calibration of the ml mmho meter Please follow local regulations or guidelines 4 3 Repair In case a device or accessory is defective or differs in any way from its original setu
34. nability to use of the device or accessory or relating in any way to the defect in or failure of the device or accessory including but not limited to claims based upon loss of use lost profits or revenue environmental damage increased expenses of operation cost of replacement goods PATH medical s warranty and liability is directed to the distributor and limited to the regulations in the respective distribution contract and German law The end user shall address warranty claims only to the authorized distributor from whom the device was purchased PATH medical reserves the right to refuse warranty claims against products or services that are obtained and or used in contravention of the laws of any country Page 28 40 8 Notes on Safety A In order to allow safe performance of Sentiero handheld and desktop please read the following notes on safety carefully and follow the provided instructions If not followed risks of danger to persons and or the device may be the consequence Retain this manual for later use and make sure to hand over this manual to any person who uses this device Applicable local government rules and regulations must be followed at all times 8 1 General Usage A Follow relevant regulations in your facility regarding maintenance and calibration of audiometric equipment This includes regular servicing of the device and calibration of transducers See section 4 Service and Maintenance Do not try to op
35. ormation see separate PATH Service Tool manual or contact PATH medical service pathme de Page 20 40 4 Service and Maintenance 4 1 General Service Information PATH medical is committed to customer satisfaction Please contact your distributor for li ordering supplies obtaining information on training courses and service contracts getting help with device related problems suggesting desired features or finding answers not addressed in the device online help or associated manuals General information on your device and on PATH medical can be found at www pathme de Updates to software firmware and documentation e g user manual are available on the PATH medical homepage If updates are available PATH medical distributors will be informed It is the responsibility of the local distributor to inform the end customer If you are not sure whether your software firmware or documentation is up to date please check www pathme de support or contact your distributor Service activities and repairs of the device and its electro medical accessories must only be conducted by PATH medical or its authorized service partners Authorized service partners are enabled from PATH medical with necessary documentation and training in order to conduct specified service activities and repairs PATH medical reserves the right to decline any responsibility for the safety in operation reliability and capability of the device or accessory if any service
36. p PATH medical or an authorized service partner will repair re calibrate or exchange the device or accessory All repairs are subject to parts and material availability Please contact your distributor to find out about the lead time of any repair activity Prior to sending any equipment for repair please provide relevant information to your service partner e g model serial number firmware version contact information shipping information detailed description of experienced issue or defect This may help in speeding up the repair process and failure analysis and in excluding issues that can be solved without sending the device Additional information may be requested by your service partner See also sections 4 1 General Service Information and 7 Warranty Page 22 40 5 Cleaning Cleaning the device and its accessories is very important for compliance with hygienic requirements and to avoid any cross infection Please always consider local regulations and read this section carefully Before cleaning the device the device must be switched off and removed from all connected components e g power supply unit Wipe the surface of the device with a cloth slightly dampened with mild detergent or normal hospital bactericides or antiseptic solution The following quantities of chemical substances are allowed ethanol 70 80 propanol 70 80 aldehyde 2 4 Do not immerse the device and make sure that no liquid gets into the device
37. p contains an additional pressure outlet socket not shown in Figure 6 nearby the ear probe connector socket red socket in Figure 6 bottom 3 4 4 Charging the Device Connect the power supply unit to the device see section 3 4 3 Device Sockets For charging the device connect the power plug to a power mains socket with appropriate output voltage and frequency For more information about power supply units please see section 9 Technical Specifications and information provided on the power supply unit The charging process starts automatically and is finished within about 2 hours handheld or 8 hours desktop respectively The battery status can be derived from the battery status icon symbol fully charged EZ charging E EE EF status indicator from empty to full 3 5 Device Functions Page 15 40 3 5 1 User Management With the Mira PC software you can activate or de activate the user management on your device see Mira online help for more information If the user management is activated after switching on the device you will be asked to select a user and to enter the user password Please follow the explanations on the device If you would like to change a user you need to logoff from the device and restart the device If the user management is active you are only enabled to change module parameters when logged in as Administrator 3 5 2 Patient Management After switching on the device and if applicable after login a
38. rces and environmental impacts Extreme storage and operating conditions may result e g in breakage of the touch screen display at extremely low temperatures or in impairment of the device and or transducer calibration If the device is moved from a cold location to a warmer one there will be a risk of condensation If condensation occurs the device must be allowed to achieve normal room temperature before it is switched on Also make sure that the below operating conditions are fulfilled TRANSPORT AND STORAGE CONDITIONS Transport temperature 20 to 60 C 4 to 140 F Storage temperature 0 to 40 C 32 to 104 F Relative air humidity lt 90 non condensing Barometric pressure 50 to 106 kPa OPERATING CONDITIONS Temperature 10 to 40 C 50 to 104 F Relative air humidity 20 to 90 non condensing Barometric pressure 60 to 106 kPa At locations where the normal air pressure is below 80 kPa at altitudes of more than 2000 meters it is recommended to recalibrate the transducers Page 34 40 10 Electromagnetic Compatibility Information Electromagnetic compatibility EMC as stated by standard IEC 60601 1 2 Medical electrical equipment Part 1 2 General requirements for basic safety and essential performance Collateral standard Electromagnetic compatibility Requirements and tests and 60601 2 40 Medical electrical equipment Part 2 40 Particular requirements for the safety of
39. s are especially indicated for use in defining the type and configuration of hearing loss particularly for individuals whose behavioral audiometric results are deemed unreliable or to assist in the diagnosis of otologic disorders Estimation of behavioral hearing thresholds is possible at various frequencies without the need of cooperative interaction with the patient Acoustic reflex and tympanometry are featured to evaluate the functional condition of the middle and outer ear For each method several protocols can be configured The results are to be used to make further recommendations regarding appropriate intervention strategies Therefore Sentiero is intended for use by trained personnel such as audiologists pediatricians ENT doctors and other health care professionals In the United States of America Federal law restricts this device to sale by or on the order of a licensed physician Available psycho acoustical methods on Sentiero are especially indicated for use with cooperative patients starting at the age of 2 years or adequate development age which enables them to do play interactive audiometry All other modules are suitable to be used for all ages Sentiero is designed for 1 Diagnostics monitoring and follow up after newborn hearing screening 2 Pre school school and adult hearing screening 3 ENT diagnostics based on measurement of a Otoacoustic emissions b Tympanometry and acoustic reflex c Auditory Brainstem Responses
40. se check the below list and proceed as recommended in Table 4 Further information about error handling can be found in section 3 5 4 Hardware Tests or in the online FAQ www pathme de support faq Error Recommended action for troubleshooting Black display The display is automatically deactivated after 2 minutes without user activity in order to increase use time without recharging Touch the display in order to leave the power saving mode No feedback After 10 minutes without user activity the device automatically powers down black display completely Start the device by pressing the on switch No feedback If the device does not respond to user action you might need to restart the black display device by pressing the reset switch see section 3 4 2 Device Reset Charge the device stalled battery if necessary Error message ai A Remove the connector cable of the label printer or the RS232 cable Remove cable Error message The error message appears if there is a permanent pressure on the touch Touch screen screen during startup of the device Check if there is a particle between the error display and the surrounding display frame Remove the particle with a small and soft tool e g paper strip Table 4 Errors and recommended actions If the recommended actions in Table 4 or in the online FAQ do not help in solving the problem please contact your distributor 3 6 Mira PC Software Th
41. so a sound insulation headphone can be used In contrast to the above mentioned modules for AEP measurements e g ABR ASSR acoustical noise is less influential on measurement performance than muscle artefacts e g patient movement Please consider local regulations regarding requirements for the test environment li OAEs are most likely 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 Please use only the large ear tips together with the large probe tip PT A and the small ear li tips together with the small probe tip PT S A wrong combination of ear tip and probe tip may deteriorate test performance See also advice in the accessory box If in doubt about what combination is correct please contact your distributor If possible do not hold the ear probe while it is placed inside the ear during OAE testing This may introduce noise into the measurement Common sources of noise are acoustical Page 18 40 room noise biological patient breathing moving talking chewing etc or physical ear probe movement noise For further information and details about the various test modules potential clinical applications and recommendations for combining different test procedures please refer to the How To Manual which can be downloaded from www pathme de support 3 5 9 Error Handling If an error occurs with your device plea
42. tion Single use only Do not reuse the respective item The respective item is provided non sterile Page 9 40 Page 10 40 3 Operational Concept After switching on the device the device can be operated via a touch sensitive display In the following the most important device functions and screen elements are explained Further information and details about the various test modules potential clinical BA applications and recommendations for combining several test procedures are explained in the guide for practical application How To Manual You can download this document from www pathme de support Further technical details as e g maximum levels for the various test modules and for all BA available transducers and specifications regarding test module parameters are described in a separate Technical Specification document You can download this document from www pathme de support Please note that screen shots or references to test modules in this manual may not reflect the actual test configuration of your device 3 1 Screen Layout The device screen is in general split up in three sections see Figure 1 12 00 TESTDEMO 4 MF 1 Header D Main screen 6 Footer Figure 1 Device screen layout D Header including the following elements Device time e g 12 00 Screen related information e g selected patient name selected test module preset name USB connection is
43. ure that both the device and the label printer are connected to the power supply unit otherwise no printout will be possible For handheld devices see Figure 4 and Figure 5 the sockets can be used as described in Table 1 Socket Connectable accessory Blue Headphones insert earphones free field loudspeaker Sentiero Sentiero Advanced 2 ear probe Q Red Ear probe i Sentiero Advanced Bone conductor Grey Sentiero Patient response button label printer power supply bone conductor 9 White Sentiero Advanced Electrode cable patient response button label printer power supply USB socket USB cable with type mini B connector References to Sentiero also include Sentiero and Sentiero Eco Table 1 Device socket overview for handheld devices Figure 4 Socket panel of handheld devices from left to right Sentiero Sentiero Advanced Figure 5 USB socket Page 14 40 For desktop devices see Figure 6 the sockets can be used as described in Table 2 Socket Connectable accessory Q Blue Sentiero Desktop Headphones insert earphones free field loudspeaker D Red Sentiero Desktop Bone conductor uf G Patient response button A a Label printer gt USB cable with type B connector oO 6 Power supply Table 2 Device socket overview for desktop devices Figure 6 Socket panel of desktop devices Please note that Sentiero Deskto
44. your distributor if you would like to upgrade your license to include more modules 1 2 Device Versions There are multiple versions available within the Sentiero device family HANDHELD DEVICES Sentiero Including Sentiero Sentiero and Sentiero Eco Model SOH100098 Sentiero Advanced Model SOH100360 Sentiero differs from Sentiero in extended internal memory e g for speech tests Sentiero Eco is limited to otoacoustic emission OAE tests and does not offer patient management Sentiero Advanced differs from Sentiero in socket layout and offers the additional ability to conduct acoustically evoked potential AEP tests DESKTOP DEVICES Sentiero Desktop Model SOD100497 Page 5 40 Sentiero Desktop offers the same modules as Sentiero together with the ability to conduct tympanometry and acoustic reflex measurements 1 3 Intended Use Sentiero is a portable instrument to diagnose all ages for hearing loss The instrument offers different test methods which can be configured to fit the professional s needs for screening or diagnostic purposes It offers physiological test methods such as Distortion Product Otoacoustic Emissions DPOAE Transient Evoked Otoacoustic Emissions TEOAE Auditory Brainstem Response ABR Auditory Steady State Response ASSR Auditory Impedance and acoustic reflex TYMP Additionally if offers standard audiometry psycho acoustical All physiological test method
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