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User Manual

Senti & Sentiero

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Содержание Senti

Страница 1: ...User Manual Senti Sentiero...

Страница 2: ...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 c...

Страница 3: ...13 3 4 3 Device Sockets 14 3 4 4 Charging the Device 15 3 5 Device Functions 16 3 5 1 User Management 16 3 5 2 Patient Management 16 3 5 3 Device Settings 16 3 5 4 Hardware Tests 17 3 5 5 License Mana...

Страница 4: ...ical Safety 32 8 4 Electromagnetic Compatibility 33 8 5 Accessories 34 8 6 Waste Disposal 35 9 Technical Specifications 37 9 1 General Device Information 37 9 2 Device Characteristics 37 9 3 Power Sup...

Страница 5: ...ware modules in this manual may not be included with your license Please contact your distributor if you would like to upgrade your license to include more modules 1 2 Device Versions There are multip...

Страница 6: ...ally indicated for use with cooperative patients starting at the age of two years or adequate development age which enables them to do play interactive audiometry All other physiological modules are s...

Страница 7: ...o 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 SIDE EFFECTS There are no kno...

Страница 8: ...Page 8 44...

Страница 9: ...uirements according to DIN EN 60601 1 Device with safety class II according to DIN EN 60601 1 Direct current input The device is electronic equipment covered by the directive 2012 19 EC on waste elect...

Страница 10: ...Page 10 44...

Страница 11: ...d for all 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 suppo...

Страница 12: ...wing 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 further test interpretation n...

Страница 13: ...f switch can be used in some test modules e g MAGIC SUN to show the footer which may be hidden in these modules during the test Figure 2 On off switch for handheld left and desktop device right marked...

Страница 14: ...used as described in Table 1 Socket Connectable accessory Blue Headphones insert earphones free field loudspeaker Sentiero Sentiero Advanced 2nd ear probe ear coupler cable tympanometry add on PCB rev...

Страница 15: ...nt response button Label printer modem USB cable with type B connector Power supply Table 2 Device socket overview for desktop devices Figure 6 Socket panel of desktop devices top Senti Desktop bottom...

Страница 16: ...Patient Management After switching on the device and if applicable after login a patient can be added selected from the list of patients or the test module selection can be called in Anonymous mode i...

Страница 17: ...eck if the ear probe is properly connected to the device If not connect the ear probe to the device Probe failed 1 Check if the ear probe is placed in the correct test cavity If not use the correct te...

Страница 18: ...ce 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 permanen...

Страница 19: ...ination 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 sourc...

Страница 20: ...or Error ID Device error recognized by device self test Contact your service partner for more information Table 4 Errors and recommended actions If the recommended actions in Table 4 or in the online...

Страница 21: ...ailable 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 devi...

Страница 22: ...Page 22 44...

Страница 23: ...irs 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 activities or repairs were conducted...

Страница 24: ...e may influence the calibration accuracy For more information please refer to section 8 2 Handling Transport and Storage In addition to the annual metrological inspection a regular visual inspection a...

Страница 25: ...be 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 ca...

Страница 26: ...Page 26 44...

Страница 27: ...lectrode cable yes 1 8 m 71 Electrode trunk cable EC 03 connected to electrode lead cable no 1 4 m 55 Electrode lead cable Multiple configurations connected to electrode trunk cable yes 0 5 m 20 Relat...

Страница 28: ...t your distributor for an up to date list of available accessories Please note that the same accessory may be available with different connectors and therefore different article numbers for different...

Страница 29: ...lid in cases of breakage malfunction due to manipulation or unintended usage negligence non observance of manufacturer s instructions including cleaning instructions crashes or accidents damages by ex...

Страница 30: ...ng 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 opera...

Страница 31: ...ests 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 de...

Страница 32: ...ve 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 compo...

Страница 33: ...or with other electronic equipment in a stacked form should be avoided as this could result in improper operation Senti Sentiero e g occurrence of unwanted noise Electronic equipment may include e g m...

Страница 34: ...o 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 transduc...

Страница 35: ...rrect 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...

Страница 36: ...Page 36 44...

Страница 37: ...9 3 DIN EN ISO 389 4 DIN EN ISO 389 5 DIN EN ISO 389 8 transducer calibration DIN EN ISO 10993 1 biocompatibility DIN EN ISO 15223 1 manual DIN EN 60601 1 electrical safety DIN EN 60601 1 2 EMC DIN EN...

Страница 38: ...andheld 9V 1 2 A Desktop 9 12 V 0 4 A Rechargeable battery pack Handheld 4 8 V NiMH Desktop 3 7 V Li Ion Maximum operating time with fully charged batteries ca 6 8 hours dependent on usage Maximum cha...

Страница 39: ...to 40 C 50 to 104 F Relative air humidity 20 to 90 non condensing Barometric pressure 70 to 106 kPa In the following cases a transducer recalibration at the point of use is recommended Air pressure a...

Страница 40: ...Page 40 44...

Страница 41: ...ence 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 residentia...

Страница 42: ...ce tests and resulting requirements for electromagnetic environment The user must take care that the device is used in an environment with minimum distances to potential radiators as described in Tabl...

Страница 43: ...Page 43 44 The device is intended for use in an environment in which high frequency disturbances are controlled...

Страница 44: ...PATH MEDICAL GmbH Landsberger Stra e 65 82110 Germering Germany Tel 49 89 800 765 02 Fax 49 89 800 765 03 Internet www pathme de Contact information from distributor service partner...

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