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8.5

 

Accessories 

 

 

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 the 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. 

 

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 these 
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. 

Summary of Contents for Senti

Page 1: ...User Manual Senti Sentiero...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 8: ...Page 8 44...

Page 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...

Page 10: ...Page 10 44...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 22: ...Page 22 44...

Page 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...

Page 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...

Page 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...

Page 26: ...Page 26 44...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 36: ...Page 36 44...

Page 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...

Page 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...

Page 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...

Page 40: ...Page 40 44...

Page 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...

Page 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...

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

Page 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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