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For calibrated transducers differences in environmental conditions between the point of 
calibration  and  the  point  of  use  may  influence  the  calibration  accuracy.  For  more 
information please refer to section 

8.2: Handling, Transport, and Storage

. 

 
 
 

There are no device parts, which can be serviced during use with 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 

 

 

Do  not  drop  or  otherwise  cause  undue  impact  to  the  device  or  any  accessory.  If  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 
and/or degradation of functionality. 

 

Do  not  transport,  store  or  operate  the  device  at  environmental  conditions  exceeding 
those  stated  in  section 

9:

 

Technical  Specifications

.  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 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 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 

 

 

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 Senti/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. 

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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