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TECHNICAL SPECIFICATION

 

 

 

 

                                                             29 

D-0014930-A 

– Otowave 102-C Operating Manual 

                                

 

15.

 

TECHNICAL SPECIFICATION 

15.1.

 

PERFORMANCE 

Tympanometry 

 

Instrument type 

Meatus compensated tympanometer 

Analysis performed 

Compliance  peak  level  (in  ml)  &  pressure;  Gradient  (in 
daPa); 
Ear Canal Volume (ECV) @ 200 daPa 

Probe tone levels and accuracy 

226Hz +/- 2%; 85dB SPL +/-2dB over range 0.2ml to 5ml 

Pressure levels and accuracy 

+200daPa to -4/-10daPa or +/-10% (whichever 
is larger) over range 

Ear volume measurement range and 
accuracy 

0.2ml to 5ml +/- 0.1ml or +/-5% (whichever is larger) over 
entire range 

Sweep speed 

Typically  200-300daPa/sec;  dependent  on  ear/cavity 
volume 

Pressure limits (safety cutout) 

+600 to -800 daPa 

Number of samples stored 

100 per tympanogram 

Reflex measurements 

 

Measurement mode 

Ipsilateral 

Reflex tone levels and accuracy 
 
 

500Hz,1kHz,2kHz,4kHz (+/-2%) 
 
Configurable  over  range  70dB  to100dBHL  (4kHz 
restricted  to  95dBHL)  +/-3dB,  referenced  to  2cc 
calibration  volume;  Compensates  for  measured  ear 
volume  

Number of reflex levels  

Four:  100dB  with  5dB  or  10  dB  steps;  95dB,  90dB  or 
85dB with 5 dB steps 

Reflex analysis 

Reflex pass/fail at each level tested; maximum amplitude 
of each reflex; nominal pressure used for the reflex test 
(computer display only) 

Pressure used for reflex measurement 

Pressure at tympanogram peak, or at 0daPa (if no peak 
found) 

Reflex stimulus control 

Stimulus presented at all levels, or 
stimulus ceases when a reflex is found 

Reflex detection threshold and accuracy 

0.01ml to 0.5ml +/-0.01ml (configurable in 0.01ml steps) 

Reflex tone duration 

0.6 seconds 

Data Management 

 

Number of records stored in Patient 
Database 

32 

Data storage 

Any  recording  can  be  stored  once  the  tympanogram  is 
viewed.  Patient  Initials  (A-Z,  0-

9,  “-“)  must  be  entered 

before storage. 

Data held 

Patient  Initials,  Tympanogram  and  Reflex  graphs  and 
analysis for Left Ear and/or Right Ear, Time and Date of 
recording,  which  ears  were  tested,  whether  or  not  the 
record  has  been  printed  and/or  sent  to  a  computer, 
parameters  used  for  analysis,  128  bit  Globally  Unique 
Identifier (GUID) 

Display mode 

Records listed in reverse chronological order (latest first), 
with indication of data stored as described above 
 

Real Time Clock 

 

Time stamps 

Time and date stamp applied to all recordings, and to the 
last calibration date 

Summary of Contents for Otowave 102-C

Page 1: ...Otowave 102 C Operating Manual...

Page 2: ...ivox Ltd 3800 Parkside Solihull Parkway Birmingham Business Park Birmingham West Midlands B37 7YG United Kingdom www amplivox com For all enquiries please contact us Amplivox Ltd 10393 West 70th Stree...

Page 3: ...If supplied in the US please note Caution Federal Law restricts this device to sale by or on the order of a licenced medical professional...

Page 4: ...e 6 4 1 Battery PACK 6 4 2 Operating language 6 4 3 The Cradle 6 4 3 1 General 6 4 3 2 Connectors 6 4 3 3 Indicators 7 4 4 Controls and indicators Handheld Unit 8 4 5 The probe 9 4 6 Start up and menu...

Page 5: ...Maintenance 26 13 1 Cleaning the Otowave 26 13 2 Ear tip and Probe 26 13 3 Calibration and Repair of the Instrument 26 14 Error Messages Fault Conditions 27 15 Technical Specification 29 15 1 Perform...

Page 6: ...in non volatile memory Configurable settings for user preferences held in non volatile memory Printout of data to a printer Data transfer to a computer via USB for storage viewing printing using eith...

Page 7: ...ip Otowave 14mm 25 pieces 8012979 Ear tip Otowave 15mm 25 pieces 8012981 Ear tip Otowave 19mm 25 pieces 8012983 1 6 GUARANTEE All Amplivox instruments are guaranteed against faulty materials and manuf...

Page 8: ...trument and its accessories and the function of single use parts Do not use the instrument in an oxygen rich environment or in the presence of a flammable anaesthetic mixture or other flammable agents...

Page 9: ...ng a microphone and the admittance calculated from the result In line with normal audiometric practice admittance is displayed as an equivalent volume of air in ml for 226 Hz The residual ear canal vo...

Page 10: ...e to become stiffer or a preset maximum level is reached When the change in admittance exceeds a predetermined threshold this constitutes a reflex and the change in admittance at that level when the s...

Page 11: ...onfiguration the contents of the database the calibration settings or the results of the last test 4 2 OPERATING LANGUAGE To set the operating language English French Spanish Italian Portugese or Germ...

Page 12: ...ter USB USB connector Type B Computer via USB port For connected parts marked make sure to only connect the parts or accessories supplied with the instrument or supplied by Amplivox or an Amplivox dis...

Page 13: ...r go to the next step Press the left navigation key to cancel an operation or go back to the previous step The function of the left and right keys is usually shown on the bottom line of the display Wh...

Page 14: ...s blocked or damaged Do not remove the nut securing the boss to the body of the instrument Please note When replacing the probe tip ensure that the seal is correctly located with the flat side aligned...

Page 15: ...ting Manual 4 7 INITIAL SETTINGS Use the CONFIGURATION options see Section 6 to select the following options as required display contrast for ease of viewing correct local date and time date format DD...

Page 16: ...se note The probe tip must be fitted with a new ear tip before it is presented to a patient s ear canal The ear tip must be fitted completely to the probe tip and must not occlude any of the four hole...

Page 17: ...default this test is only performed if a peak is found in the tympanogram This and other reflex test options may be changed in the CONFIGURATION menu see Section 6 Before starting the reflex test the...

Page 18: ...elect an alternative peak using the and keys The figures displayed will change to reflect the peak selected and will be saved with the tympanogram To repeat the test press When satisfied with the tymp...

Page 19: ...ns Print the results Save the results in the internal database Review the results as described above Return to the main menu The results of the last test performed remain available even if the Otowave...

Page 20: ...ISPLAYED INDICATOR STATUS LIKELY CAUSE S WITHDRAW PROBE Yellow Flashing The probe has been moved during measurement Re insert the probe to repeat the test Volume outside range WITHDRAW PROBE Yellow Fl...

Page 21: ...eload Defaults Reset the sweep settings to its original settings 6 2 REFLEX OPTIONS Amplivox YouTube Video available on how to add ipsilateral reflexes to test protocol ITEM DESCRIPTION DEFAULT Level...

Page 22: ...t produces a response By setting REFLEX AUTO STOP to NO the Otowave 102 C will test for a reflex at all selected levels Note that 100dBHL at 4000Hz is not available No Polarity Define the polarity of...

Page 23: ...epartment Allows the department name to be entered The name will appear at the top of the print out Defaults Reset the system settings to the original settings Language Change the operation language t...

Page 24: ...stored records this same identifier may be used for different tests for the same patient 7 1 DATA ENTRY PATIENT INITIALS _____ ABCDEFGHIJKLM NOPQRSTUVWXYZ 01233456789 Hold to enter cancel To enter the...

Page 25: ...ults to a dedicated thermal printer or a suitably equipped computer via a USB link When printing directly to the printer the data is received through a cable connected between the cradle and the print...

Page 26: ...the analysis and the results The name of the hospital the department and the calibration dates for the instrument may also be printed if required There is space for additional details to be handwritte...

Page 27: ...st select LIST RECORDS All other options operate on groups of records 10 1 LIST RECORDS LIST RECORDS shows the stored tests 6 at a time most recent first Records Stored 6 30 ABC 02 01 06 14 15 2 DEF 3...

Page 28: ...DELETE RECORDS allows a group of records to be deleted It is possible to delete all records all records that have been printed or all records that have been sent to a computer Confirmation of the dele...

Page 29: ...nto the hole at the 2ml end of the test cavity Make sure that the probe is pushed in fully and is held tight against the stop The probe must be square to the end of the test cavity The display should...

Page 30: ...C Operating Manual 12 SYSTEM INFORMATION 1 Battery Remaining battery capacity 2 Last Cal Last calibration date 3 Next Cal Next calibration date 4 Serial No Serial number of Otowave 5 Ver Firmware vers...

Page 31: ...d be replaced if necessary The seal should be replaced when the probe tip is replaced if it shows signs of wear or if a pressure leak is suspected Handle the probe and accessories with care Do not all...

Page 32: ...ast measured data cannot be found under VIEW THE LAST TEST NEW TEST might have been selected in between and thereby deleted the last test s from the short term memory Data you wish to be stored should...

Page 33: ...IRED Indicator LED c steady light The current date is later than the next calibration date Check that the clock is set to the correct date If so arrange for the instrument to be recalibrated Tests can...

Page 34: ...95dB 90dB or 85dB with 5 dB steps Reflex analysis Reflex pass fail at each level tested maximum amplitude of each reflex nominal pressure used for the reflex test computer display only Pressure used...

Page 35: ...rent 70mA Current while testing 230mA Physical Display 128 x 64 pixels 8 lines of 21 characters Dimensions 230mm L x 115mm W x 70mm H Total Weight handset and cradle 650g Environmental Operating tempe...

Page 36: ...dby condition Definition Refer to instruction manual mandatory Definition Type BF applied part an applied part providing a higher degree of protection against electric shock than that provided by a Ty...

Page 37: ...ion of waste electrical items from the general waste stream and into reuse recovery and recycling routes Therefore for any waste electrical units purchased from Amplivox that either bear the crossed o...

Page 38: ...tly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Harmonic emissions IEC 61000 3 2 Not applicable Voltage fluctuations flicker emissions I...

Page 39: ...ines IEC 61000 4 11 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 sec Not applicable Not applicable Power frequency 50 60 Hz...

Page 40: ...F transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the...

Page 41: ...o the maximum output power of the communications equipment Rated maximum output power of transmitter W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz d 1 2 P 80 MHz to 8...

Page 42: ...s to ensure that the general requirements of clause 16 of IEC 60601 1 2005 are met External equipment intended for connection to signal input signal output or other connectors shall comply with the re...

Page 43: ...ELECTRICAL EQUIPMENT 38 D 0014930 A Otowave 102 C Operating Manual Diagram 1 Otowave 102 C used with the designated printer Mains Outlet Printer via USB Cradle Connection Printer Power Supply Otowave...

Page 44: ...LECTRICAL EQUIPMENT 39 D 0014930 A Otowave 102 C Operating Manual Diagram 2 Otowave 102 C used with a computer USB connection Mains Outlet Computer via USB Cradle Connection Computer Power Supply Otow...

Page 45: ...NT 40 D 0014930 A Otowave 102 C Operating Manual Copyright 2020 Amplivox Ltd All rights reserved No part of this publication may be reproduced or transmitted in any form or by any means without the pr...

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