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EMC GUIDANCE & MANUFACTURER’S DECLARATION

 

 

 

 

                                                             34 

D-0115690-C (OM001) 

– Otowave 102 Operating Manual 

                                

 

Guidance and 

manufacturer’s declaration – electromagnetic immunity (2) 

The Otowave 102 Tympanometer is intended for use in the electromagnetic environment specified below. 
The  customer  or  user  of  the  Otowave  102  Tympanometer  should  assure  that  it  is  used  in  such  an 
environment. 

Immunity test

 

IEC 60601 test level

 

Compliance 

level

 

Electromagnetic environment 

– guidance

 

 
 
 
 
 
 
 
 
 
 
 
Radiated RF 

IEC 61000-4-3 

 
 
 
 
 
 
 
 
 
 
 
3 V/m 

80MHz to 2.5GHz 

 
 
 
 
 
 
 
 
 
 
 
3 V/m 

Portable  and  mobile  RF  communications 
equipment should be used no closer to any 
part  of  the  Otowave  102  Tympanometer, 
including  cables,  than  the  recommended 
separation  distance  calculated  from  the 
equation  applicable  to  the  frequency  of  the 
transmitter. 
 
Recommended separation distance 
 
d = 1.2√P 80MHz to 800MHz 
 
d = 

2.3√P 800MHz to 2.5GHz 

 
where P is the maximum output power rating 
of the transmitter in Watts (W) according to 
the  transmitter  manufacturer  and  d  is  the 
recommended separation distance in metres 
(m). 
 
Field  strengths  from  fixed  RF  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  following 
symbol: 
 
 
 
 

 

NOTE 1 At 80MHz and 800MHz, the higher frequency range applies. 
 

NOTE  2  These  guidelines  may  not  apply  in  all  situations.  Electromagnetic  propagation  is  affected  by 
absorption and reflection from structures, objects and people. 

Содержание Otowave 102

Страница 1: ...Otowave 102 Operating Manual...

Страница 2: ...n 1 0 0 072100 onwards see System Information screen This product is manufactured by Amplivox Ltd 6 Oasis Park Eynsham Oxfordshire OX29 4TP United Kingdom www amplivox ltd uk Amplivox Ltd 10393 West 7...

Страница 3: ...For supply in US only Caution Federal Law restricts this device to sale by or on the order of a licenced medical professional...

Страница 4: ...eplacing batteries 5 4 2 Operating language 5 4 3 Controls and indicators 5 4 4 The probe 6 4 5 Start up and menu displays 7 4 6 Initial settings 7 5 Taking measurements 8 5 1 Prior to testing and Amb...

Страница 5: ...tip and Probe 24 13 3 Calibration and Repair of the Instrument 24 14 Error Messages Fault Conditions 25 15 Technical Specification 27 15 1 Performance 27 15 2 Equipment classification 28 15 3 Symbols...

Страница 6: ...gram is taken 1 3 FEATURES Automatic measurement of ear canal volume tympanic compliance peak placement of the peak and the gradient Automatic detection of stapedial reflexes Up to 30 dual ear patient...

Страница 7: ...nical support 1 7 GUARANTEE All Amplivox instruments are guaranteed against faulty materials and manufacture The instrument will be repaired free of charge for a period of two years from the date of d...

Страница 8: ...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 Do not drop or...

Страница 9: ...membrane The changing compliance with pressure is displayed as a graph 3 3 STAPEDIAL REFLEX MEASUREMENT Using the same principle it is also possible to establish whether a stapedial reflex is present...

Страница 10: ...be replaced when the symbol appears next to the battery state indicator or when advised to do so for example at switch on Changing the batteries does not affect the configuration the contents of the...

Страница 11: ...be is held steady while an ear seal is obtained Off Flashing slow Testing tympanogram and or reflex measurement Flashing slow Off For a full description of indicators used messages displayed and possi...

Страница 12: ...boss and replace the nose cone Make sure that the nose cone is screwed home firmly but do not over tighten Do not use any tools to tighten the nose cone After replacing the tip a Daily Check should be...

Страница 13: ...ar tip These must be selected and fitted by a practitioner qualified to perform tympanometric tests Please note The probe tip must be fitted with a new ear tip before it is presented to a patient s ea...

Страница 14: ...r tip to the ear and obtain a seal If a good seal has been detected the following sequence of messages will be seen TESTING LEFT EAR Equalising Pressure Cancel TESTING LEFT EAR Pressure Settling Cance...

Страница 15: ...es from flashing green to steady green The display confirms that the test has been completed along with the instruction WITHDRAW PROBE Remove the ear tip from the patient and after a short period the...

Страница 16: ...a reflex tone was not presented at the level indicated REFLEX SUMMARY dB 100 X 90 X 80 X 70 X X X Hz 500 1k 2k 4k Press to return and view the tympanogram reflex results or to repeat the test When sat...

Страница 17: ...te Results of the last test will be erased as soon as a new test is started Test results should be saved to the Otowave s database printed or sent to a computer to ensure that data is not lost 5 4 EAR...

Страница 18: ...uring measurement Re insert the probe to repeat the test Volume outside range WITHDRAW PROBE Yellow Flashing The ear canal volume is above the 5ml This message can also occur when the probe is not pro...

Страница 19: ...the quality of the seal The EXTENDED function is especially helpful if small ear canal volumes should not experience excessive pressure Standard Defaults Reset the sweep settings of the selected profi...

Страница 20: ...if a compliance peak is found or only after confirmation is made at the start of the test sequence In cases where a compliance peak has not been established a pressure of 0daPa is used Press the key...

Страница 21: ...the time when device shuts off to save power 90 s Contrast Adjust the display contrast using the and keys Cal Dates Select PRINT CAL DATES to show the serial number for the base unit and the transduce...

Страница 22: ...ate time of a test to refer to stored records this same identifier may be used for different tests for the same patient 7 1 DATA ENTRY PATIENT INITIALS _____ ABCDEFGHIJKLM NOPQRSTUVWXYZ 01233456789 Ho...

Страница 23: ...ons but may need to be modified depending on the environment The two communication windows should be in line and pointing directly at each other 10 20cm apart Both units must be out of direct sunlight...

Страница 24: ...mal paper printouts can fade with exposure to light or heat Consider transferring the data to a computer for permanent storage 9 2 DATA TRANSFER TO NOAH OR AMPLISUITE To transfer test results stored w...

Страница 25: ...ividual test 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...

Страница 26: ...ecords that have been printed or all records that have been sent to a computer Confirmation of the deletion is required 10 3 PRINT RECORDS PRINT RECORDS allows a group of records to be sent to the pri...

Страница 27: ...tip into the hole at the 2ml end of the test cavity Make sure that the probe is pushed fully home and is held tight against the stop The probe must be square to the end of the test cavity The display...

Страница 28: ...INFORMATION 1 Variant Instrument version Dual Tone High Frequency option enabled 2 Battery Voltage Information 3 Last Cal Last calibration date 4 Next Cal Next calibration date 5 Serial No Serial numb...

Страница 29: ...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 allow moisture co...

Страница 30: ...place the probe tip Reposition the probe Change the ear tip No reflex test is conducted after the tympanometry even though the reflex test is active in the REFLEX SEQUENCE In REFLEX SELECTION the sett...

Страница 31: ...AIRFLOW ERROR RESTART THE UNIT Indicator LED c steady light Fault with air system and or pump Restart the unit If problem persists contact your Amplivox service center WARNING CALIBRATION EXPIRED Indi...

Страница 32: ...B 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 refle...

Страница 33: ...70mA Current while testing 230mA Physical Display 128 x 64 pixels 8 lines of 21 characters Dimensions 190mm long x 80mm wide x 40mm high excluding probe 210mm long including probe Weight without batte...

Страница 34: ...o 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 Type B applied part particularly r...

Страница 35: ...T209 Ear tip Otowave 9mm T210 Ear tip Otowave 10mm T211 Ear tip Otowave 11mm T212 Ear tip Otowave 12mm T209 Ear tip Otowave 9mm T210 Ear tip Otowave 10mm T211 Ear tip Otowave 11mm T212 Ear tip Otowave...

Страница 36: ...ation 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...

Страница 37: ...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...

Страница 38: ...lines 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 H...

Страница 39: ...s than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 1 2 P 80MHz to 800MHz d 2 3 P 800MHz to 2 5GHz...

Страница 40: ...ave 102 Tympanometer is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the Otowave 102 Tympanometer can help prevent el...

Страница 41: ...ter uses an industry standard infra red means of communication an IrDA port in order to reduce any potential hazard associated with the use of mains powered equipment connecting to this interface Exte...

Страница 42: ...MEDICAL ELECTRICAL EQUIPMENT 37 D 0115690 C OM001 Otowave 102 Operating Manual Diagram 1 Otowave 102 used with the supplied printer Mains Outlet Printer via IrDA Link Printer Power Supply Otowave 102...

Страница 43: ...EDICAL ELECTRICAL EQUIPMENT 38 D 0115690 C OM001 Otowave 102 Operating Manual Diagram 2 Otowave 102 used with a computer IrDA Link Mains Outlet Computer via IrDA Link Computer Power Supply Otowave 102...

Страница 44: ...39 D 0115690 C OM001 Otowave 102 Operating Manual Copyright 2018 Amplivox Ltd All rights reserved No part of this publication may be reproduced or transmitted in any form or by any means without the...

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