AmpliVox CA850 series 5 Скачать руководство пользователя страница 32 | Manualshive

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TECHNICAL SPECIFICATION

29

OM033-4 - CA850 Series 5 Operating Manual

Equipment mobility

Portable

The CA850 audiometer is classified as a Class IIa device under Annex IX of the EU Medical Devices Directive.
It is intended for transient use as a screening audiometer instrument.

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Содержание CA850 series 5

Страница 1: ...CA850 Series 5 Audiometer Operating Manual 12 December 2017 CA850 Series 5 Automatic Audiometer Operating Manual...

Страница 2: ...s manual is valid for the CA850 Series 5 applies from firmware version 0V56 onwards see Setup screen This product is manufactured by Amplivox Ltd 6 Oasis Park Eynsham Oxfordshire OX29 4TP United Kingd...

Страница 3: ...RESPONSE SWITCH 7 3 4 USING THE TALKOVER FUNCTION 7 3 5 TEST TYPES AVAILABLE 7 3 6 USING AUDIOMETRIC DATA 8 4 AUDIOMETRY PREPARATION 9 4 1 AMBIENT CONDITIONS 9 4 2 TEST SYSTEM ARRANGEMENT 9 4 3 HEADS...

Страница 4: ...NG CATEGORISATION 27 13 TECHNICAL SPECIFICATION 28 13 1 INPUT OUTPUT 28 13 2 AUDIOMETRIC 28 13 3 EARPHONE SOUND ATTENUATION CHARACTERISTICS 28 13 4 OTHER FEATURES 28 13 5 PHYSICAL ENVIRONMENTAL 28 13...

Страница 5: ...wed by printing and or saving the results may be accomplished easily 1 2 UNPACKING INSTRUCTIONS Open the shipping carton and carefully remove all the equipment Check against the delivery note that all...

Страница 6: ...n 13 Do not attempt to open modify or service the instrument Return the instrument to the manufacturer or distributor for all repair and servicing requirements Opening the instrument will void the war...

Страница 7: ...use only No user access permitted USB PC USB Connector Type B Slave Computer via USB port See 2 6 The relevant part numbers are indicated in Section 17 For connected parts marked only connect the acc...

Страница 8: ...AL INFORMATION Amplivox Limited is fully compliant with the WEEE Waste Electrical and Electronic Equipment Regulations Our PRN Producer Registration Number is WEE GA0116XU and we are registered with t...

Страница 9: ...panel layout No warm up time is required but the instrument will load and run a diagnostic check which will take a few seconds to perform To switch off press the key again and then the Switch off sof...

Страница 10: ...upon the criteria selected for recording a threshold see Section 11 2 9 the instrument will record a threshold at that particular frequency The next test frequency is then used in the same way and so...

Страница 11: ...nt number which should be uniquely assigned to each patient 3 6 3 Exporting test results Audiometric and patient data may be transferred to a computer running the Amplivox Audibase database software o...

Страница 12: ...erator as shown The patient is seated in front of the desk facing away from the operator The patient wears a headset see Section 4 3 and responds to test stimuli by use of a hand held switch which is...

Страница 13: ...quency for both ears 5 3 BEKESY AND COMPUTER TESTING If necessary switch between these test methods as described in Section 11 2 3 Press the Run Test softkey and then press a softkey to specify a test...

Страница 14: ...the manual test keys are operated the audiometer will assume a mixed test mode has been entered and will adjust the display accordingly To ensure exit from the mixed mode of testing use Erase This tes...

Страница 15: ...to retry the same frequency skip to the next frequency or cancel the test If the test is cancelled then any thresholds that have been established will be retained 6 3 INCONSISTENT RESPONSE FROM PATIE...

Страница 16: ...OPERATIONAL DIAGRAM 13 OM033 4 CA850 Series 5 Operating Manual 7 OPERATIONAL DIAGRAM...

Страница 17: ...st be in the TEST mode When first powered up the audiometer enters TEST mode and displays the Audiogram page see Section 9 3 This is to allow the operator to perform the checks necessary to confirm th...

Страница 18: ...ormation about a patient the patient details page is used see below Patient details are added or modified by using the and keys to select the required line and then using the keyboard to enter the det...

Страница 19: ...ove the LEFT or RIGHT key will illuminate 9 3 1 4 Cancel Pressing the Cancel softkey will cancel the Run Test function 9 3 1 5 Familiarise When the test selection has been made the option to run a fam...

Страница 20: ...ave been omitted from the test see Section 11 2 6 the key may be used to skip over these data fields Refer to Section 9 5 for details of how to enter patient details and previous data and then immedia...

Страница 21: ...s test refer to Section 9 4 if necessary these are entered in the Current columns Please pay particular attention to the following steps h Once the final threshold has been entered for example Right e...

Страница 22: ...o the Previous column If incorrect data has been entered at step g then the record may be erased using the database functions see Section 10 4 8 and the above steps may be repeated The re test at step...

Страница 23: ...er to Section 10 4 7 for details of how to perform this operation For additional security access to the database is possible only by entering a five digit security passcode which is unique to each aud...

Страница 24: ...s on a single audiogram See also the example in Section 10 5 The original record in the internal database is not changed in any way 10 4 2 Get record Having moved the cursor to the required test recor...

Страница 25: ...nter amend the parameter within the brackets so that that the parameter matches the requirement i e SMITH Press the OK softkey The records within the internal database that are identified as Smith wou...

Страница 26: ...atabase will always be named exportdata cry and will be associated with this password Similarly if a 16 character password is entered USB import will always search for a file named exportdata cry and...

Страница 27: ...urrent patient from the Patient Details page press New Person b In TEST mode erase details of any current test from the Audiogram page press Erase and then This test c In DATABASE mode select the requ...

Страница 28: ...between Bekesy and Computer test as the default automatic test routine 11 2 4 Retries If a hearing threshold level is not established in Bekesy or Computer test mode this option will enable an automa...

Страница 29: ...ntinuous 11 2 11 Plot Previous When set to Yes the results of any previous test are plotted on the Audiogram page when set to No these results are not plotted although they are still presented on the...

Страница 30: ...arned about hearing ability or referred for further medical advice For detail of the derivation and application of these categories the user operator is referred to the regulations As long as the requ...

Страница 31: ...ic force 4 5N 13 3 EARPHONE SOUND ATTENUATION CHARACTERISTICS Frequency Hz 125 250 500 1000 2000 4000 8000 Attenuation dB 2 5 7 15 25 31 23 13 4 OTHER FEATURES a Keyboard Standard layout for data entr...

Страница 32: ...A850 Series 5 Operating Manual Equipment mobility Portable The CA850 audiometer is classified as a Class IIa device under Annex IX of the EU Medical Devices Directive It is intended for transient use...

Страница 33: ...l 14PERFORMANCE STANDARDS The CA850 Audiometer complies with the relevant parts of following standards a IEC 60601 1 plus UL CSA EN deviations Safety and Essential Performance b IEC 60601 1 2 Electrom...

Страница 34: ...rent and patient auxiliary current Definition The output from the Mains AC adaptor is Direct Current The applied parts are the left right earphones patient response switch and the associated cables De...

Страница 35: ...used with a recognised disinfectant e g a Mediswab During the cleaning process do not allow moisture to enter the earphone or other parts of the instrument 16 3 MAINS ADAPTER MAINTENANCE Before use c...

Страница 36: ...only guaranteed against faulty materials or manufacture 16 6 DISPOSAL OF INTERNAL BATTERY At the end of the life of a CA 850 audiometer the internal battery needs to be removed and disposed of separat...

Страница 37: ...DD45 A030 Headset lead BC0004 Carrying case A091 7 Approved mains adapter see Section 2 3 A085 Patient response switch C017 Audiogram paper pack of 250 A073 Booth Leads HP200 Hewlett Packard OfficeJe...

Страница 38: ...e extension back to exe As freeware Amplivox provides no warranty implied or otherwise regarding this software and will not be liable for any aspect or consequences of its copying or use on a 3rd part...

Страница 39: ...anged to exportdata cry before importing to the CA850 Next enter a 16 character alphanumeric password pass phrase which will be used to encrypt the file This password will be uniquely associated with...

Страница 40: ...e after exporting data from the CA850 Encrypted data that has been exported from the CA850 will initially reside on a USB memory stick although it may be copied to any convenient location on a compute...

Страница 41: ...uired to use this file with Audibase immediately it should be named exportdata csv as above Otherwise the filename can be set as something more meaningful but it must be changed to exportdata csv befo...

Страница 42: ...be created in the selected location This file may then be imported to Audibase after renaming to exportdata csv if necessary as described in the Audibase operating manual A1 4 Error Conditions If the...

Страница 43: ...er encrypting or decrypting a file the following message is displayed If the destination file is already open or in use the following message is displayed If an incorrect 16 character alphanumeric pas...

Страница 44: ...ssions test Compliance Electromagnetic environment guidance RF emissions CISPR 11 Group 1 The CA850 Audiometer uses RF energy only for its internal function Therefore its RF emissions are very low and...

Страница 45: ...tal environment Voltage dips short interruptions and voltage variations on power supply input 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 fo...

Страница 46: ...terference 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...

Страница 47: ...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 800 MHz d 1 2 P 800 MHz to 2 5 GHz d 2 3 P 0 01 0...

Страница 48: ...onnected to these inputs and outputs Socket Identification Socket Type Socket Function Typical Connection USB PRINTER USB Type A Master USB device connection Printer USB Drive USB PC USB Type B Slave...

Страница 49: ...approved mains adapter and printer Mains Outlet Medical Mains Adapter CA850 Audiometer Mains Outlet Printer Power Printer via USB Supply PRINTER Socket Diagram 3 CA850 used with the medically approve...

Страница 50: ...MENT 47 OM033 4 CA850 Series 5 Operating Manual Copyright 2017 Amplivox Ltd All rights reserved No part of this publication may be reproduced or transmitted in any form or by any means without the pri...

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