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Tremetrics RA660, Operation Manual

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Tremetrics RA660 Operation Manual Download Page 15

 

 

RA660 Operation Manual

 

 

8509790 Rev. 2 

13 

18/04/2018

 

 

2.11 Device Control 

The user of the instrument should perform a subjective instrument check once a day. 
For  performing  the  automatic  daily  Biological  in  order  to  verify  the  audiometer 
calibration using the integrated bio-acoustic simulator see section 5.6 

“Perform a Daily 

Biological

”. 

 
Annual  calibration  recommended.  Have  an  authorized  service  technician  perform 
electrical safety checks on the unit in order to maintain continued compliance to IEC 
and UL 60601-1. 

2.12  Operation 

The  instrument  should  only  be  handled  and  operated  by  trained  personnel 
(Audiologists, ENT doctors or personnel with similar qualifications). 
 

Summary of Contents for RA660

Page 1: ...RA660 Operation Manual RA660 PC based group audiometer...

Page 2: ...RA660 Operation Manual...

Page 3: ...ns without the prior written permission of MAICO The information in this publication is proprietary to MAICO Compliance MAICO Diagnostics GmbH is an ISO 13485 certified corporation Caution for USA Fed...

Page 4: ...y EMC 12 2 9 Warning Explosion 12 2 10 Measuring Security 12 2 11 Device Control 13 2 12 Operation 13 3 Warranty Care Maintenance 14 3 1 Warranty 14 3 2 Cleaning Disinfection 15 3 3 Use of Ear Tips be...

Page 5: ...ions 43 5 7 3 Room Monitor 44 5 7 4 Miscellaneous 45 5 7 5 Daily Biological 46 5 8 Reports 47 5 9 Room Monitor 48 5 10 Exporting and Importing Data 51 5 10 1 Exporting Data 52 5 10 2 Importing Data 53...

Page 6: ...e headphones independently The hearing test is suitable for subjects from 5 years to geriatric The RA660 is a modular system allowing up to 8 audiometers to be connected to a single USB port through t...

Page 7: ...eline Storage for audiograms Allows storage for large hearing conservation programs Reports Reports to help manage your hearing conservation program Who has been tested and is due for testing Who has...

Page 8: ...bels identify potentially dangerous or destructive conditions and procedures The WARNING label identifies conditions or practices that may present danger to the subject and or user The CAUTION label i...

Page 9: ...e Special Disposal Required Reference Number Type B Patient Applied Part According to IEC60601 1 Follow instructions for use Keep Dry Transport and Storage Temperature range Transport and Storage Humi...

Page 10: ...to the equipment and injury to the operator or subject The employer should instruct each employee in the recognition and avoidance of unsafe conditions and the regulations applicable to his or her wo...

Page 11: ...nents will perform reliably only when operated and maintained in accordance with the instructions contained in this manual accompanying labels and or inserts A defective product should not be used Mak...

Page 12: ...pulling the plug out of the power socket Do not position the instrument in a way that it is difficult to operate the disconnection device The supply mains and the power socket shall be accessible at a...

Page 13: ...ouching the PC and patient simultaneously A Separation Device isolation device is needed to isolate the equipment located outside the patient environment from the equipment located inside the patient...

Page 14: ...Users should consider the possibility of explosions or fire when using this device in close proximity to flammable anesthetic gases Do NOT use the RA660 in a highly oxygen enriched environment such a...

Page 15: ...r calibration using the integrated bio acoustic simulator see section 5 6 Perform a Daily Biological Annual calibration recommended Have an authorized service technician perform electrical safety chec...

Page 16: ...ranted only for the remaining unexpired portion of the original warranty This warranty shall not apply where goods have been subject to misuse neglect accident or improper application or have been rep...

Page 17: ...s are contaminated it is strongly recommended that you remove them from the transducer before they are cleaned To avoid person to person cross contamination of communicable diseases ear tips should on...

Page 18: ...it up and back to open and straighten the ear canal While holding the canal open slide the compressed foam ear tip into the ear canal The foam should be completely surrounded by the canal with virtual...

Page 19: ...ts listed in the packing list have been received in good condition The RA660 is a modular system the number of audiometers and associated accessories supplied will depend on the order The RA 660 comes...

Page 20: ...ing transport please wait until it has warmed to room temperature before using You shall also consider the influence of direct sunlight as well as the relative position to other devices that can produ...

Page 21: ...4 3 Set Up and Installation 4 3 1 RA660 Front View The picture below shows the device in the front view with the following features 1 Touch Screen and Color LCD 2 Right Coupler for bio acoustic simula...

Page 22: ...ormal operation Interface Connection to Interface Box Response yellow Connection for the patient response handswitch Phones L blue Connection for the blue headset plug for the left ear Phones R red Co...

Page 23: ...computer Power Power input 24 VDC Line In Talk forward line input Alternate talk forward input for a line level signal Not implemented in current software RA660 Interface Box connections back view Th...

Page 24: ...3 5 RA660 Interconnect Diagram Connect all the components as shown below Do not plug in the line cord untill all the componets are properly connected and you are instructed to due so in the software...

Page 25: ...and that the device has been installed and is ready to use The RA660 software now needs to be installed The RA660 software is supplied on the same USB memory stick that this manual is supplied on Use...

Page 26: ...ear showing all the connected RA660 audiometers and the status of each The example below shows 8 connected audiometers All the booths are active An audiometer can be made Active or Inactive be clickin...

Page 27: ...5 18 04 2018 5 Operating the RA660 5 1 Starting the RA660 Software The installation software placed a shortcut to the RA660 software on your desktop To start the program double click the shortcut The...

Page 28: ...base From the opening screen select the Utilities tab at the top of the screen and then select the Organization Levels icon The Organization Levels screen will open Click on the to the right of Compan...

Page 29: ...60 Operation Manual 8509790 Rev 2 27 18 04 2018 5 3 Enter Examiners The next thing that need to be done is create a list of examiners for this location Select the Examiners Icon at the top of the scre...

Page 30: ...miner name and click the Save box Repeat for each examiner When complete select one of the names and click the Set Default box to designate that examiner as the default When finished select Save and C...

Page 31: ...The minimum information required to enter a new employee are employee number birthday first name last name and sex When complete select Save at the bottom right side of the screen 5 5 Run a Test To r...

Page 32: ...0 18 04 2018 The audiometer Overview screen will open It is possible to run tests from this Overview screen or from the audiometer Details screen This example will use the Details screen Click on the...

Page 33: ...selected booth will open Click on Select an Employee to select an employee that is already in the database If the employee is not in the database click Add New Employee and enter the employee informa...

Page 34: ...elect New Test The automatic test will begin The test will contnue automatically after about four minutes the test will complete The test results will be displayed on the left and right audiograms and...

Page 35: ...ch RF 1 kHz Retest Error Failed 1 kHz validity The first ear fails the 1000 Hz retest This validity check is performed by testing each ear twice at 1000 Hz The thresholds must agree 5 dB If the RA 800...

Page 36: ...ck in the Employee Name and number field of the audiometer to be selected A drop down menu will appear From this drop down menu it is possible to start an individual audiometer with New Test or all th...

Page 37: ...e Talkover activates talkover only to the selected audiometer Talk Over All activates talkover to all audiometers From the Details screen talkover is activated with this icon Only talkover for the sel...

Page 38: ...ily Biological 5 6 1 Integrated Bio acoustic Simulator The RA660 has an integrated bio acoustic simulator which is an OSHA acceptable substitute for a human subject for performing the Daily Audiometer...

Page 39: ...RA660 Operation Manual 8509790 Rev 2 37 18 04 2018 2 From the Audiometrics Overview screen select the audiometer to be tested Select the Daily Checks button as shown below...

Page 40: ...test If the difference is greater than 5 dB there will be an error message displayed In this case reseat the headphones and rerun the test 5 6 3 The Listening Check The second and equally important pa...

Page 41: ...RA660 Operation Manual 8509790 Rev 2 39 18 04 2018 RA660 Daily Listening Check Screens...

Page 42: ...RA660 Operation Manual 8509790 Rev 2 40 18 04 2018 3 Back at the PC select Save and Close on the Daily Biological window The Daily Biological window closes and the Daily Biological is complete...

Page 43: ...in the Employee Name and number field of the audiometer to be selected A drop down menu will appear From this drop down menu it is possible to start a Daily Biological on an individual audiometer with...

Page 44: ...ts Other allows custom test parameters 2 Language Selects language for voice prompts 3 End of Test Message Turns on the End of Test voice prompt 4 Idle Tone at End of Test Continues to present test to...

Page 45: ...s the automatic intensity decrease 12 Optional Frequencies Allows frequencies to be turned off 5 7 1 Retest Options The RA660 will go back and retest frequencies for any of the enabled conditions belo...

Page 46: ...50 or 500 Hz a retest will occur 5 Retest if difference from baseline 15 dB if a baseline is present and the current threshold differ by 15 dB or more a retest occurs 5 7 2 Room Monitor Pause Testing...

Page 47: ...ions window at the start of a test 2 Provide General Questions Enables general employee questions 3 Provide Employee History Questions Enables employee history questions 4 Allow Reordering of Audiomet...

Page 48: ...ck is required as part of the Daily Biological test 2 Require Daily Biological Per Day When enabled a Daily Biological Test must have been completed in the past 24 hours to begin a new test 3 Auto Pri...

Page 49: ...tested employees 2 Audio Listing a list of tests for the selected employee 3 Notifications current test report for the selected employee 4 STS Change a list of employees with a Standard Threshold Shi...

Page 50: ...m monitor feature also requires a Room Monitor License This license key is entered into the RA660 the room monitor microphone is plugged into The microphone has to be plugged into the RA660 with the l...

Page 51: ...n the drop down menu box and select the RA660 audiometers to be in the zone One of the RA660 audiometers in the group must have a room monitor microphone plugged in and licensed To create additional z...

Page 52: ...ev 2 50 18 04 2018 Example of two zones ZONE 1 RA660 1 4 ZONE 2 RA660 5 8 The measurement results are displayed on the Details screen of each RA660 in the zone The results are displayed as a bar graph...

Page 53: ...is set in the Setting Room Monitor screen Also on this screen is the Pause Testing If Over Limits switch If this switch is on the audiometers will automatically pause the test if the room noise excee...

Page 54: ...atabase information It will display the Record and Employee count for verification of the data Under Step 2 enter a location to export the data The Browse button can be used to find a location Under S...

Page 55: ...be used to verify all the data has correctly loaded If the data counts look correct go to Step 3 and click on Import to Current Database or Import to New Database to import the data 5 11Wall Mount Kit...

Page 56: ...RA660 Operation Manual 8509790 Rev 2 54 18 04 2018...

Page 57: ...irective MDD to comply with EC Directive 93 42 EEC Test Frequencies 250 Hz 8000 Hz Maximum Test Levels 100 dBHL 250 Hz 8000 Hz 90 dBHL IP 30 6 kHz 8 kHz Headset AC with Earphone TDH 39P or DD45 Insert...

Page 58: ...H 210 mm x 110 mm x 35 mm Weight Audiometer 5 kg Interface Box 4 kg Power Supply ONLY UE60 240250SPA3 Fuhua Electronic 100 V 240 V 50 60 Hz Power Consumption 60 W maximum 6 2 Audiometer Connections CO...

Page 59: ...ght Subject response 6 3 mm Stereo Signal One Wire ID Ground Room Monitor Microphone 3 5 mm Stereo Signal Bias One Wire ID Ground USB In 5 VDC Data Data Ground INTERFACE RJ45 Socket RJ45 Cable Plug 1...

Page 60: ...FICATION Mic In ZI 3 k UI 0 5 50 mVeff USB in USB 2 0 Power In 24 VDC Line In ZI 10 k UI 50 500 mVeff Audiometer 1 8 Custom SOCKET CONNECTOR PIN 1 PIN 2 PIN 3 PIN 4 Mic In 3 5 mm Stereo Signal Bias Gr...

Page 61: ...ta 7 Power 8 Ground 6 4 Sound Attenuation for Headphones Sound Attenuation for Earphones per ISO 4869 1 Frequency Hz Attenuation TDH39 DD45 with MX41 AR or PH51 Cushion dB EAR Tone 3A IP30 inserts dB...

Page 62: ...00 13 0 100 750 6 5 100 1000 6 0 100 1500 8 0 100 2000 8 0 100 3000 8 0 100 4000 9 0 100 6000 20 5 100 8000 12 0 100 6 6 Calibration values and Max Levels Headphone TDH 39P Coupler IEC 60318 3 Force 4...

Page 63: ...s Insert phone RADIOEAR IP 30 Coupler IEC 60318 5 ISO 389 2 1994 or ANSI S3 6 2010 FREQUENCY TONE RETSPL MAX TONE IEC 60318 5 RE 20 PA HZ DB DBHL 250 14 0 100 500 5 5 100 750 2 0 100 1000 0 0 100 1500...

Page 64: ...ransducers and cables can be found in this appendix Portable RF communications equipment including peripherals such as antenna cables and external antennas should be used no closer than 30 cm 12 inche...

Page 65: ...ent in which radiated RF disturbances are controlled The customer or the user of the RA660 can help prevent electromagnetic interferences by maintaining a minimum distance between portable and mobile...

Page 66: ...l mode 2 kV common mode 1 kV differential mode 2 kV common mode Mains power quality should be that of a typical commercial or residential environment Voltage dips short interruptions and voltage varia...

Page 67: ...2 800 MHz to 2 5 GHz 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 meters m Field...

Page 68: ...80 MHz field strengths should be less than 3 V m To ensure compliance with the EMC requirements as specified in IEC 60601 1 2 it is essential to use only the following accessories ITEM MANUFACTURER M...

Page 69: ...RA660 Operation Manual 8509790 Rev 2 67 18 04 2018 7 Appendix Export Import Formats 7 1 Export Data Format...

Page 70: ...RA660 Operation Manual 8509790 Rev 2 68 18 04 2018...

Page 71: ...RA660 Operation Manual 8509790 Rev 2 69 18 04 2018 7 2 Import Data Format...

Page 72: ...ghly from 20 to 20000 Hz The word audio may be used as a modifier to indicate a device or system intended to operate at audio frequencies for example audio amplifier Audiogram A test printout showing...

Page 73: ...f parameters at a specific point in time in order to define existing conditions and variations with time Baud rate Data transmission speed in events per second C C Degree Celsius Calibration The elect...

Page 74: ...o doing The decibel is one tenth of a bel DC Direct Current Dosimeter A device worn on the person for determining the accumulated sound exposure with regard to level and time DS Data System Dynamic ra...

Page 75: ...ing loss originating in the conductive mechanism of the ear Sensori Neural A hearing loss originating in the cochlea or the fibers of the auditory nerve Formerly called perceptive deafness Noise Induc...

Page 76: ...on The term noise control is meaningful only when noise control components and the points of observation are fully specified O Ohm Outer ear The outermost portion of the hearing mechanism filled with...

Page 77: ...iscous or the superposition of such propagated oscillations In case of possible confusion the term sound wave or elastic wave may be used for concept b and the term sound sensation for concept a Not a...

Page 78: ...ss is recovered during an arbitrary period of time when one is on longer subjected to the noise Test printout See audiogram Threshold In audiology the least audible sound pressure level Often defined...

Page 79: ...al 8509790 Rev 2 77 18 04 2018 Specifications are subject to change MAICO Diagnostics GmbH Sickingenstr 70 71 10553 Berlin Germany Tel 49 30 70 71 46 50 Fax 49 30 70 71 46 99 E mail sales maico biz In...

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