Related Manuals for OSCILLA T830
Summary of Contents for OSCILLA T830
- Page 1 T830 / T840 Screening Tympanometer User Guide Doc. No. 7-50-1810-EN/03 Part No. 7-50-18100-EN...
- Page 2 Copyright notice © 2016, 2017 Inmedico A/S. All rights reserved. Oscilla® is a registered trademark of Inmedico A/S in the U.S.A. and/or other coun- tries. Version release date 2017-10-31 (167384) Technical support Please contact your supplier. Inmedico A/S - T830/T840...
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Page 3: Table Of Contents
Intended use Unpacking Installation The probe and the contralateral phone Tympanometry testing using the device Testing using the Oscilla® AudioConsole software Tympanometry testing using AudioConsole Device setup using AudioConsole 10 Service, cleaning and calibration 11 Technical specifications 12 Standards and warnings... -
Page 4: Overview
Operating the device You can operate the device either as a stand-alone unit using the front panel buttons and display, or from the Oscilla® AudioConsole PC software. Note •... -
Page 5: Intended Use
If the patient suffers from acute trauma • If the patient experiences severe discomfort • If the patient displays symptoms of tinnitus or hyperacusis, in which case using excessively loud acoustic stimuli • for acoustic reflex measurements should be avoided. Inmedico A/S - T830/T840... -
Page 6: Unpacking
Storage or transportation at temperatures exceeding -20°C (-4°F) or +60°C (140°F) may cause permanent • damage to the device. Testing is facilitated by a moderately quiet room. A sound cabin or sound treated room is not necessary. Inmedico A/S - T830/T840... - Page 7 We recommend that you carry out a probe check daily to verify that the system measures correctly. Powering • Powering the device ► Oscilla® AudioConsole For a general introduction to Oscilla® AudioConsole, please see the Oscilla® AudioConsole User Manual (operator setup, database management, reports and data import/export). The connection panel T830/T840 A. On/Off switch B. PC/USB connection C.
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Page 8: The Probe And The Contralateral Phone
User Guide Connecting to the PC To connect the device to the PC, you must install Oscilla® AudioConsole on the PC. For instructions on installing AudioConsole, see the AudioConsole User Manual. Caution Use only the USB cable supplied with the device. - Page 9 1. Firmly push and twist the eartip onto the probe tip, until it rests firmly against the base of the probe tip. Removing the eartip • To remove the eartip, grasp the stem of the eartip and pull the eartip straight off the probe tip. Inmedico A/S - T830/T840...
- Page 10 Indicates that the air seal between the probe and the ear is not tight. The contralateral phone (T840 only) If you wish to test for the contralateral reflex, use the contralateral phone to present the stimulus to the non-probe ear. Inmedico A/S - T830/T840...
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Page 11: Tympanometry Testing Using The Device
Some ear canals may collapse and prevent the stimulus from entering the ear. In such cases either use the • insert phone or follow local recommendations. Tympanometry testing using the device The main screen The tympanometry main screen is shown on the display when you start up the device. Inmedico A/S - T830/T840... - Page 12 Indicates that probe tip is blocked (this may be caused by incorrect positioning of the probe in the ear). Leak Indicates that the air seal between the probe and the ear is not tight. Tymp Indicates that the tympanometric test is in process. Inmedico A/S - T830/T840...
- Page 13 You can save up to 200 measurements. Measurement IDs are numbered from 1 to 200. If the memory is full, you can use the Oscil- la®AudioConsole software, if available, for storing more measurements. Inmedico A/S - T830/T840...
- Page 14 Tympanometer settings In the menu, you can adjust and configure a number of settings. 2. Use the up/down arrow buttons to navigate, and Enter press the softbutton to select. Inmedico A/S - T830/T840...
- Page 15 User Guide Reflex levels If needed, adjust the reflex stimulus tones for ipsi- lateral and contralateral reflex tests and set the reflex sensitivity (T830 supports 500 to 3000 Hz). Reflex levels – Use the -/+ buttons to adjust the reflex levels from 80 to 110 dB HL.
- Page 16 If either of these messages is displayed, adjust the position of the probe slightly to continue the test. If the message Leak or Blocked reappears, remove the probe from the patient’s ear and start a new test. Remove 7. The status indicator shows when the test is completed by displaying the message Inmedico A/S - T830/T840...
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Page 17: Testing Using The Oscilla® Audioconsole Software
8. If needed, press the softbutton to select the other ear and repeat the test. Testing using the Oscilla® AudioConsole software With AudioConsole you can carry out measurements from the PC, save patient data in the AudioConsole patient database, generate customized PDF reports, and export data to most patient management systems. -
Page 18: Device Setup Using Audioconsole
To set up the device for tympanometry testing, see Setting up tympanometry testing Service, cleaning and calibration Warning Under no circumstances disassemble T830/T840. Contact your supplier. Parts inside T830/T840 must only • be checked or serviced by authorized personnel. Warning For the sake of safety and in order not to void the warranty, service and repair of electro-medical equip- •... - Page 19 We recommend that you set up a schedule for cleaning the device and accessories such as probes and/or earphones. Prerequisites • Before cleaning, switch off T830/T840 and disconnect it from any external power source. • If needed, unplug the contralateral phone from the device.
- Page 20 4. Dry the probe tip thoroughly. 5. Carefully fit the probe tip back on the probe. 10.1.3 The test cavities If a test cavity becomes contaminated, do not use it. Dispose of it and replace it with a new one. Inmedico A/S - T830/T840...
- Page 21 1. Make sure that the probe tip has been cleaned and disinfected, before you place it in the test cavity. This is to make sure that the probe tip does not influence the probe test, and that the test cavity is not contaminated. Inmedico A/S - T830/T840...
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Page 22: Technical Specifications
• If the probe is faulty, contact an authorized service department for repair. Technical specifications Type identification T830/T840 is type 1100 from Inmedico A/S Standards Safety: IEC 60601-1, UL 2601-1, CAN/CSA - C22.2 NO 601.1-90 ANSI/AAMI ES60601-1 + AMD 1, CAN/CSA-C22.2 No. 60601-1... - Page 23 5 dB Temporal characteristics Rise/fall time: 50 ms Stimulus On time: 460 ms Stimulus Off time: 860 ms On-Off ratio: 70 dB (for stimulus level > 95 dB HL) A weighted SPL in Off: < 25 dB Inmedico A/S - T830/T840...
- Page 24 Ambient temperature: -20°C (-4°F) or +60°C (140°F) Relative humidity: 90% or less (non-condensing) Air pressure: 700 hPa to 1060 hPa Disposal T830/T840 can be disposed of as normal electronic waste, according to WEEE and local regulations. Inmedico A/S - T830/T840...
- Page 25 T830/T840. Guidance and manufacturer's declaration - electromagnetic emissions for all equipment and systems T830/T840 is intended for use in the electromagnetic environment specified below. The user of T830/T840 should ensure that it is used in such an environment. Emissions test...
- Page 26 User Guide Guidance and manufacturer's declaration - electromagnetic immunity for all equipment and systems T830/T840 is intended for use in the electromagnetic environment specified below. The user of T830/T840 should ensure that it is used in such an environment. Immunity test...
- Page 27 TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which T830/T840 is used exceeds the applicable RF com- pliance level above, the T830/T840 should be observed to verify normal operation.
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Page 28: Standards And Warnings
Consult user manual for warnings and cautions. Consult user manual for warnings and cautions. Complies with Type B requirements of IEC60601-1. Complies with Medical Devices Directive 93/42/EEC. Complies with RoHS Directive (2011/65/EC). Inmedico A/S - T830/T840... - Page 29 1. This class of equipment is allowed in domestic establishments when used under the jurisdiction of a health care pro- fessional. 2. T830/T840 is intended for diagnostic and clinical use by audiologists and other trained health care professionals in test- ing the hearing of their patients.
- Page 30 Do not touch the output DC plug of the power supply or connectors of the device or connected devices and the patient at the same time. 22. To comply with IEC 60601-1(3rd) computer and printer must be placed out of reach of the client, i.e. not closer than approx. 1.5 meters/5 ft. Inmedico A/S - T830/T840...
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Page 31: Other References
User Guide Other references For instructions on installing Oscilla® AudioConsole, see the Oscilla® AudioConsole Manual. Manufacturer Inmedico A/S Johann Gutenbergs Vej 3, DK-8200 Aarhus N Denmark +45 86 74 26 22 www.oscillahearing.com support@oscillahearing.com 14.1 Responsibility of the manufacturer The manufacturer is to be considered responsible for effects on safety, reliability, and performance of the equipment only •... - Page 32 14 Manufacturer Inmedico A/S - T830/T840...
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Questions and answers
What is the cause of the problem and how to fix it
Common problems with the OSCILLA T830 include:
1. Probe error:
- Cause: The probe may be occluded or faulty.
- Fix: If occluded, clean the probe tip. If faulty, contact an authorized service department.
2. Calibration error:
- Cause: Incorrect placement or environmental changes.
- Fix: Ensure the probe is correctly placed in the test cavity and repeat calibration. Perform daily calibration, especially if humidity or altitude has changed.
3. Battery issue:
- Cause: Using the wrong battery type.
- Fix: Replace only with a non-rechargeable lithium/manganese dioxide CR2032 battery.
For all other issues, follow the user guide and service instructions, or contact authorized service personnel.
This answer is automatically generated
The device is on and the message device is not activated remains.
The OSCILLA T830 displays a "device is not activated" message when powered on because the device has not been registered with a valid license key in the Oscilla® AudioConsole software. When the device is first connected to a PC, AudioConsole detects it and prompts the user to enter the license key. Until this key is registered, the device remains inactive.
This answer is automatically generated
The device is on and the message device is not activated remains.
The OSCILLA T830 displays a "device is not activated" message when powered on because the device has not been registered with a valid license key in the Oscilla® AudioConsole software. The software automatically detects the device upon connection to a PC and prompts for a license key. If the key has not been entered or registered, the device remains inactive.
This answer is automatically generated
Can I get the lends for the machine typanometer