natus Madsen Astera 2 User Manual
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natus Madsen Astera 2 User Manual

natus Madsen Astera 2 User Manual

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MADSEN Astera²
User Guide
Doc. No.7-50-1350-EN/12
Part No.7-50-13500-EN

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Summary of Contents for natus Madsen Astera 2

  • Page 1 MADSEN Astera² User Guide Doc. No.7-50-1350-EN/12 Part No.7-50-13500-EN...
  • Page 2 Copyright notice © 2013, 2020 Natus Medical Denmark ApS. All rights reserved. ® Otometrics, the Otometrics Icon, Aurical, Madsen, HI-PRO 2, Oto- scan, ICS and HORTMANN are registered trademarks of Natus Medical Denmark ApS in the U.S.A. and/or other countries. Version release date...

  • Page 3: Table Of Contents

    Table of Contents Device description Intended use Unpacking Installation Powering the device Connecting MADSEN Astera² to Otosuite On-screen controls PC keyboard controls Toolbar icons in the Audiometry Module 10 The Sunshine Panel 11 Proper transducer placement 12 Performing tone audiometry 13 Performing speech audiometry 14 Service, cleaning and calibration 15 Other references...

  • Page 4: Device Description

    1 Device description Device description MADSEN Astera² is a PC-controlled audiometer for testing a person's hearing.The audiometer is operated from the Oto- suite Audiometry Module PC software. With MADSEN Astera² you can perform all standard audiometric tests, tone and speech audiometry and special tests. •...

  • Page 5: Unpacking

    3 Unpacking To obtain a free printed copy of the user documentation, contact Natus Medical Denmark ApS (www.natus.com). Unpacking 1. Unpack the device carefully. When you unpack the device and accessories, it is a good idea to keep the packing material in which they were delivered.
  • Page 6 4 Installation 2. Lift off the cable cover. Connect accessories Connecting accessories to MADSEN Astera² ► Connect the ACP If you are using the ACP: Connecting the ACP to MADSEN Astera² ► Connecting the ACP to the PC ► Secure cables to MADSEN Astera² 1.
  • Page 7 4 Installation Connecting the ACP to MADSEN Astera² Caution Install Otosuite on the PC before you connect to MADSEN Astera² from the PC. • 1. Remove the cable cover from MADSEN Astera². 2. Connect the ACP to the MADSEN Astera² connection panel.
  • Page 8 4 Installation Connecting the ACP to the PC The ACP is powered from the PC through a USB connection. Caution Install Otosuite on the PC before you connect the ACP to the PC. • Caution To connect the ACP to the PC, use the supplied USB cable. The cable length must not exceed 3 •...
  • Page 9 4 Installation Direct connection to PC using single USB cable Caution Make sure that the total length of the USB cable used for connecting the ACP to the PC does not exceed 3 • meters (10 feet). 1. Unfold the feet of the ACP. 2.
  • Page 10 4 Installation The following applies only when used with the specified power supply, External power supply, Delta Elec- tronics Inc., type MDS-090AAS24: The installation must be carried out in accordance with Medical Electrical Systems clause 16 in IEC 60601-1 (3rd), AAMI ES60601-1 and CSA C22.2 NO. 60601-1-08-CAN/CSA. The supplementary provisions on the reli- ability of electro-medical systems.

  • Page 11: Powering The Device

    5 Powering the device Caution When you connect other electrical equipment to MADSEN Astera², remember that equipment that does not • comply with the same safety standards as MADSEN Astera² can lead to a general reduction in the system's safety level.

  • Page 12: Connecting Madsen Astera² To Otosuite

    6 Connecting MADSEN Astera² to Otosuite Switching off MADSEN Astera² 1. To switch off MADSEN Astera², disconnect the power supply from the mains outlet. Connecting MADSEN Astera² to Otosuite When you use MADSEN Astera² for the first time, run the Configuration Wizard to set up the connection between MADSEN Astera²...

  • Page 13: Pc Keyboard Controls

    8 PC keyboard controls PC keyboard controls You can open a separate PDF-file to have a proper view of the keyboard short- cuts. After you install Otosuite, you can find Otosuite manuals and related doc- Start Otosuite Manuals umentation on your PC. In the (Start) menu, open which contains an overview with links to all manuals.
  • Page 14 9 Toolbar icons in the Audiometry Module Menu item Icon Description The graph shows up to 20,000 Hz. MADSEN Astera² presents stimulus Standard Frequencies up to 12,500 Hz. (Standard All Fre- Frequencies)/ • Click to choose between viewing: quencies (All Fre- Standard Frequencies (Standard Frequencies) High...

  • Page 15: The Sunshine Panel

    10 The Sunshine Panel The Sunshine Panel Control Panel Click the (Control Panel) icon in the toolbar to activate the Control Panel. Sunshine Panel Click the (Sunshine Panel) icon in the toolbar to select or deselect the Sunshine Panel in either Tone (Tone) or...
  • Page 16 10 The Sunshine Panel Function Icon Description Stimulus Ear Selection Click to select test ear: (Stimulus Ear Selec- Right • (Right) tion) Binaural • (Binaural) Left • (Left) Transducer Selection Click to select the transducer used for the test ear: (Transducer Selection) •...

  • Page 17: Proper Transducer Placement

    11 Proper transducer placement Function Icon Description Curve Selection (Curve Click to select the curve type: Selection) • (THR) (Threshold level) (Tone) • (MCL) (Most Comfortable Loudness level) • (UCL) (Uncomfortable Loudness level) • (SDT) (Speech Detection Threshold) (Speech) • (SRT) (Speech Recognition Threshold) (Speech) WRS/SRS •...
  • Page 18 11 Proper transducer placement 2. It is best to clip the insert earphone transducers behind the child or on the back of their clothing and then fit the foam eartip into the child's ears. Bone Oscillator Note For unmasked bone thresholds, you can store binaural data: •...

  • Page 19: Performing Tone Audiometry

    12 Performing tone audiometry Performing tone audiometry Sunshine Panel A. Ear selection B. Stimulus transducer C. Masking, transducer and On/Off D. Stimulus type Test type Talk Forward dialog G. Monitor/Level H. Test Selector Classic Control Panel A. Control Panel B. Test Options panel C.

  • Page 20: Performing Speech Audiometry

    13 Performing speech audiometry Store 7. Use the (Store) button (the S key on the keypad) to store the data point and proceed to the next frequency. 8. Repeat steps 4 to 7 until all the measurements you need have been completed. If needed, did you test: –...
  • Page 21 13 Performing speech audiometry Classic Control Panel A. Control Panel B. Test Options panel C. Monitor/Level panel Whenever the test buttons and other functions are used, you can use the corresponding keys on the keyboard, or the on- screen controls located at the top of the screen or in the Control Panel to the left. For detailed examples of audiometric testing, see the MADSEN Astera²...
  • Page 22 13 Performing speech audiometry range 250 to 4000 Hz. The headset microphone should be turned to a position just below the operator’s mouth. If an external playback device is used to generate speech stimuli via the line input of MADSEN Astera², only a high quality CD player or similar device should be used;...

  • Page 23: Service, Cleaning And Calibration

    14 Service, cleaning and calibration If the patient is exposed to excessive levels of noise during the session, the system will interrupt the signal and display a warning. (1) Noise Exposure: Explanation of OSHA and NIOSH Safe.Exposure Limits and the Importance of Noise Dosimetry by Patricia A.

  • Page 24: Other References

    15 Other references Disposal There are no special requirements for the disposal of eartips, i.e. they can be discarded according to local regulations. 14.3 Calibration Annual calibration The audiometer, headphones, bone oscillators, and sound field speakers must be calibrated once a year by your authorized service department.

  • Page 25: Technical Specifications

    16 Technical specifications Technical specifications 16.1 MADSEN Astera² Type identification MADSEN Astera² is type 1066 from Natus Medical Denmark ApS. Channels Two separate and identical channels Frequency range TDH39 earphones: Standard frequencies: 125 - 12500 Hz HDA 300 earphones: Standard frequencies: 125 - 20000 Hz Insert earphones: Standard frequencies: 125 - 8000 Hz...
  • Page 26 16 Technical specifications Masking types • Narrow Band Noise Correlated – AC and BC Non-correlated – • Speech Weighted Noise Correlated – AC and BC Non-correlated – • White Noise (Wide band noise) Correlated – AC and BC Non-correlated – A.
  • Page 27 16 Technical specifications Stimulus modulation FM (Warble): Adjustable modulation rate and depth • Modulation rate: 1-20 Hz (default: 5 Hz). • Modulation depth: 1-25% of center frequency (default: 5%). SISI: 5, 2, 1 dB increments Accuracy of sound level Entire level range (AC): 125 to 5000 Hz: ±3 dB 5000 to 20000 Hz: ±5 dB Entire level range (BC):...
  • Page 28 16 Technical specifications SF power output: 5 x terminals, Ω 5 x 40 W peak, 8 load SF line output: 3 x mini XLR 6 pin 5 x +6 dBu, balanced External inputs Ω CD/Analog line in: 0.2 to 2.0 Vrms, 10 k 2 x RCA phone Talk Back microphone: •...
  • Page 29 16 Technical specifications USB port connector Type: USB device port Interface: USB 2.0 Speed: Full-speed (12 Mb/s) Transport and storage Temperature: -30°C to +60°C (-22°F to 140°F) Air humidity: 10% to 90%, non-condensing Air pressure: 500 hPa to 1060 hPa Operating environment Mode of operation: Continuous...
  • Page 30 16 Technical specifications Patient Safety when used with the specified power supply, Delta Electronics, Inc., type MDS-090AAS24: • Complies with IEC 60601-1 (3rd), Class 1, Type B; AAMI ES60601-1; CSA C22.2 NO. 60601-1-08-CAN/CSA. • EMC: IEC 60601-1-2 XP Power Output: 24 V DC, 3.33 A max PCM80PS24 Input: 100-240 V AC, 47-63 Hz, 1.1 A - 0.45 A Patient Safety when used with the specified power supply, XP Power, type...
  • Page 31 16 Technical specifications 16.2 Outputs Ω Monitor headphone 3.5 mm jack (32 Boom microphone 3.5 mm jack Desktop microphone 3.5 mm jack Inputs Ω Monitor headphone 3.5 mm jack (32 Boom microphone 3.5 mm jack Desktop microphone 3.5 mm jack Ω...
  • Page 32 16 Technical specifications Dimensions Approx. 410 x 290 x 36 mm (16.1 x 11.4 x 1.4 inches) Weight Approx. 2.1 kg (4.6 lb) Power supply No external power supply. Supplied by the USB (5 V). Note If you are using a USB hub, use a powered USB hub.
  • Page 33 16 Technical specifications • Power supply and mains cable • Wall mounting plate • Connection cables • Aurical® FreeFit • MADSEN Astera² Reference Manual • MADSEN Astera² User Guide • USB cables • Wrist support 16.4 Notes on EMC (Electromagnetic Compatibility) • MADSEN Astera² is part of a medical electrical system and is thus subject to special safety precautions. For this reason, the installation and operating instructions provided in this document should be followed closely.
  • Page 34 16 Technical specifications Electrostatic discharge (ESD) +/- 8 kV contact +/- 8 kV contact Floors should be wood, concrete or ceramic tile. If floors IEC 61000-4-2 +/- 2 kV, +/- 4 kV, +/- 2 kV, +/- 4 kV, are covered with synthetic material, the relative humid- +/- 8 kV, +/- 15 kV air +/- 8 kV, +/- 15 kV air ity should be at least 30 %.
  • Page 35 16 Technical specifications Proximity fields from RF wireless com- 27 V/m 27 V/m Separation distance between any electronic munications 385 MHz 385 MHz parts of MADSEN Astera² and any RF wireless IEC 61000-4-3 communication equipment must be more 28 V/m 28 V/m than 30 cm (11.8 inches).
  • Page 36 16 Technical specifications For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equa- tion applicable to the frequency of the transmitter, where is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
  • Page 37 16 Technical specifications Voltage dips, short inter- Mains power quality should be that of a typical commercial or <5 % U (>95 % dip in U <5 % U (>95 % dip in U ruptions and voltage vari- for 0.5 cycle for 0.5 cycle hospital environment.
  • Page 38 16 Technical specifications a. The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6.765 MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40,70 MHz. b. The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2.5 GHz are intended to decrease the likelihood that mobile/portable communications equipment could cause interference if it is inadvertently brought into patient areas.

  • Page 39: Definition Of Symbols

    This requirement applies in the European Union. Do not dispose of these products as unsorted municipal waste. You can return your device and accessories to Natus Medical Denmark ApS, or to any Natus Medical Denmark ApS supplier. You can also contact your local authorities for advice on disposal.
  • Page 40 18 Warning notes Definition of symbols ► Connector warning notes ► General warning notes ► 18.1 Connector warning notes Warning Never mix connections between the two types of connectors shown below: • Direct connectors • All connectors within the red frame are connected directly to patient transducers. Fig.
  • Page 41 18 Warning notes 5. For the sake of safety and in order not to void the warranty, service and repair of electro-medical equipment should be carried out only by the equipment manufacturer or by service personnel at authorized workshops. In case of any defects, make a detailed description of the defect(s) and contact your supplier.

  • Page 42: Manufacturer

    1.5 meters/5 ft. 23. Do not touch non-medical parts, such as the laptop/computer or printer and the patient at the same time. Manufacturer Natus Medical Denmark ApS Hoerskaetten 9, 2630 Taastrup Denmark +45 45 75 55 55 www.natus.com...
  • Page 43 19 Manufacturer The manufacturer reserves the right to disclaim all responsibility for the operating safety, reliability and performance of equipment serviced or repaired by other parties. MADSEN Astera²...
  • Page 44 19 Manufacturer MADSEN Astera²...

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