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Table of Contents

1

Device description

2

Intended use

3

4

Installation

5

Powering the device

6

Connecting MADSEN Astera² to Otosuite

7

On-screen controls

8

PC keyboard controls

9

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

16 Technical specifications

17 Definition of symbols

18 Warning notes

19 Manufacturer

MADSEN Astera²

3

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Содержание Madsen Astera 2

Страница 1: ...MADSEN Astera User Guide Doc No 7 50 1350 EN 12 Part No 7 50 13500 EN...

Страница 2: ...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 2020 06...

Страница 3: ...12 8 PC keyboard controls 13 9 Toolbar icons in the Audiometry Module 13 10 The Sunshine Panel 15 11 Proper transducer placement 17 12 Performing tone audiometry 19 13 Performing speech audiometry 20...

Страница 4: ...and other information are shown on the PC mon itor 2 Intended use MADSEN Astera and the Audiometry module Users audiologists ENTs and other health care professionals in testing the hearing of their p...

Страница 5: ...4 Check the Test Report Calibration Certificate make sure that the transducers headphones and bone oscillator are the correct ones and that they comply with the ordered calibration standards 4 Install...

Страница 6: ...e back of MADSEN Astera with the rubber bands provided Remount the cable cover 1 Remount the cable cover by inserting the blue tags of the cable cover into the grooves of MADSEN Astera and swinging th...

Страница 7: ...e socket in the MADSEN Astera rear panel to the Operator desktop microphone socket in the ACP Operator monitor headset with boom microphone Connect the green cable in the cable bundle from the Operato...

Страница 8: ...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 It is a general rule for all electrical equipment used in the proxim...

Страница 9: ...10 feet Power up sequence with externally powered USB hub 1 Connect the externally powered USB hub to the mains socket and switch it on 2 Plug the single USB cable from the externally powered USB hub...

Страница 10: ...ra Reference Manual Connection panel MADSEN Astera The connections are located at the back of MADSEN Astera All four cables for connecting accessories are joined in a bundle and color coded for easy c...

Страница 11: ...cessories Operator desktop microphone Operator monitor headset with boom microphone 5 Powering the device MADSEN Astera is powered through an external power supply connected directly to the mains outl...

Страница 12: ...7 On screen controls Test controls provide a means of operating the audiometer if you use the mouse and on screen options to perform tests To enable test controls select Tools Options Audiometry Gene...

Страница 13: ...on the test function that you have selected Audiometry icons Tone audiometry Speech audiometry Menu item Icon Description Combined Audiogram Combined Audiogram Click to toggle between viewing both ear...

Страница 14: ...es the monitor speaker for monitoring stimuli presen ted to the patient from the Stimulus Stimulus or Masking Masking channel Desktop Headset Microphone Desktop Headset Microphone Toggle microphone ty...

Страница 15: ...shown in the Stimulus Stimulus bar and as symbols in the audiogram See also Performing tone audiometry 19 Performing speech audiometry 20 Customizing the Sunshine Panel You can customize the Sunshine...

Страница 16: ...ispeaker Multispeaker Masking Transducer Selection Masking Transducer Selection Click to select the transducer used for the masked ear Insert Insert earphones Phone Phone standard headphones High Freq...

Страница 17: ...11 Proper transducer placement Headphones 1 Loosen the headband and place both the left and right side of the headphones simultaneously Note If the headphones are not placed properly there is risk of...

Страница 18: ...masking is needed Mastoid placement 1 Move any hair covering the mastoid out of the way and place the flat round part of the bone oscillator securely on the boniest portion of the mastoid without any...

Страница 19: ...Reference Manual 1 Select the Tone Tone screen in the Otosuite Audiometry module 2 Prepare the patient If you wish to instruct the patient after you have placed the transducers on the head of the pati...

Страница 20: ...Mask button or M on the keypad Audiogram threshold MCL MCL and UCL UCL 9 Save the audiogram Caution If you are using white noise instead of the recommended narrow band noise in pure tone masking see...

Страница 21: ...test type 5 Select the stimulus level with the Up Down arrow buttons or on keypad 6 Select speech input signals You can choose from either microphone input or recorded input source Combining recorded...

Страница 22: ...ormally accompanied by a description of this relationship You should follow the instructions supplied with the speech materials using the VU meter in Otosuite for adjust ment of input gain If you are...

Страница 23: ...e a defective device 14 2 Cleaning There are no specific requirements to sterilization or disinfection of the device The device Remove dust using a soft brush Use a soft slightly damp cloth with a sma...

Страница 24: ...new calibration data on your system TeamViewer is located at Help Help Remote support Remote support The technician installs the calibration data via the menu function Tools Tools Audiometer service A...

Страница 25: ...ies 125 20000 Hz Tone accuracy 0 03 FRESH noise stimulus Available in entire frequency range within the transducer specified range for SF 125 12500 Hz Accuracy 0 3 Narrow Band Noise masking Available...

Страница 26: ...elect the attenuator setting required to obtain a specific level in dB SPL Table 2 Note As the sound pressure level of the white noise signal will be quite high even for moderate attenuator settings a...

Страница 27: ...C 10 to 120 dB HL 500 to 4000 Hz supra aural earphones BC 10 to 80 dB HL 1500 to 3000 Hz mastoid placement SF 103 dB HL Note with external amplifier Total harmonic distortion Air 2 5 Bone 5 Selectable...

Страница 28: ...al is pulsed Pulse duration 225 ms on and 225 ms off default Operator accessories Operator monitor speaker 1 5W 8 connected between tip and ring sleeve floating 3 5 mm jack Operator monitor headset he...

Страница 29: ...hPa Operation in temperatures exceeding 20 C 4 F or 60 C 140 F may cause permanent damage Warm up time 5 min Note Should be extended if MADSEN Astera has been stored in a cold environment Disposal MAD...

Страница 30: ...V UK PLUG 8 71 82700 POWER CABLE AUSTRALIA 8 71 86400 POWER CABLE CHINA 7 08 027 MAINS CORD H05VV CH PLUG 7 08 017 POWER CABLE SJ US HOSP PLUG Essential performance MADSEN Astera has no essential perf...

Страница 31: ...or Type USB device port Compliant 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 Operating environment Mode of opera...

Страница 32: ...IEC 60601 1 2 2007 and EN 60601 1 2 2007 IEC 60601 1 2 2014 and EN 60601 1 2 2015 16 3 Accessories Standard accessories and optional accessories may vary from country to country please consult your lo...

Страница 33: ...uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR11 Class A MADSEN A...

Страница 34: ...5 30 cycles Single phase at 0 Mains power quality should be that of a typical com mercial or hospital environment If the user of the MADSEN Astera requires continued operation during power mains inter...

Страница 35: ...ransmitters an electromagnetic site survey should be considered If the measured field strength in the location in which MADSEN Astera is used exceeds the applicable RF compliance level above the MADSE...

Страница 36: ...urposes Note The EMISSIONS characteristics of this equipment make it suitable for use in industrial areas and hospitals CISPR 11 class A If it is used in a residential environment for which CISPR 11 c...

Страница 37: ...stera should ensure that it is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Conducted RF IEC 61000 4 6 3 V rms 150 kHzto 80 MHz...

Страница 38: ...the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m Recommended separation distancesbetween portable and mobile RF communicationsequipment and MADSEN Astera The MADSEN Aste...

Страница 39: ...e Complies with Type B requirements of IEC60601 1 CE marking of conformity Certification mark that indicates conformity with applicable regulations and directives for the European Economic Area MEDICA...

Страница 40: ...nectors used in the MADSEN Astera audiometer Fig 2 Connectors isolated from patient transducers MADSEN Astera connection panel 18 2 General warning notes 1 MADSEN Astera is suitable for use in hospita...

Страница 41: ...ts on EMC accessories connected to the equipment s outlet fittings must be identical to the type supplied with the system 14 It is recommended that an annual calibration be performed on accessories co...

Страница 42: ...se of connected equipment in a patient environment Proof that connected equipment has been tested in accordance with IEC 60601 1 3rd AAMI ES60601 1 and CAN CSA C22 2 NO 60601 1 08 CAN CSA Do not touch...

Страница 43: ...e manufacturer reserves the right to disclaim all responsibility for the operating safety reliability and performance of equipment serviced or repaired by other parties MADSEN Astera 43 19 Manufacture...

Страница 44: ...19 Manufacturer 44 MADSEN Astera...

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