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EC 60601-1,
Reference
no. Table
D.2, Safety
sign 10 (ISO
7010-M002)

Medical electrical equipment
— Part 1: General require-
ments for basic safety and
essential performance.

Follow instructions
for use

Refer to instruction
manual/ Booklet.

NOTE on ME EQUIPMENT
"Follow instructions for
use”

ISO 7000

Reference
no. 0623

Graphical symbols for use on
equipment - registered sym-
bols

This way up

N/A

Directive
2012/19/EU

Waste Electrical and Elec-
tronic Equipment (WEEE)

Disposal at end of
operating life
instructions

Indicates that electrical
and electronic waste
equipment waste should
not be discarded together
with unseparated waste
but must be collected sep-
arately.

An indication of
Medical device

The product is a medical
device.

21 CFR Part
801.109(b)(1)

Labeling-Prescription devices.

Prescription only

Indicates the product is
authorized for sale by or
on the order of a licensed
healthcare practitioner.

UL Listing

N/A

Nationally Recognized
Testing Laboratories
(NRTL) certifications

Madsen A450

17 Definition of symbols

Содержание Madsen A450

Страница 1: ...Madsen A450 User Guide Doc No 7 50 1830 EN 06 Part No 7 50 18300 EN...

Страница 2: ...Natus the Natus Icon Aurical Madsen HI PRO 2 Otoscan ICS and HORTMANN are registered trademarks of Natus Medical Denmark ApS in the U S A and or other countries Version release date 2021 06 01 221163...

Страница 3: ...8 Control panels and on screen controls 10 9 Toolbar icons in the Audiometry Module 15 10 PC keyboard controls 16 11 Proper transducer placement 16 12 Performing tone audiometry 17 13 Performing speec...

Страница 4: ...Madsen A450 4...

Страница 5: ...atients in all age groups who are able to respond to the stimuli User Environment Professional healthcare facility environment The system is intended for use in a quiet environment within normal offic...

Страница 6: ...eration Contact your local distributor for assistance 3 Check with the packing list to make sure that you have received all necessary parts and accessories If your package is incomplete contact your l...

Страница 7: ...4 Fix the two screws in the wall 5 Hang Madsen A450 on the screws Madsen A450 cabling A External power supply cable B USB cable between Madsen A450 and the PC 5 Connecting accessories to Madsen A450...

Страница 8: ...esponds to Left and red corresponds to Right Warning Use only the power supply provided by Natus Note When you connect other electrical equipment to Madsen A450 remember that equipment that does not c...

Страница 9: ...wer socket in the con nection panel 2 Plug the mains plug of the external power supply into an AC mains outlet with a three wire protective ground Switching on Madsen A450 Warning Use only the power s...

Страница 10: ...o select a combination of functions Your selections are shown in the Stimulus bar and as symbols in the audiogram You can control the monitor level activate the Talk Forward dialog and use the Test Se...

Страница 11: ...Field speaker unaided SF Aided 1 and SF Aided 2 Sound field speaker Aided 1 and 2 Stimulus type selection Tone Warble FRESH noise Pulsed Test type selection AUD audiogram threshold curve SRT Speech R...

Страница 12: ...enting live speech stimulus Recorded stimulus Talk Forward Click to open the Talk Forward dialog See the Madsen A450 Reference Manual Enables communicating with the patient in the sound booth This wil...

Страница 13: ...ction Insert Phones Bone SF Unaided SF Aided 1 SF Aided 2 Stimulus Selection Tone Tone Warble FRESH Pulsed stimulus Stim Lock Tracking 1 dB step 5 dB step Speech Mic Recorded Source A Recorded Source...

Страница 14: ...ests To enable test controls select Tools Options Audiometry General On screen controls Show On Button Description Present Click to present the stimulus Store Click to store the data point or row Mask...

Страница 15: ...diogram com bined audiogram or both a left and a right audiogram on your screen Combined View Click to view both ears in a single audiogram Split View Click to view separate audiograms for each ear Sc...

Страница 16: ...ears 3 Tighten the headband while holding the headphones in place with your thumbs 4 Examine the placement of the headphones to make sure they are level and properly positioned Insert Earphones 1 Sele...

Страница 17: ...he environment in which sound field audiometry is performed may affect the sound field near the patient The performance of loudspeakers for Madsen A450 was tested by Natus under free field conditions...

Страница 18: ...completed If needed did you test Both ears Air conduction Bone conduction Masking Mask button or M on the keypad Audiogram threshold AUD MCL and UCL 9 Save the audiogram Note White noise can be selec...

Страница 19: ...lar sound files Line In analog input from external sound players e g CD MD MP3 or cassette recorders connected to the audi ometer via the Line In input Note If an external playback device is used to g...

Страница 20: ...to score 11 Store the current data as the result either by clicking Store in the highlighted field or by pressing S on the keyboard 12 Repeat until all the measurements you need have been completed Do...

Страница 21: ...f the defect s and contact your supplier Do not use a defective device 14 2 Cleaning The device Remove dust using a soft brush Use a soft slightly damp cloth with a small amount of mild detergent Warn...

Страница 22: ...port The technician installs the calibration data via the menu function Tools Audiometer service The data is password protected 5 When the installation has ended hold the new transducer within hearing...

Страница 23: ...range for SF 125 8000 Hz Accuracy 0 3 Narrow Band Noise masking Available for each stimulus frequency Frequency resolution 125 to 8000 Hz at standard frequencies Stimulus types Tone Warble Pulsed tone...

Страница 24: ...0 6000 8000 9000 10000 11200 12500 Offset dB N A 53 37 32 31 29 30 29 27 31 27 26 26 25 25 This table indicates the number Offset to be added to the displayed masking level in order to calculate the s...

Страница 25: ...conductor output is not corrected to obtain a free field equivalent sound force level uncorrected output meas ured by an artificial mastoid IEC 60318 6 is produced Calibration of speech signals is per...

Страница 26: ...lowed THD 125 250 75 65 2 5 315 400 90 80 2 5 500 5000 110 100 2 5 Specification of allowable distortion levels for bone conducted sound test level and distortion Frequency Hz Test level for bone vibr...

Страница 27: ...shall be applied HB8 is in compliance with ISO 389 For children and below normal skull size HB7 shall be applied HB7 provides a greater force required to accommodate smaller skull size For audiometri...

Страница 28: ...2 x 1 6 Vrms External inputs CD Analog line in 0 2 to 2 0 Vrms 10 k 1 stereo 3 5 mm 1 8 inch jack Talk Back microphone Electret microphone Input voltage 0 002 to 0 02 Vrms Input resistance 2 21 k 3 5...

Страница 29: ...imum output may be set lower than the physically available output level installation option As the maximum available output level will result in significant distortion from the bone conductor the spec...

Страница 30: ...30 C to 60 C 22 F to 140 F Air humidity 10 to 90 non condensing Air pressure 50 kPa to 106 kPa Operating environment Mode of operation Continuous Temperature 15 C to 35 C 59 F to 95 F Air humidity 20...

Страница 31: ...IEC 60601 1 2 2014 and EN 60601 1 2 2015 16 1 Accessories Standard accessories and optional accessories may vary from country to country please consult your local distributor Madsen A450 Accessories G...

Страница 32: ...6 Speech Material CD CN Speech Material 8 49 88200 1066 Speech Material CD UK Speech Material 8 49 88300 1066 Speech Material DVD DE Speech Material 8 49 88400 1066 Speech Material DVD FR Speech Mater...

Страница 33: ...Speech Material 22600920 International Matrix Test Basler Speech Material 22600923 International Matrix Test DANTALLE II Speech Material 22600919 International Matrix Test UK English Speech Material 2...

Страница 34: ...Guidance and manufacturer sdeclaration electromagnetic immunity for all equipment and systems Madsen A450 is intended for use in the electromagnetic environment specified below The user of Madsen A45...

Страница 35: ...nt and systemswithin Professional Healthcare use environment Madsen A450 is intended for use in the electromagnetic environment specified below The user of Madsen A450 should ensure that it is used in...

Страница 36: ...ct 8 kV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humid ity should be at least 30 Electrical fast transient burst IEC 61000 4 4 2 kV...

Страница 37: ...the higher frequency range applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Fie...

Страница 38: ...elines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 17 Definition of symbols Symbol Standards Reference Stand...

Страница 39: ...23 1 Reference no 5 1 6 Medical devices Symbols to be used with medical device labels labelling and inform ation to be supplied Catalogue number Indicates the man ufacturer s catalogue num ber so that...

Страница 40: ...ation ISO 7000 Atmospheric Pressure limitation ISO 15223 1 2016 Refer ence no 5 2 8 ISO 7000 2606 Medical devices Symbols to be used with medical device labels labelling and inform ation to be supplie...

Страница 41: ...that cannot for a variety of reasons be presented on the medical device itself ISO 15223 1 2016 Refer ence no 5 4 5 ISO 7000 symbol 2025 Medical devices Symbols to be used with medical device labels...

Страница 42: ...e Electrical and Elec tronic Equipment WEEE Disposal at end of operating life instructions Indicates that electrical and electronic waste equipment waste should not be discarded together with unsepara...

Страница 43: ...d user unless other arrangements have been made Please contact us for details on the collection and recovery systems available to you in your region at www natus com Electrical and electronic equipmen...

Страница 44: ...between the Direct Connectors Isolated Connectors Direct connectors All connectors within the red frame are connected directly to patient transducers Fig 1 Sockets with direct connections to patient...

Страница 45: ...o pull the mains plug out of the wall mains Warning Accidental damage and incorrect handling can have a negative effect on the functionality of the device Contact your supplier for advice Warning Do n...

Страница 46: ...udiologists ENTs other health care professionals or trained personnel Caution Do not use the device for purposes other than the applications defined in the intended use Caution Madsen A450 requires re...

Страница 47: ...atus com 19 1 Responsibility of the manufacturer The manufacturer is to be considered responsible for effects on safety reliability and performance of the equipment only if All assembly operations ext...

Страница 48: ...19 Manufacturer 48 Madsen A450...

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