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ISO 15223-
1:2016 Refer-
ence no.
5.1.4. (ISO
7000-2607)

Medical devices — Symbols to
be used with medical device
labels, labeling, and inform-
ation to be supplied – Part 1:
General requirements.

Use-by date

Indicates the date after
which the medical device
is not to be used.

ISO 15223-1
Reference
no. 5.1.5

Medical devices — Symbols to
be used with medical device
labels, labelling and inform-
ation to be supplied.

Batch or Lot code

Indicates the man-
ufacturer's batch code so
that the batch or lot can
be identified.

ISO 15223-1
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 the medical
device can be identified.

ISO 15223-
1:2016 Refer-
ence no.
5.1.7. (ISO
7000-2498)

Medical devices — Symbols to
be used with medical device
labels, labeling, and inform-
ation to be supplied – Part 1:
General requirements.

Serial number

Indicates the man-
ufacturer's serial number
so that a specific medical
device can be identified

ISO 15223-
1:2016 Refer-
ence no.
5.3.1. (ISO
7000-0621)

Medical devices — Symbols to
be used with medical device
labels, labeling, and inform-
ation to be supplied – Part 1:
General requirements.

Fragile, handle
with care

Indicates a medical device
that can be broken or
damaged if not handled
carefully

ISO 15223-
1:2016

Reference
no. 5.3.4.
(ISO 7000-
0626)

Medical devices — Symbols to
be used with medical device
labels, labeling, and inform-
ation to be supplied – Part 1:
General requirements.

Keep dry

Keep away from
rain

Indicates a medical device
that needs protection
from moisture

ISO 15223 Keep dry

ISO 7000 Keep away from
rain

ISO 15223-1
Reference
no. 5.3.7(ISO
7000-0632)

Medical devices —Symbols to
be used with medical device
labels, labelling and inform-
ation to be supplied.

Temperature lim-
itations

Indicates the temperature
limits to which the med-
ical device can be safely
exposed

ISO 15223-
1:2016 Refer-
ence no.
5.3.8. (ISO
7000-2620)

Medical devices —Symbols to
be used with medical device
labels, labelling and inform-
ation to be supplied.

Humidity lim-
itations

Indicates the range of
(storage) humidity to
which the medical device
can be safely exposed.

Aurical Aud

18 Definition of symbols

Содержание Aurical Aud

Страница 1: ...Aurical Aud User Guide Doc No 7 50 1270 EN 13 Part No 7 50 12700 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 04 12 220758...

Страница 3: ...8 On screen controls 10 9 PC keyboard controls 10 10 Toolbar icons in the Audiometry Module 10 11 Proper transducer placement 12 12 The Masking Assistant 13 13 Performing tone audiometry 16 14 Perfor...

Страница 4: ...ounseling using the Otosuite Counseling and Simulations module Note For information about the PMM software see the manual for AURICAL FreeFit and the PMM module and for information about the Counselin...

Страница 5: ...ath or serious injury to the user or patient Caution Indicates that there is a risk of injury to the user or patient or risk of damage to data or the device Note Indicates that you should take special...

Страница 6: ...ave to connect the cables Warning To connect Aurical Aud to the PC use the supplied USB cable The cable length must not exceed 3 m approx 10 feet Aurical Aud A External power supply cable B USB cable...

Страница 7: ...tal line out F Sound field speakers power output G Insert earphones H Headphones air conduction I Patient Responder J Bone conductor K Speaker Analog line output L Line in M Operator monitor headset h...

Страница 8: ...cover A USB to Aurical Aud B BT Bluetooth for PMM communication C 24V DC out power supply to Aurical Aud D 24V DC in for external power supply E Speaker input for connecting to Aurical Aud Connecting...

Страница 9: ...xternal power supply directly to an AC mains outlet with a three wire protective ground 2 Switch on the mains supply 3 The On Off indicator on Aurical Aud lights green Aurical Aud Aurical Aud with Hi...

Страница 10: ...r and the person being tested are in the same room To enable silence mode select Tools Options Audiometry General On screen controls Silence Mode On Tools Options Audiometry General On screen controls...

Страница 11: ...The Masking Assistant causes an unmasked threshold to flash repeatedly if masking is recommended Standard All High frequencies Standard All High fre quencies The graph shows up to 20000 Hz Aurical Aud...

Страница 12: ...screen for graph and table views You can also select the location of the stimulus control 11 Proper transducer placement Headphones 1 Loosen the headband and place both the left and right side of the...

Страница 13: ...and bone conductor fit on the patient s head Loudspeaker placement The environment in which sound field audiometry is performed may affect the sound field near the patient The performance of loudspeak...

Страница 14: ...masked threshold has been stored the flashing stops for that frequency denotes configurable Air Bone gap criterion Tools Configuration Wizard Audiometry Tools Configuration Wizard Audiometry Configure...

Страница 15: ...w BJA 1999 4000 50 Katz J Munro Agnew BJA 1999 6000 44 Hall J W III Mueller G H III Munro Agnew BJA 1999 8000 42 Katz J Munro Agnew BJA 1999 Min IA insert phone Hz dB 125 60 N A traditional value 250...

Страница 16: ...e patient to adjust the patient com munication levels when Talk Forward Talk Forward is active 3 In the Control Panel select test conditions for ear transducer unmasked masked and test type 4 Select t...

Страница 17: ...ometry module 2 If needed click the Scoring and Playing Scoring and Playing icon to set up word or phoneme scoring 3 Prepare the patient If you wish to instruct the patient after you have placed the t...

Страница 18: ...e used tape recordings may not provide a sufficient signal to noise ratio Preferably the external device should deliver its output via a fixed level line out connector The input gain on Aurical Aud sh...

Страница 19: ...g 1 Noise Exposure Explanation of OSHA and NIOSH Safe Exposure Limits and the Importance of Noise Dosimetry by Patricia A Niquette AuD Etymotic Research Inc 15 Maintenance Aurical Aud requires regular...

Страница 20: ...o special requirements for the disposal of eartips i e they can be discarded according to local regulations 15 3 Calibration Annual calibration The audiometer headphones bone conductors and sound fiel...

Страница 21: ...ct your local distributor first 16 Other references For more information see the online Help in Otosuite which contains detailed reference information about Aurical Aud and the Otosuite modules For Ot...

Страница 22: ...se used for masking of pure tones is indicated in dB of effective masking level in Otosuite This means that the sound pressure level of the power contained in a third octave band around the presented...

Страница 23: ...level depend on the type of audi ometer Aurical Aud can be calibrated as either a corrected Type AE or uncorrected Type A speech audiometer Type AE calibration The output sound pressure level and fre...

Страница 24: ...ver the minimum requirements from IEC 60645 1 2007 and ANSI 63 6 2004 are fulfilled for all units They are specified in the following Frequencies and minimum output levels dB HL Frequency Supra aural...

Страница 25: ...ers audiologists should determine if levels higher than those specified above can be used for a particular test Total harmonic distortion Air conduction AC 2 5 Bone conduction BC 5 Selectable transduc...

Страница 26: ...n values for earphones Frequency Attenuation Hz TDH39 with MX41 AR cushion dB EAR 3A dB HDA300 dB 63 12 5 125 3 33 12 5 160 4 34 200 5 35 250 5 36 12 7 315 5 37 400 6 37 500 7 38 9 4 630 9 37 750 800...

Страница 27: ...utput level from the bone conductor depends on the actual sensitivity of the vibrator The actual maximum output is therefore determined at the time of calibration The actual maximum output level may b...

Страница 28: ...headset 40 mW 16 3 5 mm 1 8 inch stereo jack Operator microphone desktop or boom Electret microphone Input voltage 0 002 to 0 02 Vrms Input resistance 2 21 k 3 5 mm 1 8 inch jack USB interface Connec...

Страница 29: ...d environment Disposal Aurical Aud and relevant accessories can be disposed of as normal electronic waste according to WEEE and local reg ulation Refer to the disposal instructions described in this m...

Страница 30: ...2014 EMC IEC 60601 1 2 2014 and EN 60601 1 2 2015 IEC 60601 1 2 2007 and EN 60601 1 2 2007 17 2 Hi Pro 2 built in Ports for hearing instruments 1 x 6 pin mini DIN sockets For connecting programmable...

Страница 31: ...ails Headphone 8 75 780 Headset HB 7 12 kHz matched TDH39 phones jack Headphone 8 75 790 TDH 39 headphones Headband HB 8 Headphone 8 75 620 HOLMCO headphones Headphone 8 75 82600 Headset HDA 300 Headp...

Страница 32: ...90 dB paired 8 75 85500 Headset Speaker Microphone Speaker System 90 dB single 8 75 85501 Headset Speaker Microphone Talk forward Microphone 2 17 13000 Power Supply Power supply and mains cable 5 01 1...

Страница 33: ...066 Speech Material DVD SE 8 49 89300 Speech Material 1066 Speech Material CD DK 8 49 89400 Speech Material 1066 Speech Material CD NO 8 49 89500 Speech Material 1066 Speech Material CD NZ 8 49 89600...

Страница 34: ...erial International Matrix Test Italian Simplified 22600927 Speech Material International Matrix Test Arabic 22600928 Speech Material Oldenburger Messprogramm 22600901 UP Speech Material Oldenburger S...

Страница 35: ...ines Mains power quality should be that of a typical com mercial or hospital environment Surge IEC 61000 4 5 1 kV line s to line s 2 kV line s to earth 2 kV DC input line s to earth 1 kV DC input line...

Страница 36: ...V m 5240 MHz 5500 MHz 5785 MHz Separation distance between any electronic parts of Aur ical Aud and any RF wireless communication equipment must be more than 30 cm 11 8 inches Note These guidelines m...

Страница 37: ...kV line s to earth Mains power quality should be that of a typical com mercial or hospital environment Voltage dips short inter ruptions and voltage vari ations on power supply input lines IEC 61000 4...

Страница 38: ...and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters a...

Страница 39: ...PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices amending Dir ective 2001 83 EC Regu lation EC No 178 2002 and Regulation EC No 1223 2009 and repealing Council Dir ectives 90 385 EEC a...

Страница 40: ...dical device can be identified ISO 15223 1 2016 Refer ence no 5 3 1 ISO 7000 0621 Medical devices Symbols to be used with medical device labels labeling and inform ation to be supplied Part 1 General...

Страница 41: ...nd inform ation to be supplied Part 1 General requirements Do not re use Indicates a medical device that is intended for one single use only NOTE Synonyms for Do not reuse are single use and use only...

Страница 42: ...C 60601 1 Reference no Table D 1 Symbol 19 ICE 60417 5480 Medical electrical equipment Part 1 General require ments for basic safety and essential performance Type B Applied Part To identify a type B...

Страница 43: ...itioner UL Listing N A N A Nationally Recognized Testing Laboratories NRTL certifications INMETRO in conjunction with UL for Latin America InMetro and UL marking of conformity MEDICAL Gen eral Medical...

Страница 44: ...ste carriers to reduce adverse environmental impacts in connection with disposal of waste electrical and electronic equipment and to increase opportunities for reuse recycling and recovery of waste el...

Страница 45: ...ng To avoid the risk of electric shock this equipment must only be connected to a mains supply with pro tective ground Warning For the sake of safety and in order not to void the warranty service and...

Страница 46: ...r than approx 1 5 meters 5 ft Warning Any PC connected to the device must comply with the requirements of IEC 62368 1 2020 Warning The use of this device in domestic establishments is allowed only und...

Страница 47: ...o be used only by Audiologists ENTs other health care professionals or trained personnel Caution Do not use the device for uses other than those described in the section Intended use Caution Do not us...

Страница 48: ...eliability and performance of the equipment only if All assembly operations extensions re adjustments modifications or repairs are carried out by the equipment man ufacturer or personnel authorized by...

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