otometrics MADSEN Astera2 Скачать руководство пользователя страница 34 | Manualshive

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background image

Complies with Medical Devices Directive 93/42/EEC and RoHS Directive (2011/65/EC).

MEDICAL - General Medical Equipment as to electrical shock, fire and mechanical hazards only in accord-
ance with UL 60601-1, first edition, 2003 CAN/CSA-22.2 No. 601.1-M90.

MEDICAL - General Medical Equipment as to electrical shock, fire and mechanical hazards only in accord-
ance with medical- general medical equipment ANSI/AAMI ES60601-1 (2005), CAN/CSA-C22.2 No. 60601-
1 (2008) 90 EA.

Used in error message dialogs if software program fails. See the detailed information in the dialog box.

18

Warning notes

This manual contains information and warnings, which must be followed to ensure the safe performance of the devices and
software covered by this manual. Local government rules and regulations, if applicable, should also be followed at all times.

Standards and safety-related issues relating to the MADSEN Astera² Audiometer Control Panel (ACP) are comprised by the
MADSEN Astera² symbols, standards and warning notes.

See

Definition of symbols

►

33

,

Connector warning notes

►

34

and

General warning notes

►

35

.

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. 1

Sockets with direct connections to patient transducers - MADSEN Astera² connection panel

Isolated connectors

•

All connectors within the red frame are isolated from patient transducers.

34

Otometrics - MADSEN Astera²

18 Warning notes

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Содержание MADSEN Astera2

Страница 1: ...MADSEN Astera User Guide Doc No 7 50 1350 EN 04 Part No 7 50 13500 EN ...

Страница 2: ... latest productinformation available atthe time of publication GN Otometrics A Sreserves the right tomake changes atany time without notice Registeredtrademarks andTrademarks MADSEN IteraII MADSEN OTOflex 100 OTOsuite AURICAL FreeFit AURICAL Visible Speech MADSEN Astera MADSEN Xeta ICS Chartr 200 VNG ENG ICSChartr EP OTOcam300 MADSEN AccuScreen MADSEN AccuLink ICS AirCal AURICAL Aud AURICAL HIT IC...

Страница 3: ... PC keyboard controls 12 9 Toolbar icons in the Audiometry Module 12 10 The Sunshine Panel 14 11 Proper transducer placement 17 12 Performing tone audiometry 18 13 Performing speech audiometry 20 14 Service cleaning and calibration 21 15 Other references 22 16 Technical Specifications 23 17 Definition of symbols 33 18 Warningnotes 34 19 Manufacturer 37 Otometrics MADSEN Astera 3 ...

Страница 4: ...d 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 patients Use diagnostic and clinical audiometric testing The MADSEN Astera Audiometer ControlPanel ACP The ACP is intended as a supplementary user interface connected to MADSEN Astera 2 1 Typographical co...

Страница 5: ...d bone oscillator are the correct ones and that they comply with the ordered calibration standards 4 Installation Install OTOsuite on the PC before you connect to MADSEN Astera from the PC For instructions on installing OTOsuite see the OTOsuite Installation Guide which you can find on the OTOsuite install ation medium disk or memory stick To mount MADSEN Astera on the wall or under the desktop se...

Страница 6: ...unt the cable cover 1 Remount the cable cover by inserting the blue tags ofthe cable cover into the grooves of MADSEN Astera and swinging the cover into place until you hear aclick Connectingto OTOsuite Run the OTOsuite Configuration Wizard to connect to and set up communication with MADSEN Astera Select Tools Configuration Wizard 4 1 Connecting the ACP to MADSEN Astera Caution Install OTOsuite on...

Страница 7: ...t the green cable in the cable bundle from the Operator monitor headset head phones socket in the MADSEN Astera rear panel to the Operator monitor headset headphones socket in the ACP Connect the pink cable in the cable bundle from the Operatormonitor headset boom microphone socket in the MADSEN Astera rear panel to the Operator monitor headset boom microphone socket in the ACP Speaker built into ...

Страница 8: ... Thefollowing applies only when used with thespecified power supply XP Power type PCM80PS24 The installation must be carried out in accordance with IEC 60601 1 1 UL 60601 1 and CAN CSA C22 2 NO 601 1 90 The supplementary provisions on the reliability ofelectro medical systems It is ageneral rule for all electrical equipment used in the proximity of the client that The connected equipment must comp...

Страница 9: ...must be carried out in accordance with IEC 60601 1 1 UL 60601 1 and CAN CSA C22 2 NO 601 1 90 The supplementary provisions on the reliability ofelectro medical systems It is ageneral rule for all electrical equipment used in the proximity of the client that The connected equipment must comply with IEC 60601 1 2nd and or IEC 60601 1 1 except for the PC and equipment connected to the line in and the...

Страница 10: ...eadset headphones G Operator monitor headset boom microphone H Operator monitor speaker I Operator desktop microphone J Talkback microphone K Assistant monitor headset L Sound field speakers power output M External power supply N PC USB connection O Line in P Sound field speakers line output Note Blue corresponds to Left and red corresponds to Right Warning Use only the power supply provided by Ot...

Страница 11: ... an AC mains outlet with a three wire protective ground 2 Switch on the mains supply 3 The On Off indicator on MADSEN Astera lights green Press the ON OFF button on the front ofMADSEN Astera Switchingoff MADSEN Astera 1 To switch off MADSEN Astera disconnect the power supply from the mains outlet 6 Connecting MADSEN Astera to OTOsuite When you use MADSEN Astera for the first time run the Configura...

Страница 12: ... tested are in the same room To enable silence mode select Tools Options Audiometry General On screen controls Silence Mode On To change the level and frequency by more than one click at atime use the mouse scroll wheel 8 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 um...

Страница 13: ... The Masking Assistant causes an unmasked threshold to flash repeatedly if masking is recommended Standard Frequencies All Fre quencies High Fre quencies The graph shows up to 20 000 Hz MADSEN Astera presents stimulus up to 12 500 Hz Click to choose between viewing StandardFrequencies Displaysthe audiogram from 125 to 8000 Hz All Frequencies Displaysthe audiogram from 125 to 20 000 Hz High Frequen...

Страница 14: ... active Enable Talk to Assist ant Click to enable or disable talking to another party usually a second tester in the booth Talk Forward Enablescommunicating with the patient in the sound booth This will displaythe Talk Forward dialog box where you can control the talk for ward microphone sensitivity and the output level in dB HL to the patient Select Orientation Click to select the perspective of ...

Страница 15: ...e the Sunshine Panel to display one or several buttons for some ofthe functions For instance you can dis play one or more of the curve selection buttons on the panel When the right click menu for abutton includes the selection Add remove buttons you can customize the setup 1 Enable disable the button s you wish to display 2 Click to disable the selection Use Single Button The enabled buttons are d...

Страница 16: ...Aided 2 Sound field speaker Aided 1 and 2 Masking Options Mask Click to enable or disable masking Stimulus Selection Click to select stimulus type Tone Tone testing Warble Tone testing FRESH noise Tone testing Pre recorded stimulus Speech Microphone to present live speech stimulus Speech Curve Selection Click to select the curve type THR Threshold level Tone MCL Most Comfortable Loudnesslevel UCL ...

Страница 17: ...hile holding the headphones in place with your thumbs 4 Examine the placement ofthe headphones to make sure they are level and properly positioned Insert Earphones Young children tolerate insert earphones better than headphones 1 Select the largest foam eartip that will fit into the patient s ear Ifthe eartip is too small the sound will leak out and the dB level will not be accurate at the eardrum...

Страница 18: ...emple on the opposite side of the head so that the headband of the earphones and bone oscillator fit on the patient s head Frontalbone placement 1 For frontal bone placement place the flat round part of the bone oscillator securely on the middle of the forehead about an inch 2 5 cm below the hairline 2 Make sure the bone oscillator is tight on the forehead but still comfortable 12 Performing tone ...

Страница 19: ...nt you can use the Talk Forwardbutton You can talk to the patient to adjust the patient communication levels when Talk Forward is active 3 In the Control Panel select test conditions for ear transducer unmasked masked and test type 4 Select the test frequency with the Right Left arrow buttons 5 Select the stimulus level with the Up Down arrow buttons 6 Present the tone with the Stimulus Presentati...

Страница 20: ...iled examples ofaudiometric testing see the MADSEN Astera Reference Manual 1 Select the Speech screen in the OTOsuite Audiometry module 2 Ifneeded click the Scoring and Playing icon to set up word or phoneme scoring 3 Prepare the patient Ifyou wish to instruct the patient after you have placed the transducers on the head of the patient you can use the Talk Forwardbutton You can talk to the patient...

Страница 21: ...rated word list the word list is shown on the screen 9 Present the word lists with the Play button 10 Use the Correct and Incorrect buttons or click directly on the key word to score 11 Store the current data as the result either by clicking in the highlighted field or by pressingStore S on the keyboard 12 Repeat until all the measurements you need have been completed 14 Service cleaning and calib...

Страница 22: ...be cleaned or re used Bone oscillator Clean the bone oscillator between patients e g with a non alcohol based antibacterial wipe such as Audiowipes Disposal There are no special requirements for the disposal ofeartips 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 on...

Страница 23: ...ise stimulus Available in entire frequency range within the transducer specified range for SF 125 12500 Hz Accuracy 0 3 Narrow Band Noise masking Available in entire frequency range Frequency resolution 1 48 1 24 1 12 and 1 6 oct 1 Hz step Stimulustypes Tone Warble Pulsed tone Pulsed warble FRESH noise Frequency specific hearing assessment noise Consistsof noise bands with frequency specific filte...

Страница 24: ...l Entire level range AC 125 to 5000 Hz 3 dB 5000 to 20000 Hz 5 dB Entire level range BC 250 to 5000 Hz 4 dB 5000 to 8000 Hz 5 dB Level resolution 1 2 or 5 dB step resolution over the entire range HL Range Maximum output will be limited by the transducer AC 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 amplif...

Страница 25: ...k Back microphone Electret microphone Input voltage 0 002 to 0 02 Vrms Input resistance 2 21 kΩ 3 5 mm jack Stimuluspresentation Normal The signal is presented when the Stimulate button is pressed Continuous ON The signal is interrupted when the Stimulate button is pressed Pulse The signal is pulsed Pulse duration 225 ms on and 225 ms off default Operator accessories Operator monitor speaker 1 5W ...

Страница 26: ... 22 F to 140 F Air humidity 10 to 90 non condensing Air pressure 500 hPa to 1060 hPa Operatingenvironment Mode ofoperation Continuous Temperature 15 C to 35 C 59 F to 95 F Air humidity 30 to 90 non condensing Air pressure 980 hPa to 1040 hPa Operation in temperatures exceeding 20 C 4 F or 60 C 140 F may cause permanent damage Warm uptime 5 min Note Should be extended if MADSEN Astera has been stor...

Страница 27: ...ower PCM80PS24 Output 24 V DC 3 33 A max Input 100 240 VAC 47 63 Hz 1 1 A 0 45 A Patient Safety when used with the specified power supply XP Power type PCM80PS24 Complieswith IEC 60601 1 2nd Class 1 Type B UL 60601 1 CAN CSA C22 2 NO 601 1 90 Power consumption 90 VA Mains cables 8 71 240 POWER CABLE W SCHUKO PLUG 8 71 290 MAINS CORD H05VV DK PLUG 8 71 80200 MAINS CORD H05VV UK PLUG 8 71 82700 POWE...

Страница 28: ... 60601 1 2 16 2 ACP Outputs Monitor headphone 3 5 mm jack 32 Ω Boom microphone 3 5 mm jack Desktop microphone 3 5 mm jack Inputs Monitor headphone 3 5 mm jack 32 Ω Boom microphone 3 5 mm jack Desktop microphone 3 5 mm jack Built in monitor speaker 3 5 mm jack 8 Ω Operator interface 76 buttons 61 with built in LEDs 2 rotary knobs 32 steps in each rotation USBport connector Type USB device port Comp...

Страница 29: ... 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 Ifyou are using a USB hub use a powered USB hub Power consumption Normal operation 360 mA 5 V Suspend mode 500 µA 5 V Standards Patient Safety Complieswith IEC 60601 1 Class 1 Type B UL 60601 1 CAN CSA C22 2 NO 601 1 90 EMC IEC 60601 1 2 16 3 Accessories Standard accessories and opti...

Страница 30: ...able and mobile high frequency communication devices such as mobile phones may interfere with the func tioningof MADSEN Astera Guidanceand manufacturer sdeclaration electromagnetic emissionsfor allequipment and systems MADSEN Astera isintended foruse in the electromagnetic environment specified below Theuser of MADSEN Astera should ensure that itis used in such an environment Emissionstest Complia...

Страница 31: ... on power supply input lines IEC 61000 4 11 5 UT 95 dip in UT for0 5cycle 40 UT 60 dip in UT for 5cycles 70 UT 30 dip in UT for 25cycles 5 UT 95 dip in UT for5 s 5 UT 95 dip in UT for0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for5 s Mains power quality should bethat of a typical commercialor hospital environment If theuser of theMADSEN Astera requi...

Страница 32: ...hat mobile portable communications equipment could causeinterference if it isinadvertently broughtinto patient areas Forthis reason an additionalfactor of 10 3is used in calculatingtherecommended separation distance for transmittersin thesefrequencyranges Field strengthsfrom fixed transmitters such as basestations for radio cellular cordless telephones and land mobile radios amateur radio AM and F...

Страница 33: ...pply in allsituations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 17 Definition of symbols Electronic equipment covered by the Directive 2002 96 EC on waste electrical and electronic equipment WEEE All electrical and electronic products batteries and accumulators must be taken to separate collection at the end of their working life This r...

Страница 34: ...e the safe performance of the devices and software covered by this manual Local government rules and regulations ifapplicable should also be followed at all times Standardsand safety related issues relating to the MADSEN Astera Audiometer Control Panel ACP are comprised by the MADSEN Astera symbols standards and warning notes See Definition of symbols 33 Connector warning notes 34 and General warn...

Страница 35: ...operate the device at temperatures and humidity exceeding those stated in the Technical Spe cifications Transport and storage 8 Keep the unit away from liquids Do not allow moisture inside the unit Moisture inside the unit can damage the instrument and it may result in a risk of electrical shock to the user or patient 9 Do not use the instrument in the presence of flammable agents gases or in an o...

Страница 36: ... MADSEN Astera Reference Manual When assembling an electro medical system the person carrying out the assembly must take into account that other connected equipment which does not comply with the same safety requirements as this product e g PC and or printer may lead to a reduction in the overall safety level ofthe system The equipment must comply with UL IEC 60950 Thefollowing applies only when u...

Страница 37: ...nsions re adjustments modifications or repairs are carried out by the equipment man ufacturer or personnel authorized by the manufacturer The electrical installation to which the equipment is connected complies with EN IEC requirements The equipment is used in accordance with the instructions for use The manufacturer reserves the right to disclaim all responsibility for the operating safety reliab...

Страница 38: ...19 Manufacturer 38 Otometrics MADSEN Astera ...

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