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Calibration

Equipment should be calibrated regularly according to EN 60645-5 and ANSI S3.39

Essential performance

MADSEN Zodiac has no essential performance and accordingly, the applicable requirements are as stated in the following:

1. Impedance/admittance as defined by

EN 60645-5:2005 Type 2, ANSI S3.39 1987 (R2012) Type 2

2. Basic safety as defined by

IEC 60601-1

3. Electromagnetic compatibility as defined by

IEC 60601-1-2:2007 and EN 60601-1-2:2007

IEC 60601-1-2:2014 and EN 60601-1-2:2015

Standards

Safety:

IEC 60601-1:2005+AMD1:2012
EN 60601-1:2006+A1:2013

ANSI/AAMI ES60601-1:2005 + A1:2012

CAN/CSA-C22.2 NO. 60601-1:14

Class II, externally powered, Type BF, IPX0

EMC:

IEC 60601-1-2:2007 and EN 60601-1-2:2007

IEC 60601-1-2:2014 and EN 60601-1-2:2015

Impedance/Admittance:

Quick Check: EN 60645-5:2005 Type 2, ANSI S3.39 1987 (R2012) Type 2

Power supply:

Class I, externally powered supply

Disposal

MADSEN Zodiac can be disposed of as normal electronic waste, according to WEEE and local regulations.

13.1

Accessories

The accessories listed depend on the configuration of the MADSEN Zodiac supplied.

•

Diagnostic probe, Classic

•

Diagnostic probe, Comfort

•

Quick Check probe

•

Eartips

•

Eartip box

•

Otometrics insert phone, contralateral

•

Contralateral phone, TDH-39

•

Inserts for contralateral phones

•

Shoulder strap hook

•

Probe home for Quick Check probe, wall-mounted or device-mounted

•

2 cc cavity for probe check

•

Multi-frequency cavity kit

User Guide

Otometrics - MADSEN Zodiac

Содержание Madsen Zodiac

Страница 1: ...MADSEN Zodiac Quick Check Stand alone User Guide Doc No 7 50 1600 EN 05 Part No 7 50 16000 EN ...

Страница 2: ...turer 2016 2018 GN Otometrics A S All rights reserved Otometrics the Otometrics Icon AURICAL MADSEN Otoscan ICS and HORTMANN are registered trademarks of GN Otometrics A S in the U S A and or other countries Version release date 2018 12 06 204106 Technical support Please contact your supplier Otometrics MADSEN Zodiac 2 ...

Страница 3: ...ac menu 13 8 Testing with Zodiac Quick Check Stand alone 14 9 Managing test results in MADSEN Zodiac 19 10 Printing and data transfer from Zodiac 20 11 Troubleshooting 20 12 Service cleaning and calibration 20 13 Technical specifications 26 14 Standards and warnings 37 15 Other references 40 16 Manufacturer 40 3 User Guide Otometrics MADSEN Zodiac ...

Страница 4: ...s and functionalities Tympanometry Reflex Screening MADSEN Zodiac OTOsuite interfacing MADSEN Zodiac is designed to operate with the OTOsuite Immittance module From the OTOsuite Immittance module which is NOAH compatible you can perform tests monitor test results create User Tests store and export data and print reports Noah The Noah System is a HIMSA product for managing clients patients launchin...

Страница 5: ...the test stop the test The test is interrupted immediately Already measured results are kept Warning Look into the ear canal It is strongly recommended that you perform an otoscopy to assess the status of the outer ear before you insert the probe If the ear canal is blocked this may affect the result of the test Clean the ear canal if needed Make sure that there is no residual fluid in the patient...

Страница 6: ...mage has occurred do not put the device into operation 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 local distributor 4 Installation To ensure safe performance of the device make sure that MADSEN Zodiac is correctly installed and that the requirements li...

Страница 7: ...nal power supply socket on the back of the device Connecting the external power supply to the mains supply 1 Connect the mains plug of the external power supply directly to an AC mains outlet with a three wire protective ground 2 If applicable switch on the mains supply The first time you switch on the device Note The first time you switch on the device leave it turned on for at least an hour to l...

Страница 8: ...Zodiac Connect the USB cable from the USB socket on the back of the device to a USB socket on the PC The OTO suite Immittance software module automatically detects the device 4 3 The built in printer The built in printer which is optional is placed on the back of Zodiac The printer is controlled from the front panel of the device 1 To open the printer cover press the printer cover button 2 To clos...

Страница 9: ...e bottom of the com partment When you pull the paper upwards before closing the cover you will see the Otometrics watermark 6 Tear off the part of the paper where glue has held the roll together 7 Make sure that the loose end of the paper roll emerges through the paper slot 8 To close the printer cover press the printer cover into place until the lock clicks shut 5 The Quick Check probe Zodiac is ...

Страница 10: ...the probe 15 Cleaning the probe and probe tip 22 Warning Always fit an eartip on the probe before inserting it into the ear of the patient Warning The eartip can be used for both ears If you suspect infection in one ear use a clean eartip and probe tip before you continue testing on the other ear Holding the probe Underhand grip Overhand grip Otometrics MADSEN Zodiac User Guide 10 ...

Страница 11: ... Depending on the configuration of the stand alone version of Zodiac the front panel has a range of function buttons a dial and three soft buttons Starting and ending a session New Session Press this button to create a new session Report The function of this button depends on the configuration of the system Zodiac with a built in printer Press this button to print all test results for the current ...

Страница 12: ... Press this button to select Broadband noise as a reflex stimulus Ear This button is placed both on the device and on the probes Press this button to toggle the ear selection associated with the current measurement The button lights up in the color of the selected ear Delete Press this button to delete individual measurements Probe check Probe check Place the probe in the probe check cavity and pr...

Страница 13: ...light the desired area on the screen 7 The Zodiac menu If you use a stand alone version of Zodiac you can use the function specific buttons to activate the most commonly used functions for testing changing test settings and managing test results If you need to make further changes to a test setup or other more specific functions press Menu or Special for more choices The menu system Press the Menu...

Страница 14: ...diac after changing and saving the test settings the protocol will be locked again If you wish to save the changed protocol settings permanently select the left hand column scroll to Save to Protocol name and press the Save soft button Canceling changed test settings If you wish to cancel the settings you have changed select the protocol and press the Reload soft button 8 Testing with Zodiac Quick...

Страница 15: ... the Menu button to exit the menu The selected test setup will be used for testing 8 3 Fitting the eartip on the probe The Quick Check probe We recommend that you use an oversized eartip with the Quick Check probe Fitting the eartip on the probe 1 Firmly push and twist the eartip onto the probe tip until it rests firmly against the base of the probe tip Removing the eartip To remove the eartip gra...

Страница 16: ...nal 2 Fit the eartip on the probe 3 Ask the patient to sit very still and quiet during the test without moving head or jaw 4 Press the probe against the patient s ear canal so that a hermetic seal is achieved The meas urement starts automatically 5 To stabilize the probe and to avoid blocking the probe against the ear canal of the patient grasp the pinna and gently pull the pinna back and slightly...

Страница 17: ... there is a probe leak during testing this will be shown on the MADSEN Zodiac and OTOsuite screens If you are using the Quick Check probe the leakage indication will remain until you remove the probe from the ear and try again Probe blocked If the probe is blocked during testing this will be shown on the MADSEN Zodiac and OTOsuite screens If you are using the Quick Check probe the blocked probe in...

Страница 18: ... to fit the curves Tympanometric curves Pressure and admittance scales Ear canal volume bar The ear canal volume is shown to the right of the graph Norm area C Reflex Screening results The detected reflex is shown in the results area Stimulus type level Progress indicator during measurements Deflection curves are shown when a reflex has been detected If a reflex is not detected the highest stimulu...

Страница 19: ...tbutton Changing tympanogram curve type Press the Edit TPP softbutton Press the Change Type softbutton until the desired type is shown and press the Done softbutton Deleting a curve Select the curve you wish to delete and press the Delete button To replace a single measurement delete a curve and adjust the measurement selections to redo the single measurement 9 Managing test results in MADSEN Zodi...

Страница 20: ...sible causes Testing may be complicated by a number of factors which can result in leakage or probe problems The eartip does not fit well The eartip is not inserted properly in the ear canal The probe tip opening is blocked by the wall of the ear canal The eartip may be old or hardened The probe tip has not been attached properly to the probe body Hairs in the ear canal get between the eartip and ...

Страница 21: ...e Caution Make sure that you comply with local infection control regulations Caution Use only the cleaning agents prescribed for cleaning the device See Recommended cleaning agents 22 Frequency We recommend that you set up a schedule for cleaning Zodiac and accessories such as probes and or earphones Prerequisites Before cleaning switch off MADSEN Zodiac and disconnect it from any external power s...

Страница 22: ...esigned to be easily cleaned care should be taken to make sure that they last a long time Note Check the sound channels in the probe tip every time you have used the probe Even small amounts of cerumen or vernix can block the sound channels Clean the sound channels if needed Note Accurate testing is only guaranteed if you use the eartips approved specifically for MADSEN Zodiac by Oto metrics Ear c...

Страница 23: ... blocked use the probe tip flossing thread to clean the probe tip channels Note Always comply with local hygienic standards for disinfection A Probe body B Probe ring C Probe tip 1 To remove the probe tip hold the probe by the probe body and twist the probe ring slightly counter clockwise This will loosen the probe tip Caution Even the slightest amount of mois ture may dissolve any residual cerume...

Страница 24: ... and disconnect it from any external power source Warning When you open the paper compartment be careful not to injure your hands on the cutter blades Caution When you clean the paper compartment never use metal objects or liquids Cleaning the paper compartment 1 To remove paper dust use canned compressed air to clean the compartment Do not use liquids to clean the paper compartment 2 If the therm...

Страница 25: ...d that you perform a probe check at the start of each day Caution Always clean and disinfect the probe tip before you insert it into a test cavity Note If the test environment changes for instance if there is an increase in humidity or if you are going to test at a different altitude make a probe check to verify that the system measures correctly 1 Use a new probe tip or make sure that the probe t...

Страница 26: ...Technical specifications Type identification MADSEN Zodiac is type 1096 from GN Otometrics A S Compliance measuring system Probe tone 226 Hz at 85 dB SPL 3 dB Dynamic probe tone level The probe tone level will be compensated to accommodate varying ear canal volumes The output level will be decreased in volumes 1 7 ml The output level will be increased in volumes 2 3 ml THD 1 in 2 cc Frequency accu...

Страница 27: ...0 for levels above 110 dB HL Range BBN LPN HPN at 50 to 110 dB SPL 3 dB measured in calibration coupler Screening range BBN at 50 to 90 dB SPL 3 dB measured in calibration coupler Step size dB 1 2 5 10 dB Decay range 50 to 100 dB HL artifacts may start to occur at levels above 95 dB HL in 0 5 cc Temporal characteristics Reflex Decay Contralateral Reflex Threshold and Screen ing Ipsilateral Reflex ...

Страница 28: ...0 daPa s 53 43 42 32 Broadband noise Bandwidth 400 4000 Hz Tolerance 5 dB re 1 kHz level Slope Spectrum level drops between 4000 and 7000 Hz and remains below 23 dB re 1 kHz level for frequencies above 7000 Hz Level Noise level is indicated in dB HL Tolerance 5 dB ANSI IEC reflex stimulus RETSPL values Frequencies Hz Ipsilateral probe HA 1 2 Insert phone HA 1 2 Insert phone HA 2 2 Supra aural phon...

Страница 29: ...ositive to negative or negative to positive Safety Separate safety 530 daPa and 730 daPa 70 daPa Graph units Unit of admittance graph Y axis ml cc mmho µl Unit of graph X axis daPa sec Device display Display 7 inch 15 9 WVGA Resolution 800 x 480 pixel USB port connector Type USB device port Power supply External power supply XP Power type AFM60US24 Output 24 V 2 5 A Input 100 240 V AC 50 60 Hz 1 5...

Страница 30: ...ude m Increase in mmho 0 0 500 6 1000 13 1500 20 2000 27 2500 36 3000 45 Storage and handling Temperature 20 C to 60 C 4 F to 140 F Relative humidity 90 non condensing Air pressure 500 hPa to 1060 hPa Dimensions HxWxD Stand alone version 190 mm x 248 mm x 261 mm 7 5 x 9 8 x 10 3 PC based version 100 mm x 240 mm x 240 mm 3 9 x 9 4 x 9 4 Probe dimensions HxWxD Quick Check probe 28 mm x 22 mm x 100 m...

Страница 31: ...s II externally powered Type BF IPX0 EMC IEC 60601 1 2 2007 and EN 60601 1 2 2007 IEC 60601 1 2 2014 and EN 60601 1 2 2015 Impedance Admittance Quick Check EN 60645 5 2005 Type 2 ANSI S3 39 1987 R2012 Type 2 Power supply Class I externally powered supply Disposal MADSEN Zodiac can be disposed of as normal electronic waste according to WEEE and local regulations 13 1 Accessories The accessories lis...

Страница 32: ...odiac should ensure that it is used in such an environment Emissionstest Compliance Electromagnetic environment guidance RF emissions CISPR 11 Group 1 MADSEN Zodiac 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 CISPR 11 Class B MADSEN Zodiac is suitable for use in all en...

Страница 33: ...s Single phase at 0 Mains power quality should be that of a typical com mercial or hospital environment If the user of the MADSEN Zodiac requires continued operation during power mains interruptions it is recommended that the MADSEN Zodiac be powered from an uninterruptible power supply or a battery Voltage interruptions on power supply input lines IEC 61000 4 11 0 UT 250 300 cycles 0 UT 250 300 c...

Страница 34: ...est Compliance Electromagnetic environment guidance RF emissions CISPR 11 Group 1 MADSEN Zodiac 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 CISPR 11 Class B MADSEN Zodiac is suitable for use in all environments including domestic environments and those directly connect...

Страница 35: ...n in a typical commercial or hospital environment UT is the AC mains voltage prior to application of the test level Guidance and manufacturer sdeclaration electromagnetic immunity for equipment and systemsthat are NOT life supporting MADSEN Zodiac is intended for use in the electromagnetic environment specified below The user of MADSEN Zodiac should ensure that it is used in such an environment Im...

Страница 36: ...SEN Zodiac The MADSEN Zodiac is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the MADSEN Zodiac can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equip ment transmitters and the MADSEN Zodiac as recommended below according to the maximum outp...

Страница 37: ...is only permitted to use the device indoors This device complies with part 15 of the FCC rules Operation is subject to the following two conditions This device must not cause harmful interference This device must accept any interference received including interference that may cause undesired operation The term IC before the certification registration number signifies that the Industry Canada tech...

Страница 38: ...ve device 7 It is recommended to install the unit in an environment that minimizes the amount of static electricity For example anti static carpeting is recommended 8 We recommend that the device should not be stacked with other equipment or placed in a poorly ventilated space as this may affect the performance of the device If it is stacked or placed adjacent to other equipment make sure that the...

Страница 39: ...ts as this product e g PC and or printer may lead to a reduction in the overall safety level of the system The equipment must comply with UL IEC 60950 When selecting accessories connected to the device the following points must be considered Use 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 C...

Страница 40: ...5 55 55 www otometrics com 16 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 extensions 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 eq...

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