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Maico touchTymp MI 26, Руководство по эксплуатации

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Operation Manual touchTymp MI 26 and MI 36 Version  

 

 

 

 

8511780 Rev. 4

 

90 

30/06/2021  

 

6.5 Electromagnetic Compatibility (EMC) 

ESSENTIAL PERFORMANCE for this device is defined by the manufacturer as: 

•

  This device does not have an ESSENTIAL PERFORMANCE 

•

  Absence  or  loss  of  ESSENTIAL  PERFORMANCE  cannot  lead  to  any 

unacceptable immediate risk. Final diagnosis shall always be based on clinical 
knowledge. 

This device is in compliance with IEC 60601-1-2:2014, emission class B group 1 

NOTICE:

 There are no deviations from the collateral standard and allowances uses. 

NOTICE:

 All necessary instruction for maintaining compliance with regard to EMC can be 

found in the general maintenance section in this instruction. No further steps required. 

To ensure compliance with the EMC requirements as specified in IEC 60601-1-2, it is 
essential to use only the accessories listed in the following table. Conformance to the 
EMC requirements as specified in IEC 60601-1-2 is ensured if the cable types and 
cable lengths are as specified. 
 

Item 

Manufacturer  Model 

Cable 

SIP/SOP 

Length 
[meter] 

Screened 
[Y/N] 

Socket 
ID 

Type 

Probe System: 
Pen  Probe 
(Hand-held) 

Maico 

8105703 

2.1 

Combined  13 

Various 

Contra 
Headset 

Radioear 

DD45 C 

2.0 

Y 

9 

Audio 
output 

Headsets: 

Audiometric 
Headset 

Radioear 

IP30 

2.0 

Y 

6 & 7 

Audio 
output 

Bone 
Conductor 

Radioear 

B71W 

2.0 

Y 

8 

Audio 
output 

Monitor 
Headset  w. 
microphone 

Sennheiser 

PC131 

2.9 

Y 

11 

Audio 
output 

12 

Audio 
input 

Various: 

Talk 

Back 

Microphone 

Radioear 

EMS400 

2.0 

Y 

10 

Audio 
input 

Patient 
response 
switch 

Radioear 

APS3 

2.0 

Y 

5 

DC 
level 

LAN  

For production and service use only 

1 

Data 

Cable  USB 
A/B 

(w. 

dummy) 

Sanibel 

8011241 

2.0 

Y 

3 

Data 

USB A 

Only for connection of USB flash drive during firmware update 
or error log export. Socket has no use on daily basis 

1 

Data 

USB A 

2 

Data 

Power 
Supply 

UE / Fuhua 

UES65-240250SPA3 

1.0 

Y 

4 

DC 
power 

Содержание touchTymp MI 26

Страница 1: ...Operation Manual touchTymp MI 26 and MI 36 Version...

Страница 2: ......

Страница 3: ...1 Warranty 15 3 2 Maintenance 15 3 3 Cleaning and Disinfection Recommendations 15 3 4 Disposables 19 3 5 Components Replacement Parts 19 3 6 Troubleshooting 19 3 7 Recycling and Disposal 20 4 Unpackin...

Страница 4: ...t www maico biz Germany https www maico diagnostics com german support resources International https www maico diagnostics com support resources Copyright 2021 MAICO Diagnostics All rights reserved No...

Страница 5: ...r and to assess hearing The touchTymp Tympanometer with Audiometry intended to be used for the identification of hearing loss and the factors that contribute to the occurrence of the hearing loss in t...

Страница 6: ...the patient is too young sick or uncooperative to perform the tasks 1 4 Features and Benefits of the touchTymp 1 4 1 General Information About the touchTymp The touchTymp is available as a version wi...

Страница 7: ...results from the touchTymp are accomplished in a variety of ways Use the build in printer to directly print results Transfer touchTymp test data into the PC software and print results on your PC prin...

Страница 8: ...hich changes the compliance of the middle ear system As in Tympanometry a probe tone is used to measure this change in compliance When the stimulus presentation and measurement are made in the same ea...

Страница 9: ...not distinguish between a conductive versus a sensorineural abnormality 1 5 7 Bone Conduction Testing MI 26 Version Extra License MI 36 Version Included Hearing threshold levels can be determined by p...

Страница 10: ...ing safety information as well as maintenance and cleaning recommendations READ THIS ENTIRE OPERATION MANUAL BEFORE ATTEMPTING TO USE THIS SYSTEM Use this device only as described in this manual All i...

Страница 11: ...contained in this manual accompanying labels and or inserts A defective product should not be used Make sure all connections to external accessories are snug and secured properly Parts which may be br...

Страница 12: ...cturer Caution consult accompanying documents Warning consult accompanying documents Return to authorized representative special disposal required Reference number Medical Device Patient applied part...

Страница 13: ...he manufacturer for repair and or calibration Do not use the device if any damage is suspected Calibration of the device The device and the transducers complement each other and share the same serial...

Страница 14: ...IEC 60601 1 shall be kept outside the patient environment i e at least 1 5 m from the patient support or shall be supplied via a separation transformer to reduce the leakage currents Any person who co...

Страница 15: ...s for magnetic resonance imaging where the intensity of electromagnetic disturbance is high The device fulfills the relevant EMC requirements Avoid unnecessary exposure to electromagnetic fields e g f...

Страница 16: ...anty In the event of repair during the guarantee period please enclose evidence of purchase with the device 3 2 Maintenance In order to ensure that the device works properly it has to be checked and c...

Страница 17: ...have contacted the system components or accessories the unit should not be used until deemed safe by a MAICO certified service technician Do not use hard or pointed objects on the device or its acces...

Страница 18: ...remove cerumen from the probe tip s small acoustic and air pressure channels Therefore please follow the illustrated instructions below The pictures show the procedure on the Pen Probe left and the S...

Страница 19: ...the probe system can only be serviced by MAICO Cleaning alternative Figure 8 Figure 9 Use the cleaning set from the eartip box Figure 8 Take the cleaning tool apart to find the thin brush and thin rig...

Страница 20: ...closed Otherwise follow the suggestions in Probe tip No start of measurement Probe tip 1 Clean the probe tip as described in the manual If the system still does not run proceed with step 2 2 Use a new...

Страница 21: ...are marked with a crossed out wheeled bin Within the limits of Article 9 of DIRECTIVE 2002 96 EC on waste electrical and electronic equipment WEEE MAICO has changed their sales policy To avoid additi...

Страница 22: ...hipment If any component is missing contact your distributor immediately to report the shortage If any component appears to be damaged in shipment contact your distributor immediately to report it Do...

Страница 23: ...nscable USB Cable Thermal Paper Rolls EarTip Kit Probe Floss Kit Cleaning Cloth Touch Pen MAICO Sessions Kit Operation Manual Quick Guide Components for Testing Tympanometry and Acoustic Reflexes Pen...

Страница 24: ...Acoustic Reflexes Ipsi and Contra Reflex Decay Ipsi and Contra ETF Audiometry Air Conduction Audiometry Bone Conduction Includes Masking Extra Licenses Tympanometry 1000 Hz RaceCar PC Connection Disp...

Страница 25: ...ystem given in this section Figure 16 Table 3 Connections on Backside of Device CONNECTIONS 1 Ethernet USB out Dual connector Ethernet no function in actual touchTymp version USB A connection for conn...

Страница 26: ...Hawp43VS3_Y l ist PLonI5JzuDcd7lxKobEy7BW3DS59QCsbAG Connect and disconnect the probe as follows 1 To connect position the probe connector over the locating pins Figure 17 2 Push the connector until...

Страница 27: ...0950 If a non medical device is used within the patient environment 1 5 m from patient as defined in IEC 60601 a voltage transformer must be used exception a battery driven laptop is used Table 4 PC C...

Страница 28: ...16 Table 5 shows the explanation of the probe design for both Pen Probe and Shoulder Box The further explanation of the indication light and the light bar in this section applies to both probes Table...

Страница 29: ...he indication light displays the different states of the measurement by color and the presentation modus flashing continuous Table 6 gives explanation to the different indications Table 6 Indication L...

Страница 30: ...ing up dependent on the values normative box While completing Tympanometry testing the Light Bar will light up indicating the height of the compliance according to the following Table 8 Table 8 Light...

Страница 31: ...8 Test Cavities Figure 27 You can use the 0 5 ml 1 0 ml 2 0 ml and 5 0 ml test cavities for validity check of the probe calibration Figure 27 To perform a probe check select a protocol that measures...

Страница 32: ...following routine check procedures for audiometric equipment 5 1 2 Where to Setup The touchTymp should be operated in a quiet room so that the audiometric examinations are not influenced by outside no...

Страница 33: ...ection 3 2 5 1 4 Switching Off the Device Figure 33 The device can be shut down from any screen by pressing the Front key Choose one of the options Shutdown or Standby offered in a message box and pre...

Страница 34: ...ittance Testing 5 4 1 General Immittance The following sections 5 4 2 to 5 4 5 offer information about the modules Tympanometry Tympanometry and Acoustic Reflexes MI 26 and MI 36 version Reflex Decay...

Страница 35: ...the measurement completed will be transferred Only the test results of the currently selected probe tone will be transferred Print Print to print the results of all completed tests and of all probe t...

Страница 36: ...Decay module ETF ETF to open the ETF module for intact or perforated ETF testing 5 4 3 Preparing for Testing Immittance 5 4 3 1 Preparing the Patient Also check out our training videos MAICO Training...

Страница 37: ...finger slightly into the ear canal o One or more tones will be heard during the test No participation is expected from the patient The aim of Acoustic Reflexes is to test the condition of the Musculus...

Страница 38: ...pull gently up and back on the outer ear i e Pinna during insertion to straighten the ear canal Hold the adapter and aim and twist gently the eartip into the ear canal The fit of the eartip should be...

Страница 39: ...out of ear Probe is in the ear and is sealing test is running or test is done Probe is in the ear and blocked or leaking 1 Reinsert probe for better placement 2 Check eartip size and condition 3 Inspe...

Страница 40: ...creasetheinterceptsofthegraphs RaceCar Licensed function to display RaceCar animation during testing See section 5 4 4 3 for more information Figure 43 NOTE If you print the test results it will be pr...

Страница 41: ...witched on the normative boxes can be shown for 226 Hz and 1000 Hz The box indicates the normative area where the peak of the Tympanogram is expected The Pass and No Response criteria are based on the...

Страница 42: ...d in the ear when in the Basic Settings menu the automatic start of the measurement is selected see section 5 6 3 or the Play button is pressed when the manual start of the measurement is selected Whe...

Страница 43: ...oise stimuli MI 36 Version Only Figure 50 The MI 36 version includes pure tone and noise stimuli for Acoustic Reflex testing Pure tone 500 Hz 1000 Hz 2000 Hz 4000 Hz Noise BB Broadband HP High Pass LP...

Страница 44: ...ow of the display provides result information for the highlighted reflex i e stimulus 500 Hz Ipsi deflection value 08 ml intensity 90 dB HL Editing the displayed reflex Figure 54 To change the reflex...

Страница 45: ...tic Reflex test modules 3 Once entered the RaceCar screen shows the car running and waiting to start the race 4 Inform the child to sit very still and watch their car RACE to the finish line 5 The rac...

Страница 46: ...surement NOTE Tympanometry and Acoustic Reflex measurements are recommended to be performed before each Reflex Decay test to find the maximum compliance pressure and Acoustic Reflex threshold The resu...

Страница 47: ...re displayed in the large window while the test is performing and immediately duplicated in the small window upon the completion of the test Figure 64 To continue on testing 1 Select the next stimulus...

Страница 48: ...e tympanograms on a multilayer display Before testing begins instruct the patient not to move or talk until the test is completed Any sound or movement may give unreliable results Figure 69 As the tes...

Страница 49: ...t the patient not to move or talk until the test is over When a seal is obtained the device displays a message to swallow as many times during the test duration NOTE Automatic and manual mode are oper...

Страница 50: ...st practice to delete results after testing is completed for each patient 5 4 5 4 Printing Test Results with the Built in Printer Test results can be directly printed with the built in printer Press o...

Страница 51: ...lts to PC Note For data transfer between touchTymp and MAICO Sessions it is necessary to activate the license for PC connection which can be additionally purchased Before transferring data to a PC mak...

Страница 52: ...ar include Table 12 Table 12 Icons in the Tool Bar ICON FUNCTION EXPLANATION Test Screen Delete Delete to delete the stored measurements Select the button and a message box will appear to confirm whic...

Страница 53: ...tion Setting screen Default Default to set the device back to factory settings Save Save to save current selection NOTE An active button is displayed in blue Audiometry Main Screen Display Versions MI...

Страница 54: ...Also a green indicator is displayed on the left side of the status bar See Status Bar for more information Interrupter mode Touch to stop the signal being presented NOTE See Settings to change the Te...

Страница 55: ...When speaking 0 is the optimal level 2 Talk Back Allows the tester to hear the patient through the monitor headphone via an optional talk back microphone The talk back microphone must first be Enable...

Страница 56: ...ng noise 2 Stimulus symbol i e pure tone pulse etc for test ear 3 Hearing level of test signal displayed in the color of the ear being tested Right ear Red Left ear Blue 4 Frequency of test signal 5 M...

Страница 57: ...l Turns the volume level of the tone up down 2 Present The function of Present is determined by the Test mode of the device Presenter mode Touch to present the signal When this button is blue it is pr...

Страница 58: ...r voice for optimal sound quality When speaking 0 is the optimal level 2 Talk Back Allows the tester to hear the patient through the monitor headphone via an optional talk back microphone The talk bac...

Страница 59: ...transferring to the PC The display can be configured to Graph Table or None from the Settings See section 5 6 16 for more information NOTE None display does not allow storing of results Delete point O...

Страница 60: ...foam is still compressed grasp the patient s ear and gently pull it up and back to open and straighten the ear canal While holding the canal open slide the compressed foam ear tip into the ear canal...

Страница 61: ...ansmitted by the headphone For pure tone audiometry a narrowband noise is used This noise changes its center frequency according to the frequency of the test signal Adjust the level of the masking noi...

Страница 62: ...displayed on the touchTymp 5 5 5 5 Understanding the Print Out for Audiometry Built In Printer The following describes the printout for Audiometry only Figure 96 Figure 96 1 MAICO logo and name of dev...

Страница 63: ...Immittance NOTE The PC software must be opened prior to selecting transfer for successful transfer to occur 5 5 5 7 Editing Test Results Stored results can be edited by the Edit button within the too...

Страница 64: ...Settings Basic General Figure 100 Start Screen Adjust the start screen to your needs Choose Tympanometry or Tympanometry and Acoustic Reflexes for upon boot up the chosen screen is automatically ente...

Страница 65: ...ly Figure 104 NOTE Data will be lost when the device turns off It is possible to turn off this function by setting the value to never Figure 105 Brightness Set the maximum brightness of the display Fi...

Страница 66: ...rintout shall show the Facility and Patient fields Figure 111 NOTE Facility information can be entered into the device See section 5 6 6 5 6 5 Settings Basic Date Time Figure 112 Date format Select th...

Страница 67: ...tic Dynamic from 600 daPa s for low gradient and 200 daPa s for a gradient larger than 5 daPa Minimum 50 daPa s slow very precise results Medium 250 daPa s compromise of speed and precision Maximum 40...

Страница 68: ...see Appendix A for further information NOTE Values of US and International normative boxes will be displayed but cannot be changed User defined allows the user to define their own normative box Defin...

Страница 69: ...Define user s own pass criterion out of 0 01 to 0 1 ml Once user defined is checked the are active to make a selection Figure 127 Display pass no response If active the result Pass No Response will be...

Страница 70: ...l for Ipsi and Contra in 5 dB steps either for the level range if Automatic is selected or a single level if Fixed is selected Levels can be selected between Ipsi min 70 dB HL max 105 dB HL Contra min...

Страница 71: ...determines the color of the tympanometry graphs Swallow represented by Orange Valsalva represented by Green Figure 139 Pump speed Selection of pump speed determines how precisely and quickly the test...

Страница 72: ...hoose between 250 ms and 500 ms Figure 146 Default hearing level Select a level the test signal will return to with the following actions Enter Audiometry module Change ear Change transducer Delete Pr...

Страница 73: ...to the monitor phone as it is being delivered to the patient 5 6 16 Settings Audiometry Display Display type Selection of the test screen display Figure 151 Choose between None The test screen removes...

Страница 74: ...55 Right and Left graph is placed based on ear Display see section 5 6 3 Figure 108 MI26 Two audiogram MI 36 Two audiogram Figure 155 Figure 156 Symbol set Selection of country specific symbols to be...

Страница 75: ...requency selection moves to 125 Hz When the lowest frequency is reached and is selected frequency movement is to the highest frequency i e 125 Hz moves to 8000 Hz Back Frequency movement return to 100...

Страница 76: ...hin the MI 26 version If this is not licensed Bone is greyed out 5 6 18 Settings Audiometry Masking NOTE Masking is included in the optional Bone Conduction license with the MI 26 version If device is...

Страница 77: ...e box will be shown telling you to verify the code Figure 171 Ask your local distributor if any problems occur If you entered a correct code a message box will tell you Licensing completed 5 6 20 Sett...

Страница 78: ...via USB flash drive Figure 180 A message box will be shown to ask you if you want to continue updating Figure 181 NOTE The device will be restarted after application update Figure 182 Export Settings...

Страница 79: ...s only for editing by service The dealer can enter his contact information to display in the Quick Info screen Figure 187 5 6 23 Quick Info Figure 188 Shows information in a message box about the firm...

Страница 80: ...tions The performance and specifications of the device can only be guaranteed if it is subject to technical maintenance at least once every 12 months MAICO Diagnostics puts diagrams and service manual...

Страница 81: ...ian Polish Russian Spanish Turkish Connectors External USB out USB in USB out power socket Contra headphone jack probe connector Data interfaces USB 1 1 Ethernet not implemented PC Connection USB the...

Страница 82: ...Pa s for low gradient and 200 daPa s for a gradient larger than 5 daPa Minimum 50 daPa s slow very precise results Medium 250 daPa s compromise of speed and precision Maximum 400 daPa s fast screening...

Страница 83: ...Graphical display x axis Volume in ml y axis Time in ms Level in dB HL Ipsi earphone Earphone integrated in probe Contralateral headphones Insert earphone Headphone s IP30 DD45 C Test types Automated...

Страница 84: ...dioEar Standard Values Bone Conduction B71 B81 ISO 389 3 ANSI S3 6 ISO 389 3 ANSI S3 6 Placement Mastoid Effective masking ISO 389 4 ANSI S3 6 Transducers Headband tension DD45 Headband Static Force 4...

Страница 85: ...Not applicable in actual version 1 2 USB out 2 x USB 1 1 3 USB in USB 1 1 4 24 V 2 5 A 24V DC 2 5A Part No Power Supply UES65 240250SPA3 5 Response RI 2000 6 Phone L ZA 10 UA 3 Veff 7 Phone R ZA 10 UA...

Страница 86: ...d Signal TLK FW Ground Right Left TLK BK Ground Right Left USB A OUT USB B IN 1 5 VDC 1 5 VDC 2 Data 2 Data 3 Data 3 Data 4 Ground 4 Ground PROBE CONNECTOR PIN FUNCTION LAN Eth 15 pin D sub highdensit...

Страница 87: ...adioEar Standard Values REFERENCE VALUES FOR STIMULUS CALIBRATION Fre quency Hz Reference equivalent threshold sound pressure level RETSPL dB re 20 Pa IP30 ISO 389 2 DD45 C IOWA Probe MAICO Standard V...

Страница 88: ...14 0 120 105 2000 8 0 14 0 120 105 26 3000 8 0 14 0 120 105 4000 9 0 14 0 120 105 32 6000 20 5 25 5 110 95 8000 12 0 17 0 105 95 24 White Noise 0 0 120 Calibration Values Insert Earphone IP30 Referen...

Страница 89: ...00 11 0 15 0 115 90 9 4 750 6 0 11 0 115 95 1000 5 5 11 5 115 95 12 8 1500 5 5 11 5 110 95 2000 4 5 10 5 110 95 15 1 3000 2 5 8 5 115 95 4000 9 5 14 5 110 95 28 8 6000 17 0 22 0 100 85 8000 17 5 22 5...

Страница 90: ...Conductor Radioear B81 Coupler ISO 389 3 ANSI S3 6 Frequency Hz Reference equivalent threshold force level for tone Max level ISO 389 3 dB re 1 N Tone dB HL 250 67 0 45 500 58 0 70 750 48 5 75 1000 42...

Страница 91: ...al to use only the accessories listed in the following table Conformance to the EMC requirements as specified in IEC 60601 1 2 is ensured if the cable types and cable lengths are as specified Item Man...

Страница 92: ...RF emissions CISPR 11 Class B The touchTymp is suitable for use in all commercial industrial business and residential environments Harmonic emissions IEC 61000 3 2 Complies Class A Category Voltage fl...

Страница 93: ...environment Surge IEC 61000 4 5 1 kV differential mode 2 kV common mode 1 kV differential mode 2 kV common mode Mains power quality should be that of a typical commercial or residential environment Vo...

Страница 94: ...n meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the...

Страница 95: ...nt Safety Part 1 General Requirements 5 IEC 60601 1 1 2000 General requirements for safety Collateral standard Safety requirements for medical electrical systems 6 IEC 60601 1 2 2014 Medical Electrica...

Страница 96: ...Operation Manual touchTymp MI 26 and MI 36 Version 8511780 Rev 4 95 30 06 2021 6 7 Checklist for subjective Audiometer Testing...

Страница 97: ...v 46 11 905 8 Rafidah Mazlan Joseph Kei Louise Hickson Asaduzzaman Khan John Gavranich Ron Linning High Frequency 1000 HZ Tympanometry Findings in Newborns Normative Data Using a Component Compensated...

Страница 98: ...ecifications are subject to change without notice MAICO Diagnostics GmbH Sickingenstr 70 71 10553 Berlin Germany Tel 49 30 70 71 46 50 Fax 49 30 70 71 46 99 E mail sales maico biz Internet www maico b...

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