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Operation Manual touchTymp MI 24 and MI 34 Version

8107420 Rev. 6

03/09/2018

Title: Operation Manual touchTymp

– MI 24 and MI 34 Version

Date of issue/last revision: 03/09/2018

All rights reserved. No part of this publication may be reproduced or transmitted in any
form or by any means without the prior written permission of MAICO Diagnostics. The
information in this publication is proprietary to MAICO Diagnostics.

Compliance

MAICO Diagnostics GmbH is an ISO 13485 certified corporation.

Caution for USA:

Federal Law restricts this device to sale by or on the order of a

licensed medical professional.

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:

[email protected]

Internet:

www.maico.biz

Содержание MI 24

Страница 1: ...Operation Manual touchTymp MI 24 and MI 34 Version...

Страница 2: ......

Страница 3: ...bility EMC 13 3 Warranty Maintenance and After Sales Service 14 3 1 Warranty 14 3 2 Maintenance 14 3 3 Cleaning and Disinfection Recommendations 14 3 4 Disposables 17 3 5 Components Replacement Parts...

Страница 4: ...any form or by any means without the prior written permission of MAICO Diagnostics The information in this publication is proprietary to MAICO Diagnostics Compliance MAICO Diagnostics GmbH is an ISO 1...

Страница 5: ...when performing Immittance tests If you have questions or suggestions for further improvements please do not hesitate to contact MAICO 1 2 Intended Use Statement The touchTymp Tympanometer is used to...

Страница 6: ...ecay Eustachian Tube Function Optional high frequency probe tone Optional RaceCar animation Multiple transducer options for contralateral reflex testing Automatic test function in Immittance modules I...

Страница 7: ...esented to the ear canal by means of the hand held probe This tone is used to measure the change in compliance in the middle ear system while the air pressure is varied automatically from a positive v...

Страница 8: ...liance greater than the selected value is detected a reflex is considered present Because this is an extremely small compliance change any movement of the probe during the test may produce an artifact...

Страница 9: ...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 10: ...with the instructions 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...

Страница 11: ...on consult accompanying documents Warning consult accompanying documents Return to authorized representative special disposal required Reference number Patient applied part type B according to IEC 606...

Страница 12: ...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 nu...

Страница 13: ...with the leakage current requirements in 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 redu...

Страница 14: ...7 Device Control The user of the device should perform a subjective device check once a week according ISO 8253 1 For annual calibration see section 2 5 and 3 2 2 8 Electromagnetic Compatibility EMC E...

Страница 15: ...r or by an authorized service center Opening the device case will void the warranty No modification of this equipment is allowed In the event of repair during the guarantee period please enclose evide...

Страница 16: ...in the presence of fluid that can come into contact with any of the electronic components or wiring Should the user suspect fluids have contacted the system components or accessories the unit should...

Страница 17: ...on the Pen Probe left and the Shoulder Box right Never clean the probe tip while the tip is still attached to the probe Figure 2 Unscrew the probe cap by turning it in a counter clockwise direction F...

Страница 18: ...n rigid plastic cord Figure 9 Figure 10 Use the plastic cord or brush to push debris out of the probe tip Figure 10 Figure 11 Always enter the probe tip from the rear to avoid accumulation of debris i...

Страница 19: ...roceed with step 2 2 Use a new probe tip If the system still does not run proceed with step 3 Change the complete probe and check if the system is running Screen is frozen Hold the Front key button fo...

Страница 20: ...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 21: ...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 22: ...Flash Drive Kit Power Supply 24V 60W UE60 240250SPAx Country Specific Mainscable USB Cable Thermal Paper Rolls EarTip Kit Probe Floss Kit Cleaning Cloth Touch Pen MAICO Software Module Bundle Operati...

Страница 23: ...n 9 mm Mushroom Silicone Eartips 10 pcs Sanibel Red 3 5 mm Flanged Silicone Eartips 10 pcs Sanibel Blue 11 mm Mushroom Silicone Eartips 10 pcs Sanibel Green 13 mm Mushroom Silicone Eartips 10 pcs Sani...

Страница 24: ...hernet no function in actual touchTymp version USB A connection for connection of USB flash drive 2 USB out USB A connection for connection of USB flash drive 3 USB in USB B connection for data transf...

Страница 25: ...ia USB is required If the touchTymp is used with office equipment that is not a medical device itself see Table 4 make sure to establish the PC connection in one of the following ways see Table 4 PC C...

Страница 26: ...ontralateral headphone Figure 22 Both the Pen Probe Figure 20 and the Shoulder Box Figure 21 are connected to the device in plug 13 Figure 16 Table 5 shows the explanation of the probe design for both...

Страница 27: ...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 28: ...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 29: ...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 30: ...ake a long time depending on the conditions like environmental humidity You can reduce the condensation by storing the device in its original packaging If the device is stored under warmer conditions...

Страница 31: ...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 32: ...offer information about the modules Tympanometry Tympanometry and Acoustic Reflexes MI 24 and MI 34 version Reflex Decay and Eustachian Tube Function MI 34 version only 5 4 2 The Screen Format The ge...

Страница 33: ...robe tone will be transferred Print Print to print the results of all completed tests and of all probe tones Selection of ears Ear to select an ear for testing or repeating the measurement on the same...

Страница 34: ...table if necessary Small children may feel more comfortable sitting on a parent s lap Keep in mind the indication and contraindications of use given in sections 1 2 and 1 3 5 4 3 2 Visual Inspection...

Страница 35: ...patient searcanals Do not insert the probe without having an eartip attached to prevent damage to the patient s ear canals Figure 37 Put the eartip tightly on the probe tip making sure it is pushed al...

Страница 36: ...be is 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...

Страница 37: ...uring testing See section 5 4 4 3 for more information Figure 43 NOTE If you print the test results it will be printed with the view as displayed on the screen Figure 44 The measurement will be starte...

Страница 38: ...ormative area where the peak of the Tympanogram is expected The Pass and No Response criteria are based on the placement of the Tympanogram peak within the normative box A result is considered a Pass...

Страница 39: ...easurement is selected see section 5 6 3 or the Play button is pressed when the manual start of the measurement is selected When performing Acoustic Reflex testing it is possible to interrupt the meas...

Страница 40: ...d noise stimuli for Acoustic Reflex testing Pure tone 500 Hz 1000 Hz 2000 Hz 4000 Hz Noise BB Broadband HP High Pass LP Low Pass Select the stimulus type to set or confirm test stimuli prior to starti...

Страница 41: ...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 42: ...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 43: ...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 44: ...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 45: ...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 46: ...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 47: ...actice 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 on the...

Страница 48: ...d with graphical and numerical information 5 4 5 6 Transferring Test Results to PC Before transferring data to a PC make sure that you have installed the PC software properly according to the separate...

Страница 49: ...the Fixed Function Bar to access the list of setting menus MI 34 version offers two additional menus Reflex Decay and ETF MI 24 Figure 84 MI 34 Figure 85 Figure 84 Figure 85 Each menu consists of one...

Страница 50: ...tive if Audiometry is selected as Start Screen Figure 87 Figure 89 Language Choose one of the supported languages incorporated in the device Figure 89 Figure 90 Standby Set the period of inactivity af...

Страница 51: ...utton and graph for the left and the right ear shall be displayed Figure 95 Figure 96 Light bar Activates or deactivates the light bar function on the probe Figure 96 5 6 4 Settings Basic Print Figure...

Страница 52: ...Empty fields will not be printed Figure 103 Also see section Fehler Verweisquelle konnte nicht gefunden werden 5 6 7 Settings Tympanometry General Figure 104 Pump speed Selection of pump speed determ...

Страница 53: ...established US and International standards Normative Box options include Off to not display any normative box in the Tympanometry screen Display Pass No Response is disabled with this setting US to us...

Страница 54: ...flex Decay display for MI 34 version Figure 113 Pass criterion Defines the deflection value that must be measured for the reflex to be considered an accepted measurement Figure 113 The options for sel...

Страница 55: ...which level change is used when entering the Acoustic Reflex module Options include Automatic touchTymp starts Acoustic Reflex test at the minimum level and increases in 5 dB steps automatically until...

Страница 56: ...fined within the Acoustic Reflex settings 5 6 13 Settings ETF Intact MI 34 Version Figure 125 First Test Defines the message while the test is in progression The end user can select which maneuver wil...

Страница 57: ...he time the test will be conducted Figure 130 Test duration can be configured in 5 s increments from 30 s to 100 s 5 6 16 Settings License Management General The License Management screen allows addit...

Страница 58: ...y for Service Figure 138 Figure 139 Test printout prints a test printout without a session result Figure 139 Figure 140 Figure 141 Export error log If an error is occurring you can export the error lo...

Страница 59: ...shown Figure 148 Figure 148 5 6 19 Settings Service Support Figure 149 This menu is only for editing by service The dealer can enter his contact information to display in the Quick Info screen Figure...

Страница 60: ...ns The performance and specifications of the device can only be guaranteed if it is subject to technical maintenance at least once per year MAICO Diagnostics puts diagrams and service manuals at the d...

Страница 61: ...an Italian 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 U...

Страница 62: ...ic 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 400 daPa s...

Страница 63: ...d Values 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 IP30 CIR22 CIR55 DD45 C Te...

Страница 64: ...ents are minor and will not activate the reflex detection system 6 2 Connections Figure 151 Table 15 Connections on Backside of Device CONNECTIONS No Connection socket Specification 1 Ethernet Not app...

Страница 65: ...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 66: ...IBRATION Fre quency Hz Reference equivalent threshold sound pressure level RETSPL dB re 20 Pa IP30 CIR22 CIR55 ISO 389 2 DD45 C IOW Probe MAICO Standard Values MAICO Standard Values SOUND ATTENUA TION...

Страница 67: ...17 80 MHz to 800 MHz d 1 17 800 MHz to 2 5 GHz d 2 23 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0 74 1 1 17 1 17 2 33 10 3 70 3 70 7 37 100 11 70 11 70 23 30 For transmitters rated at a maximum output power n...

Страница 68: ...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 69: ...60601 1 1 2000 General requirements for safety Collateral standard Safety requirements for medical electrical systems 5 IEC 60601 1 2 2014 Medical Electrical Equipment Part 1 2 General Requirements fo...

Страница 70: ...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 71: ...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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