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easyTymp
Operation Manual
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Operation Manual
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Maico easytymp Operation Manual

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Operation Manual easyTymp
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Contents
Introduction ............................................................................................................. 3
1.1 General ............................................................................................................ 3
1.2 Intended Use Statement ................................................................................... 3
1.3 Contraindications of Use .................................................................................. 3
1.4 Essential Performance ....................................................................................... 4
1.5 Features and Benefits of the easyTymp ............................................................. 4
1.6 Description ....................................................................................................... 5
For Your Safety ......................................................................................................... 7
2.1 How to Read This Operation Manual ................................................................ 7
2.2 Customer Responsibility .................................................................................... 8
2.3 Manufacturer’s Liability .................................................................................... 8
2.4 Regulatory Symbols .......................................................................................... 9
2.5 General Precautions ........................................................................................ 10
2.6 Electrical Safety and Measuring Security .......................................................... 10
2.7 Device Control ............................................................................................... 12
2.8 Electromagnetic Compatibility (EMC) .............................................................. 12
2.9 Battery Safety ................................................................................................. 12
Warranty, Maintenance and After-Sales Service ...................................................... 13
3.1 Warranty ........................................................................................................ 13
3.2 Maintenance .................................................................................................. 13
3.3 Cleaning and Disinfection Recommendations .................................................. 14
3.4 Troubleshooting ............................................................................................. 18
3.5 Recycling and Disposal .................................................................................... 20
Unpacking and Installation...................................................................................... 21
4.1 Unpacking the system .................................................................................... 21
4.2 System Installation .......................................................................................... 24
4.3 Software ........................................................................................................ 29
4.4 Using the MPT-IIThermal Printer ...................................................................... 29
Operating the Device .............................................................................................. 31
5.1 Getting started with the easyTymp ................................................................. 31
5.2 Preparing for Testing ...................................................................................... 31
5.3 Start the Test .................................................................................................. 34
5.4 Probe Status Indication ................................................................................... 34
5.5 Testing ........................................................................................................... 34
5.6 Setup Menu ................................................................................................... 42
5.7 Managing Test Results .................................................................................... 45
Technical Data ........................................................................................................ 47
6.1 easyTymp Hardware ....................................................................................... 47
6.2 Connections and Pin Assignment .................................................................... 54
6.3 Reference values for stimulus calibration ......................................................... 56
6.4 Electromagnetic Compatibility ........................................................................ 57
6.5 Electrical Safety, EMC and Associated Standards ............................................. 60
6.6 Test Protocols ................................................................................................. 61
Appendix ................................................................................................................ 63
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Title: easyTymp – Operation Manual Date of issue/last revision: 17/01/2018
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.biz
FOR NORTH- AND SOUTH AMERICA
MAICO Diagnostics 10393 West 70th Street Eden Prairie, MN 55344 United States Tel.: +1 (888) 941 4201 Fax: +1 (952) 903 4100 E-mail: info@maico-diagnostics.com Internet: www.maico-diagnostics.com
Copyright © 2017 MAICO Diagnostics.
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. The information in this publication is proprietary to MAICO.
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.
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Introduction
This section offers you important information about:
the intended use of the device indications and contraindications for use essential performance features and benefits a description of the device
1.1 General
Thank you for purchasing a quality product from the MAICO product family. The easyTymp is designed and manufactured to meet all quality and safety requirements.
When designing the easyTymp, MAICO placed particular importance on making it a user­friendly device. The intent was to make its operation easy-to-learn, thus making the device simple and easy to operate.
This user manual is meant to make it as easy as possible for the operator to become familiar with the operation and functions of the easyTymp when performing Impedance tests. If you have questions or suggestions for further improvements, please, do not hesitate to contact MAICO.
This operation manual provides instruction about different versions of the easyTymp. Please, confirm your version for relevant sections to your purchased device.
1.2 Intended Use Statement
The tympanometer is used to obtain information on medical conditions affecting the middle ear and to assess hearing.
Indications for Use The easyTymp is an electroacoustic test device that produces controlled levels of test tones and signals intended for use in conduction diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders. It features tympanometry and acoustics reflex.
Target population
The easyTymp intended to be used for the identification of hearing loss and the factors that contribute to the occurrence of the hearing loss in the age range of infant to adults.
1.3 Contraindications of Use
Testing should not be performed on patients with one of the following symptoms without a medical doctor’s approval:
Recent stapedectomy or other middle ear surgery Discharging ear Acute external auditory canal trauma Discomfort (e.g. severe otitis externa) Occlusion of the external auditory canal Presence of tinnitus, hyperacusis or other sensitivity to loud sounds may
contraindicate testing when high intensity stimuli are used Visual inspection for obvious structural abnormalities of the external ear structure and positioning as well as the external ear canal should be performed before testing.
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1.4 Essential Performance
The following is considered essential performance: To generate and present stimulus signals in the audio and pressure ranges as specified
in the applicable IEC 60645/ANSI S3.39 series in normal condition. It is intended to be used by audiologists, ENTs, hearing healthcare professionals, or other
trained technicians in a hospital, clinic, healthcare facility or preferably other suitable quiet environment as defined in standard ISO 8253-1.
The easyTymp can be used on patients in the age range of infants, children and adults.
1.5 Features and Benefits of the easyTymp
The purpose of the easyTymp test system is to provide a rapid Tympanometry and Acoustic reflex measurements to measure the middle ear status where a pass or no response notation is identified. easyTymp provides an optional 1 kHz probe tone for testing infants. Factory defined
protocols allow for simple screening measurements, and different versions are available that
provide diagnostic testing functions. As with any type of hearing screening, a “pass” result should not overrule any additional concerns regarding middle ear function. A referral to physician should be administered if concerns about middle ear function persists.
The easyTymp cradle serves as a docking and recharging station for the handheld device and includes an opening for placement of the eartip box.
Using the included Software, the handheld unit will transfer data to a PC via USB­connection while in the docking station, or it can also transfer data directly via USB cable when no docking station is available.
The easyTymp comes in multiple versions and configurations dependent on the country and service partner. Each version provides specific testing functionalities dependent upon the user needs.
easyTymp (as Standard Version)
Rapid tympanometry measurement Ipsilateral acoustic reflex measurements at several frequencies 1 kHz probe tone (option)
easyTymp Plus Version (Contra Probe Required)
Rapid tympanometry measurement Ipsilateral acoustic reflex measurements at several frequencies Contralateral acoustic reflex measurements at several frequencies 1 kHz probe tone (option)
easyTymp Pro Version (Contra Probe Required)
Rapid tympanometry measurement Ipsilateral acoustic reflex measurements at several frequencies Contralateral acoustic reflex measurements at several frequencies Acoustic reflex decay (Ipsilateral and Contralateral) Eustachian tube function 1 kHz probe tone (option)
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1.6 Description
1.6.1 General
Dependent on the configuration the easyTymp offers the following Impedance measurements:
Tympanometry Acoustic Reflex Contralateral Acoustic Reflex Acoustic Reflex Decay Eustachian Tube Function Test
Further information on the different tests are given in sections 1.6.2 to 1.6.6.
1.6.2 Tympanometry
Tympanometry is the objective measurement of middle ear mobility (compliance1) and pressure2 within the middle ear system (Figure 1). During the test, a low-pitched probe tone (226 Hz) is presented 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 value (i.e. +200 daPa) to a negative value (i.e. -400 daPa max).
Figure 1
Maximum compliance of the middle ear system occurs, when the pressure in the middle ear cavity is equal to the pressure in the external auditory canal. This is the highest peak of the curve as it is recorded on the chart. The position of the peak on the horizontal axis and on the vertical axis of the chart will provide diagnostic information regarding the function of the middle ear system. Gradient calculations are reported as the Tympanogram width at half of peak compliance expressed in daPa. A normative box is available on both the display and printout to aid in diagnosis.
NOTE: 1.02 mmH2O = 1.0 daPa.
1
Compliance is measured with respect to an equivalent volume of air, with the scientific quantity milliliter (ml).
2
Air pressure is measured in deca-Pascals (daPa).
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1.6.3 Acoustic Reflex
An Acoustic Reflex, or contraction of the stapedial muscle, occurs under normal conditions when a sufficiently intense sound is presented to the auditory pathway. This contraction of the muscle causes a stiffening of the ossicular chain which 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 ear by means of the probe, this acoustical reflex is referred to as an Ipsilateral Acoustic Reflex. When the stimulus presentation is made in the opposite ear of where the measurement is made, this acoustical reflex is referred to as a Contralateral Acoustic Reflex.
For best results, this reflex measurement is automatically conducted at the air pressure value where the compliance peak occurred during the Tympanometric test. Stimulus tones of varying intensities at 500 Hz, 1000 Hz, 2000 Hz or 4000 Hz are presented as short bursts. If a change in compliance 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 (false response). The test result is recorded as Pass/No Response, and in graphical form.
If the Tympanometric results display any abnormal findings, the results of the Acoustic Reflex testing may be inconclusive and should be interpreted with care. Theoretically, a compliance peak is necessary to observe a reflex at peak pressure.
1.6.4 Contralateral Acoustic Reflex
A Contralateral Acoustic Reflex is available with the easyTymp Plus and Pro Version. When the stimulus presentation and measurement are made in the different ears by means of the Contra Probe.
1.6.5 Acoustic Reflex Decay
An Acoustic Reflex Decay is available with the easyTymp Pro Version. Acoustic reflex decay, also known as adaptation, is the measurement of the Acoustic reflex response during sustained stimulus presentation. Ipsilateral and Contralateral Reflex Decay can be performed.
1.6.6 Eustachian Tube Function Test
The Eustachian tube connects the middle ear with the nasopharynx. Its function is to equalize pressure between the middle ear and the atmosphere.
The Eustachian tube test is available with the easyTymp Pro Version. It can be used to determine if the Eustachian tube is functioning properly in patients with an intact tympanic membrane or in patients who have a perforated TM or pressure equalization tubes.
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For Your Safety
This section offers you important information about:
how to read the operation manual where to spend special attention the customer responsibility the explanation of all regulatory symbols used important cautions and warnings that have to be considered while
handling and operating your device
2.1 How to Read This Operation Manual
This Operation Manual contains information pertinent to the use of the MAICO easyTymp system including safety information as well as maintenance and cleaning recommendations.
READ THIS ENTIRE MANUAL BEFORE ATTEMPTING TO USE THIS SYSTEM!
Use this device only as described in this manual. All images and screenshots are only examples and may differ in
appearance from the actual device settings.
In this manual, the following two labels identify potentially dangerous or destructive conditions and procedures:
The WARNING label identifies conditions or practices that may present danger to the patient and/or user.
The CAUTION label identifies conditions or practices that could result in damage to the equipment
WARNING
CAUTION
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2.2 Customer Responsibility
All safety precautions given in this operation manual must be observed at all times. Failure to observe these precautions could result in damage to the equipment and injury to the operator or subject.
The employer should instruct each employee in the recognition and avoidance of unsafe conditions and the regulations applicable to his or her work environment to control or eliminate any hazards or other exposure to illness or injury.
It is understood that safety rules within individual organizations vary. If a conflict exists between the material contained in this manual and the rules of the organization using this device, the more stringent rules should take precedence.
This product and its components will perform reliably only when operated and maintained in accordance 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. Parts which may be broken or missing or are visibly worn, distorted, or contaminated should be replaced immediately with clean, genuine replacement parts manufactured by or available from MAICO.
2.3 Manufacturer’s Liability
Usage of the device in a way deviant from the intended use will lead to a limitation or termination of the manufacturer’s liability in case of damage. Improper use includes disregarding the operation manual, the operation of the device by underqualified personnel as well as making unauthorized alterations on the device.
WARNING
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2.4 Regulatory Symbols
The following Table 1 gives an explanation of the symbols used on the device itself, on the packaging and the accompanying documents including the Operation Manual.
Table 1 Regulatory Symbols
REGULATORY SYMBOLS
SYMBOL
DESCRIPTION
Serial number
Date of manufacture
Manufacturer
Caution, consult accompanying documents
Warning, consult accompanying documents
Return to authorized representative, special disposal required
Reference number
Patient applied part type B according to IEC 60601-1
Refer to instruction manual (mandatory)
Keep away from rain
Transport and storage temperature range
Transport and storage humidity limitations
Transport and storage atmospheric pressure limitations
Voltage transformer
Electrostatic sensitive devices
Do not reuse
Conforms to European Medical Device Directive 93/42/EEC
Non-ionizing electromagnetic radiation
ETL listed mark
Logo
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2.5 General Precautions
Before starting a measurement make sure, that the device works properly.
Use and store the device indoors only. For operation, storage and transport conditions see table in section 6.
For operation in certain places, a recalibration may be necessary.
No modification of this equipment is allowed. Equipment is not user repairable. Repairs must be
performed by a qualified service representative only. No modifications of the equipment are allowed by anyone other than a qualified MAICO representative. Modification of the equipment could be hazardous. No part of the equipment can be serviced or maintained while in use with the patient.
Do not drop or otherwise cause undue impact to this device. If the device is dropped or otherwise damaged, return it to the 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 number (i.e. MA7663252). Therefore, the device shall not be used with any other transducer prior to recalibration. Recalibration also needs to be conducted, when a defected headphone is replaced.
Uncalibrated devices may lead to faulty measurement results and could even damage the hearing of the examinee.
2.6 Electrical Safety and Measuring Security
This icon indicates that patient applied parts of the device conform to IEC 60601-1 Type B requirements.
The protection class of the system depends on the used power supply.
In Case of Emergency
In case of emergency, disconnect the device from the computer.
In Case of Emergency
In case of emergency, disconnect the device from the power supply.
WARNING
WARNING
WARNING
WARNING
WARNING
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Do not position the cradle or the printer in a way that it is difficult to operate the disconnection device. The supply mains and the power socket shall be accessible at all times.
Do not use the device if the mains cable and/or the outlet is damaged.
Safety against electrical hazard is guaranteed only when the connected notebook computer is powered by batteries respectively the computer´s power supply accords to the IEC 60601-1 or IEC 60950-1 safety regulations.
To transfer data to a PC, establishing a PC-connection via USB is required. See section 4.2.3 on how to safely establish a connection with a power supplied PC or laptop (medical device/non-medical device) or to a battery-driven laptop.
This equipment is intended to be connected to other equipment thus forming a Medical Electrical System. External equipment intended for connection to signal input, signal output or other connectors shall comply with the relevant product standard e.g. IEC 60950-1 for IT equipment and the IEC 60601-series for medical electrical equipment. In addition, all such combinations – Medical Electrical Systems – shall comply with the safety requirements stated the general standard IEC 60601-1, edition 3, clause 16. Any equipment not complying 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 reduce the leakage currents. Any person who connects external equipment to signal input, signal output or other connectors has formed a Medical Electrical System and is therefore responsible for the system to comply with the requirements. If in doubt, contact qualified medical technician or your local representative. If the device is connect to a PC (IT equipment forming a system) ensure not to touch the patient while operating the PC. Do not touch the patient and the printer at the same time.
If the device is connect to a PC (IT equipment forming a system) assembly and modifications shall be evaluated by qualified medical technician according to safety regulations in IEC 60601-series.
The device is not intended for operation in areas with an explosion hazard. Do NOT use the device in a highly oxygen­enriched environment, such as a hyperbaric chamber, oxygen tent, etc. If the device is not used switch it off and disconnect it from the power supply.
Never short-circuit the terminals.
WARNING
WARNING
WARNING
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To avoid the risk of electric shock, this equipment must only be connected to the medical power supply originally delivered by MAICO. Using another power supply can also lead to electrical damage on the device.
In order to maintain a high level of safety and to ensure the device works properly, it is necessary to have the device and its power supply checked according to the medical electrical safety standard IEC 60601-1 by a qualified service technician at least once a year. For more information please see section 3.2.
The use of non-calibrated devices can lead to incorrect test results and is not advisable.
Prevent cable breakage: cables must not be bend or buckled.
Remove batteries both in the hand held unit and the cradle if the device will not be used for some time.
2.7 Device Control
The user of the device should perform a subjective device check once a week according ISO 8253-1. For annual calibration please see section 3.2.
See section 4.2.1.7 for volume check.
2.8 Electromagnetic Compatibility (EMC)
Electrostatic discharge (ESD) according to IEC 61000-4-2. Use the device only in an electrostatic controlled environment.
To avoid the risk of electric shock, this equipment must only be connected to supply mains with protective earth.
The device fulfils the relevant EMC requirements. Avoid unnecessary exposure to electromagnetic fields, e.g. from mobile phones etc. If the device is used adjacent to other equipment it must be observed that no mutual disturbance appears.
See also EMC consideration in section 6.5.
2.9 Battery Safety
Observe the following precautions at any times:
- Keep the battery fully charged.
- Do not place the battery in fire or apply heat to the battery.
- Do not damage the battery or use a damaged battery.
- Do not expose the battery to water.
- Do not short circuit the battery or reverse the polarity.
- Use only the charger provided with the easyTymp.
- Please see the following section for estimated charging times.
CAUTION
WARNING
WARNING
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Warranty, Maintenance and After-Sales Service
This section offers you important information about:
warranty conditions maintenance cleaning and disinfection recommendations handling disposables troubleshooting recycling and disposal of the device
3.1 Warranty
The MAICO device is guaranteed for at least one year. Ask your authorized local distributor for more information.
This warranty is extended to the original purchaser of the device by MAICO through the distributor from whom it was purchased and covers defects in material and workmanship for a period of at least one year from date of delivery of the device to the original purchaser.
The device shall only be repaired and serviced by your distributor 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 evidence of purchase with the device.
3.2 Maintenance
In order to ensure that the device works properly, it has to be checked and calibrated at least every twelve months.
The service and calibration must be performed by your dealer or to a service center authorized by MAICO.
When returning the device for repairs or calibration it is essential to send the accessories (i.e. probe, cables, contra transducer, cradle, printer) with the device. Please include a detailed description of faults. In order to prevent damage in transit, please use the original packing when returning the device.
WARNING
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3.3 Cleaning and Disinfection Recommendations
3.3.1 General
It is recommended that parts (device and accessories like headphones, ear cushions) which come in direct contact with the patient be subjected to standard cleaning and disinfecting procedure between patients.
Recommendations for cleaning and disinfection of MAICO device presented in this document are not intended to replace or contradict policies in effect or procedures required for infection control at the facility.
If there is not a high infection potential, MAICO recommends:
Before cleaning always switch off and disconnect the device from power supply. For cleaning use a lightly dampened cloth with soap water solution. Disinfect the plastic housing of the easyTymp and its accessories by wiping the
surfaces with wet Sani-Cloth® Active wipes or a comparable product. Follow the instructions on the specific disinfection product.
Wipe before and after each patient After contamination After infectious patients
Disinfect computer, keyboard, transport trolley etc. with Sani-Cloth® Active wipes:
once a week after contamination when polluted
To avoid damage of the device and its accessories, please mind the following:
Do not autoclave or sterilize. Do not use the device 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 not be used until deemed safe by a MAICO certified service technician.
Do not use hard or pointed objects on the device or its accessories.
Discard single-use equipment after use! In case of re-use of the single-use equipment you enhance the risk of cross contamination!
For more detailed cleaning recommendations see the following sections 3.3.2 to 3.3.3.
CAUTION
WARNING
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3.3.2 Cleaning the Case and Cables
Use caution while cleaning. Use a damp cloth to clean the plastic parts of the easyTymp. If disinfection is required, use a disinfectant wipe rather than
a spray product. Make sure that excess liquid from the wipe does not seep into any sensitive areas such as connectors and seams where plastic pieces connect such as the edges around the touch screen.
Follow the instructions on the disinfection product.
3.3.3 Cleaning the probe tip
In order to secure correct impedance measurements it is important to make sure that the probe system is kept clean at all times. Therefore please clean the probe on a periodic basis. It is indispensable to remove cerumen from the probe tip’s small Acoustic and air pressure channels. Therefore please follow the illustrated instructions below.
Figure 2
Never clean the probe tip while the tip is still attached to the probe (Figure 2).
Figure 3
1. Unscrew the probe cap by turning it in a counter clockwise direction (Figure 3).
Figure 4
2. Take the plastic probe tip out of the probe (Figure 4).
CAUTION
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Figure 5
3. Insert the blue end of the floss from back to front through one of the probe channels. Pull the floss along its entire length through the channel (Figure 5).
Figure 6
4. Proceed in the same way with all 4 probe channels. Use the floss only once (Figure 6).
Figure 7
5. Place the probe tip back onto the probe. Make sure that the plastic pegs are inserted into the appropriate corresponding cavities (Figure 7).
Figure 8
6. Screw the probe cap back on the probe (Figure 8). The force of tightening the cap will tighten the screw sufficiently. Never use tools to fix the probe cap!
If any blockage or damage occurs to the sealing gasket, the probe system can only be serviced by MAICO.
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Cleaning alternative:
Figure 9
Figure 10
Use the cleaning set from the eartip box (Figure 9): Take the cleaning tool apart to find the thin brush and thin rigid plastic cord (Figure 10).
Figure 11
Use the plastic cord or brush to push debris out of the probe tip (Figure 11).
Figure 12
Always enter the probe tip from the rear to avoid accumulation of debris inside the vents (Figure 12).
Figure 13
This procedure destroys the probe (Figure 13).
Figure 14
This procedure destroys the probe (Figure 14).
CAUTION
CAUTION
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3.3.4 Disposables
Figure 15
Operating the easyTymp will require the use of eartips – either mushroom shaped (1) or umbrella (2) eartips (Figure 15).
Eartips are intended for single-use only. These should be discarded after use. They cannot be cleaned.
In case of re-use of the single-use equipment you enhance the risk of cross contamination!
MAICO strongly recommends to use Sanibel eartips only. In case you want to purchase further disposables, please contact MAICO or your local distributor.
3.3.5 Components/Replacement Parts
Some reusable components are subject to wear with use over time. MAICO recommends that you keep theses replacement parts available (as appropriate for your easyTymp device configuration).
3.4 Troubleshooting
Table 2 Troubleshooting
Issue
Solution
White Screen
If the device shows white screen after turning on, make sure battery is fully charged.
Frozen Display
If the display freezes try
to restart the unit to shut off the system and change the battery
NOTE: Please do not take out the battery before turn off. Always turn off the device and then take out the battery.
Battery cavity
Please check that the battery is properly inserted into the compartment. Please check that the battery connector (spring contacts) inside
the compartment is clean and working properly.
Probe
Make sure the probe tip is inserted correctly into the probe. Otherwise, follow the suggestions in Probe tip.
Probe tip
1. Please clean the probe tip as described in the manual. If the system still does not run proceed with step 2.
2. Use a new probe tip. If the system still does not run proceed with step 3.
3. Change the complete probe and check if the system is running.
Extension cable
If the device shows leaking, please
1. Follow the suggestions for probe tip/ Probe.
2. If step 1 is not helpful, please change the extension cable. If the problem persists follow the suggestions for Probe tip/Probe.
WARNING
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Issue
Solution
Battery slot
1. If the spare battery is not charging, please, check if the battery is properly inserted and the terminals are in contact (springs in cradle).
2. Please make sure the battery contacts are clean in the case.
Connection in cradle
1. Make sure the handheld is properly inserted after the test. Improper docking may lead to no connection between device and the cradle.
2. Please make sure battery contacts are clean in the case.
Printer problem
(wireless printer)
1. Please check if the printer function in the device is set to Wireless.
2. Please check the printer icon is displayed at the top right corner of the screen.
3. Please check if the printer paper is properly inserted.
4. Make sure nothing is disturbing the connection between printer and device (distance, persons or objects between printer and device). If the connection has been disturbed while printing, restart the printing process by pressing Print.
5. Make sure the printer battery is fully inserted and is charged (also see section
4.4.1. for more information on charging light indicator). If the battery is not sufficiently charged, charge it using the power supply for the printer.
Make sure to only use the right power supply for the printer with the label shown in Figure 16 (12 V/1 A UE15WCP1-120125SPA). Otherwise the printer could get damaged due to excessive voltage.
Figure 16
PC Connections
1. Make sure the Patient database and the printer is deactivated from handheld.
2. Handheld: a. Please check the USB connection in the PC and the system. b. Use another USB cable.
3. Cradle: a. Make sure the device is properly placed into the Cradle. b. Make sure the Cradle is powered while transferring the result to PC.
4. Make sure the easyTymp option is selected in the PC software (for detail contact your distributor).
5. Try to reinstall the PC software. Check the device manager in the PC. If the easyTymp does not appear in the list install the driver again using the installation CD.
CAUTION
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3.5 Recycling and Disposal
Within the European Union it is illegal to dispose of electric and electronic waste as unsorted municipal waste. According to this, all MAICO products sold after August 13, 2005, 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 additional distribution costs we assign the responsibility for the proper collection and treatment according to legal regulations to our customers.
Non-European countries
Outside the European Union, local regulations should be followed when disposing of the product after its useful life.
Batteries may explode or cause burns, if disassembled, crushed or exposed to fire or high temperatures.
WARNING
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Unpacking and Installation
This section provides information on:
unpacking the system becoming familiar with the hardware inclusive connections how to store the device becoming familiar with the Probe and the External Probe using the MPT-II thermal printer
4.1 Unpacking the system
Check Box and Contents for Damage
It is recommended that you unpack your easyTymp carefully making sure that all
components are removed from the packing materials.
Verify that all components are included as shown on the packing slip included with
your shipment.
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 not attempt to use any component or device that appears to be damaged.
Reporting Imperfections
Notify the carrier immediately if any mechanical damage is noted. This will insure that a proper claim is made. Save all packaging material so the claim adjuster can inspect it as well.
Report Immediately any Faults
Any missing part or malfunction should be reported immediately to the supplier of the device together with the invoice, serial number, and a detailed report of the problem.
Keep Packaging for Future Shipment
Save all the original packing material and the shipping container so the device can be properly packed if it needs to be returned for service or calibration (see section 3.2).
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The easyTymp comes with different components (see the following tables). The availability of configurations with the following components is country and version specific. Contact your local distributor for more information.
Components
easyTymp Handheld Unit
MAICO Impedance Module Bundle
Probe*
Short extention cable (350 mm incl. cable)*
Cradle Kit (component list, see below)
Printer Kit (component list, see below)
Power Supply Unit (5 V/2.5 A) UE24WCP-050250SPA incl. USB Adapter for easyTymp Handheld Unit
Rechargeable Battery
Eartip Box (See Below)
Probe Cleaning Kit
Test Cavity
Operation Manual
Quick Guide
Carrying Case
Wall Mount Kit for cradle with integrated eartip box, power supply unit and additional rechargeable battery
Only for Plus and Pro Version
Contra Probe (1400 mm incl. cable)*
CIR55 (Contralateral Earphone)*
DD45C (Contralateral Headset)*
IP30 Contralateral Earphone*
Quick Guide (Pro or Plus Version)
*Applied parts according to IEC 60601-1
Cradle Kit
Cradle
USB Cable
Power Supply (24 V/1 A) UE24WCP-240100SPA
Rechargeable Battery
Printer Kit
MPT-II printer
MPT-II rechargeable battery pack
Thermal printer paper
Printer Power supply/charger with plug adapters (12 V/1 A) UE15WCP1-120125SPA
Licenses
Licenses
License for High Frequency Probe Tone of 1 kHz
License for Plus Version: Acoustic Reflexes Contra
License for Pro Version: Acoustic Reflexes Contra, Decay and ETF
NOTE: License for Plus and Pro version: An upgrade to the device version is required.
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Disposables Supplied
NOTE: MAICO strongly recommends to use Sanibel eartips for reliable results.
Eartip Box
Sanibel Blue, 7 mm Mushroom, Silicone Eartips (10 pcs.)
Sanibel Green, 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.)
Sanibel Blue, 15 mm Mushroom, Silicone Eartips (5 pcs.)
Sanibel Red, 15 mm Umbrella, Silicone Eartips (5 pcs.)
Sanibel Yellow, 19 mm Mushroom, Silicone Eartips (5 pcs.)
Sanibel Blue, 19 mm Umbrella, Silicone Eartips (5 pcs.)
Probe Tip (1 pc.)
Probe Cleaning Tool (1 pc.)
Eartip Removal Tool (1 pc.)
Allen key SW: s = 2 mm (See section 4.2.1.7)
NOTE: It is possible to purchase either the whole Eartip Box or single items listed.
Consumable Material:
Consumable Material
Printer Paper
Replacement Eartips
Probe Tip
Cleaning Floss
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4.2 System Installation
4.2.1 Hardware Installation
4.2.1.1 Installing the Cradle
Figure 17
1 = USB in 2 = USB out 3 = USB out 4 = USB out 5 = Power 24 V 6 = Follow the
instructions for use
Put the enclosed mains cable into the power connection socket #5 and the mains plug into a power socket.
NOTE: In case you also use the wireless printer make sure you take the right power supply (24 V, UE24WCP-240100SPA) to connect to the cradle. Otherwise loading times can rise.
4.2.1.2 Cradle Indication Lights
The cradle has two indication lights (Figure 18).
Figure 18
easyTymp LED shows solid blue when it is placed
inside the cradle. The battery will be charged automatically and will be fully charged after approximately three hours. The current battery state of charge may be seen on the easyTymp display.
Battery LED shows solid blue when the spare battery
in the cradle is fully charged. The LED will flash while the battery is charging.
NOTE: Upon initial setup, always plug the cradle into the outlet while the easyTymp is out of the cradle.
4.2.1.3 Installing the easyTymp Battery
Figure 19
The battery compartment is opened by gently pressing the indentation and pushing the cover downwards (Figure 19).
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Figure 20
Place the battery inside the compartment (Figure 20).
Figure 21
Make sure the battery contacts are aligned before pushing the battery into place (1) and the removal-tab is easy to reach (2) (Figure 21).
Figure 22
The removal-tab, attached to the back of the battery case, should be wrapped around the battery to remove it easily (Figure 22).
Figure 23
Replace the lid on the easyTymp and push it upwards to close the battery compartment (Figure 23).
It is recommended that the battery is removed from the device when it is not in use for extended time periods.
4.2.1.4 Charging the easyTymp Battery
Figure 24
NOTE: Please note that the battery needs to be charged for a
minimum period of approximately 6 hours prior to first use of the easyTymp hand-held Tympanometer (Figure 24). To charge the battery please place the easyTymp into the cradle and connect the cradle to the mains power with the use of the easyTymp power supply provided.
Figure 25
The spare battery is stored and charged in the back of the cradle (Figure 25).
1
2
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4.2.1.5 Battery Life
The following table gives an estimate of the charging time (CT) in hours for the battery. Be aware that negative numbers mean that the battery is discharging. Charge times are the same for the spare battery in the cradle and the battery in the cradled easyTymp. See also Table 3.
Table 3 Charging time easyTymp
CT through cradle up to 80 %
CT through USB (PC) up to 80 %
CT through cradle up to 100 %
CT through USB (PC) up to 80 %
Off
1.5
3.8
2.3
5.7
On (pump off)
2.8
-32
4.1
-47
4.2.1.6 Changing Probes
Figure 26
To release the probe, press the circular button on the back of the device and pull the probe out (Figure 26).
NOTE: Do not pull on the extension cable as this can damage the tubing connection!
Figure 27
Connect the probe to the easyTymp by lining up the red triangles and pushing the probe into the unit (Figure 27).
Figure 28
The probe can be attached to the extension cable by correctly lining up the pins and clicking the probe into the end of the extension cable (Figure 28).
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4.2.1.7 Adjust the Cradle
Figure 29
Use the Allen key to adjust the cradle on the Figure 29. NOTE: An Allen key is enclosed in the packaging of the eartip
box to enable adjustment of the pair of adjustable feet located on the bottom of the cradle.
Please ensure that the Allen key is only used to adjust the setting of the adjustable feet on the cradle and that this tool is not used for any other purpose on the easyTymp unit.
4.2.1.8 Mounting the Cradle on the Wall (optional accessory)
Figure 30
In order to mount the cradle on the wall, an optional wall mount kit is available (Figure 30).
4.2.1.9 easyTymp Plus and Pro Version: Connecting the Contralateral Headphone or Insert Phone
Figure 31
To measure Contralateral Reflexes it is necessary to connect the Contra Probe to the easyTymp as described previously.
Find the jack labeled “Contra” on the Contra Probe. Insert the Contralateral transducer into this jack (Figure 18).
The Contra Probe must be calibrated to the selected Contralateral transducer type. This calibration is already completed if the Contra Probe and transducer are purchased at the same time. Otherwise the Contra Probe and transducer need to be sent to an authorized service center to perform the calibration.
NOTE: Three different Contra phones can be purchased for use with the easyTymp. The Contra phones need to be calibrated to the Contra Probe before use. If a new Contra phone should be used a recalibration of the Contra Probe is necessary. We strongly advise against using an uncalibrated Contra Phone! Uncalibrated devices may lead to faulty measurements and possibly damage the patient’s hearing.
4.2.2 Test cavities
The easyTymp comes with a separate test cavity which can be used to quickly check the probe calibration validity. The test cavity includes 0.2 ml, 0.5 ml, 2.0 ml and 5.0 ml cylinders.
We strongly recommend calibrating each probe at least once a year. If a probe is handled roughly (e.g. has fallen onto a hard surface) it might need to be calibrated again. Calibration values of the probe are stored in the probe itself. Therefore probes can be exchanged at all times.
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4.2.3 Establishing a PC-Connection
To transfer data to a PC, establishing a PC-connection via USB is required. If the easyTymp is used with office equipment that is not a medical device itself (see Table 4, PC­Connection 1), make sure to establish the PC-connection in one of the following ways (see Table 4, PC Connection 2, 3 or 4).
Make sure you use only office equipment with the device that is a medical device itself or meets the requirements of IEC 60950. 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-Connections
PC CONNECTIONS
PC Connection 1: Medical device – Medical Device
PC Connection 2: Medical device – Non-Medical Device
PC Connection 3: Medical device – Non-Medical Device
PC Connection 4: Medical device – Laptop (battery-driven)
4.2.4 Storage
When the easyTymp is not in use, store it in the optional carry case or in a location where it will be safe from damage to the touchscreen or other sensitive components such as the Acoustic transducers and cables. Store according to the recommended temperature conditions described in section 6.1.
WARNING
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4.3 Software
You can view and store all measurements with the MAICO Impedance Software Module. NOTE: For installation and functions see the software operation manual. For transferring
data to the PC see section 5.6.
4.4 Using the MPT-IIThermal Printer
4.4.1 Powering the Thermal Printer
Battery pack insertion
Figure 32
Insert battery as shown (Figure 32).
Charging the battery
Figure 33
The thermal printer is powered by a Lithium-ion battery. In order to charge the battery you must insert the plug of the power supply into the laterally placed socket and plug the power supply with the proper plug adapter into an outlet (Figure 33 ).
Make sure to only use the right power supply for the printer with the label shown in Figure 16 (12 V/1 A UE15WCP1­120125SPA). Otherwise the printer could get damaged due to excessive voltage.
Figure 34
Power on
Push power button for two seconds in order to power on or off. One short beep will be heard at power on, two short beeps at power off.
Figure 35
Green Power indicator will be lit if printer is powered by battery (Figure 35).
NOTE: Selecting Print on the easyTymp when the printer is off will result in an error message. Printer must be on and in close proximity of the easyTymp for printing to proceed.
CAUTION
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Charging Light Indicators
Table 5 MLP-II Charging Light Indicator
Green LED indicator
Blue LED indicator
Status
Sound
Note
Off
Fast flash
Charging
-
Power On
Off
On
Charging
-
Power Off
Off
Slow flash
Battery nearly discharged
-
-
Off
On
Charging completed
-
Power On
Off
Off
Charging completed
-
Power Off
On
Off
Power ON, battery
-
-
Slow flash
Slow flash
Out of paper
Beep
-
Slow flash
Off
Sleep mode
-
-
Self-test
When printer is powered off, press and hold paper feed button, then press and hold power button simultaneously. When beep is heard after approx. 3 seconds, release both buttons,
and a test page will print with information on current status and character samples.
4.4.2 Paper Loading
Open the lid by pushing on the sides (Figure 36), insert paper roll as shown (Figure 37), and close the lid (Figure 38).
Figure 36
Figure 37
Figure 38
Paper feed
When powered press paper feed button. Paper will feed as long as the button is pressed.
NOTE: Reorder paper from MAICO or your local distributor.
4.4.3 Connecting the MPT-II Thermal Printer to easyTymp
The connection of the easyTymp and the printer is made via wireless pairing. See section 5.6.5. NOTE: It is possible to pair four devices with one printer. Do not have several printers powered
on and within range while searching.
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Operating the Device
This section offers you information about:
how to get started with the easyTymp the operating panel preparing the patient for testing performing impedance testing settings to be made managing the test results
5.1 Getting started with the easyTymp
5.1.1 Use of Equipment After Transport and Storage
Make sure the device is functioning correctly before use. If the device has been stored in a colder environment (even for short time) allow the device to become acclimatized. This can take 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 than the use conditions no special precaution are required before use. Always ensure proper operation of the device by following routine check procedures for audiometric equipment.
5.1.2 Operating Panel
Figure 39
Function Keys (Figure 39):
Top buttons: Function of the keys is related to the functions indicated in the display above the individual function key. (e.g. Select Test, Patient, Stop)
Arrow Keys: Turn on easyTymp by pressing
the right or left arrow key. Turn off easyTymp by pressing both keys at the same time. Selection of the right or left ear to be tested.
Up and down buttons: Scroll through the different easyTymp settings menu, test protocols or scroll up and down on the display.
5.2 Preparing for Testing
5.2.1 Preparing the Patient
Make sure that the patient is comfortable on a chair or on an examination 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.
WARNING
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5.2.2 Visual Inspection of the Ear Canal
Check the external ear canal for wax with an otoscope. Excessive wax should be removed by a qualified professional to prevent the probe opening from clogging which will inhibit testing. Excessive hairs may have to be cut for a seal to be obtained.
5.2.3 Impedance Measurements
Show the probe to the patient and then explain the following:
An ear tip is placed on the tip of the probe and inserted into the ear canal. A seal
must be achieved for the test to progress.
Coughing, talking and swallowing will disturb test results. The aim of Tympanometry is to test the mobility of the eardrum and the condition
of the middle ear. A small amount of air will flow through the probe to move the eardrum; it
produces a sensation equal to pressing a finger slightly into the ear canal.
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 stapedius.
One or more louder tones will be heard during the test. No participation is
expected from the patient.
5.2.4 Handling the Eartips
Choose the proper size of eartips based on your inspection of the size of the patient’s ear canals.
Do not insert the probe without having an ear tip attached to prevent damage to the patient’s ear canals.
Figure 40
Put the ear tip tightly on the probe tip making sure it is pushed all the way down (Figure 40).
Figure 41
Insert the probe with ear tip attached into the patient’s ear.
For children and adults, 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 ear tip into the ear canal. The fit of the ear tip should be secure; not superficial (Figure 41). Release the earlobe. When testing infants, gently pull the Pinna down and back to straighten the ear canal.
WARNING
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Each ear tip should only be used once. For more detailed information see section 3.3.4.
Figure 42
In order to remove the ear tip, grasp the ear tip at the base using the eartip removal tool and pull it smoothly straight off the probe tube (Figure 42).
NOTE: If the probe tip becomes dirty or clogged, it must be cleaned (see section 3.3.3) or replaced
5.2.5 easyTymp Plus and Pro Version: Placing and Using the Contra Probe
Figure 43
A clip is located on the back of the Contra Probe which can be attached to the patient’s clothing (Figure 43). For most patients it is easiest to clip the Contra Probe to the patient. When a child is being held by a parent, clip the Contra Probe to the parent’s clothing.
Figure 44
Press the button on the Contra Probe to start or stop/pause the current measurement or switch between right and left when the probe is not inserted to the ear (Figure 44).
5.2.6 easyTymp Plus and Pro Version: Placement of Contralateral Earphones
Multiple transducers are available for purchase to perform Contralateral measurements.
Figure 45
If the CIR55 or insert phone is used, place the proper eartip on the insert before inserting the phone into the non test-ear (Figure 45).
Figure 46
If the DD45C is used, place the head band over the
patient’s head. The audiometric headphone is placed
over the non test-ear (or Contralateral Reflex ear) (Figure 46).
WARNING
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5.3 Start the Test
To get started, removing the easyTymp from the cradle will turn the device on automatically. If you don’t store the easyTymp in the cradle, press either the red or blue arrow key to
switch the device on. The easyTymp will always start within the test screen, ready to start a measurement. It
will always default to the same protocol as previously used.
5.4 Probe Status Indication
If you use the optional external probe the light at the back of the probe indicates the probe status with the following colors (Figure 47):
Figure 47
Red – Right ear is selected. Probe is out of ear. Blue – Left ear is selected. Probe is out of ear. Green – Probe is in the ear and is sealing, test is running. Yellow – Probe is in the ear and blocked or leaking. White – The probe has just been attached. Probe status is unknown. The probe status
stays white in hand held use if the easyTymp is not monitoring the probe status. If the probe light stays white in any other situation easyTymp might need to be switched off and on again to regain proper probe status.
Flashing color – easyTymp is pausing during a protocol and waits for you to press continue. The color in which the probe light is flashing indicates the probe status like above.
Flashing green to red/blue – easyTymp just finished the protocol.
5.5 Testing
5.5.1 General
Operating the easyTymp is very intuitive. After switching the device on, it will usually start in the Test Screen and is ready to test the same protocol as was used last. After disconnecting easyTymp from a PC it will start in the Select Protocol screen and the desired protocol should be selected.
The battery status bar will show the current battery power status. If the battery is empty, you will be warned, the measurement will be stopped and all recorded data will be stored. If this occurs shut down the device and change the battery to continue testing. The measurement data will be recovered when you start up again, so the measurement can continue without restarting the test.
NOTE: If a white screen appears and the easyTymp does not proceed with the next screen, the battery is almost empty. Please change the battery to proceed.
The following paragraphs describe the precise operation of the different screens you will observe during the use of easyTymp.
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5.5.2 Test
Figure 48
Usually the easyTymp starts with the Test screen. When deleting or saving data after a measurement, you will also return to this screen (Figure 48).
The graphics of the ongoing test will also be displayed. The box indicates the normative area where the peak of the tympanogram is expected to fall. The measured curve will be directly shown in the graphic while the measurement is being taken. Below the graphic the measured values (Volume, Pressure, Compliance and Gradient) are shown following the measurement.
The header shows the status of the probe. It might show Ready, In Ear, Leaking or Blocked. When Connected is displayed, the device is connected to a cradle or directly to the PC.
- In the upper right corner the battery status is indicated . When the easyTymp is placed in the cradle, it will charge the battery and a flashing battery icon will be shown.
- In the upper right corner an icon indicates if the easyTymp is testing the left ear
or right ear .
- In the upper right corner a printer icon indicates the easyTymp is connect to the wireless printer.
- When entering the Test screen, the second line shows the name of the protocol which is in use. As soon as the easyTymp detects that the probe is in the ear, the second line will show which test of the protocol is running.
Operating from this screen:
Putting the probe in the ear and obtaining a seal will automatically start the test.
- : The top left button will bring you to the Select Test screen where you can select a different test protocol.
- : The top middle button will bring you to the View Patients screen where patient data can be viewed and earlier sessions can be reviewed and/or printed. This function is only displayed if the patient management is activated.
- : The top right button, when the measurement is stopped the top buttons will change to give the option to print, save or delete and Done! will appear in the upper left hand corner of the screen.
- arrows will select respectively right or left ear for testing.
- If data on one or both ears is still available, the up and down buttons will bring you
back to the Done! screen and allow you scroll through the measurement results.
If a protocol includes an instruction message, pressing the Contra Probe button results in continuing the protocol, no matter what the probe status indicates.
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5.5.3 Select Test Screen
Figure 49
To change the selected protocol, first highlight the protocol and then press . The following measurements are available in the standard easyTymp (Figure 49):
01 Tymp 226 Hz 03 Tymp 226 Hz + Auto Reflex 04 Tymp 226 Hz + Reflex 90dB
NOTE: Protocol list is based on version and licensing. Unlicensed protocols are ghosted.
Operating from this screen:
- takes you to the Setup screen.
- selects the highlighted protocol and returns to the Test screen.
- buttons allow scrolling up or down to select one protocol.
- buttons will bring you to the top or bottom of the protocol list
respectively.
5.5.4 Done!
Figure 50
easyTymp will automatically go to the Done! screen when it has finished testing (Figure 50).
From here, measurements of both ears can be reviewed, printed and/or saved. To start a new measurement in the Test screen, delete the current test ears result or switch ears. Only one result per ear is saved for review, printing or transferring to a PC.
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Operating from this screen:
- : Top left button will print the test results of the left and right ear. The
printer must be on and a connection to the printer prior to starting the test. Printer icon displays in the top right corner of the screen when connected.
- : Top middle button will save the measurement of both ears.
- : Top right button will present a popup message saying “Delete current
or both ears?” the top left button will cancel the process. The top middle button will delete the data of the currently selected ear and bring you back to the Test screen. The top right button will delete data for both ears and bring you back to the Test screen.
- buttons will select respectively right or left ear for testing and bring you back to the Test screen. The existing data of the selected ear will only be deleted after the probe detects that it is in the ear with a proper seal.
- buttons make you scroll through the different test results. When viewing the
first or last test of an ear, pressing up or down respectively will bring you to the test results of the other ear.
5.5.5 Advanced Testing: easyTymp Plus and Pro Version
Acoustic Reflex Testing (Ipsi and Contra)
Figure 51
Figure 52
Before performing Ipsilateral (Figure 51) and Contralateral reflex (Figure 52) testing Tympanometry will be performed.
NOTE: Deflection of reflexes can be positive or negative and is selected within the setup menu.
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5.5.6 Advanced Testing: easyTymp Pro Version
Acoustic Reflex Decay
Figure 53
Ipsilateral and Contralateral Reflex Decay testing can be performed (Figure 53).
ETF Intact
Figure 54
Instructions for testing are displayed at the top of the screen. (Figure 54).
(1) Red or Blue: represents test ear. (2) Grey: represents “Swallow”. (3) Green: represents “Valsalvation”.
ETF Perforated
Figure 55
Instruct the patient to swallow. Measurement of changing pressure indicates status of
Eustachian tube (Figure 55).
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5.5.7 easyTymp Plus and Pro Version: Contra Probe Button
The Contra Probe button will change ears as long as the probe detects it is not in the ear. When the probe is in an ear it will interrupt the testing and bring you to the Done! Screen,
and from there also back to the Test screen with a second press of the button. If a protocol includes an instruction message, pressing the Contra Probe button results in continuing the protocol, no matter what the probe status.
5.5.8 Select Patient & Save
Figure 56
The Select Patient & Save screen is accessible once a measurement is completed and is selected form
the test screen. Results can either be saved to an existing patient or to a new patient (Figure 56). New patient will always get the name “New Patient: Number #”, where # is always the next available number.
When saving results to a patient, the patient management function must be On in the settings (see section 5.6.8).
Operating from this screen:
- will bring you back to the Done! screen without saving and without deleting data.
- opens a screen for editing new patient details.
- will save the data to the selected patient. After saving, all data is deleted
and easyTymp returns in the Test screen, ready for testing.
- buttons will bring you to the top or bottom of the patient list respectively.
- buttons scroll up or down as one patient’s information is viewed.
5.5.9 Edit New
Figure 57
With this screen you can input data for a new patient before saving the measurement (Figure 57).
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Operating from this screen:
- saves the patient details and brings you back to Select Patient & Save.
- will select the highlighted field. Backspace is an arrow in the top right
corner. Space is a bar underneath the keyboard
- will select the next details for editing.
- arrows buttons will move the selection of the keyboard one character to
the left or right.
- buttons will move the selection of the keyboard one character up or down. When editing the birth date the up and down button will change the numerical value.
5.5.10 View Patients
Figure 58
View Patients screen is accessed from the test screen by selecting (Figure 58).
When one or more sessions are stored, the square in front of the patient’s name is filled. If a session is not stored yet, this square will be empty.
Operating from this screen:
- brings you back to the Test screen.
- brings you to the View Details screen where the data of the selected
patient is shown.
- will bring you to the View Results screen where the available sessions of the selected patient can be reviewed and printed.
- will bring you to the top or bottom of the patient list respectively.
- buttons scroll up or down as one patient’s information is viewed.
5.5.11 View Details
Figure 59
This screen shows demographics of the selected patient (Figure 59).
From here you can either use to go back to the View Patients screen or to edit the patient details in the Edit Details screen.
button will delete either this patient, or all
patients.
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5.5.12 Edit Details
Figure 60
This screen shows the patient ID, First Name, Last Name, and Birth Date (Figure 60).
Operating from this screen:
- brings you back to the View Patients screen.
- selects the highlighted character and put it
where the cursor is placed. Backspace is an arrow in the top right corner. Space is a bar underneath the keyboard
- selects the next details for editing.
- will move the selection of the keyboard one
character to the left or right.
- buttons will move the selection of the keyboard one character up or down. When editing the birth date the up and down button will change the numerical value.
5.5.13 View Results
View Results – select session
Figure 61
For the selected patient, the screen shows a list of available sessions (Figure 61).
Operating from this screen:
prompts
you and ask for confirmation
before it deletes the selected session or all sessions.
Results screen (see Figure 39).
or bottom of the result list.
View Results – show results
Figure 62
This screen displays the test recordings of the selected session (Figure 62).
Operating from this screen:
- brings you back to the View Results screen.
- button will print all results which are
stored in the selected session.
- The top right button has no function.
- buttons will show the recordings of the
right or left ears respectively, if available.
- buttons scroll through the different tests which are included in the selected session.
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5.6 Setup Menu
5.6.1 Setup
Figure 63
To change the Setup of the easyTymp navigate from Test screen to Select Test and then to easyTymp (Figure 63).
Operating from this screen:
- brings you back to the Select test screen.
- The top middle button has no function.
- selects the highlighted setting to be viewed.
- buttons have no function.
- buttons scroll up and down to the next item.
5.6.2 Setup Language
Figure 64
Use right and left arrow keys to adjust language (Figure
64). Available languages are English, Deutsch, Español, Français, Italiano, Polski,
日本語, 中文
, and русский.
5.6.3 Setup Time
Figure 65
arrow keys will scroll through the options (Figure 65).
buttons adjust Date, Date format and Time.
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5.6.4 Setup easyTymp
Figure 66
will scroll through the options. buttons to
adjust selection (Figure 66). The Power Save can be set to Never or 1, 2, 3, 4 or 5 min. The Power Off can be set to Never or from 1 to 10 min.
Show Pass/NR: If On the test result will display with a Pass / NR (No Response) symbol depending on
Normative Values defined internally. Show Calibration Warning: When On, calibration
reminder will display on device, when turned on. Reflex Presentation: Negative or Positive deflection in
the graphs.
5.6.5 Setup Printer
Figure 67
Figure 68
buttons will scroll through the options.
buttons to adjust selection (Figure 67).
Printing: Can be set to Wireless printer, Cradle printer or Disabled. Selection of the printing type
will hide not applicable printing options. NOTE: Cradle printer is selectable for a
discontinued configuration where a cradle printer was provided.
Pairing Wireless printer: Press to start searching for the wireless printer. This process takes about 1 minute.
Select the printer using the buttons and press
to configure the device to the wireless
printer provided by MAICO (Figure 68). Select
or to exit the Setup Printer screen.
NOTE: The printer must be turned on by pressing the
power button before starting the pairing process.
Reflex Presentation: Choose between Table or Graph by pressing the buttons (Figure 67).
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5.6.6 Setup Clinic Info
Figure 69
Use Up, Down, Right and Left arrow keys to move the cursor over the keyboard (Figure 69).
to select the highlighted character. Backspace is an arrow in the top right corner. Space is a bar underneath the keyboard.
to select the next details for editing.
to save and return to the Setup screen.
5.6.7 Setup License
Figure 70
Option to buy licenses to unlock further measurements (Figure 70):
: By pressing the Top right button you can select the module to view, add or change the license key.
NOTE: License should be modified by the licensed distributor only.
Figure 71
Use Left, Right, Up and Down arrow keys to move the cursor over the keyboard (Figure 71).
: The top middle button will select the highlighted character. Backspace is an arrow in the top right corner. Space is a bar underneath the keyboard.
: The top left button will save and return to the Setup screen
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5.6.8 Setup Patient Management
Figure 72
Turns the internal patient data management On or Off (Figure 72).
NOTE: When changing from On to Off, all measured and/or stored data will be deleted.
5.6.9 About
Figure 73
About displays the firmware version and calibration dates (Figure 73).
5.7 Managing Test Results
5.7.1 General
Dependent on the configuration there are different possibilities to manage test results. It is possible to delete test results, print the session directly with the thermal printer or transfer the data to a PC for further processing.
5.7.2 Deleting Test Results
The procedure of deleting test results depends on whether patient management is active or not.
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Deleting Test Results Directly After Testing Deleting a measurement is possible by pressing the button directly after having
finished a measurement and the Done! screen is shown. It is possible to delete measurements of one or both ears. See section 5.5.4 for more information.
NOTE: Making a measurement on the same ear without having saved the previous measurement will overwrite the previous test result.
Deleting Test Results in the Patient Management Using the patient management it is possible to delete either single or all results of a patient or one or all patients including test results. See section 5.5.13 on how to delete single or all test results of a patient. See section 5.5.11 on how to delete a single or all patients including test results.
NOTE: If the management system is getting activated or deactivated, a message box warns that all measurement data will be deleted. Press to change the setting and
delete the data or to keep the settings. See also section 5.6.8.
5.7.3 Printing Test Results with the Thermal Printer
Print directly from the Done! screen (see section 5.5.4) or after viewing results via patient management (see section 5.5.13).
5.7.4 Data Transfer Between easyTymp and Impedance Software Module
NOTE: Data transfer between the easyTymp and the Impedance Software Module is only
possible, if the patient management system is deactivated. See section 5.6.8 on how to deactivate the patient management system.
It is not possible to transfer data from the patient management system to PC. To transfer data between easyTymp and the Impedance Software Module, complete the
measurement and connect the easyTymp to the PC. Connection is made via the USB cable inserted directly into the USB port on the device or placement of easyTymp in a connected cradle. The transfer process will start automatically.
NOTE: The easyTymp cannot make a measurement if it is connected to the running Impedance Software Module.
See the Software Operation Manual of the Impedance Software Module for more information.
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Technical Data
This section offers you important information about
the easyTymp hardware specifications connections the pin assignment impedance calibration values electromagnetic compatibility (EMC) electrical safety, EMC and associated Standards
6.1 easyTymp Hardware
Medical CE-mark
Yes
Safety Standards
IEC 60601-1, Class II, Type B
EMC Standards
IEC 60601-1-2
Tympanometer Standards
IEC 60645-5, Type 2 ANSI S3.39, Type 2
Normative Box:
Appendix A
The easyTymp is an active, diagnostic medical product according to the class IIa of the EU medical directive 93/42/EEC.
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Environment Conditions:
Operation
+15 °C to +35 °C / +59 °F to +95 °F Humidity: 30 % to 90 %, non-condensing
Air pressure 98 kPa to 104 kPa1 Maximum altitude: 2000 m / 6561 ft
above sea level
Storage
0 °C to +50 °C / +32 °F to +122 °F Humidity: 10 % … 95 %, non-condensing
Transport
-20 °C to +50 °C / -4 °F to +122 °F Humidity: 10 % to 95 %, non-condensing
Power, easyTymp
Fuses:
3 A (5 V)
Battery Type
NP120 Li-Ion
3.7 V 1700 mAh
Dimension and weight:
Dimension
80 mm x 300 mm x 70 mm
3.15” x 11.81” x 2.76”
Weight
427 g / 1 lb
Display:
Display size:
2.2” diagonal
Resolution:
240 x 320
PC connection:
USB:
Input/output for computer communication.
Memory:
Stores test results for up to 499 patients. The easyTymp hand held unit is delivered with a 8 GB memory card
Mode of operation
Continuous
Dimensions Probe
34 mm
Dimensions External Probe:
350 mm (cable)
Dimensions Contra Probe:
1400 mm (cable)
Warm-up time:
less than 10 minutes
__________
1
Environment conditions during operating according IEC 60645-1
NOTE: Reference equivalent threshold sound pressure levels may differ significantly with ambient pressures outside the above range. Therefore recalibration around the normal ambient pressure at the site of the user should be undertaken in those circumstances where the calibration site and the user site do not share similar ambient conditions.
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Probe tone:
Frequency:
226 Hz, 1000 Hz
Level:
85 dB SPL at 226 Hz, 69 dB SPL at 1000 Hz with AGC, assuring constant level at different ear canal volumes.
Air pressure:
Control:
Automatic.
Indicator:
Measured value is displayed on the graphical display.
Pressure change rate:
Speed at compliance peak (change in settings):
Automatic (Dynamic from 60 daPa/s for low gradient and 200 daPa/s for a gradient larger than 5 daPa)
Minimum 950 daPa/s): slow, very precise results
Medium (250 daPa/s): compromise of speed and precision
Maximum (>400 daPa/s): fast, screening
Range:
-400 daPa to +200 daPa.
Pressure limitation:
-750 daPa and +550 daPa.
Compliance:
Range:
0.1 ml to 8.0 ml at 226 Hz probe tone (Ear volume: 0.1 ml to 8.0 ml) and 0.1 mmho to 15 mmho at 1000 Hz probe tone.
Test types:
Tympanometry
Automatic.
Indicators:
Graphical display
Compliance is indicated as ml for 226 Hz and as mmho for 1000 Hz and pressure as daPa.
Stimulus level is indicated as dB HL.
Memory:
Tympanometry:
1 curve per ear, per Tympanometry test. And theoretically an infinite number of tests per protocol.
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Stimulus:
Type:
Ipsilateral and Contralateral:
Pure tone (500, 1000,
2000, 4000 Hz)
Broad-band noise (BBN)
Level:
Automatic pure tone: 70-100 dB HL in 5 dB steps
Fixed pure tone: 90 dB HL
Fixed BBN: 80 dB HL
Outputs:
Ipsi earphone:
Probe earphone incorporated in the probe system for reflex measurements.
Contra earphone:
CIR55 insert, DD45C, IP30 for reflex measurements.
Air:
Connection of the air system to the probe.
Test types:
Ipsi- and contralateral
Single intensities Reflex auto search
Test method
Ipsi- and contralateral
Test signals:
Pure Tones:
500 Hz, 1000 Hz, 2000 Hz, 4000 Hz each with ± 3 %
Test level:
Ipsilateral: Contralateral:
70 dB HL to 110 dB HL 70 dB HL to 120 dB HL
Control Acoustic Reflexes:
Automatic
Automatic reflexes: Single reflex auto search
Tone presentation:
10 s
Compliance Range:
-0.05 ml to 0.25 ml
Graphical display:
y-axis: Compliance in ml x-axis:Time in s Level in dB HL
Ipsi earphone:
Earphone integrated in probe
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Test signals:
Pure tone: 226 Hz with ± 1 %
Test level:
85 dB SPL ±1.5 dB measured in an IEC 60318-5 Acoustic coupler. The level is constant for all volumes in the measurement range.
Control Tympanometry:
Automatic
Time range:
0 s to 30 s (settings)
Pressure range:
0 daPa to 400 daPa
Accuracy:
Compliance:
5 % or 10 daPa, whichever is greater
Pressure:
5 % or 0.1 ml, whichever is greater
Graphical display:
x-axis: Time in s y-axis: Pressure in daPa
Calibrated transducers:
Probe system:
Ipsilateral and Contralateral Earphone: is integrated in the probe system.
Probe frequency transmitter and receiver and pressure transducer is integrated in the probe system.
Accuracy:
General
Generally the device is made and calibrated to be within and better than the tolerances required in the specified standards:
Reflex frequencies:
3 %
Ipsilateral reflex tone levels:
3 dB for 500 Hz to 4000 Hz
Contralateral Reflex Tone Levels:
3 dB for 500 Hz to 4000 Hz
Pressure measurement:
5 % or 10 daPa, whichever is greater
Compliance measurement:
5 % or 0.1 ml, whichever is greater
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Probe tone
Frequencies:
226 Hz 1 %, 1000 Hz 1 %
Level:
85 dB SPL 1.5 dB measured in an IEC 60318-5 Acoustic coupler. The level is constant for all volumes in the measurement range.
On-Off ratio: SNR ratio: A-Weighted noise in
off condition: Rise-Fall times
> 70 dB > 70 dB < 25 dB
> 5 ms
Distortion:
Max. 1 % THD
Compliance
Range:
0.1 ml to 8.0 ml
Temperature dependence:
-0.003 ml/C Pressure dependence:
-0.00020 ml/daPa
Reflex sensitivity:
0.001 ml is the lowest detectable volume change
Temporal reflex characteristics:
Initial latency = 35 ms (5 ms) Rise time = 45 ms (5 ms) Terminal latency = 35 ms (5 ms) Fall time = 45 ms (5 ms) Overshoot = max. 1 % Undershoot = max. 1 %
Pressure
Range:
-400 daPa to +200 daPa
Safety limits:
-750 daPa and +550 daPa, 50 daPa
General
Specifications for stimulus signals are made to follow IEC 60645-5
Ipsi- and Contra-
Pure tone:
3 dB for 500 Hz to 4000 Hz
lateral Earphone
Broad-band noise (BBN): Spectral properties:
MAICO Standard As “Broad-band noise” specified in
IEC 60645-5, but with 500 Hz as lower cut-off frequency.
General about levels:
The actual sound pressure level at the eardrum will depend on the volume of the ear.
The risk of artifacts at higher stimulus levels in reflex measurements are minor and will not activate the reflex detection system.
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Power supply, UE24WCP-240100SPA
Consumption:
0.6 A
Mains voltages and fuses:
100 - 240 VAC, 50 - 60 Hz
Power
Fuses:
24V/3 A
Dimensions and Weight
Dimensions
Max. 280 mm x 250 mm x 120 mm
11.02” x 9.84” x 4.71”
Weight
980 g / 2.16 lbs
Print mode
Thermal line dot print Printing width: 48 mm (1.9 in) Resolution: 8 dots/mm (203 dots per in (dpi)) Dots per line: 384 dots
Thermal paper
Paper width = 56mm +/- 1 mm (2.2 in +/- 0.04 in) max. 40 mm (1.6 in) diameter
Battery pack
2-cell Li-Ion battery pack 7.4 V-1500 mAh
Power supply / charger
12 V/1 A UE15WCP1-120125SPA Maximum current consumption 0.5 A (see also Figure 74)
Size
02 mm x 75 mm x 45 mm (4.02 in x 2.95 in x 1.77 in)
Weight
Weight: 205 g including battery, without paper
Environment Conditions:
Operational temperature range: -10 °C to +50 °C (+14 °F to +122 °F) Operational humidity range: 20 % to 85 % Storage temperature range: -20 °C to +70 °C (-4 °F to +158 °F)
Figure 74
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6.2 Connections and Pin Assignment
easyTymp device
Table 6 Pin Assignment easyTymp
OUTPUTS
CONNECTOR TYPE
PIN ASSIGNMENT
USB mini
USB Type „B“”
USB port for communication
Probe connector
Probe connector, 12-pole
CH1 out CH1 GND DGND GND Microphone Microphone – input / Analog balanced in Microphone + input / Analog balanced in Power supply +3/+5V CH2 out CH2 GND I2C CLK I2C DATA I2C Interrupt
Data connector
Data connector, 30-pole
STAT2_HH Cradle+5V Cradle+5V Cradle+5V DGND DGND DGND USB+5V USBDP USBDN Temp.bat PRT_BUSY IC33-NO2 PRT_ACK/U2RX TP116 IC33-NO1
TRIGGER-OUT2 RESET# TRIGGER-IN2 KEY_DOWN / POWER ON Vbat PRT_ACK/U2RX Strobe# DATA0 DATA1 DATA2 DATA3 DATA4 DATA5 DATA6 DATA7
Contra Phone
3.5 mm Mono
Ground
Signal
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Cradle
Figure 75
Table 7 Pin Assigment Cradle
NO.
CONNECTOR TYPE
PIN ASSIGNMENT
1
USB in
USB 2.0
1. +5 VDC
2. Data -
3. Data +
4. Ground
2 to 4
USB out
USB 2.0
1. +5 VDC
2. Data -
3. Data +
4. Ground
5
Mains DC socket
24 V/3 A
-
Data connector
Data connector, 30-pole
STAT2_HH Cradle+5V Cradle+5V Cradle+5V DGND DGND DGND USB+5V USBDP USBDN Temp.bat PRT_BUSY IC33-NO2 PRT_ACK/U2RX TP116 IC33-NO1
TRIGGER-OUT2 RESET# TRIGGER-IN2 KEY_DOWN / POWER ON Vbat PRT_ACK/U2RX Strobe# DATA0 DATA1 DATA2 DATA3 DATA4 DATA5 DATA6 DATA7
-
Charging connector
- pole
ground
+ pole
1
2
3
4
5
4
5
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6.3 Reference values for stimulus calibration
Table 8
COUPLER TYPES USED BY CALIBRATION
IOW Probe (probe system):
Calibrated using a IEC 60380-5 (2cc) Acoustic coupler made in accordance to MAICO Standard Values
CIR55 :
Calibrated using a IEC 60380-5 (2cc) Acoustic coupler made in accordance to ISO 389-2:1994
DD45C:
Calibrated using a IEC 60318-3 (6cc) Acoustic coupler made in accordance to MAICO Standard Values
Table 9 Reference Values for Stimulus Calibration
REFERENCE VALUES FOR STIMULUS CALIBRATION
Fre­quency [Hz]
Reference equivalent threshold sound pressure level [RETSPL, dB re. 20 Pa]
CIR55
ISO 389-2
DD45 C
MAICO Standard Values
IOW Probe
MAICO Standard Values
125
26.0
47.5*
41.0*
250
14.0
27.0*
24.5*
500
5.5
13.0*
9.5*
750
2.0
6.5*
9.0*
1000
0.0
6.0*
6.5*
1500
2.0
8.0*
5.0*
2000
3.0
8.0*
12.0*
3000
3.5
8.0*
11.0*
4000
5.5
9.0*
3.5*
6000
2.0
20.5*
3.0*
8000
0.0
12.0*
-5.0*
WB
-5.0
-8.0*
-5.0*
*All values marked with at star are MAICO Standard Values.
Table 10 Frequencies and Intensity Ranges for Impedance
FREQUENCIES AND MAXIMUM VALUES FOR IMPEDANCE
Center Frequency [Hz]
Intensities [dB HL]
CIR55
DD45 C
IOW Probe
Tone
Tone
Tone
125
85
80
70
250
100
100
85
500
110
115
100
750
110
120
100
1000
115
120
105
1500
115
115
110
2000
115
115
105
3000
115
125
95
4000
110
115
100
6000
95
110
85
8000
80
105
80
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6.4 Electromagnetic Compatibility
The device fulfils the relevant EMC requirements. Precautions should be taken to avoid unnecessary exposure to electromagnetic fields, e.g. from mobile phones etc. If the device is used adjacent to other equipment it must be observed that no mutual disturbance appears.
Portable and mobile RF communications equipment can affect the easyTymp. Install and operate the device according to the EMC information presented in this chapter.
The device has been tested for EMC emissions and immunity as a standalone device. Do not use the device adjacent to or stacked with other electronic equipment. If adjacent or stacked use is necessary, the user should verify normal operation in the configuration.
The use of accessories, transducers and cables other than delivered from MAICO, with the exception of servicing parts sold by MAICO as replacement parts for internal components, may result in increased emissions or decreased immunity of the device.
Anyone connecting additional equipment is responsible for making sure the system complies with the IEC 60601-1-2 standard.
Guidance and manufacturer’s declaration - electromagnetic emissions
The easyTymp is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment.
Emissions Test
Compliance
Electromagnetic environment - guidance
RF emissions CISPR 11
Group 1
The device 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
The device is suitable for use in all commercial, industrial, business, and residential environments.
Harmonic emissions IEC 61000-3-2
Complies Class A Category
Voltage fluctuations /flicker emissions
IEC 61000-3-3
Complies Recommended separation distances between portable and mobile RF communications equipment and the
easyTymp.
The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the device can help prevent electromagnetic interferences by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the device as recommended below, according to the maximum output power of the communications equipment.
Rated Maximum output power of transmitter
[W] Separation distance according to frequency of transmitter
[m]
150 kHz to 80 MHz d = 1.17√P
80 MHz to 800 MHz d = 1.17√P
800 MHz to 2.5 GHz d = 2.23√P
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 not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
Note 1 At 80 MHz and 800 MHZ, the higher frequency range applies. Note 2 These guidelines may not apply to all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
CAUTION
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Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
The easyTymp is intended for use in the electromagnetic environment specified below. The customer or the user of the device is should assure that it is used in such an environment.
Immunity Test
IEC 60601 Test level
Compliance
Electromagnetic Environment-Guidance
Electrostatic Discharge (ESD)
IEC 61000-4-2
+6 kV contact
+8 kV air
+6 kV contact
+8 kV air
Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be greater than 30%.
Electrical fast transient/burst
IEC 61000-4-4
+2 kV for power supply lines
+1 kV for input/output lines
+2 kV for power supply lines
+1 kV for input/output lines
Mains power quality should be that of a typical commercial or residential 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.
Voltage dips, short interruptions and voltage variations on power supply lines
IEC 61000-4-11
< 5 % UT (>95 % dip in UT) for 0.5
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) for 5
sec
< 5 % UT (>95 % dip in UT)
for 0.5 cycle
40 % UT (60 % dip in UT) for
5 cycles
70% UT (30 % dip in UT) for
25 cycles
<5 % UT
Mains power quality should be that of a typical commercial or residential environment. In case of a power failure the device will automatically shut down within 10 s. If the user of the device requires continued operation during power mains interruptions, it is recommended that the device be powered from an uninterruptable power supply or its battery.
Power frequency (50/60 Hz)
IEC 61000-4-8
3 A/m
3 A/m
Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or residential environment.
Note: UT is the A.C. mains voltage prior to application of the test level.
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Guidance and manufacturer’s declaration — electromagnetic immunity
The easyTymp is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment.
Immunity test
IEC 60601 test level
Compliance level
Electromagnetic environment – guidance
Portable and mobile RF communications equipment should be used no closer to any parts of the device, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
Recommended separation distance:
Conducted RF IEC 61000-4-6
3 Vrms 150 kHz to
80 MHz
3 Vrms
Pd 2,1
Radiated RF IEC 61000-4-3
3 V/m 80 MHz to
2,5 GHz
3 V/m
Pd 2,1
80 MHz to 800 MHz
Pd 3,2
800 MHz to 2.5 GHz
Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in 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 vicinity of equipment marked with the following symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.
(a)
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones 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, an electromagnetic site survey should be considered. If the measured field strength in the location in which the device is used exceeds the applicable RF compliance level above, the device should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the device.
(b)
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
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6.5 Electrical Safety, EMC and Associated Standards
1. IEC 60601-1:2012/ ANSI/AAMI ES 60601-1: 2005 / A2:2010: Medical Electrical Equipment, Part 1 General Requirements for Safety
2. CAN/CSA-C22.2 No. 60601-1:2008: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
3. UL/IEC/EN 60950-1:2005: Information Technology Equipment - Safety - Part 1: General Requirements
4. IEC 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 for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements and tests
6. DIN/EN/ISO 14971:2012 - Application of risk management to medical devices
7. Essential Requirements of the current European Union Medical Device Directive 93/42/EEC
8. DIRECTIVE 2011/65/EU on the restriction of the use of certain hazardous substances in electrical and electronic equipment (RoHS 2)
9. Directive 2002/96/EC on waste electrical and electronic equipment (WEEE)
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6.6 Test Protocols
NOTE: Test protocols are configuration dependent.
01 226Hz
Tympanometry, Frequency: 226 Hz Earside: Ipsilateral
02 1kHz
Tympanometry, Frequency: 1 kHz Earside: Ipsilateral
03 226Hz + Ipsi Reflex Auto
Tympanometry, Frequency: 226 Hz Number of Reflexes tested = 4, Frequencies: 0.5, 1.0, 2.0, 4.0 kHz Intensity Reflex Min (Intensity in dB HL) = 70 Intensity Reflex Max (Intensity in dB HL) = 100 Probe frequency during reflexes: 226 Hz Earside: Ipsilateral
04 226Hz + Ipsi Reflex 90 dB
Tympanometry, Frequency: 226 Hz Number of Reflexes tested = 4, Frequencies: 0.5, 1.0, 2.0, 4.0 kHz Intensity Reflex (Intensity in dB HL) = 90 Probe frequency during reflexes: 226 Hz Earside: Ipsilateral
05 1kHz + Ipsi Reflex Auto
Tympanometry, Frequency: 1 kHz Number of Reflexes tested = 4, Frequencies: 0.5, 1.0, 2.0, 4.0 kHz Intensity Reflex Min (Intensity in dB HL) = 70 Intensity Reflex Max (Intensity in dB HL) = 100 Probe frequency during reflexes: 226 Hz Earside: Ipsilateral
06 1kHz + Ipsi Reflex 80 dB BB
Tympanometry, Frequency: 1 kHz Number of Reflexes tested = 1, Test signal: Broad-band noise Intensity Reflex (Intensity in dB HL) = 80 dB Probe frequency during reflexes: 226 Hz Earside: Ipsilateral
07 226Hz + Ipsi-Contra Auto
Tympanometry, Frequency: 226 Hz Number of Reflexes tested = 8, Frequencies: 0.5, 1.0, 2.0, 4.0 kHz Intensity Reflex Min (Intensity in dB HL) = 70 Intensity Reflex Max (Intensity in dB HL) = 100 Probe frequency during reflexes: 226 Hz Earside: Ipsi- and Contralateral
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08 226Hz + Ipsi-Contra 90 dB
Tympanometry, Frequency: 226 Hz Number of Reflexes tested = 8, Frequencies: 0.5, 1.0, 2.0, 4.0 kHz Intensity Reflex (Intensity in dB HL) = 90 Probe frequency during reflexes: 226 Hz Earside: Ipsi- and Contralateral
09 1kHz + Ipsi-Contra Auto
Tympanometry, Frequency: 1 kHz Number of Reflexes tested = 8, Frequencies: 0.5, 1.0, 2.0, 4.0 kHz Intensity Reflex Min (Intensity in dB HL) = 70 Intensity Reflex Max (Intensity in dB HL) = 100 Probe frequency during reflexes: 226 Hz Earside: Ipsi- and Contralateral
10 1kHz + Ipsi-Contra 80 dB BB
Tympanometry, Frequency: 1 kHz Number of Reflexes tested = 2, Test signal: 80 Broad-band noise Intensity Reflex (Intensity in dB HL) = 80 Probe frequency during reflexes: 226 Hz Earside: Ipsi- and Contralateral
11 Decay Ipsi
Number of Reflexes tested = 4, Frequencies: 0.5, 1.0, 2.0, 4.0 kHz Intensity Reflex Min (Intensity in dB HL) = 70 Intensity Reflex Max (Intensity in dB HL) = 110 Probe frequency during reflexes: 226 Hz Duration of Signal: 10 s Earside: Ipsilateral
12 Decay Contra
Number of Reflexes tested = 4, Frequencies: 0.5, 1.0, 2.0, 4.0 kHz Intensity Reflex Min (Intensity in dB HL) = 70 Intensity Reflex Max (Intensity in dB HL) = 120 Probe frequency during reflexes: 226 Hz Duration of Signal: 10 s Earside: Contralateral
13 ETF Intact
Tympanometry, Frequency: 226 Hz Number of Measurements = 3 Earside: Ipsilateral
14 ETF Perforated
Frequency during Testing: 226 Hz Duration of Signal: 30 s Earside: Ipsilateral
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Appendix
Literature
L. Macedo de Resende; J. dos Santos Ferreira; S. Alves da Silva Carvalho; I. Oliveira; I. Barreto Bassi, „Tympanometry with 226 and 1000 Hertz tone probes in infants” Braz. j. otorhinolaryngol. vol.78 no.1 São Paulo Jan./Feb. 2012
Carvallo RMM, „Medida de imitância acústica em crianças de zero a oito meses de idade.” São Paulo: Universidade Federal de São Paulo - Escola Paulista de Medicina; 1992
Lu JS, Zhang J, Tang L, Ding W, Zhang L, Guo XP, Zai NL. “Analysis of the 1000 Hz Tympanometry in normal hearing neonates“, Zhonghua Er Bi Yan Hou Tou Jing Wai Ke Za Zhi. 2011 Nov;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 Admittance Approach” Australian and
New Zealand Journal of Audiology, Volume 31, Issue 1, May 2009, pages 15-24 DOI:
10.1375/audi.31.1.15
Kei J, Allison-Levick J, Dockray J, Harrys R, Kirkegard C, Wong J, “High-frequency (1000 Hz) Tympanometry in normal neonates.” J Am Acad Audiol. 2003;14(1):20-8
Shanks, J., & Shohet, J (2009), “Tympanometry in clinical practice.” In J. Katz, L. Medwetsky, R. Burkard, & L. Hood (Eds.), Handbook of clinical audiology (6th ed.) (pp. 157-188)
Baltimore: Lippincott, Williams & Wilkins
Mrowinski, D., Scholz, G., “Audiometrie Eine Anleitung für die praktische Hörprüfung.”
2006, 3. Auflage, Thieme Verlag
Jerger, J., Norhtern, J.,“Clinical impedance audiometry” 1980, Thieme Verlag
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