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Operation Manual easyScreen

8508935 Rev. 4

04/04/2019

2 Warnings and Cautions

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 during the
whole time handling and operating your device

2.1 Reading this Operation Manual

This operation manual contains information pertinent to the use of the easyScreen
system including safety information as well as maintenance and cleaning
recommendations.

It is highly recommended that users read the manual in its entirety prior to use of the
easyScreen device on a patient.

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

NOTE

: Notes help you identify areas of possible confusion and avoid potential problems

during system operation.

WARNING

CAUTION

Содержание easyScreen

Страница 1: ...easyScreen Operation Manual...

Страница 2: ...Blank Page...

Страница 3: ...me Healthcare Environment 16 2 9 Battery Safety and Capacity 16 3 Warranty Maintenance and After Sales Service 17 3 1 Warranty 17 3 2 Maintenance 17 3 3 Cleaning and Disinfection Recommendations 18 3...

Страница 4: ...Managing Test Results 64 5 14 Setup 68 5 15 License Upgrade 69 5 16 Pass Checker Optional Use for ABR Hardware Testing 71 5 17 Infant Ear Simulator Optional Use for OAE Probe Testing 73 6 Technical D...

Страница 5: ...e information in this publication is proprietary to MAICO Compliance MAICO Diagnostics is an ISO 13485 certified corporation Caution for USA Federal Law restricts this device to sale by or on the orde...

Страница 6: ...d documentation of ear disorders using Transient Otoacoustic Emissions technology or Distortion Product Otoacoustic Emissions The device ABR module is intended for use in the audiologic evaluation and...

Страница 7: ...aindications Contraindications to testing include recent stapedectomy or middle ear surgery a discharging ear acute external auditory canal trauma discomfort e g severe otitis externa or occlusion of...

Страница 8: ...e test data transferred from the easyScreen Transfer names of patients requiring testing to the easyScreen Print test results on a standard PC compatible printer Export patient and test data HiTrack O...

Страница 9: ...he patient s skin as well as a transducer for delivery of the acoustic stimulus It eliminates the need for traditional disposable electrodes and ear couplers The BERAphone is a non critical patient ca...

Страница 10: ...ndations It is highly recommended that users read the manual in its entirety prior to use of the easyScreen device on a patient READ THIS ENTIRE MANUAL BEFORE ATTEMPTING TO USE THIS SYSTEM Use this de...

Страница 11: ...structions 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 whic...

Страница 12: ...accompanying documents Return to authorized representative special disposal required Reference number Patient applied part type B according to IEC 60601 1 Patient applied part type BF according to IEC...

Страница 13: ...equipment could be hazardous No parts of the equipment can be serviced or maintained while in use with the patient Use of accessories transducers and cables other than those specified or provided by t...

Страница 14: ...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 se...

Страница 15: ...he patient Do not open the case of the easyScreen device Refer servicing to qualified personnel 2 7 Electromagnetic Compatibility EMC The device fulfills the relevant EMC requirements Avoid unnecessar...

Страница 16: ...g excessive charging current or reversing the poles can overcharge or destroy the battery Do not open alter or dismantle the battery Do not place the battery in contact with metal objects The terminal...

Страница 17: ...dify this equipment without authorization of the manufacturer If this equipment is modified appropriate inspection and testing must be conducted to ensure continued safe use of the equipment No modifi...

Страница 18: ...wipes Follow the instructions on the specific disinfection product Wipe before and after each patient After contamination After infectious patients To avoid damage of the device and its accessories p...

Страница 19: ...be cleaned and disinfected with a medical or hospital grade disinfectant prior to re use Use of a non alcohol based disinfectant is recommended Non alcohol based products contain the active ingredient...

Страница 20: ...re 1 Figure 1 4 Clean the stainless steel part of the electrode with an alcohol or disinfectant wipe The stainless steel part of the detached electrode can be autoclaved if desired 5 Clean the gel pro...

Страница 21: ...ip while the tip is still attached to the probe Figure 2 Use the Bridge Implant Floss or the ProxySoft 3 in 1 Floss for cleaning Figure 2 Discard floss after use Figure 3 Unscrew the probe cap by turn...

Страница 22: ...e to ensure wax debris is pushed out of the probe tip instead of into it This also protects the gasket from being damaged Figure 11 If the inside of the probe beyond the removable probe tip is clogged...

Страница 23: ...recording only when the baby is quiet Electrode is losing contact with the skin Check electrode contact to skin making sure it is contacting the prepared skin Electrode lead wire has a short in the w...

Страница 24: ...aps between the coupler and baby s skin For eartips make sure that the ear tip is securely inserted into the baby s ear canal Stimulus is not coming through the transducer Check the connection of the...

Страница 25: ...move to a new location 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...

Страница 26: ...tributor 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 appe...

Страница 27: ...ad Wires NuPrep Skin Preparation Gel Transducers One or More Included as Selected at Time of Purchase IP30 50 Insert Earphone With Eartip Adapters Kit IP30 50 Insert Earphone With EarCupTM Adapters Ki...

Страница 28: ...ation of the device by following routine check procedures for audiometric equipment 4 3 easyScreen Hardware Display Switch and Charging Light Indicator on the easyScreen Viewing your easyScreen from t...

Страница 29: ...ves Figure 17 It responds to the pressure of touching the icons This can be accomplished with a finger or a pointing device Care should be taken not to scratch the surface of the touch screen overlay...

Страница 30: ...gure 21 OAE Ear Probe for ABR and OAE The OAE ear probe must be used for OAE screening However it can also be used as the transducer to deliver the acoustic stimulus for ABR screening as well In this...

Страница 31: ...plug at the end of the BERAphone cable the preamplifier cable or OAE probe with the socket at the top of the easyScreen which also has a small dot to assist with alignment Insert the plug and push it...

Страница 32: ...he connector in the socket Connecting the Electrode Lead Wires to the Preamplifier Figure 27 Connect the three electrode lead wires securely into the electrode jacks on top of the preamplifier matchin...

Страница 33: ...is not required for patient testing With the Pass Checker turned on perform a standard ABR test The impedance values should be low enough to begin the measurement and the measurement should provide a...

Страница 34: ...To remove it lift the lower part of the BERAphone first The cradle can be mounted to a table or other flat surface with two screws Components of the BERAphone The BERAphone components are as follows...

Страница 35: ...ction via USB is required If the easyScreen is used with office equipment that is not a medical device itself see Table 5 PC Connection 1 make sure to establish the PC connection in one of the followi...

Страница 36: ...d by a rechargeable Lithium ion Li ion battery The battery is charged by placing the device in the AC powered cradle The battery can also be charged by Connecting the device to a powered PC using the...

Страница 37: ...and plugging the other end into an AC outlet using the appropriate adapter for your region The cradle LED will light up when it is powered on Use only the power supply delivered by MAICO for powering...

Страница 38: ...ng in the cradle once the charge is sufficient to support testing Screening can be performed when easyScreen is connected to the powered PC via the USB cable or with the power supply plugged directly...

Страница 39: ...aper end through the paper exit slot in the cover and close the cover Figure 42 and Figure 43 Turn the printer on and press the feed button on the left side so that the printer can properly align the...

Страница 40: ...ed during the boot up process This could include Calibration expiration reminder Low battery charge warning Power Saving Mode and Power off When the easyScreen is inactive for some time period the dev...

Страница 41: ...ontrol bar with common function buttons 5 3 Common Function Buttons The common function buttons are explained in Table 8 Table 8 Common Function Buttons OK accept save Cancel Add comment Change logged...

Страница 42: ...the User Optional Figure 45 The easyScreen can be set to require screener login via the HearSIMTM PC application This is disabled by default When login is enabled a list of screeners that you created...

Страница 43: ...s entered a message will appear indicating that the password you entered was incorrect The message will display for several seconds and then disappear clearing the entry field so that you can try agai...

Страница 44: ...he list for selection of a new screener Setup Select Setup to access a list of the device settings that can be made directly on easyScreen Some settings can only be made via use of the HearSIMTM PC ap...

Страница 45: ...figuring the risk factors list Refer to section 6 6 of the HearSIM Instructions for information about transferring settings to your easyScreen device Be sure that the Risk Factors checkbox is selected...

Страница 46: ...a square is present and the appearance of the square reflects the test status as described below Figure 53 No tests are saved in the device for this patient Figure 53 Figure 54 Tests are saved in the...

Страница 47: ...is being performed Ask parents to take other children out of the mother s room during the test 5 8 1 3 Electrical Noise ABR Electrical noise in the screening environment can cause high artifact level...

Страница 48: ...y in a blanket with the arms wrapped inside is recommended This will calm the baby and keep the baby from interfering with the screening device components Risk of choking Always keep eartips and simil...

Страница 49: ...fact and ensure optimum test outcome in the shortest time Make sure that the face neck and shoulder of the baby are relaxed and free of any obstructions IMPORTANT NOTE Make sure that the gel areas rem...

Страница 50: ...Center of the forehead at the hairline Cheek either side or shoulder Nape of the neck An alternate electrode montage can be used as seen below However the screening time for the right ear may be prol...

Страница 51: ...e neck Left mastoid Press gently around the entire surface of each electrode to help secure its adhesive to the skin Figure 60 5 8 4 1 Preparing for Classic ABR Testing with EarCups At the time of pur...

Страница 52: ...cavity is not occluded by any contact with the ear Peel the EarCupTM attached to the blue tubing from the backing card Place it around the baby s left ear Press around the entire circumference of the...

Страница 53: ...rts with eartips are different from calibration values for inserts used with EarCupsTM Never modify an insert earphone by replacing the original tubes and adapters with the other adapter type This wil...

Страница 54: ...Test button will not appear on the Home screen Select the Test Button Press the Test button to start the process toward screening Depending on several factors about the configuration of your device s...

Страница 55: ...e entry by proceeding with selection of the Test button if the current items displayed in the fields are correct If you have logged into the device upon boot up then your screener name will also be sa...

Страница 56: ...reener ABR Initial Test Screen The initial ABR screen displays some setup instructions Table 12 Table 12 ABR Initial Test Screen Screen Screen Area Graphic Function Name Description Figure 69 Patient...

Страница 57: ...ce check feedback Feedback about the impedance values Green good impedance Yellow poor impedance Stop test button Stops the test Pause resume screening button Pause resume the measurement If any imped...

Страница 58: ...show helpful information about the testing status Testing Test is proceeding Done Test is complete Reconnect electrode Electrode has fallen off reconnect it Too noisy Artifacts are occurring consider...

Страница 59: ...ol can also be used to toggle between the last ABR test performed on the right and left ear during the session Table 15 Test Done Screen Screen Screen Area Graphic Function Name Description Figure 72...

Страница 60: ...eck information is displayed regarding the quality of the fit of the probe in the ear canal and the amount of acoustic background noise Table 17 Once the probe fit is good and the acoustic noise is be...

Страница 61: ...Additionally horizontal bars for probe stability noise and test progress appear When noise and probe stability are acceptable a checkmark appears next to the horizontal bar NOTE Probe stability during...

Страница 62: ...on of those samples If this occurs you should Pause the test and attend to the acoustic noise by calming the baby or managing other sources of ambient noise The fit of the probe should also be checked...

Страница 63: ...t Quick tests can be printed immediately after the test is completed but no identifying information will appear on the print out One Quick Test session is saved temporarily in the Patient List of the...

Страница 64: ...ttom control bar to page through the list You can use the Search button in the bottom control bar to open a keyboard screen Type in all or a portion of the patient s last name or ID number and select...

Страница 65: ...ction 5 13 3 2 Figure 79 Each row in the View Test List screen shows the following information Result symbol for Pass Refer or Incomplete Test ear symbol for Right Left or Both ears Test date time Tec...

Страница 66: ...the label printer can be accomplished either directly after screening from the Test Done screen or at a later time from the View Tests screen entered from the Patient information screen Start Print Pr...

Страница 67: ...ter icon at the right side of the row You can deselect by touching the symbol You can select other tests in the list for printing according to your preferences If only one right and one left ear scree...

Страница 68: ...nguage Figure 86 Setup Device Set your time preference for Power Save and Power Off features Figure 86 Power Save Standby can be set to Never 1 5 minutes or 10 minutes Power Off can be set to Never or...

Страница 69: ...about the easyScreen Figure 89 including Software versions Serial numbers and calibration dates Battery information Licenses 5 15 License Upgrade License upgrades to a MAICO easyscreen can be added a...

Страница 70: ...ing the code from the USB flash drive to the correct license field If you received the license code on a paper certificate enter the number manually into the correct license field being careful to mat...

Страница 71: ...e ring around the posts Figure 91 Insert the insert earphone adapters securely into the holes on either side of the Pass Checker Figure 92 If the black EarCupTM adapters are used with your system thes...

Страница 72: ...cable jack is not secure Check the connection of the insert earphone connector into the preamplifier cable remove it and re insert it verifying that it is securely attached Insert earphone cable is n...

Страница 73: ...at such a cavity does not reflect the properties of an infant ear Testing this way can produce false responses due to the resonance characteristics of the hard walled cavity making it difficult to ass...

Страница 74: ...ifications The performance and specifications of the device can only be guaranteed if it is subjected to technical maintenance at least once per year MAICO Diagnostics puts diagrams and service manual...

Страница 75: ...ansport IP20 This marking can be found on the device parts meaning that the parts are not protected against water NOTE The charger power supply and cradle are not to be used in home healthcare environ...

Страница 76: ...me ABR impedance measurement Measurement frequency 33 Hz Measurement current 11 25 A Waveform Rectangular Acceptable Impedance Range 1 k to 50 k DPOAE Stimulus Frequency range 1500 Hz to 6000 Hz Defau...

Страница 77: ...inimum 5 dB SPL Freq for pass Depends on selected protocol Default 3 of 4 TEOAE Stimulus Stimulus type Non Linear click according to IEC 60645 3 Level range 60 dB peSPL to 83 dB peSPL Default level 83...

Страница 78: ...Weight incl cables 13 g 0 46 oz short cable 19 g 0 67 oz long cable BERAphone Supported tests ABR monaural Preamplifier Channels One Gain 72 dB Frequency response 0 5 Hz to 5000 Hz Noise 25 nV Hz CMR...

Страница 79: ...e length 112 cm 44 in Electrode lead wire length 51 cm 20 in CRADLE Charging Wireless inductive charging Dimensions 142 mm x 140 mm x 62 mm 5 6 in x 5 5 in x 2 4 in Weight 270 g 0 6 lb Power supply Ty...

Страница 80: ...ly easyScreen ABR OAE Connector for ABR Preamplifier Probe Transducer connector BERAphone and Insert earphones PROBE CONNECTOR PIN FUNCTION 12 pol connector 1 CH1 out 2 CH1 GND 3 DGND 4 GND A GND Micr...

Страница 81: ...e of 5 N Stimulus The ABR stimulus is different from the one specified in the standard IEC 60645 3 This CE CHIRP stimulus has the same linear magnitude frequency response like the click stimulus speci...

Страница 82: ...uipment should be avoided because it could result in improper operation If such use is necessary this instrument and the other equipment should be observed to verify that they are operating normally P...

Страница 83: ...800 MHz to 2 5 GHz d 2 23 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0 74 1 1 17 1 17 2 33 10 3 70 3 70 7 37 100 11 70 11 70 23 30 For transmitters rated at a maximum output power not listed above the recommen...

Страница 84: ...erence may occur in the vicinity of equipment marked with the following symbol NOTE1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations El...

Страница 85: ...T EQUIPMENT Item Manufacturer Model Cable SIP SOP Serial no Length m Screened Y N Socket ID Type Power Supply UE Fuhua UE08WCP 050160SPA Mains power AC supply 1 5 N Micro USB on the wireless charger c...

Страница 86: ...tion of risk management to medical devices Essential Requirements of the current European Union Medical Device Directive 93 42 EEC RoHS Restriction of the use of certain Hazardous Substance 6 7 Screen...

Страница 87: ...L1 L2 65 55 dB SPL F2 F1 Ratio 1 22 Max test time 60 s Freq for pass 3 4 Pass criteria for each frequency Min OAE level 5 dB SPL Min SNR 6 dB Artifact rejection level 30 dB SPL 99 6 DPOAE D01 1 5 4 kH...

Страница 88: ...None 99 6 TEOAE T02 1 5 4 kHz 3_4 80 dB SPL Center Frequencies 1 4k 2k 2 8k 4k Hz Stimulus type Click non linear Level 80 dB peSPL Max test time 60 s Freq for pass 3 4 Min OAE level 5 dB SPL Pass cri...

Страница 89: ...2 Max test time 60 s Freq for pass 3 4 Mic correction disabled to comply with standard Pass criteria for each frequency Min OAE level 5 dB SPL Min SNR 6 dB Artifact rejection level 30 dB SPL 99 6 TEOA...

Страница 90: ...ecifications are subject to change without notice MAICO Diagnostics GmbH Sickingenstr 70 71 10553 Berlin Germany Tel 49 30 70 71 46 50 Fax 49 30 70 71 46 99 E mail sales maico biz Internet www maico b...

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