Tyto Care K160401 Electronic medical device that enables wireless transmission of heart/lugs sound, video streaming, pictures capturing or body temperature directly to physician. User Manual
Tyto Care Ltd. Electronic medical device that enables wireless transmission of heart/lugs sound, video streaming, pictures capturing or body temperature directly to physician.
User Manual
TytoPro User Guide TytoCare Base Unit Version 1.0 TytoPro Base Unit User Manual Table of Contents 1. General Safety Messages ............................................................... 5 2. Product Overview .......................................................................... 8 2.1. Intended use and indications for use ................................ 8 3. What’s in the Box ........................................................................... 9 4. How the System works................................................................. 13 5. Download, Registering the App and Adding Patients .................. 14 5.1. Downloading the App ...................................................... 14 5.2. Registration ......................... Error! Bookmark not defined. 5.3. Tutorial Videos ................................................................. 14 6. First Time Setup ........................................................................... 15 6.1. What do I need to start working with the Device? .......... 15 6.2. Setting up the Wi-Fi Connection ...................................... 15 7. User Role: Unguided and Guided Exams ....... Error! Bookmark not defined. 7.1. Choosing Unguided or Guided Exams Error! Bookmark not defined. 8. Start visit ...................................................................................... 20 8.1. User login ......................................................................... 21 8.2. Identify patient ................................................................ 22 8.2.1. Add a New Patient ........................................................ 24 8.2.2. Choose Type of Exam .................................................... 25 8.2.3. Request an Online Meeting ............ Error! Bookmark not defined. 8.3. Select an Exam ................................................................. 26 Page 2 of 50 TytoPro Base Unit User Manual 8.4. Perform the Exam ............................................................ 28 8.4.1. Exams and Add-On Devices .......................................... 29 8.5. After the Exam .................... Error! Bookmark not defined. 8.6. Confirmation screen after Save visit . Error! Bookmark not defined. 9. Online Visit & Exam ...................................................................... 36 9.1. Log in and Choose a Clinician........................................... 36 9.2. Clinician Accepts Your Visit Request ................................ 37 9.3. Using the Mobile Device Stand ........................................ 38 10. INBOX ......................................................................................... 41 11. User Settings .............................................................................. 42 12. System Labels and Symbols ....................................................... 43 12.1. System Labels................................................................. 43 12.2. Explanation of Symbols .................................................. 44 Appendix A: Headphones................................................................. 45 A.1 Connecting headphones to the device ............................. 46 A.2 Advanced Clinician settings .............................................. 47 A.3 Advanced Technician settings .......................................... 47 Appendix B: Forgot Password .......................................................... 48 Appendix C: Frequently Asked Questions ........................................ 49 Page 3 of 50 TytoPro Base Unit User Manual Important This User Guide is subject to periodic review, update and revision. The user of this product has sole responsibility for any malfunction that results from improper use, faulty maintenance, improper repair, unauthorized service, damage, or alteration by anyone other than Tyto Care Ltd. (TytoCare). The safety, reliability, and performance of this device can only be assured under the following conditions: The device has been used for its indicated use and according to the operating instructions in this User Manual. All fittings, extensions, readjustments, changes, or repairs have been carried out by a TytoCare authorized representative. This product is protected by the following US patent applications: US 8,953,837 and US-20130338447 and other pending US patents. The device complies with requirements of IEC/EN 60601-1 for general requirements for safety of medical electrical equipment (Type BF applied part, mode of operation: spot measurement, degree of mobility: portable). The unit has IEC 60601-1-2 Class A compliance. TytoCare reserves the right to change or improve its products and accompanying technical literature without specific notice of changes or improvements. No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form by any means, electronic, mechanical, photo reproductive, recording or otherwise without the express prior written permission of TytoCare. Tyto support may be contacted at +1-866-971-TYTO 12 Haomanut St. Netanya 4250445 Israel Tel: + 972 (72) 2210750 Fax: +972 (72) 2210752 E-mail: support@TytoCare.com http://www.TytoCare.com PLEASE READ THIS USER MANUAL BEFORE OPERATING THE SYSTEM. Page 4 of 50 TytoPro Base Unit User Manual 1. General Safety Messages Warnings: A warning indicates precautions to avoid the possibility of personal injury or death. If the device packaging, the device itself or any of its accessories are damaged or not intact – do not use the device. Do not immerse the device or any of its accessories in water or in any other liquid. Do not use a wet device. If the device becomes wet, wipe off all moisture and allow at least 48 hours to dry before operating. The system contains no user-serviceable components. Do not disassemble, service or repair this product or any of its parts. Disposal of this device should be performed in accordance with local regulations. If device is not working as expected, discontinue use. Refer servicing to qualified service personnel. Use the equipment only for the purpose described, as explained in this user manual. Do not use accessories which are not supplied or recommended by the manufacturer. Do not remove the covers of the device components. Only perform maintenance procedures specifically described in this user manual. Do not use device during defibrillator use. Do not use the device on an open wound or on infected skin. Keep these instructions for use. Cautions: A caution indicates a condition that may lead to damage to equipment, or a lower quality of treatment. Connect only authorized accessories to the device. If the LCD screen is broken or cracked, please contact TytoCare Support. If the LCD screen is dirty, clean the screen with a dry cloth or towel. If the device does not turn on or initialize properly, or the Splash screen does not appear as shown, or it cannot be turned off, contact TytoCare Support. If the audible speaker does not sound briefly during system initialization, contact TytoCare Support. The Restore to Factory Defaults action from the menu will erase all device settings and data and will restore the device to its initial as-new state. Use 70% alcohol moisture wipes for disinfection of the device if in contact with skin. Contact with solvents can cause severe deterioration of the plastic parts and malfunctioning of the instrument and accessories. Examinations cannot be done while the device is charging. Use only the charger provided with the device. If the device does not charge, contact TytoCare Support. Use only a secured Wi-Fi network such as WPA2 wireless encryption. If data or instructions are not displayed on the iPhone during an examination, view the device screen. Page 5 of 50 TytoPro Base Unit User Manual Notes: A note provides other important information. If for any reason you cannot perform the connection between the device and the TytoCare App, contact TytoCare Support. When performing a measurement, a date and time stamp is automatically included with the recording. If you do not see the date and time of the recording, contact TytoCare Support. The device connection screen in the TytoCare App should only be used to connect to another device or to disconnect from an existing device. Storage and operating conditions: 0°-40° Celsius / 15-93% humidity. When charging, the activity LED should be orange, and when charging is complete, it should turn green. The device is a class II device intended for use under prescription. The device complies with wireless standard IEEE 802.11 g/n (2.4GHz). Repair Policy When under warranty, repair and service must be performed by TytoCare. When the TytoCare warranty is not applicable, repairs may be made by TytoCare or authorized representatives, on a parts and labor basis. The device has a one-year warranty. Warning: Do not remove the covers of the device components. Only perform maintenance procedures specifically described in this User Guide. Disclaimer Information provided by TytoCare is believed to be accurate and reliable. However, TytoCare assumes no responsibility for the use of such information, nor for any infringements of patents or other rights of third parties, that may result from its use. Page 6 of 50 TytoPro Base Unit User Manual FCC Radio frequency interference statement This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: is connected. er or an experienced radio/TV technician for help. TytoCare Inc. is not responsible for any radio or communication interference caused by using other than specified or recommended cables and battery or by unauthorized changes or modifications to this equipment. Changes or modifications not expressly approved by the manufacturer could void the user’s authority to operate the equipment. This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: 1. This device may not cause harmful interference, and 2. This device must accept any interference received, including interference that may cause undesired operation. Page 7 of 50 TytoPro Base Unit User Manual 2. Product Overview The TytoCare Base Unit is a user-friendly electronic device that allows you to perform examinations, and to optionally transmit these sound, video or image data to a medical professional in another location. The Base Unit is used with additional add-on units to perform the following types of examinations: Lungs Throat Heart Temperature Heart Rate Skin Ears General audio auscultation The Base Unit connects to your mobile device (iPhone, iPad, iPad mini or iPod touch) to facilitate the process of communicating examination data and performing an online visit with the clinician. This device is designed for use in a clinical environment. It can be used in a number of scenarios: By an individual clinician/medical professional at his clinic By a clinician/healthcare professional, who forwards exam data to another healthcare professional for later analysis By a clinician/healthcare professional, who collaborates online with another healthcare professional during or after the exams 2.1. Intended use and indications for use The device is the base unit that, when coupled with add-on devices, allows the performance of examinations, and the transmission of the resulting data. The exams may be conducted by a clinician at one location on a network, who can listen to the auscultation sounds of a patient on site or at a different location on the network, with the signal carried on a connection between the two locations. The TytoPro device is intended for use by professional users in a clinical environment or at patients’ homes. Page 8 of 50 TytoPro Base Unit User Manual 3. What’s in the Box Base Unit Otoscope Stethoscope Tongue Depressor Platter Includes an LCD touch screen, main processing unit, rechargeable battery, camera, illumination, sensors and connector which is used to mount the add-on devices (see Section 8.5.2. Exams and AddOns User Guides ), and which is held when taking an exam Add-on device for ears exam Add-on device for heart and lungs auscultations Optional tool for throat exam, including a re-usable holder, and a disposable blade Holder for device and add-ons. To be used during examinations Page 9 of 50 TytoPro Disposables Carrying Case Base Unit User Manual 10 adult ear specula 10 child ear specula 10 adult tongue depressor blades 10 child tongue depressor blades Holds the entire TytoCare product, including base unit, add-ons, disposables, and can also be used as a mobile stand, to hold the iPhone during examination and online virtual visit Page 10 of 50 TytoPro Charger Base Unit User Manual Used to charge base unit. The charger is equipped with a 110V adaptor plug. Please install it on the power supply box before charging. To charge the base unit, connect the power supply plug into the wall electrical wall socket, and the cord plug into the charger socket in device, as seen in this picture: Note: The device base unit comes pre-charged. If it does not power on initially, you can connect the charging cable to the base unit to recharge it. You cannot perform exams during the charging process. It is recommended to fully charge the battery before use. Page 11 of 50 TytoPro Base Unit User Manual Note: It is recommended to store the device charged, and to re-charge it once in every 3 months. Storing the device when battery is drained may shorten the battery life. Page 12 of 50 TytoPro Base Unit User Manual 4. How the System works The diagram below shows how the various components of the TytoCare system work together to help you communicate with the clinician. Tyto Server Secured communication between user and clinician and data (iPhone, iPad, iPad mini) repository Initiate an online exam with a clinician. Send store-and-forward data to a clinician for review. Manage and store patients’ recorded data TytoCare App Runs on Mobile Device Clinician Receiving Platform Clinician responds to store-and-forward requests & performs online visits Wi-Fi Base Device + Add-On Perform the examination Page 13 of 50 TytoPro Base Unit User Manual 5. Download the Tyto User App 5.1. Downloading the App Visit the Apple App Store on your iPhone. Search for “TytoCare” and download the free App by clicking “Get” The TytoCare App allows and assists you to perform exams, share the recorded exams with clinicians, perform online virtual visits, featuring live video conference, with the clinician and obtain exam results from clinicians. After downloading and installing the TytoCare App on your iPhone, you can run it from the Apps Menu. 5.2. Help Menu The user manual and tutorial videos may be reached at any time by pressing the help icon of the App. Page 14 of 50 TytoPro Base Unit User Manual 6. First Time Setup 6.1. What do I need to start working with the Device? A Wi-Fi network, secured by a known password, that I can connect to The device Tyto User App, installed on any of the following iOS mobile devices: iPhone 5 and up, iPad 4 and up, iPad mini 2 and up The carrying case, or any mobile stand, to hold the mobile device during work. Internet access via the Wi-Fi network For best performance, the following connection speed is recommended: Download 20 Mbps \ Upload 5 Mbps At minimum, the following connection speed is required: Download 5 Mbps \ Upload 1.5 Mbps 6.2. Pairing the device and iPhone User App In order to start using the TytoCare device, you must perform a short pairing process between the device and user app. This pairing enables the communication between the two devices, over the WiFi network. This process is done once per device. Before pairing, please make sure that your iPhone is connected to your Wi-Fi network and you know its password. Note: If your Wi-Fi network is not secured by a password, you will not be able to pair the device and app. Page 15 of 50 TytoPro Base Unit User Manual 1. Turn ON the device by pressing the button on the top edge of the device: The screen displayed on the device will prompt you to download the TytoCare App onto your iPhone. App Download Screen If you have already downloaded the App on your iPhone, press “I have the App”, and continue with step 2 below. 2. Now return to the TytoCare App on your iPhone and enter your Wi-Fi network password in the App. Press “Connect to TytoCare”. This creates a QR code on the iPhone screen: Page 16 of 50 TytoPro Enter Wi-Fi password Base Unit User Manual Press “Connect to TytoCare” QR code created on iPhone Page 17 of 50 TytoPro Base Unit User Manual 3. You now want to use the base unit camera to read the QR code from the iPhone screen: A) Hold the base unit and press “Scan Barcode”, which activates its camera. The base unit screen enters scan mode (with helpful cross-hairs to assist your aim). B) Position the cross-hairs over the QR code displayed in the TytoCare App. Wait for a confirmation message on both the base unit screen and the TytoCare App: Confirmation on iPhone App Read QR code using the device camera from the iPhone screen Confirmation on Device Scanning the Barcode and Pairing the Devices Note: If an error occurs, retry the pairing process again. If error persists, see Appendix D: Frequently Asked Questions. 4. Click “OK” on the TytoCare App to continue: Page 18 of 50 TytoPro Base Unit User Manual Note: The connectivity status of the base unit to the TytoCare App is indicated in the upper right corner of the base unit screen as well as on the iPhone app. It is either connected or not connected to the TytoCare App running on your iPhone: Device connected to the TytoCare App running on iPhone Device not connected to the TytoCare App Page 19 of 50 Pro Base Unit User Manual 7. Starting a visit A visit includes all the recorded exams for a single patient. Before Starting a new visit, you should identify the patient you are about to examine. Then, you can perform and record the needed exams. When finished, you should press "Save Visit" to end and keep the visit, and then select how you would like to share it with a clinician - either by an online visit, featuring a video conference, or offline as a store-and-forward visit. In addition, if you wish to start the examination immediately, without identifying the patient in advance, you may choose the "Start Unidentified Visit" option, available through the device. Please note that in any case, if you wish to save or share a visit with a clinician, you'll have to identify the patient at the end of the visit. Page 20 of 50 Base Unit User Manual Pro 8. Performing an Identified Visit An identified visit is one where the patient is identified at the beginning of the visit. This is the standard and recommended procedure. For situations where you do not wish to identify the patient in advance, see Section 9. Starting an Unidentified Visit. 8.1. User login After turning on the device and the App, the following screens display: Device App Please login using your User name and Password on the App. Page 21 of 50 Base Unit User Manual Pro 8.2. Identify patient The Identify Patient screen appears in the iPhone app as follows: Device App Type the patient name, first name and/or last name, or patient ID in the search box. After typing the first two letters, the system will try automatically to match the relevant patients. You may Page 22 of 50 Pro Base Unit User Manual continue typing the complete name or ID, or select the patient from the list, if you have identified the correct patient. Select the correct patient, or choose the Add new patient button, in case the patient was not found as it has probably not been defined in the system yet. When the correct patient is selected and highlighted, press the Select Patient icon to start the visit. Note: After the patient was identified, its name will appear on the upper blue line, which allows you to always know which patient is currently being examined. Page 23 of 50 Pro Base Unit User Manual 8.2.1. Add a New Patient Press the button on the Patient Identification screen in the app, to Add a New Patient: Follow the needed steps and fill out the requested information to add the new patient. Page 24 of 50 Base Unit User Manual Pro 8.3. Choose Type of Visit The next screen on the App asks how you would like to perform the visit: Store-and-forward (offline) exam: Perform the examinations now independently, with the option later to send the exam results to another clinician or have an online visit using the examination data you have already collected. See a clinician online: Initiate an online video conference now with another clinician, before performing examinations. The other clinician will remotely control your device, and request that you perform exams under his guidance. For more details, see Section 9. Online Visit . Inbox: The Inbox keeps the notes, sent by the clinician after he reviewed and diagnosed the recorded exams. Once the notes are completed and sent by the clinician, you'll be notified using a notification in your iPhone/iPad. Use the Inbox option to view your notes as well as review the status of your selected patient sent examinations. For more details - see Section 10. INBOX. Page 25 of 50 Base Unit User Manual Pro 8.4. Starting Visit and Selecting Exams After the patient was identified, and the Store-and-Forward option was selected, you can start performing the exams. The examinations are done and managed using the device. Press on the device screen to choose which type of exam to perform. Device App Note that in the identified visit workflow, the upper left corner of the device has the name of the patient (LORI in this example). Please note additional exams (Skin and Audio – not displayed here) are available in the second screen in the device. Swipe to Page 26 of 50 Pro Base Unit User Manual the left, using your finger, to access the second exams selection screen. Warning: Always make sure the correct patient is identified before starting a new visit. Page 27 of 50 Pro Base Unit User Manual 8.5. Performing Exams 8.5.1. User Role: Performing Unguided and Guided Exams Two methods can be used for examinations conducted with the TytoPro system. Unguided exams are intended for healthcare professionals, who have medical knowledge, and are proficient in heart and lungs auscultation, and in performing ears and throat exams. Unguided exams provide a streamlined approach allowing more flexible recording and faster operation, without any instructions for use. Guided exams are intended for any person who is not a healthcare professional, which require a more detailed, step-bystep approach to the exam. Guided exams lead the user through the process of performing and viewing exams. Information in this Base Unit User Guide is identical for Unguided and Guided users, as the difference between those two methods affects only the process of performing the exams themselves. The Add-Ons User Guides provide two sets of instructions, for both Unguided and Guided users. The type of user role, guided or unguided, is defined by the System Administrator when your user was created. Contact the System Administrator of your TytoCare system to determine whether your user is defined as Unguided or Guided, or in case you wish to change your user role. The exact instructions for each type of exam are described in the separate Add-On User Guides. Refer to the appropriate User Guide for detailed instructions for performing the exam. Page 28 of 50 Base Unit User Manual Pro 8.5.2. Exams and Add-Ons User Guides Exam Heart, Lungs, Heart Rate, Audio Add-On Tyto Stethoscope Ears Tyto Otoscope Temperature Tyto Thermometer Throat and Skin Tyto Exam Camera Reference Tyto Stethoscope PRO Add-On Unit User Guide, document no. xxxxxxxxx Tyto Otoscope PRO Add-On Unit User Guide, document no. xxxxxxxxx Tyto PRO Thermometer User Guide, document no. xxxxxxxxx Tyto PRO Camera Add-On Unit for Throat and Skin Examinations User Guide, document no. xxxxxxxxx Once a certain exam was recorded, it will be marked in blue and with a check mark on the device, and will be listed on the app. In this example of the device, the EARS exam was performed. Please note you may re-do the blue marked exam by pressing it again. The existing recorded exam will be kept. Page 29 of 50 Pro Base Unit User Manual Page 30 of 50 Pro Base Unit User Manual In the iPhone User App, each recorded exam will be displayed as a separate line, enabling to review the recorded exam (play sound, view video etc.), and optionally delete it, in case the exam was not acquired properly. Note: The sound recording of the back and front of the lungs, as well as the video recording of the left and right ears, are displayed as separate lines/exams. You can use this screen both to review the recorded exam, to make sure the exam was successful (for example, that the tonsils are visible in the Throat exam, that the eardrum is seen, that the heart or lungs auscultation is heard clearly etc.) and to show the patient the recorded exam and involve him in his treatment. You can choose from the following actions: 1. You can play back the heart or lungs exam by pressing on the exam line on the app, for example: Every selected area on the chest or back (e.g. aortic in Heart or RUL in Lungs) will be displayed in the playback bar. Press the area mark to listen to that marked area. Page 31 of 50 Pro Base Unit User Manual 2. You can delete an exam from this visit. This is done by pressing on the trash can icon of the relevant line in the app. 3. You can continue performing more exams for this patient. Press on one of the icons on the device, for example the Heart icon. This will begin a new exam. You can perform any number of exams during a visit, and can perform the same type of exam more than once. Page 32 of 50 Pro Base Unit User Manual 8.6. Completing the Exam When you finish examining the patient and you wish to complete the visit, you have two options, using the two buttons at the bottom of the device’s screen: 1. SAVE VISIT – Choose this option to save the recorded exams, share the visit and end the visit. You will then need to complete the visit, and optionally select the relevant clinician, using the iPhone app. In case you are in an unidentified mode, you’ll also be prompted at this point in the app to identify the patient. 2. DISCARD VISIT – choose this option in case you don't see a need to keep the recorded exams for sharing with a clinician or any future use, and you wish to delete them. A confirmation pop-up message will ensure that you didn't press this option by mistake. Warning: discarding a visit is an irreversible action and all recorded exams will be deleted! Page 33 of 50 Pro Base Unit User Manual 8.7. Confirmation screen after Save visit After you press Save visit, a message is displayed on the device confirming the visit was saved under the specified patient. Please use this message to make sure the visit was saved under the correct patient name. 8.8. Sharing saved visit and finish After you press Save visit, you have a choice of several final actions: Page 34 of 50 Pro Base Unit User Manual Send to clinician – Send the exams for this visit to another clinician for their review (“store and forward”). See a clinician online – Request an online visit, with a video conference with a clinician. The recorded exams will be shared with the clinician before the online visit begins, to allow him review before seeing the patient. See Section 9. Online Visit. Save and Exit – Save and end this visit without sending it to anyone. The recorded exams will be saved for future use, such as having complete exams history for the patient, e.g. to allow comparison over time of a clinical condition, or to allow consultations between clinicians using the Clinician web application. Page 35 of 50 Pro Base Unit User Manual 9. Online Visit 9.1. Starting an Online Visit An online visit can be started immediately after choosing a patient, in which case the video conference will take place while you are performing the exams. You can also initiate an online visit after you have performed exams. An online visit is a videoconference session with a doctor or other healthcare professional. During the online visit, the clinician controls remotely the device and can hear and view the results captured by the device, and can direct you in its operation If necessary. 9.2. Choose a Clinician To initiate a live, remote, online visit, click “See a Clinician” (item in the illustration), and confirm your selection when prompted. Pick an available clinician with whom you’d like to request a virtual visit (item in the illustration). Choose SEE A CLINICIAN Choose which clinician A clinician is available if he is online and ready to enter a video conference now. Busy indicates that the clinician is online but currently engaged in another video conference. If the clinician is offline, he is not available and cannot participate in a video conference. Page 36 of 50 Base Unit User Manual Pro Fill in the short questionnaire explaining the clinical background, medical history, patient’s symptoms and the main complaint for which you want to have this virtual visit with the clinician. Press “See a Clinician”. You will receive a confirmation screen that the request has been sent, and an indication that you should wait for the clinician to respond. This may take some time depending on clinician availability. 9.3. Clinician Accepts Your Online Visit Request Once the clinician accepts your visit request, you are prompted by the TytoCare App to accept the video conference. Click “Join” to initiate the video conference and activate your iPhone camera. Now you’re connected with the clinician via video conference. The clinician will remotely control your device and will guide you through the exam process. A yellow outline on the device screen indicates that the device is under remote control. Device – Under remote control of clinician TytoCare App – In video conference & Waiting for the clinician to begin examination Page 37 of 50 Pro 9.4. Using the iPhone Stand To allow operating the device while performing the video conference, place your iPhone on the designated location on the upper side of the carrying case.. Make sure you position the iPhone camera so the clinician can see where you are placing the device on yourself, or on the person you are performing the exam on. Base Unit User Manual Using the iPhone stand 9.5. Clinician Begins Exam Once the clinician selects the relevant exams, these will automatically appear on your device and TytoCare App screens. See example of heart exam performed during an online visit with a clinician. Example of Device display during an online heart examination Example of TytoCare App display during an online heart examination Page 38 of 50 Pro Base Unit User Manual This is what the clinician sees during the examination. Page 39 of 50 Pro Base Unit User Manual 9.6. Using the Device during a virtual online visit Follow the clinician instructions and the indications on the device screen regarding proper placement of the device in the right locations on the body. 9.7. Completing the Online Visit After the visit is completed by the clinician, you will receive a summary notes of the visit automatically, which will be available through the Inbox. In addition, a notification will be sent to you when the clinician's notes are ready for your review. Page 40 of 50 Pro Base Unit User Manual 10. INBOX The INBOX screen shows the status of all of your examinations. Exam ready to be sent means that an exam was performed and was not sent to a clinician yet. Waiting for response means that an exam was sent to a clinician but there is not response yet. RESPONSE (ONLINE) means that you have performed an online exam and received the clinician’s response. RESPONSE means that you have sent a store-andforward exam for clinician review and have received his response. Page 41 of 50 Base Unit User Manual Pro 11. User Settings Press the Settings button to access the User Settings screen: Each of these options is shown below. Change your phone & email. Change your password Select a different device. Press New Tyto to add a new device. Color coding: Green – Currently paired device Gray – Device available in network, but not paired Note: The device connection screen should only be used when needed to connect to another device or disconnect from an existing device. Page 42 of 50 Pro Base Unit User Manual 12. System Labels, Symbols and Technical Specification 12.1. System Labels The following symbols are on the device or shipping materials. Base Unit Label Product Package Label Page 43 of 50 Base Unit User Manual Pro 12.2. Explanation of Symbols BF Applied part Water proof in Ip22 level Must read User Manual before use 1D/2D barcode contain Serial Number, Part Number and Manufacture Date European approval European Notify Body Input Voltage level Manufacturing Address Product Serial Number Product Model Number Manufacturing date Label P/N FCC approval Do not dispose Storage temperature limits Storage humidity limitations Keep device dry Package is recyclable Page 44 of 50 Base Unit User Manual Pro 12.3 Technical Specifications Storage conditions: temperature range: -20°c to +60°c Humidity range: 15%-70% Operation conditions: temperature range: +5°c to +40°c Humidity range: 15%-85% Atmospheric pressure: 700hPa to 1060hPa Typical Operation time: 8 hours Page 45 of 50 Pro Base Unit User Manual Appendix A: Headphones The clinician should listen to the auscultations directly by connecting headphones or earbuds to the base unit audio jack. If the audio is not clear, repeat the exam. If the audio quality is still not clear, contact TytoCare service. A.1 Connecting headphones to the device To listen to the sounds directly, connect headphones to the base unit audio jack as shown in the images below. Prior to entering the exam (heart, heart rate or lungs) a notification will be shown until the headphones are connected. Once connected, the exam will continue. Connect headphones to the base unit Headphones connected Note: The headphones must meet the following specifications: Impedance minimum: 16 ohm, typical 32 ohm Frequency response: minimum 20 – 10,000Hz Plug jack: 3.5mm stereo Page 46 of 50 Pro Base Unit User Manual A.2 Advanced Clinician settings The clinician has access to the Advanced Clinician option of the device Settings menu. These settings can be used to change the default audio filters on the sound heard via the headphones. Default audio filter for heart / heart rate exam is Bell and for lungs exam is Diaphragm. Additionally, the volume of sound heard via the headphones can also be controlled. Select ‘Advanced Clinician’ Select Audio Filter and Adjust Volume A.3 Advanced Technician settings These settings are primarily reserved for use when requested by the TytoCare support center. One feature that is useful for the user is the Back to factory defaults option, which resets the device to its out-of-the-box initial settings. Select ‘Advanced Technician’ Select ‘Back to factory defaults’ Page 47 of 50 Base Unit User Manual Pro Appendix B: Forgot Password If FORGOT PASSWORD? is clicked in the login screen of the TytoCare App, the user will need to input the e-mail address they used during the registration process and click SEND. An email with the reset password will be sent to the e-mail address. Reset Password To update the password, fill in the old password, then the new password then a repetition of the new password and click SAVE. Page 48 of 50 Pro Base Unit User Manual Appendix C: Frequently Asked Questions Why can’t I pair/connect the base unit and my iPhone running the TytoCare App? You may see one of these screens while attemptin g to connect the iPhone to the device: Waiting for connection Cannot connect In order to establish a connection between the Base Unit and TytoCare App, a Wi-Fi connection is required. Make sure that your Wi-Fi network is working properly and that your iPhone is connected to it. Make sure that the Wi-Fi network password that you have is the right one (try it on your iPhone). Try not to be located too far away from the Wi-Fi router. Then retry the pairing process by generating the QR code in the TytoCare App and scanning it with the base unit. If the problem persists also after few trials, contact TytoCare Service. Why doesn’t my Base Unit turn ON? It might not be charged. Connect the charging cable to the Base Unit and to the power outlet. Let it charge for at least several hours. You should see an orange LED near the Base Unit LCD indicating that the Base Unit is charging. After charging, when the LED indicator is green, disconnect from the charging cable and turn the base unit on. If the problem persists, contact TytoCare Service. Page 49 of 50 Pro Base Unit User Manual Why can’t I login into the TytoCare App? Try using your user login details (username / password). Make sure you have internet connection in your iPhone. Also, try "killing" the app. If this does not work, go through the forgot my password flow where a new password will be generated.. If the problem persists, contact TytoCare Service. Why can’t I get a good signal when performing an exam? Try to eliminate external noise when doing the exam. Also, do not move the device on the body when recording a measurement and make sure the device is in full contact with the patient’s body. Make sure the device is placed firmly on the patient’s body and if possible place it directly on the patient’s skin. If the problem persists, contact TytoCare Service. Why is the TytoCare App not allowing me to START the exam? During an exam, the TytoCare App is not used to conduct the exam. The device is used to perform the exam. The picture on the TytoCare App is a fixed representation of the device screen and is for informational purposes only. Page 50 of 50
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