Quanta Otoscope Q-tube-O User Manual Version 1.0 Document number: Q6T418-02 DOCUMENT REVISION HISTORY Version Date Status Author Comments 0.1 0.2 0.3 0.4 0.5 2016.1.22 2016.1.25 2016.2.23 2016.2.24 2016.2.26 P U U U U Monica Shyu Katrina Wu Creation Katrina Wu P. 8 26 (Focusfocus in/out) Monica Shyu Update P.9 Sleep mode & Charging Battery status P.7 Caution P.12 Chain Hsu Integration and review Monica Shyu Update P.8 Focus button function 0.6 2016.3.8 U Katrina Wu Chain Hsu P. 3 Manufacturer name, trademark, address, phone P. 4 P. 5 : P. 6 Packaging P. 7 P. 12 P. 13 Q-TubeQ-Tube P. 14 Smart Device BTBT Q-Tube P. 16 WPA/WPA2 SSID < 20 P. 27 / P. 29 P. 30 31 P. 32 (TBD by Chain) P. 33-35 Remove model name 0.7 0.8 0.9 1.0 2016.3.9 2016.3.21 2016.4.28 2016.5.6 U U U U Chain Hsu P. 6 Packaging*
P. 27 /
P. 29 Katrina Wu P. 7 Katrina Wu Model name P. 36-38 CE/FCC P. 39-44 EMC Katrina Wu P. 36-38 CE/FCC P. 39-44 EMC 2 This is not a sale of the software or any copy of the software; all rights, title, and ownership of the software remain with Quanta Computer Inc. and/or its vendors. Caution: Changes or modifications not expressly approved by Quanta Computer Inc. will void the purchasers authority to operate the equipment and its warranty. QUANTA COMPUTER INC. Address: 211, Wen Hwa 2nd Rd., Guishan Dist., Tao Yuan City 33377, Taiwan Phone: +886-3-327-2345 2016 by Quanta Computer Inc. All rights are reserved. No one is permitted to reproduce or duplicate, in any form, this manual or any part thereof without permission from Quanta Computer Inc. Quanta Computer Inc. assumes no responsibility for any injury, or for any illegal or improper use of the product, that may result from failure to use this product in accordance with the instructions, cautions, warnings, or indications for use published in this manual. Software in this product is copyright of Quanta Computer Inc. and its vendors. All rights are reserved. The software may not be copied, decompiled, reverse-
engineered, disassembled or otherwise reduced to human-perceivable form. 3 Table Introduction Intended Use Packaging Warning & Caution Product Operation Appearance Indicator Lights Power Management Pairing Q-tube-I with Smart Device Patient ID Photo & Video Settings Troubleshooting Product Specification Hardware Specification Application Software Specification Used Symbol Description Maintenance Cleaning & Disinfecting the Camera Cleaning the Camera Disinfecting the Camera Inspecting the Camera for Damage Protective Sleeve for the Camera Disposal of Waste Warranty & Service Manufacturers Declaration FCC Statement CE marking CE RF Exposure Compliance EMC Declaration Tables 4 Introduction Intended Use The Quanta Otoscope Q-tube-O is a hand-held digital camera device intended to view the ear canal and tympanic membrane under magnification. The Quanta Otoscope Q-tube-O is intended for chairside use by licensed doctors during examinations, not for patients. 5 Packaging of Quanta Otoscope Q-tube-O The Quanta Otoscope Q-tube-O consists of a wireless digital otoscope, software application, a charge cable and docking station. Item 1 2 3 4 5 6 Description Q-tube-O (Otoscope) AC charger(*) Charging dock Ear muff 3mm Ear muff 4mm Ear muff 5mm Quantity 1 1 1 1 1 1
(*)Note : AC Charger specifications Model: MIL050200U AC Input: 100-240V~, 50~60Hz DC Output: +5V 2A max 6 Warning & Caution Please make sure to familiarize all operating personnel with the general safety information in this summary. Specific warnings and cautions are also found throughout this manual. Such specific warnings and cautions may not appear here in this summary. Caution A caution statement in this manual identifies condition or practice, which if not corrected or discontinued immediately, could lead to equipment failure, equipment damage, or data loss. Thoroughly read this manual to ensure patient safety and obtain optimum performance . Do not attempt to disinfect the Quanta Otoscope Q-
tube-O using ethylene oxide gas, steam, glutaraldehyde products or any other gas or liquid disinfectant except alcohol. Do not use the Quanta Otoscope Q-tube-O if you notice any signs of damage to the components of the system. Contact customer service for assistance. Do not apply chemicals, or water to the lens. Any liquids or solution entering the optical assembly will damage internal components. Before each use, the outer surface of Quanta Otoscope Q-tube-O which is intended to be inserted into a PATIENT should be checked to ensure there are no unintended rough surfaces, sharp edges or protrusions which may Cause a SAFETY HAZARD. Warning A warning statement in this manual identifies a condition or practice which if not corrected or discontinued immediately, could lead to injury, illness, or death. Do not use Quanta Otoscope Q-tube-O in the presence of flammable anesthetics. This instrument is not intended to be used in the eye. Do not stare at them in order to avoid any ocular risk. The camera must be barrier protected with the protective sheath before use. This product has no user replaceable parts. Refer all service to qualified personnel. Do not stare at the light on Q-tube-O when it is illuminating. Otherwise it may damage your eyesight. 7 Product Operation Appearance 1 2 3 4 5 1 Indicator Lights Button Function Focus 2 Focus Photo 3 Take a photo (incl. during video mode) Operation Repeat press Quick press Record 4 Take a video Quick press Turn on Turn off Press and hold (5 seconds) Press and hold (5 seconds) Power 5 Wake from sleep mode Quick press Return to previous page Quick press at preview page Automatic sleep mode after 2 minutes of idle time Automatic shutdown after 3 hours of idle time 8 Indicator Lights Turning On Ready for use Sleep mode Bluetooth/Wi-Fi Connecting Sufficient Low Battery Charging Battery Low battery Charging Fully charged When Q-tube-O battery is low and not connected to the docking station, no indicator light will turn on and the device will not turn on. Solid Blinking 9 Power Management Power Display Battery status is shown at the upper right corner of the Image Capture screen in the Q-Tube App. When the battery is low, connect Q-tube-O to the docking station to charge. The battery of Q-tube-O is sufficient. Fully charged 75% battery remaining 50% battery remaining 25% battery remaining No charge 10 Turning On Sleep mode is indicated on the preview screen 1. Press and hold the power button for 5 seconds to turn on Q-tube-O (solid blue indicator light) 2. Q-tube-O is ready to use when the indicator light turns solid green Turning Off 1. Press and hold the power button for 5 seconds to turn off Q-tube-O 2. Q-tube-O is shut down when the indicator light turns off Auto Sleep Mode/Auto Shutdown Q-tube-O uses a non-removable battery. For efficient battery management, Q-tube-O automatically enters sleep mode after 2 minutes of idle time (solid yellow indicator light) and automatically turns off after 3 hours of idle time
(indicator light turns off).
* If Q-tube-O is unpaired, it will automatically enter sleep mode after 20 minutes of idle time. This changes to 2 minutes after the first pairing. 1. 2. If Q-tube-O has never paired with smart device, please press the button. Pressing the button can leaving the preview page. Waking Up Wake up Q-tube-O from sleep mode by pressing the power button (solid green indicator light). 11 Low Battery Notification 1. 2. The battery indicator light blinks red when less than 20% charge remains. Battery status is shown at the upper right corner of the Image Capture screen in the Q-Tube App. Charge Q-tube-O as soon as possible. 1. Press here to close notification. Charging the Battery 1. Place Q-tube-O in the charging station and connect the power supply. 1 1. Indicator lights on docking station CAUTION Charging Q-tube-O is intended for environment without any patient. Please ensure that no patient is around the environment Q-tube-O is charged in. 12 Pairing Q-tube-O with Smart Device Getting Started The welcome page appears the first time you install the Q-Tube App. Press Start to pair Q-
tube-O with your smart device. Step 1. Restarting Q-tube-O Press power button on Q-tube-O Otoscope 5 seconds to turn off, and press power button 5 seconds to turn on. Restart Q-Tube Press power button on Q-Tube Intraoral Camera 5 seconds to turn off, and press power button 5 seconds to turn on. 1. Press here to start pairing Q-tube-O with smart device. 1. 2. After restarting Q-tube-O, please press here to enter next step of pairing setting. Press here to cancel the pairing flow. 13 Step 2. Turn on Bluetooth on your smart device Turn on Bluetooth on your smart device; then press Next
[Error Message] Smart device Bluetooth is off Ensure that Bluetooth is on and press Retry 1. 2. Turn on Bluetooth on smart device and press here to enter next step of pairing setting. Press here to cancel the pairing flow. 1. 2. After restarting Q-Tube and confirm Bluetooth on smart device is turn on, press here to enter next step of pairing setting. Press here to cancel the pairing flow. 14 Step 3. Confirm Q-tube-O pairing Step 4. Connect smart device to Wi-Fi When the indicator light on your Q-tube-O blinks blue, press the shutter button to confirm pairing Connect your smart device to an available Wi-Fi network; then press Next (iOS) or Settings
(Android) 1. Press here to cancel the pairing flow. 1. 2. Connect your smart device to the available Wi-Fi network; then press here to enter next step of pairing setting. Press here to cancel the pairing flow. 15 Step 5. Enter router password
[Error Message] Password Incorrect Enter the password for the router your smart device is connected to; then press Next Confirm that the password of Wi-Fi is correct;
then press Next. 1. 2. 3. Insert the SSID (with 20-character limit) of the Wi-Fi router your smart device connected to. Insert the password of the Wi-Fi router your smart device connected to. After inserting the SSID & password of the Wi-Fi router, press here to submit. Press here to cancel the pairing flow. 4.
* Only Wi-Fi network with WPA/WPA2 encryption is accessible by Q-Tube App. 16 Pairing Complete Cancel Pairing Pairing is completed. Press OK to start using the Q-Tube App. To cancel pairing the device, press Exit at any time during Step 1-5 and press OK to confirm 1. Press here to complete the pairing settings between Q-tube-O & smart device. 1. 2. To cancel pairing settings between Q-tube-O &
smart device, press here to cancel the pairing flow. Press here to return to the pairing flow. 17 Patient ID Enter Patient ID Enter the medical record number for the patient
(must be 12 characters in length containing letters or numbers); then press Submit Photo & Video Photo Press the photo button to take a photo. 1. 2. 3. 4. Page Title: indicates the function of this page. Press here to go to device management page and view the Q-tube-O device information pairing with smart device. Insert the patient id to be searched here. After inserting the patient id to be searched, press here to submit. 1. 2. 3. 4. 5. 6. Back button: press here to return to previous page Indicated the operation related to preview page. Press the photo button on Q-tube-O to take a picture. The remaining battery of Q-tube-O Real-time video streaming view The thumbnail image of the newest photo and video. Press here to view photos & videos. The id of the examined patient. 18 Video Press the record button on Q-tube-O to start/stop recording Preview Photo/Video Step 1. Press on the thumbnail image in the lower left corner of the screen to preview Photo/Video. 1. 2. 3. 4. 5. 6. Back button: press here to return to previous page Display how long it has recorded when recording video. The remaining battery of Q-tube-O Real-time video streaming view The thumbnail image of the newest photo and video. Press here to view photos & videos. The id of the examined patient. 19 View a Photo View a Video 1. 2. 3. 4. Back button: press here to return to previous page The photo obtained from Q-tube-O. View the next/last photo or video by sliding to left/right. Patient id: indicates the patient the photo belongs to. The taken time of the photo. 1. 2. 3. 4. 5. Back button: press here to return to previous page Play button: press here to play video The video obtained from Q-tube-O. View the next/last photo or video by sliding to left/right. Patient id: indicates the patient the video belongs to. The taken time of the video. 20 Video Playing Back button: press here to return to previous page Turn-back button: turn back the video Pause button: pause the playing video Fast-forward button: fast-forward the video Video progress bar: click to go to the specified progress Volume up button: click to increase the system volume 1. 2. 3. 4. 5. 6. 7. Mute button: click to mute the system volume 21 Access Photos/Videos (iOS version) Step 1. Press Photo Album at the bottom of the screen Step 2. Select the folder corresponding to the patient ID, for example, 123456789012 22 Step 3. Select a photo/video for an enlarged view Step 4. Built-in photo/video management functions can be used for enlarged photos/videos 23 Access Photo/Video (iOS version) Low Storage Space Notification Please open the file management application on smart device, and go to DCIM > Q-tube-O folder to search for specified patient id. You can find all photos & videos of the patient. e.g., to find the patient whose id is 1234-5678-
9012, please go to DCIM > Q-tube-O > 0000-
1234-0000 to view all photos & videos of the patient. A low storage space notification is shown when available storage space on the smart device is less than 5%; press OK to open the Photo Album to delete files 24 Settings View Paired Device On the Enter Patient ID page, press the Settings icon in the upper right corner to see information about the device paired with the Q-Tube App Change Paired Device To change the device paired with the Q-Tube App, press Use Other Device and press OK to confirm 25 Troubleshooting Problem Solution Q-tube-O does not turn on/off or operate normally The battery may be too low (indicator light is solid red and Q-tube-O does not turn on after connecting Q-tube-O to the docking station). Turn on Q-
tube-O after the battery is fully charged. If the problem is still not solved, simultaneously press the and power buttons to force shut down Q-tube-O. Then press the power button again to turn it on. 26 Product Specification Hardware Specification Item Dimension Otoscope Docking station Weight Otoscope Docking station Sensor Focus Magnification (Pixel/mm) Lighting Battery Power consumption Continuous operation time Standby time White balance Exposure Environment Operating temperature Transportation and storage temperature Operating Relative humidity Transportation and storage Relative Humidity Operating Atmospheric pressure Transportation and Storage Atmospheric Pressure Specification 175.1(L) x 28(W) x 34.5(D) mm 66.1mm(Diameter) x 27mm(H) 164g +/- 15g 30 +/- 5g OV5648, 1/4 Inch 5MP CMOS 0~35mm (From the small hole of Otoscope specula) About 80x 4 LED, CRI > 85 2600mAh, the battery is not replaceable Active: 2.7W / Suspend: 0.3W About 2-3 hours About 30 hours Manual Automatic 0~ 35
-30 ~ 65 0 ~ 85 % RH 0 ~ 85 % RH 700-1013 hPa 700-1013 hPa 27 Application Software Specification Item System Requirement OS Communication interface Communication Bluetooth Wi-Fi Remote Control Mechanism Streaming Encryption Image Capability Resolution SNR Photo Video Specification Android 5.0 / iOS 9.1 Wi-Fi and BT 4.0 BT 4.0 IEEE 802.11b/g/n RPC WPA2/WPA Up to 640x640 36 dB Format JPEG H.264, fps up to 15, average bit rate ~400kbps 28 Used Symbol Description Symbol Description The CE symbol ensures that the product herein specified meets the provisions of European Council Directive 93/42 EEC concerning medical devices. Correct Disposal of This Product
(Waste Electrical & Electronic Equipment) Please refer to user manual before you use this product
=type B Applied part Caution : Please refer to the written instructions of this manual Storage and transportation conditions: -30 ~ 65 Transportation and storage Relative Humidity: 0 ~ 85 % RH Transportation and Storage Atmospheric Pressure: 700-1013 hPa Maintenance Perform the following maintenance activities on your camera and accessories regularly. The camera is not delivered in disinfected condition. To ensure maximum hygienic safety for the patient, carefully follow the instructions to disinfect the camera before use. Cleaning & Disinfecting the Camera Before applying cleaning or disinfecting solution disconnect the camera from power and the USB cable from the USB port. Do not soak the camera. Always dry completely after cleaning or disinfecting. To clean: Use a lint-free cloth to apply a solution of mild soap and water. To disinfect: Use a lint-free cloth to apply isopropyl alcohol (70%). Cleaning the Camera If the camera is visibly contaminated with blood or body fluids, you must clean the camera before disinfecting it. To clean the camera, follow these steps:
Dampen (not soak) a lint-free cloth with lukewarm water. Remove the blood or body fluids with the dampened lint-free cloth. Wipe with isopropyl alcohol (70%) between patients. 30 Disinfecting the Camera Before each patient, the camera must be thoroughly disinfected. To adequately disinfect the camera, follow the disinfectant manufacturers instructions for the appropriate contact time. To disinfect the camera, follow these steps:
1. Remove the protective sleeve. 2. Remove all visible soil (If the camera is visibly soiled, it must be thoroughly cleaned prior to disinfecting.) 3. Dampen (not soak) a lint-free cloth with isopropyl alcohol (70%). 4. Wipe all surfaces of the camera thoroughly. 5. Allow to dry in the open air. Inspecting the Camera for Damage Inspect the camera for signs of deterioration, such as the buttons. If damage is noted, do not use the camera and contact your representative. 31 Disposal of Waste Within the EU Do not dispose of this product as unsorted municipal refuse. Submit for separate collection as specified by Directive 2002/96/EC of the European Parliament and the Council of the European Union on Waste Electronic and Electrical Equipment (WEEE). If this product is contaminated, this directive does not apply. For more specific disposal information contact Customer Service. Outside the EU When the product and its components reach end of life, recycle the product according to national, state, and local regulations. For information on disposal/recycling options in the European Union, see the European Portable Battery Association (EPBA) at http://www.epbaeurope.net/. 32 Warranty & Service Limited Hardware Warranty (through distributors & resellers) Quanta hardware products come with a 1-year limited hardware warranty. The warranty is extended through Quanta authorized representatives and resellers. If you have a warranty claim, please contact the store, distributor, or website through which the product was purchased. 33 Manufacturers Declaration Any changes not following User Manual to the it-network could cause Q-tube-O and Q-Tube App not able to work normally. Changes to the it-network include:
changes in network configuration connection of additional items disconnection of Q-tube-O and your smart device. operating system of smart device is updated or upgraded to a not supported version, which is specified in application software specification of user manual. Please use this device with fine WIFI connection and do not use it in static environment. If the poor quality of the network connection, or accidentally under static environment, the Q-Tube App will pop up a prompt window, and pause preview screen, you can wait for the automatic connection or restart. 34 This camera, classified as Medical Electrical Equipment, requires special precautions regarding EMC and must be installed and put into service according to the EMC information provided in the accompanying product documentation. Portable and mobile RF communications equipment can effect Medical Electrical Equipment. This camera complies with EMC requirements when used with the cables and accessories supplied with the product. The use of accessories and cables other than those sold by Quanta Computer Inc. and specified as replacement parts for internal components, may result in increased emissions or decreased immunity of this camera. This camera should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, this camera should be observed to verify normal operation in the configuration in which it will be used. 35 Federal Communications Commission (FCC) Statement 15.19 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 of the device. 15.21 You are cautioned that changes or modifications not expressly approved by the part responsible for compliance could void the users authority to operate the equipment. 15.105(b) 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. 36 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:
-Reorient or relocate the receiving antenna.
-Increase the separation between the equipment and receiver.
-Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
-Consult the dealer or an experienced radio/TV technician for help. For body worn operation, this device has been tested and meets FCC RF exposure guidelines when used with an accessory that contains no metal and that positions the handset a minimum of 5 mm from the body. Use of other accessories may not ensure compliance with FCC RF exposure guidelines The highest FCC SAR values:
0.214 W/Kg (1g) (Body) 37 CE marking This equipment complies with the requirements of Directive 1999/5/EC of the European Parliament and Commission from 9 March, 1999 governing Radio and Telecommunications Equipment and mutual recognition of conformity. The device complies with the following harmonized European EN 301489-1 V1.9.2 / EN 301489-17 V2.2.1 / EN 300328 V1.9.1 EN 50566: 2013 / EN 62209-2:2010 / EN 62479: 2010 CE RF Exposure Compliance This device meets the EU requirements (1999/519/EC) on the limitation of exposure of the general public to electromagnetic fields by way of health protection. For body-worn operation, this device has been tested and meets the ICNIRP guidelines and the European Standard EN 62209-2, for use with dedicated accessories. SAR is measured with this device at a separation of 5 mm to the body, while transmitting at the highest certified output power level in all frequency bands of this device. Use of other accessories which contain metals may not ensure compliance with ICNIRP exposure guidelines. The highest CE SAR values for the device is 0.404 W/Kg (10g) (Body) 38 EMC Declaration Table 39 40 41 42 43 44