0000679 Rev.2 - Instructions for Use (Wireless intra oral sensor WIOS-S2) OPERATOR’S MANUAL ™ ©2020 Athlos Oy All rights reserved.
Information in this manual applies to DC-Air™ Intraoral Sensor System (DC-Air™ Intraoral Sensor model WIOS-S2 and DC-Air™ Docking Station model WIOS-DS2). This manual and the product described herein are protected by copyright laws and international copyright treaties, as well as other intellectual property laws and treaties. This manual contains original instructions by Athlos Oy.
Contents CONTENTS 1 INTRODUCTION ....................................................................................................................................................5 1.1 About the DC-Air™................................................................................................................................................5 1.2 Intended Use ............................................................................................................................................
Contents 4.3 5 Exposing the Sensor............................................................................................................................................16 MAINTENANCE ...................................................................................................................................................18 5.1 Care and Maintenance........................................................................................................................................18 5.1.
Introduction 1 INTRODUCTION 1.1 About the DC-Air™ DC-Air™ is the world’s first wireless intraoral sensor that uses the latest Bluetooth® 5.0 communication standards for reliable and rapid transmission of radiographic images. DC-Air™ is also the world’s first intraoral X-ray sensor to utilize direct-conversion X-ray technology which converts X-ray photons directly into digital image data without scintillating photons into visible light.
Introduction Alerts the operator of potential risks related to radiation exposure. Informs the operator of proper instructions for device use or a process involving the device and components. Informs operator of unusual or important point of device use or process. 1.4 Essential Performance Essential performance of the DC-Air™ sensor system is to be able to generate an X-ray image of acceptable quality.
Introduction In this manual, DC-Air™ Intraoral Sensor model WIOS-S2 is referred to as DC-Air™ Intraoral Sensor or intraoral sensor or sensor. In this manual, DC-Air™ Docking Station model WIOS-DS2 is referred to as DC-Air™ Docking Station or docking station. When referring to different sections in this manual, section names are enclosed in double quotes. Any illustrations appearing in this manual are provided as examples only. 0000679 | 18.12.
Product Overview 2 PRODUCT OVERVIEW 2.1 Product Description The DC-Air™ sensor is a direct converting X-ray detector, which converts X-ray photons directly into digital image data. The DC-Air™ sensor system support wireless Bluetooth® 5.0 communications protocol and supports USB 2.0 connectivity to Personal Computers (PCs). Wireless Interface Characteristics Parameter: Description: Technology: Bluetooth® 5.0 - Low Energy Frequency: 2.4GHz: 2402 – 2480 MHz (Channels 0 – 39) | US, Canada, E.
Product Overview 2.2.1 DC-Air™ Sensor Figure 1: Back, side, and front view of the DC-Air™ Sensor. (1) Sensor’s contact points, (2) sensor indicator light (green or yellow), (3) sensor connection hub, and (4) sensor active area (35.1 X 24.7 mm2) Sensor Indicator Lights The sensor indicator light (green or yellow) locates at the back of the sensor next to the sensor’s contact points and above the battery compartment (see Figure 1, item (2) above).
Product Overview Color: Function: Indication: Green/ Yellow Un/Docked: Flash; 2 x 100ms Green & 2 x 100ms Yellow Sensor reset. Green/ Yellow Undocked: Flash; 1 x 75msec Green, 100ms pause, 25ms Yellow; Period 2s Sensor in sleep mode. 2.2.2 DC-Air™ Docking Station Figure 2: Front, top and back view of the DC-Air™ docking station. (1) Docking station antenna, (2) docking station indicator lights (blue), (3) docking station sensor port, and (4) docking station USB-C port.
Product Overview 2.3 Hardware and Software Requirements The DC-Air™ sensor system is compatible with the following minimum specifications of PC (Windows), operating systems and components. All IT components used in connection with the DC-Air™ sensor system need to be in compliance with the applicable safety standards. Refer to “Appendix B: Specifications and Standards” and “Appendix C: EMC Information“ for more information. 2.3.1 PC (Windows) The supported operating system is Windows 7 and 10.
Product Overview 2.5.1 Mains Isolation Disconnection from the supply mains occurs at the input to the computer (PC or laptop). The DC-Air™ docking station can also be disconnected from the computer. 2.5.2 X-Ray Protection The rules of dental radiography still apply to digital X-ray systems. Please continue to use protection for your patients. As a clinician, clear the immediate area when exposing the sensor. 2.5.
Product Overview 2.6 Operating Modes DC-Air™ sensor system has the following operating modes. Installation This mode is used when the docking station is connected to the PC for the first time. When the DC-Air™ system is connected to a PC or laptop for the first time, the user needs to run the installation application included in the flash memory delivered together with the system. Docked | Charging | Recovering the Last Image This mode is used when the DC-Air™ sensor is placed on the docking station.
Product Overview 2.7.2 System Failure In rare occasions, the DC-Air™ sensor system may fail in a way that an X-ray image has been acquired, but not returned to the PC or the third-party Imaging Software freeze. In such a case, follow the steps defined below: 1. 2. 3. 4. 5. 6. Place the DC-Air™ sensor onto the docking station. Close the third-party Imaging Software. Disconnect the USB cable of the docking station form the PC side. Wait for 10 seconds.
Set-Up Instructions 3 SET-UP INSTRUCTIONS 3.1 Connecting the DC-Air™ Docking station Place the DC-Air™ docking station in desired location on a countertop. Connect the USB cable provided in the package of the docking station to the USB port on the docking station and to the USB port in your PC or laptop. The DC-Air™ connection cables have a length of 2m (~6ft.). Other lengths may be available. Ask technical support for options. 3.
Taking the First Human X-Ray 4 TAKING THE FIRST HUMAN X-RAY 4.1 Placing the Sensor into a Sensor Barrier Place the sensor into a disposable sensor barrier before each use, before placing the sensor onto the holder and into the patient’s mouth. See the list of accessories in “Appendix: E: Accessories” for more information on recommended sensor barriers and sleeves. Never use or place the DC-Air™ sensor in a patient’s mouth without the use of an approved sensor barrier.
Taking the First Human X-Ray Avoid positioning the docking station behind the patient's head as the Bluetooth® signal would be weakest at that position. The docking station can be placed up to 5m (15ft.) away from the PC. Once the exposure button is pushed and to optimize return time and comfort the user, remove the DC-Air™ sensor from the patient’s mouth, wait for the preview, and reposition the sensor for the next exposure.
Maintenance 5 MAINTENANCE 5.1 Care and Maintenance 5.1.1 DC-Air™ Sensor DC-Air™ sensor is reusable and can be used with multiple patients. Clean the sensor after each use by following the disinfection protocols described in this manual in section “5.2.1 Cleaning and Disinfection of DC-Air™ Sensor”. Always place the DC-Air™ sensor with proper positioning into its docking station after use to allow charging and to avoid misplacement of the sensor.
Maintenance 5.2.1 Cleaning and Disinfection of DC-Air™ Sensor Disinfect the DC-Air™ sensor after each use in accordance with the CDC – or your country’s standards (e.g., OSAP) – for infection control.
Appendix A: Additional Help and Support Appendix A: Additional Help and Support DC-Air™ on the Internet TBD DC-Air™ Customer Care (United States) TBD 0000679 | 18.12.
Appendix B: Specifications and Standards Appendix B: Specifications and Standards DC-Air™ Sensor Specifications SENSOR ARCHITECTURE Direct converting dental IO X-ray sensor bonded to CMOS 1350 by 950 pixels 26 µm pixel pitch 19 lp/mm visible MTF: 90% @ 2lp/mm, 70% @ 5lp/mm, 40% @10lp/mm, 10% @ 16lp/mm X-RAY PARAMETERS Sensor can be used with dental X-ray generators in the range of 50 to 75 kV; at minimal 40µGy incident dose.
Appendix B: Specifications and Standards DC-Air™ Docking Station Specifications ELECTRICAL RATINGS DC 5V, 0.5A CONNECTION TO PC USB 2.
Appendix C: EMC Information Appendix C: EMC Information The DC-Air™ sensor and the DC-Air™ docking station1 are subject to electromagnetic interactions with other electronic devices. The EMC information in this chapter is provided for the medical system established by establishing the connection between the DC-Air™ sensor and the DC-Air™ docking station and by connecting the DC-Air™ docking station to a computer (PC or laptop).
Appendix C: EMC Information Guidance and Manufacturer’s Declaration – ELECTROMAGNETIC EMISSIONS The DC-Air™ sensor system is intended for use in the electromagnetic environment specified below. The customer or the user of the DC-Air™ sensor system should assure that it is used in such an environment. EMISSION TEST COMPLIANCE ELECTROMAGNETIC ENVIRONMENT - GUIDANCE RF emissions Group 1 The DC-Air™ sensor system utilizes Bluetooth® technology to transmit data.
Appendix C: EMC Information VDI specs per 3rd edition: <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 s Power Frequency (50/60 Hz) Magnetic Field Not applicable Not applicable - IEC 61000-4-8 (*) Computer used with the DC-Air™ sensor system must meet this rating.
Appendix C: EMC Information MHz, 18,07 MHz to 18,17 MHz, 21,0 MHz to 21,4 MHz, 24,89 MHz to 24,99 MHz, 28,0 MHz to 29,7 MHz and 50,0 MHz to 54,0 MHz. 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.
Appendix D: Symbols Appendix D: Symbols Symbols Used on Device Labeling Attention. Type BF applied part. WASTE OF ELECTRICAL AND ELECTRICAL EQUIPMENT (WEEE): This symbol indicates that this device should not be disposed as unsorted municipal waste but must be sent to separate collection facilities for recovery and recycling. Manufacturer: This symbol is accompanied by the name and address of the manufacturer. Manufacturing date: This symbol is accompanied by the date of manufacture.
Appendix D: Symbols Bluetooth trademark. USB port. Direct current (DC) Keep away from rain. Keep dry. Temperature limitations. Atmospheric pressure limitations. Humidity limitations. Label Information The Unique Device Identifier (UDI) of the DC-Air™ intraoral sensor is provided as direct markings on the enclosure of the sensor. The UDI identified each individual sensor. The UDI is replicated on the type label of the sensor.
Appendix E: Accessories Appendix E: Accessories DC-Air™ sensor system is intended for use with third-party accessories suitable and intended for use with size 2 intraoral sensors. These accessories include those listed below.
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Signatures: Document Reviewed: Name: I have reviewed the contents of this document Matt Powell ATHLOS\matt.powell Title: Matt Powell Electronically Signed in Document Approved: Name: 2020-12-18 14:14:39 (UTC+00:00) Timestamp I approve this document to be immediately released for use Matt Powell ATHLOS\matt.
