Summary of Contents for Digital Doc Blu
- Page 1 ® Intraoral Sensor Use and Maintenance Manual Date:10/19/2020 1.800.518.1102 Language: English Rev: 3-8 digi-doc.com Code Blu12.r3-EN...
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Page 3: Table Of Contents
TABLE OF CONTENTS Document Status ..................2 Introduction ....................3 Important notices .................... 3 Scope ......................... 3 Scope ......................... 3 Icons used on the manual ................5 Use of this Manual .................... 5 Symbols Used in this Manual ................5 SYSTEM PRESENTATION ................ - Page 4 WEEE information according to directive 2002/96/EC ......22 TECHNICAL DATA ..................23 General characteristics ................23 Technical Specifications................23 Electrical and Optical Specifications ............23 Sensor performance specifications............24 Environmental Characteristics ..............24 USE........................25 Precautions When Using the Sensor ............25 About the user and patient .................
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Page 6: Document Status
1 DOCUMENT STATUS VERSION DATE PARTS/PAGES MODIFIED 18/06/2019 First issue 11/11/2019 Manual updated according to OEM information Added paragraph 6.3 (Usability), 6.5 (Imaging 11/12/2019 performance) and 6.11 (Acceptance Tests) Added paragraph Errore. L'origine riferimento non è stata trovata., Labels for USA market (par. Errore. 14/01/2020 L'origine riferimento non è... -
Page 7: Introduction
2 INTRODUCTION Thank you for trusting our company and choosing as your Intraoral sensor unit. We appreciate your support and hope that serves you well. Our continued commitment lies in the complete customer satisfaction for each and every product we sell. This manual will assist you on the installation and general operation of your . -
Page 9: Icons Used On The Manual
Use and Maintenance Manual Icons used on the manual On this manual are used the following icons: Shows a NOTE ; Shows a WARNING ; Use of this Manual All documentation supplied with intraoral sensor, has been designed to help the operator in performing the operations. - Page 10 SYMBOL DESCRIPTION NON-STERILE. is a non-sterile product and cannot be sterili ed. Do not reuse Product identification code Serial number Date of manufacture (year and month) Name and address of manufacturer Consult accompanying documents Conforms with EC Directive 93/42 and its amendments and supplements...
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Page 11: System Presentation
3 SYSTEM PRESENTATION About is a receptor of intraoral digital radiographic images. The images are obtained from the exposure of the tissues of the mouth to a radiation source or X-ray generator. By interposing the tissue between the radiation source and the receptor, the densest parts appear with different tones within greyscale: structures that are dense, such as bones or metal, will block most X-ray particles and appear white, air-containing structures will look black, and muscles, fat and fluids will appear as shadows of grey color. -
Page 12: Se A
3.1.1 Sen or par Body ( ): it is composed of a rounded edge housing, with a thickness of 4.8 mm and constructed in black ABS, which contains the CMOS sensor. USB Type A connector: connect the sensor directly to the PC where the image acquisition software runs. -
Page 13: Sensor Measures
The sensor is protected by a flexible and lightweight cover that prevents scratches and damage from bumps or falls. 3.1.2 Sensor measures is available in two sizes: Measures Active Area (mm) (mm) Size 1 25,4 x 36,8 x 4,8 20 x 30 Size 2 31,3 x 42,9 x 4,8 26 x 36... -
Page 14: Main Advantages
3.1.3 Main advantages Immediate images, without the use of films or chemicals. Perfect exposure. High resolution of images with the lowest radiation exposure possible. Safe and efficient preservation of more information in digital archives. Work space optimization. Physical Principles of Operation sensor works like a regular digital sensor, i.e. -
Page 15: Type Of Installation
Dental prostheses Surgical dentistry Implantology Orthodontics Contraindications Representation of cartilaginous structures. Representation of soft Type of Installation is used as a temporary device and is not connected to the mains power source; power is supplied directly from the computer via the USB connection. The sensor connects directly to the type A USB port of the computer and is compatible with the standard USB 2. -
Page 16: Applicable Standards
3.7.2 Applicable standards Reference standard Description Medical electrical equipment -- Part 1: General IEC 60601-1:2005/A1:2012 requirements for basic safety and essential performance Medical electrical equipment Part 1-2: General requirements for basic safety and essential IEC 60601-1-2:2014 performance Collateral standard: Electromagnetic compatibility Requirements and tests Medical electrical equipment... -
Page 17: Identification
3.9.1 Identification The sensor identification is fixed on the flat surface of the USB connector, it contains the serial number and sensor size. 3.9.2 Label for USA market A silver label, of the black carton that contains the sensor, shows the device's main data: The following label, that states the restriction of use to the order of physician and holds the UDI, will be attached near the Identification label above. -
Page 18: Label For Non-Usa Market
RX only label The UDI shown has the following fields that completely identify the device: (01): Manufacturer ID (21): Device type and S/N (11): Manufacturing date 3.9.3 Label for non-USA Market A silver label, stuck on the base of the black carton that contains the sensor, shows the device's main data: Label for size 1 Label for size 2... - Page 19 Where: X = 1for Size 1, 2 for size 2 YY =last two digit of manufacturing year NNNN= Progressive number of sensor Internal reference for identify the sensor Reference Name Size Software Software Notified Body of the CE mark: IMQ (0051) Voltage, maximum current and connector type Other symbols used on the label: Icon...
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Page 20: Package And Contents
Icon Meaning Manufacturer address 3.10 Package and contents. is delivered in a solid black cardboard box with the logo n the cover. Box Measures: 30 x 20 x15 cm Box Weight: 0.5 Kg Box Contents: (1)The sensor with m USB cable length. -
Page 21: Safety Aspects
4 SAFETY ASPECTS This chapter contains very important information concerning system, operator and patient safety. Read this chapter very carefully. Trident S.r.l. designs and manufactures these devices in compliance with all relevant safety requirements. It also provides all necessary information for appropriate use and warnings on the risks associated with using X-rays for diagnostic purposes. -
Page 22: Electromagnetic Environment
Do not immerse the USB connector of the sensor in cleaning fluids. For proper operation the sensor must be connected to a personal computer designed for image acquisition and image processing. The dedicated software must be installed on the personal computer. Water and other liquids must be kept at a distance to avoid penetration of the device. - Page 23 EMISSIONS TEST COMPLIANCE EMC ENVIRONMENT - GUIDANCE The device uses RF energy only for its internal function. Therefore, its RF emissions RF (Radio Frequency) Emissions Group 1 are very low and are not likely to cause any CISPR 11 interference nearby electronic equipment.
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Page 24: Immunity
<5% UT (> 95% dip in <5% UT (> 95% dip in Mains power quality should be that of a typical commercial or for 0.5 cycle for 0.5 cycles hospital environment. Voltage dips, short 40% UT (60% dip in UT) 40% UT (60% dip in If the user of the device interruptions... -
Page 25: Recommended Separation Distances Between Portable And Mobile Rf Communications Equipment And
IEC 60601 COMPLIANCE EMC ENVIRONMENT - IMMUNITY TEST TEST LEVEL LEVEL GUIDANCE Recommended separation distance d = 1,2 P 80 MH 800 MH d = 2,3 P 800 MH 2.5 GHz d = 1,2 P Where (P) is the maximum output power rating of the transmitter watts... -
Page 26: Weee Information According To Directive 2002/96/Ec
Separation distance according frequency transmitter (m) Rated maximum output power of 80 MHz to 800 800 MHz to 2.5 150 kHz to 80 MHz transmitter (W) d = 1,2 P d = 1,2 P d = 2,3 P 0.01 0.12 0.12 0.23 0.38... -
Page 27: Technical Data
TECHNICAL DATA General characteristics CHARACTERISTIC VALUE Unit name Trident Srl Castenedolo, 25014 , (BS) Italy Manufacturer Class (according to IEC 60601-1 Class I with Type BF applied parts classification) Technical Specifications Parameter Unit Size 1 Size 2 CMOS array of photodiodes Sensitive area structure Sensitive area structure FOS: FOP + CsI... -
Page 28: Sensor Performance Specifications
Sensor performance specifications CHARACTERISTIC VALUE size 2 Unit ≥35 ≥35 Sensitivity ADU/µGy 5.0 to 8.0 5.0 to 8.0 3 lp/mm ≥50 ≥50 Spatial resolution 6 lp/mm ≥25 ≥25 8 lp/mm ≥15 ≥15 Noise <2.0 <2.0 A/D converter bits Energy range From 60 to 70 From 60 to 70 Environmental Characteristics... -
Page 29: Use
6 USE Precautions When Using the Sensor For a proper use of the sensor, consult the manual. Before using the sensor, make sure it is in good condition (no cracks in the protective part of the sensor, cord ripped, etc..)In case of any problems or fault do not use the product and inform to your dealer. -
Page 30: About The User And Patient
About the user and patient 6.2.1 U er profile , intraoral sensor was designed to be used in radiography and dental facilities. In both cases the primary user is a professional who has the knowledge required to properly weigh the risks and benefits associated with their radiological imaging technologies. -
Page 31: Imaging Performance
Use and Maintenance Manual The X-Ray interacting in the scintillator is converted directly to light. This light exits from the scintillator passes coupling material (between scintillator and photodiode arrays) and will be absorbed at photodiode arrays. The photodiode arrays convert light to electrical signals proportional to the intensity of the light. -
Page 32: Minimum Pc Requirements
Dose for edentulous patients Reduce dose by 20% Exposure time at 60 kVp, 7 mA: 0.5 mm suggested, 0.7 mm Focal spot to sensor: 22 cm A beam limiting device reducing the exposed area to image receptor can be further reduce the dose to patient. Minimum PC Requirements The minimum requirements for the computer to install the sensor are shown in the following table:... -
Page 33: Software Characteristics
High Transmittance for perfect panel brightness. Water and dust resistance; easily cleaned and disinfected. A high contrast and high definition monitor that has at least a 17" screen is preferable. Software Characteristics CMOS intraoral sensor only works when connected to a PC on which you have previously installed the software CHARACTERISTIC VALUE... -
Page 34: Installing And Using
Please carefully read and follow the instruction of the Manual before using your sensor for the first time . 6.9.2 Installing and using Remove the system from the original package. Please save the original box and packing materials if you ever need to ship your sensor. -
Page 35: Acceptance Tests
Using the with a Sensor Using the with intraoral X-ray positioning system (optional) e age, O i i i g I age P ea e hi e he i age i bei g optimized. The image will appear after optimization is complete. 6.11 Acceptance tests as an electro medical device is subjected to inspection and testing in... -
Page 36: Cleaning And Disinfection
7 CLEANING AND DISINFECTION Cleaning and its accessories are supplied non-sterile and cannot be heat sterilized. To protect the health and safety of patients and prevent possible risks of contamination and/or cross-infection, please read and carefully follow the general following guidelines Cleaning operations must be performed with the device disconnected from the computer. - Page 37 In order to prevent infection, wipe the front plate of the sensor unit with ethanol or glutaraldehyde solution you plan to use a disinfectant other than those specified above, or you are mixing another disinfectant with ethanol, please consult a specialist because it may damage the plate. This cleaning procedure must be followed when the sensor is used for the first time or when after used, it is clear that the protective sheath is not damaged.
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Page 38: Error Messages
8 ERROR MESSAGES Message Solution USB device driver is not installed Please install device driver again. Check and re-connect USB Box (USB be i i ia i ed. connector). USB device driver is not working properly. Re-install the driver. Capture program is already running. Please close any other programs. -
Page 39: Maintenance And Repair
9 MAINTENANCE AND REPAIR intraoral sensor is not susceptible to be repaired. Please do not try to open or attempt to repair neither the sensor housing nor the USB connector. In case you have any inconvenience with your sensor call your dealer and fully describe the problem. - Page 40 1.800.518.1102 digi-doc.com / 9/2020 Date: Language: English Rev: 3-8 ©2020, Digital Doc LLC, 4789 Golden Foothill Parkway, El Dorado Hills, CA 95762. The Digital Doc and Bl¯ u logos Code Blu12.r3-EN are trademarks of Digital Doc LLC. All rights reserved.
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