Related Manuals for Trident I-View Gold
Summary of Contents for Trident I-View Gold
- Page 1 Use and Maintenance Manual I-View Gold Intraoral Sensor 0051 Date:18/05/2021 Language: English Rev: 6 Code: TM12-EN.r6-I-View Gold-Use and Maintenance Manual...
- Page 2 This manual is the exclusive property of TRIDENT Srl. It is forbidden to reproduce, adapt or translate this document without the prior written authorization of TRIDENT Srl. TRIDENT Srl reserves the right to carry out technical modifications without updating this manual.
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Page 3: Table Of Contents
Electromagnetic emissions 4.2.2 Guidance and manufacturer’s declaration: ………………………….. Electromagnetic immunity 4.2.3 Recommended separation distances ………………………….. between portable mobile communications equipment and I-View Gold. Disposal hazards ………………………….. TECHNICAL DATA ………………………….. General characteristics ………………………….. Specifications ………………………….. Recommended Environmental Operating Conditions ………………………….. USAGE ………………………….. - Page 4 Cleaning ………………………….. Disinfection Procedures ………………………….. 7.2.1 First level disinfection ………………………….. 7.2.2 Second level disinfection ………………………….. Disinfection Products Compatible with I-View Gold ………………………….. MAINTENANCE AND REPAIR ………………………….. ANNEX 1 MESSAGES ........ANNEX 2 ERROR ........ANNEX 3 SENSOR HOLDER USAGE ........
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Page 5: Document Status
-View Gold Use and Maintenance Manual 1 DOCUMENT STATUS VERSION DATE PARTS/PAGES MODIFIED June 18 2019 First release 11/11/2019 Manual updated according to OEM information Added paragraph 2.3 Usability 11/12/2019 6.3 Imaging performance 6.8 Acceptance Test Added paragraph 23/01/2020 3.4 Physical principles of operation Added Child definition and indications for pediatric 27/03/2020 Changed the exposure parameters table inserting a... -
Page 6: Introduction
Use and Maintenance Manual 2 INTRODUCTION Thank you for trusting our company and choosing I-View Gold as your Intraoral sensor unit. We appreciate your support and hope that I-View Gold serves you well. Our continued commitment lies in the complete customer satisfaction for each and every product we sell. -
Page 7: Icons Used In This Manual
NON-STERILE. I-View Gold is a non-sterile product and cannot be sterilised. Do not reuse Product identification reference Serial number... -
Page 8: Sensor Presentation
3 SENSOR PRESENTATION 3.1 About I-View Gold I-View Gold 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... -
Page 9: Sensor Measures
-View Gold Use and Maintenance Manual 3.1.2 Sensor measures I-View Gold 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 38... -
Page 10: Type Of Installation
Work space optimization. 3.2 Normal Intended Use I-View Gold intraoral sensor is a digital image receptor, used to take X-rays of the teeth and surrounding tissues. The sensor requires an X-ray generator and a computer for its intended use; the sensor can be used on all patients, regardless of their age and gender. -
Page 11: Device Classification
I-View Gold sensor works like a regular digital sensor, i.e. it transforms the measured dose which strikes each element of the sensor (pixel) in an electric signal that can be processed through an analog-to-digital converter. -
Page 12: Manufacturer Address
Part 1: General requirements Where applicable, the following national references must be applicable: FDA: 21 CFR1020.30 Diagnostic X-Ray systems and their major components 1020.31 Radiographic equipment 3.7 Manufacturer Address Trident S.r.l. Via Artigiani 4 25014 Castenedolo (BS) Italy Website: www.trident-dental.com... -
Page 13: Device Identification And Labels
-View Gold Use and Maintenance Manual 3.8 Device Identification and Labels 3.8.1 Identification The sensor identification is fixed on the flat surface of the USB connector, it contains the serial number and sensor size. Sensor size and S/N 3.8.2 Labels A silver label, stuck on the base of the black carton that contains the sensor, shows the device's main data: Label for sensor size 2... - Page 14 The company name in lowercase letters, font Century Gothic, with three points representing the "i" which identifies the company logo. • Device name: I View Gold, for sensor size 1; I-View Gold size 2 for size 2. • Manufacturing Date, in the year-month-day format.
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Page 15: Labels For Usa Market
-View Gold Use and Maintenance Manual 3.8.3 Label for 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 sensor size 2 Label for sensor size 1 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 16: Package And Contents
-View Gold Use and Maintenance Manual 3.9 Package and contents I-View Gold is delivered in a solid black cardboard box with the Trident logo stamped in the cover. Package Measures Weight Contents (cm) (Kg) Qtty Item Sensor with software, 18 x 13 x 4,5... -
Page 17: Safety Aspects
X-rays for diagnostic purposes. Therefore, Trident S.r.l. shall not be held liable for: 1. Use of I-View Gold sensor for any purpose other those for which it has been designed, 2. Damage to the device, injuries to the operator or patient caused by either incorrect... -
Page 18: Electromagnetic Environment
They may result in increased emissions or decreased immunity of the device. I-View Gold is intended for use in the electromagnetic environment specified below. The customer or user of the device should assure that it is used in such an environment. - Page 19 -View Gold Use and Maintenance Manual Mains power quality should be Surge ± 1 kV line to line ± 1 kV line to line that of a typical commercial or IEC 61000-4-5 ± 2 kV line to earth ± 2 kV line to earth hospital environment.
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Page 20: Recommended Separation Distances
I-View Gold. The I-View Gold sensor is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the device as recommended below, according to the maximum output power of the communications euipment. -
Page 21: Technical Data
-View Gold Use and Maintenance Manual 5 TECHNICAL DATA 5.1 General Characteristics Unit name I-View Gold Trident Srl Manufacturer Via Artigiani 4, Castenedolo, 25014 (BS) Italy Classification according Class IIa with Type BF applied parts Directive EC 93/42 5.2 Technical Specifications... -
Page 22: Recommended Environmental Operating Conditions
-View Gold Use and Maintenance Manual Parameter Unit Size 1 Size 2 ≥ 35 ≥ 35 Sensitivity ADU/µGy 5,0 to 8,0 5,0 to 8,0 ≥ 50 ≥ 50 3lp/mm ≥ 25 ≥ 25 Resolution 6lp/mm ≥ 15 ≥ 15 8lp/mm Noise ≤... -
Page 23: How To Use The Sensor
6.2 About the user and patient 6.2.1 User Profile I-View Gold, intraoral sensor was designed to be used in radiological 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. End users must have basic knowledge about: •... -
Page 24: Patient Profile
I-View Gold is not used as an integrated X-Ray image detector integrated into a specific X-Ray device. As all digital intra oral sensors, I-View Gold achieves a good quality of the image also with a reduction of the emitted dose from X-Ray equipment. The balance of the benefit/risk ratio is part of the operator experience. -
Page 25: Exposure Parameters
6.3.1 Exposures parameters I-View Gold can be used with any kind of X-Ray generator technology. However, the best performance can be achieved using a DC type generator, due to the fact that this kind of generators reduce “soft emitted radiation”. -
Page 26: Pc And Monitor Requirements
The computer and all other associated equipment must be placed outside of the patient environment (about 1.5 m away from the chair). Do not plug the PC used for the I-VIEW GOLD sensor in a power strip. The minimum PC requirements to install the sensor are shown in the following table:... -
Page 27: Deep-View Software Characteristics
A high contrast and high definition monitor that has at least a 17" screen is preferable. 6.5 Deep-View Software Characteristics Deep-View is the software used in all Trident intraoral sensors. The tools featured by Deep View software allow to efficiently create, organize, store and share, patients’ data files and images: •... - Page 28 The USB contains the software and calibration files for each single device. In case 2 or more I-View Gold sensors are working on the same PC, be sure to run the installation setup for every serial number. The calibration files will be automatically...
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Page 29: Image Acquisition
Once the image optimization is completed the image will appear on the monitor. 6.8 Acceptance Test I-View Gold as an electro medical device is subjected to inspection and testing in compliance with laws, regulations and supervisory directives applicable in the country... -
Page 30: Frequency Of The Q.a. Test
Use special test tool for digital intra oral sensor that allows the acquisition of Line Pair up to 20 lp/mm [QUART dent/digitest M2] • Insert I-View Gold into the relevant slot of the test tool and place it at the end of the beam limiting device, using the centering ring to correctly positioning it. •... -
Page 31: Cleaning And Disinfection
/ or operator. 7.2 Disinfection Procedures I-View Gold sensor must be disinfected using a first or second level procedure, depending on the conditions observed and as described below: 7.2.1 First Level Disinfection After each use, remove the disposable protective sheath and throw it away. -
Page 32: Disinfection Products Compatible With I-View Gold
Use and Maintenance Manual 7.3 Disinfection Products Compatible with I-View Gold Use 70% isopropyl alcohol to properly clean and disinfect the I-View Gold sensor, tests carried out by the manufacture have shown that the sensor can be immersed in this disinfection solution without suffering any damage. -
Page 33: Maintenance And Repair
Use and Maintenance Manual 8 MAINTENANCE AND REPAIR I-View Gold intraoral sensor is not susceptible to be repaired. PLEASE DO NOT TRY TO OPEN THE SENSOR In case you have any inconvenience with your sensor call your dealer and fully describe the problem. -
Page 34: Annex 1 Messages
Re-connect USB Box. This means that the user cancelled image Cancelled image capturing. capture. Please try again. Restore the I-View Gold calibration data from the S/W installation CD or recalibrate the Can't find dark frame. sensor. If the same message displayed again, contact Customer Service. -
Page 35: Annex 2 Error
-View Gold Use and Maintenance Manual ANNEX 2 ERROR Image Error Solution Configuration of Control Panel* Abnormal image received Control Panel Configuration 1. Click the Windows button 2. Write Control Panel 3. Click on Control Panel 4. Select Small Icons 5. - Page 36 -View Gold Use and Maintenance Manual 6. Double Click on System Devices 7. Right-click Intel® Management Engine Interface. 8. Click on Properties 9. Click on Power Management 10. Uncheck Allow the computer to turn off this device to save power 11.
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Page 37: Annex 3 Sensor Holder Usage
-View Gold Use and Maintenance Manual ANNEX 3 SENSOR HOLDER USAGE Name Image Teeth to be exposed Bitewing Endo UL/LR Endo UR/LL Periapical UL/LR Periapical UR-LL... - Page 38 -View Gold Use and Maintenance Manual Posterior UL/LR Posterior UR/LL...
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