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Summary of Contents for New Life Radiology MQI006-0
- Page 1 Intraoral Sensor DIGISENS Use and Maintenance Manual 0051 Mod. MQI006-0 / Doc. HBE110-2...
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Page 2: Table Of Contents
5.2.2 Second level disinfection ....................17 6 IDENTIFICATION AND DESCRIPTION ................18 6.1 Nameplates ..........................18 6.2 Versions..........................18 7 TECHNICAL FEATURES ......................18 7.1 General characteristics ......................18 Mechanical Characteristics ......................19 Electrical Characteristics......................19 Electro-optical Charatteristics.....................19 Environmental Charatteristics.....................19 Connection Characteristics......................20 Computer Features ........................20 Mod. MQI006-0 / Doc. HBE110-2... - Page 3 15.4.1 Periodicity of low contrast resolution check..............44 15.5 Periodic maintenance ......................45 This version of the DIGISENS user manual in English is the original version. The translations of this manual into the various languages reflect this version. Mod. MQI006-0 / Doc. HBE110-2...
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Page 4: Introduction
The device contains solid materials which, at the end of the device's life cycle, must be disposed of at the recovery centres designated by local regulations in order to avoid possible damage to the environment and health caused by improper disposal. Mod. MQI006-0 / Doc. HBE110-2... - Page 5 DIGISENS is not a sterile product and cannot be sterilised. Temperature limits Product identification code Serial number Date of manufacture (year and month) Date of manufacture (year and month) Consult the accompanying documentation Conformity with EC Directive 93/42 and its amendments and additions. Mod. MQI006-0 / Doc. HBE110-2...
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Page 6: General Introduction
2 GENERAL DESCRIPTION OF THE SYSTEM DIGISENS, produced by New Life Radiology S.r.l., is a digital intraoral sensor that is characterized by the simplicity of use. Special features of the system are:... -
Page 7: Intended Use
The standards applicable to the device mainly concern the general safety standards (patient and operator) and the electromagnetic emission standards. The applicable standards are therefore as follows: Reference standard Description Medical electrical equipment Part 1: General requirements for CEI EN 60601-1:2005 basic safety and essential performance Mod. MQI006-0 / Doc. HBE110-2... -
Page 8: Type Of Installation
In this way, each element of the image (pixel) accumulates a number of charges proportional to both the amount of incident light rays and the exposure time. 3 SYSTEM USABILITY 3.1 User profile and required knowledge The DIGISENS Medical System is intended for use in radiology or dental practices. Mod. MQI006-0 / Doc. HBE110-2... -
Page 9: Training
Before using the equipment, it is recommended that you read this manual carefully. 4 SAFETY ASPECTS WARNING This chapter contains very important information regarding system, operator and patient safety. Please read this chapter carefully. Mod. MQI006-0 / Doc. HBE110-2... -
Page 10: General Warnings
3. mechanical and/or electrical modifications made during and after installation, other than those indicated in the Service Manual. 4. only personnel authorized by New Life Radiology S.r.l. may install and carry out technical interventions on the appliance. 4.1 General warnings WARNING DIGISENS should be used in dental, radiological and hospital settings. -
Page 11: Electromagnetic Environment
This equipment is intended for use by healthcare professionals only. This equipment may cause radio interference or may interrupt operation of nearby equipment. Mitigation measures, such as repositioning or using DIGISENS in another room or by shielding the location, may be required. Mod. MQI006-0 / Doc. HBE110-2... - Page 12 The DIGISENS equipment is intended for use in the electromagnetic environment specified below. The customer or user of the equipment must ensure that it is used in such an environment. Level of Level of Immunity Test Evidence EMC environment of use Conformity IEC 60601-1-2 Mod. MQI006-0 / Doc. HBE110-2...
- Page 13 3 A/m 3 A/m hospital commercial rete (50/60 Hz) environment IEC 61000-4-8 NOTA: UT is the alternating mains voltage before the application of the test level. 60601-1-2 Tabella 1 Mod. MQI006-0 / Doc. HBE110-2...
- Page 14 Maximum rated 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz output power of the transmitter 0,01 0,12 0,12 0,23 0,38 0,38 0,73 Mod. MQI006-0 / Doc. HBE110-2...
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Page 15: Disposal Hazards
5 CLEANING AND DISINFECTION In order to ensure proper hygiene and cleanliness, the following procedures should be strictly observed. Mod. MQI006-0 / Doc. HBE110-2... -
Page 16: Digisens-Compatible Disinfectants
For a thorough cleaning and disinfection of DIGISENS, we recommend the use of 70% isopropyl alcohol. Tests have shown that the DIGISENS sensor can be immersed in the above disinfection liquid without suffering any damage. Mod. MQI006-0 / Doc. HBE110-2... -
Page 17: Disinfection Procedures
Do not use disinfection liquids containing aldehydes (formaldehyde, glutaraldehyde, glycoxal.). NOTE New Life Radiology Dental recommends to use only and exclusively disinfectants that comply with the EC Directive 93/42 concerning Medical Devices and that bear the CE marking. 5.2 Disinfection procedures The DIGISENS sensor must be disinfected using a first or second level procedure depending on the conditions observed and as described below. -
Page 18: Identification And Description
Corso Canonico Allamano 13/15 interno G 10095 Grugliasco (TO) - Italy Belonging class EN 60601-1) Class I with type BF applied according to classification parts parts Protection Degree Equivalent to IP67 30 x 20 mm (size 1) Sensitive Surface Mod. MQI006-0 / Doc. HBE110-2... -
Page 19: Mechanical Characteristics
± 30 % Maximum absorbable dose 50 Gy Environmental Charatteristics Characteristic Value Operating Temperature 0 ÷ 35° C Storage temperature -20 ÷ +70°C Degree of protection of the sensor Equivalent to IP67 Storage Humidity Below 75% non-condensing Mod. MQI006-0 / Doc. HBE110-2... -
Page 20: Connection Characteristics
The good quality of the monitor is an essential requirement for a correct diagnosis of the examination by image analysis. A monitor that does not pass the required tests is not to be considered diagnostic. The use of a non-diagnostic quality monitor makes the DIGISENS Mod. MQI006-0 / Doc. HBE110-2... -
Page 21: Hardware Installation
Use disposable protection (not supplied) to prevent various infections among patients. Failure to use the disposable protection may result in serious injury to the patient's health. Do not sterilize the product by dry heat, in an autoclave or with a UV device. Mod. MQI006-0 / Doc. HBE110-2... - Page 22 Do not twist, bend, pull or crush the cable with force. Do not pull the cable to remove the disposable protection. Connect and disconnect the sensor using the USB connector, tightening it between your fingers and without holding the cable. Mod. MQI006-0 / Doc. HBE110-2...
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Page 23: Software Installation
Insert the CD/DVD supplied with the sensor into the CD player of the computer on which you want to install the program; wait a few moments until the installation start window appears automatically, as shown below. NOTE In the main screen you can select the language Mod. MQI006-0 / Doc. HBE110-2... -
Page 24: Installing The Program
In which you must tick the item "accept the license terms". Clicking on "Next" will take you to the next screen where you can choose to install both the drivers for the USB Key and those for the sensor: Mod. MQI006-0 / Doc. HBE110-2... -
Page 25: Ending The Installation Process
As they are in pdf format, they can be consulted using the free access software Adobe Reader; if the PC used has not been installed, the program can be downloaded free of charge from the website http://get.adobe.com/it/reader/.. Read carefully the user documentation of the ARCHIMED SUITE program before starting to use it. Mod. MQI006-0 / Doc. HBE110-2... -
Page 26: Software Configuration
- The application is protected by identifying the user with different levels of authorization; - The first time the software is run, this window will appear in which you will have to enter the study data: Mod. MQI006-0 / Doc. HBE110-2... - Page 27 Click on "Yes" and the following window will be displayed in which the data of the clinic/study will be inserted: Click on "Save" to access the main screen of the program (shown below): Mod. MQI006-0 / Doc. HBE110-2...
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Page 28: Password Recovery
9.5 Password recovery Click on "Forgotten password" from the following screen: Then answer the question that was set by you when you created the user, if the answer is correct the program will indicate it. Mod. MQI006-0 / Doc. HBE110-2... -
Page 29: License Management
The license data can be changed by accessing the following page and clicking on the symbol The management page of the various options of the program will open, among which is the section "License management": Mod. MQI006-0 / Doc. HBE110-2... - Page 30 Clicking on "Manage license" will open the following screen: Mod. MQI006-0 / Doc. HBE110-2...
- Page 31 To update the data click on the button and the following screen will open: Clicking on "Yes" will take you to the next screen: Clicking on "Yes" again will take you to the screen where you can change the license data: Mod. MQI006-0 / Doc. HBE110-2...
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Page 32: User Management
To add a new user click on the icon at the bottom right of the main screen , the following screen will open: Click on "Login Administrator" enter the password for the login, then click on "Confirm": Mod. MQI006-0 / Doc. HBE110-2... - Page 33 ∑ User management (adding and deleting users) ∑ Viewing archives and adding new discs ∑ Viewing the access log ∑ Viewing Patient List and Tabs ∑ Creation of new patients and modification of the master data Mod. MQI006-0 / Doc. HBE110-2...
- Page 34 - Viewing archives and adding new discs - Viewing Patient List and Tabs Remove a user: To add a new user click on the icon at the bottom right of the main screen, the following screen will open: Mod. MQI006-0 / Doc. HBE110-2...
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Page 35: Disk Management
ArchiMed Suite gives you the possibility to manage multiple disks at the same time. To access the section dedicated to disk management, click on the icon from which you can access the following screen: By clicking on the "Database Settings" box you can access the disk management: Mod. MQI006-0 / Doc. HBE110-2... - Page 36 To add a disk just select it: After selecting it press "Add", and the disk will be in the list of disks in use as shown in the figure below: Mod. MQI006-0 / Doc. HBE110-2...
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Page 37: Create A New Patient
12 CREATE A NEW PATIENT After logging in, you will enter the following page: To create a new patient click on and the following screen will be displayed: Mod. MQI006-0 / Doc. HBE110-2... -
Page 38: Sensor Configuration
"Confirm". The patient will be listed in the patient list: 13 SENSOR CONFIGURATION To configure the sensor (operation to be done only at first access) press the desired patient and then "Images": Mod. MQI006-0 / Doc. HBE110-2... - Page 39 You will enter the patient's page where you can configure the sensor: Pressing and then you enter the configuration section of the sensor: Mod. MQI006-0 / Doc. HBE110-2...
- Page 40 Select "IO Sensor H #1" OR "IO Sensor H #2" and the correct size of the sensor in your possession (Size 1 or Size 2) and click on save and then on "Previous", thus returning to the patient's page: Mod. MQI006-0 / Doc. HBE110-2...
- Page 41 To take an X-ray, press to open the following screen for initialization and calibration of the sensor: Then the sensor will be ready to acquire the image: Mod. MQI006-0 / Doc. HBE110-2...
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Page 42: Labeling
15.1 Checking that the installation is correct This check is performed by starting the ARCHIMED SUITE software and verifying that it is working correctly and that it recognizes the DIGISENS sensor when it is connected to the acquisition PC. Mod. MQI006-0 / Doc. HBE110-2... -
Page 43: Periodicity Of Monitor Control Operations
The test is considered passed for a spatial resolution greater than 10 lp/mm. This test must be performed on all the RX generators that will use the digital sensor, distinguishing the images for each sensor. Mod. MQI006-0 / Doc. HBE110-2... -
Page 44: Periodicity Of The Spatial Resolution Check
This check must be performed with the same periodicity as the spatial resolution, and the same results as the acceptance test must be obtained. In the case of non-compliant periodic testing, the same considerations as above apply to the spatial resolution test. Mod. MQI006-0 / Doc. HBE110-2... -
Page 45: Periodic Maintenance
Check the presence and legibility of the identification plate located near the USB connector; if it is damaged or illegible, request a copy from the manufacturer. Check the integrity of the USB cable and its connector. Mod. MQI006-0 / Doc. HBE110-2...
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