New Life Radiology MQI006-0 User manual

Mod. MQI006-0 / Doc. HBE110-2
Intraoral Sensor
DIGISENS
Use and Maintenance Manual
0051

Mod. MQI006-0 / Doc. HBE110-2
DOCUMENT INDEX
SUMMARY
1 INTRODUCTION...................................................................................................................... 4
1.1 Icons in the manual .................................................................................................................4
1.2 Symbols used...........................................................................................................................4
1.3 General introduction................................................................................................................6
2 GENERAL DESCRIPTION OF THE SYSTEM ......................................................................6
2.1 Intended use.............................................................................................................................7
2.2 Classification of the device according to CE 93/42................................................................ 7
2.3 Applicable standards ...............................................................................................................7
2.4 Type of installation.................................................................................................................. 8
2.5 Manufacturer's address............................................................................................................ 8
2.6 Physical principles of operation.............................................................................................. 8
3 SYSTEM USABILITY ..............................................................................................................8
3.1 User profile and required knowledge......................................................................................8
3.2 Training ................................................................................................................................... 9
3.3 Patient profile ..........................................................................................................................9
3.4 Usability ..................................................................................................................................9
4 SAFETY ASPECTS................................................................................................................... 9
4.1 General warnings................................................................................................................... 10
4.1.1 Electromagnetic environment ............................................................................................11
4.1.2 Electromagnetic emissions.................................................................................................11
4.1.3 Disposal hazards.................................................................................................................15
4.1.3.1 Information on the correct disposal of the system or its parts........................................15
5 CLEANING AND DISINFECTION .......................................................................................15
5.1 DIGISENS-compatible disinfectants ....................................................................................16
5.2 Disinfection procedures ........................................................................................................17
5.2.1 First-Level Disinfection .....................................................................................................17
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

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Monitor Characteristics ...............................................................................................................20
Hardware Installation ..................................................................................................................21
8 PRECAUTIONS WHEN USING THE SENSOR...................................................................21
9 SOFTWARE INSTALLATION ..............................................................................................23
9.1 Installing the program ...........................................................................................................24
9.2 Ending the installation process .............................................................................................25
9.3 Using the Archimed Suite program ......................................................................................25
9.4 Software configuration..........................................................................................................26
9.5 Password recovery.................................................................................................................28
9.6 License management .............................................................................................................29
10 USER MANAGEMENT........................................................................................................32
11 DISK MANAGEMENT.........................................................................................................35
12 CREATE A NEW PATIENT.................................................................................................37
13 SENSOR CONFIGURATION...............................................................................................38
14 LABELING ............................................................................................................................42
15 INSTALLATION CHECKS AND PERIODIC CHECKS....................................................42
15.1 Checking that the installation is correct..............................................................................42
15.2 Periodicity of monitor control operations ...........................................................................43
15.3 Checking the spatial resolution ...........................................................................................43
15.3.1 Periodicity of the spatial resolution check .......................................................................44
15.4 Checking the low contrast resolution..................................................................................44
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
1 INTRODUCTION
Dear Customer,
thanking you for the preference given to our product, we invite you to read carefully these
instructions that will help you to get the most diagnostic information of your X-rays with the
minimum effort of X-rays.
The purpose of this manual is to provide the user with instructions for correct, safe and efficient
operation.
The sensor must be used in accordance with the procedures contained in the manual and never for
purposes other than those specified in it.
The User is responsible for all legal obligations relating to the installation and operation of the
sensor itself.
If the sensor is not operated properly or is not maintained properly, the manufacturer cannot be
held responsible for any breakage, injury or malfunction.
1.1 Icons in the manual
The following icons are used in this manual:
Indicates a "
NOTE
"; particular attention is recommended when reading the
topics identified with this icon
Indicates a "WARNING"; the topics identified with this icon concern aspects of
patient and/or operator safety
1.2 Symbols used
The following symbols are used in this manual and on the DIGISENS delivery box:
Symbol Description
Apparatus with applied parts Type BF
This symbol indicates that the DIGISENS sensor contains electronic parts
that are sensitive to static electricity and can damage them. Refer to
Precautions for Use.
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
NOT STERILE.
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
1.3 General introduction
The purpose of this manual is to provide the user with instructions for safe and efficient operation
of the described device.
NOTE
This manual is updated to the state of the product with which it is sold to ensure
that the user has adequate reference in the use of the appliance and with regard
to all aspects related to safety in use.
The manual may not reflect product variations that have no impact on operating
methods or safety in use.
WARNING
DIGISENS is an electromedical apparatus and as such may only be used by
qualified personnel, dentists, radiologists or legally qualified personnel.
For its proper functioning, it must be used in combination with X-ray equipment
and with the necessary knowledge of X-ray protection.
The equipment must be used in accordance with the procedures contained in the
manual and never for purposes other than those specified in it.
The user is responsible for all legal obligations relating to the installation and
operation of the equipment.
Before using the equipment, it is recommended that you carefully read this
manual, which should in any case be kept close to the equipment for
consultation.
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:
- The rounded apical edges
- The rounded body
- The high flexibility of the cable,
- Direct connection to the acquisition PC via direct USB connector.

Mod. MQI006-0 / Doc. HBE110-2
DIGISENS is based on CMOS technology, which allows a reduced pixel size (20 µm) ensuring
excellent spatial resolution, also guaranteed by the use of a fiber optic plate (FOP), which ensures
a high quality image and at the same time increases the life of the sensor protecting it from
incident X-rays.
The scintillating layer can be supplied in both Cesium Iodide (CsI) and Gadolinium Oxyisulphide
(GOS) technology.
The size of the sensitive area is available in the format corresponding to the standard size 1 of
intraoral films.
All these features make DIGISENS the ideal tool for any type of positioning, while ensuring
maximum patient comfort.
DIGISENS uses the ARCHIMED SUITE image acquisition and management software that saves
images directly in DICOM format.
2.1 Intended use
The system is intended for the execution of endoral X-rays of the human dental complex; the
device can be used without distinction of sex, race and type of patient.
The device is intended for both the market of dentists and radiologists, so it can be installed both
in dedicated facilities (hospitals or clinics) and in housing facilities equipped with appropriate
shielding systems.
2.2 Classification of the device according to CE 93/42
DIGISENS, in all its configurations, is an active medical device, invasive through natural
cavities, for temporary use, intended for diagnostics.
Applying the classification rules of Annex IX of the EC 93/42, as amended by Directive
2007/47/EC, DIGISENS falls into class IIa.
2.3 Applicable standards
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
CEI EN 60601-1:2005 Medical electrical equipment Part 1: General requirements for
basic safety and essential performance

Mod. MQI006-0 / Doc. HBE110-2
Reference standard Description
EN 60601-1-2:2007
Medical electrical equipment - Part 1: General requirements for
basic safety and essential performance - Collateral standard:
Electromagnetic compatibility - Requirements and tests
2.4 Type of installation
DIGISENS is used as a temporary device, not connected to the power supply and is powered
directly from the acquisition PC through the USB connection.
2.5 Manufacturer's address
The manufacturer's address is as follows:
New Life Radiology Srl
Corso Canonico Allamano 13/15 interno G
10095 Grugliasco (TO) - Italy
Website: www.newliferadiology.it
2.6 Physical principles of operation
The DIGISENS sensor works like a normal digital sensor, i.e. it transforms the dose amount that
affects each individual sensor element (pixel) into an electrical signal that can be processed
through an analog-to-digital conversion system.
This transformation takes place through the following steps:
1) Transformation of incident X-rays into light rays; this transformation takes place in the CsI or
GOS sensitive layer.
2) The light rays are transferred, through the Optical Fiber, on the sensitive layer of the CMOS.
3) The CMOS sensor transforms the light rays into electrical charges, which are stored in special
structures until the time of reading.
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
In both cases, the main user is a professional who has the necessary knowledge to correctly
assess the risk/benefit ratio associated with his/her radiological imaging techniques.
End users are required to have a basic knowledge of the subject:
- Use of ionising radiation emissions
- Hazards of biological damage from excessive use of ionising radiation
- Methods to reduce the risk of excessive radiation to the patient (use of leaded protections, etc.)
The operator is required to be familiar with the use of Personal Computers (PCs) and related
programs, so that the functions on the PC can be used easily.
3.2 Training
At the end of the installation of the system, the operator will be trained both in the use of the
system and in the programs for the acquisition and visualization of images.
The training does not require the use of special tools, but only the digital sensor and its
acquisition program.
3.3 Patient profile
The machine is suitable for all types of patients.
The different modalities of execution of each examination according to the type of patient depend
on the radiological system used and are not part of this manual.
3.4 Usability
All the documentation supplied with the DIGISENS system has been designed to facilitate the
operator's operations.
The information in this manual reflects the knowledge described for the user profile.
Information on the use of the DIGISENS sensor image acquisition, archiving and processing
system can be found in the user manual, to which reference should be made.
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
New Life Radiology S.r.l. designs and manufactures the equipment in accordance with safety
requirements; it also provides all the information necessary for proper use and warnings
regarding the dangers associated with the use of X-rays for diagnostics.
New Life Radiology S.r.l. assumes no responsibility for:
1. use of the DIGISENS apparatus other than that for which it was designed.
2. damage to the apparatus, the operator, the patient caused by installations and maintenance
other than those contained in the documentation accompanying the apparatus, or by incorrect
operating techniques
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.
WARNING:
DIGISENS and its accessories are supplied non-sterile and cannot be hot
sterilized.
Follow the instructions below for proper patient and caregiver care.
WARNING:
The DIGISENS sensor should not be autoclaved or dry-heat sterilized. Do not
sterilize with UV equipment.
WARNING:
Do not immerse the USB connector of the sensor in cleaning fluids.
WARNING
: DO NOT IMMERSE THE SENSOR USB CONNECTOR IN
CLEANING FLUIDS:
DIGISENS must be connected to the PC for image acquisition and image
processing in order to function properly. The PC must also have the imaging
software installed.

Mod. MQI006-0 / Doc. HBE110-2
WARNING:
The PC to which the DIGISENS sensor must be connected must comply with
the standards in force.
WARNING
:
The PC and all devices connected to it must be positioned outside the patient
area (about 1.50 m from the patient chair).
WARNING
:
Only the sensor and the X-ray generator can be positioned in the so-called
patient area when using the sensor.
WARNING
:
The PC and all equipment connected to it must be connected to the power
supply via a dedicated line and equipped with protective devices.
WARNING:
Do not use multiple outlet blocks.
4.1.1 Electromagnetic environment
WARNING
DIGISENS complies with the requirements of the IEC 60601-1-2 standard
regarding electromagnetic emissions, and is therefore suitable for use in
electromagnetic environments that meet the conditions described below.
The customer or user of the system must ensure that it is used in such an
environment.
4.1.2 Electromagnetic emissions
WARNING
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
WARNING
The system is supplied with all the cables necessary for its operation and
connection with the acquisition PC.
The use of other cables not supplied by the manufacturer or additional to
those supplied by the manufacturer can significantly influence the
electromagnetic behavior of DIGISENS, increasing its emission capacity or
decreasing its susceptibility.
Electromagnetic Emissions
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.
Emissions test Compliance EMC environment of use
RF Emissions
CISPR 11 Group 1
The equipment generates RF energy only for internal
operation.
Therefore, the level of RF emissions generated is not
such as to cause interference with electrical devices
used in its vicinity.
RF Emissions
CISPR 11 Class B
DIGISENS is suitable for use in domestic
environments and in environments directly
connected to the public low-voltage electricity grid
that supplies buildings for domestic use.
Harmonics emitted
IEC 61000-3-2 Class A
Fluctuations of
Voltage / Emissions
flicker
IEC 60000-3-3
Conforms to
60601-1-2 Table 1
Electromagnetic immunity
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.
Immunity Test
Level of
Evidence
IEC 60601-1-2
Level of
Conformity EMC environment of use

Mod. MQI006-0 / Doc. HBE110-2
Electromagnetic immunity
Electrostatic
Discharge (ESD)
IEC 61000-4-2 ± 6 kV contact
± 8 kV air
± 6 kV contact
± 8 kV air
Floors must be made of wood,
concrete or ceramic tiles.
If floors are covered with synthetic
material, the relative humidity
must be at least 30%.
Fast transients
(burst)
IEC 61000-4-4
2 kV for power
supply lines
1 kV for
input/ouput
lines > 3 m
2 kV for power
supply lines
1 kV for
input/ouput lines
> 3 m
Mains power quality should be that
of a typical commercial or hospital
environment.
Voltage pulses
IEC 61000-4-5
± 1 kV
differencial
mode
± 2 kV common
mode
± 1 kV
differencial mode
± 2 kV common
mode
Mains power quality should be that
of a typical commercial or hospital
environment.
Voltage dips, short
interruptions and
voltage variations
of power supply
input lines
61000-4-11
<5% UT
(> 95% di UT)
for 0,5 cycles
40% UT
(60% di UT)
for 5 cycles
70% UT
(30% di UT)
for 25 cycles
<5% UT
(> 95% di UT)
for 5 s
<5% UT
(> 95% di UT)
for 0,5 cycles
40% UT
(60% di UT)
for 5 cycles
70% UT
(30% di UT)
for 25 cycles
<5% UT
(> 95% di UT)
for 5 s
Mains power quality should be that
of a typical commercial or hospital
environment.
If the user requires continuous
operation during power outages, it
is recommended that the
phototherapy equipment be
powered by an uninterruptible
power supply or battery.
Campo
elettromagnetico
alla frequenza di
rete (50/60 Hz)
IEC 61000-4-8
3 A/m 3 A/m
Mains frequency magnetic fields
should be at levels characteristic of
a hospital or commercial
environment
NOTA: UT is the alternating mains voltage before the application of the test level.
60601-1-2 Tabella 1

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Electromagnetic Immunity
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.
Immunity test Level of Evidence
IEC 60601-1-2
Level of
Conformity
EMC environment of use
Electrostatic discharge
(ESD)
Conducted RF
Emissions
IEC 61000-4-6
3 Vrms
150 kHz at 80 MHz
3 Vrms
150 kHz at
80 MHz
Radiated Emissions
IEC 61000-4-6
3 V/m
80 MHz at 2,5 GHz 3 V/m from 80 MHz at 800 MHz
from 800 MHz at 2.5 GHz
Where "P" is the maximum rated output power of the transmitter in watts (W) according to the
transmitter manufacturer and "d" is the recommended separation distance in meters (m).
Field strengths of fixed RF transmitters, as determined by an electromagnetic site survey, may
be less than the compliance level in each frequency range.
Interference may occur in the vicinity of equipment marked with the symbol.
NOTE 1 At 80 MHz and 800 MHz, the upper frequency range should be used.
NOTE 2 These guidelines may not be applicable in all situations.
Electromagnetic propagation is affected by absorption and reflection by structures, objects and
people.
60601-1-2 Table 2
Recommended separation distances between portable and mobile RF communication
equipment and DIGISENS equipment
The DIGISENS equipment is intended for use in environments where the electromagnetic
disturbances emitted are controlled.
To prevent electromagnetic interference, portable and mobile RF communication devices
(transmitters) should not be used at a separation distance of any part of DIGISENS, including
power cords, less than that recommended below and calculated from the maximum output power
of the transmitter.
Maximum rated
output power of the
transmitter
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
0,01 0,12 0,12 0,23
0,1 0,38 0,38 0,73
1 1,2 1,2 2,3

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10 3,8 3,8 7,3
100 12 12 23
60601-1-2 Table 3
4.1.3 Disposal hazards
The apparatus contains, in some parts, solid materials that at the end of the life cycle of the
apparatus must be disposed of at the recovery centers designated by local regulations.
In particular, the apparatus contains the following materials and/or components:
- Plastic, lead, electronic boards, electronic components.
4.1.3.1 Information on the correct disposal of the system or its parts
Applicable in the European Union and other European countries with separate collection systems.
Pursuant to art. 13 of Legislative Decree no. 151 of 25 July 2005 "Implementation of Directives
2002/95/EC, 2002/96/EC and 2003/108/EC on the reduction of the use of hazardous substances
in electrical and electronic equipment and the disposal of waste".
The crossed-out wheeled bin mark on the equipment and/or its packaging
indicates that:
∑was placed on the market after August 13, 2005,
∑complies with the European Directives on the disposal of electrical and
electronic equipment;
∑that the product at the end of its useful life must be collected separately
from other waste and must not be treated as household waste but must
be disposed of separately and delivered to the appropriate collection
point for the recycling of electrical and electronic equipment.
∑dispose of it in accordance with local waste disposal regulations
The separate collection of this equipment at the end of its life is organized and managed by the
manufacturer. The user who wants to dispose of this equipment should therefore contact the
manufacturer or his representative and follow the system that he has adopted to allow the
separate collection of the equipment at the end of its life.
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
WARNING
Cleaning operations must be carried out with the sensor disconnected from the
imaging PC.
WARNING:
DIGISENS and its accessories are supplied non-sterile and cannot be hot
sterilized.
To safeguard the patient's health and avoid possible risks of cross-
contamination and/or cross-infection, it is recommended that the following
general rules are strictly followed.
For each intervention, it is essential to apply a protection on the sensor. This
protection generally consists of a disposable sheath to be inserted on the sensor
before use.
A new sleeve must be used with each new patient. For greater effectiveness, it
is recommended to use the special sleeves produced specifically for the size of
the sensor.
Do not pull out the disposable sleeves by pulling on the sensor cable
. These
guards must be removed by gently cutting them or by using the appropriate tear
(if provided by the sheath manufacturer).
Before use with each patient, the sensor, the connection cable (only at the exit
of the sensor) and any accessories used must be thoroughly disinfected.
5.1 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.

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WARNINGS
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.
5.2.1 First-Level Disinfection
This disinfection procedure must be followed during the first use or when, after use, it is checked
that the protective sleeve is not broken.
- Remove the protection of the sensor and accessories and check that there is no residue of blood,
saliva, tissue or secretions.
- Carefully check the sensor and accessories used for the absence of material parts of biological
origin.
- Prepare the disinfectant solution according to the manufacturer's instructions.
- Thoroughly disinfect the sensor according to the instructions of the disinfectant manufacturer.
5.2.2 Second level disinfection
This procedure shall be followed if one or more of the following points are noted during the
visual check:
1. the protective sheath is torn off
2. you notice residues of organic origin (blood, saliva or other secretions, tissue residues) on the
sensor and / or on the cable connecting sensor - PC.
In this case, a second level disinfection procedure must be followed, proceeding as follows:
- Thoroughly wash the sensor with soap and water to remove all residues of organic material,
paying particular attention not to immerse the end of the cable with the USB connector.
- Prepare the disinfectant solution according to the manufacturer's instructions.
- Thoroughly disinfect the sensor according to the instructions of the disinfectant manufacturer.

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6 IDENTIFICATION AND DESCRIPTION
DIGISENS is intended for endoral radiographs of the human dental complex.
They are not included during normal use and for its operation:
- administration of biological substances
- sterilization of the product components, because only normal cleaning is necessary
- interpretation of the final results
- updating and modifying the control software.
6.1 Nameplates
The dimensions of the sensor do not allow to apply the identification plates on the same, also for
reasons of hygiene.
The sensor is sold in a package that contains all the data necessary for its correct identification, as
shown in the following image.
In addition, a label with the serial number of the sensor is attached to the USB connector.
6.2 Versions
DIGISENS is available in the following configurations:
- DIGISENS 1, which identifies a size 1 sensor;
DIGISENS can be equipped with either CsI or GOS sensitive layer.
7 TECHNICAL FEATURES
7.1 General characteristics
Characteristic Value
Devic Type DIGISENS
Manufacturer New Life Radiology Srl
Corso Canonico Allamano 13/15 interno G
10095 Grugliasco (TO) - Italy
Belonging class
(according to classification EN 60601-1) Class I with type BF applied
parts parts
Protection Degree Equivalent to IP67
Sensitive Surface 30 x 20 mm (size 1)

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Pixel Dimensions 20 x 20 µm
Pixel number 1500 x 1000 (size 1)
Spatial resolution 20 lp/mm tipic (theoritical 25 lp/mm)
Dynamic Range 58 dB
Type of Scintillator CsI or GOS
Detection photodiodes Positioned on the extension of the sensitive
area
Mechanical Characteristics
Characteristic Value
Mechanical Dimensions 25 x 39 x 12,5 mm (size 1) (L x S x H)
USB cable length 2 m
Electrical Characteristics
Characteristic Value
Power supply voltage 5 V DC
Power Supply Directly from USB connection
Maximum current consumption 275 mA
Frame rate 0,7 fps
Electro-optical Charatteristics
Characteristic Value
Dark current typical @25°C 350 LSB/s
Saturation dose (@70 kV) 340 µGy
Dynamic range 57 dB
Sensitivity 15 LSM/µGy
Non-uniformity of response RX (XRNU) ± 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

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WARNING
Using the sensor at temperatures outside of the above values may result in
nondiagnostic images.
In particular, image noise at temperatures above 35°C may render the image
undiagnostic.
Connection Characteristics
The DIGISENS sensor connects directly to the USB port, type A, of the imaging computer.
The sensor is USB 2 compatible and the PC can recognize up to three sensors connected to the
PC at the same time.
Computer Features
The image acquisition and storage computer shall have the following minimum characteristics.
Characteristic Specific
Operating System
Windows XP® SP3, Windows® 7 (32/64 bit) SP1, Windows® 8 64 bit
Windows® 10 32/64 bit
Non compatible with previous Windows® versions.
CPU Intel i5-2520M 2.5 GHz or upper
RAM memory 4 GB or greater
Hard disk Minimum 10 GB
USB Port 2.0
Video Card 1024x768 points at 65.000 colours (ideal 1280x1024 16 milions of
colors 32 bits)
The size of the hard disk must be proportional to the size of the archive that you create and
especially by the images that you store.
It is suggested to have a free space on the Hard Disk, after installing the program, considering the
following data:
∑Each X-ray image occupies a disk space that varies between 500KB and 4 MB.
∑A camera image occupies from 500 KB to 2 MB.
Monitor Characteristics
Preferably use a high contrast, high-definition monitor that is at least 17" in size. You can check
the quality of the monitor you are using by using special images (see 0).
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
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