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USER AND MAINTENANCE MANUAL

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THIS MANUAL WAS ORIGINALLY WRITTEN IN ITALIAN LANGUAGE, ITALIAN VERSION
PREVAILS IN ANY UNCERTAINTY SITUATION.

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WARNINGS

All users of the medical device described herein are strongly recommended to read carefully all
instruction in this manual and to respect recommendations reported about safety before
attempting any operation of installation, service or clinical use of the device.

Installation, service and maintenance of all devices which are part of the system is reserved to
technical personnel, qualified and trained, with adequate experience and professional background.

Even if the unit has been designed and manufactured to ensure utmost safety during use,
installation and examination, a lack of respect of the indication herein reported can result in a
potential risk for user patient and things.

The system configuration must not be changed during the lifetime of the device.

Do not use this device for application different from the original defined use purpose.

IONIZING RADIATION PROTECTION

An excess of X-Ray dose is a well known risk for health, and an improper use of Radio diagnostic
devices can result as well in a possible risk for health of patient and user.

Users of X-ray units, like those described in this manual, and technicians in charge of installation
and maintenance, are mandatory required to be informed on risk connected to exposure to an
excess of direct and diffracted X-rays and to keep safe themselves as well as patient and all
people eventually exposed to the same risk. A proper use of all standard means of protection is
needed in this purpose.

Specifically is mandatory that users and all personnel eventually required in the radiological room
for normal examination practice, will be informed on the International regulations for X-Ray
protection and respect all indication mentioned there.

SPECIFIC WARNINGS

All mechanical components and mobile parts which are included in the standard featuring of this
unit shall be used carefully and precisely, in respect of what described herein and according to the
indication of the present manual. A lack of respect of these indications may result in a collision
with patient, users, other operator or object present in the X-Ray room.

Access to the internal part of the devices by removing protective cores and carters, especially
access to electrical boards is allowed only to technical personnel in charge for ordinary and non
ordinary maintenance.

This unit can be used for paediatric x-ray investigation if combined with suitable devices (e.g.
paediatric x-ray transparent cradles)

It is requested utmost attention and care while using mobile phones, sources of electro-
magnetic radiation and other potential sources of interferences to electrical and
electronic components. Given the medical device is not in need of any specific shielding
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to ensure safety, use of such devices like those here mentioned should be prohibited in
the immediate proximity of the medical device and, in every case, in the X-Ray room.

Intellectual property rights

The content of the present manual, technical, planning and design, is an intellectual property of
the manufacturer.
Readers are required to contact directly the manufacture and mention all violation to this right,
may it be in form of unauthorized copy, improper diffusion or other.

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INDEX

I - Medical Device description ....................................................................................................... 7

II - Combination and related clinical application ................................................................... 8
III – Technical and functional feature, dimensions encumbrances, weights and
ambient environmental .................................................................................................................. 11
IV – Norms and declaration of conformity ............................................................................. 17
V - V - Safety ..................................................................................................................................... 21
V.1 - Declaration of responsibility ......................................................................................... 21
V.2 – Protection Classes ............................................................................................................ 22
V.3 – Protection against collision ........................................................................................... 22
V.4 – Protection against ionizing radiations ...................................................................... 23
V.5 - Biocompatibility of Materials......................................................................................... 23
V.7 – EMC Compatibility ............................................................................................................ 24
V.8 – Cables and wires............................................................................................................... 26
V.9 – Recommended separation distances for EM devices or EM systems
different from vital functions sustaining apparatuses ................................................... 27
VI - Instruction.................................................................................................................................. 28
VI.1 – Examination with chest bucky................................................................................... 28
VI.2 – Accessories, installation and use.............................................................................. 32
VII – Cleaning Operations and ordinary maintenance ...................................................... 36
VIII – Labelling and identification of products...................................................................... 37
IX – Disposal ...................................................................................................................................... 39
X – Symbols ....................................................................................................................................... 40
XI - References and manufacturer address ........................................................................... 42
XII – CE Mark..................................................................................................................................... 43

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I - Medical Device description

Intended use
DTR is an X-ray unit that is combined with other devices to compose a general
radiological system for clinical diagnosis on patient. Typical application is intended
with patient in vertical position.

The chest bucky DTR, is intended with use exclusively in a hospital environment,
only operated by technical skilled personnel.

Description:
Chest bucky designed for exam on vertical detector, to DTR could be coupled an
external tray for non-standard detector (see the detail below). It is equipped with
a support for digital or analogue detector.

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II - Combination and related clinical application

In order to realize a complete X-ray diagnostic system, ready to work, the unit
here described will require connection with an X-ray generator, an X-ray tube
housing, a collimator, and HT cables.

The medical device subject of the present manual, can be therefore combined
with all devices manufactured by the manufacturer. In case of combination with a
device not manufactured by others, given that these must be conform to directive
93/42/CEE, 2007/47/CEE and as well conform to international regulations for
safety.

Warning
In the eventual combination of the medical device subject to the present manual
with other manufacturer devices (main elements and accessories), whom
compatibility is not expressively declared in the present manual, assuming these
are all conform to the mentioned CE directives and norms, it is due to user
diligence to perform all needed controls to avoid dangerous situations for patients
and medical personnel. It is strongly recommended to contact directly each
manufacturer of the devices composing the system.

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LIST OF DEVICES ALREADY CHECKED FOR COMPATIBILITY

Rad Room

The medical device DTR, has been developed for use in a radiological room,
generally identified. Therefore the device has no limitation in use with any other
device used in a standard radiological room.

Potter Bucky

The medical device DTR, includes and connect with a Potter Bucky device.
The Manufacturer verified compatibility of the unit with the following cassette
holder with mobile grid (potter Bucky type):

Manufacturer Model
ARCOM HARRY
POLYRES Potter PBXX
PROTEC LRE Bucky Family

A compatibility with different devices can be assessed, given these will respect
the following mandatory encumbrances:

- Height: 68 mm
- Length: 572 mm
- Width: 584 mm

Digital Detectors:

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The medical device DTR, is designed for mounting of a digital detector.
The Manufacturer verified compatibility of the unit with fixed height with the
digital detectors:

Manufacturer Model
ATLAIM ATAL8 Flat Panel Detector
SCHAEF Systemtechnik DRF-L4343C
TRIXELL Pixium 3543 EZ
TRIXELL Pixium RAD 4143
TRIXELL Pixium RAD 4343
Varian 4636R

A compatibility with different devices can be assessed, given these will respect
the following mandatory encumbrances:
• 500 mm With x 570mm depth x 45mm height

Moreover, all CR cassette and all cassette size flat panels are compatible.

X-Ray Generators

The medical device DTR, is designed for electrical connection with an X-Ray
generator through the image detector.

Please refer to any indication from the Detector manufacturer to assess

compatibility with the generator.

X-Ray tube housing

The medical device DTR, is not affecting the performances of x-ray tube housing.

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III – Technical and functional feature, dimensions
encumbrances, weights and ambient environmental

The unit DTR is proposed in 4 different configurations, identified by as many

codes:

CODE DESCRIPTION
Chest Bucky without base-plate, with Potter Bucky and anti-
DTR600
scattering grid.

Chest Bucky with base-plate, Potter Bucky and anti-

DTR601
scattering grid.

Chest Bucky without base-plate, with anti-scattering grid.

DTR604
Ready for digital detector
Chest Bucky with base-plate and anti-scattering grid. Ready
DTR605
for digital detector

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DTR600
Features and encumbrances dimensions.

- Stand fixation on wall

- Vertical Potter Bucky movement 1550 mm
- Minimum distance from floor of imaging area 400 mm
Maximum distance from floor of imaging area 1968 mm
- Vertical movement balance Counterweight
- Vertical movement brake mechanical
- Standard potter bucky grid R 10 - 120 l/”
f.d. 150 cm
dim 480x438 cm
- Film to patient skin distance 40 mm
- Device Weight 105 kg

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DTR601
Features and encumbrances dimensions.

- Stand fixation on wall and pavement

- Vertical Potter Bucky movement 1550 mm
- Minimum distance from floor of imaging area 400 mm
Maximum distance from floor of imaging area 1968 mm
- Vertical movement balance Counterweight
- Vertical movement brake mechanical
- Standard potter bucky grid R 10 - 120 l/”
f.d. 150 cm
dim 480x438 cm
- Film to patient skin distance 40 mm
- Device Weight 125 kg

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DTR604
Features and encumbrances dimensions.

- Stand fixation on wall

- Vertical Potter Bucky movement 1550 mm
- Minimum distance from floor of imaging area Depends on detector
- Maximum distance from floor of imaging area 1550+X mm
- Vertical movement balance Counterweight
- Vertical movement brake mechanical
- Standard potter bucky grid Depends on detector
- Detector to patient skin distance Depends on detector
- Detector size Depends on detector
- Power supply Depends on detector
- Device Weight 90 kg

X =Depends on detector

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DTR605
Features and encumbrances dimensions.

- Stand fixation on wall and pavement

- Vertical Potter Bucky movement 1550 mm
- Minimum distance from floor of imaging area Depends on detector
- Maximum distance from floor of imaging area 1550+X mm
- Vertical movement balance Counterweight
- Vertical movement brake mechanical
- Standard potter bucky grid Depends on detector
- Detector to patient skin distance Depends on detector
- Detector size Depends on detector
- Power supply Depends on detector
- Device Weight 110 kg
.

X =Depends on detector

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Unit of
Feature Ref
Measure
24Vac – 24 Vdc – 230 Vac –
Voltage Vac - Vdc
115 Vac
Power Supply
Frequency Hz 50/60 Hz
(with Potter Bucky)
20VA (115-230Vac) – 11VA
Adsorbed Power VA
(24V)
Power Supply
Not appliable
(without Potter Bucky)
Type EN 60601-1 Classe I
Electrical protection
Grade EN 60601-1 B
Protection against liquid
Grade EN 60529 IPX0
penetration
Equivalent filtration Tabletop 0,9 mm Al

Temperature °C -20°C + 60°C

Storage conditions Humidity %RH < 95% no condensate

Pressure hPa > 630 hPa

Temperature °C From + 10 to + 40 °C

Operative Conditions Humidity %RH < 80%

Pressure hPa 700-1100 hPa

Max height m < 2000 m

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IV – Norms and declaration of conformity

The X-ray devices subject of this manual are designed and manufactured in
conformity to the Dlg 46/97, that receipt the EU Directive 93/42/CEE, and further
modification and integration such as those provided by the Dlg 25 January 2010,
n. 37, that receipt the EU Directive 2007/47/CE. The device has been classified as
Medical Devices in Class IIb.

Product classification according to Annex IX (Classification Criteria)

The medical device, subject of this manual has been classified as active medical
device in Class IIb, according to rule 10, of 3rd paragraph that refer to additional
rules applicable to active medical devices, in annex IX of the Dlg 46/97, that
receipt the EU Directive 93/42/CEE, and further modification and integration such
as those provided by the Dlg 25 January 2010, n. 37, that receipt the EU
Directive 2007/47/CEE.

Rule application:
The medical device “DTR”, subject of this manual has been classified as active
medical device in Class IIb, according to rule 10, of 3rd paragraph that refer to
additional rules applicable to active medical devices, in annex IX of the Dlg 46/97,
that receipt the EU Directive 93/42/CEE, and further modification and integration
such as those provided by the Dlg 25 January 2010, n. 37, that receipt the EU
Directive 2007/47/CE.
Hence the last comma of rule 10 states what follows “devices intended to emit
ionizing radiation and designed for diagnosis, radiotherapy or interventional
radiology, including those devices that controls them or directly influence their
performances are included in class IIb” . The device subject to this document, has
a direct influence on the result of radio diagnostic applications: as a matter of
fact, as it includes proper patient positioning means and acting as direct
influence in the imaging process, it falls into given definition.

Classification rationale
The chest stand DTR includes for a proper use an Anti scatter grid, intended to be
installed between the X-Ray source to reduce the diffracted radiation affecting the
surface and so improving the image contrast of the primary image. As a
consequence, the device is directly influencing the performance of the ionizing
radiation.
Moreover the potter bucky and the digital pack are both in direct connection with
the generator, influencing the X-Ray emission moment and duration, which are
not going to happen if not after a proper “go” signal form the Potter or the Digital
Pack.

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Finally the Al equivalent filtration of the front panel and the homogeneity of the
material has a direct influence on the image quality, considering also the
importance given to this point by the technical norm CEI EN 60601-1-3 that
verifies the attenuation in equivalent Al mm and determines a max value. A
proper material used to hold the patient and so positioned between patient and
detector, avoid an excess of attenuation that may result in a high value of dose
needed to achieve the desired image.

The product has a life period of 10 years, shelf life depends on the use made out
of the product and on the level of maintenance and consumption.

In conformity of what provided by EU directive 2007/47/CE, that modifies the

EU Directive 93/42/CEE, ARCOM SRL company declares that:
The device subject of this document do not incorporate, as integral part,
any substance or derivate substance of human blood as per point 7.4,
annex I of the mentioned directive;
In manufacturing this device, there has been no use of animal origin
tissues as per Dir. 2003/32/CE.

Rule application
The X-Ray table ETS is CE Marked in conformity to what expected by annex II of
MDD 93/42, as described in art.11 and respond to all essential requirements in
annex I.

The Declaration of Conformity is available under request, at the archive of the

manufacturer.

NORM REFERENCES

EU norms and laws

• Directive 93/42/CEE date 14 June 1993 on medical devices and further

modifications and integrations (Directive 2007/47/CE date 5.9.2007)
• Dlg 46 date 24.2.1997 and further modifications and integrations (Dlg 95
date 25.2.1998) – actuation of directive 93/42/CEE on medical devices; Dlg
37 del 25.1.2010 – actuation of directive 2007/47/CEE on medical devices.

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Harmonized norms

• UNI CEI EN ISO 13485:2012 + EC 1-2012.

Dispositivi medici. Sistemi di gestione per la qualità. Requisiti per scopo
regolamentari.
Medical devices. Quality management systems. Requirements for regulatory
purposes.

• UNI CEI EN ISO 14971:2012.

Dispositivi medici. Applicazione della gestione dei rischi ai dispositivi medici
Medical devices. Application of risk management to medical devices.

• CEI EN 60601-1: 2007. Ed.III+EC IEC:2007+IS IEC:2008 + CEI EN 60601-

1/EC:2010 + CEI EN 60601-1/A11:2012
Apparecchi elettromedicali. Parte 1 Prescrizioni generali relative alla
sicurezza fondamentale e alle prestazioni essenziali (2007)
Medical electrical equipment. Part 1: General requirements for basic safety
and essential performance (2007)

• CEI EN 60601-1-2: 2010 (ed.III) + CEI EN 60601-1-2/EC:2010

Apparecchi elettromedicali.
Parte 1: Prescrizioni generali per la sicurezza fondamentale e prescrizioni
essenziali – norma collaterale: compatibilità elettromagnetica – prescrizioni
e prove
Medical electrical equipment
Part 1: General requirements for basic safety and essential performance -
Collateral standard: Electromagnetic compatibility - Requirements and tests

• CEI EN 60601-1-6: 2011.

Apparecchi elettromedicali.
Parte1: Prescrizioni generali relative alla sicurezza fondamentale e alle
prestazioni essenziali – Norma collaterale: Usabilità
Medical electrical equipment
Part 1: General requirements for basic safety and essential performance -
Collateral standard: Usability

• CEI EN 60601-2-54: 2011 + CEI EN 60601-2-54/EC:2012

Apparecchi elettromedicali.
Parte 2: Prescrizioni particolari per la sicurezza e le prestazioni fondamentali
di apparecchi a raggi X per radiografia e radioscopia
Medical electrical equipment.
Part 2: Particular requirements for basic safety and essential performance
of X-ray equipment for radiology and radioscopy
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• CEI EN 62366: 2008 (Ed.I)
Dispositivi medici
Applicazione dell’ingegneria delle caratteristiche utilizzative ai dispositivi
medici
Medical devices
Application of usability engineering to medical devices

• UNI CEI EN ISO 15223-1:2012

Dispositivi medici – Simboli da utilizzare nelle etichette del dispositivo
medico, nell’etichettatura e nelle informazioni che devono essere fornite –
Parte 1: Requisiti generali
Medical devices. Symbols to be used with medical device labels, labelling,
and information to be supplied – Part 1: General requirement

• UNI CEI EN 1041:2009

Informazioni fornite dal fabbricante di dispositivi medici.
Information supplied by the manufacturer of medical devices

• UNI EN ISO 10993-1:2010 + EC 1-2010

Valutazione biologica dei dispositivi medici.
Parte 1: Valutazione e prove all’interno di un processo di gestione del
rischio.
Biological evaluation of medical devices
Part 1: Evaluation and testing

Essential performances
In line with the reference norm (IEC 60601-1) here follows the essential
performances of the medical device subject of this manual:
• Safety movement of the x-ray source, meaning the movement cannot harm
accidentally the patient\user;
• Absence of electrical shock to user and patient
• Safety in floor fixation (stability)

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V - V - Safety

The medical device subject of this manual must be used only by qualified and
duly trained personnel, in respect of what specified in this manual about safety.

In all cases when the unit is combined and made working with devices from other
manufacturer, the compatibility of which is not specified by the manufacturer, the
user is required to take care that no risk can be generated to patients and users.

In these situations it is mandatory to take contact with the manufacturer and with
the manufacturers of all devices for the needed controls of compatibility.

The X-Ray unit described in this manual requires ordinary, periodic operation of
cleaning and maintenance, as specified in the appropriate section of this manual.

Moreover it is absolutely forbidden to attempt any kind of examination or

investigations that may result in a spread of liquids of any kind on the tabletop of
the x-ray unit, in order to avoid damages to the electronic components.

V.1 - Declaration of responsibility

The manufacturer declines all responsibility for damages occurred to things or

human beings as well as for risky situation caused directly or indirectly by:
o Improper use of the system or use that differs in any way to what
described in this manual,
o Installation of the units performed in a different way than what stated in
this manual
o Maintenance and service operations are not performed in respect of what
stated in this manual

It is here reminded that the manufacturer is responsible of the safety of its

products only if installation, service and repair operations are performed by
technically skilled personnel authorized with a suitable training course.

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V.2 – Protection Classes

The Medical Device subject of this manual is classified as follows:

Feature Unit of Measure Reference

Type EN 60601-1 Class I

Electrical protection
Grade EN 60601-1 B
Protection against
Grade EN 60529 IPX0
liquid penetration

The medical device subject of this manual must be installed in proper

environment with adequate earth protection means in respect of currently
applicable norms.

Protection against electrical discharges has been achieved through earth

connection on all parts and metal covers off the unit.

The Medical Device cannot operate at all, in every situation where a potential risk
of explosion is detected, as in presence of anaesthetic gases or flammable
agents, such as for example those used for cleaning or disinfection of the skin or
of the parts of the units.

The operator must be aware of the importance to disconnect the unit for the
electrical line of power supply before starting the operation for cleaning and
disinfection.

V.3 – Protection against collision

The medical device subject of this manual is not provided of safety devices that
may impede an eventual collision with any object and person present in the radio
diagnostic room.

By mean of this it is requested the utmost attention from the operator during the
use.

Moreover, during installation phase, it is necessary to provide an adequate area

around the x-ray unit, which is kept free form any obstacles to the movement of
the unit in every working modality. For more details, refers to Chapter “III –
Technical and functional feature, dimensions encumbrances and
weights”.

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V.4 – Protection against ionizing radiations

It is full responsibility of the installation staff to:

• provide the needed Anti-X shielding in the room where the x-ray system
is installed, and some protection for the operators;
• check that the rooms of the installation has been properly shielded
against ionizing radiation, while the final user is mandatorily requested
to check these conditions

It is full responsibility of the user to evaluate the effects which may result by an
exposure o x-ray radiation, direct and diffracted, and provide in order tot have
the exams conducted in respect of the safety radioprotection norms, especially for
what is up for:

- Careful limitation of the surface exposed to the X-Ray beam, in respect of

the anatomic area of interest

- Use of leaded protective shields, on patient and user, any time when is
possible to protect the anatomical areas close to the irradiated area.

- Use of stationary and mobile barriers and shields, which shall be given in
the installation.

- Use of adequate leaded anti X clothes such as gloves an collars any time
the user is necessary aside of the patient during the examination. Please
note to always have care of being out of the primary X-Ray beam.

- Check the perfect closure of the doors for access and exit to the X-Ray
room. Always have care to leave in the x-ray room only the people strictly
necessary for the good result of the examination

- Check correct use and positioning of the personal dose measurer of the
personnel, according g to the indication of the radioprotection specialist.

V.5 - Biocompatibility of Materials

Control over materials biocompatibility has been set according to norm UNI EN
ISO 10993-1, that states in point 3.8 the possibility to check biocompatibility of a
medical device by collecting all certifications from the suppliers of raw materials,
or checking the late presence on the market of similar devices, with intended use
at least of the same level of the medical device under examination.

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Following the rationale mentioned in the norms, the manufacturer can state that
all material used in manufacturing of the medical device are complying the
biocompatibility criteria, because these are long used for manufacturing of
electro-medical devices and other devices with contact with the patient

• X-ray transparent tabletop

• Aluminium profile
• Selr-Base self-standing
• Rear handles

Duration and frequency of the contact

The medical device is classified on the base of the use condition as usage
“continuous with temporary contact”
Esteem of common x-ray examination in 5 minutes while more complex
examination can last up to approx 15 minutes

V.7 – EMC Compatibility

WARNING! Portable and mobile radio-communication devices can affect the

normal use of the electro-medical device.

Table 01 ELETTROMAGNETIC EMISSIONS

GUIDE AND DECLARATION OF THE MANUFACTURER – ELETTROMAGNETIC EMISSIONS

THE ELECTROMEDICAL DEVICE is designed to be used in the herein under specified electromagnetic environment.
The customer or user of the ELECTROMEDICALDEVICE must ensure that this is used in such an environment.
Emissions Test Compliance Electromagnetic Environment

THE ELECTROMEDICAL DEVICE is suitable for use in all rooms

Class A included domestic and those directly connected to a power
supply from public network in low tension.
RF Emissions
CISPR 11 THE ELECTROMEDICAL DEVICE uses RF energy only for its
inner work. Therefore the RF emissions are considerably low
Group 1
and likely are not providing interference with nearby
electronic devices
THE ELECTROMEDICAL DEVICE is suitable for use in rooms not
Harmonic Emission
inapplicable directly connected to public, low tension, power supply
IEC 61000-3-2
network
Voltage fluctuation THE ELECTROMEDICAL DEVICE is suitable for use in rooms not
Flicker’s emission inapplicable directly connected to public, low tension, power supply
IEC 61000-3-3 network

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Table 02 ELETTROMAGNETIC IMMUNITY

GUIDE AND MANUFACTURER DECLARATION – ELECTROMAGNETIC IMMUNITY

TELECTROMEDICAL DEVICE is designed to be used in the herein under specified electromagnetic environment. The
customer or user of the ELECTROMEDICALDEVICE must ensure that this is used in such an environment.
Test level
Immunity Test Conformity level Electromagnetic environment
IEC 60601-1-2
Electrostatic Discharge
± 6 KV Contact
(ESD) EN 60601-1-2 Hospital
± 8 KV air
IEC 61000-4-2
Non-life-supporting
equipment
3 V/m
Radiated RF 80 MHz – 2.5 GHz EN 60601-1-2 Hospital
IEC 61000-4-3
Life –supporting equipment
10 V/m
80 MHz – 2.5 GHz
Non-life-supporting
equipment
3V
Conducted RF 150 kHz – 80 MHz EN 60601-1-2 Hospital
IEC 61000-4-6
Life –supporting equipment
3 V Outside ISM band
10V inside ISM band
Electrical fast 2 KV for power supply lines
transient/burst 1kV for input/output lines EN 60601-1-2 Hospital
EN61000-4-4 >3m
Surge – Overvoltage 1 kV differential mode
EN 60601-1-2 Hospital
EN 61000-4-5 2 kV common mode
Tension holes, small
0% Un for 0,5 cycles
interruption and variation
40% Un for 5 cycles
on power supply income EN 60601-1-2 Hospital
70% Un for 25 cycles
line
0% Un for 5 sec
IEC 61000-4-11
Power frequency
(50/60 Hz)
3 A/m EN 60601-1-2 Hospital
magnetic field
EN 61000-4-8

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V.8 – Cables and wires
WARNING! Changing factory cables (following list) with others non compatibles
or with different features may affect the electromagnetic safety of the device

Cable Description Length Note

PCB board-
HARC01 7G0.75 30 cm
microswitches
Cap ground 1x1.5 Yellow/Green 30 cm GND

Generator connection 7G0.75 150 cm -

Cap ground 1x4 Yellow/Green 150 cm GND

WARNING! To avoid electric shock this EM device MUST be connected to a power

source properly earthed

WARNING! Changing the non detachable POWER SUPPLY CORD, non detachable
is only possible by service authorized staff. For a proper procedure of substitution
and attachment of power supply cord, please take direct contact with the
manufacturer.

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V.9 – Recommended separation distances for EM devices or EM
systems different from vital functions sustaining apparatuses
The medical device subject of this manual is designed to be used in an electromagnetic environment
where irradiation RF noise is under control. The customer or user of the device can contribute in
prevention of EMC interference by ensuring a minimum distance between mobile and portable RF
communication devices and the medical device, as recommended herein under, in reason of the
maximum power of the radio communication devices
Separation distance at transmitting frequency
Nominal max output
of transmitting (m)
from 150kHz to from 80MHz to from 800MHz to
(W) 80MHz 800MHz 2.5GHz
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For specified transmitting, for max output non specie herein, the recommended separation distance,
in mt (m) can be calculated using the applicable equation at the transmitting frequency, where P in
max nominal outputs of transmitting in Watt (W) according to transmitting manufacturer.

Note:
(1) at 80 MHz it is needed to apply the separation distance for the highest frequency batch;
(2) these guidelines may not be applicable in all situations. The electromagnetic spreading is
affected by adsorption and reflection of the facility, objects and people

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VI - Instruction

In case the medical device DTR, in every configuration, is used in association

with devices or apparatuses of other manufacturers, the instructions here
reported need integration with the proper manual of all other devices or
accessories.

The DTR unit is designed for permanent installation, all units composing the
system has no switch on \ switch off button.

The power supply, needed only in the configuration with potter bucky and with
digital detector, is taken from directly the power line or from the HV generator.
To identify that the unit is correctly powered, a green light is placed as described
in the following picture: (lighted on means DTR powered):

VI.1 – Examination with chest bucky

The serigraphy on the panel indicates and identifies, the position on the
radiografic cassette (approx.).

Per le riprese su teleradiografo, utilizzando il complesso tubo-guaina montato

sullo stativo a colonna, suggeriamo la seguente sequenza operativa :
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1. Rotate the tube / housing group of 90°, this will place the X-ray beam in
the direction of the chest bucky.

2. Set the right SID for the examination on progress.

3. Position the patient and adjust the height of the imaging area of the
chest bucky. The vertical adjustment of the Chest bucky is selectable as
described below:

a. Acting on control 1 in Pic.6-1, grabbing the handle.

b. Keep pushed the handle to allow the vertical movement of the

detector.

c. Release the handle to reactive the safety brake.

Pic.6-1
Black handle to release the vertical movement of the imaging area

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ONLY FOR ANALOG VERSION:

1. Insert the X-Ray film on the cassette.

2. Remove the cassette tray from the Potter.

3. Release the knob and open the jaws.

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MTE906

4. Lock the cassette using the jaws

5. Tight the know to lock the cassette.

6. Push the cassette tray till the end.

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VI.2 – Accessories, installation and use

The Chest Bucky DTR could be connected with the following accessories:

External cassette-tray PCM900

Removable device designed to be installed on the external side of the Chest
Bucky with settable jaws to support non-standard cassette. The maximum
allowed cassette is 35x90 cm.

Installation
a. Push the handle (1) and apply the PCM900 to Chest Bucky as descrive
in the picture below.
b. Release the handle (1) to lock the cassette tray.
c. Release the knob (2).
d. Insert the cassette and set the jaws (3) to lock the cassette.
e. Screw the knob (2) to lock the entire system.

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2
1

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Arm Support DTR930
Removable device designed to aim the patient to support the arm during
projection that require the patient arm to be raised.

Installation
a. Insert the handle to right or left side in the holes placed in the upper
side of the Chest Bucky.

b. Remove the devices at the end of the X-Ray exam.

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Rear handle
Device designed to aim the patient during the exam in orthostatic position placed
with shoulder facing the X-Ray beam. This accessories is installed in factory.

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VII – Cleaning Operations and ordinary maintenance

The user is required of a few cleaning and ordinary maintenance operations, and
a few visual check of some moving part. These simple operations are anyway
highly important for a safe use and a long life cycle of the devices.

All controls and maintenance operation which requires the access to the internal
parts of the devices, as well as some ordinary and extraordinary maintenance
operations are exclusive duty of authorized personnel.

In the following table we report all common cleaning operation and visual check
recommended for a correct use of the devices.

Warning!
• Before attempting any cleaning or disinfection operation of the structure,
disconnect the device from power supply.
• Take care that cleaning and disinfection products are not aggressive and
not abrasive.
• Avoid that all liquids used for cleaning get in touch with powered parts of
the structures.

Frequency Operation

Cleaning and disinfection of all surfaces in contact with the

After every use
patient (use a clean cloth and non aggressive product)

Check the correct work of all light signals and the correct
Daily readability of all labels and indications placed on the
structures.

Check eventual unusual noises, during movement or during

Weekly
brake activation / deactivation

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VIII – Labelling and identification of products

The Medical Device is identifiable by a label positioned in the following picture:

Models 600/1
• 24Vac/Vdc power supply

• 115 Vac power supply

• 230 Vac power supply

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Models 604/605 – No power supply

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IX – Disposal

This medical device must be managed in full respect of Article 13 of Dlg July 25,
2005, Nr 151 ’’Attuazione delle direttive 2002/95/CE, 2002/96/CE e
2003/108/CE,” related to the reduction of the use of the dangerous material on
the electrical and electronic devices, as well as to the garbage disposal.

The symbol with the crossed garbage bin indicates that the product, at the end of
its shelf life must be collected in separated way from the other garbage.

The separate collection of this device must be arranged and managed and by the
manufacture.
The users that want to dispose this device will contact the manufacture and follow
is protocol for the garbage disposal.

A correct separate collection to perform a compatible recycling, treatment and

disposal of the device, aids to avoid negative effects to the environment and to
the health, it also supports a reuse and/or a recycling of the materials of the
device.
The abusive disposal of the device by the side of user involves the applying of
fines estimated by the in force law.

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X – Symbols

The Medical Device presents several symbols, that here follow with detailed
explanations.
Users and technicians are carefully intended to be aware of the meaning of each
symbol and to respect them in every operation.
User and technician are forbidden to remove any of the signals present on the
device.

Manufacturer

Identify the production data with format year/month

Product code.

Identify the serial number of the unit given by manufacturer

Applied part Type B

Instruction. WARNING! REFERENCE ON THE MANUALS

CE conformity mark

Earth protection

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Store in dry environment

WAEE Disposal

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XI - References and manufacturer address

Via Marzabotto, 21 / 23
20871 VIMERCATE (MB)
-ITALY-.
Tel. 039/6080443
Fax 039/6082557

General Information [email protected]

Commercial Information [email protected]
Technical Service [email protected]
Website

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XII – CE Mark

The EM device is a medical device with CE mark achieve with support of a

notified body of the European Union.

0051

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