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UPPER

USER AND MAINTENANCE MANUAL

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 ....................................................................................................... 6

II - Combination and related clinical application ................................................................... 7
III – Technical and functional feature, dimensions encumbrances and weights .... 10
IV – Condizione di immagazzinamento ed operative......................................................... 13
V – Norms and declaration of conformity............................................................................... 14
VI - Safety........................................................................................................................................... 18
VI.1 - Declaration of responsibility........................................................................................ 18
VI.2 – Protection Classes .......................................................................................................... 19
VI.3 – Protection against collision ......................................................................................... 19
VI.4 – Protection against ionizing radiations..................................................................... 20
VI.5 - Biocompatibility of Materials....................................................................................... 20
VI.6 – Applied parts .................................................................................................................... 21
VI.7 – EMC Compatibility .......................................................................................................... 21
VI.8 – Cables and wires............................................................................................................. 23
VI.9 – Recommended separation distances for EM devices or EM systems
different from vital functions sustaining apparatuses ................................................... 23
VII - Instruction ................................................................................................................................ 24
VII.1 - Table movement and patient positioning............................................................. 24
VII.2 - Installation and use of the accessories................................................................. 28
VIII – Cleaning Operations and ordinary maintenance..................................................... 32
IX – Labelling and identification of products ......................................................................... 33
X – Disposal........................................................................................................................................ 34
XI – Symbols...................................................................................................................................... 35
XII - References and manufacturer address ......................................................................... 37
XIII – CE Mark ................................................................................................................................... 38

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I - Medical Device description

Intended use
The medical device subject of the present manual is intended for general x-ray
examination in horizontal (prone) patient position. The device is therefore
intended only as a mean to achieve radiographic images of bone, soft and
cartilaginous tissues for diagnostic purposes.

The radiological table with variable height UPPER, when properly installed, allows
supporting the patient while performing radiological exams, providing as well
suitable support for the Radiological cassette or the flat panel detector.
The variable height of tabletop allows an easier positioning of invalid patients,
patient on wheelchair, traumatized or –generally- all patient with movement
difficulties.

Description:
Horizontal Bucky Table with variable height, X-Ray transparent tabletop and given
of 2 degrees of freedom. It is equipped with analogical or digital detector.
The variable height of the X-Ray transparent tabletop help the access to the table
to the patient and it is recommended for exams to the disabled patient injured.

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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 UPPER, horizontal Bucky table with variable height, 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 UPPER, includes and connect with a Potter Bucky device.
The Manufacturer verified compatibility of the horizontal Bucky table UPPER with
variable height 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

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Digital Detectors:

The medical device UPPER, is designed for mounting of a digital detector.

The Manufacturer verified compatibility of the horizontal Bucky table 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 UPPER, 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 UPPER, is not affecting the performances of x-ray tube
housing.

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III – Technical and functional feature, dimensions
encumbrances and weights

The Radiological table UPPER is commercialized in 4 different configurations,

identified by 2 different codes:

CODE DESCRIPTION

LIA001 Horizontal table with variable height and Potter Bucky device,
tabletop with 2 degrees of freedom, supporting structure.

Horizontal table with variable height and Potter Bucky device,

LIA004 tabletop with 2 degrees of freedom, supporting structure. Set for
Digital detector.

LIA001
- Tabletop X-ray transparent
Laminate
- Tabletop adsorption 0,9 mm Al equivalent
- Tabletop size 2200x810 mm
- Tabletop longitudinal movement 900 mm (±450mm)
- Longitudinal movement brake electromagnetic
- Tabletop transversal movement ± 110 mm
- Transversal movement brake electromagnetic
- Minimum tabletop height 500 mm
- Maximum tabletop height 825 mm
- Height variation 325 mm
- Height variation speed 18 mm/s
- Potter-bucky movement 550 mm
- Potter-bucky movement brake electromagnetic
- Film/tabletop distance 70 mm
- Potter Bucky standard grid R 10 - 120 l”
f. d. 120 cm
- Accepted cassette size min 13x18cm
max 35x43cm
(both directions)
- Max Patient weight accepted 200 kg
- Table Power Supply (cable lgt. 15m) 230 Vac – 50/60 Hz
- Absorbed power 0,9kVA
- Device weight 250 Kg

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LIA004

- Tabletop X-ray transparent

laminate
- Tabletop adsorption 0,9 mm Al equivalent
- Tabletop size 2200x810 mm
- Tabletop longitudinal movement 900 mm (±450mm)
- Longitudinal movement brake electromagnetic
- Tabletop transversal movement ± 110 mm
- Transversal movement brake electromagnetic
- Minimum tabletop height 500 mm
- Maximum tabletop height 825 mm
- Height variation 325 mm
- Height variation speed 18 mm/s

- Flat Panel movement 550 mm

- Flat Panel movement brake electromagnetic
- Film/tabletop distance 73 mm
- Anti-scattering grid (optional) R 10 - 215 l”
f. d. 120 cm
- Max Patient weight accepted 200 kg
- Power Supply (cable lgt. 15m) 230 Vac – 50/60 Hz
- Absorbed power 0,9kVA
- Device weight 250 Kg

Encumbrances of the radiological table UPPER (all versions)

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Fig.3-1

Dimensioni di ingombro e movimentazioni del tavolo radiografico UPPER

Feature Unit of Measure Ref

Voltage Vac 230 Vac

Power Supply Frequency Hz 50/60 Hz

Adsorbed Power VA 0.75kVA

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IV – Working and storage environment

Temperature °C -20°C + 60°C

Storage conditions Humidity %RH < 95% no condensate

Pressure hPa > 630 hPa

Temperature °C From + 10 to + 40 °C

Humidity %RH < 80%

Operative Conditions
Pressure hPa 700-1100 hPa

Max height m < 2000 m

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V – 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 UPPER, is considered in class IIb as 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.

This medical device is provided in non sterile condition.

Classification rationale
The tabletop and the image detector, includes in its standard usage, an anti-
scattering grid with the purpose of being positioned beside the imaging surface to
reduce scattered radiation affecting the surface and, so doing, improving the
image contrast of primary image. In reason of this, the device has a direct
influence on the performances of the ionizing radiation.
Moreover the Potter Bucky or the digital detector has a communication with the
generator, influencing so the x-ray emission, which is not happening if not
approved.

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.

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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 UPPER 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:

Garantire la capacità di sostenere il paziente

Movimentazione del tavolo in altezza e del pannello porta paziente flottante,
che non possa danneggiare accidentalmente il paziente/operatore
Assenza di shock elettrico al paziente o utilizzatore
Sicurezza del fissaggio a pavimento (stabilità)

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VI - 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.

VI.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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VI.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.

VI.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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VI.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.

VI.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

VI.6 – Applied parts

The medical device subject of this manual, in its normal use, gets in direct
contact with the patient (e.g. thorax, arms legs) by mean of:
• x-ray transparent, patient supporting tabletop;
• aluminium profile;
• accessories: handgrips and compression band;

This contact is needed to provide the patient the necessary support during
examination to the end of avoiding unintended movement during x-ray
examinations.

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

VI.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
RF Emissions
supply from public network in low tension.
CISPR 11
THE ELECTROMEDICAL DEVICE uses RF energy only for its
Group 1
inner work. Therefore the RF emissions are considerably low

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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

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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VI.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

General power
3G 2,5 15m -
supply

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.

VI.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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VII - Instruction

When the table UPPER, 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 table UPPER is designed for permanent installation, all units composing the
system has no dedicated “ON/OFF” switch.
The power supply is taken directly through the main plug of the room plant,
usually placed on the control board of the X-Ray generator.

VII.1 - Table movement and patient positioning

The vertical movement of the radiological table UPPER, make easy to the patient
the access to the table itself. During this operation the tabletop is locked by
electromagnetic brakes, and in every case must be helped by authorized
personnel.
7 4

6
5

3 1 2a 2b

Radiographic table UPPER : 1-light lamp indicating “table ON” ( it points out
the electric feeding of the table); 2a- control pedal of the vertical movement
“towards up” of the exam panel; 2b- control pedal of vertical movement
“towards down” of the panel; 3- unblock pedal of longitudinal and transversal
movements of the exam panel; 4- grip of panel movement; 5- control button
of longitudinal running of the potter; 6- emergency switch; 7-anti-electrical
shock switch

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WARNING: during use, the medical procedure requires the use of a monouse
disinfected sheet in paper of cloth. This procedure doesn’t exclude the disinfection
of the tabletop, that avoid the risks for the patient.

How to move vertically the tabletop:

1. Facing the table.

2. Push and keep pushed the pedal with the symbol (UP arrow) to lift
UP the tabletop.

3. Release the movement to lock the movement.

4. Push and keep pushed the pedal with the symbol (DOWN arrow) to
lift DOWN the tabletop.

5. Release the movement to lock the movement.

Note: the UPPER table is provided with safety end run microswitch for both
vertical movements!

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Safety button.
During every dangerous situation, it is possible to stop the vertical movement
pressing the red safety button.
This button doesn’t affect the planar movement of the tabletop.

The safety button is placed on the left side of the table (facing it):

How to move transversally and longitudinally the tabletop:

The transversal and the longitudinal movements of tabletop for the centring of
the anatomical zone to examine, is performed deactivating the electromagnetic
brakes:
1. Push and keep pushed the pedal 3;
2. Move the tabletop using the detector handle 4, till the wished position.
3. Release the pedal to lock the tabletop in the wished position.

How to move the detector longitudinally:

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The detector movement is performer releasing the electromagnetic brake under
the tabletop:
1. Push and keep pushed the green button 5 to unlock the brake.
2. Move the tray till the wished position.
3. Release the button to reactive the brake.

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VII.2 - Installation and use of the accessories

Handles

The handles protect patients’ hands and avoid accidental hurts while moving the
tabletop in positioning operations.
It is recommended to tell the patient to grab the handles during these operations

Pic.7.2

Detail of the mounting part of handles on the aluminium profile of table

Handles must be installed on the aluminium profiles of the tabletop, adjusting

their position with patients’ size run them on the aluminium profile. Take care
that the handles are properly blocked before examination starts (Pic.7-1).

Installation procedure:
1. Unlock the blocking knob.
2. Insert the handle along the aluminium profile.
3. Adjust the position in reason of patient size.
4. Block the position by locking the knob clockwise.

Pressing Band

The pressing band allows reducing the scattered radiation dose on soft tissue
examination: when the anatomic area of investigation has enough elastic
property the pressing band allows reducing the thickness of the examination
improving as well the image quality.

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The extremity of the pressing band accessory and the gear which holds the band
itself are designed for a fixation on the aluminium profiles of all ARCOM tabletops
as displayed in Pic.7-2.

Pic.7-3

Details of the mounting parts of pressing band and gear on tabletops aluminium
profiles.
1- Hook of fixation to pressing band extremity; 2- Grip to operate on the gear: A
clockwise rotation will revise the pressure of the band; 3- Unlocking device of the
pressing band.

Install the pressing band on the tabletop profile form any side (head or feet) and
position it in the desired area of examination; ensure that is fixed in a proper
way.

Installation procedure:
1. Unlock the band by mean of device nr 3 in Pic.7.3 in order to act on
desired area of examination; fix the extremity of the band to the opposite
profile with hook nr 1 in Pic. 7.3.
2. Attach to extremity of the band to the other side of the tabletop by mean of
the hook (detail 1 in Pic. 7.3).
3. Act on the knob (detail 2 ion Pic. 7.3) to tighten the band.
4. When got the desired pressure on the band, this is automatically blocked by
detail 3.
5. Push detail 3 to release the band

It is recommended to warn the patient before pressure with the band, and its
effect and purposes.

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Lateral cassette support

This support accepts cassettes from size 13x18 cm to 35x43 cm; it is helpful
when the examination on progress requires latero-lateral projections of certain
anatomical parts. The use of this device made easier to perform this examination
without force the patient to uncomfortable positions.

(B) (A)

Pic.7-4

Lateral cassette support: (A) - detail of mounting part for cassette support on
the aluminium profile of tabletop with blocking gear (1)
(B)- Lateral view of cassette support.

In Pic.7.4 (A) and (B) some mounting part detail of the lateral cassette support
are displayed to show the installation on the aluminium support, by mean of the
proper guides.

Installation procedure:
1. Unlock the blocking knob
2. Insert the cassette holder along the aluminium profile
3. Adjust the position in reason of imaging area
4. stabilize the position by locking the blocking knob clockwise

The specific configuration of this support allows the use of X-ray cassettes with
size 13x18 cm to 35x43 cm in both directions.
For a more practical use and a better imaging result it is suggested to employ
cassette incorporating the X-ray grid.

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Tabletop moving handle

The floating movement of the tabletop of the x-ray table AIN is made easier
thought the use of the properly designed knob. This item must be installed on the
aluminium profile on the user side, and must be blocked properly as in Pic. 7-5.

Pic.7-5
Installation procedure:
1. Unlock the blocking knob
2. Insert the knob along the aluminium profile
3. Adjust the position to have it comfortable for the user
stabilize the position by locking the blocking knob clockwise

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VIII – 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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IX – Labelling and identification of products

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

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X – 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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XI – 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
0051

Earth protection

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Store in dry environment

RAEE Disposal

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XII - References and manufacturer address

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

General Information info@arcomonline.com

Commercial Information commerciale@arcomonline.com
Technical Service service@arcomonline.com
Website www.arcomonline.com

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XIII – 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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