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INSTALLATION AND SERVICE 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 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.
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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 - Description of Medical Device ............................................................................................6

II - Combination and related clinical application ..............................................................7
III – Technical and functional feature, dimensions encumbrances, weights and
ambient environmental ...............................................................................................................9
IV – Norms and declaration of conformity ........................................................................19
V - Safety .......................................................................................................................................23
V.1 - Declaration of responsibility ....................................................................................23
V.2 – Protection Classes .......................................................................................................24
V.3 – Protection against collision ......................................................................................24
V.4 – Protection against ionizing radiations .................................................................25
V.5 - Biocompatibility of Materials....................................................................................25
V.6 – Applied parts .................................................................................................................26
V.7 – EMC Compatibility .......................................................................................................26
V.8 – Cables and wires..........................................................................................................28
V.9 – Recommended separation distances for EM devices or EM systems
different from vital functions sustaining apparatuses ..............................................29
VI - Unpacking..............................................................................................................................30
VII - Installation ..........................................................................................................................32
VII.1 - Preliminary check .....................................................................................................32
VII.2 - Environmental conditions ......................................................................................33
VII.3 – Installation Kit...........................................................................................................33
VII.4 – Installation..................................................................................................................36
VII.5 - Tuning ...........................................................................................................................52
VIII - Tube protection cover ...................................................................................................58
IX - Adjustment of base bearings.........................................................................................59
X - Chest bucky distance reference block installation (code CTC900/B)..............60
XI – Electrical connections.......................................................................................................63
XII – Cleaning Operations and ordinary maintenance .................................................71
XIII – Ordinary and extraordinary maintenance ............................................................72
XIV – Spare Parts........................................................................................................................75
XV – Labelling and identification of products...................................................................76
XVI – Disposal ..............................................................................................................................77
XVII – Symbols ............................................................................................................................78
XVIII - References and manufacturer address................................................................80
XIX – CE Mark...............................................................................................................................81
XX - Installation Report ............................................................................................................82

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I - Description of Medical Device

Intended use
The medical device ETS is a radiological unit, that properly matched with other
devices composes radiological systems for general applications where patients
are typically in horizontal or vertical position. The Tubestand medical device
ETS, properly installed, supports x-ray source (tube housing) and includes
collimator for radiological examinations having diagnostic purpose only.

This medical device is intended for exclusive use in hospital environment and
by specialized personnel only (either medical or technical).

Description:
ETS is a tubestand that supports x-ray source, mounted on a floor rail, and
includes a suitable collimator to perform radiologic examinations.
The tubestand device ETS, properly installed, supports the x-ray source (tube
housing).
This device, in its more complex configuration, has 5 mechanical movement
with ELM or mechanical brakes.

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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

Radiologic Room
The Tubestand medical device ETS has been developed for use in a standard
bone \ pulmonary radiological room, therefore this device has no limitations
when used with other devices present in the room, as long as these devices
feature a free 24V exit as power source (4A).

X-ray tubes
The Tube support allows installation of every kind of tube housings with a
maximum diameter of 200mm, with measures shown in drawing CFC700

Collimator
The standard collimator used with the Tubestand medical device ETS is Ralco
Mod 302/A. All collimators can be used with medical device ETS as long as
these respects the drawing CFC700.

CFC700

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

The tube stand ETS is proposed in 4 different configurations, identified by as

many codes:

CODE DESCRIPTION

Tube stand, No stand rotation, tube rotation, horizontal rail

ETS001
movement, comprehend the collimator.

Tube stand, with stand rotation (+/- 90°), tube rotation,

ETS002
horizontal rail movement. comprehend the collimator.

Tube stand, no stand rotation, tube rotation, horizontal rail

ETS003 movement and telescopic movement of the x-ray source,
comprehend the collimator.

Tube stand, with stand rotation(+/- 90°), tube rotation,

ETS004 horizontal rail movement and telescopic movement of the x-
ray source, comprehend the collimator.

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ETS001
Features and encumbrances dimensions.

- Longitudinal Movement 1850 mm

- Longitudinal Movement brake electromagnetic
- Tube/housing movement:
o Rotation around support axis ± 180 ° continuous
Memories every 90°
o Transversal movement NO, static distance
650mm
from the tube stand
o Vertical movement 1650 mm

- Minimum distance X-ray beam to floor 400 mm

- maximum distance X-ray beam to floor 2050 mm
- Vertical movement balance Counterweight
- Tube/housing movement brake electromagnetic
- Stand rotation on its axis NO
- Stand rotation Brake -
- Power supply 24 Vdc
- Device weight 210 kg with collimator

All the following measures are in millimetres:

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ETS002
Features and encumbrances dimensions.

- Longitudinal Movement 1850 mm

- Longitudinal Movement brake electromagnetic
- Tube/housing movement:
o Rotation around support axis ± 180 ° continuous
Memories every 90°
o Transversal movement NO, static distance
650mm
from the tube stand
o Vertical movement 1650 mm

- Minimum distance X-ray beam to floor 400 mm

- maximum distance X-ray beam to floor 2050 mm
- Vertical movement balance Counterweight
- Tube/housing movement brake electromagnetic
- Stand rotation on its axis ± 180°
- Stand rotation Brake mechanical
- Power supply 24 Vdc
- Device weight 210 kg with collimator

All the following measures are in millimetres:

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ETS003
Features and encumbrances dimensions.

- Longitudinal Movement 1850 mm

- Longitudinal Movement brake electromagnetic
- Tube/housing movement:
o Rotation around support axis ± 180 ° continuous
Memories every 90°
o Transversal movement from 580 to 780mm
centre at 680mm
from the tube stand
o Vertical movement 1650 mm

- Minimum distance X-ray beam to floor 400 mm

- maximum distance X-ray beam to floor 2050 mm
- Vertical movement balance Counterweight
- Tube/housing movement brake electromagnetic
- Stand rotation on its axis NO
- Stand rotation Brake -
- Power supply 24 Vdc
- Device weight 210 kg with collimator

All the following measures are in millimetres:

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ETS004
Features and encumbrances dimensions.

- Longitudinal Movement 1850 mm

- Longitudinal Movement brake electromagnetic
- Tube/housing movement:
o Rotation around support axis ± 180 ° continuous
Memories every 90°
o Transversal movement from 580 to 780mm
centre at 680mm
from the tube stand
o Vertical movement 1650 mm

- Minimum distance X-ray beam to floor 400 mm

- maximum distance X-ray beam to floor 2050 mm
- Vertical movement balance Counterweight
- Tube/housing movement brake electromagnetic
- Stand rotation on its axis ± 180°
- Stand rotation Brake mechanical
- Power supply 24 Vdc
- Device weight 210 kg with the collimator

All the following measures are in millimetres:

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Feature Unit of Measure Ref

Voltage Vac 24 Vdc

Power Supply Frequency Hz 50/60 Hz

Adsorbed Power VA 90VA (24V)

Type EN 60601-1 Class I

Electrical protection
Grade EN 60601-1 B
Protection against
Grade EN 60529 IPX0
liquid penetration
Temperature °C -20°C + 60°C

Storage conditions Humidity %RH < 95% no condensate

Pressure hPa > 630 hPa

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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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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 ETS, stated in class IIb, must respond to essential
requirements defined in Annex I and be manufactured in conformity of what
stated in Annex II of European Directive 93/42/CEE and further integrations
and modifications (such as European directive 2007/47/CE).
The medical device ETS 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.

In fact, including suitable positioning means for the tube housing and being an
element with direct influence on the imaging process, it is included in given
definition.

The tubestand ETS, is a Medical device that does not incorporate, as integral
part, drugs or substances or human blood derivate as per point 7.4 of Annex I
of Directive 93/42/CEE and does not incorporate animal tissue as per Directive
2003/23/CEE, as it is made out of iron/steel/aluminium.

This medical device is provided in non sterile condition.

Classification rationale
This unit comprehend the radiologic collimator, therefore is IIb classified.

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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

• CEI EN 62366: 2008 (Ed.I)

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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)
• Safety in keeping the tube housing position

Collimator essential performances- included in the tubestand - : please ref to

tech file by the manufacturer of the mentioned medical device.

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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.

Following the rationale mentioned in the norms, the manufacturer can state
that all material used in manufacturing of the medical device are complying the

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biocompatibility criteria, because these are long used for manufacturing of
electro-medical devices and other devices with contact with the patient

V.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:

• Collimator

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

General power
7G 0,75 8m -
supply
Column brake power
7G 0,75 4m -
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.

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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 - Unpacking

ETS unit is singly packed and protected in a wooden cage or in a wooden crate,
the dimensions and the unpacking procedure are the same for both type of
packing.

Dimensions:
• 2650x730xh1050mm

Weight:
• Cage Kg.48
• Crate Kg.68

To move this type of packing is mandatory to use proper gear (for example a
pallet truck).

The below image show the wooden cage package.

Follows the unpacking procedure.

1. Remove the top cover:

a. Unscrew all the screws in the top
b. Lift and remove the top cover

2. Remove the top cover unscrew all the screws in the top.

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3. Remove the ETS unit from the cage/crate with, fro example, a pallet
truck.
4. Remove the internal protection (plastic film, adhesive band, cardboard
and so on).

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VII - Installation

THE INSTALLATION OF EM DEVICE (EVERY MODEL) MUST BE

PERFOMED ONLY BY QUALIFIED STAFF TRAINED DIRECTLY BY THE
MANUFACTURER DURING THE MANDATORY TRAINING COURSE.

VII.1 - Preliminary check

Verify that the room of destination of the X-Ray units has dimensions and
structures wide enough to host the devices, considered the encumbrances
already described in this manual and the need for installation of an X-ray
generator and its control console. As well, verify that the room allows hosting
all accessories and other objects eventually needed for examination.

It is important to check that around the X-ray devices is kept enough free
space to allow the operator movement and to avoid collision with things and
people.

When an X-ray transparent stretcher on pivoting wheels is used with the

system, a specific care is required to verify room dimensions. It is important to
check that the room will save enough space for stretcher access and
movement inside the room.

Moreover verify that all components, devices and accessories, not

manufactured by the Manufacturer of the MD object of this manual, needed for
the use of the X-ray system hosted in the room in association with the X-Ray
system, responds to the following parameters:

- CE mark of conformity, where required;

- Perfect compatibility (mechanical, electrical and functional for all
component of the system;
- Position in the room which helps as much as possible the devices access
by operators and patient, and made as easy as possible examination
performing

For what concerns the elements which are not part of the functional
configuration EM device, that could be used during some special exams or the
furniture elements: for all these elements take care that their presence will not
result as an obstacle for device movement and ordinary work of the unit.

Room features:

The room designed for installation of the system must respond to the following
features:
- Conformity and certification in line of international and local laws for
room designed to host an X-Ray source
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- Electric plant in line of international and local laws, and according to all
devices designed to work in the base of the same power plant. For
ARCOM devices, please ref to the present manual, for other
complementary or alternative devices, please ref to the proper manuals
and documents.
- Walls, floors and ceilings adequate to insert of fixing parts, and strong
enough to handle the weight of the different structures installed.

VII.2 - Environmental conditions

All devices described in the present manual can be used in the following
environmental conditions:

- Temperature : from + 0 °C (≈ 32 °F) to + 55 °C (≈ 131 °F)

- Maximum relative humidity: < 85 %
- Maximum Altitude (sea level): < 2000 m

VII.3 – Installation Kit

Every unit is delivered with an installation kit packed a plastic bag and placed
under the ETS arm (tube support). The installation kit is composed by:

1) N° 10 - Plug for rail M8Ø14 + N°10 Screws M8x60 UNI5739 + N°10 Flat
washer M8

2) N° 4 - Screws M6x30 UNI 5933

3) N° 4 – Screws M6x35 UNI 5933

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4) N° 10 - Spacer for rail 1,5 mm (Cod. ATS104)

5) N° 3 - Spacer for collimator 1,5 mm (Cod. ATS173)

6) N° 1 – Special key for base eccentric bearings 1,5 mm (Cod. ETS029)

7) N°1 – Powder Paint RAL9002

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Every unit is equipped with some counterweight pace and placed in the 4
corner of the cage/crate.

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VII.4 – Installation

THE FOLLOWING PROCEDURE MUST BE PERFORMED BY TWO

TECHNICIANS (MINIMUM).

1. Remove from the rail the cover placed on the extremity and on the middle
on the rail:

Back side
with ELM
brake plate

2. Place the rail in the installation site (minimum distance from the wall 60
mm) and block it with the proper plug on its entire length.

Check the centre of the bubble of the rail, if necessary use some tsupplied
spacer (Cod. ATS104).

Not tight the screws before the end of the installation, in this way it is
possible to make some adjustments on the column position.

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If the column must be installed in a already existing system, please

make attention to the following distances:

Modelli ETS001 e ETS002 Modelli ETS003 e ETS004

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3. If the unit will be coupled with tables code AINXXX or LIAXXX, follows the
below schematics:
Models: ETS001 and ETS002

Models: AINXXX Models: LIAXXX

Models: ETS003 e ETS004

Models AINXXX Models LIAXXX

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4. Place the column in vertical position and put the tray inside the rail: keep
attention to not damage the bearings!

5. After the column is placed in vertical position, connect the tube support with
following procedure:

I. Remove the 4 nuts that lock the plate for centre of gravity tuning.

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II. Pass the connector through the rounded hole of the tube support.

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III. Pass the two “counter-screws” in the holes on plate for centre of
gravity tuning

IV. Tight the 4 screws, that go out from the plate for centre of gravity
tuning, on the 4 holes on the tube support

V. Connect the connector “E” (from the column arm) to the same on the
tube support

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VI. Place the X-Ray tube on the tube support. Keep attention to not
damage the wires.

VII. Insert, if necessary, the given spacers (ATS173) to achieve the

neede focus/collimator distance. Connect the cone CFC700 under the
tube support with the given screws (M6x30 with no spacers, M6x35
with spacers).

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6. Install the collimator:

I. Remove the back cover of collimator and close completely the

shutters acting on the frontal knob.

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II. Untight completely the 4 grains on the 4 collimator corners.

3
1

III. Place the collimator and tight the grains 1 turn per time, making a
cross as shown in the previous image (sequence 1 -2 -3 - 4).

Repeat the sequence till the end of the grains run.

With this procedure the collimator is about centred.

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IV. Connect the power supply cables (24Vac) from the tube support (see
collimator service manual for details).

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V. Remount the back cover.

7. Counterweight the arm/tube/collimator following the below procedure:

I. Remove the cover on the base of the column.

II. Remove the nut that locks the counterweiths and fill the tray till fullfill
it and reach the counterweights lock.

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III. Untight the counterweights lock: if the tray go up add more

counterweights till reach stability.

IV. Tight the nut to lock the counterweights and remove the
counterweights lock.

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V. Check the fluidiy of group arm/tube/collimator group.

VI. Repeat the sequenca till obtain the perfect balance.

VII. Remount the cover on the base.

Power up the column brakes with a 24Vdc power supply: if the unit is
coupled with table code AINXXX or LIAXXX follows the below schemes

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Collimator light
24Vac

MAIN POWER SUPPLY GND

24Vdc
Connect to M5 on the
PCB101 table board

ETS – POWER
TABLE BOARD CONNECTOR PINS
SUPPLY WIRE
3 SAME
M5
AIN 4 SAME
(all codes) PCB101 GND
Same from
(same from H1 to YELLOW/GREEN
H1 to H9
H9)
3 SAME
M5
4 SAME
UPPER
PCB101 GND
(all codes) Same from
(same from H1 to YELLOW/GREEN
H1 to H9
H9)

PCB101 – layout (placed inside the ARCOM table)

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GND

M5 Column brake

8. Connect the collimator power supply as described in the collimator service

manual: if the unit is coupled with a table code AINXXX or LIAXXX follows the
below procedure.

Collimator light
24Vac power supply

AIN Table UPPER Table

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Collimator
light fuses
FA – FB

9. Centring the X-Ray beam.

10. Tight the rail fixing screws.

11. Replace the rail covers.

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VII.5 - Tuning

Centre of mass e centring (ALL MODELS)

1. Loosen the 4 “horizontal” screws (A) and screw a bit the other 2 (B).

a. Upper view (2 screws)

ARM

b. Lower view (4 screws)

B
ARM

2. Screw and unscrew the “vertical” screw to find the centre of gravity of
the entire assembly

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ARM

3. To reach the centre of gravity, rotate the column head from + to – 90°
and check that the intermediate position will be kept.

4. Act on the 2 smaller “horizontal” screws to regulate orthogonality with

the patient panel

ARM

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5. Once orthogonality has been reached, tighten the 4 bigger “horizontal”
screws to lock the position

a. Upper view (2 screws)

ARM

b. Lower view (2 screws)

ARM

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Tube/Collimator group centring (ONLY ETS001/ETS002)

In the tube stand with static arm, during the centring phase, it is possible to
tuning further on the tube/tube support group:

1. Loosen the 4 screws (two per side) showed in the below picture.

2. Move the tube in the arrows verse.

3. Once the wished tuning is achieved, tight the screws to lock the
movement.

Centring (ONLY ETS003 and ETS004)

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In the tube stand with telescopic arm, during the centring phase, it is possible
to tuning further to change the distance of the tube/tube support group: this is
achieved varying the position of centre lock of the telescopic movement:
680±5mm

1. Remove the BLUE cover (unscrew the screws in the green circle).

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2. Remove the lateral cover (unscrew the screws in the red circle).

Upper view

Lower view

3. Unscrew the 3 screw that lock the centring reference support.MOve the
centring reference in the wished position

4. Remount the cover.

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VIII - Tube protection cover

Connect the given cover in the indicated holes with the given screws:

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IX - Adjustment of base bearings

The following procedure describes the bearings tuning of the ETS base.

1. Remove the lock at the extremities of the rail on the floor (Allen Key size
3).
2. Remove the column.
3. Adjust the internal eccentric bearings on front/back side of the base:
a. Internal bearings (red circle): move them a bit up or down.

4. For bearings adjustment a special size 19 wrench (code ETS029) is

needed. This wrench is included in the installation kit:

5. Remount the entire column.

6. Verify the result of the adjustment:

NOTE:
a. The hole of the eccentric bearing is 12,5 mm, and the bearing
pivot is of 12mm, the adjustment is very very small.remember
that this adjustment could cause some column vibration.
b. After the adjustment, check or redo the centring of the X_Ray
beam.

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X - Chest bucky distance reference block installation (code
CTC900/B)

I. Remove the lateral lock of the rail.

Insert 1 or more block and placed at the proper distance.

I. Fix the reference distance blocks, tighting the external screws.

If the the reference distance block i sto hard follows the next tunign
procedure.

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Centring lock tuning: in the front of the column tray, untight the centring
lock and shift it up and down.

Spring strength tuning of centring lock:

o Remove the centring lock

o Untight the screw in the green circle and remove the bearing

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o Remove the spring.
o Remove 1 or 2 washer to make soft the centring lock.

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XI – Electrical connections

The tube stand ETS, every model, is a medical device supplied by 24Vdc low
voltage. Refer to the following schemes for the connections:

ETS001 – ETS002

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ETS003 – ETS004

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XII – 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

After every use
the 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

Weekly
during brake activation / deactivation

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XIII – Ordinary and extraordinary maintenance

All the following activities of ordinary and extraordinary maintenance must be

performed only by technical, specialized personnel.

In following table are listed all recommended operations for periodically

ordinary maintenance:

Frequency Operations

• Check of brake efficiency and regularity of movements

Each six months
• Cleaning of guides and mechanisms

• Check visually of the ropes usury

yearly
• Check of the X-Ray beam centring

• Substitution of the ropes (independent to the ropes

usury)
Each 3 years
THE SUBTUTION PROCEDURE WILL BE PROVIDE AT
THE SPARE REQUEST.

Maintenance description (every ETS model):

- Check of brake efficiency and regularity of movements: Unlock one

movement with the proper button and check the smoothness and the
noisiness.

- Cleaning of guides and mechanisms: use a ”pull-trough” inserting it in the

guide. MAKE GREAT ATTENTION TO NOT SCRATCH THE SURFACE.

- Check visually of the ropes usury:

1. Remove the upper cover of the column unscrewing the screws showed
in the following picture.

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2. Move up and down the tube/tube support group and check the usury
of the ropes.

3. Check the ropes status on the entire ropes run. The inspection
couldn’t be to much deteriorated;

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4. At the end of the inspection, remount the cover.

For every extraordinary maintenance operation as repair, spare parts

substitution or every operation that needs technical service not
described in this manual, please contact the manufacturer service
staff.

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XIV – Spare Parts

Code Part Quantity

ETSSP01 Floor - rail (standard length 2500 mm ) 1
ETSSP02 Floor - rail module 62cm ( Only single
1
module, no aluminium profile )
ETSSP03 Counterweight brake with support 1
ETSSP04 Stand 1
ETSSP05 Counterweight chariot 1
ETSSP06 Complete chariot group (without brake and 1
brake support)
ETSSP07 Ropes 2
ETSSP08 ELM brake 1
ETSSP09 Rail slider for column without rotation 1
(ETS001 and ETS003)
Rail slider for column with rotation 1
ETSSP10
(ETS002 and ETS004)

ETSSP11 Rotation mechanism with pedal (ETS002 1

and ETS004)
ETSSP12 Rail slider bearings kit 1
ETSSP13 Complete telescopic arm ( solo ETS003 e 1
ETS004 )
ETSSP14 Complete column slider 1
ETSSP15 Column slider bearings kit 1
ETSSP16 Tube rotation pivot + ring nut 1
Housing connection + centre of gravity
ETSSP17 1
tuner
Telescopic arm bearings kit (ETS003 and
ETSSP18 1
ETS004)
ETSSP19 Collimator 1
ETSSP20 Push-button console kit 1
ETSSP21 Brake button 1
ETSSP22 Lamp for telescopic arm centring 1
ETSSP23 Power supply lamp 1
ETSSP24 Microswitch for telescopic arm centring 1

NOTE
Italicized parts and codes are not available as spare parts; in cases where these part and
codes will show defect and malfunction not fixable on site, the whole device will be retired and
completely exchanged with a new one

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XV – Labelling and identification of products

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

Every unit could be shipped dismantled in 3 pieces (rail, column and tube
support) in the same package, every component is labelled with S/N placed
on:

• Package
• Single part

This care avoids exchanging the single components with ones from other table
of the same model.

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XVI – 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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XVII – 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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XVIII - 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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XIX – 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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Via Marzabotto, 21/ 23
20871 VIMERCATE (MB)
Tel. 039/6080443
XX - Installation Report Fax 039/6082557
info@arcomonline.com
www.arcomonline.com

Product
Code:
Serial
Customer: Number:

Manufacturing Installation
Date: Date:

Technician: Installation requested by:

Measur. Registered
Test and check Test Reference C NC NA Note
instrument Values

1.0 REVIEW
1.1 Mechanical structure integrity visual - - -
1.2 Painting integrity visual - - -

Measur. Registered
Test and check Test Reference C NC NA Note
instrument Values

2.0 FIRST START

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Table power supply brakes
2.1 visual - - -
lamp turned on
2.2 Tabletop brakes powered visual - - -

Measur. Registered
Test and check Test Reference C NC NA Note
instrument Values

Mechanical
3.0
Movements
Column longitudinal
movements
3.1 Movement locked by ELM visual - - -
Movement unlocked by
3.2 visual - - -
proper command

Movement smoothness
3.3 visual - - -
Dx/Sx

X-Ray tube rotation

movement
3.4 Movement locked by ELM visual - - -
Movement unlocked by
3.5
proper command
Movement smoothness
3.6 visual - - -
-90°/+90°
Goniometer: show the
3.7
rotation angle correctly
X-ray tube vertical
movement
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3.8 Movement locked by ELM visual - - -
Movement unlocked by
3.9
proper command
Movement smoothness
3.10 visual - - -
Up/Down
Column rotation movement
(only ETS002 and ETS004)
Movement locked by
3.11 visual - - -
mechanical lock
3.12 Movement unlocked by pedal
Movement smoothness
3.13 visual - - -
-90°/+90°
X-ray tube telescopic
movement (solo ETS003 ed
ETS004)
3.14 Movement locked by ELM visual - - -
Movement unlocked by
3.15
proper command
Movement smoothness
3.16 visual - - -
-90°/+90°
All movements
3.17 Movements locked by ELM visual - - -
Movements unlocked by
3.18 visual - - -
proper command

Measur. Registered
Test and check Test Reference C NC NA Note
instrument Values

4.0 Final User Training

4.1 Train authorized final user on
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correct use of this medical
device.

C: Complying - NC: Not Complying - NA: Not applicable

NOTE:

TEST RESULT Complying Not Complying

DATE Tester Signature

Note: send to manufacturer Srl by fax at the following number +39 (0) 39 6082557

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