Iota S Iota S: Manual For Use and Maintenance

Emission date: 18-04-11 (R 2.
0)
Revision date: 13/06/2011
Manual code: MUT003 IOTA S
IOTA S
MANUAL FOR USE AND MAINTENANCE
THIS MANUAL WAS ORIGINALLY WRITTEN IN ITALIAN LANGUAGE, ITALIAN VERSION

PREVAILS IN ANY UNCERTAINTY SITUATION.
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Emission date: 18-04-11 (R 2.0)
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WARNINGS
All users of IOTA S unit 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 use of
these devices.
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 IOTA S 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.
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 will be informed on the International regulations for X-Ray
protection and respect all indication mentioned there.
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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.
It is forbidden for all non authorized personnel to access to the internal part of
the devices, especially removing protective cores and carters: only skilled and
qualified personnel can remove these carters and attempt intervention to
powered parts or other components for ordinary and non ordinary maintenance.
It’s 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 IOTA S 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.
Intellectual property rights
The content of the present manual, technical, planning and design, is an

intellectual property of GMI SRL.
Readers are required to contact directly GMI SRL 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 the medical device IOTA S ....................................................................... 6

II - Combination and related clinical application................................................................. 7
III – Technical and functional feature, dimensions encumbrances and weights ...... 8
IV – Norms and declaration of conformity .......................................................................... 17
V.1 - Declaration of responsibility ...................................................................................... 18
V.2 – Protection Classes ........................................................................................................ 18
V.3 - Protection against collision ........................................................................................ 19
V.4 - Protection against ionizing radiations .................................................................... 19
VI.1 – Command...................................................................................................................... 21
VI.1.1 – Vertical Movement.............................................................................................. 23
VI.1.2 – Longitudinal Movement..................................................................................... 23
VI.1.3 – X-Ray Telescopic Movement ........................................................................... 24
VI.1.4 – All movements ..................................................................................................... 24
VI.1.5 – Rotary movement of the X-Ray source ....................................................... 25
VI.1.6 – Column rotation. ................................................................................................. 25
VIII – Labelling and identification of products ................................................................... 28
IX - Symbols ................................................................................................................................. 29
X - References and manufacturer address .......................................................................... 30
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I - Description of the medical device IOTA S
IOTA S is an X-ray unit that is combined with other devices to compose a general
radiological system for clinical diagnosis on patient. Typical application is intended
with patient in prone or orthostatic position.
The tube stand IOTA S is intended with use exclusively in a hospital
environment, only operated by technical skilled personnel.
Description:
IOTA S is tube stand that holds the X-Ray source for radiological investigation, is
mounted on a floor-rail and has as standard supply a collimator.
This column, with a proper installation, support the X-ray source.
The unit, with its complete configuration, has 5 movements braked by
electromagnetic 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 IOTA
S unit here described will require connection with an X-ray generator, an X-ray
source, a collimator, and HT cables.
The medical device IOTA S can be combined with devices that may or may not
be manufactured by GMI itself. In case of combination with a device not
manufactured by GMI, it is mandatory to contact GMI itself to check compatibility
with IOTA S. In any case, all devices used in combination with IOTA S must
be CE marked and conform to international rules and laws for safety.
Warning
In the eventual combination of GMI SRL devices with other manufacturer devices
(main elements and accessories), please check compatibility through these
pages: where no mention of clear compatibility is declared in this manual the user
is required to check the conformity to the mentioned norms and regulations and
the eventual presence of non predictable risks due to lack of compatibility
between the devices.
It is mandatory to contact GMI SRL in this connection, as well as the
manufacturer of each device.
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III – Technical and functional feature, dimensions
encumbrances and weights
The tube stand IOTA S is proposed in 4 different configurations:
CODE DESCRIPTION
Tube stand, No stand rotation, tube rotation, horizontal rail

Conf. 1
movement, comprehend the collimator.
Tube stand, with stand rotation (+/- 90°), tube rotation,

Conf. 2
horizontal rail movement. comprehend the collimator.
Tube stand, no stand rotation, tube rotation, horizontal rail

Conf. 3 movement and telescopic movement of the x-ray source,
comprehend the collimator.
Tube stand, with stand rotation(+/- 90°), tube rotation,

Conf. 4 horizontal rail movement and telescopic movement of the x-
ray source, comprehend the collimator.
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Conf. 1
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 the collimator
All the following measures are in millimetres:
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Conf. 2

Memories every 90°
o Transversal movement NO, static distance 650mm
from the tube stand

- Stand rotation on its axis ± 180°
- Stand rotation Brake mechanical
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Conf. 3

Memories every 90°
o Transversal movement from 570 to 730mm
centre at 650mm
from the tube stand

- Stand rotation on its axis NO
- Stand rotation Brake -
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Conf. 4

Memories every 90°
o Transversal movement from 570 to 730mm
centre at 650mm
from the tube stand

- Stand rotation on its axis ± 180°
- Stand rotation Brake mechanical
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IV – Norms and declaration of conformity
IOTA S is an X-Ray device designed and manufactured in conformity with Dlg
46/97, which receipt EU Dir. 93/42/CEE, and further modification and
integrations, as those provided by Dlg. January 25th, 2010, n. 37, which receipt
EU Dir 2007/47/CE. IOTA S is also recognized as Medical Devices in Class IIb.
Product classification according to Annex IX (Classification Criteria)
The medical device Tube-stand “IOTA S”, Subject of this tech file, has been
classified as active medical device (non invasive) in class IIb, according to rule 10
of par. 3 of Annex IX of the Dlg46/97, which receipt EU Dir. 93/42/CEE, and
further modification and integrations, as those provided by Dlg. January 25th,
2010, n. 37, which receipt EU Dir 2007/47/CE.
In facts the last comma of rule 10 states what follows: “the medical devices
intended to emit ionizing radiation and indented for diagnosis, radiotherapy or
interventional radiology, including all devices that controls them, or directly affect
their performances, as included in class IIb”. It is given that the device here
considered is directly influencing the outcome of radio diagnostic examinations: in
facts, as it includes proper means of collimation and direction of the x-ray beam
and creating a direct influence on the imaging process, it falls under given
definition.
Classification rationale
The device subject of this text includes the collimator, so the final classification of
the complete devices is that of the collimator, IIb.
The product has a life cycle limited to 20 years. The shelf life depends on how the
device is used and on the level of usage an maintenance.
In conformity of what provided by EU directive 2007/47/CE, that modifies the

EU Directive 93/42/CEE, GMI 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
This unit is CE Marked in conformity to what stateri annex II of MDD 93/42, as
described in art.11 and respond to all essential requirements in annex I.
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V - Safety
The X-Ray units IOTA S 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 IOTA S units are combined and made working with devices
from other manufacturer, the compatibility of those devices must be specified in
this manual and 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 GMI s.r.l. and with the
manufacturers of all devices in the room or with qualified experts for the needed
controls of compatibility.
The X-Ray units IOTA S 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, in order to avoid
damages to the electronic components.
V.1 - Declaration of responsibility
GMI SRL 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 GMI is responsible of the safety of its products only if
Installation, service and repair operations are performed by technically skilled
personnel authorized by GMI with a suitable training course.
V.2 – Protection Classes
IOTA S units are so classified:
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- Protection type against electric contacts …………………. Class 1
- Degrees of protection against electric contacts………. Type B
Protection against electrical discharges has been achieved through earth

connection on all parts and metal covers off the unit.
The X-Ray systems 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 system for the
electrical line of power supply before starting the operation for cleaning and
disinfection.
V.3 - Protection against collision
The tube stand IOTA S 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 keep 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”.
V.4 - Protection against ionizing radiations
It is full responsibility of the installation staff to ensure that the installation site
has adequate protection for the ionizing radiation. The user has mandate to check
that this obligation is fulfilled properly.
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
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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
- Us of leaded protective shields, on patient and user, for any possible

application where this is not impeding the exam
- 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 field.
- 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.
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VI - Instruction for use
In case the medical device IOTA S, 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 IOTA S unit is designed for permanent installation, all units composing the
system has no switch on \ switch off button.
The column could be supplied by every 24Vdc power supply, usually this voltage
is provided by the control board of the table o by the high voltage generator.
VI.1 – Command
In this paragraph are descried all commands for the movements of the tube-
stand IOTA S. For the utilization of the collimator, please refer to its manual.
In the following grid are showed the movement available for each IOTA S model:
Conf. 1 Conf. 2 Conf. 3 Conf. 4
Vertical
YES YES YES YES
Movement
Longitudinal
YES YES YES YES
Movement
Telescopic
NO NO YES YES
Movement
X-Ray source
YES YES YES YES
Rotation
Column
NO YES NO YES
Rotation
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2
4
3
1 – Button to unlock vertical movement

2 – Button to unlock longitudinal movement
3 – Button to unlock telescopic movement of X-Ray source
4 – Button to unlock all movements
5 – Button to unlock X-Ray source rotation
6 – Handle
7 – Goniometer (indicator of X-Ray source inclination in degrees)
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VI.1.1 – Vertical Movement
The X-Ray source vertical movement, to choose the proper FILM/FOCUS distance
for the X-Ray exam, is activated pushing the “1” button, placed on the command
push-button panel, with the following symbol:
1. hold the handle “6”.

2. Push and keep pushed the button “1” to release the brake. The button light
will turn off.
3. Keep pushed the button “1” and move up/down the X-Ray source till
reaching the desired focal distance.
4. Release the button “1” to reactivate the brake.
The check the focal distance use the collimator ruler (OPTIONAL). To this
measure, the distance film/tabletop MUST be added (please for this measure
refer to the table/chest bucky coupled with the column).
VI.1.2 – Longitudinal Movement
The column longitudinal movement, to choose anatomical region for the X-Ray
exam, is activated pushing the “2” button, placed on the command push-button
panel, with the following symbol:
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1. Hold the handle “6”.
will turn off.
3. Keep pushed the button “2” and move the tube-stand on the rail.
VI.1.3 – X-Ray Telescopic Movement
The telescopic movement is unlocked pushing the button “3”, placed on the
command push-button panel, with the following symbol:

will turn off.
3. Keep pushed the button “3” and move in/out the X-Ray source till reaching
the desired anatomical region.
VI.1.4 – All movements
It is possible to unlock all the movements with the single button “4”, the
associated symbol is the following:
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2. Push and keep pushed the button “4” to release all the brakes. The buttons
light will turn off.
3. Keep pushed the button “4” and move the column/X-Ray source to the
wished position.
4. Release the button “4” to reactivate the brakes.
VI.1.5 – Rotary movement of the X-Ray source
The oblique projection will be performed by the rotation of the X-Ray source on
its own axis, this rotation is obtained using the button “5” on the push-button
panel. Symbol:

will turn off.
3. Keep pushed the button “5” and turn the X-Ray source to the wished
position.
4. The X-Ray source angle is displayed in the goniometer “7” placed upon the
push-button panel.
VI.1.6 – Column rotation.
This operation is necessary when the operator want to perform a latero-lateral

projection without move the patient, that remains supine on the tabletop, or
when an “out-field” exam would be performed on some external devices (e.g.
using stretchers).
The rotation is obtained pushing the pedal “8” at the base of the column:
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2. Push and keep pushed the pedal “8” to release the rotation movement.
3. Keep pushed the pedal “8” and turn the column left/right on its own axis.
4. Release the pedal “8” to lock the tube-stand in the wished position.
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VII– Cleaning Operations and ordinary maintenance
The user is required of a few cleaning and ordinary maintenance operations, and
a few visual check of some moving part. These simple operations are anyway
highly important for a safe use and a long life cycle of the devices.
All controls and maintenance operation which requires the access to the internal
parts of the devices, as well as some ordinary and extraordinary maintenance
operations are exclusive duty of authorized personnel.
In the following table we report all common cleaning operation and visual check
recommended for a correct use of the devices.
Before attempting any cleaning or disinfection operation of the structures:
o Disconnect all devices from power supply

o Take care that cleaning and disinfection products are not aggressive and
not abrading
o Avoid that all liquids used for cleaning get in touch with powered parts of
the structures
Frequency Operation
Cleaning and disinfection of all surfaces in contact with the

After every use
patient (use a clean cloth and non aggressive product)
Check the correct work of all light signals and the correct
Daily readability of all labels and indications placed on the
structures.
Check eventual unusual noises, during movement or during

Weekly
brake activation / deactivation
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VIII – Labelling and identification of products
All IOTA S units are identifiable by a label positioned as showed in the followings.
General Medical Italia s.r.l.

Via Pontesabato zona Industriale ASI
www.gmitalia.eu 83030 Prata Principato Ultra (AV) Italy
IOTA room –
Model : Read carefully the user’s
Column
manual before trying any use
S/n : XXYYYZZ
Manufactured date : month/year Read all documents of the
devices supplied with the
Classification : Class I b system before trying any use
Voltage : 24 Vdc
Current absorption : 16A 0051

Rule X Annex 9 EEC 93/42 and 2007/47/EC TYPE B
Label positioning
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IX - Symbols
The tube stand IOTA S 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.
Earth protection
WARINING! REFERENCE ON THE MANUALS

Carefully read the accompanying documents before attempting any
intervention of maintenance or any operations in the area marked
with this symbol.
Applied Part Type B
CE conformity mark
0051
Instruction
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X - References and manufacturer address
For all additional information or to receive technical assistance in case of

damages, failure or spare needs, please contact our offices as follows.
Via Pontesabato
Zona Industriale ASI
83030 Prata di Principato Ultra (AV)
Tel 0825607224
Fax 0825607316
www.gmitalia.eu
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XI – CE Mark
IOTA S is a medical device with CE mark achieve with support of a notified body
of the European Union.
0051
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Emission date: 18-04-11 (R 2.

THIS MANUAL WAS ORIGINALLY WRITTEN IN ITALIAN LANGUAGE, ITALIAN VERSION

This Page was intentionally left white

IONIZING RADIATION PROTECTION

Intellectual property rights

The content of the present manual, technical, planning and design, is an

I - Description of the medical device IOTA S ....................................................................... 6

The tube stand IOTA S is proposed in 4 different configurations:

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

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

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

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

Features and encumbrances dimensions.

- Longitudinal Movement 1850 mm

- Minimum distance X-ray beam to floor 400 mm

All the following measures are in millimetres:

Features and encumbrances dimensions.

- Longitudinal Movement 1850 mm

- Minimum distance X-ray beam to floor 400 mm

All the following measures are in millimetres:

Features and encumbrances dimensions.

- Longitudinal Movement 1850 mm

- Minimum distance X-ray beam to floor 400 mm

All the following measures are in millimetres:

Features and encumbrances dimensions.

- Longitudinal Movement 1850 mm

- Minimum distance X-ray beam to floor 400 mm

All the following measures are in millimetres:

Product classification according to Annex IX (Classification Criteria)

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

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

V.1 - Declaration of responsibility

V.2 – Protection Classes

IOTA S units are so classified:

- Degrees of protection against electric contacts………. Type B

Protection against electrical discharges has been achieved through earth

V.3 - Protection against collision

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

V.4 - Protection against ionizing radiations

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

- Us of leaded protective shields, on patient and user, for any possible

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

Conf. 1 Conf. 2 Conf. 3 Conf. 4

1 – Button to unlock vertical movement

1. hold the handle “6”.

VI.1.2 – Longitudinal Movement

VI.1.3 – X-Ray Telescopic Movement

1. Hold the handle “6”.

VI.1.4 – All movements

VI.1.5 – Rotary movement of the X-Ray source

1. Hold the handle “6”.

VI.1.6 – Column rotation.

This operation is necessary when the operator want to perform a latero-lateral

1. Hold the handle “6”.

Before attempting any cleaning or disinfection operation of the structures:

o Disconnect all devices from power supply

Cleaning and disinfection of all surfaces in contact with the

Check eventual unusual noises, during movement or during

General Medical Italia s.r.l.

Current absorption : 16A 0051

WARINING! REFERENCE ON THE MANUALS

Applied Part Type B

For all additional information or to receive technical assistance in case of