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BCL-TA

TECHNICAL MANUAL
BCL-TA TECHNICAL MANUAL

The technical manual should be read before starting using the equipment. It is
recommended to follow strictly the instructions of the present in order to avoid
any illegitimate use of the unit. the unit is supposed to be used by qualified
and authorized people only.
The installation and maintenance must be carried out by people authorized by
the manufacturer.

NOTE:
THE ORIGINAL VERSION OF THIS DOCUMENT WAS WRITTEN IN ITALIAN AND
USED TO PRODUCE TRANSLATIONS INTO OTHER LANGUAGES. THE ORIGINAL
VERSION SHALL BE REFERRED TO IN THE EVENT OF A DISPUTE.

0051

REVISION RECORD

REVISION DATE DESCRIPTION


00 14/07/2014 First issue

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WARNINGS

All users of BCL-TA 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 BCL-TA 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.

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 BCL-TA 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
BMI BIOMEDICAL INTERNATIONAL SRL.
Readers are required to contact directly BMI BIOMEDICAL INTERNATIONAL and mention all
violation to this right, may it be in form of unauthorized copy, improper diffusion or other.

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INDEX

REVISION RECORD ............................................................................................................................... 2


I - Description of the medical device BCL-TA ......................................................................... 7
II - Combination and related clinical application ................................................................... 8
III – Technical and functional feature, dimensions encumbrances, weights and
ambient environmental .................................................................................................................... 9
IV – Norms and declaration of conformity ............................................................................. 12
V - Safety ............................................................................................................................................ 13
V.1 - Declaration of responsibility ......................................................................................... 13
V.2 – Protection Classes ............................................................................................................ 13
V.3 - Protection against collision ............................................................................................ 14
V.4 - Protection against ionizing radiations ....................................................................... 14
VI - Installation ................................................................................................................................. 16
VI.1 - Preliminary check ............................................................................................................ 16
VI.2 - Environmental conditions ............................................................................................. 17
VI.3 – Installation Kit.................................................................................................................. 17
VI.4 – Installation ........................................................................................................................ 19
VI.5 - Tuning .................................................................................................................................. 36
VII – Tube protection cover ......................................................................................................... 41
VII - Adjustment of base bearings ............................................................................................ 42
IX – Chest bucky distance reference block installation (code CTC900/B) ................ 43
X – Electrical connections ............................................................................................................. 46
XI – Cleaning Operations and ordinary maintenance ........................................................ 50
XII – Ordinary and extraordinary maintenance ................................................................... 51
XIII – Label ......................................................................................................................................... 54
XIV – Disposal ................................................................................................................................... 55
XV – Symbols ..................................................................................................................................... 56
XVI - References and manufacturer address ........................................................................ 58
XVII – CE Mark .................................................................................................................................. 59
XVIII - Installation Report ............................................................................................................ 60

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I - Description of the medical device BCL-TA

BCL-TA 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 BCL-TA is intended with use exclusively in a hospital
environment, only operated by technical skilled personnel.

Description:
BCL-TA 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 BCL-
TA unit here described will require connection with an X-ray generator, an X-ray
source, a collimator, and HT cables.

The medical device BCL-TA can be combined with devices that may or may not
be manufactured by BMI BIOMEDICAL INTERNATIONAL itself. In case of
combination with a device not manufactured by BMI BIOMEDICAL
INTERNATIONAL , it is mandatory to contact BMI BIOMEDICAL INTERNATIONAL
itself to check compatibility with BCL-TA. In any case, all devices used in
combination with BCL-TA must be CE marked and conform to
international rules and laws for safety.

Warning
In the eventual combination of BMI BIOMEDICAL INTERNATIONAL 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 BMI BIOMEDICAL INTERNATIONAL in this connection,
as well as the manufacturer of each device.

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III – Technical and functional feature, dimensions


encumbrances, weights and ambient environmental

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

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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Characteristic Unit of Measurement Reference

Voltage Vdc 24 Vdc

Power Supply Frequency Hz 50/60 Hz

Power VA 90VA (24V)

Type EN 60601-1 Class I


Electrical Protection
Grade EN 60601-1 B
Protection against
Grade EN 60529 IPX0
liquid
Temperature °C -20°C + 60°C
Storage
Humidity %RH < 95% non condensing
Environmental
Pressure hPa > 630 hPa

Temperature °C da + 10 a + 40 °C

Operative Humidity %RH < 80%


Environmental Pressure hPa 700-1100 hPa

Max Altitude m < 2000 m

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IV – Norms and declaration of conformity

BCL-TA 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. BCL-TA is also recognized as Medical Devices in Class IIb.

Product classification according to Annex IX (Classification Criteria)

The medical device Tube-stand “BCL-TA”, Subject of this manual, 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 a maintenance.

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


EU Directive 93/42/CEE, BMI BIOMEDICAL INTERNATIONAL 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 column BCL-TA is CE Marked in conformity to what stated in 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 on request.

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V - Safety

The X-Ray units BCL-TA 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 BCL-TA 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 BMI BIOMEDICAL


INTERNATIONAL 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 BCL-TA 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

BMI BIOMEDICAL INTERNATIONAL 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 BMI BIOMEDICAL INTERNATIONAL is responsible of the


safety of its products only if Installation, service and repair operations are
performed by technically skilled personnel authorized by BMI BIOMEDICAL
INTERNATIONAL with a suitable training course.

V.2 – Protection Classes

BCL-TA units are so classified:

- Protection type against electric contacts …………………. Class 1

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- 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 BCL-TA 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 a full responsibility of the company or person that handle the installation to


verify that the rooms intended for the installation are adequately shielded against
ionizing radiation. The final user is mandatory committed to control the shielding
before attempting any use of the device.

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 - 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.

VI.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:

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- Conformity and certification in line of international and local laws for room
designed to host an X-Ray source
- 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 BMI
BIOMEDICAL INTERNATIONAL 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.

VI.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

VI.3 – Installation Kit

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

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

2) N° 4 - Screws M6x30

3) N° 4 – Screws M6x35

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4) N° 10 - Spacer for rail 1,5 mm

5) N° 3 - Spacer for collimator 1,5 mm

6) N° 1 – Special key for base eccentric bearings 1,5 mm

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.

VI.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 supplied
spacer (Cod. ATS104).

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.

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

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


attention to the following distances:

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3. If the unit will be coupled with tables, follows the below schematics:

Models horizontal table Models horizontal elevating table

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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:

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

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

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

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

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

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

o Insert, if necessary, the given spacers (ATS173) to achieve the needed


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:

o Remove the back cover of collimator and close completely the shutters
acting on the frontal knob.

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

3
1

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

o Remount the back cover.

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


o Remove the cover on the base of the column.

o Remove the nut that locks the counterweights and fill the tray till fulfil it
and reach the counterweights lock.

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o Untight the counterweights lock: if the tray go up add more


counterweights till reach stability.

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

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o Check the fluidity of group arm/tube/collimator group.

o Repeat the sequence till obtain the perfect balance.

o Remount the cover on the base.

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

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Collimator light
24Vac

MAIN POWER SUPPLY GND


24Vdc
Connect to M5 on the
PCB101 table board

BCL-TA –
TABLE BOARD CONNECTOR PINS POWER
SUPPLY WIRE
3 SAME
M5
4 SAME
horizontal
Same
table PCB101 TERRA
from
(same from YELLOW/GREEN
H1 to
H1 to H9)
H9
3 SAME
M5
4 SAME
horizontal
Same
elevating PCB101 TERRA
from
table (same from YELLOW/GREEN
H1 to
H1 to H9)
H9

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PCB101 – layout (placed inside table)

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 follows the below procedure.

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Collimator light
24Vac power supply

horizontal table horizontal elevating


table

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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VI.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

5. Once orthogonality has been reached, tighten the 4 bigger “horizontal”


screws to lock the position

a. Upper view (2 screws)

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b.

ARM

c. Lower view (2 screws)

ARM

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Tube/Collimator group centring

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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VII – Tube protection cover

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

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VII - Adjustment of base bearings

The following procedure describes the bearings tuning of the BCL-TA 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 BCL-TA 029) 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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IX – 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.

II. Fix the reference distance blocks, tightening the external screws.

If the reference distance block too hard follows the next tuning procedure.

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

Spring strength tuning of centring lock:

o Remove the centring lock


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

o Remove the spring.


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

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X – Electrical connections

The tube stand BCL-TA, is a medical device supplied by 24Vdc low voltage. Refer
to the following schemes for the connections:

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XI – 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 device.

WARNING!

• Disconnect all devices from power supply


• Take care that cleaning and disinfection products are not aggressive and
not abrading
• 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 and report eventual unusual noises, during


Weekly
movement or during brake activation / deactivation

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XII – 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:

- 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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XIII – Label

The Medical Device is identifiable by a label positioned as showed in the


followings.

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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XIV – 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 indicate 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 user that want to get rid of 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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XV – Symbols

The EM 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.

Symbols for manufacturer

Symbols to identify production date (month/year)

Product code reference

Serial number

Type B applied part

Instruction on manual.

CE mark with notified body code.


0051

Earth protection

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Storage in dry location

RAEE Disposal

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XVI - References and manufacturer address

BMI BIOMEDICAL INTERNATIONAL s.r.l.


Via Enrico Fermi 52 Q/R
24035 Curno (Bergamo) Italy
Telephone: +39 035 4376381
Telefax: +39 035 4376401
Web site: www.bmibiomedical.it
E-Mail: info@bmibiomedical.it

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XVII – CE Mark

The unit object of this manual, is a medical device with CE mark achieve with
support of a notified body of the European Union.

0051

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XVIII - Installation Report

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


2.1 Table power supply brakes visual - - -
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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
3.8 Movement locked by ELM visual - - -
3.9 Movement unlocked by

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proper command
Movement smoothness
3.10 visual - - -
Up/Down
Column rotation movement

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
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


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

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

TEST RESULT Complying Not Complying

DATE Tester Signature

Note: send to BMI BIOMEDICAL INTERNATIONAL Srl

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