Calypso AFS - Technical Manual [PDF]

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CALYPSO AFS Technical Manual

CONTACT INFORMATION Distributor: GENERAL MEDICAL MERATE S.p.A. Via Partigiani, 25 - 24068 - Seriate (BG) - ITALY Tel. (0039) 035 4525311 - Fax (0039) 035 297787 http: www.gmmspa.com e-mail: [email protected] Manufacturer: M.T. MEDICAL TECHNOLOGY S.r.l. Via Machiavelli, 22 24068 Seriate (BG) – ITALY tel. +039 249 4841 email. [email protected] fax. +039 249 9003 web. www.emmetisrl.com

TS7630-ST Floor Stand for X-Ray Tube Support

Technical Manual TM76301-EN Rev.0 2018JUL

TECHNICAL MANUAL

EQUIPMENT IDENTIFICATION Description

EQUIP.ID*

1

Floorstand Unit

TS7630-ST, Calypso-F/M, Calypso/AFS

2

Table with Elevating Top

ET8530, ET8532, MTOE/M

3

Wall Stand Unit

TRN430, TRN43D, TRN43X, TRT430, TRT43D, TRT43X

*See section “2” for additional information regarding equipment specifications.

MANUAL REVISIONS HISTORY Code:

Rev.

Date:

Remarks:

TM76301-EN

0

2018JUL

First edition for series TS7630-ST

The original version of this publication was prepared in the Italian language and to that you will make any reference to any dispute of interpretation.

CONTACT INFORMATION

Address inquires regarding this document or to the object(s) subject of this document to: The Original Equipment Manufacturer:

M.T. Medical Technology S.r.l. Via Friuli 6/2 20853 Biassono (MB) – Italy tel. +039 249 4841 email. [email protected] fax. +039 249 9003 web. www.emmetisrl.com This publication or its parts cannot be copied, saved on a memorization support, transmitted or translated into any languages (common or data processing), in any form or through any kinds of means (electrical, mechanical, magnetic, optical manual or other) without a clear written authorization by M.T. M.T. does not extend warranties concerning reproductions of this documentation, either partially or in its entirety, unless specifically authorized by M.T. As well M.T. does not extend warranties concerning additions and/or modifications to the original documentation made by and held by M.T. Copyright © M.T. Medical Technology S.r.l. - All Rights Reserved

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TECHNICAL MANUAL

WARNING

The instructions contained in this manual are based upon configuration of the system at the time of construction. The manufacturer will provide and inform the client operator when to make changes and/or updates as they are made available after that date.

FOR THE USER OF THIS MANUAL

The installer/operator must before using this equipment read carefully and in its entirety this manual to assure that it perfectly meets their requirements. Even if the user has practical experience with similar systems as described in this manual there may have been changes in its design, in the production or in the procedures of its application that may affect its proper use. The installation and the maintenance of the installation described in this document must be performed by qualified personnel and authorized by the manufacturer.

DIAGNOSTIC X-RAY SYSTEMS RADIATION WARNING

X-ray and gamma-rays are dangerous to both operator and others in the vicinity unless established safe exposure procedures are strictly observed. The useful and scattered beams can produce serious or fatal bodily injuries to any person in the surrounding area if used by an unskilled operator. Adequate precautions must always be taken to avoid exposure to the useful beam, as well as to scattered radiation resulting from the passage of radiation through matter. Those authorized to operate, participate in, or supervise the operation of the equipment must be thoroughly familiar and comply completely with the current established safe exposures factors and procedures described in publications, such as: subchapter J of title 21 of the code of federal regulations, “Diagnostic X-ray Systems and their Major Components”, and “IEC 60601 General and Collateral Standards” as revised or replaced in the future. Those responsible for the planning of X-ray and gamma-ray equipment installations must be thoroughly familiar and comply completely with: NCRP no. 49 “Structural Shielding Design and Evaluation for Medical X-rays and Gamma-rays of Energies up to 10 MeV” and IEC-407 “Radiation Protection in Medical X-ray Equipments 10kV - 400kV” as revised or replaced in the future. INSTALLATION, ENVIRONMENT & THE USE OF RADIOLOGIC EQUIPMENT

Except for installations requiring certification by the manufacturer per federal standards, see that a radiation protection survey is made by a qualified expert in accordance with NCRP 102, section 7 or IEC related general and collateral standard as revised or replaced in the future. Perform a survey after every change in equipment, workload, or operating conditions which might significantly increase the probability of persons receiving more than the maximum permissible dose equivalent.

MECHANICAL - ELECTRICAL WARNING

All of the movable assemblies and parts of this equipment should be operated with care and routinely inspected in accordance with the manufacturer’s recommendations contained in the equipment manuals. Only properly trained and qualified personnel should be permitted access to any internal parts. Live electrical terminals are deadly; be sure line disconnect switches are opened and other appropriate precautions are taken before opening access doors, removing enclosures panels, or attaching accessories. Do not remove flexible high voltage cables from X-ray tube housing or high tension generator and/or access covers from generator until the main and auxiliary power supplies have been disconnected.

Failure to comply with the foregoing may result in serious or fatal body injuries to the operator or those in the area.

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TABLE OF CONTENTS

1

GENERAL INFORMATION.................................................................................................. 7

2

SYSTEM DESCRIPTION & TECHNICAL DATA ..................................................................... 9

2.1

The Floor Stand Unit ................................................................................................... 10

2.1.1

Hardware Description............................................................................................ 10

2.1.2

Floor Stand Specifications ..................................................................................... 11

2.2

Table with Elevating Top............................................................................................. 12

2.2.1

Table Unit Hardware Description .......................................................................... 12

2.2.2

Table Unit Specifications ....................................................................................... 13

2.3

Wall Stand Unit ........................................................................................................... 14

2.3.1

Wall Stand Unit Hardware Description ................................................................. 14

2.3.2

Wall Stand Unit Specifications............................................................................... 15

2.4

Transport / Stocking / Operating Ambient Conditions .............................................. 16

2.5

Other Technical Specifications ................................................................................... 16

2.6

Technical Designs ........................................................................................................ 16

2.7

Identification & Attention Labeling ............................................................................ 17

3

SAFETY & PRECAUTIONS ................................................................................................ 21

3.1

General Warnings ....................................................................................................... 21

3.2

Residual Risks & Accident Hazards ............................................................................. 22

3.3

Electrical Safety........................................................................................................... 22

3.4

Protection Against Radiation Hazards ........................................................................ 22

4

SYSTEM INSTALLATION .................................................................................................. 23

4.1

Pre-Planning & Process Flow ...................................................................................... 23

4.2

Room Preparation....................................................................................................... 26

4.2.1

The Room Construction......................................................................................... 26

4.2.2

Tools Required ....................................................................................................... 26

4.2.3

The Receiving Area ................................................................................................ 26

4.2.4

Equipment Storage and Transport Conditions ...................................................... 26

4.2.5

Equipment Receiving / Inventory .......................................................................... 28

4.2.6

Equipment Unpacking ........................................................................................... 32

4.3

Fixing the Equipment in the Room ............................................................................. 33

4.3.1

Examples of Equipment Technical Drawings......................................................... 33

4.3.2

A Typical Room Design .......................................................................................... 39

4.3.3

Electrical Cables Routing ....................................................................................... 40

4.3.4

Important Notes About Installing the Equipment................................................. 41

4.4

Fixing the Tube Support Stand Floor Rails into Place ................................................. 45

4.4.1

Floor Rails + Table Installation Hardware Kits ....................................................... 46

4.4.2

Fixing of the Table (ET8530_ET8532 series) ......................................................... 48

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4.5 4.5.1

TABLE OF CONTENTS

Mounting the Wallstand ............................................................................................. 50 Fixing to Wall and Floor ......................................................................................... 50

4.5.1.1

TRA031 – TELE AL-FLOOR FIXING PLATE ........................................................... 51

4.5.1.2

TRA032 – TELE AL-FLOOR/WALL FIXING KIT ..................................................... 51

4.5.2 5 5.1

Mounting of the Base Support Plate (option) ....................................................... 54 TUBE SUPPORT STAND MECHANICAL ASSEMBLY .......................................................... 57 Mounting of the Floor Stand Unit .............................................................................. 57

5.1.1

Mounting of the Stand Base .................................................................................. 57

5.1.2

Stand mounting ..................................................................................................... 57

5.1.3

Inserting the stand in the rail on floor .................................................................. 58

5.2

Stand Mechanical Assembly ....................................................................................... 60

5.3

The X-Ray tube mounting ........................................................................................... 60

5.3.1

Mounting of the C100 headcuff. ........................................................................... 62

5.3.2

TSA006 – 92x21 M6 Tubestand X-Ray Tube Spacers for IAE C52 ......................... 64

5.3.3

TSA008 – 92x21 M6 X-Ray Tube Support for C52 Super....................................... 66

5.3.4

101753 – 92x21 M6 X-Ray Tube Support without Trunnion ................................ 68

5.3.5

CSA081 – Rotating Collimator R302 Kit For Mounting Plastic Control Board....... 70

5.4

The Collimator Mounting............................................................................................ 71

5.5

Electrical Parts Assembly ............................................................................................ 71

5.5.1

The Control Board Mounting................................................................................. 71

5.5.2

The H.T. Cables Mounting ..................................................................................... 71

5.5.3

Main Controller Cable and External Controller Rack ............................................ 72

5.6

Tube Stand Balancing.................................................................................................. 73

5.6.1

Balancing of the Radiogenic Unit Rotation Movement on the Horizontal Axis .... 73

5.6.2

Vertical Movement Balancing ............................................................................... 73

5.6.3

Unlocking of the Vertical Carriage......................................................................... 75

6

TABLE UNIT MECHANICAL ASSEMBLY ............................................................................ 77

6.1

Unlocking the Bucky Table.......................................................................................... 77

6.2

Mounting a Receptor in the Mobile Carriage (Transversal Frame Extraction) .......... 77

6.3

Regulation of the Guide Bearing and Roller Bearing for the Patient Table Top ........ 79

6.4

Patient Table Top Mounting ....................................................................................... 79

6.4.1

Table Top Installation ............................................................................................ 79

6.4.2

Installation of the Table Top in Confined Areas .................................................... 80

6.5

AEC Unit Installation for Flat Panel Receptors ........................................................... 81

6.6

Electrical Device Connections of the Table Unit ........................................................ 82

6.6.1

Standard Bucky Units............................................................................................. 82

6.6.2

Docking Stations .................................................................................................... 82

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TABLE OF CONTENTS

6.6.3

Fixed Flat Panel for Digital Radiography Systems ................................................. 82

6.6.4

Interconnection Cable(s) to an External Controller Rack ...................................... 84

7

WALL STAND UNIT MECHANICAL ASSEMBLY................................................................. 85

7.1

Mounting of the Receptor in the Mobile Carriage ..................................................... 85

7.2

Locking / Unlocking of the Vertical Carriage .............................................................. 87

7.3

AEC Unit Installation for Flat Panel Receptors ........................................................... 89

7.4

Electrical Device Connections of the Wall Stand Unit ................................................ 90

7.4.1

Standard Bucky Units............................................................................................. 90

7.4.2

Docking Stations .................................................................................................... 90

7.4.3

Fixed Flat Panel for Digital Imaging Systems ......................................................... 90

7.4.4

Interconnection Cable(s) to an External Controller Rack ...................................... 92

8 8.1

MECHANICAL ADJUSTMENTS ......................................................................................... 93 Centering the Primary Beam to the Receptor ............................................................ 93

8.1.1

Light Field to X-Ray Field Alignment ...................................................................... 93

8.1.2

Light Field to Receptor Alignment ......................................................................... 93

8.2

Regulating the Horizontal Support Arm around the Vertical Axis.............................. 94

8.3

Regulating the X-ray Tube Inclination Angle .............................................................. 95

8.3.1

Standard Support Arm Applications ...................................................................... 95

8.3.2

Motorized Support Arm Applications.................................................................... 95

8.4

Regulating the Column Inclination on the Vertical Axis ............................................. 96

8.5

Regulating the Horizontal Support Arm on the Horizontal Axis ................................. 96

9

EQUIPMENT DECOMMISSIONING .................................................................................. 97

9.1

Expected Life Span Of The Equipment ....................................................................... 97

9.2

Disposal Of Materials .................................................................................................. 97

10

MAINTENANCE ............................................................................................................... 99

10.1

General Controls ......................................................................................................... 99

10.2

Frequency To Make The Controls ............................................................................. 100

10.3

Control of the Suspensions Wire Ropes ................................................................... 102

10.4

Cleaning And Disinfection ......................................................................................... 103

10.4.1

Cleaning ............................................................................................................... 103

10.4.2

Disinfecting .......................................................................................................... 103

Equipment Maintenance Register ............................................................................................ 105 Glossary ..................................................................................................................................... 107

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TECHNICAL MANUAL

1 GENERAL INFORMATION All the documentation accompanying the equipment, and especially this manual, must be preserved and made available to operators and technical support. This documentation is to be considered as an integral part of the equipment. The equipment specified here is designed for use in the radiological field in accordance with its intended use. Any other use is considered unexpected use.

•

Scope of this Manual

The purpose of this manual is to fully inform the operator, installer and responsible party’s of the installation characteristics, requirements, and precautions to be taken during the setup, use and required maintenance to which it must be subjected to ensure its efficiency and reliability.

•

Document Rights

This manual, including drawings, tables and photographs it contains, is the exclusive property of the manufacturer. It may not be disclosed, copied or reproduced in part or by any means without the written authorization. M.T. reserves the right to edit / revise this documentation without prior notice.

•

Documents Enclosed w ith the Equipment

The documentation supplied with the equipment and especially this manual must be carefully kept and made available to the beneficiaries. This documentation is an integral part of the device and is delivered along with it.

•

Guarantee

The equipment, subject of this manual, comes with a limited warranty. The duration and obligations of the warranty are subject to a contractual agreement made between the seller of the equipment and the buyer and it is to be confirmed in writing. The validity of the guarantee is subject to the scrupulous respect of the information contained herein. ATTENTION! Guarantee is voided immediately if works on the equipment is made by unauthorized personnel.

•

Manuf acturer Responsibility

The manufacturer declines any liability for material damage or personal injury resulting from use other than that intended, and these consequences are the sole responsibility of the user. The scrupulous observance of the mode of operation, maintenance and repair as specified by the manufacturer is also considered an essential part of the intended use of the equipment. Modifications not authorized by the manufacturer will void its liability for damages and accidents that could result.

•

European Community standards and saf ety compliance (CE)

The unit is manufactured in compliance with the requirements of European Directive 2007-47-CE for Class 1 devices (Annex VII). The unit was manufactured and tested respecting EN60601 safety rule for electro-medical units. The declaration of conformity of the unit is supplied with the accompanying documentation. A copy of this document can be obtained from the manufacturer.

•

Manual Conventions: Symbols, Orientation & Measuring Units

The following symbols are used throughout this manual to advise the operator to take note of additional information, warnings and / or risks associated with the use of equipment: The reference numbers in this document refer to the figures in it and their meanings are: [ Fig.1-2 = figure 2 of chapter 1 ] / [ 1 / Fig.1-2 = point-out 1 of the figure 2 of chapter 1 ] The physical orientation of LEFT and RIGHT are determined by the operator standing in front of the control board station, or work station, of the equipment when in it is in its default working position. The measures in this manual are expressed exclusively in the Decimal Metric System (International), including multiples and submultiples (the temperature is expressed in degrees Celsius (° C)).

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TECHNICAL MANUAL

General INFO

WARNING / ATTENTION / CAUTION The topics identified with this icon cover aspects of the safety of the patient and / or operator. IMPORTANT INFORMATION

Caution should be observed in the reading of the topics identified by this symbol. •

Warning Symbols on the Equipment

The following symbols may be found on the equipment to advise the operator to take note of information, warnings and / or risks associated with the use of equipment. Warning Symbols Symbol

Description

Symbol

Description

Follow instruction for use / Refer to instruction manuals for its use

Pushbutton for the emergency shut off

General mandatory action sign

Emergency stop

Warning symbol that indicates potential generic danger for the equipment or the operator. Check the equipment documentation for other details.

Warning symbol that indicates electrical components which are sensitive to electrostatic discharge.

Warning symbol that indicates live electrical parts with a possible risk of electric shock.

Warning symbol that indicates that fingers may be crushed.

Hazard symbol that indicates X-ray radiation exposure.

Indicates that a laser is present and presents a low risk to eyes.

General prohibit sign

Sitting prohibited

Pushing prohibited

Stepping prohibited

Symbol of earth protection

Symbol of filtration

Ground

Where presented, indicates the risk of electromagnetic interference

Symbol of applied part B type.

Symbol that indicates electrical and electronic components which must be collected separately.

Maximum allowable weight

This side must face towards the X-ray Tube (grid insertion)

The equipment manufacturer.

Fluoroscopy and radiography foot pedal

The date of equipment manufacturing.

Injector

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TECHNICAL MANUAL

2 SYSTEM DESCRIPTION & TECHNICAL DATA

The equipment may be supplied with different options in relation to what is depicted here. This can include differences in physical appearance, optional hardware and even operating characteristics. Read further about the functions, components, and other optional devices, that may not be indicated here, in the accompanying OPERATOR MANUAL.

Fig. 2-1 Example: OEM System Configuration (Complete)

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TECHNICAL MANUAL

2.1

Technical Data

The Floor Stand Unit

2.1.1 Hardware Description The compatible Floor Mounted Tube Support Stand Unit, in its standard configuration, is comprised of the following items:

4 7 8

5

9

3

1

2

6

Fig. 2-2 Equipment schematic – Tube Stand Pos.

Description

Quantity

1

Floor Rail

1

2

Column Support Carriage

1

3

Column

1

4

Tube Arm Support Assembly

1

5

Pushbutton “Tubestand” (in various compositions)

1

6

External Controller Rack

1***

7

X-Ray Tube

*

8

X-Ray Tube Cover (in various compositions)

**

9

Collimator

**

* Not supplied ** Supplied upon request *** Motorized units only

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TECHNICAL MANUAL

Technical Data

2.1.2 Floor Stand Specifications • Floor Rails

Length

254 cm

Type of movement

fixed to floor

• Column / Carriage

Travel of Carriage on the longitudinal rails

200 cm

Column length

218 cm (249 cm total length)

Focus to floor minimum distance

49 cm

Vertical travel

140 cm

Kind of braking

permanent electromagnetic

Kind of moving

manual / motorized (optional)

Velocity of motorized movements

75 mm/sec avg.

Kind of balancing

by counterweights

Angle of column rotation around the vertical axis

± 90°

Column rotation unlocking device

By foot pedal

• H o r i z o n t a l S u p p o r t Ar m

Inclination angle around horizontal axis

+120° / -200° or +210° / -110°

Type of braking

permanent electromagnetic

Kind of moving

manual / motorized (optional)

Velocity of motorized movements

75 mm/sec avg.

Transversal movement

fixed

• Co n tr o l B o ar d Station System display (ANG / SID)

LCD options: 16x1 character / LCD-5.7” / LCD-8.0”

Hand devices for movements

Integrated handle bar

Tubestand brakes control

by push buttons

Motor controls

by push buttons

Table top up/down remote control

by push buttons

• Netwo r k / COM co m p atib ility

(on ly with comp atib le con troller rack)

Communication protocol

Controller Area Network (CAN)

Format in use

2.0 A (11 bit ID)

Bus speed

500 Kbit/sec

Galvanic Isolation

no

• Powering

(with external rack unit)

Tension / frequency

230 VAC 50/60 Hz (single phase)

Maximum absorbed power

310 VA

• Colors of Painted Parts

Parts in metal

RAL 9016

Adhesive membrane

grey

• Weight

Stand, floor rails

∼200 Kg

* Specifications based on Tube Stand OEM series TS7630-ST

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TECHNICAL MANUAL

2.2

Technical Data

Table with Elevating Top

These devices, or OEM compatible units with similar specifications, are designed and prepared to be connected with the Floor Stand unit for best operating performance. This Floorstand Unit can be connected to equipment other than described here. In that case, refer directly to the documentation that is supplied with the other devices for their setup, care and use.

2.2.1 Table Unit Hardware Description The complimentary table unit model, is comprised of the following items:

5

4 2

3

6

1

Fig. 2-3 Equipment schematic – Table

Pos.

Description

Quantity

1

Table support base

1

2

Mobile receptor support carriage (motorized long. movement**)

1

3

Receptor

4

Table top mobile support frame, for transversal movement

1

5

Table top (in various compositions)

1

6

Foot controller panel

1

***

* Not supplied ** Supplied upon request *** A standard bucky is available as option; The receptor support carriage is built to the clients specifications

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TECHNICAL MANUAL

Technical Data

2.2.2 Table Unit Specifications • Operator Controls

UP/DOWN table movements

by foot pedal

Braking controls

by foot pedal

• Table Top

Attenuation according to I.E.C. 60 601-2-35

0,9 mm Al eq.

Longitudinal travel of table top

81 cm (40,5 cm each side)

Transversal travel of table top

26 cm (13 cm each side)

Type of table top braking

electromagnetic

Patient maximum weight

150 kg (laminated plastic material) / 250kg (fiber carbon, in option)

Table top to film distance

7 cm

Table top maximum distance to floor

86,8 cm (DR) / 85,3 cm (standard bucky)

Table top minimum distance to floor

54,8 cm (DR) / 53,3 cm (standard bucky)

Velocity of motorized vertical movements

70 mm/s avg.

• Bucky Carriage

(only with compatible controller rack)

Longitudinal travel

57 cm for bucky, 61 cm for detector

Type of movement

Manual / Motorized (with auto tracking)

Braking control

push button

Type of braking

electromagnetic

Velocity of motorized longitudinal movements

70 mm/s avg.

Type of receptor supported

various

• Network / COM compatibility

Communication protocols

none

• Powering

Electrical power

230VAC/ 50/60 Hz, single phase

Maximum absorbed power

595 VA

• Colours

Painted parts

RAL 9016

Overlays

grey

• Weight

Elevating bucky table (no receptor)

∼290 kg

* Specifications based on Table OEM series ET853x (ver. ET8530-x)

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TECHNICAL MANUAL

2.3

Technical Data

Wall Stand Unit

2.3.1 Wall Stand Unit Hardware Description The compatible Wall Stand Unit, in its standard configuration is comprised of the following items:

1

3 6

4

7

2

5

Fig. 2-4 Equipment schematic – Wall Stand Pos.

Description

Quantity

1

Vertical Column

1

2

Vertical Sliding Carriage, with support arm of Receptor unit

1

3

Control Panel (optional, with embedded system controls)

**

4

Vertical Brake Handle (optional)

**

5

Receptor Support Frame (in various configurations)

1

6

Handle Bar Support

**

7

Receptor

* / ***

* Not supplied ** Supplied upon request *** Only a standard bucky is available as option; The receptor support carriage is built to the clients specifications

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TECHNICAL MANUAL

Technical Data

2.3.2 Wall Stand Unit Specifications • Wall Column

Length of vertical column

218 cm

Total height

230 cm manual type / 239 cm, if motorized

Type of movement

fixed to wall

• R e c e p t o r S u p p o r t Ar m

Vertical travel

157 cm

Type of braking

permanent electromagnetic

Type of moving

manual / motorized (optional)

Velocity of motorized movements

75 mm/sec avg.

Type of balancing

by counterweights

Receptor support

fixed vertical upright position

Focalized Point to floor maximum distance

193 cm

Focalized Point to floor minimum distance

36 cm

Type of receptor supported

various

• Control Panel

System display

none (LED status only)

Hand devices for movements

gripped handle

Braking controls

by push buttons

Motoring controls

by push buttons

• Network / COM compatibility

(only with compatible controller rack)

Communication protocols

Controller Area Network (CAN; with special options)

Format in use

2.0 A (11 bit ID)

Bus speed

500 Kbit/sec

Galvanic Isolation

No

• Powering

(with external rack unit)

Tension / frequency

230 VAC 50/60 Hz, single phase

Maximum absorbed power

185 VA

• Colour

Metal parts

RAL9016

Overlays

Grey

• Weight

Wall Stand (no receptor)

∼165 kg

* Specifications based on Wall Stand OEM series TRxyyz (ver. TRN43X) ** Available also with tilting receptor support. Contact equipment dealer for specifications.

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TECHNICAL MANUAL

2.4

Technical Data

Transport / Stocking / Operating Ambient Conditions

• Am b i e n t T r a n s p o r t & S t o c k i n g C o n d i t i o n s

Average temperature

0 °C ÷ 50 °C

Average relative humidity

10% ÷ 90%

Average atmospheric pressure

50 kPa ÷ 110 kPa

• Am b i e n t O p e r a t i n g C o n d i t i o n s

Average temperature

10 °C ÷ 40 °C

Average relative humidity

30% ÷ 75%

Average atmospheric pressure

70 kPa ÷ 110 kPa

For the conditions of packaging, transportation and storage it is recommended to also refer to the operator instructions that comes with the unit(s).

2.5

Other Technical Specifications

Additional information about technical specifications and operating characteristics can be found in the OPERATOR MANUAL that also is supplied with this equipment. This information includes: •

Destination of use

•

Protection classification

•

Compliance to standards and directives

•

Electromagnetic compatibility

•

Compatibility with other components and devices

•

Accessories and available options

The operator must also refer to the instruction manuals of the individual components.

2.6

Technical Designs

Technical drawing examples of the mechanical configurations, for aid in installation and servicing, are presented within this manual. Check for file addendums supplied with the documents, or other file attachments that may be attached directly to the unit at time of packing and shipping, which may indicate system updates, modifications, or special ordered options that are not discussed in this instruction set. Send a request to the dealer/manufacturer know about obtaining copies of the related technical drawings or to know about any system updates not discussed within this manual.

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TECHNICAL MANUAL

2.7

Technical Data

Identification & Attention Labeling

The units are identified with a series of adhesive labels positioned on the them. These labels are applied to identify the product both from the commercial point of view both to fulfil the requirements of the standards currently in force. On the rating plate shows the device name, the address of the company and the place of production. It also lists the following information: •

Model

•

Serial number and lot number

•

Date of production (month and year)

•

The nominal tension, number of phases, current absorption, and line frequency

•

Label for registering cable substitution (if applicable)

•

Labels of warning and dangers

•

Serial number (not externally visible)

Make reference to the figures on the following pages for identification of the units.

Do not remove the manufacturer labels applied to the equipment, they are an integral part of the instructions and documentation that accompany it.

The equipment identification label may be different from what is illustrated here, if the equipment has been supplied by an authorized equipment dealer and the unit has been connected to their own proprietary equipment in order to produce a fully integrated system for the end-user. Additional documentation, provided by the dealer of the equipment, may also be presented to indicate the model, serial number, equipment options and other customizations offered by them.

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TECHNICAL MANUAL

Technical Data

Fig. 2-5 Identification and labels for Tube Support

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TECHNICAL MANUAL

Technical Data

Fig. 2-6 Identification and labels for Table

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TECHNICAL MANUAL

Technical Data

Fig. 2-7 Identification and labels for Wall Stand

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TECHNICAL MANUAL

3 SAFETY & PRECAUTIONS The installer must read and follow the instructions found in the Operator’s Manual that comes with this unit(s) and those instructions that come with any accessories for detailed information about safety precautions and warnings.

3.1

General Warnings WARNING! There shall be no modification of this device! Changes to the product are not allowed unless specifically indicated for and authorized by the manufacturer. Unauthorized changes can compromise the equipment functioning and safety, as well as voiding the manufacturer’s guarantee. Any modification to the equipment with the purpose to increase its travels, performances and/or load capacity are strictly prohibited. In particular, it is not possible to disable or replace devices and/or circuits which permit uncontrolled radiation emissions, in accordance to safety laws. After the installation of the unit, the end user must assess the need for audio and video communication tools between the operator and the patient.

In addition to the warning and instructions located in the documents that come with the devices, the installer/operator is reminded to follow this advice: •

Read the instructions and take heed of the warnings in the documents!

•

Refer to the drawings and to the technical features, written in this manual, to be aware of the performances and the maximum loads that can be supported.

•

The X-ray equipment is to be installed and used in the radiological diagnosis by qualified personnel, who know exactly what the inherent risks are for systems that use ionizing radiation and are able to take the necessary protective measures.

•

The regulations and laws in force in the various countries for the type of equipment are to be considered and observed both by the installer and by the operator.

•

The X-ray equipment can be installed and operated only in areas designated for medical use (refer to local regulations).

•

The equipment covered by this manual is not intended for use in areas at risk of explosion.

•

The powers and responsibilities of the individuals with respect to installation, commissioning, operation and maintenance of the equipment, must be clearly defined and strictly adhered to.

•

All operations to do on the unit must be carried out when it does not work. The person who is responsible of the maintenance must completely disconnect the unit, before the adjustment or replacement of an equipment part.

•

Keep hands, feet, dresses, jewels and hair at safety distance from any moving part in order to avoid their getting caught.

•

Keep all parts in good condition and correctly installed. Repair immediately damages, replacing the consumed and broken parts with genuine or OEM compatible parts.

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3.2

Safety Precautions

Residual Risks & Accident Hazards In the event that the compatibility between the Floor Mounted Tubestand, together with its accessories, is not explicitly stated in the documentation, the user of the equipment must ensure that no dangerous situations can occur for the patient and for auxiliary staff.

The FLOOR MOUNTED TUBESTAND has been designed to conform to the most recent safety principles. However, during its use, especially if improper, may result in residual risks. More information about this will be found in the Operator Manual that comes with this equipment.

3.3

Electrical Safety WARNING! This installation requires working with high tensions. WARNING! To avoid the risk of electric shock, this unit must be connected to a supply mains with protective earth. This equipments destination of use is specified for a permanent-type installation. It cannot be connected to a power strip or extension cord. Connect only the specified items as part of the FLOOR MOUNTED TUBESTAND or compatible with it. More information about electrical safety and installation warnings can be found in the Electrical Technical Instructions manual that comes with this unit.

Protection relating to electric shocks complies with current whose compliance was validated by a notified body. It is therefore extremely important that periodically the ground wires of the system are tested in order to maintain the standards of safety.

3.4

Protection Against Radiation Hazards KEEP A SAFE DISTANCE AWAY FROM THE X-RAY SOURCE! The protection regulations to be observed also apply to service personnel. The activities in controlled areas, involves an obligation to always wear a personal dosimeter.

It is the responsibility of the installer to foresee at the time of installation the screening that must protect the personnel from radiation and consent at the same time the steadfast verification of the state of the patient. To protect the patients, the operators and whomever else is at risk from the radiation, anti-radiation protections and procedures must be employed to comply with regulations regarding X-ray emission.

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4 SYSTEM INSTALLATION

4.1

Pre-Planning & Process Flow

Here is presented, as an example, the basic flowchart of the works to be performed. These topics are to be reviewed carefully by the project manager whose responsibility it is to ensure that all important factors regarding installation are considered and a secure plan is devised and carried out.

SITE PREPARATION

INSTALLATION

CALIBRATION

FINISH

SITE PREPARATION •

Client input and requirements have been approved and finalized?

•

Schematic of floor plan finalized, based on the equipment manufacturer configuration and installation drawings, and verified to work within the minimum required space?

•

Legal permits and approvals given?

•

Paths of equipment electrical cabling planned out?

•

Mains electrical power for the room to be ready for connection?

•

Other critical items addressed? (HVAC, mains power, lighting, radiation protection, etc)

•

Communications? (LAN, DICOM, high-speed internet, etc)

•

The instruction manuals are available for this equipment and have been previously studied?

•

Restructuring / remodelling of the room is to be finished prior to equipment delivery?

•

A timeline has been set to stay ontrack and to stay on budget?

•

Have all the responsibilities been divided and everyone knows what their responsibilities are?

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INSTALLATION •

All devices / components should be present, accounted for, and ready for installation. Take note of any parts, hardware or equipment components that appear to be missing and that may hinder the completion of the installation and report it immediately to a supervisor.

•

Communicate immediately to the project manager, dealer or manufacturer for any deviations / modifications to the room drawings or the equipment drawings to acknowledge any types of inconformity’s or incompatibilities with the equipment being installed.

•

The heavy construction modifications of the installation site should already be performed before starting the main installation. The electrical cable conduits/supports/ducting should be considered into part of the rooms construction. The equipment manufacturer or dealer may have special kits or parts to help in this regards.

•

The main mechanical installation of the primary components of the unit must be set into place before the heavy electrical cabling takes place. The installation site can be very dangerous place; only the necessary personnel for the installation must be in the room during these operations -- all unauthorized people must be sent out of the work area.

CALIBRATION •

Make all the mechanical adjustments after the units power has been turned on – keep in mind to install the unit’s covers towards the end of the installation phase to allow fine-tuning of the system.

•

The electronic/electrical calibration can only be performed after the mechanical adjustments have been completed. Due to the various possibilities of configurations, and destination of use, the generator and receptor setup and calibrations are not discussed within this instruction manual. FINISH

•

Perform safety tests and obtain permits to operate.

•

Instruct the operators how to use this equipment

•

Instruct the operators how this equipment interacts with the other devices in the room (generator, receptor, digital imaging system, etc)

•

Discuss with the operator the installation modifications not discussed in these instructions or not clearly defined or stated in the operators manual.

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This is only an example of the work processes. Some types of work have priority over others. Make an evaluation of the works to be performed, before starting, and create a real plan to carry out the installation and to stay on time with the foreseen time allotted for the installation. Consult with the dealer or manufacturer of the equipment for any clarifications, or questions that need answers, or to gain helpful tips to make the installation proceed in a timely manner.

SITE PREPARATION

INSTALLATION

CALIBRATION

Mount the external controller rack

Make equipment mechanical adjustments

Make electrical safety tests and obtain permit to operate

Make equipment electronic adjustments

Applications training

Room construction

Insert the Table into place without table top

Receiving of system and other parts

Set longitudinal floor rails into place

Main devices ready for installation

Insert the Tube Stand unit onto the floor rails

Mount the Wall Stand receptor hardware

Setup generator and receptor

Locations of devices marked out clearly for the installation

Mount the X-ray tube and collimator

Cable the units, generator, and accessories

Check over and testing

Mount the Table receptor hardware

Powering ON the unit.

Install the Wall Stand unit

Fig. 4-1 Example Flowchart of Works to be Performed

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FINISH

Patient examinations

TECHNICAL MANUAL

4.2

System Installation

Room Preparation ATTENTION! All masonry works for the room preparation are at customers or installers expense. •

It is important to know exactly the room features where the unit will be installed in order to make correct preparations and to make them in accordance to the local building regulations as well.

•

Before starting the installation, check that the rooms predisposition and the walls works have been done according to what shown on the installation drawings.

•

It is vitally important that all the necessary construction such as underground / in-wall canals for passage of electrical cabling is performed as required.

•

When planning the electrical cables that serve the equipment, verify that the lengths of the cables are adequate enough to reach all the intended connection points.

4.2.1 The Room Construction It is the duty of the clients project manager to plan, ahead of time, all the necessary works required to complete the installation. This subject matter is previously discuss in section Pre-Planning & Process Flow. (see also 4.3.1 Examples of Equipment Technical Drawings) The information found within these instructions, and the documents that come with the equipment, must be observed in order to obtain the units complete performance in the best room fitness. Specific information about this is generally given separately by the manufacturer or the project manager, who are in any case at full disposal for any further needs. 4.2.2 Tools Required The equipment mounting does not need specials tools, but common use ones, like those listed below. Other special tools may be required for construction modifications.  set of open-end wrenches/spanners  measuring tools  set of box-end wrenches/ring spanners  drilling machine, percussion-typewith a set  set of Allen keys of drill bits for concrete  set of screwdrivers  lifting device (is available)  levelling tools 4.2.3 The Receiving Area It may require the allocation of an external working area outside of the actual place of installation to allow the unpacking of each device for preparation of placement of the primary devices into their installation positions. Check with site administrators for authorizations. Take into consideration the size of the equipment and the amount of space required to move it through doors and openings and to allow for safe passage of pedestrians. 4.2.4 Equipment Storage and Transport Conditions Once the unit is assembled in the factory, it is subjected to careful controls and a tests from trained personnel. The equipment is packed with corrugated card-board and wrapping paper (pluriball). For international shipment, or upon customer’s request, the equipment is crated in one or more wooden cases. Before the installation, the unit can be kept in the warehouse for some time with its original packaging. In any case, although every metal part is carefully covered by protection paint or oxidation superficial treatment, the equipment is not planned to work or be stocked outdoors. It cannot withstand the humidity; for this reason, do not keep it outdoor or in extreme environment conditions. Read the technical specification for the equipment regarding the specifications of the equipment storage and operating environment conditions.

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The wooden cases are made to be lifted through a lifting device (forklift truck). If they must be lifted from the top (by crane), it is necessary to sling them through suitable ropes, which must twine round the case.

It is absolutely forbidden to pass by or under the load during the lifting operations.

Make sure the cases are well fixed during the transport to avoid blows which could damage their contents.

Make sure the cases are well fixed during the transport to avoid blows which could damage their contents.

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4.2.5 Equipment Receiving / Inventory The equipment is contained in several cases, whose contents is briefly listed below. The exact cases contents are specified in the Packing List which is attached on the case.

CASE N. 1 – Tube Stand; Case dimensions are 267 x97 x126 cm and its weight is about 250 kg. It contains:    

The stand (fastened in a lay down position), The floor rail, The top panel of the Bucky table (if mated with table), The carton box with the control board and the small parts to put on the equipment.

CASE N.2 – Table unit; Case dimensions are 157 x 92 x 86 cm, without table top panel (245 x 92 x 86 with top panel @ 240cm), and weighs about 350 kg. It contains:  The bucky table unit without the top panel,  The top panel of the Bucky table (if not with Tube Stand),  The optional accessories to complete the equipment.

CASE N.3 – Wall Stand; dimensions are 250 x 82 x 61 cm and its weight is of about 150 kg. It contains:  The Wall Stand unit (fastened lying down in a horizontal position), complete with bucky carriage (and possibly with bucky and grid, according to the customer’s requests),  The disassembled base support (option),  The box containing the additional counterweights and the optional accessories to complete the equipment installation. Any kind of damage must be immediately communicated to the forwarder and the manufacturer. The wooden cases are made to be lifted through a lifting device (forklift truck). If they must be lifted from the top (crane), it is necessary to sling them through suitable ropes, which must twine round the case. Pay attention to possible notices on the packaging, which show the recommended ways the equipment must be moved and lifted.

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Fig. 4-2 Stand Case Content Pos.

Description

Quantity

01

CASE COVER

-

02

BUCKY TABLE PATIENT TABLE TOP (if with table)

1

03

MANUALS AND DOCUMENTS

-

04

ACCESSORIES BOX

1

- COLLIMATOR (OPTION)

-

05

STAND

1

06

STAND FLOOR RAIL

1

07

CASE LATERAL WALL

-

08

CASE

-

09

PACKING LIST

-

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Fig. 4-3 Table Case Content Pos.

Description

Quantity

01

CASE TOP COVER

-

02

WOODEN CASE

1

03

PACKING LIST

-

04

TABLE TOP (if not, with Tube Stand)

1

05

MANUALS AND DOCUMENTS

1

06

ET TABLE

1

07

ACCESSORIES BOX

-

08

CASE LATERAL WALL

-

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Fig. 4-4 Wall Stand Case Content Pos.

Description

Quantity

01

CASE UPPER COVER

-

02

CASE

-

03

PACKING LIST

-

04

ENVELOPE WITH MANUALS AND DOCUMENTS

-

05

BOX OF ACCESSORIES

-

06

STAND

-

07

FLOOR BASE MOUNT (OPTION)

-

08

CASE LATERAL WALL

-

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4.2.6 Equipment Unpacking Unpacking of the equipment should be performed only when the installation area has been prepped and the exact installation locations of each device are clearly marked out so that the equipment can be moved directly into position after extracting them from the cases.

To extract the Tube Stand from its case, do as follows: 1. Remove the upper cover of the case. 2. Remove one of the long case side. 3. Bring the stand to its vertical position, i.e. in its effective working position, then remove the paper of packing and inspect that the parts did not suffer from damages during transport.

To extract the Table from its case, do as follows: 1. Identify the envelope that contains all the documents and the assembling instructions and carefully keep them. 2. Extract the box containing the accessories. 3. Bring the table in its working position, then remove the packing paper and inspect that the parts do not suffer from damages during transport.

To extract the Wall Stand from its case, do as follows: 1. Remove the upper cover of the case. 2. Remove one of the long sides of the case. 3. Locate the envelope that contains the documents and the assembling instructions and store them carefully for future use. 4. Take off the box that contains the accessories. 5. Take off the optional base support (option). 6. Place the stand vertically (in its working position) , then remove the wrapping paper and control carefully that all parts were not damaged during the transport.

Do not pass by, or under, the load during the lifting operations!

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4.3

System Installation

Fixing the Equipment in the Room ATTENTION! These drawings given here are not construction drawings! They are given only as an example for assistance in planning and preparation. A final drawing to complete the room construction must be prepared by a qualified project manager, architect, or the main contractors in charge of the project. Check for addendums or other file attachments, that may be attached directly to the units, or supplied separately with the documents, which may indicate system updates or special ordered options not discussed here. Make an inquiry to the dealer or manufacturer for any compatibility issues or installation conflicts of the mating parts indicated in the drawings presented here. Examine the technical drawings to distinguish the working zones that the equipment occupies and that it does not create collision conflicts with other devices present in the examination room.

The technical drawings referenced here are provided only as an example and are subject to manufacturer revisions and special options ordered at the time of manufacturing. Study the technical drawings that are supplied with the equipment, or from the project manager, to know the specific requirements and dimensions for the installation or modifications to the designs for installation site. Contact the project manager, dealer or equipment manufacturer for assistance with this.

4.3.1 Examples of Equipment Technical Drawings • The equipments standard configuration drawings: Index of drawings on the following pages. (see Fig. 4-5 to Fig. 4-9) Date

Code

10/2017

F_ts34+et3+trn43x

04/2018

F_ts34+et3+trn43d

09/2017

F_Calypso F-M

07/2017

F_Calypso F-M

04/2018

F_ix261_man

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Title TUB3 STITCH 5,7” / ET3 DIGIT / TRN43X-(col. 218) FLOOR RAIL 254cm TUB3 STITCH 5,7” / ET3 DOCK 35x43 / TRN43D-(col. 218) FLOOR RAIL 254cm TUB3 STITCH 8” / ET3 / TRN43X-(col. 218) FLOOR RAIL 254cm TUB3 STITCH 8” / ET3 DOCK 35x43 / TRN43D-(col.218) FLOOR RAIL 254cm

Description

TUBESTAND 7630-ST / ET8530 / TRN43X FLOOR RAIL 254cm

Recommended floor plan and electrical cable ducting (ref. wallstand right side loading).

33

Wallstand Right-Side loading; full options Wallstand Left-Side loading; full options

TECHNICAL MANUAL

System Installation

Fig. 4-5 Example: MT-Standard Installation Configuration (Right-side)

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Fig. 4-6 Example: MT-Standard Installation Configuration (Left-side)

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Fig. 4-7 Example: GMM-Standard Installation Configuration (Right-side)

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Fig. 4-8 Example: GMM-Standard Installation Configuration (Right-side)

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Fig. 4-9 Example: Floor Rails Installation with Optional Table and Electrical Cable Ducts (DX)

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4.3.2 A Typical Room Design Identify the areas where the devices will be installed. This will aid in understanding which device / unit must be unpacked first and what should be put into place first. It will also aid in which work will have priority over the other.

Index of drawing (see Fig. 4-10) Pos.

01 02 03 04 05 06 07 08

Description

Operator Workstation X-ray Generator Digital Imaging Hardware Mains Network Support Equipment External Controller Rack Tube Support Stand and Rails Table Receptor Unit Wall Stand Receptor Unit

Fig. 4-10 Room Layout Example: Identifying Equipment Locations

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Fig. 4-11 Room Electrical Connection Points for the Support Equipment

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Mains Power Interconnection Cable

System ‘X-ray Ready’ Interconnection Cable

CAN Communication Interconnection Cable

LEGEND

Support Equipment Interconnection Cable

4.3.3 Electrical Cables Routing It is important that the room construction has been prepared for electrical assembly such as the preparation of cable raceways and conduits to allow the passing of interconnection cables between the separate pieces of equipment and the external controller racks. (see also Fig. 4-10) See the electrical technical instructions that come with the equipment for the recommended cable requirements. See also in this manual section “Tube Support Stand Mechanical Assembly” for more information about the electrical assembly processes.

TECHNICAL MANUAL

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4.3.4 Important Notes About Installing the Equipment Demonstrated, in the Fig. 4-12 is an example of a complete system installed into a typical examination room using the standard equipment dimensions given by the manufacturer. Give attention to the following installation notes: 1. In the Fig. 4-12, reference point “1”, it demonstrates the minimum displaced working zone (along

the X axis). a. Compare the CONTRUCTORS technical drawings (and the technical drawings that are supplied with this system) to know the exact minimum space requirements. The dimensions may change according to pre-planning arrangements, but always based on the manufacturers original template design. b. This dimension may be modified, if there is no permanent table being installed. 2. The reference point “2” demonstrates three important centrelines running parallel to the X axis and

intersecting the Y axis: the centreline axis of the X-ray tube output, the centerline axis of the Table, and the centreline axis of the Wall Stand unit. a. This referencing point “2” also indicates the minimum distance of the centerline axis between the X-ray tube Focal Point and the wall in the background. This can be increased if it is desired to have more working space around the equipment. However, it cannot be less than this indicated distance or it will cause collision conflicts between the Tube Stand unit and any other devices, such the option external controller rack or X-ray generator, placed behind it. b. The minimum distance between the outside edge of the floor rails to the back wall is calculated to 345mm (with the recommended installation distance of 1200 mm from the back wall to the X-ray tube housing centreline). c. The position of the Wall Stand unit is locked to the centerline axis of the X-ray tube output. 3. The reference point “3” indicates the cross centreline axis of the Table, running parallel to the Y

axis intersecting the X axis. a. The indicated centreline distance, intersecting the X axis, must be respected to stay within the maximum limits of the working area. It is the variation of the table top to the extreme outer edge, in contrast to the installation location of the Wall Stand unit, which dictates the minimum working zone required. b. This distance value also sets a (very important) minimum working zone between the Table unit and the Wall Stand unit. 4. The reference point “4” indicates the starting point at where the Tube Stand floor rails should be set

along the X axis. a. The indicated floor rail position must be respected to have the optimum working distance to the Wall Stand unit. Using the standard distance dimension, of “920 mm” referencing point to the wall, the minimum Focal Distance (SID) can be about “697 mm” (this measure depends on the type of Wall Stand receptor unit that is being used). b. The floor rails installation position is very important when coupled with a Table. There is a small working zone, between the starting point until the Table zone begins: this distance must be adequate enough to allow the X-ray tube to be lowered, to achieve its maximum vertical travel, without coming into contact with the permanently installed Table unit.

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ATTENTION! For systems with electronic referencing hardware: any deviations or changes to the floor rails installation referencing point must be planned out carefully. The electronic calibration methods may have lateral SID minimum / maximum referencing points thus requiring that the installation dimensions stated by the manufacturers technical drawings to be absolutely adhered to. 5. The reference point “5” indicates where the Wall Stand unit should be located.

a. The centreline of the Wallstand unit is located on the centreline axis of the Table unit, or the calculated Focal Point output from the X-ray tube. (see referencing point “2”) b. The installation of the Wall Stand unit must be made only after installation of the Tube Support Stand unit. The centering of the Wall Stand unit is easily found after the X-ray tube support stand has been aligned and adjusted to its working conditions.

ATTENTION! It is recommended to install the Wall Stand unit, only after having mounted and fixed the Tube Stand and Table into place -- and ONLY after the X-ray field to light field has been aligned. The X-ray tube horizontal support arm is non-adjustable: it does not have any type of mechanical adjustments, to correct the transversal alignments (on the Y axis).

6. The reference points “6” indicates where the optional OEM external controller rack and OEM cable

support devices can be installed.

ATTENTION! The electrical interconnection cables are at fixed lengths. It is mandatory to follow the recommended installation locations to ensure that the cables reach their associated interconnection points.

ATTENTION! Study the manufacturer technical drawings that come with the system to know the specific recommended dimensions for the installation or modifications to the designs. The technical data referenced here is only an example. See also section “8 MECHANICAL ADJUSTMENTS” for information about performing mechanical adjustments.

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System Installation

1

3

4

5

6

2

TECHNICAL MANUAL

Fig. 4-12 Example: Equipment Installation Locations

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ATTENTION! Important information given here!

TUBE STAND – TO – TABLE ALIGNMENT

800 mm

Minimum installation distance!

1200 mm

Fig. 4-13 Aligning the Tube Stand to the Table Unit

The X-ray tube horizontal support arm is non-adjustable: it does not have any type of mechanical adjustments, to correct the transversal alignments of the X-ray field to the receptors on the Y axis (Fig. 4-12) The factory specified alignments, a compatible X-ray tube housing and attaching hardware must be used. Read further in this manual, in § “5 TUBE SUPPORT STAND MECHANICAL ASSEMBLY”, which discusses the recommended methods for X-ray tube housing mounting to maintain the alignment specifications as indicated in the provided installation drawings. For alignment with the Table units: the alignment of the X-ray field to the Table receptor and can only be corrected by adjusting the distance between the table base and the floor rails. This is in relationship to having the correct mounting of the X-ray tube housing. If there are any doubts about the alignment, fix the floor rails and/or table base in a temporary way until the X-ray tube and collimator unit are mounted to verify that they can be aligned correctly to the receptor. (see Fig. 4-13) It is recommended to install the Wall Stand unit, only after having mounted and fixed the Tube Stand and Table into place -- and ONLY after the collimated X-ray field has been aligned properly.

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According to the rooms dimensions, this information must be observed in order to obtain the unit complete performance and optimize the room space. Specific information about this is generally given separately by the manufacturer who is, in any case, at full disposal for any further needs.

4.4

Fixing the Tube Support Stand Floor Rails into Place

See the drawing, of Fig. 4-14, as a reference. Check for any revisions to the technical drawings, that may accompany the equipments documentation, which indicate specific recommended dimensions for the installation. The technical data referenced here is shown only an example.

Following the procedure for correct fastening of the Tube Stand Unit rail system: 1

Bring the rail on floor near the table, putting it in the position which is shown in the drawing;

2

Mark on the floor where holes must be done, paying attention not to make mistakes. To this aim look carefully at the enclosed plan;

3

Move the rails away from the working area to work freely;

4

Through the use of a power drill with percussion and D14 Vidiam drill, make the fixing holes, whose depth must be 65 mm at least;

5

Insert the D14 and M8 metal fisher in the holes, so that they do not project from floor (for this operation use a hammer);

6

Position the rail and then fix it using 10 screws TCCE M8x50, wide flat washer D8 and flat washer D8 (rail rear fixing). The fixing screws are not supplied, as standard, by the manufacturer; the described fixing hardware has to be considered as the suggested one. Other fixing systems could be used, but as recommended by the manufacturer. It is possible to order, from the manufacturer, the complete kit for the stand and the elevating table fixing (code: pn. TFEA01). Take into consideration that the X-ray tube support arm is of fixed design. If using Xray tube housings that are not specified as compatible for use, or using non-OEM tube housing mounting hardware, the alignment of the X-ray field to the table receptor may not be correct. In this case, the alignment can only be corrected by adjusting the distance between the table base and the floor rails. Both the Stand and Table have slotted fixing points for making small adjustments during the installation. If there are any doubts about the X-ray field-to-Receptor alignment, fix the rails in a temporary way until the X-ray tube and collimator unit are mounted to verify that they can be aligned correctly to the receptor of the Table unit.

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4.4.1 Floor Rails + Table Installation Hardware Kits For Tube Stand with Table applications, it is recommended the use of installation hardware n.2 Kit TFEA01 Kit TFEA01 Picture index, following page (Fig. 4-14, Kit TFEA01). Pos.

Description

Quantity

01

ANCHOR SLM 8

3

02

SCREW TCCE M8X50

3

03

WASHER D8

3

04

WIDE FLAT WASHER D8 24

3

05

ANCHOR SLM 8

2

06

SCREW TCCE M8X50

2

07

WASHER D8

2

08

WIDE FLAT WASHER D8 24

2

09

ANCHOR SLM 10

2

10

HEXAGONAL SCREW M10X60

2

11

WASHER D10

2

12

WIDE FLAT WASHER D10 30

2

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Code

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Fig. 4-14 Floor Fixing of the Tube Stand and the Table ‘ET’ (Kit TFEA01)

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4.4.2 Fixing of the Table (ET8530_ET8532 series)

Check for any revisions to the technical drawings, that may accompany the equipments documentation, which indicate specific recommended dimensions for the installation. The technical data referenced here is only an example.

See the drawings of Fig. 4-9 and Fig. 4-14 as a reference to this guide. For new installations, see the illustrations of Fig. 4-15 and Fig. 4-16 for assistance with raising the table upper section to gain access to the base of the table to make the works. To fasten the Table it is necessary to reach the fastening holes inside the table base:  Remove the rear panels (inferior and superior) of the bucky table. To make the bucky table fixing and assembling operations easier, lift at about 70 cm from floor the upper part of the table, rotating by hand the driving pulley of the elevating system. To this aim, use the handle (which is issued with the table and fixed to one of the crossbars of the elevating system), whose pins enter frontally the holes of the driving pulley.  mark on the floor where holes must be done, paying attention not to make mistakes. To this aim look carefully at the enclosed plan;  move the table away from the working area to work freely;  through a power drill with percussion and D16 Vidiam drill, make the fixing holes, whose depth must be 80 mm at least;  insert the D16 and M10 metal fisher in the holes, so that they do not project from floor (for this operation use a hammer);  position the table and then fix it using 4 hexagonal-head screws TE M10x60, wide flat washer D10 and flat washer D10 (only on the front fastenings).

Before tightening, check the parallelism and the distance of the table from the stand rail. If needed, correct the positions by using the possibility offered by the fastening holes. Fix the table on level, using a level as control instrument. If necessary shim, being sure that the screws clamping does not create any deformations in the table base structure.

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Fig. 4-15 Raising the Upper Section of the Table

The Table is supplied with a schot cable lead that is connected to the ST1 mains strip terminal. The table mains power conductor cable can be connected to this short lead TEMPORARILY to the power the table ON and elevate the upper section in ordet to remove the rear panel and gain accesss to the table base components and connections. This short cable must discarded after use and replaced by the permanent power cable! If it becomes necessari, the upper part of the table can be raised, manually, by rotatine by hand the driving pulley of the elevatine system. To this aim, use the handle (which Is issued with the table and fixed to one of the crossbar of the elevating system), whose pins eneter frontally the holes of the driving pulley.

Fig. 4-16 Manual elevation of the bucky table (for elevating table)

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4.5

System Installation

Mounting the Wallstand

4.5.1 Fixing to Wall and Floor The basic version is foreseen to be fixed directly to floor and wall. For its positioning and mounting it is necessary to follow the following procedures (reference Fig. 4-17 /Fig. 4-18):  position the stand in vertical position, making it slide until the chosen working position;  through a pencil mark to wall and to floor the fixing holes positions;  lightly move away the stand, check using the drawing attached to the following page, the exact correspondance of all the quotes;  then proceed with making the holes;  through the use of a percussion drill, with a Widiam D12 drill bit, make holes 40 mm deep.

As a fixing system, use 4 metallic anchor Fisher D12-M6 (which are readily available on the market) and 4 hexagonal screws TE M6x40 + a large washer D6.

It is important to verify carefully that the position reached is the required one.

ATTENTION! The maximum load in horizontal direction and acting on the fixings to wall is about 500 N. It is important that the support surfaces are carefully smoothed. Possible little differences can be corrected during the mounting phase, inserting the suitable thicknesses between the base and the support surface.

ATTENTION! The fixing system, which has just been described, is the most common one and must be considered as the preferred method of installation. The measuring of the stand support structures is exclusively under the competence of the designer, who is responsible of the room’s preparation.

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4.5.1.1

System Installation

TRA031 – TELE AL-FLOOR FIXING PLATE

(reference Fig. 4-17 /Fig. 4-18) Pos.

Description

001

SCREW TSCE UNI5933 CL10.9 M6X14

002

FLOOR BASE

4.5.1.2

TRA032 – TELE AL-FLOOR/WALL FIXING KIT

(reference Fig. 4-17 /Fig. 4-18) Pos.

Description

001

SCREW TSCE UNI5933 CL10.9 M6X14

002

FLOOR BASE

003

WALL BRACKET

004

PLAIN WASHER UNI6592 D5

005

SPRING WASHER UNI1751 D5

006

SCREW TCCE UNI5931 CL8.8 M5X20

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Fig. 4-17 Floor Fixing Plate and Floor/Wall Fixing Kit

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Fig. 4-18 Floor/ Wall fixing Example

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4.5.2 Mounting of the Base Support Plate (option) If the Stand is equipped with the optional floor base support plate (001/Fig. 4-19), it is necessary to first proceed with its mounting at the base of the column of the Stand. To do this operation, it is recommended to proceed as follows:  Rest the column of the Stand, horizontally, upon two sawhorses;  Inspect the base support plate (001/Fig. 4-19) to understand in which direction that it must be mounted to the column (the non-slip rubber must face upwards toward the column);  Position the base support plate to the base of the column (Fig. 4-19);  Permanently fix it by using the 6 – M6x25 TSCE screws with threadlocker (002/Fig. 4-19);  When the operation is completed, raise the stand into the vertical working position.

The floor support base is provided with non-slip rubber at the area where the patient's feet rest. Make sure that this non-slip rubber is facing upwards towards the column and NOT towards the floor! The presence of the support base does not require any masonry work and allows a quick and easy positioning of the stand in the most appropriate working position.

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Fig. 4-19 Optional Base Support Plate for Wall Stand Unit

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Intentionally Blank Page

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5 TUBE SUPPORT STAND MECHANICAL ASSEMBLY The equipment may be supplied with different options in relation to what is depicted here. This can include differences in physical appearance, optional hardware and even operating characteristics.

5.1

Mounting of the Floor Stand Unit

5.1.1 Mounting of the Stand Base First ensure the floor rail has been fixed to the floor. To do so, refer to the drawing attached to the previous chapter. ATTENTION! Fix in a proper way the rail to the floor, to avoid a dangerous stand knocking over during the mounting or the normal working. The stand base is already mounted by the manufacturer; so it needs no operation before the stand inserting into its rail.

5.1.2 Stand mounting The second phase consists in bringing the stand in its vertical position and free it from the packaging used for shipping. Pay attention to possible notices on the packaging, which show the stand moving and lifting ways.

 Bring the stand in its vertical position, i.e. in its effective working position, then remove the packaging paper and inspect that the parts did not suffer from damages during transport. Any kind of damage must be immediately communicated to the forwarder and the manufacturer.

The stand is already assembled at factory, therefore it does not need of any operations before inserting it in its sliding rail.

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5.1.3 Inserting the stand in the rail on floor During the stand inserting into the rails, act carefully to avoid the guiding and / or sliding bearings damaging. Moreover, it should be better to cover the final part of the rail with a metal thin sheet, in order to make easier the inserting and to avoid the extruded aluminium rail damaging. Do as follows:  remove the closing crossbar on one of the rail short side (13 / Fig. 5-1);  bring the stand base near the rail head;  lift vertically the stand and insert the carriage (15 / Fig. 5-1) in the rail (9 / Fig. 5-1), paying attention not to force its bearing;  mount again the closing cover (13 / Fig. 5-1) and lock the screws (14 / Fig. 5-1).

ATTENTION! The insertion of the carriage column in the floor rail,must be performed AFTER moving away the 4 contrast bearings and AFTER disassembling the electromagnetic brake. When this operation is finished, it should be better to bring the stand on the side which is more projecting from the table; then start the X-Ray tube and the collimator mounting.

WARNING! Check that the supporting and sliding bearings are correctly inserted in the guides, which are fixed to the rails. This control is very important in order to avoid injuries to patients or technical personnel or damages to the unit.

When carriage is inserted, put the contrast bearings in contrast with the rail, so to reduce at the minimum the play, and re-assemble the electromagnetic brake leaving a distance of about 1 mm between the contact surfaces.

WARNING! The slider of the stand is kept locked, during transport,by a safety bolt (see fig. 8). This prevents the counterweight in the column to exercise its weight force when the contrast constituted by the weight of the radiogen system is missing. Before Removing the fastening bolt,at least contrast this force partially by mounting the x-ray tube.

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Tube Stand Assembly

Fig. 5-1 Inserting of the stand in the rails. Pos.

Description

Quantity

01

CAP (FOR VERT. MOTOR)

1

02

COLUMN 2180

1

03

TUBESTAND VERTICAL SLIDER L=400

1

04

XR TUBE COVERING (OPTION)

OPT

05

PUSHBUTTON “TUBESTAND”

1

06

ARM COVERING (IN 2 HALVES)

1

07

FIXED HORIZONTAL ARM

1

08

COLLIMATOR (OPTION)

-

09

TUBESTAND – FLAT FLOOR RAIL 254cm

1

10

COLUMN ROTATION COVERING

1

11

COLUMN ROTATION UNLOCKING PEDAL

1

12

BUMPER

2

13

RAILS HEAD

2

14

SCREW WHITE HEAD

8

15

CARRIAGE

1

* Image shown may change according to system options.

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5.2

Tube Stand Assembly

Stand Mechanical Assembly The equipment supplied may be supplied with different options in relation to what is depicted here. This can include differences in physical appearance, optional hardware and even operating characteristics.

5.3

The X-Ray tube mounting

On the stand horizontal arm, a block with four vertical holes is mounted (03 / Fig. 5-2); among them four screws must be inserted (02 / Fig. 5-2) to be screwed in the four holes M6 on the rear side of the X-Ray tube (05 / Fig. 5-2). Between the X-Ray tube and the support must be inserted the control board support bracket (04 / Fig. 5-2). On the bracket there are two rows of holes that permit to adapt the position of the control board support fork (07 / Fig. 5-2) to the diameter of the tube bracket that is to be mounted. The holes to use are those which allow to keep the support fork at the minimum distance from the tube. Index of the picture Fig. 5-2 in the following page. Pos.

01 02* 03

Description

Quantity

TUBE SIDE HOSE SUPPORT

4

SCREW TE 6 x 30

4

PLAIN WASHER WIDE UNI6593 D6

4

X-RAY TUBE BRACKET

1

HORIZONTAL ARM HOSE SUPPORT

04

X-RAY TUBE BRACKET

1

05

X-RAY TUBE

-

06

SCREW TCCE 10X20

2

07

“TUBESTAND” CONTROL BOARD

1

08

COLLIMATOR RING SPACER

-

09

COLLIMATOR CONE

-

10

COLLIMATOR

-

X-RAY TUBE COVER

1

SCREW TBCE

4

11**

Code

* Fastening screws for tube fastening are not supplied (the shown dimensions must be meant as the suggested ones) ** The plastic cover of the XRAY TUBE is available as option

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Fig. 5-2 file: me310006-a-1

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5.3.1 Mounting of the C100 headcuff. On request, the optional kit for the RX tubes C100 type fastening is available (refer to Fig. 5-3). The modality of fastening is the same as the one written above, with the only difference that it is needed to use the screws M10x30 to fasten the control board to the control board attach point, by interposing the alluminium spacer. Additionaly it is necessary to mount the extension on the cable support on the arm, by used the supplied screws.

RIF. DRAW CSA047 Pos.

Code

Description

Fin.

Q.ty

Um

001

CS TUBE HOSE SUPPORT EXTENSION

ZNB

1

PZ

002

SCREW TBCE ISO 7380 CL10.9 M8X12

ZNB

1

PZ

003

SCREW TBCE ISO 7380 CL10.9 M4X12

ZNB

1

PZ

004

SCREW STCE PA UNI 5923 CL12.9 M8X40

ZNB

4

PZ

005

PLAIN WASHER UNI 6592 D8

ZNB

4

PZ

006

SPRING WASHER UNI 1751 D8

ZNB

4

PZ

007

MED HEX. NUT UNI 5588 CL8 M8 H6,5

ZNB

4

PZ

008

PUSHBUTTON FIXING SPACER H10

-

2

PZ

009

SCREW TCCEE INFI CL8.8 UNI5739 M10X30

-

2

PZ

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Tube Stand Assembly

Fig. 5-3 File: CSA047

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5.3.2 TSA006 – 92x21 M6 Tubestand X-Ray Tube Spacers for IAE C52 A fastener kit for the X-ray tube type C52 is available, as an ordered option. The mode of fastening is the same as the standard one, with the only difference the spacers are required to keep the centreline of the focal point at the recommended distance from the control board bracket mounting point.

RIF. DRAW TSA006 Pos.

Code

Description

Fin.

Q.ty

Um

-

4

PZ

001

SCREW STCE PA UNI5923 CL12.9 M6X40

002

PLAIN WASHER UNI 6592 D6

ZNB

4

PZ

003

SPRING WASHER UNI 1751 D6

ZNB

4

PZ

004

MED HEX. NUT UNI 5588 CL8 M6 H5

ZNB

4

PZ

005

X-RAY TUBE FIXING SPACER 4mm

-

3

PZ

006

X-RAY TUBE FIXING SPACER 2mm

-

1

PZ

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Tube Stand Assembly

Fig. 5-4 File: tsa006

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5.3.3 TSA008 – 92x21 M6 X-Ray Tube Support for C52 Super A fastener kit for the X-ray tube type C52 SUPER is available, as an ordered option. The mode of fastening is the same as the standard one, with the only difference that it is required to use an off-set bracket to keep the centerline of the focal point at the recommended distance from the mounting point.

RIF. DRAW TSA008 Pos.

Code

Description

Fin.

Q.ty

Um

001

SCREW TSCE UNI5933 CL10.9 M6X30

ZNB

4

PZ

002

PLAIN WASHER UNI 6592 D6

ZNB

4

PZ

003

SPRING WASHER UNI 1751 D6

ZNB

4

PZ

004

MED HEX. NUT UNI 5588 CL8 M6 H5

ZNB

4

PZ

005

SCREW TE INFI CL8.8 UNI5739 M8X20

ZNB

4

PZ

006

SPRING WASHER UNI 1751 D8

ZNB

4

PZ

007

PLAIN WASHER UNI 6592 D8

ZMB

4

PZ

008

C52 SUPER FIXING BRACKET

VR1

1

PZ

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Tube Stand Assembly

Fig. 5-5 File: tsa008

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5.3.4 101753 – 92x21 M6 X-Ray Tube Support without Trunnion A fastener kit for the X-ray tube types that do not use a trunnion ring is available, as an ordered option. The mode of fastening is the same as the standard one, with the only difference that it is required to use a fixed bracket to keep the centerline of the focal point at the recommended distance from the mounting point.

RIF. DRAW 101753 Pos.

Code

Description

Fin.

Q.ty

Um

001

SCREW TE INFI CL8.8 UNI5739 M6x30

ZNB

4

PZ

002

PLAIN WASHER UNI 6592 D6

ZNB

4

PZ

003

SPRING WASHER UNI 1751 D6

ZNB

4

PZ

004

X-RAY TUBE BRACKET GENDEX-TOSHIBA

-

1

PZ

005

SCREW TCCEE INFI CL8.8 UNI5739 M6X30

ZNB

4

PZ

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Tube Stand Assembly

Fig. 5-6 File: 101753

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5.3.5 CSA081 – Rotating Collimator R302 Kit For Mounting Plastic Control Board Fastener kit for mountinf of the control board station with particular plastic housing enclosure in conjunction with the use of collimator model R302.

RIF. DRAW CSA081 Pos.

Code

Description

001

CONTROL BOARD BLOCK FOR COLL R302 ROT

002

SCREW TCCE UNI 5931 CL8.8 M10X20

Fig. 5-7 File:CSA081 TM76301-EN Rev.0 2018JUL

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Fin.

Q.ty

Um

-

2

PZ

ZNB

4

PZ

TECHNICAL MANUAL

5.4

Tube Stand Assembly

The Collimator Mounting

To make the collimator positioning easier, the X-Ray tube 180° rotation is suggested, so that the collimator (rotated of 180° as well) (10 / Fig. 5-2) can be safely positioned on the x-ray tube (05 / Fig. 5-2). In this way, collimator damage by an accidental drop is avoided if the fixing flange has not been correctly tighten. Mount the collimator support flange (09 / Fig. 5-2) on the rays window, putting the necessary number of spacers (08 / Fig. 5-2) to respect the collimator positioning towards the rays emission cone. For additional information refer to the instructions which are issued with the collimator.

5.5

Electrical Parts Assembly For additional information about electrical assembly, refer to the separate Electrical Technical Instructions manuals which are issued separately with this unit.

From the electric point of view the equipment is composed of the following elements: •

Tube Support Stand

•

Control board station

•

X-Ray tube

•

Collimator

•

External controller rack (if present)

5.5.1 The Control Board Mounting The mounting of the stand interconnection and working cables starts from the control board. Fix the control board using the two screws M10 in supply. Wait to make control board electrical connections and closure of the control board (for aluminium-style body only) until the final installation phase. 5.5.2 The H.T. Cables Mounting Mount the working cables of the XRAY tube (H.T., starter, rotating anode, etc) and lay them, together with the cable coming from the control board, on the two saddles at the column sides. •

On each column side a group of cables will pass, this must be conveniently grouped (by strings) not to create confusion or obstacles to the equipment movement.

•

Then end the cables disposition addressing them in the wall support saddle.

•

Then proceed with mounting the Xray tube plastic cover (if present). Before going on with the cables mounting, check that the ones mounted do not limit in any way the mobility of the radiogenic system, bringing it in the extreme positions of its vertical travel and rotations. Connect all cables and electrical devices and check that all correctly works, before mounting the covers. For the correct connection sequence refer to the separately supplied electrical diagrams.

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5.5.3 Main Controller Cable and External Controller Rack For units with electronic processing control, such as automatic motorized functions, or compatible units with network capability, an external controller rack will be required to be installed. For its placement, turn to the specific installation drawings that indicate its correct placement and the recommended placement of cable ducting. See also previous §4 Important Notes About Installing the Equipment for more details.

External controller rack unit Column Head Cabling Points Client wall cable ducting

Control Box/ X-ray tube Cabling Point

Horizontal Arm Junction Point

Fig. 5-8 Floorstand Electrical Assembly

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5.6

Tube Stand Assembly

Tube Stand Balancing Only after the mechanical and electrical assembling, it is possible to remove the safety bolt that avoids the counterweight movement inside the column.

5.6.1 Balancing of the Radiogenic Unit Rotation Movement on the Horizontal Axis This balancing must be done at the end of the mounting , when it is possible to unlock the permanent electromagnetic brake of the rotating movement on the horizontal axis. It is important that all cables of the equipment are correctly positioned as well. Proceed as indicated to balance the assembly and find the barycentre. • Procedure: Unlock the brake and rotate the radiogenic unit to verify it is balanced. If balancing is not correct, find the barycentre by moving the radiogenic unit up and down in its housing support by utilizing the regulation possibilities which are offered by the elongated holes on the mounting plate.

1 2

5.6.2 Vertical Movement Balancing In mounting of the control board and of the electrical cables, nearly the whole final weight rests on the stand; At this time, the vertical movement can be approximately balanced (this must be perfected in final phases of assembly). The balancing system uses, as active element, a big lead counterweight inside the column, and some iron counterweight plates to be laterally fastened, in the proper spaces, to the horizontal arm of the radiogen system. Balance, at least approximately, this movement by acting on the number of plates that are in the stand arm. The definitive balancing of the vertical movement must be performed at the end of the equipment assembling, when all the parts that influence the balancing are present. Index of the illustration found on the following page. (see Fig. 5-9) Pos.

Description

Quantity

01

TUB – COLUMN

1

02

TUB – VERTICAL SLIDER

1

03

TUB – ELECTRICAL DEVICES

1

05

COUNTERWEIGHT PLATES (2 SETS)

1

06

NUT M5 – LOW PROFILE

4

07

ARM COVER (IN 2 HALVES)

1

08

PLASTIC SCREW

8

09

ADDITIONAL COUNTERWEIGHT

1

04

* For Tubestand-ST version

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* Image shown may change according to system options.

Fig. 5-9 File me340004

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5.6.3 Unlocking of the Vertical Carriage After mounting of the x-ray tube housing, which is required to counter-balance the counterweights inside of the column, it is possible to proceed to the vertical carriage unlocking. During the transport, to avoid equipment damage, the vertical carriage is blocked to the lower end of travel. Proceed as indicated to unlock the carriage. • Procedure: 1

Remove the screws (1 / Fig. 5-10) that fasten the plastic cover (2 / Fig. 5-10).

2

Individuated the lock nut (3 / Fig. 5-10) and remove it.

3

Remount at this point the cover (2 / Fig. 5-10) being careful to fasten it by the supplied screws (1 / Fig. 5-10).

Index of the illustration found on the following page (see Fig. 5-10) Pos.

Description

Quantity

1

PLASTIC SCREW

2

2

CAP

1

LOCKING HEX NUT

1

PLAIN WASHER D12

1

3 4

Code

1

5

COUNTERWEIGHT

1

6

COLUMN, SLIDER

1

ATTENTION!!! Proceed carefully to prevent the counterweight (which slides inside the column) from injuring persons or damaging things, if it is not correctly balanced. To avoid damage to the braking systems, limit the forced movements of the equipment until the equipments power is turned ON, at which time it will be possible to use the electrical brake releases to move the unit around freely.

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Tube Stand Assembly

Fig. 5-10 Counterweight Unlocking (after the mounting)

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6 TABLE UNIT MECHANICAL ASSEMBLY 6.1

Unlocking the Bucky Table

Once the table is set working, the upper top frame can be unlocked. During the transport this top is kept in position through appropriate clamps or wrapping paper. Before closing the table with the front panel, make the necessary electrical connections. ATTENTION! Verify that the top and the bucky carriage are completely unlocked, before using the equipment in order to permit a good working and to avoid the unit damaging.

6.2

Mounting a Receptor in the Mobile Carriage (Transversal Frame Extraction)

In order to get the receptor unit, located in the carriage under the table, in the case it is not installed by the table manufacturer, it is necessary to extract the transversal frame from the sliding guides. This involves a two-step procedure: 1) disconnect the cable, which connect it to the below fixed part; 2) take out the stop block at the end of the transversal movement of the frame.

Once the frame is extracted from the guides, the bucky cover can be removed and it is possible to gain access to the receptor or insert one if it is not present. To disconnect the connecting cable: 1

Take out the two screws which lock the cable connector support to the table structure (07 / Fig. 6-1)

2

Disconnect the connector, which comes from the table interior, from the connector that is fixed to the support.

To remove the stop block:  Remove the internal cover from the left support of the transversal frame sliding guide;  Remove the screws which fix the stop block (08 / Fig. 6-2).

When the Table unit is supplied, the receptor unit may be already be mounted in factory—only if the customer had requested it.

Read further in this manual section for information regarding the electrical connection requirements of the receptor to be installed. (see 6.6 Electrical Device Connections of the Table Unit)

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Table Assembly

Support Tray with Bucky wiring harness

Fig. 6-1 Brakes and Bearing Regulation

08 Fig. 6-2 Underpanel Regulation

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6.3

Table Assembly

Regulation of the Guide Bearing and Roller Bearing for the Patient Table Top

The guide bearings and the support bearings of the patient table top are shown in the figures 6-1 and 6-2. It is possible to correct the off-sets by utilizing an open-ended wrench (an english key) on the bearings that have eccentric bolts. It is also possible to correct the working distance of the electromagnetic brakes by acting on the bolts that the brake leaf-spring support is fastened to. (03 / Fig. 6-1) Index of the illustration found on the previous page (see Fig. 6-1 and Fig. 6-2) Pos.

Description

Quantity

1

LATERAL BEARING

4

2

LOWER CONTRAST BEARING

4

3

RECTANGULAR ELECTROMAGNETIC BRAKE 28x130

2

4

LATERAL BEARING OF GUIDE

2

5

MAIN BEARING

4

6

RECTANGULAR ELECTROMAGNETIC BRAKE 28x130

1

7

BUCKY CONNECTOR SUPPORT

1

8

LATERAL END OF TRAVEL

1

8

SCREW TCCE 5x20

2

Code

To perform these procedures, it may be necessary to remove the panel and the under panel. In this case, please refer to the drawings and instructions that are in the following pages.

6.4

Patient Table Top Mounting

6.4.1 Table Top Installation The hardware to install the table top is shipped with the necessary hardware already attached to it. To mount the table top, it is necessary to: 1 Locate and install the (2) nylon lateral side-thrust rollers and install them on the roller-bearing supports. (05 / Fig. 6-3; 04 / Fig. 6-2) 2

The table top panel has two end-stop devices: each are located on opposite ends of the table top channel guides. Remove one of the end-stop devices, located at the bottom of the table top, and set it aside. (03 / Fig. 6-3)

3

Remove the plastic end caps of the table top, from the side that is near to the end-stop device that was removed. (01 / Fig. 6-3)

4

Remove one of the two panel heads (02 / Fig. 6-3) Insert the table top onto the transversal frame: the panel can be inserted on the transversal frame only in one way. To identify which one, consider that the electromagnetic brake must work on the metallic plate (04 / Fig. 6-3) which is positioned on one of the two lateral guides.

5

6

Before continuing, turn the table power ON and check the action of the electromagnetic brake for any anomalies/noises and make corrections as required.

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7 8

Table Assembly

Re-install the end-stop device into its original location. Re-install the plastic end caps of the table top.

05

03

01

02 04 Fig. 6-3 Table Top Installation

6.4.2 Installation of the Table Top in Confined Areas The patient table top is put on the transversal frame. If it is not possible, because there isn’t enough space, it is necessary to follow the previous instructions for mounting of the receptor and removal of the transversal frame.

2

Extract the transversal frame from its guides. Put the patient table top on the frame.

3

Mount the complete assembly on the transversal guides.

1

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6.5

Table Assembly

AEC Unit Installation for Flat Panel Receptors

As an option, special materials and instructions may be ordered from the equipment manufacturer for installation of compatible Automatic Exposure Control (AEC) units.

01

02

03

Fig. 6-4 Parts Identification Pos.

Description

Quantity

01

AEC unit

–

02

Hook & Loop Strip Tape (Male), L1M

1*

02

Hook & Loop Strip Tape (Female) , L1M

1*

03

Flat Panel, for Digital Imaging Systems

–

Code

* Cut to fit.

The hook and loop strip tape is an optional component that is sold separately. It can be ordered from the manufacturer or dealer.

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6.6

Table Assembly

Electrical Device Connections of the Table Unit Receptor units of different producers and characterized by different diagrams can be present inside the table or inserted later. Refer to the electrical technical instructions that come with the receptor units for their cabling requirements; Refer to the Electrical Technical instructions manual that serves this table for its requirements. The Table unit operation does not depend on any type of connections to the receptor or X-ray generator to operate properly.

6.6.1 Standard Bucky Units For table units destined for use with standard bucky units, the table may be pre-wired for easy connections to common types of bucky units to provide power, start-up and bucky ready contacts. The connections are integrated into the electrical wiring harness of the table and connect the bucky unit to the base of the table, at a junction block, for easier cabling and future servicing. (see Fig. 6-2 & Fig. 4-15) Follow the electrical wiring diagrams that come with the bucky unit and compare them to the table electrical wire diagrams to complete the electrical connections.

6.6.2 Docking Stations The table can be specially equipped to accept a compatible docking station for installation by the client or it may even be installed by the table manufacturer -- by special order only. If installed by the manufacturer of the Table , the connections may be integrated into the electrical wiring harness of the table which connects the docking station to the base of the table, at a junction block, for easier cabling and future servicing. Follow the electrical wiring diagrams that come with the docking station unit and compare them to the table electrical wire diagrams to complete the electrical connections. In any other case, it is the responsibility of the installer / project manager to supply the correct methods for its installation and electrical connections.

6.6.3 Fixed Flat Panel for Digital Radiography Systems Due to the fragile characteristics of the flat panel units, they may be delivered separately from the table unit in its own packing and must be inserted by the installer. Follow the instructions that come with the unit for its care, cabling and installation requirements. These instructions may also be part of a complete system integration that should be furnished by the system integrator or system dealer. The client digital imaging system connections should be compared with the electrical wire diagrams that come with the table to ensure that there are no prohibited electrical connections between them: this must be thoroughly checked to prevent hardware damage to the external controller systems.

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Table Assembly

Important note for digital imaging systems and grid sensor switches connections: The digital system connections should be compared with the electrical wire diagrams that come with the Table unit to ensure that there are no parallel connections between them to prevent hardware damage to external controller systems! Verify that the switches are disconnected from the OEM Table unit controller rack if the sensor switches must be connected to another client controller system. If they are connected in parallel to the OEM Table controller and the digital imaging controller unit -- it will damage or destroy one or more electronic control devices!

Fig. 6-5 Auxiliary PSU Installations (DR System)

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Table Assembly

6.6.4 Interconnection Cable(s) to an External Controller Rack For tables with elevating top, grid switching circuits, or with the optional auto-centering receptor-to-tube function, it is required that the related table components be connected to an external controller rack. The interconnection cables may be passed underneath the table and into the cable ducting along with the cables that serve the Detector Unit main power supply source. Follow the electrical wiring diagrams that come with the Table unit complete the electrical connections. Verify that the cables are fastened securely and that they are not obstructing the movements of the equipment.

External controller rack unit

Main Interface Plate

Table with Motorized Bucky Connections

Vertical Height Referencing

GND / MAINS/ACC -ST1/ -ST2 / -ST4

Vertical Height Referencing

REMOVE AFTER INSTALLATION!

Fig. 6-6 Option External Rack Interface

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7 WALL STAND UNIT MECHANICAL ASSEMBLY 7.1

Mounting of the Receptor in the Mobile Carriage WARNING! Before attempting to unlock the vertical sliding carriage: the receptor unit must be installed, to provide a contrasting load, before the safety bolt can be released. Proceed carefully to prevent the counterweight (which slides inside the column) from injuring persons or damaging things, if it is not correctly balanced.

When the Wall Stand unit is supplied, the receptor unit may be already be mounted in factory—only if the customer had requested it. In any case, the Wall Stand unit will be produced to support the type of receptor indicated for use by the client. Due to the open design, the mounting of the receptor unit is simple and foreword. However, the major hardware, including fasteners and electrical cabling, are not usually included unless it has been specified. Receptor units of different producers and characterized by different diagrams can be present inside or inserted later. Refer to the technical instructions that come with the receptor units for their cabling requirements. Here is depicted an example of a standard bucky unit onto the support plate of the Wall Stand. Index of the illustration found on the following page (Fig. 7-1) Pos.

Description

Quantity

1

CAP

1

2

SCREW TBCE M4x8

2

SCREW TCCE M5x16

4

WASHER D5

4

SPRING WASHER D5

4

4

WALL FIXING BRACKET

1

5

COLUMN, SLIDER

1

6

BRAKE

1

7

FLOOR FIXING BASE

1

8

SCREW TSCE M6x14

1

9

NEUTRAL LAMINATED PANEL

1

10

BUCKY COVER

1

SCREW TBO CE M5x20

4

WASHER PIANA D5 (upper side)

2

LARGE WASHER D5 (lower side)

2

12

PLATE FOR BALANCING CORRECTION

3

13

BUCKY

1

14

BUCKY LATERAL COVER

1

WASHER D5

2

SPRING WASHER D5

2

NUT M5

2

DOWEL 5x20

2

3

11

15 16

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Wall Stand Assembly

Fig. 7-1 Wall Stand Assembly with Bucky Frame

Special installation instructions may furnished, by the manufacturer, with the unit to aid in installation of the type of receptor unit to be installed on the Wall Stand unit. The equipment may be supplied with different options in relation to what is depicted here. This can include differences in physical appearance, optional hardware and even operating characteristics.

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7.2

Wall Stand Assembly

Locking / Unlocking of the Vertical Carriage WARNING! The vertical sliding carriage of the Wall Stand unit is kept locked, during transport, by a safety bolt (see 03 / Fig.7-2). Before removing the safety bolt, the force of the counterweight in the column must be contrasted by installing the receptor unit to prevent the uncontrolled movement when the safety bolt is removed.

After fastening the Wall Stand to the wall and after mounting the bucky or other receptor device (if this has not been already mounted at the factory), it is possible to proceed to the bucky carriage unlocking. During the transport, to avoid equipment damaging, the bucky carriage is blocked to the lower end of travel. Proceed as indicated to unlock the carriage. • Procedure: 1

Remove the screws (Pos. 1 / Fig. 7-2) that fasten the plastic cover (Pos. 2 / Fig. 7-2).

2 3

Individuated the lock nut (Pos. 3 / Fig. 7-2) and remove it. Remount at this point the cover (Pos. 2 / Fig. 7-2) being careful to fasten it by the supplied screws (Pos. 1 / Fig. 7-2).

Index of the illustration found on the following page (Fig. 7-2) Pos.

Description

Quantity

1

PLASTIC SCREW

2

2

CAP

1

LOCKING NUT

1

WASHER D12

1

3 4

Code

–

5

COUNTERWEIGHT

1

6

COLUMN, SLIDER

1

ATTENTION! Proceed carefully to prevent the counterweight (which slides inside the column) from injuring persons or damaging things, if it is not correctly balanced. Only after the installation of the receptor unit, is it possible to remove the safety bolt that avoids the counterweight sliding inside the column. Verify that the unit is locked down, by the safety bolt, whenever it becomes necessary to remove the weight for servicing.

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Wall Stand Assembly

Fig. 7-2 Counterweight Unlocking (after the hardware mounting)

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7.3

Wall Stand Assembly

AEC Unit Installation for Flat Panel Receptors

As an option, special materials and instructions may be ordered from the equipment manufacturer for installation of compatible Automatic Exposure Control (AEC) units.

01

02

03 Fig. 7-3 Automatic Exposure Control Unit Application

Pos.

Description

Quantity

01

AEC unit

–

02

Hook & Loop Strip Tape (Male), L1M

1*

02

Hook & Loop Strip Tape (Female) , L1M

1*

03

Flat Panel, for Digital Imaging Systems

–

Code

* Cut to fit.

The hook and loop strip tape is an optional component that is sold separately. It can be ordered from the manufacturer or dealer.

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7.4

Wall Stand Assembly

Electrical Device Connections of the Wall Stand Unit

Receptor units of different producers and characterized by different diagrams can be present inside the Wall Stand unit or inserted later. Refer to the electrical technical instructions that come with the receptor units for their cabling requirements; Refer to the Electrical Technical instructions manual that serves this Wall Stand unit for its requirements. The Wall Stand unit operation does not depend on any type of connections to the receptor or X-ray generator to operate properly. 7.4.1 Standard Bucky Units For Wall Stand units destined for use with standard bucky units, it only requires that the bucky unit is cabled directly to the generator, or other control unit, to make it work. Follow the electrical wiring diagrams that come with the bucky unit and compare them to the Wall Stand electrical wire diagrams to complete the electrical connections.

7.4.2 Docking Stations The table can be specially equipped to accept a compatible docking station for installation by the client or it may even be installed by the table manufacturer -- by special order only. If installed by the manufacturer of the Table , the connections may be integrated into the electrical wiring harness of the table which connects the docking station to the base of the table, at a junction block, for easier cabling and future servicing. Follow the electrical wiring diagrams that come with the docking station unit and compare them to the table electrical wire diagrams to complete the electrical connections. In any other case, it is the responsibility of the installer / project manager to supply the correct methods for its installation and electrical connections.

7.4.3 Fixed Flat Panel for Digital Imaging Systems Due to the fragile characteristics of the flat panel units, they are almost always delivered separately from the table unit in its own packing and must be inserted by the installer. Follow the instructions that come with the unit for its care, cabling and installation requirements. These instructions may also be part of a complete system integration that should be furnished by the system integrator or system dealer. The client digital imaging system connections should be compared with the electrical wire diagrams that come with the table to ensure that there are no prohibited electrical connections between them: this must be thoroughly checked to prevent hardware damage to the external controller systems.

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Wall Stand Assembly

ATTENTION! Important note for digital imaging systems and grid sensor switches connections:

The digital system connections should be compared with the electrical wire diagrams that come with the Wall Stand unit to ensure that there are no parallel connections between them to prevent hardware damage to external controller systems! Verify that the switches are disconnected from the OEM Wall Stand unit controller rack if the sensor switches must be connected to another client controller system. If they are connected in parallel to the OEM Wall Stand controller and the digital imaging controller unit -- it will damage or destroy one or more electronic control devices!

GRID SWITCH SENSOR (2)

GRID SWITCH SENSOR (1)

GRID PRESENCE SWITCH SENSOR

Fig. 7-4 Example: Flat Panel DR System Installation

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Wall Stand Assembly

7.4.4 Interconnection Cable(s) to an External Controller Rack For all connected Wallstand types, the unit must be connected to the external rack unit of the Floorstand unit. Such as the Wallstand with stitching mode option, the main controller cable is to be connected between the controller rack and the horizontal support arm of the Wall Stand. The controller cable may be passed inside of the provided flexable cable sheath along with the cables that serve the Detector Unit or any other device that must be connected to the horizontal support arm of the Wall Stand. Verify that the cables are fastened securely and that they are not obstructing the mobility of the support stand..

Controller Rack

Horizontal Support Arm

Controller Rack

Client Wall Cable Ducting

Horizontal Support Arm

Fig. 7-5 Wallstand Connection

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8 MECHANICAL ADJUSTMENTS 8.1

Centering the Primary Beam to the Receptor

Before the shipment, the equipment is subjected to tests and detailed inspections in the factory. Also the mechanical parts adjustment is made during the inspection, but because of the impossibility to reproduce the same installation conditions (different way of mounting of rails and components), little adjustments could be necessary.

Adjustments must be done at the end of the mounting, when X-Ray tube and collimator are installed. Verify that the contrast bearings of the mobile carriages are sufficiently adjusted to ensure proper braking control, carriage stability and eliminate misalignments between devices. 8.1.1 Light Field to X-Ray Field Alignment Before performing any type of mechanical or electronic calibrations, it will be necessary to confirm that the collimator unit is properly adjusted to limit the X-ray beam and the light field coincides with the X-ray output. When this has been performed, only then can the light field of the collimator unit be used as a visual aid in making quick alignments. The instructions to check alignment and make adjustments are usually found with the technical service instructions that come with the collimator unit. LIGHT FIELD to X-RAY FIELD ALIGNMENT X-RAY FIELD LIGHT FIELD

Fig. 8-1 X-ray Field to Receptor Alignment

Only after assuring that the LIGHT FIELD to X-RAY FIELD ALIGNMENT is found to be within tolerances, the light field of the collimator unit can be used for quick referencing to make the mechanical and electronic calibrations.

8.1.2 Light Field to Receptor Alignment The mechanical alignment of the Primary Beam to the receptor is obtained by stringent regulations regarding the fixed (limited adjustment) mechanical devices that support the radiology equipment. If the installation was carried using the specified OEM components - and compatible devices - the work to make

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Mechanical Adjustments

alignment of the X-ray field to the Receptors will be greatly reduced. Read further for more information about making mechanical adjustments to the radiology supporting equipment. LIGHT FIELD -to- RECEPTOR ALIGNMENT RECEPTOR LIGHT FIELD

Fig. 8-2 Light Field to Receptor Alignment

8.2

Regulating the Horizontal Support Arm around the Vertical Axis

The column rotation is blocked into position by the mechanical-type foot pedal locker. The foot pedal locker can be adjusted in order correct small variances of the column rotation around the vertical axis pivot and to fine-tune the centering of the X-ray tube output to the receptor. • Procedure:

2

Locate the regulation screws placed under the unlock pedal for the column rotation (Pos. 01 / Fig. 8-3) By using a fixed key no. 19 regulate adjust the block assembly and rotate the column and align the horizontal support arm, in parallel to the Y axis, and centered on the (table) receptor. (Pos. 02 / Fig. 8-3 )

3

Repeat the operation as necessary.

1

01

02

Fig. 8-3 Column Rotation Adjustment

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8.3

Mechanical Adjustments

Regulating the X-ray Tube Inclination Angle

8.3.1 Standard Support Arm Applications The X-ray tube is equipped with mechanical detent to reveal the orthogonal positions at every 90°. It is possible to regulate the detent position in order to correct the alignment to the receptors. (see Fig. 8-4). • Procedure: 2

Remove the horizontal arm cover. By using an Allen key , no. 6, insert in the screw placed on the rear side of the horizontal arm (Pos. 02 / Fig. 8-4) and an open-ended spanner, no. 15, that holds the eccentric bolt (Pos. 02 / Fig. 8-4), and lightly slacken the holding screw.

3

Activate the push button brake control, around the horizontal axis and keep it activated.

4

Act on the eccentric bolt in order to find the required working angle condition, in parallel to the Zaxis, and aligned perpendicular to the table receptor. (Pos. 03 / Fig. 8-4)

5

Fix the eccentric bolt into the new position by keeping it firmly in place by the open-ended spanner and screw it down by using the Allen key.

6

Repeat the procedure, until a good alignment around the horizontal axis is obtained.

1

03

01

02

Fig. 8-4 Tube Inclination Adjustment (standard models)

8.3.2 Motorized Support Arm Applications With this option, the X-ray tube does not have any type of mechanical detent to be adjusted. The regulation of the tube inclination angle is performed by electronic calibration. Consult the Electrical/Electronic Technical Instructions that come with the unit to perform this calibration procedure.

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8.4

Mechanical Adjustments

Regulating the Column Inclination on the Vertical Axis

The adjustment of the Tube Stand column inclination, around the Y-Z axis is not possible. It is a fixed hardware design. In the case of misalignment of the X-ray tube to the receptor, it is not possible to make adjustments, except through the use of an adjustable trunnion ring for X-ray tube support.

8.5

Regulating the Horizontal Support Arm on the Horizontal Axis

The adjustment of the Tube Stand horizontal support arm, around the Y-Z axis is possible. In the case of misalignment of the X-ray tube to the receptor, it is possible to make slight adjustments by adjusting the roller bearings of the stands mobile carriage. This is performed by acting on fixing screws (Pos. 01 / Fig. 8-5) and on the bearings (Pos. 02 / Fig. 8-5) that have the eccentric bolt fixing.

Non Adjustable

Bearing Adjustment

02

01

Fig. 8-5 Column Regulation on the Vertical Axis

Verify that the roller bearings and side thrust bearings, of the mobile carriage on the floor rails, are adjusted properly to keep the Stand alignments to within an acceptable amount of tolerance.

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9 EQUIPMENT DECOMMISSIONING 9.1

Expected Life Span Of The Equipment

The lifespan of the equipment and the availability of spare parts are guaranteed for 10 years from the date of its placing on the market. At the end of operational life, the decommissioning and scrapping of the equipment and its accessories must be made in accordance to the requirements of the provisions concerning waste disposal.

9.2

Disposal Of Materials

At the end of operational life, the decommissioning and scrapping of the equipment and its accessories must be made in accordance to the requirements of the provisions concerning waste disposal. For more information about this, contact the dealer/manufacturer of the equipment or a company who specializes in waste disposal and who is authorized by a competent national authority. The disposal and the material waste treatment applying to the equipment composing materials must be done in accordance with the applicable law when the equipment is disposed of. The equipment may contain electrical parts and for this it can be subject to the provisions contained in the European Directive 2002/96 Waste Electrical and Electronic Equipment (WEEE/RAEE). Almost all the equipment is made of metallic materials such as aluminum, steel, copper and, in a minimum part, plastic materials and electrical / electronic components. •

Metal parts can be recovered as scrap.

•

The equipment contains lead which must not be dispersed in nature.

•

The electrical components and plastic materials must be treated separately as special waste.

•

The disposal / recovery of the materials constituting the equipment must in any case take place, in accordance with the regulations in force at the time when this operation is carried out.

This symbol, found on the nameplate of the equipment, indicates that it is composed of parts that must be treated and disposed of as hazardous waste.

This unit must be disposed of by qualified personnel in order to prevent the occurrence of danger. When disposing of the COLLIMATOR, X-RAY TUBE, GENERATOR, or other significant system devices that may be connected to this device, refer to the operator manuals that come with them.

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End-Of-Life

1 2 3 5

9

9

8

4

6 7

• Pos.

FLOOR STAND FOR X-RAY TUBE SUPPORT Component

Quantity*

1

Column

kg

2

Vertical slider

kg

3

Horizontal support arm

kg

6

Carriage

kg

7

Floor rails

kg

Other __________________ Console

kg

5

Tube cover

kg

6

Rocchetti

kg

Bocchette cavi

Characteristics

Alluminium and its alloys

Totally recyclable material

Plastic and Polyrethane

Inactive material to be treated in dumping

kg

4

7

Material

kg

8

Electrical cables, Plastic Sheaths

kg

Copper, Insulating enamel, PVC, Synthetic rubber

RAEE material to be treated following the directive WEEE

9

Electronic boards, passive electronic component

kg

Epoxy resins, fibre glass, plastic insulating compound

RAEE material to be treated following the directive WEEE

Internal guides

kg

Counterweights

kg

Iron and its alloys, lead

Totally recyclable material

Copper, Iron and its alloys

RAEE material to be treated following the directive WEEE

Other _________________ Motors, transformer, electric brakes

kg kg

* All of the weights indicated are approximate values and can vary according to the model and the options that have been installed on the system that is to be disposed of. * Tutti i pesi e i quantitativi sono approssimati e possono variare a seconda dei modelli di apparecchiature e delle opzioni che compongono l’impianto da dismettere

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10 MAINTENANCE

Before proceeding with the maintenance operations it is recommended to read attentively the section in this manual relating to safety, use and servicing of the equipment.

10.1 General Controls In general, all the equipment used in radiology include electrical and mechanical parts in order to ensure continuity, safety and operating instructions should be subject to regular checks and maintenance. The burden of maintenance after the warranty period (12 months from the date of delivery of the equipment, unless agreed otherwise signed), is charged to the final user. The service of technical assistance from the vendor is available to the user which must agreed upon to arrange for post-warranty maintenance activities. The manufacturer assumes no responsibility in case of malfunction due to:    

Use of the equipment by untrained or unauthorized personnel. Maintenance not performed, insufficient, or not documented. Use of non-original replacement parts. Maintenance performed by untrained or unauthorized personnel. It is the duty of the operator to check, daily, that all safety circuits and signaling are fully functional. The operator must investigate that the controls and ordinary technical interventions of maintenance are made at the programmed intervals. The operator should not take personal initiative in this regard but promptly notify service advisors as soon as there has been a malfunction or a risk of malfunction. The use of the equipment shall be suspended until such time as it was decided to bring in good, safe condition. The responsible party for the safety and maintenance of the equipment must respond to both user calls and for the execution of the maintenance plan provided by the manufacturer. Any work performed on the equipment must be properly registered: Every technical intervention must be recorded in the Maintenance Register (found on the following pages) and in the special adhesive labels placed on the equipment stating the date of execution. This documentation is to be kept with the documentation supplied with the equipment. In order to get a more immediate response from the manufacturer or vendor, it is recommended to indicate the serial number of the equipment and its revision referring the labels applied to the machine.

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10.2 Frequency To Make The Controls Checks of the equipment and its general operating conditions are to be made at intervals not exceeding 12 months. More frequent checks must be made if the equipment is subject to particularly heavy use or in the case of restoring the system after a prolonged downtime.

Disregard for the obligations of maintenance and documentation will void automatically any responsibility of the manufacturer of the equipment. Report to those responsible for the maintenance of the equipment any damage, even in small quantities (e.g. the paint finish), to avoid creating further damage and compromising its integrity. In order to maintain a high quality radiology equipment, and to guarantee its continuous and safe operation, a constant control of the tests and maintenance must be made at regular intervals as recommended by the manufacturer with an expiration of at least every year or whenever it is requested by local legislation (refer to Directive 60601-2-54). The principle types of controls and their frequency in which they normally must be made are listed here: GENERAL CONTROLS

INTERVALS

Cleaning of the slides and ball bearings

12 months

Cleaning and lubrication of the bearings and pivots

12 months

Check and regulation of the ball bearings

12 months

Tightening of the screwed parts

12 months

Check of the braking efficiency

12 months

Verification of the accessories cleanliness and functioning

12 months

Control the condition of the table tops

12 months

Check the efficiency of the alignment and centering devices

12 months

Check the efficiency of the command controls and warning devices

12 months

Verify the earthing connections and the dispersion of the current

12 months

Check the conditions of the cables and cable sheaths

6 months

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 If the unit presents dents, repair them; in case of damaged painted surfaces, touch them up using the paint issued by the manufacturer.

It is very important to repair as soon as possible the unit damages. In particular, remember that every scratch to the protection paint must be touched up with specific paints supplied by the producer; if this operation is well done, it avoids a dangerous oxidative phenomenon, which could compromise the efficiency and the resistance of the stand metal structure. The unit painting is made using powder paint and baking in furnace. To touch up the unit, a small bottle containing some original powder is supplied; this must be dissolved through a drop of paint thinner (NITRO preferred) and applied by using a soft brush.  Grease bearing and pins, which can be reached.

For the greasing use common universal grease, which is on sale. DO NOT use oils or other lubricants, that could cause draw or dirty the unit or the working area.  Check the functioning backlash of bearings and of guiding and braking devices. It is very important to check the slack of the ball bearings and, if necessary, make their regulation following the instructions written in the previous chapter. This is required to also maintain the correct alignments and tolerances between devices and components  Check the correct functioning of the control and braking devices as well.  Check the correct tightening of the nuts and bolts.  Check the correct functioning of the electrical parts as well, that means the functioning of push buttons and brakes and the integrity of cables and safety devices.

The earthing connections and tests must be made according to the local regulations and directives of the country in which the system is installed.

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10.3 Control of the Suspensions Wire Ropes The vertical balancing of the TUBE SUPPORT STAND is served by a counterweight (positioned internally in the column) and is connected by two wire ropes for support of the X-ray assembly group. Special attention and maintenance of the suspended parts is requested in as much that it could represent a serious danger.

Do not use the unit if damage is found at one or both of the two wire ropes or they show telltale signs of breakage or are used up. Contact technical support for replacement of the broken wire ropes.

The controls of the steel wire ropes must be planned out following the data indicated in the following table. CONTROLS OF THE WIRE ROPES

INTERVALS

Conditions of the wire ropes

12 months

Conditions of the ropes pulley system

12 months

PARTS TO REPLACE

INTERVALS

Steel wire ropes

10 years

It is possible to ask for the replacement parts or updates from the constructor that remains at the disposition for any interventions of maintenance, assistance or extraordinary renovation of the equipment as well. If it becomes necessary to contact the manufacturer for technical problems or the equipment maintenance, take note, in advance, of the units serial number and revisions in order to quicken and focus the technical support intervention. This information can be easily obtained from the identification label, which is placed on the equipment.

The wire ropes must be replaced at the intervals prescribed and as indicated on the equipment labels. The technical personnel that carries out the controls must always fill out the appropriate spaces on the labels by registering the date of its execution and by signing their name on it. If any malfunctions are found during the check ,it is necessary to immediately replace both the ropes and check that also the pulleys and the winding lead nut do not show damages or tear and wear signs. In contrary case, it will be necessary to replace them too.

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10.4 Cleaning And Disinfection The equipment does not require particular cleaning operations. However, it is recommended that during the operations to give proper attention to avoid damaging it.  The mains power must be disconnected before proceeding with the cleaning operations. The water in quantities should not be used, to avoid dangerous infiltrations and undesirable phenomena of corrosion of the metal parts.  Even products used to clean and disinfect the skin can create an explosion risk.  For disinfection, use commercial products whose effects are tested. Do not use disinfectants gaseous formaldehyde and aerosol products that could generate dangerous and damaging infiltration into the equipment.

More information and directions are available in manuals and instructions for disinfection and protection against explosions.

10.4.1 Cleaning  Clean the equipment with a damp cloth or a cotton swab. Use a non-abrasive cleaning material. To moisten, use water or lukewarm water with a diluted solution of liquid detergent of the common household type.  Do not use abrasive cleaners or organic solvents or cleaning agents containing solvents (eg. alcohol, ether, etc.). Do not use hydrogen peroxide which enhances the corrosion of metals.  Do not use spray liquids! Agents for cleaning fluids must not enter under any circumstances within the enclosures!

It is recommend to use a damp cloth, preferably hot, taking care to dry very thoroughly treated surfaces.

10.4.2 Disinfecting For surface disinfection, it is recommended to use aqueous solutions commercially available for the disinfection of surfaces based on aldehyde or amphoteric surfactants (eg, Tego 103, Korsolin). Disinfectant substitutes based on phenolic and chlorine-containing compounds are partially aggressive and therefore normally to be avoided. The same limitations apply to agents which have an alcohol content when they are applied in undiluted form (eg for the disinfection of hands). Strictly prohibited are spray disinfectants, because the spray could penetrate inside the device. As a result, the safety of the appliance can no longer be guaranteed (damage to electronic components, formation of flammable mixtures of air and solvent vapors). Where the entire exam room is to be disinfected, remember to cover the unit with plastic sheeting.

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TM76301-EN Rev.0 2018JUL

104

TECHNICAL MANUAL

Equipment Maintenance Register This information must be filled out whenever the prescribed servicing and maintenance procedures have been performed on the unit(s) at the time intervals specified. • Equipment Registry Information Model

Serial number

Options

Installation date

• General Checks, to Perform at Every 6 Months GENERAL CHECKS

INTERVAL

Condition of sheaths and electrical cables

6 months

Date

TM76301-EN Rev.0 2018JUL

Signature

Date

105

Signature

TECHNICAL MANUAL

Glossary

• General Checks, to Perform at Every 12 Months GENERAL CHECKS

INTERVAL

Cleaning of the slides and ball bearings

12 months

Cleaning and lubrication of the bearings and pivots

12 months

Check and regulation of the ball bearings

12 months

Tightening of the screwed parts

12 months

Check of the braking efficiency

12 months

Verification of the accessories cleanliness and functioning

12 months

Control the condition of the table tops

12 months

Check the efficiency of the alignment and centering devices

12 months

Check the efficiency of the command controls and warning devices

12 months

Verify the earthing connections and the dispersion of the current

12 months

Check the conditions of the cables and cable sheaths

6 months

SUSPENSION CABLES CHECKS

INTERVAL

Condition of the steel ropes

12 months

Condition of the ropes pulleys

12 months

Date

Signature

Date

Signature

• Mandatory Parts to Replace, at Every 120 Months (10 years) PART S T O REPLACE

INT ERVAL

Steel ropes

10 years

Date

TM76301-EN Rev.0 2018JUL

Signature

Date

106

Signature

TECHNICAL MANUAL

Glossary

Terms

Definitions

Forms of Measurement

°C

Degree scale in Celsius. It is the unit for measuring the temperature.

°F

Degree scale in Fahrenheit. It is the unit for measuring the temperature.

cm m/M

Centimeter (metric system). The International System of Units (SI) for measuring the length. 0,01 m. Meter (metric system). The International System of Units (SI) for measuring the length.

kg

Kilogram (metric system). The International System of Units (SI) for measuring the mass.

in

Inches (imperial system). I It is a unit of length measurement that is widely used in the countries of Anglo-Saxon culture.

ft

Foot (imperial system). It is a unit of length measurement that is widely used in the countries of Anglo-Saxon culture.

lb / lbs

Pounds (imperial system). The pound (pounds) is a unit of mass measurement.

N

Newton (measuring unit). It is the unit of measurement of force that is part of the derived units of the International System of Units (SI).

s

Second (minute second). It is a unit of measurement of time and one of the seven basic units of the International System (SI).

hPa

Hectopascal. It is the conventional unit of measurement of atmospheric pressure.

Kbit/sec

Kilobyte per second. Related to communication protocols.

Reference Designator ST J

denomination for electrical connector

L

Inductor

PB PS / PSU SW

TM76301-EN Rev.0 2018JUL

Strip terminal; morsettiera

Push button; pulsante Power supply unit; Alimentatore Switch/microswitch; interruttore/microinterruttore

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TECHNICAL MANUAL

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BT7630 Radiographic Table at Fixed Height

Technical Manual

BT7630MTE00 – 19-06-2018

Technical Manual EQUIPMENT

Description

1

EQUIP.ID

Radiography Table at Fixed Height

BT7630 / BT7632 / MTOp

REVISIONS

The original version of this document was drawn up in the Italian language and to this it will be referenced to for any possible controversy of interpretation. Date:

Code:

Rev.

06/2018

BT7630MTI0

0

Remarks:

Edit by:

App’d by:

First edition, translated from Italian.

CONTACT INFO

The equipment subject of this manual has been developed, assembled, and tested by:

M.T. Medical Technology s.r.l. Via Friuli, 6/2 – 20853 Biassono (MB) – Italy tel. +39 039 249 4841 fax. +39 039 249 9003 email. [email protected] web. www.emmetisrl.com This publication or its parts cannot be copied, saved on a memorization support, transmitted or translated into any languages (common or data processing), in any form or through any kinds of means (electrical, mechanical, magnetic, optical manual or other) without a clear written authorization by M.T. M.T. does not extend warranties concerning reproductions of this documentation, either partially or in its entirety, unless specifically authorized by M.T. As well M.T. does not extend warranties concerning additions and/or modifications to the original documentation made by and held by M.T. Copyright © M.T. Medical Technology S.r.l. - All Rights Reserved

BT7630MTE00 – 19-06-2018 Page 2 / 46

Technical Manual

WARNING The instructions contained in this manual are based upon configuration of the system at the time of construction. The manufacturer will provide and inform the client operator when to make changes and/or updates as they are made available after that date. FOR THE USER OF THIS MANUAL

The installer/operator must before using this equipment read carefully and in its entirety this manual to assure that it perfectly meets their requirements. Even if the user has practical experience with similar systems as described in this manual there may have been changes in its design, in the production or in the procedures of its application that may affect its proper use. The installation and the maintenance of the installation described in this document must be performed by qualified personnel and authorized by the manufacturer. DIAGNOSTIC X-RAY SYSTEMS RADIATION WARNING

X-ray and gamma-rays are dangerous to both operator and others in the vicinity unless established safe exposure procedures are strictly observed. The useful and scattered beams can produce serious or fatal bodily injuries to any person in the surrounding area if used by an unskilled operator. Adequate precautions must always be taken to avoid exposure to the useful beam, as well as to scattered radiation resulting from the passage of radiation through matter. Those authorized to operate, participate in, or supervise the operation of the equipment must be thoroughly familiar and comply completely with the current established safe exposures factors and procedures described in publications, such as: subchapter J of title 21 of the code of federal regulations, “Diagnostic X-ray Systems and their Major Components”, and “IEC 60601 General and Collateral Standards” as revised or replaced in the future. Those responsible for the planning of X-ray and gamma-ray equipment installations must be thoroughly familiar and comply completely with: NCRP no. 49 “Structural Shielding Design and Evaluation for Medical X-rays and Gamma-rays of Energies up to 10 MeV” and IEC-407 “Radiation Protection in Medical X-ray Equipments 10kV - 400kV” as revised or replaced in the future. INSTALLATION, ENVIRONMENT & THE USE OF RADIOLOGIC EQUIPMENT

Except for installations requiring certification by the manufacturer per federal standards, see that a radiation protection survey is made by a qualified expert in accordance with NCRP 102, section 7 or IEC related general and collateral standard as revised or replaced in the future. Perform a survey after every change in equipment, workload, or operating conditions which might significantly increase the probability of persons receiving more than the maximum permissible dose equivalent. MECHANICAL - ELECTRICAL WARNING

All of the movable assemblies and parts of this equipment should be operated with care and routinely inspected in accordance with the manufacturer’s recommendations contained in the equipment manuals. Only properly trained and qualified personnel should be permitted access to any internal parts. Live electrical terminals are deadly; be sure line disconnect switches are opened and other appropriate precautions are taken before opening access doors, removing enclosures panels, or attaching accessories. Do not remove flexible high voltage cables from X-ray tube housing or high tension generator and/or access covers from generator until the main and auxiliary power supplies have been disconnected.

Failure to comply with the foregoing may result in serious or fatal body injuries to the operator or those in the area.

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Technical Manual CONTENTS 1

General Information ........................................................................................................... 7

2 Equipment Description and Technical Specifications ......................................................... 9 2.1 Unit Description ............................................................................................................. 9 2.2 Tavolo bucky .................................................................................................................. 9 2.3 Patient Table Top ........................................................................................................... 9 2.4 Bucky Carriage ............................................................................................................... 9 2.5 Technical Specifications ............................................................................................... 10 2.6 Parts to Compliment the Equipment ........................................................................... 11 2.7 Optional Accessories .................................................................................................... 11 2.8 Other Technical Specifications..................................................................................... 11 2.9 Technical Designs ......................................................................................................... 12 2.10 Identification & Attention Labeling ............................................................................. 12 3 3.1 3.2 3.3 3.4

Safety Measures for Use ................................................................................................... 17 General Warnings ........................................................................................................ 17 Residual Risks & Accident Hazards .............................................................................. 18 Electrical Safety............................................................................................................ 18 Protection Against Radiation Hazards ......................................................................... 18

4 4.1 4.2 4.3 4.4 4.5 4.6

Installation ........................................................................................................................ 19 Room Preparation........................................................................................................ 19 Tools Required for the Installation .............................................................................. 19 Equipment Storage and Transport Conditions ............................................................ 19 Equipment Receiving ................................................................................................... 21 Positioning and Fixing of the Bucky Table ................................................................... 23 Unblocking the Table Bucky......................................................................................... 23

5 Assembly ........................................................................................................................... 25 5.1 Mounting of the Receptor ........................................................................................... 25 5.1.1 Mounting of the Bucky in the Mobile Carriage ...................................................... 25 5.1.2 Docking Station Installation .................................................................................... 25 5.1.3 Fixed Panel Installation ........................................................................................... 26 5.2 Adjustment of Guide Bearings and Table Top Brakes ................................................. 26 5.3 Mounting of the Patient Table Top.............................................................................. 27 5.4 Installation of the AEC Unit.......................................................................................... 28 5.4.1 AEC unit with potter bucky ..................................................................................... 28 5.4.2 AEC unit with Docking Station ................................................................................ 28 5.4.3 AEC unit with Fixed Panel ....................................................................................... 28 6 6.1 6.2 6.3

Electrical Connections ....................................................................................................... 29 Connection to the Mains ............................................................................................. 29 List of Electrical Components for the Bucky Table ...................................................... 30 Bucky Connections ....................................................................................................... 32 BT7630MTE00 – 19-06-2018 Page 5 / 46

Technical Manual CONTENTS 6.4 6.5 6.6

Docking Station Connection......................................................................................... 32 Fixed Panel and Digital Systems................................................................................... 32 Connection of an External OEM Electronic Controller System (option) ...................... 33

7 7.1 7.2

Equipment Decommissioning ........................................................................................... 35 Expected Life Span of the Equipment .......................................................................... 35 Categorizing and Disposal of the Materials ................................................................. 35

8 Maintenance ..................................................................................................................... 37 8.1 Safety Measures for the Maintenance ........................................................................ 37 8.2 Tools Required ............................................................................................................. 37 8.3 General Controls .......................................................................................................... 38 8.4 Periodic Controls.......................................................................................................... 39 8.5 Cleaning and Disinfection ............................................................................................ 41 8.5.1 Cleaning .................................................................................................................. 41 8.5.2 Disinfecting ............................................................................................................. 41 Maintenance Register ................................................................................................................. 43 Glossary ....................................................................................................................................... 45

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Technical Manual

1 General Information All the documentation accompanying the equipment, and especially this manual, must be preserved and made available to operators and technical support. This documentation is to be considered as an integral part of the equipment. The equipment specified here is designed for use in the radiological field in accordance with its intended use. Any other use is considered unexpected use. •

Scope of this Manual

The purpose of this manual is to fully inform the operator, installer and responsible party’s of the installation characteristics, requirements, and precautions to be taken during the setup, use and required maintenance to which it must be subjected to ensure its efficiency and reliability.

•

Document Rights

This manual, including drawings, tables and photographs it contains, is the exclusive property of the manufacturer. It may not be disclosed, copied or reproduced in part or by any means without the written authorization. M.T. reserves the right to edit / revise this documentation without prior notice.

•

Documents Enclosed with the Equi pment

The documentation supplied with the equipment and especially this manual must be carefully kept and made available to the beneficiaries. This documentation is an integral part of the device and is delivered along with it.

•

Guarantee

The equipment, subject of this manual, comes with a limited warranty. The duration and obligations of the warranty are subject to a contractual agreement made between the seller of the equipment and the buyer and it is to be confirmed in writing. The validity of the guarantee is subject to the scrupulous respect of the information contained herein.

ATTENTION! Guarantee is voided immediately if works on the equipment is made by unauthorized personnel. •

Manufactur er Res ponsibility

The manufacturer declines any liability for material damage or personal injury resulting from use other than that intended, and these consequences are the sole responsibility of the user. The scrupulous observance of the mode of operation, maintenance and repair as specified by the manufacturer is also considered an essential part of the intended use of the equipment. Modifications not authorized by the manufacturer will void its liability for damages and accidents that could result.

•

European C ommunity standar ds and s afety compliance (CE)

The unit is manufactured in compliance with the requirements of European Directive 2007-47-CE for Class 1 devices (Annex VII). The unit was manufactured and tested respecting EN60601 safety rule for electro-medical units. The declaration of conformity of the unit is supplied with the accompanying documentation. A copy of this document can be obtained from the manufacturer.

•

Manual Conventi ons : Symbols, Orientati on & Measuring Units

The physical orientation of LEFT and RIGHT are determined by the operator standing in front of the control board station, or work station, of the equipment when in it is in its default working position. The measures in this manual are expressed exclusively in the Decimal Metric System (International), including multiples and submultiples (the temperature is expressed in degrees Celsius (° C)). The reference numbers in this document refer to the figures in it and their meanings are: [ Fig.1–2 = figure 2 of chapter 1 ] / [ 1 / Fig.1–2 = point-out 1 of the figure 2 of chapter 1 ] The following symbols are used throughout this manual to advise the operator to take note of additional information, warnings and / or risks associated with the use of equipment:

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Technical Manual

WARNING / ATTENTION / CAUTION The topics identified with this icon concern safety aspects for the patient and / or the operator. IMPORTANT INFORMATION Particular attention is recommended when reading the topics identified with this symbol.

•

Warni ng Sym bols on the Equi pment

The following symbols may be found on the equipment to advise the operator to take note of information, warnings and / or risks associated with the use of equipment. Warning Symbols Symbol

Description

Symbol

Description

Follow instruction for use / Refer to instruction manuals for its use

Pushbutton for the emergency shut off

General mandatory action sign

Emergency stop

Warning symbol that indicates potential generic danger for the equipment or the operator. Check the equipment documentation for other details.

Warning symbol that indicates electrical components which are sensitive to electrostatic discharge.

Warning symbol that indicates live electrical parts with a possible risk of electric shock.

Warning symbol that indicates that fingers may be crushed.

Hazard symbol that indicates X-ray radiation exposure.

Indicates that a laser is present and presents a low risk to eyes.

General prohibit sign

Sitting prohibited

Pushing prohibited

Stepping prohibited

Symbol of earth protection

Symbol of filtration

Ground

Where presented, indicates the risk of electromagnetic interference

Symbol of applied part B type.

Symbol that indicates electrical and electronic components which must be collected separately.

Maximum allowable weight

This side must face towards the X-ray Tube (grid insertion)

The equipment manufacturer.

Fluoroscopy and radiography foot pedal

The date of equipment manufacturing.

Injector

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Technical Manual

2 Equipment Description and Technical Specifications 2.1

Unit Description

The radiographic unit object of this manual consists of a fixed height bucky table, whose patient table top, made of laminated plastic, can be longitudinally and transversally moved. Recently designed, the equipment benefits from structural technologies and functional methods that can guarantee high quality standards.

2.2

Tavolo bucky

The bucky table has a basic structure composed of a fixed lower part (made of bent, welded and reinforced sheet steel) and of a movable upper part that rests directly on the base structure. The examination plane can be moved manually in the four directions and is kept in position by electromagnetic pedal-controlled brakes. The brake release pedal is located at the base of the table.

2.3

Patient Table Top

The patient table top is in radiotranslucent plastic laminate with low absorption (or built with a “sandwich” structure in carbon fiber as option). The lateral table profiles, in laminated extrusions, have a lateral groove for the accessories fastening, allowing them, at the same time, the greatest freedom in movements. The table top can be moved manually on the horizontal table and it’s kept in position by electromagnetic brakes that are controlled by foot pedal. The table in its basic configuration is equipped with electromagnetic brakes that operate when energized by current.

2.4

Bucky Carriage

The bucky carriage slides in the special guides under the patient table top. A special handle incorporates the electromagnetic brake release push button of the carriage, the emergency stop control (red mushroom type pushbutton, if equipped with option motorization) for de-activation of the motorized movements and also allows for the positioning of the bucky carriage. The bucky carriage has special housings for the grid and the ionization chamber. The buckys can have the measuring chamber for the AEC systems (Automatic Exposure Control) and the measuring device of the cassette size for the ACS (Automatic Collimation System). The equipment is predisposed for the installation of the longitudinal motorization group for the bucky. On request from the client, the table can be supplied with this option. The table can be requested to support detector or docking station for digital systems.

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Technical Manual

2.5

Technical Specifications

Patient Table Top

•

Material

laminated or fibre carbon

•

Dimensions

•

Movement

220 x 76 cm (laminated panel) 220 x 76 cm (fibre carbon panel)* 240 x 76 cm (fibre carbon panel)* Manual

•

91 cm (± 40,5) 101 cm (± 50,5)*

• • •

Longitudinal travel total TT 2200mm (laminated or fibre carbon) Travel longitudinal total TT 2400mm (fibre carbon)* Trasversal travel Braking

•

Distance from table top to film

≈ 7 cm

26 cm (± 13) Electromagnetic

Bucky Carriage

• •

Movement Travel longitudinal

•

Braking

Manual or motorized* 57 cm for table bucky standard 61 cm for table with detector or docking station for digital systems Electromagnetic

Power Supply

Monophase

• •

230 (220/240) Vac 50/60 Hz 150 VA

Tension / frequency Maximum aborbed power

Painted parts

•

RAL 9016

Metallic parts

Weight

•

180 kg

Table at fixed height

Transport and stocking environment

•

Temperature in °C

• •

Relative humidity (without condensation) Atmospheric pressure range

0 °C ÷ 50 °C 10% ÷ 90% 50 ÷ 110 kPa

Operating environment

• •

Temperature in °C Relative humidity (without condensation)

10 °C ÷ 40 °C 30% ÷ 75%

•

Atmospheric pressure range

70 ÷ 110 kPa

Equipment classification

• • •

Classification according to EN 60601 Type of Installation Functioning mode

Class I - Type B Permanently connected Continuous

Standard compliance

• •

Electromagnetic compatibility Safety regulations

European directive 89/336 EN 60 601

*opzione

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Technical Manual 2.6

Parts to Compliment the Equipment

Bucky with cassette tray Grid (standard supply)

2.7

Per f.ti from 13x18 to 35x43cm DF=100cm R=12:1 36L/cm

Optional Accessories

Carbon fibre table top 220x76 cm Carbon fibre table top 240x76 cm Longitudinal motorizzazione of the bucky Arm support (without clamp) Flebo support (without clamp) Aluminium clamp (universale) Pair of patient handgrips (lateral) Curtain / compression band (lateral) articulated lateral cassette holder (24 x 30 cm) lateral cassette holder (35 x 43 cm) Pair of leg supports (lateral) Pair of table top edges Matress 220X65X4 for ET/BT

2.8

Other Technical Specifications

Additional information about technical specifications and operating characteristics can be found in the OPERATOR MANUAL that also is supplied with this equipment. This information includes: •

Destination of use

•

Protection classification

•

Compliance to standards and directives

•

Electromagnetic compatibility

•

Compatibility with other components and devices

•

Accessories and available options The operator must also refer to the instruction manuals of the individual components.

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Technical Manual

2.9

Technical Designs

Technical drawing examples of the mechanical configurations, and for aid in installation and servicing, are presented within this manual. Check for file addendums supplied with the documents, or other file attachments that may be attached directly to the unit at time of packing and shipping, which may indicate system updates, modifications, or special ordered options that are not discussed in this instruction set. Send a request to the dealer/manufacturer know about obtaining copies of the related technical drawings or to know about any system updates not discussed within this manual.

2.10 Identification & Attention Labeling The units are identified with a series of adhesive labels positioned on them. These labels are applied to identify the product both from the commercial point of view both to fulfil the requirements of the standards currently in force. On the rating plate shows the device name, the address of the company and the place of production. It also lists the following information: •

Model

•

Serial number and lot number

•

Date of production (month and year)

•

The nominal tension, number of phases, current absorption, and line frequency

•

Label for registering cable substitution (if applicable)

•

Labels of warning and dangers

•

Serial number (not externally visible)

Make reference to the figures on the following pages for identification of the units. Do not remove the manufacturer labels applied to the equipment; they are an integral part of the instructions and documentation that accompany it. The equipment identification label may be different from what is illustrated here, if the equipment has been supplied by an authorized equipment dealer and the unit has been connected to their own proprietary equipment in order to produce a fully integrated system for the end-user. Additional documentation, provided by the dealer of the equipment, may also be presented to indicate the model, serial number, equipment options and other customizations offered by them.

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Fig. 2-1 Drawing : Table with Potter Bucky BT7630MTE00 – 19-06-2018 Page 13 / 46

Technical Manual

Fig. 2-2 Drawing: Table with Fixed Panel (digital)

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Fig. 2-3 Product Identification Label

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3 Safety Measures for Use The installer must read and follow the instructions found in the Operator’s Manual that comes with this unit(s) and those instructions that come with any accessories for detailed information about safety precautions and warnings.

3.1

General Warnings ATTENTION! THERE SHALL BE NO MODIFICATIONS TO THIS DEVICE! Changes to the product are not allowed unless specifically indicated for and authorized by the manufacturer. Unauthorized changes can compromise the equipment functioning and safety, as well as voiding the manufacturer’s guarantee. Any modifications to the equipment with the purpose to increase its travels, performances and/or load capacity are strictly prohibited. In particular, it is not possible to disable or replace devices and/or circuits which permit uncontrolled radiation emissions, in accordance to safety laws. After the installation of the unit, the end user must assess the need for audio and video communication tools between the operator and the patient.

In addition to the warning and instructions located in the documents that come with the devices, the installer/operator is reminded to follow this advice: •

Read the instructions and take heed of the warnings in the documents!

•

Refer to the drawings and to the technical features, written in this manual, to be aware of the performances and the maximum loads that can be supported.

•

The X-ray equipment is to be installed and used in the radiological diagnosis by qualified personnel, who know exactly what the inherent risks are for systems that use ionizing radiation and are able to take the necessary protective measures.

•

The regulations and laws in force in the various countries for the type of equipment are to be considered and observed both by the installer and by the operator.

•

The X-ray equipment can be installed and operated only in areas designated for medical use (refer to local regulations).

•

The equipment covered by this manual is not intended for use in areas at risk of explosion.

•

The powers and responsibilities of the individuals with respect to installation, commissioning, operation and maintenance of the equipment, must be clearly defined and strictly adhered to.

•

All operations to do on the unit must be carried out when it does not work. The person who is responsible of the maintenance must completely disconnect the unit, before the adjustment or replacement of an equipment part.

•

Keep hands, feet, dresses, jewels and hair at safety distance from any moving part in order to avoid their getting caught.

•

Keep all parts in good condition and correctly installed. Repair immediately damages, replacing the consumed and broken parts with genuine or OEM compatible parts.

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Technical Manual

3.2

Residual Risks & Accident Hazards In the event that the compatibility between the vertical Bucky Stand, together with its accessories, is not explicitly stated in the documentation, the user of the equipment must ensure that no dangerous situations can occur for the patient and for auxiliary staff.

The TABLE BUCKY has been designed to conform to the most recent safety principles. However, during its use, especially if improper, may result in residual risks. More information about this will be found in the Operator Manual that comes with this equipment.

3.3

Electrical Safety WARNING! This installation requires working with high tensions. WARNING! To avoid the risk of electric shock, this unit must be connected to supply mains with protective earth. This equipments destination of use is specified for a permanent-type installation. It cannot be connected to a power strip or extension cord. Connect only the specified items as part of the TABLE BUCKY or compatible with it. Further information on electrical safety and installation warnings can be found in the electrical instruction manual supplied with this unit.

Protection relating to electric shocks complies with current whose compliance was validated by a notified body. It is therefore extremely important that periodically the ground wires of the system are tested in order to maintain the standards of safety.

3.4

Protection Against Radiation Hazards KEEP A S AFE DI STANCE AW AY FROM THE X-R AY SO URCE! The protection regulations to be observed also apply to service personnel. The activities in controlled areas, involves an obligation to always wear a personal dosimeter.

It is the responsibility of the installer to foresee at the time of installation the screening that must protect the personnel from radiation and consent at the same time the steadfast verification of the state of the patient. To protect the patients, the operators and whomever else is at risk from the radiation, anti-radiation protections and procedures must be employed to comply with regulations regarding X-ray emission.

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Technical Manual

4 Installation 4.1

Room Preparation

This chapter gives useful information to prepare the room where the unit, object of this manual, will be installed. It is the duty of the client’s project manager to plan, ahead of time, all the necessary works required to complete the installation.

4.2

Tools Required for the Installation

The equipment mounting does not need specials tools, but common use ones, like those listed below. Other special tools may be required for construction modifications.

4.3

•

set of open-end wrenches/spanners

•

set of box-end wrenches/ring spanners

•

set of Allen keys

•

set of screwdrivers

•

levelling tools

•

measuring tools

•

drilling machine, percussion-typewith a set of drill bits for concrete

•

lifting device (if available)

Equipment Storage and Transport Conditions

Once the unit is assembled in the factory, it is subjected to careful controls and tests from trained personnel. The equipment is packed with corrugated card-board and wrapping paper (pluriball). For international shipment, or upon customer’s request, the equipment is crated in one or more wooden cases. Before the installation, the unit can be kept in the warehouse for some time with its original packaging. In any case, although every metal part is carefully covered by protection paint or oxidation superficial treatment, the equipment is not planned to work or be stocked outdoors. It cannot withstand the humidity; for this reason, do not keep it outdoor or in extreme environment conditions. Before the installation, the unit can be kept in the warehouse for some time with its original packaging. In any case, although every metal part is carefully covered by protection paint or oxidation superficial treatment, the equipment is not planned to work or be stocked outdoor. It cannot withstand the humidity; for this reason, do not keep it outdoor or in extreme environment conditions.

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Technical Manual

The wooden cases are made to be lifted through a lifting device (forklift truck). If they must be lifted from the top (crane), it is necessary to sling them through suitable ropes, which must twine round the case.

It is absolutely forbidden to pass by or under the load during the lifting operations.

Make sure the cases are well fixed during the transport to avoid blows which could damage their contents.

Make sure the cases are well fixed during the transport to avoid blows which could damage their contents.

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4.4

Equipment Receiving

Refer to the instructions outside the cases for their moving and lifting.

The equipment is contained in one wooden case, whose contents are briefly listed below. The exact case contents are specified in the Packing List which is attached on the case. The CASE dimensions are 232L x 87W x 106H cm (gross weight about 190 kg) contains (Fig. 4-1): •

The table bucky (without table-top);

•

the table top;

•

any accessories.

In case the table is coupled to another device (for example a floor or ceiling stand) the table case only contains the table and accessories (157L x 92W x 101H cm), while the panel is inserted in the box containing the stand. To extract the table from its packing case it is necessary to:     

Remove the cover from the top of the case; Remove the table top from the case (resting on top) and any accessories; Locate the envelope containing the documents and assembly instructions and store them carefully; Remove one of the long case side walls; Remove the table and bring it to the working position.

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Technical Manual

01 04 05 06 07 02

03

Fig. 4-1 Case Contents (file: me940001) Pos.

01 02 03 04 05 06 07

Description

Quantity

UPPER CASE COVER WOODEN CASE PACKING LIST PATIENT TABLE TOP DOCUMENTS AND MANUAL PACKAGE TABLE STRUCTURE CASE LATERAL SIDES

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1 1 1 1 1 1 1

Technical Manual

4.5

Positioning and Fixing of the Bucky Table

In the plan view of the equipment (Fig. 4-2) are indicated: •

The fixing points of the table

•

The under track canalization for the power supply and working cables

To fix the Table:  Remove the bucky table front pannel;  Mark the fixing positions and, through a power drill with percussion and D16 widiam drill, make the fixing holes, whose depth must be of 80 mm at least;  Insert the D16 and M10 metal fisher in the holes; then fix the table using hexagonal-head screws TE M10x60 or Allen screws TCCE M10x60. Take care that the floor support is uniform and level, use a level as a control tool. Shim where necessary making sure that the tightening of the screws in the bottom does not lead to the deformation of the base structure of the table.

4.6

Unblocking the Table Bucky

Once the table has been put into place, the upper parts can be unlocked, held in position during transport. Also proceed to unlock the bucky carraige, also the latter which is blocked for transport. Before closing the table with the front panel, make the necessary electrical connections.

ATTENZIONE!

Verify that the top and the bucky carriage are completely unlocked, before using the equipment in order to permit a good working and to avoid the unit damaging.

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Fig. 4-2 Table Fixing and Cable Paths BT7630MTE00 – 19-06-2018 Page 24 / 46

Technical Manual

5 Assembly 5.1

Mounting of the Receptor

5.1.1 Mounting of the Bucky in the Mobile Carriage When the bucky table is supplied, the tray has already been mounted in factory, if the customer required it. In order to get the bucky in the carriage under the table, it is necessary to extract the transversal frame from the sliding guides. To remove the transversal frame it is necessary to: • disconnect the cable, which connect it to the below fixed part; •

take out the stop block limiter at the end of the transversal movement of the frame

To disconnect the connection cable it is necessary to:  to take out the two screws which lock the cable connector support to the table structure;  Disconnect the connector, which comes from the table interior, from the connector that is fixed to the support. To remove the stop block limiter, you must:  remove the inner cover of the transverse bearing cover fixed to the outer bearing plate from the left support of the cross-frame sliding guide (01 / Fig. 5-1)  remove the two screws that secure the stop block limiter (02 / Fig. 5-1) Once the frame is extracted from the guides, the bucky cover can be removed and it is possible to reach it or insert one if it is absent.

01

02 Fig. 5-1 Transversal end-of-travel block

5.1.2 Docking Station Installation As an option, the Table Bucky unit can be specially equipped to accept a compatible docking station for customer installation or can be installed by the table manufacturer. In any other case, it is the responsibility of the installer / project manager to provide the correct methods for installation and electrical connections. Follow the instructions for mounting the bucky. BT7630MTE00 – 19-06-2018 Page 25 / 46

Technical Manual 5.1.3 Fixed Panel Installation Because of the fragile characteristics of the fixed panels, these are almost always delivered separately from the table unit in its own packaging and must be inserted by the installer. Follow the instructions provided with the unit for its maintenance, wiring and installation requirements. These instructions can also be part of a system integration that should be provided by the system integrator or system vendor. Also, follow the instructions for mounting the bucky.

5.2

Adjustment of Guide Bearings and Table Top Brakes

The guide and support bearings of the patient table top are those shown in the Fig. 5-2 e Fig. 5-3. It is also possible to correct, within a narrow range, the working distance of the electromagnetic brakes (03 / Fig. 5-2), by acting on the nuts that fix them to the supporting leaf. To perform these operations, it may be necessary to remove the top panel and the transversal frame. In this case, refer to the figures and instructions on the previous pages.

Fig. 5-2 Transversale Frame Guide Bearings and Brakes

Fig. 5-3 Guide Bearings and Brake for Table Top

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Technical Manual

5.3

Mounting of the Patient Table Top

The patient table top is inserted into the transverse frame. And, if this is not possible, due to lack of space, it is necessary to remove the transverse frame from its guides, insert the table top onto the transverse frame and reassemble the latter on the transversal guides. The table top is inserted into the transverse frame in only one way. To identify which, one should consider that the electromagnetic brake on the transverse frame must work on the metal plate (04 / Fig. 5-5) inside one of the aluminum side members of the patient table top. To insert the patient table top on the transverse frame, it is necessary to: •

first identify and fit the 2 nylon guide side wheels correctly (01 / Fig. 5-4);

•

remove the 2 end caps (01 / Fig. 5-5);

•

remove one of the two panel heads (02 / Fig. 5-5);

•

Remove one of the two travel limiter blocks (03 / Fig. 5-5).

•

When the panel has been inserted, complete the process by reinstalling the hardware in the reverse order shown here.

01

Fig. 5-4 Nylon Guide Side Wheels

03

01

02 04

Fig. 5-5 Table top turned upside down 180°

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Technical Manual

5.4

Installation of the AEC Unit

5.4.1 AEC unit with potter bucky As an option, a camera for Automatic Exposure Control (AEC) can be installed in the bucky units. Or, the bucky unit can be set up for installation with optional hardware that must be completed by the installer. In other cases, follow the assembly procedure and the instructions in the instructions supplied with the device. 5.4.2 AEC unit with Docking Station As an option, a camera for Automatic Exposure Control (AEC) can be installed in the docking station. Or, the docking station could be set up for installation with optional hardware that will be completed by the installer. In other cases, follow the assembly procedure and the instructions in the instructions supplied with the device. 5.4.3 AEC unit with Fixed Panel As an option, special materials and instructions may be ordered of the equipment manufacturer for the installation of a compatible Automatic Exposure Control (AEC) camera. This involves the use of "hook and loop" adhesives to be applied to the time of installation of the fixed panel. As an option, the support frame of the fixed panel housing can be prepared for the installation of the camera with optional mechanical hardware and fasteners to be assembled by the installer.

01

02

03

Fig. 5-6 Automatic Exposure Control Unit Application Pos.

Description

Quantity

01

AEC unit

–

02

Hook & Loop Strip Tape (Male), L1M

1*

02

Hook & Loop Strip Tape (Female) , L1M

1*

03

Flat Panel, for Digital Imaging Systems

–

* Optional

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Code

Technical Manual

6 Electrical Connections 6.1

Connection to the Mains

The interfacing of the equipment with the outside is carried out from the plate placed inside the base near the right wall (Fig. 6-1 & Fig. 6-3).

Fig. 6-1 Electrical Connections On the electrical plate it is presented: •

The strip terminal block ST1, for connection to the mains at 230V (monophase);

•

The strip terminal block ST4, for connection to a Tubestand, Wallstand or controller system;

•

The connector J21, for potter bucky connection or other connections to the X-ray generator;

•

The earthing bar for connection of the grounding protection.

Refer to the diagrams attached to the manual for connections. ATTENTION! It is of vital importance that all necessary works, such as inserting underground / inwall canals for passage of electrical cabling, are performed as required. This can be of vital importance for the selection of the cable lengths to assure that the interconnection cables reach their points of connection.

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Technical Manual

6.2

List of Electrical Components for the Bucky Table

ST31 J32 L2A

L2 L1 L3

PB1 PS

SW1

GND Fig. 6-2 Electrical Components Ref.

Description

Quantity

L2 L1 L3 ST31

ELECTROMAGNETIC BRAKE RETANG. 28X130 ELECTROMAGNETIC BRAKE RETANG. 28X130 ELECTROMAGNETIC BRAKE RETANG. 28X130 WIRE TERMINAL UNIP.GRI. 2,5 WAGO 261.301 ENDPLATE TERM.GRI. 2,5 WAGO 261.361 PUSHBUTTON D18 1ELEM ARG TH504108.100 FOOTPEDAL SWITCH CABLE TABLE TOP BRAKE ELECTROMAGNETIC BRAKE RETANG. 28X130 POWER SUPPLY BT EARTHING BAR

1 1 1 10 1 1 1 1 1 1 1

PB1 SW1 J32 L2A PS GND

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Code

Technical Manual

Fig. 6-3 Example: Electrical connections on the electrical plate with Mains Connection

Fig. 6-4 Example: Bucky electrical connections

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Technical Manual

6.3

Bucky Connections

The bucky is to be connected to connector J21. Bucky from different manufacturers with different connection diagrams can be found in the table or inserted later. Make sure that the connections between connector J21 and the bucky present in the table are those required for the proper functioning of the latter.

6.4

Docking Station Connection

As an option, the Table Bucky unit can be specially equipped to accept a compatible docking station for customer installation or can be installed by the table manufacturer. If it was provided by the table manufacturer, check for electrical schematics for assistance with its electrical connections. In any other case, it is the responsibility of the installer / project manager to provide the correct methods for installation and electrical connections.

6.5

Fixed Panel and Digital Systems

Follow the instructions provided with the unit for its maintenance, wiring and installation requirements. These instructions can also be part of a system integration that should be provided by the system integrator or system vendor. The connections of the digital system must be compared with the wiring diagrams supplied with the table to ensure that no electrical connections are permitted between them: this must be carefully checked to avoid hardware damage to the external controller systems. GP

GD1

GD2

Fig. 6-5 Flat Panel Digital System with Grid Switches

WARNING! Importante note for digital systems and grid sensor switches: The connections of the digital system must be compared with the wiring diagrams supplied with the table to ensure that no electrical connections are allowed between them: this must be carefully checked to avoid hardware damage to the external controller systems.

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Technical Manual

6.6

Connection of an External OEM Electronic Controller System (option)

This unit can be interfaced with other OEM equipment. Unit functions, braking, electrical devices and position sensors can be connected to an external controller. For some types of Bucky table, the unit must be connected to its external rack unit; for others, it can be connected to a Tube Stand or other system controllers. In this case, it is necessary to check the documentation provided with the unit and the other equipment for the requirements on how to connect the Table Bucky unit.

Operators must also refer to the instruction manuals of the individual components.

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7 Equipment Decommissioning 7.1

Expected Life Span of the Equipment

The lifespan of the equipment and the availability of spare parts are guaranteed for 10 years from the date of its placing on the market. At the end of operational life, the decommissioning and scrapping of the equipment and its accessories must be made in accordance to the requirements of the provisions concerning waste disposal.

7.2

Categorizing and Disposal of the Materials

At the end of operational life, the decommissioning and scrapping of the equipment and its accessories must be made in accordance to the requirements of the provisions concerning waste disposal. For more information about this, contact the dealer/manufacturer of the equipment or a company who specializes in waste disposal and who is authorized by a competent national authority. The disposal and the material waste treatment applying to the equipment composing materials must be done in accordance with the applicable law when the equipment is disposed of. The equipment may contain electrical parts and for this it can be subject to the provisions contained in the European Directive 2002/96 Waste Electrical and Electronic Equipment (WEEE/RAEE). Almost all the equipment is made of metallic materials such as aluminum, steel, copper and, in a minimum part, plastic materials and electrical / electronic components. •

Metal parts can be recovered as scrap.

•

The equipment contains lead which must not be dispersed in nature.

•

The electrical components and plastic materials must be treated separately as special waste.

•

The disposal / recovery of the materials constituting the equipment must in any case take place, in accordance with the regulations in force at the time when this operation is carried out. This symbol, found on the nameplate of the equipment, indicates that it is composed of parts that must be treated and disposed of as hazardous waste. This unit must be disposed of by qualified personnel in order to prevent the occurrence of danger. When disposing of the COLLIMATOR, X-RAY TUBE, GENERATOR, or other significant system devices that may be connected to this device, refer to the operator manuals that come with them.

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8 Maintenance 8.1

Safety Measures for the Maintenance Before proceeding with the maintenance operations it is recommended to read attentively the section “SAFETY MEASURES OF USE” relating to the safety.

The user should always contact the technical staff for maintenance and repair of the machinery and must not personally carry out these tasks. • • • •

All work to be carried out on the equipment must be carried out generally only when the equipment is out of service. The maintenance manager must completely deactivate the machine before adjusting or replacing a machine element. Keep hands, feet, clothing, jewelry and hair at a safe distance from any moving parts to prevent them from becoming entangled. Keep all parts in good condition and properly installed. Repair damage immediately, replacing worn or broken parts. Before starting up the machine again after carrying out maintenance work, check the correct assembly and operation of all electrical and mechanical protection devices. Do not make changes to the machine; unauthorized modifications can compromise the operation and safety of the machine. In addition, they involve the invalidation of the guarantee provided by the manufacturer. In particular, devices and / or circuits that allow the emission of radiation not in compliance with safety regulations must not be rendered inoperative or removed. The absolute concentration of the operator is an essential safety element.

8.2

Tools Required

No specific equipment is required to carry out maintenance operations. •

Soft cloths for cleaning

•

Detergent type commercially available

•

White Vaseline Grease

•

Touch-up paint (supplied) and soft brush

•

NITRO thinner for the paint

•

Set of fixed keys.

•

Set of pipe wrenches

•

Set of hex keys.

•

Series of screwdrivers.

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Technical Manual

8.3

General Controls

In general, all the equipment used in radiology include electrical and mechanical parts in order to ensure continuity, safety and operating instructions should be subject to regular checks and maintenance. The burden of maintenance after the warranty period has expired is charged to the final user (the duration and obligations of the warranty are subject to a contractual agreement made between the seller of the equipment and the buyer). The service of technical assistance from the vendor is available to the user which must agree upon to arrange for post-warranty maintenance activities. The manufacturer assumes no responsibility in case of malfunction due to: •

Use of the equipment by untrained or unauthorized personnel;

•

Maintenance not performed, insufficient, or not documented;

•

Use of non-original replacement parts;

•

Maintenance performed by untrained or unauthorized personnel.

Any work performed on the equipment must be properly registered: Every technical intervention must be recorded in the Maintenance Register (found on the following pages) and in the special adhesive labels placed on the equipment stating the date of execution. This documentation is to be kept with the documentation supplied with the equipment. Preventive maintenance must only be carried out by authorized and qualified personnel. In order to get a more immediate response from the manufacturer or vendor, it is recommended to indicate the serial number of the equipment and its revision referring the labels applied to the machine. IMPORTANT! It is obliged of the installer to make sure that the parts of the equipment that require checks and maintenance are easily inspectable and reachable.This aspect has been taken into consideration by the manufacturer. In particular, devices and / or circuits that allow the emission of radiation in compliance with safety regulations must not be rendered inoperative or removed.

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Technical Manual

8.4

Periodic Controls

Checks of the equipment and its general operating conditions are to be made at intervals not exceeding 12 months. More frequent checks must be made if the equipment is subject to particularly heavy use or in the case of restoring the system after a prolonged downtime. Changes, updates and extraordinary maintenance must be performed by the manufacturer or by authorized qualified personnel. All work, ordinary or extraordinary, carried out on the equipment must be documented and traceable. Report to those responsible for the maintenance of the equipment any damage, even in small quantities (e.g. the paint finish), to avoid creating further damage and compromising its integrity. Disregard for the obligations of maintenance and documentation will void automatically any responsibility of the manufacturer of the equipment. In order to maintain a high quality radiology equipment, and to guarantee its continuous and safe operation, a constant control of the tests and maintenance must be made at regular intervals as recommended by the manufacturer with an expiration of at least every year or whenever it is requested by local legislation (refer to Directive 60601-2-54). The principle types of controls and their frequency in which they normally must be made are listed here:

GENERAL CONTROLS

INTERVALS

Cleaning of the slides and ball bearings

12 months

Cleaning and lubrication of the bearings and pivots

12 months

Check and regulation of the ball bearings

12 months

Tightening of the screwed parts

12 months

Check of the braking efficiency

12 months

Verification of the accessories cleanliness and functioning

12 months

Control the condition of the table tops

12 months

Check the efficiency of the alignment and centering devices

12 months

Check the efficiency of the command controls and warning devices

12 months

Verify the earthing connections and the dispersion of the current

12 months

Check the conditions of the cables and cable sheaths

6 months

Ground connections and tests must be done based on local regulations and regulations of the country where the system was installed.

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Technical Manual

It is advisable to report to the persons responsible for the maintenance of the equipment, even minor damage (for example to painting), to avoid that neglecting them leads to even more damage to its integrity.

•

If the unit presents dents, repair them; in case of damaged painted surfaces, touch them up using the paint issued by the manufacturer.

It is very important to repair as soon as possible the unit damages. In particular, remember that every scratch to the protection paint must be touched up with specific paints supplied by the producer; if this operation is well done, it avoids a dangerous oxidative phenomenon, which could compromise the efficiency and the resistance of the stand metal structure. The unit painting is made using powder paint and baking in furnace. To touch up the unit, a small bottle containing some original powder is supplied; this must be dissolved through a drop of paint thinner (NITRO preferred) and applied by using a soft brush.

• Grease bearing and pins, which can be reached. For the greasing use common universal grease, which is on sale. DO NOT use oils or other lubricants, that could cause draw or dirty the unit or the working area.

• Check the functioning backlash of bearings and of guiding and braking devices. It is very important to check the slack of the ball bearings and, if necessary, make their regulation following the instructions written in the previous chapter. This is required to also maintain the correct alignments and tolerances between devices and components. •

Check the correct functioning of the control and braking devices as well.

•

Check the correct tightening of the nuts and bolts.

•

Check the correct functioning of the electrical parts as well, that means the functioning of push buttons and brakes and the integrity of cables and safety devices.

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Technical Manual

8.5

Cleaning and Disinfection

The equipment does not require particular cleaning operations. However, it is recommended that during the operations to give proper attention to avoid damaging it. •

The mains power must be disconnected before proceeding with the cleaning operations. The water in quantities should not be used, to avoid dangerous infiltrations and undesirable phenomena of corrosion of the metal parts.

•

Even products used to clean and disinfect the skin can create an explosion risk.

•

For disinfection, use commercial products whose effects are tested. Do not use disinfectants gaseous formaldehyde and aerosol products that could generate dangerous and damaging infiltration into the equipment.

More information and directions are available in manuals and instructions for disinfection and protection against explosions.

8.5.1 Cleaning • • •

Clean the equipment with a damp cloth or a cotton swab. Use a non-abrasive cleaning material. To moisten, use water or lukewarm water with a diluted solution of liquid detergent of the common household type. Do not use abrasive cleaners or organic solvents or cleaning agents containing solvents (eg. alcohol, ether, etc.). Do not use hydrogen peroxide which enhances the corrosion of metals. Do not use spray liquids! Agents for cleaning fluids must not enter under any circumstances within the enclosures!

It is recommend to use a damp cloth, preferably hot, taking care to dry very thoroughly treated surfaces.

8.5.2 Disinfecting For surface disinfection, it is recommended to use aqueous solutions commercially available for the disinfection of surfaces based on aldehyde or amphoteric surfactants (eg, Tego 103, Korsolin). Disinfectant substitutes based on phenolic and chlorine-containing compounds are partially aggressive and therefore normally to be avoided. The same limitations apply to agents which have an alcohol content when they are applied in undiluted form (eg for the disinfection of hands). Strictly prohibited are spray disinfectants, because the spray could penetrate inside the device. As a result, the safety of the appliance can no longer be guaranteed (damage to electronic components, formation of flammable mixtures of air and solvent vapors). Where the entire exam room is to be disinfected, remember to cover the unit with plastic sheeting.

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Maintenance Register

Model

Serial Number

Options

Installation Date

Periodic Controls GENERAL CONTROLS

INTERVALS

Cleaning of the slides and ball bearings

12 months

Cleaning and lubrication of the bearings and pivots

12 months

Check and regulation of the ball bearings

12 months

Tightening of the screwed parts

12 months

Check of the braking efficiency

12 months

Verification of the accessories cleanliness and functioning

12 months

Control the condition of the table tops

12 months

Check the efficiency of the alignment and centering devices

12 months

Check the efficiency of the command controls and warning devices

12 months

Verify the earthing connections and the dispersion of the current

12 months

Check the conditions of the cables and cable sheaths

6 months

Date

Signature

Date

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Signature

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Glossary

Terms

Definitions

Forms of Measurement

°C

Degree scale in Celsius. It is the unit for measuring the temperature.

°F

Degree scale in Fahrenheit. It is the unit for measuring the temperature.

cm m/M

Centimeter (metric system). The International System of Units (SI) for measuring the length. 0,01 m. Meter (metric system). The International System of Units (SI) for measuring the length.

kg

Kilogram (metric system). The International System of Units (SI) for measuring the mass.

in

Inches (imperial system). I It is a unit of length measurement that is widely used in the countries of Anglo-Saxon culture.

ft

Foot (imperial system). It is a unit of length measurement that is widely used in the countries of Anglo-Saxon culture.

lb / lbs

Pounds (imperial system). The pound (pounds) is a unit of mass measurement.

N

Newton (measuring unit). It is the unit of measurement of force that is part of the derived units of the International System of Units (SI).

s

Second (minute second). It is a unit of measurement of time and one of the seven basic units of the International System (SI).

hPa

Hectopascal. It is the conventional unit of measurement of atmospheric pressure.

Kbit/sec

Kilobyte per second. Related to communication protocols.

Reference Designator ST

Strip terminal; morsettiera

J

denomination for electrical connector

L

Inductor

PB PS / PSU SW

Push button; pulsante Power supply unit; Alimentatore Switch/microswitch; interruttore/microinterruttore

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ET8530 – ET8532 Elevating bucky table

Technical manual

ET85MTE30 Rev.0 28/04/2017

- Technical manual -

INDEX 1 – GENERAL INFORMATION ...............................................................................................................................5 1.1 - WARNINGS ..............................................................................................................................................5 1.2 – DOCUMENTATION RIGHTS ......................................................................................................................6 1.3 - TESTS ......................................................................................................................................................6 1.4 - GUARANTEE ............................................................................................................................................6 1.5 - SYMBOLS .................................................................................................................................................6 1.6 – PRODUCT IDENTIFICATION. ....................................................................................................................6 1.7 – LABELS ...................................................................................................................................................7 1.8 – CE CONFORMITY ....................................................................................................................................7 2 – SAFETY MEASURES .....................................................................................................................................10 2.1 – SAFETY MEASURES FOR OPERATING THE UNIT .....................................................................................10 2.2- SAFETY MEASURE FOR MAINTENANCE ..................................................................................................11 3 - EQUIPMENT DESCRIPTION ............................................................................................................................13 3.1 - USE DESTINATION. ................................................................................................................................13 3.2 – EQUIPMENT COMPONENTS ...................................................................................................................13 3.2.1 – BUCKY TABLE ................................................................................................................................13 3.2.2 – PATIENT TABLE TOP .......................................................................................................................13 3.2.3 –BUCKY CARRIAGE. ..........................................................................................................................13 3.2.4 – CONTROL DEVICES.........................................................................................................................14 3.4 - TECHNICAL FEATURES ..........................................................................................................................16 3.5 – ADDITIONAL SYSTEM COMPONENTS ....................................................................................................17 3.6 – OPTIONAL ACCESSORIES ......................................................................................................................17 3.7 - STANDARD MODEL VARIATIONS ...........................................................................................................18 3.7.1 – PATIENT TABLE TOP MADE OF LOW ABSORPTION MATERIAL.........................................................18 3.7.2 – SAFETY STOP DEVICE OF THE PATIENT TABLE TOP. .......................................................................18 3.7.3 – SAFETY ELECTROMAGNETIC BRAKES. ...........................................................................................18 4 - INSTALLATION .............................................................................................................................................20 4.1 – THE ROOM PREPARATION. ....................................................................................................................20 4.2 – NECESSARY TOOLS FOR THE INSTALLATION. .......................................................................................20 4.3 – EQUIPMENT WAREHOUSING AND MOVING CONDITIONS .......................................................................21 4.4 – EQUIPMENT RECEIVING ........................................................................................................................22 4.5 - FIXING OF THE BUCKY TABLE. ..............................................................................................................24 5 - MOUNTING ...................................................................................................................................................28 5.1 - UNLOCKING THE BUCKY TABLE ............................................................................................................28 5.2 - MOUNTING OF THE BUCKY ....................................................................................................................28 5.3 - CONNECTION OF THE BUCKY ................................................................................................................30 5.4 - CONNECTION OF THE PATIENT TABLE TOP ............................................................................................31 ET85MTE30 Rev.0 28/04/2017 Pag 2/37

- Technical manual -

5.5 – REGULATION OF THE GUIDE BEARINGS AND ROLLER BEARINGS FOR THE PATIENT TABLE TOP. ..........31 APPENDIX A – MAINTENANCE SCHEDULE........................................................................................................33 A.1 – MAINTENANCE SAFETY MEASURES .....................................................................................................33 A.2 – GENERAL MAINTENANCE RULES. ........................................................................................................33 A.2.1 – NECESSARY TOOLS. ......................................................................................................................34 A.3 – MAINTENANCE. ...................................................................................................................................34 A.3.1 – GENERAL CHECKS. ........................................................................................................................34 A.4 - EQUIPMENT DISASSEMBLY ...................................................................................................................36 A.5 – MAINTENANCE REGISTER....................................................................................................................37 A.5.1 – EVERY 12 MONTHS. ......................................................................................................................37

ET85MTE30 Rev.0 28/04/2017 Pag 3/37

- Technical manual -

CHAPTER 1 GENERAL INFORMATION

ET85MTE30 Rev.0 28/04/2017 Pag 4/37

- Technical manual -

1 – GENERAL INFORMATION 1.1 - WARNINGS

READ THIS MANUAL CAREFULLY in order to learn how to operate and service this equipment correctly and to avoid personal injury or unit damage. This manual and the safety labels on the equipment may also be available in other languages (for information contact the manufacturer). The complete documentation which is shipped with the unit, and this manual in particular, must be carefully preserved for future references or necessities. THIS MANUAL should be considered a permanent part of the equipment and should remain with it. MEASURES in this manual are exclusively expressed in the metric system. THE EQUIPMENT RIGHT AND LEFT SIDES are established by the user, facing the unit (as shown in this manual cover). THIS UNIT IS DESIGNED to be exclusively used during the normal X-Ray operations as pointed out as INTENDED USE. Use in any other way is considered as contrary to the intended use. The manufacturer declines all responsibility for damage or injury caused by a use which differs from the intended use; the user is the only responsible party of these consequences. The careful observance of the functioning, maintenance and repair instructions, which are pointed out by the manufacturer, are also an essential part of the equipment use. THE RADIOGRAFIC STAND, object of this manual, MUST BE USED, OVERHAULD AND REPAIRED EXCLUSIVELY BY PERSONNEL that is qualified and familiar with all its characteristics and acquainted with the relevant safety rules (accident prevention). Laws regarding accident prevention and all industrial safety rules must always be observed. The manufacturer is not responsible for damages or injury caused by any arbitrary modification carried out on this unit.

ET85MTE30 Rev.0 28/04/2017 Pag 5/37

- Technical manual -

1.2 – DOCUMENTATION RIGHTS This instruction manual, including technical drawings, tables and photos, are a manufacturer’s freehold property. For this reason, the documentation can not be disclosed, photocopied or partially reproduced without our written consent; it can be used only by mounting, controlling and care personnel.

1.3 - TESTS The equipment testing is made by the producer during the carrying out and, in particular, at the end of the mounting in order to guarantee the correct functioning of the unit and its parts. This kind of test is exclusively carried out by qualified personnel and its result is specified on the inspection report. The manufacturer keeps, in conformity with law, the only report copy every unit has.

1.4 - GUARANTEE Guarantees are supplied only in accordance with the contract conditions. The necessary condition is that original spare parts are used. Damages caused by the use of non-original spare parts make the guarantee invalid. Damages which are caused by incorrect equipment use or by non-observance of the rules in this manual will not be considered under guarantee. ATTENTION! The guarantee is automatically voided if interventions on the unit are made by non-authorized personnel.

1.5 - SYMBOLS In this manual the following symbols are used: It means “proceed with caution” from the operator.

It means “pay attention” during some operations.

It is a warning for possible dangerous situations to people or equipment.

1.6 – PRODUCT IDENTIFICATION. Together with the unit technical documentation, the manufacturer issues a Declaration of Conformity to laws in force. If it is necessary to contact the manufacturer for technical or maintenance problems, it should be better to take note of the unit serial number and overhaul in order to make the technicians’ intervention quicker and more accurate. This information can be easily obtained from the Product Identification Label.

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1.7 – LABELS On the unit there must be:  part number label;  wire ropes replacement label;  serial number label;  Warning and/or danger labels Their shape and placement is shown in the drawings on the following pages. Do not remove the adhesive labels on the unit. They are important in order to track the manufacturer and the equipment serial number

1.8 – CE CONFORMITY The equipment mentioned below fully complies with the European CE requirements specified in the 93/42/EEC Directive for the equipment of class 1 (annex VII). The equipment complies with the requirements for safety of Medical Devices listed below: EN 60601-1 (1998) EN 60601- A1+A11+A12 (1994) EN 60601-1-2 (1993) EN 60601-1-3 (1995) EN 60601-2-32 (1994) EN 60601-1/A2 (1997) EN 60601-1/A13 (1997)

The Declaration of Conformity is supplied with the documents that come with the equipment. A copy of this Declaration of Conformity can be asked for from the manufacturer.

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CHAPTER 2 SAFETY MEASURES

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2 – SAFETY MEASURES 2.1 – SAFETY MEASURES FOR OPERATING THE UNIT All units are manufactured following the latest technical standards in safety matters. In any case, their use can be dangerous if they are not correctly used, used by untrained personnel or if they work differently from the projected aims. In particular, refer to the Operator Manual to know the safety measures for the equipment operations.  Instructions and rules which regard this kind of equipment, which are enforced by each particular country, must be respected by the operator and the installer.  The unit must work only in rooms which are used for medical aims (refer to regulations in force).  The unit is not planned to be used in rooms which are at risk for explosions. The equipment should be used and subjected to maintenance operations only by authorized and trained personnel. Specifically, they must know the possible dangers resulting from improper equipment use and the residual risks.

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2.2- SAFETY MEASURE FOR MAINTENANCE Carefully read for the proper procedures and cautions to take before starting the maintenance operations. Keep the working area clean and dry.  All maintenance operations to be performed on the unit must be carried out when it is out of service. The person responsible for the maintenance must completely disconnect the unit from the mains before the adjustment or replacement of an original equipment part.  Keep hands, feet, dresses, jewels and hair at a safe distance to avoid entanglement in any moving parts or parts extending from the unit.  Keep all parts in good working condition and correctly installed. Repair damages immediately by replacing the consumed and broken parts. Do not change any part of the unit; changes which are not authorized can compromise the equipments functions and safety--they void the manufacturer’s guarantee as well. More specifically, it is not possible to make inoperative or replace devices and/or circuits which control the radiations emission in accordance with the safety laws.  After the maintenance, it is necessary to check the correct mounting and functioning of all electrical and mechanical devices before putting the unit back into service.

The operator’s absolute attention is a safety essential element.

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CHAPTER 3 EQUIPMENT DESCRIPTION

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3 - EQUIPMENT DESCRIPTION The radiographic unit, here described, is composed by a bucky table with elevating patient table top; this manual gives the necessary instructions for the equipment correct use.

3.1 - USE DESTINATION. The equipment is to be used in fix systems for general and specialized radiological investigation with functions of radiogen source and patient’s movement.

3.2 – EQUIPMENT COMPONENTS The ET table is composed of the following parts: 1) Bucky table 2) Patient table top 3) Bucky carriage 4) Control devices

3.2.1 – BUCKY TABLE The bucky table is composed of two frames that move one inside the other. The basic structure is constituted of a fixed lower part (made of bent sheet metal that is welded and reinforced) and of an mobile upper part that is directly supported by a sturdy mechanical lifting device which is controlled by motor; These components permit the operator to make the table top assume a distance from floor that best supports the operations for moving or transport of patients.

3.2.2 – PATIENT TABLE TOP The patient table top is in radiotranslucent plastic laminate with low absorption (or built with a “sandwich” structure in carbon fiber as option). The lateral table profiles, in laminated extrusions, have a lateral groove for the accessories fastening, allowing them, at the same time, the best freedom in movements. The table top can be moved manually on the horizontal table and its kept in position by electromagnetic brakes that are controlled by foot pedal. The table in its basic configuration is equipped with electromagnetic brakes that operate when energized by current (optionally, on request, brakes at permanent magnet can be mounted). As an available option, a safety device can be installed that blocks the table downward movement if the table top meets an obstacle during its movement. This device operates by using four independent microswitches positioned at the corners of the panel support frame.

3.2.3 –BUCKY CARRIAGE. The bucky carriage slides in the special guides under the patient table top. A special handle incorporates the electromagnetic brake release push button of the carriage, the emergency stop control (red mushroom type pushbutton) for de-activation of the motorized movements and also allows for the positioning of the bucky carriage. The bucky carriage has special housings for the grid and the ionization chamber.

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The buckys can have the measuring chamber for the AEC systems (Automatic Exposure Control) and the measuring device of the cassette size for the ACS (Automatic Collimation System).

3.2.4 – CONTROL DEVICES. The controls for the patient table top movements are constituted by four foot-activated pedals placed in a vertical position at the table base to minimize the possibility to activate them accidentally. The control of the motorized lifting movements (up/down) is also available (as option) on the support device of of the radiogen system (floor stand or ceiling stand).

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3.4 - TECHNICAL FEATURES Control box Control of electromagnetic brakes and up/down table top motion

by foot pedal

Bucky table Absorption according to I.E.C. 60 601-2-35

0,9 mm Al eq.

Longitudinal travel

81cm (40,5 cm each side)

Transversal travel

26 cm (13 cm each side)

Braking through foot pedal control

electromagnetic

Patient’s maximum weight allowed

250 kg

Distance from table top to film

7 cm

Minimum distance from table top to floor

53,3 cm

Maximum distance from table top to floor

85,3 cm

Table top height variation

32 cm

Average speed

3 cm/s

Bucky carriage Kind of movement

manual

Longitudinal travel

57,0 cm

Electromagnetic brake control

by push button Monophasic 230 (220/240) Vac 50/60 Hz

Power supply Line voltage / frequency Maximum absorbed power

300 VA

Colours Painted parts

RAL 9016

Weights Elevating bucky table

290 kg

Transport and stock environment Temperature range

0 °C ÷ 50 °C

Relative humidity range (without condensing)

10% ÷ 90%

Atmospheric pressure range

50 ÷ 110 kPa

Operating environment Temperature range

10 C ÷ 40 C

Relative humidity range

30% ÷ 75%

Atmospheric pressure range

70 ÷ 110 kPa

Equipment identification Classification according to EN 60601

class I - type B

Operation mode

continuous

Typology of installation

permanently connected

Standard compliance Safety

EN 60 601

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3.5 – ADDITIONAL SYSTEM COMPONENTS Bucky with cassette tray

for cassette sizes from 13x18 to 35x43 cm

Grid JGB204 (standard supply)

90 lines/inch R=12:1 f=100 cm

3.6 – OPTIONAL ACCESSORIES Carbon fibre table top 220 x 76 cm

ETA001

Arm support (no clamp) Flebo support (no clamp) Aluminium clamp (universal) Pair of patient hand grips (lateral) Compression band (lateral) 24x30 cm articulated lateral cassette holder 35x43 cm lateral cassette holder Pair of leg supports (lateral) Pair of table top edges Contact the manufacturer to know about the availability of other accessories (not included in the chart) and/or to ask for advice regarding solutions for unique applications.

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3.7 - STANDARD MODEL VARIATIONS Here follows the standard model variations. These must be planned while the equipment is still in its preparation phase.

3.7.1 – PATIENT TABLE TOP MADE OF LOW ABSORPTION MATERIAL. On request it is also possible to mount a table top, made of low density carbon fiber instead of the laminated plastic one. The absorption that, for the laminated plastic top is of 0,9 mm of Al, reduces to 0,45 mm for the low density top.

3.7.2 – SAFETY STOP DEVICE OF THE PATIENT TABLE TOP. This device is supplied on demand; it is used to stop the motorized descending movement of the table top, if there is an obstacle (such as a stool) under it.

3.7.3 – SAFETY ELECTROMAGNETIC BRAKES. For the patient table top braking, it is possible to have safety permanent magnet brakes, whose action does not depend on the electrical supply; on the contrary the standard electromagnetic brakes need to be supplied in order to work.

For information about the possibilities of the standard model variations or updates, contact the unit manufacturer.

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CHAPTER 4 INSTALLATION

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4 - INSTALLATION Before using the equipment, the operators should read the Chapter no. 2 about the SAFETY MEASURES. The equipment must be installed and can be maintained only by authorized and trained personnel. In particular, this must be informed about the possible dangers caused by an equipment incorrect use and residual risks.

4.1 – THE ROOM PREPARATION. This chapter gives useful information to prepare the room where the unit, object of this manual, will be installed. According to the rooms dimensions, these information must be observed in order to obtain the unit complete performance in the best room fitness. Specific information about this are generally given separately by the manufacturer or the installer, who are in any case at full disposal for any further need. ATTENTION!!! All building works for the room preparation are at customer’s or installer’s expense. It is important to know exactly the room features, where the unit will be installed in order to make a correct preparation, according to the required safety rules as well.

4.2 – NECESSARY TOOLS FOR THE INSTALLATION. The equipment mounting does not need specials tools, but common use ones, like those listed below:  set of fixed wrenches;  set of box wrenches;  set of Allen wrenches;  set of screwdrivers;  water level;  electric drilling machine with a set of Vidiam drills;

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4.3 – EQUIPMENT WAREHOUSING AND MOVING CONDITIONS Once the unit is mounted in the factory, it is subjected to careful controls and a tests from trained personnel. After the cleaning, the equipment is packed with corrugated card-board and wrapping paper (pluriball). Then the unit is generally packed in one or more wooden cases by an external packager. Before the installation, the unit can be kept in the warehouse for some time with its original packaging. In any case, although every metal part is carefully covered by protection paint or oxidation superficial treatment, the equipment is not planned to work or be stocked outdoor. In fact, it cannot stand the humidity; for this reason, do not keep it outdoor or in extreme environment conditions.

It is absolutely forbidden to pass by or under the load during the lifting operations.

Make sure the cases are well fixed during the transport to avoid blows which could damage their contents.

 Pay attention to the hanging loads moving in order to avoid dangers for people or things.

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The wooden cases are made to be lifted through a lifting device (forklift truck). If they must be lifted from the top (crane), it is necessary to sling them through suitable ropes, which must twine round the case.

4.4 – EQUIPMENT RECEIVING The equipment is contained in two cases, whose contents is briefly listed below. The exact cases contents is specified in the Packing List which is attached on the case.

Refer to the instructions outside the cases for their moving and lifting.

The CASE , whose dimensions are 235x95x80 cm (gross weight, about 400 kg), contains:  the bucky table (without the table top);  the bucky table top; 

the requested accessories.

When the table is coupled to another equipment (for example to a floor or ceiling stand) the case of the table only contains the table with its accessories, while the table top panel is in the case that contains the stand. In this hypothesis, the dimensions of the case become 160x95x80 (gross weight about 360 kg). To remove the table from its crating case proceed as follows:  remove the upper cover of the case;  remove the panel (put on it) and the external accessories;  locate the envelope that contains the documents and the mounting instructions and store them in a safe place;  remove one of the long sides of the case;  take off the table and take it to the work place.

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Case content. Pos. 1 2 3 4 5 6 7 8

Description

Quantity

CASE TOP COVER WOODEN CASE PACKING LIST TABLE TOP MANUALS AND DOCUMENTS ET TABLE ACCESSORIES BOX CASE LATERAL WALL

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1 1 1 1 1 1 1

Code -

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4.5 - FIXING OF THE BUCKY TABLE. The building work for the table installation are charged to the customer or the installer. ATTENTION!!! It is important that the supporting surfaces are carefully smoothed; possible little differences can be corrected during the mounting phase inserting the suitable thicknesses between the table and supporting surfaces. On the previous page the common fixing methods are indicated. Possible particular solutions can be chosen together with the manufacturer and/or the installer.

ATTENTION!!! The dimensioning of the table supporting structures is exclusively under the competence of the designer, who is responsible of the rooms preparation. The equipment plan shows:  the fixing points of the table and the rail on floor;  the under track channels for the supply and working cables To fasten the table to the floor, proceed as follows:  Remove the rear panel (lower and upper ones) of the bucky table. To make the bucky table mounting and assembling operations easier, lift at about 70 cm from floor the upper part of the table, rotating by hand the driving pulley of the elevating system. To do this, use the handle (which is issued with the table and fixed to one of the crossbars of the elevating system), whose pins enter frontally the holes of the driving pulley.

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 Mark the fixing positions and, through a power drill with percussion and D16 widiam drill, make the fixing holes, whose depth must be 80 mm at least. Insert the D16 and M10 metal fisher in the holes; then fix the table using hexagonal-head screws TE M10x60 or Allen screws TCCE M10x60. Fix the table on level, using a level as control instrument. If necessary shim, being sure that the screws clamping does not create any deformations in the table base structure.

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CHAPTER 5 MOUNTING

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5 - MOUNTING 5.1 - UNLOCKING THE BUCKY TABLE Once the table is set working, the upper top can be unlocked (during the transport this top is kept in position through clamps, which are shown in the picture). Unlock the bucky carriage too; this is kept still through appropriate clamps or wrapping paper.

Before closing the table with the front panel, make the necessary electrical connections.

ATTENTION !!! Verify that the top and the bucky carriage are completely unlocked, before using the equipment in order to permit a good working and to avoid the unit damaging.

5.2 - MOUNTING OF THE BUCKY When the bucky table is supplied, the tray was already mounted in factory, if the customer had required it. In order to get the bucky in the carriage under the table, it is necessary to extract the transversal frame from the sliding guides. To this aim, do as follows:  disconnect the cable, which connect it to the below fixed part;  take out the stop block at the end of the transversal movement of the frame. In order to disconnect the connecting cable, it is necessary:  to take out the two screws which lock the cable connector support to the table structure (Pic. 2 – Pos. 7);  disconnect the connector, which comes from the table interior, from the connector that is fixed to the support. To remove the stop block, it is necessary to remove:  the internal cover from the left support of the transversal frame sliding guide;  the screws which fix the stop block (Pic. 2 – Pos. 8). Once the frame is extracted from the guides, the bucky cover can be removed and it is possible to get it or insert one if it is absent. During the transport, the transversal frame is locked through two clamps which are on its side, in particular on one of the sliding guides. Therefore, to remove the transversal frame of the guides, the two clamps must be unlocked. 

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Pic. 1 – Bearing and brakes regulation

Pic. 2 – Under panel regulation

5.3 - CONNECTION OF THE BUCKY The bucky is connected to the ST2 terminal board. Buckys of different producers and characterized by different diagrams can be present inside the table or inserted later. Be sure that connections between the ST2 terminal board and the bucky which is inside the table are those for its correct functioning.

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5.4 - CONNECTION OF THE PATIENT TABLE TOP The patient table top is put on the transversal frame. If it is not possible, because there isn’t enough space, it is necessary:  to extract the transversal frame from its guides;  to put the patient table top on the frame;  to mount it on the transversal guides. The panel can be inserted on the transversal frame only in one way. To identify which one, consider that the electromagnetic brake must work on the metallic plate which is positioned on one of the two lateral guides. To insert the patient table top on the transversal frame, it is necessary to take out one of the two stop blocks.

5.5 – REGULATION OF THE GUIDE BEARINGS AND ROLLER BEARINGS FOR THE PATIENT TABLE TOP. The guide bearings and the support bearings of the patient table top are shown in the pictures 1 and 2. It is possible to correct the off-sets by utilizing an open-ended wrench (an english key) on the eccentric one. It is also possible to correct the working distance of the electromagnetic brakes by acting on the bolts that the brake leaf-spring support is fastened to. To perform these procedures, it may be necessary to remove the panel and the under panel. In this case, please refer to the drawings and instructions that are in the following pages.

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APPENDIX A MAINTENANCE SCHEDULE

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APPENDIX A – MAINTENANCE SCHEDULE. A.1 – MAINTENANCE SAFETY MEASURES Before starting the maintenance operations, read carefully the procedure to follow. Keep clean and dry the working area.  All operations to do on the unit must be carried out when it does not work. The person who is responsible of the maintenance must completely disconnect the unit, before the adjustment or replacement of an equipment part.  Keep hands, feet, dresses, jewels and hair at safe distance from any moving part in order to avoid their getting caught.  Keep all parts in good condition and correctly installed. Repair immediately damages, replacing the consumed and broken parts. Do not change any part of the unit; changes which are not authorized can compromise the equipment functioning and safety. They void the manufacturer’s guarantee as well. In particular, it is not possible to make inoperative or replace devices and/or circuits which permit the radiations emission in accordance with the safety laws.  After the maintenance, it is necessary to check the correct mounting and functioning of all electrical and mechanical devices before make the unit operative again.

The operator’s absolute attention is a safety essential element.

A.2 – GENERAL MAINTENANCE RULES.  The equipment maintenance must be done by the customer.  The manufacturer has no responsibility in case of bad working, which can be caused by negligence or elusion of the basic maintenance rules listed below. The preventive maintenance must be exclusively done by qualified and authorized personnel. Subject to agreement with our administration department, we are at full disposal to supply the necessary technical support.

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 A general check of the unit and its functioning conditions must be done at intervals no longer then 12 months. More frequent controls must be done if the unit is subjected to heavy use or in case of restarting after a long stop.  Changes, up-dates and extraordinary maintenance must be done by the manufacturer or technical personnel authorized by them.  Every ordinary and extraordinary operation on the equipment must be supported by documents; these must be findable. Maintenance and documentation duties must be observed; Anything contrary to the case releases the equipment’s manufacturer from all responsibilities. Every technical intervention must be recorded on the Maintenance Register (on the following pages) and on the special adhesive labels placed on the equipment.

A.2.1 – NECESSARY TOOLS. No kind of specific tool is necessary for the maintenance:  soft clothes for the cleaning;  detergent, which is found on sale;  white Vaseline grease;  paint to touch up (issued with the unit) and soft brush;  NITRO thinner for paint;  series of fixed wrenches;  series of box wrenches;  series of hexagonal wrenches;  series of screwdrivers.

A.3 – MAINTENANCE. A.3.1 – GENERAL CHECKS. The equipment includes mechanical and electrical parts, which need to be regularly subjected to checks and maintenance in order to guarantee a unit efficient and enduring working. As suggested by the manufacturer, the main controls typology and frequency to do regularly are listed below. The user, that means the person who is responsible of the equipment, must ask for the technical support at the foreseen dates and hold all the unit documentation, that means this manual and the operator one. The user must always address the technical personnel for the equipment maintenance and repairing; these operations must never be done by the user.

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GENERAL CHECKS

INTERVAL

Cleaning of the ball bearings sliding guides Cleaning and lubrication of bearings and pins Efficiency of the centering and alignment devices Tightening of the screwed parts Efficacy of the braking devices Efficiency of the control and signal devices Condition of sheaths and electrical cables

12 months 12 months 12 months 12 months 12 months 12 months 6 months

 First remove all covers and clean carefully the equipment, using a damp cloth and a common detergent which is on sale.

Pay attention not to use abrasive products or substances which contain solvents, because they can damage the unit surface.  Check scrupulously if there are possible anomalies.  If the unit presents dents, repair them; in case of damaged painted surfaces, touch them up using the paint issued by the manufacturer. It is very important to repair as soon as possible the unit damages. In particular, remember that every scratch to the protection paint must be touched up with specific paints supplied by the producer; if this operation is well done, it avoids dangerous oxidative phenomenon, which could compromise the efficiency and the resistance of the stand metal structure. The unit painting is made using powder paint and baking in furnace. To touch up the unit, a small bottle containing some original powder is supplied; this must be dissolved through a drop of NITRO thinner and put on using a soft brush.  Check the functioning backlash of bearings and of guiding and braking devices.  Check the correct functioning of the control and braking devices as well.  Grease bearing and pins, which can be reached. For the greasing use common universal grease, which is on sale. DO NOT use oils or other lubricants, that could cause draw or dirty the unit or the working area.  Check the correct tightening of the nuts and bolts.  Check the correct functioning of the electrical parts as well, that means the functioning of push buttons and brakes and the integrity of cables and safety devices.

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IMPORTANT! Before starting work inside the table, make sure that it is disconnected from the power line and that nobody can activate the controls. This is very important to avoid the possible situation of the technician who performs the maintenance of being crushed or injured. If it is necessary to contact the manufacturer for technical problems or the equipment maintenance, it should be better to take note in advance of the unit serial number and test in order to quicken and focus the technical support intervention. These information can be easily obtained from the identification label, which is on the equipment.

A.4 - EQUIPMENT DISASSEMBLY The disassembly of the equipment must be done by authorized and qualified personnel. The unit is quite totally made of metal materials, such as aluminium, steel and copper, and presents a minimum part of plastic material and electrical/electronic components. The metal parts can be recycled as scrap. The equipment contains some lead, which must not be dispersed in the environment. The electrical components and the plastic materials must be separately considered as special rubbish.

All materials used for the unit manufacture are not toxic or dangerous for the operators’ health; that means they can be used without any particular precaution.

In any case the disassembly/recycling of the equipment materials must be done according to rules which are in force at the moment of the operation. The equipment supplier is at full disposal for any kind of information.

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A.5 – MAINTENANCE REGISTER. Model

Serial number

Options

A.5.1 – EVERY 12 MONTHS. GENERAL CHECKS

INTERVAL

Cleaning of the ball bearings sliding guides Cleaning and lubrication of bearings and pins Efficiency of the centering and alignment devices Tightening of the screwed parts Efficacy of the braking devices Efficiency of the control and signal devices

Data

Firma

Installation date

12 months 12 months 12 months 12 months 12 months 12 months

Data

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Firma

TRN430 Vertical Bucky Stand

Technical manual TRN4MTE3A – 22/02/2017

Technical manual

Manufacturer:

M.T. Medical Technology Srl Via Friuli 6/2 – 20853 Biassono (MB) – Italy tel. +39 249 4841 email. [email protected] fax. +39 249 9003 www.emmetisrl.com This publication or its parts cannot be copied, saved on a memorization support, transmitted or translated into any languages (common or data processing), in any form or through any kinds of means (electrical, mechanical, magnetic, optical manual or other) without a clear written authorization by M.T. M.T. does not extend warranties concerning reproductions of this documentation, either partially or in its entirety, unless specifically authorized by M.T. As well M.T. does not extend warranties concerning additions and/or modifications to the original documentation made by and held by M.T. Copyright © M.T. Medical Technology S.r.l. - All Rights Reserved

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Index 1 – General information ....................................................................................................................... 6 1.1 - Warnings .................................................................................................................................. 6 1.2 – Documentation rights............................................................................................................... 7 1.3 - Tests.......................................................................................................................................... 7 1.4 - Guarantee.................................................................................................................................. 7 1.5 - Symbols .................................................................................................................................... 7 1.6 – Product identification............................................................................................................... 7 1.7 – Labels ....................................................................................................................................... 8 1.8 – CE Conformity......................................................................................................................... 8 2 - Safety measures ............................................................................................................................ 11 2.1 – Safety measures for the functioning ...................................................................................... 11 2.2 - Safety measure for maintenance ............................................................................................. 11 2.3 – Precaution in using the equipment ......................................................................................... 12 3 - Equipment description .................................................................................................................. 14 3.1 - Equipment destination of use ................................................................................................. 14 3.2 – Equipment description. .......................................................................................................... 14 3.3 - Standard model variations. ..................................................................................................... 14 3.4 - Accessories on request. .......................................................................................................... 14 3.5 - Technical features ................................................................................................................... 15 3.6 – Accessories on request ........................................................................................................... 15 4 - Installation .................................................................................................................................... 18 4.1 – The room preparation. ........................................................................................................... 18 4.2 – Necessary tools for the installation. ....................................................................................... 19 4.3 – Equipment warehousing and moving conditions ................................................................... 19 4.4 – Equipment receiving .............................................................................................................. 20 5 - Mounting....................................................................................................................................... 24 5.1 – Mounting of the support base. ............................................................................................... 24 5.2 – Fixing to wall and floor. ........................................................................................................ 24 5.3 – Mounting of the bucky. .......................................................................................................... 26 5.4 – Unlocking of the vertical carriage.......................................................................................... 26 5.5 – The vertical carriage balancing .............................................................................................. 28 6 – Electrical connections .................................................................................................................. 32 6.1 - Equipment electrical connections. .......................................................................................... 32

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Technical manual Appendix A – Maintenance schedule. ............................................................................................... 35 A.1 – Maintenance safety measures................................................................................................ 35 A.2 – General maintenance rules. ................................................................................................... 35 A.2.1 – Necessary tools. .............................................................................................................. 36 A.3 – Maintenance. ......................................................................................................................... 36 A.3.1 – General checks................................................................................................................ 36 A.3.2 – Controls of the wire ropes and suspension cables .......................................................... 38 A.4 – Room disinfection and cleaning ........................................................................................... 40 A.5 - Equipment disassembly ......................................................................................................... 40 A.6 – Maintenance Register............................................................................................................ 41 A.6.1 – Every 6 months. .............................................................................................................. 41 A.6.2 – Every 12 months. ............................................................................................................ 42 A.6.3 – Every 120 months (10 years). ......................................................................................... 42

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Chapter 1 General information

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1 – General information 1.1 - Warnings

READ THIS MANUAL CAREFULLY in order to learn how to operate and service this equipment correctly and to avoid personal injury or unit damage. This manual and the safety labels on the equipment may also be available in other languages (for information contact the manufacturer). The complete documentation which is shipped with the unit, and this manual in particular, must be carefully preserved for future references or necessities. MEASURES in this manual are exclusively expressed in the metric system. THE EQUIPMENT RIGHT AND LEFT SIDES are established by the user, facing the unit (as shown in this manual cover). THIS UNIT IS DESIGNED to be exclusively used during the normal X-Ray operations as pointed out as INTENDED USE. Use in any other way is considered as contrary to the intended use. The manufacturer declines all responsibility for damage or injury caused by a use which differs from the intended use; the user is the only responsible party of these consequences. The careful observance of the functioning, maintenance and repair instructions, which are pointed out by the manufacturer, are also an essential part of the equipment use. THE RADIOGRAFIC STAND, object of this manual, MUST BE USED, OVERHAULD AND REPAIRED EXCLUSIVELY BY PERSONNEL that is qualified and familiar with all its characteristics and acquainted with the relevant safety rules (accident prevention). Laws regarding accident prevention and all industrial safety rules must always be observed. The manufacturer is not responsible for damages or injury caused by any arbitrary modification carried out on this unit.

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1.2 – Documentation rights This instruction manual, including technical drawings, tables and photos, are a manufacturer’s freehold property. These information can be used only for the purpose for which they have been produced. It is excluded from any other form of use, even partial, without explicit authorization by the manufacturer.

1.3 - Tests The equipment testing has been performed by the manufacturer with procedures that are to verify that the equipment, subject of this manual, is without faults and that its working features comply to the ones foreseen for this type of use. This kind of test is exclusively carried out by qualified personnel and its result is specified on the inspection report. The manufacturer keeps, in conformity with law, the only report copy every unit has.

1.4 - Guarantee Guarantees are supplied only in accordance with the contract conditions. Damages which are caused by incorrect equipment use or by non-observance of the rules in this manual will not be considered under guarantee. ATTENTION! The guarantee is automatically voided if interventions on the unit are made by non-authorized personnel.

1.5 - Symbols In this manual the following symbols are used: It means “proceed with caution” from the operator.

It means “pay attention” during some operations.

It is a warning for possible dangerous situations to people or equipment.

The numbers in this text are referring to the illustrations enclosed in this manual and their meaning is the following: (1.3) = part 1 of the picture 3.

1.6 – Product identification. If it is necessary to contact the manufacturer for technical or maintenance problems, take note of the unit serial number and overhaul in order to make the technicians intervention quicker and more accurate. This information can be easily obtained from the Product Identification Label (PIL) that is applied to the equipment and positioned as shown in the drawing of the next page). TRN4MTE3A – 22/02/2017 Page 7/42

Technical manual 1.7 – Labels On the unit there must be:  part number label;  wire ropes replacement label;  serial number label;  Warning and/or danger labels. Their shape and placement is shown in the drawings on the following pages. Do not remove the adhesive labels on the unit: they are an integral part of the instructions and of the documentation that accompany the equipment

1.8 – CE Conformity The equipment subject of this manual, is built craftsman like and in conformity with the EN 60 601 safety regulations for the electromedical equipment. The equipment complies with the European Directive 93/42 relating the medical devices of class 1 (annex VII). The CE mark is shown on the adhesive label that identifies the equipment. The Declaration of Conformity is supplied with the documents that come with the equipment. A copy of this Declaration of Conformity can be asked for from the manufacturer.

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Chapter 2 Safety measures

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2 - Safety measures 2.1 – Safety measures for the functioning All units are manufactured following the latest technical standards in safety matters. In any case, their use can be dangerous, if they are not correctly used by untrained personnel or if they work differently from the projected aims. In particular, refer to the Operator Manual to know the safety measures for the equipment operations.  Instructions and rule which regard this kind of equipment and are in force in a country must be respected by the operator and the installer.  The unit must work only in rooms, which are used for medical aims (refer to regulations in force).  The unit is not planned to be used in rooms which are explosions risk. The equipment can be used and subjected to maintenance operations only by authorized and trained personnel. In particular, they must know the possible dangers coming from a wrong equipment use and the residuals risk.

2.2 - Safety measure for maintenance Before starting the maintenance operations, read carefully the procedure to follow. Keep clean and dry the working area.

 All operations to do on the unit must be carried out when it does not work. The person who is responsible of the maintenance must completely disconnect the unit, before the adjustment or replacement of an equipment part.  Keep hands, feet, dresses, jewels and hair at safety distance from any moving part in order to avoid their getting caught.  Keep all parts in good condition and correctly installed. Repair immediately damages, replacing the consumed and broken parts. Do not change any part of the unit; changes which are not authorized can compromise the equipment functioning and safety. They void the manufacturer’s guarantee as well. In particular, it is not possible to make inoperative or replace devices and/or circuits which permit the radiations emission in accordance with the safety laws.  After the maintenance, it is necessary to check the correct mounting and functioning of all electrical and mechanical devices before make the unit operative again. TRN4MTE3A – 22/02/2017 Page 11/42

Technical manual

The operator’s absolute attention is a safety essential element.

2.3 – Precaution in using the equipment The unit mobile parts movement must be carefully done in order to avoid collision risks and / or damages to people in the examination room or to the unit functional integrity. When the motorized vertical movement is used, it is necessary to avoid to create situations of conflict of the telescope mobile parts against any obstacle and not to insist on the controls when the end of travels have been reached. The unit can not be subjected to damaging stresses, such as the violent stop of the mobile parts on the end of travel bumpers, the excessive torsion of the electrical function cables, the forced movements of the unit without releasing the brakes, etc. Warnings!!! All patients parts which are at risk of radiation exposure, must always be protected by additional shielding devices according to the radiation safety law.

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Chapter 3 Equipment description

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3 - Equipment description This manual describes the stand for vertical bucky features and gives instructions for its proper use and procedures to the user.

3.1 - Equipment destination of use The equipment is destined to be uses as part of a fixed system for general radiological investigation, more specifically for chest examinations.

3.2 – Equipment description. The stand consists of a column that must be fixed to the wall; along this column, slides a vertical bucky support frame. The vertical sliding is obtained manually; the mobile parts, which are balanced by counterweights, are kept in parking position by a mechanical brake. The new equipment design unifies simple constructing to excellent functional warranties. In fact, the sturdy aluminium column lacks of the big external guides for the vertical slider slide action and allows the housing of the balancing counterweights in a safer physical position (inside the column). Besides, the wide use of the aluminium allows to contain the weight of the equipment with advantage for the transport and assembling operations; besides, the use of this material makes the equipment not sensible to corrosion events that can be dangerous if found not in time. Usually the stand is supplied with a bucky, a mobile grid and a cassette holder for cassettes up to 35x43 cm size. The cassette loading is manual and can be from the right or from the left. The frame that holds the bucky has the front panel in radiotransparent plastic laminated, while the plastic cover is drawn with ergonomic shapes and, in its upper part, has a concavity to allow the patient chin rest during the x-ray examinations. The stand accepts standard buckys, which are arranged for the measuring chamber for the exposition automatic control systems, and standard buckys with automatic cassette loading and reading device of the cassette size for the automatic collimation systems.

3.3 - Standard model variations. Instead of the wall fixing, a floor base (covered by anti-slip rubber) is available to support the stand.

3.4 - Accessories on request. The vertical bucky stand can be completed with a serie of accessories as the arm supprt, insertable in the proper support on the rear part of the bucky frame. A serie of external cassette holders to hang to the rear edge of the bucky allow to perform x-rays with cassettes with sizes from 18x24 cm to 40x120 cm with or without incorporate grid. Contact the manufacturer to know the availability of other accessories (not written in the chart) and/or torequest specific solutions.

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3.5 - Technical features Column stand Column height

230,4 cm

Bucky vertical travel

157,4 cm

Types of movement / braking

manual / mechanical

Balancing Minimum distance from floor to the Bucky top Power supply

by counterweights

Voltage / frequency Painted part color

no power supply required

Metal parts Weights

RAL 9016

67,5 cm

130 Kg

Stand weight

25 Kg

Base Transport and stock environment

0 °C ÷ 50 °C

Temperature range

10% ÷ 90%

Relative humidity range Atmospheric pressure range Operating environment

50 ÷ 110 kPa 10 C ÷ 40 C

Temperature range

30% ÷ 75%

Relative humidity range Atmospheric pressure range Equipment identification

70 ÷ 110 kPa

Classification (according to EN 60 601)

class I - type B

Operation mode

continuous permanent

Typology of installation Standard compliance

EN 60 601

Safety

3.6 – Accessories on request Accessories on request Arm support External cassette holder for cassette size up to 35x43 cm External cassette holder for cassette size up to 40x90 cm External cassette holder for cassette size up to 40x120 cm Parts to complete the equipment Bucky / cassette holder Grid

for sizes from 13x18 to 35x43 cm DF=150cm R=10:1 40L/cm

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Chapter 4

Installation

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4 - Installation Before using the equipment, the operators should read the Chapter no. 2 about the SAFETY MEASURES. The equipment must be installed and can be maintained only by authorized and trained personnel. Specifically, they must be informed about the possible dangers caused by improper equipment use and the residual risks. ATTENTION!!! The installation of hanging units or pars can be very dangerous; only the necessary personnel for the installation must be in the room during this operation. All other people must be sent out.  The manufacturer assumes no responsibility in case of faulty unit operation which can be caused by negligence or elusion of the basic maintenance rules listed below.  All ordinary or extraordinary operations on the equipment must be registered, documented and the information contained must be readily findable. Maintenance and documentation duties must be observed; anything contrary to the case, the equipment manufacturer responsibilities cease automatically.

4.1 – The room preparation. This chapter gives useful information to prepare the room where the unit, object of this manual, will be installed. According to the rooms dimensions, these information must be observed in order to obtain the unit complete performance in the best room fitness. Specific information about this are generally given separately by the manufacturer or the installer, who are in any case at full disposal for any further needs. ATTENTION!!! All masonry works for the room preparation are at customers or installers expense. It is important to know exactly the room features where the unit will be installed in order to make a correct preparation, according to the required safety rules as well.

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4.2 – Necessary tools for the installation. The equipment mounting does not need specials tools, but common use ones, like those listed below:  set of fixed wrenches;  set of box wrenches;  set of Allen wrenches;  set of screwdrivers;  water level;  electric drilling machine with a set of Vidiam drills;  lifting device (if available).

4.3 – Equipment warehousing and moving conditions Once the unit is assembled in the factory, it is subjected to careful controls and a tests from trained personnel. After the cleaning, the equipment is packed with corrugated card-board and wrapping paper (pluriball). For international shipment, or upon customer’s request, the equipment is crated in one or more wooden cases. Before the installation, the unit can be kept in the warehouse for some time with its original packaging. In any case, although every metal part is carefully covered by protection paint or oxidation superficial treatment, the equipment is not planned to work or be stocked outdoor. It cannot withstand the humidity; for this reason, do not keep it outdoor or in extreme environment conditions.

It is absolutely forbidden to pass by or under the load during the lifting operations.

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Make sure the cases are well fixed during the transport to avoid blows which could damage their contents.

 Pay attention to the moving hanging loads in order to avoid dangers to people or other things. The wooden cases are made to be lifted through a lifting device (forklift truck). If they must be lifted from the top (crane), it is necessary to sling them through suitable ropes, which must twine round the case.

4.4 – Equipment receiving The equipment is contained in one wooden case, whose contents is briefly listed below. The exact case contents is specified in the Packing List which is attached on the case.

Refer to the instructions outside the cases for their moving and lifting.

The CASE dimensions are 250x85x60 cm; its weight is of about 175 kg. It contains:  The stand (fastened lying down in a horizontal position), complete with bucky carriage (and possibly with bucky and grid, according to the customer’s requests);  The disassembled base support (option);  The box containing the additional counterweights and the optional accessories to complete the equipment installation. To remove the stand from its crating case, proceed as follows:  Remove the upper cover of the case;  Remove one of the long sides of the case;  Locate the envelope that contains the documents and the assembling instructions and store them carefully for future use;  Take off the box that contains the accessories;  Take off the optional base support (option);

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To move and lift the stand, refer to drawings and attention notice which are on the stand packaging.  Place the stand vertically (in its working position) , then remove the wrapping paper and control carefully that all parts were not damaged during the transport; Any kind of damage must be immediately communicated to the forwarder and the manufacturer.

Pic. 1 – Case content.

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Technical manual

List of the items contained in the stand case (fig. 1). Pos.

Description

Quantity

1

CASE UPPER COVER

-

2

CASE

-

3

PACKING LIST

-

4

ENVELOPE WITH MANUALS AND DOCUMENTS

-

5

BOX OF ACCESSORIES

-

6

STAND

-

7

FLOOR BASE (OPTION)

-

8

CASE LATERAL WALL

-

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Chapter 5 Mounting

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5 - Mounting 5.1 – Mounting of the support base. If the stand is the one with floor support (model TRN43B) first you must mount the base on the bucky stand column. To do this, it is necessary to proceed as follows:  place the stand column horizontally on two supports;  position the floor support to the column base;  then fasten it strongly using 4 screws TSCE M6x20 + Loctite;

When the operation is over, put the stand on its work vertical position. The support base presence does not need any masonry works and permits a rapid and easy positioning of the stand in the best working position.

5.2 – Fixing to wall and floor. On the contrary, if the stand is designed to be directly fixed to wall and floor, it is necessary to proceed in a different way:  position the stand in vertical position, making it slide until the chosen working position;

It is important to verify carefully that the reached position is the required one.

 through a pencil mark to wall and to floor the fixing holes positions;  lightly move away the stand, check using the drawing attached to the following page, the exact correspondance of all the quotes;  then proceed with making the holes;  through a percussion drill with a Widiam D12 drill bit make holes 40 mm deep. As fixing system use 4 metallic anchor Fisher D12-M6 (which are on the market) and 4 hexagonal screws TE M6x40 + a large washer D6. Or optional kit: TRA024

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ATTENTION!!! The maximum load in horizontal direction and acting on the fixings to wall is about 500 N. It is important that the support surfaces are carefully smoothed. Possible little differences can be corrected during the mounting phase, inserting the suitable thicknesses between the base and the support surface. ATTENTION!!! The fixing system, which has just been described, is the most common one and must be considered as the preferred method of installation. The measuring of the stand support structures is exclusively under the competence of the designer, who is responsible of the rooms preparation.

5.3 – Mounting of the bucky. The bucky stand is supplied without the bucky, if the customer did not request or require it. ATTENTION!!! Mount the bucky before the unlocking of the clamp which avoids the vertical carriage sliding. The counterweight which slides inside the column is not correctly balanced; for this reason, it could injure persons or damage things. To do this operation:  Unscrew the screws that fasten the bucky cover (11.3);  Remove the bucky cover complete of serigrafated panel (10.3 and 09.3);  mount the bucky inside the support; Follow the mounting procedure and the indications containedin the instruction that come with the bucky.

 Re-mount the bucky cover complete with the serigrafated panel (10.3 and 09.3);  Tight the screws that fasten the bucky cover (11.3).

5.4 – Unlocking of the vertical carriage After fastening the bucky stand to the wall and after mounting the bucky (if this has not been already dismounted at the factory) it is possible to proceed to the bucky carriage unlocking. During the transport, to avoid equipment damaging, the bucky carriage is blocked to the lower end of travel. Proceed as follow:

 Remouve the screws (1.2) that fasten the plastic cover (2.2);  Individuated the lock nut (3.2) and remouve it;  Remount at this point the cover (2.2) being careful to fasten it by the supplied screws (1.2). TRN4MTE3A – 22/02/2017 Page 26/42

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ATTENTION!!! Proceed carefully to prevent the counterweight (which slides inside the column) from injuring persons or damaging things, if it is not correctly balanced.

Pic. 2 – Counterweight unlocking, after the mounting (file: me950002).. Pos.

Description

Quantity

Code

1

BUTTON HEAD HEXAGONAL CAP SCREW

2

103484

2

PLASTIC CAP

1

102621-01

3

LOCKING NUT WASHER D12

1 1

200-00012 220-00012

4

WALL FIXING

1

95E223

5

COUNTERWEIGHT 43

1

G95S000-A

6

COLUMN L=2100mm

1

95L213

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Technical manual 5.5 – The vertical carriage balancing The counterweight that slides internally to the column is around 39 kg and it is thought to offer a good balancing of the vertical slider. However, in special cases (lighter buckys for example), it may be necessary the use of the additional counterweights to be applied on the bucky support carriage to counteract this force. To do this:  Unscrew the screws that fasten the bucky cover (11.3);  Remove the bucky cover complete with the serigraph panel (10.3 and 09.3);  Add the additional counterweight plates (12.3) on the grains inserted for this purpose (16.3) by using the nuts supplied for the locking (15.3); It is possible to add from 1toa 3counterweight plates, that have an additional weight of about 1,5 kg each, to find the desired balancing

For a careful check of the balancing, it is always necessary to put in position the bucky cover (11.3) in order to have the total of the applied weight to the bucky carriage.  Remount the bucky cover complete with serigrafated panel (10.3 and 09.3);  Tight the screws that fasten the bucky cover (11.3); ATTENTION!!! During this operation block the vertical carriage well, in order to avoid dangers for the operator and / or the technician who is operating it.

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Pic. 3 – Bucky mounting (file: me950004-b). TRN4MTE3A – 22/02/2017 Page 29/42

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Pos.

Description

Quantity

Code

1

PLASTIC CAP

1

102621-01

2

BUTTON HEAD HEXAGONAL CAP SCREW

2

103484

3**

SCREW TCCE M5x20 WASHER D5 SPRING WASHER D5

4 4 4

100-05020 220-00005 223-00005

4**

WALL FIXING BRACKET

1

95E223

5

COLUMN L=2100 VERTICAL SLIDER MECHANICAL BRAKE

1

G950011 G95LCV1

6

KNOB BRAKE

1

95L344

7* **

FLOOR FIXING BASE

1

95E214

8* **

SCREW TSCE M6x14

1

120-0614

9

OVERLAY

1

95T221-B

10

PLASTIC BUCKY COVER

1

95T212-A

11

SCREW TBO CE M5x16 WASHER PIANA D5 (upper side) LARGE WASHER D5 (lower side)

4 2 2

130-05016 220-00005 222-00005

12

PLATE FOR BALANCING CORRECTION

3

95T264

13

BUCKY

1

-

14

BUCKY LATERAL COVER

1

95T253

15

WASHER D5 SPRING WASHER D5 NUT M5

2 2 2

220-00005 222-00005 200-00005

16

DOWEL 5x20

2

170-05020

* Kit cod.TRA031: TELE AL – FLOOR FIXING BASE SET (pos. 7 + pos. 8) **Kit cod.TRA032: TELE AL – FLOOR-WALL FIXING SET (pos.3+pos.4 + pos.7 + pos. 8)

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Chapter 6 Electrical connections

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6 – Electrical connections 6.1 - Equipment electrical connections. To work correctly, the equipment does not need any electrical connection. As far as the bucky at mobile grid electrical connection is concerned, it is necessary to follow the indications contained in the documentation that comes with the bucky. To reach the interfacing terminal board it is necessary to remove the bucky cover. To do this:  Unscrew the screws that fasten the bucky cover (11.3);  Remove the bucky cover (10.3 e 09.3);

At the rear of the bucky support, there is an adaptor for the cable outlet (see next page).

ATTENTION!!! Follow the instructions contained in the documentation accompanying the bucky to learn about the interconnection methods. After completing the operation:  Remount the bucky cover complete with serigraph panel (10.3 and 3);  Fasten the screws that fasten the bucky cover (11.3);

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Appendix A Maintenance schedule

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Appendix A – Maintenance schedule. A.1 – Maintenance safety measures Before starting the maintenance operations it is strongly advised to carefully read the maintenance safety dispositions contained in the chapter2  All operations to do on the unit must be carried out when it is out of service. The person who is responsible for the maintenance must completely disconnect the unit from power, before the adjustment or replacement of an equipment part.  Keep hands, feet, dresses, jewels and hair at safe distance in order to avoid their being caught in moving parts or part extensions.  Keep all parts in good condition and correctly installed. Repair damages immediately, replacing the consumed and broken parts. Do not change any part of the unit; changes which are not authorized can compromise the equipment functioning and safety. They void the manufacturer’s guarantee as well. In particular, it is not possible to make inoperative or replace devices and/or circuits which permit the radiations emission in accordance with the safety laws.  After the maintenance, it is necessary to check the correct mounting and functioning of all electrical and mechanical devices before placing the unit back into service again.

The operator’s absolute attention is a safety essential element.

A.2 – General maintenance rules.  The equipment maintenance must be done by the customer.  The manufacturer has no responsibility in the case of a units faulty operation, which can be caused by negligence or exclusion of the basic maintenance rules listed below. The preventive maintenance must be exclusively done by qualified and authorized personnel. Subject to agreement with our administration department, we are at full disposal to supply the necessary technical support. TRN4MTE3A – 22/02/2017 Page 35/42

Technical manual  A general check of the unit and its functioning conditions must be done at intervals no longer then 12 months. More frequent controls (al least 6 months) must be done if the unit is subjected to heavy use or in case of restarting after a long stop.  Changes, up-dates and extraordinary maintenance must be done by the manufacturer or technical personnel authorized by them.  Every ordinary and extraordinary operation on the equipment must be supported by documents; these must be findable. IMPORTANT! It is compulsory for the installer to act so that equipment parts that require checks and maintenance are easily open to inspection and readily available. This aspect has been taken into great consideration by the manufacturer. Maintenance and documentation duties must be observed; Anything contrary to the case releases the equipments manufacturer from all responsibilities.

Every technical intervention must be recorded in the Maintenance Register (on the following pages) and in the special adhesive labels placed on the equipment.

A.2.1 – Necessary tools. No kind of specific tool is necessary for the maintenance:  soft clothes for the cleaning;  detergent, which is found on sale;  white petroleum grease (for ex. Vaseline);  paint to touch up (issued with the unit) and soft brush;  paint thinner (for ex. NITRO);  series of fixed wrenches;  series of box wrenches;  series of hexagonal wrenches;  series of screwdrivers.

A.3 – Maintenance. A.3.1 – General checks. The equipment includes mechanical and electrical parts, which need to be subjected regularly to checks and maintenance in order to guarantee a units efficient and enduring working. Here following it is shown the typology and the frequency of the main controls that must be regularly effected (as suggested by the manufacturer).

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The user, this means the person who is responsible for the equipment, must ask for the technical support at the foreseen dates and hold all of the units documentation for quick reference—that means this manual and the operators manual. The user must always address technical personnel for the equipment maintenance and repairing—these operations must never be done by the user. GENERAL CHECKS

INTERVAL

Cleaning of the ball bearings sliding guides

12 months

Cleaning and lubrication of bearings and pins

12 months

Check and regulation of the bearing functions and play

12 months

Efficiency of the centring and alignment devices

12 months

Tightening of the screwed parts

12 months

Efficacy of the braking devices

12 months

Efficiency of the control and signal devices

12 months

Condition of sheaths and electrical cables

6 months

 First remove all covers and clean carefully the equipment, using a damp cloth and a common detergent that can be readily found.

Pay attention not to use abrasive products or substances which contain solvents, because they can damage the unit surface.

 Check scrupulously if there are possible anomalies.  If the unit presents dents, repair them; in case of damaged painted surfaces, touch them up using the paint issued by the manufacturer. It is very important to repair as soon as possible the unit damages. In particular, remember that every scratch to the protection paint must be touched up with specific paints supplied by the producer; if this operation is well done, it avoids a dangerous oxidative phenomenon, which could compromise the efficiency and the resistance of the stand metal structure. The unit painting is made using powder paint and baking in furnace. To touch up the unit, a small bottle containing some original powder is supplied; this must be dissolved through a drop of paint thinner (NITRO preferred) and applied by using a soft brush.

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Technical manual  Grease bearing and pins, which can be reached. For the greasing use common universal grease, which is on sale. DO NOT use oils or other lubricants, that could cause draw or dirty the unit or the working area.  Check the functioning backlash of bearings and of guiding and braking devices. It is very important to check the slack of the ball bearings and, if necessary, effect their regulation following the instructions written in the previous chapter.  Check the correct functioning of the control and braking devices as well.  Check the correct tightening of the nuts and bolts.  Check the correct functioning of the electrical parts as well, that means the functioning of push buttons and brakes and the integrity of cables and safety devices. If it is necessary to contact the manufacturer for technical problems or the equipment maintenance, it should be better to take note in advance of the unit serial number and test in order to quicken and focus the technical support intervention. This information can be easily obtained from the identification label, which is on the equipment.

A.3.2 – Controls of the wire ropes and suspension cables The vertical bucky balancing takes place by a counterweight (placed inside the column) and by two connecting wire ropes with the carriage that supports the bucky. Careful maintenance of the suspended parts is required in order to avoid potential dangers for the operators and to guarantee the correct functioning of the equipment itself.

The steel ropes controls must be planned following the table indications, that means every year.

WIRE ROPES CHECKS

INTERVAL

Condition of the steel wire ropes

12 months

Condition of the ropes pulleys

12 months

PARTS TO REPLACE

INTERVAL

Steel ropes

10 years

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Technical manual

This control must be done along all the length of the ropes, verifying that there are no signs of stretching, deflection or strand breakage. Moreover, verify that the ropes roll up correctly around the pulleys and their wear condition. The ropes replacement must be done in accordance with the intervals, which are indicated on the equipment labels (see chapter 1 of this manual). The technical personnel that is responsible of controls, must always fill the label, writing the date and sign it. It is very important to carry out an accurate and scrupulous control, in order to avoid dangerous situations for operators and patients. For eventual explanations apply to the manufacturer. The failure of the cable is the consequence of the missed maintenance and periodical checks; the stand requires a very careful maintenance of the suspended parts in order to avoid dangers for the operators and to guarantee the correct functioning of the equipment itself. If there are some anomalies during the control, the rope must be immediately replaced. It is also necessary to check if there are clear damages or wear signs on the pulleys. If there are, they must be replaced as well. It is possible to ask for spare parts or updating to the manufacturer. They are at full disposal for maintenance or extraordinary renovation interventions as well.

Contact the manufacturer to receive the instructions about the ropes and spare parts replacement. If it is necessary to contact the manufacturer for technical problems or the equipment maintenance, take note in advance of the units serial number and test in order to quicken and focus the technical support intervention. This information can be easily obtained from the identification label, which is placed on the equipment. Do not use in any case the stand when one of the two wire ropes show evident signs of tear and wear or if it is broken. Contact the technical support and replace the broken ropes.

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Technical manual

A.4 – Room disinfection and cleaning The power supply must be disconnected before the cleaning. Do not use water, to avoid corrosive phenomenon on the steel parts. Useful information about it can be found in the Operator Manual. Further information and advices can be read in manuals and instructions concerning disinfections and protections against explosions.

A.5 - Equipment disassembly The disassembly of the equipment must be done by authorized and qualified personnel. The unit is quite totally made of metal materials, such as aluminium, steel and copper, and presents a minimum part of plastic material and electrical/electronic components. The metal parts can be recycled as scrap. The equipment contains some lead, which must not be dispersed in the environment. The electrical components and the plastic materials must be separately considered as special rubbish. All materials used for the unit manufacture are not toxic or dangerous for the operators’ health; that means they can be used without any particular precaution. In any case the disassembly/recycling of the equipment materials must be done according to rules which are in force at the moment of the operation. The equipment supplier is at full disposal for any kind of information.

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Technical manual

A.6 – Maintenance Register. Model

Serial number

Options

Installation date

A.6.1 – Every 6 months. GENERAL CHECKS

INTERVAL

Condition of sheaths and electrical cables

6 months

Date

Signature

Date

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Signature

Technical manual

A.6.2 – Every 12 months. GENERAL CHECKS

INTERVAL

Cleaning of the ball bearings sliding guides

12 months

Cleaning and lubrication of bearings and pins

12 months

Check and regulation of the bearing play

12 months

Efficiency of the centring and alignment devices

12 months

Tightening of the screwed parts

12 months

Efficacy of the braking devices

12 months

Efficiency of the control and signal devices

12 months

WIRE ROPES CHECKS

INTERVAL

Condition of the steel ropes

12 months

Condition of the ropes pulleys

12 months

Date

Signature

Date

Signature

A.6.3 – Every 120 months (10 years). PARTS TO REPLACE

INTERVAL

Steel ropes

10 years

Date

Signature

Date

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Signature