AGFA D2RS Bedienungsanleitung

OM-RCTDRDyn.R0a Release in January 2015

Digital Remote Controlled Table with dynamic flat panel detector

User’s Manual

Digital Remote Controlled Table with dynamic flat panel detector

User’s Manual

REVISIONS HISTORY

Revision Date Reason for change

0 30 January 2015 First edition

Of reorganisation of the

manuals

Digital Remote Controlled Table with dynamic flat panel detector

User’s Manual

Please read the whole documentation before using the medical device

Digital Remote Controlled Table with dynamic flat panel detector

User’s Manual

TABLE OF CONTENTS

Note to the user ..................................................................................................................................................6

Guarantee conditions..........................................................................................................................................7

Environmental protection....................................................................................................................................8

Safety and protection..........................................................................................................................................9

1. DESCRIPTION.............................................................................................................13

1.1. Generalities........................................................................................................................................13

1.2. Table control console........................................................................................................................14

1.2.1. Table switching on .............................................................................................................14

1.2.2. Table switching off.............................................................................................................14

1.2.3. Tube movements controls with joystick .............................................................................15

1.2.4. Column reset button...........................................................................................................15

1.2.5. Collimator shutters controls with joystick...........................................................................15

1.2.6. Automatic collimation mode...............................................................................................15

1.2.7. Light beam switching on ....................................................................................................15

1.2.8. Compression controls (option)...........................................................................................16

1.2.9. Unique control for autopositioning .....................................................................................16

1.2.10. Detector IN / OUT (for version with removable detector) ..................................................16

1.2.11. Centring controls with joystick............................................................................................16

1.2.12. Tabletop longitudinal movement........................................................................................17

1.2.13. Tabletop height and tilting with joystick .............................................................................17

1.2.14. Tabletop reset button.........................................................................................................17

1.2.15. Exposure controls ..............................................................................................................17

1.2.16. Touch screen display.........................................................................................................18

1.3. Automatic collimator.........................................................................................................................19

1.4. Remote handswitch...........................................................................................................................20

Digital Remote Controlled Table with dynamic flat panel detector

User’s Manual

2. OPERATION ................................................................................................................21

2.1. Switching on ......................................................................................................................................21

2.2. Detector positionning (for version with removable detector).......................................................22

2.3. Patient positioning ............................................................................................................................23

2.3.1. Accessories Installation .......................................................................................................23

2.3.2. Patient Installation................................................................................................................23

2.3.3. Patient positioning................................................................................................................24

2.4. Table autopositioning .......................................................................................................................25

2.5. Preparation for exposure..................................................................................................................26

2.6. Generator interface use ....................................................................................................................27

Refer to Generator interface User Manual

2.7. Digital system control console use.................................................................................................27

Refer to Digital System User Manual

2.8. Detector use (for version with removable detector) ......................................................................27

2.9. Tomography use................................................................................................................................28

2.10. Stitching use (option)........................................................................................................................30

2.11. Motorised compression system use (option).................................................................................31

3. TABLE MAINTENANCE ..............................................................................................32

3.1. Cleaning and disinfecting...............................................................................................................32

3.2. Preventive maintenance .................................................................................................................33

4. ERROR MESSAGES ...................................................................................................34

4.1. Information messages.......................................................................................................................34

4.2. Operation messages .........................................................................................................................36

4.3. Failure messages...............................................................................................................................37

4.4. Service messages..............................................................................................................................39

Digital Remote Controlled Table with dynamic flat panel detector

User’s Manual

IMPORTANT ! ... X-ray Protection

X-RAY EQUIPMENT IS DANGEROUS TO BOTH PATIENT AND OPERATOR

UNLESS MEASURES OF PROTECTION ARE STRICTLY OBSERVED

X-ray equipment if not properly used may cause injury. Accordingly, the instructions herein should be thoroughly

read and understood before attempting to place this equipment in operation. We will be glad to assist and

cooperate in placing this equipment in use.

Although this apparatus is built to the highest safety standards and incorporates a high degree of protection against

X-radiation other than the useful beam, no practical design of equipment can provide complete protection. Nor can

any practical design compel the operator to take adequate precautions to prevent the possibility of any persons

carelessly, unwisely, or unknowingly exposing themselves or others to X-radiation.

It is important that everyone working with X-radiation be properly trained and take adequate steps to insure

protection against injury.

The manufacturer assumes that all operator and service personnel authorized to use, install, calibrate and maintain

this equipment is cognizant of the danger of excessive exposure to X-radiation, is sufficiently trained and has the

required knowledges for it. The equipment herein described is sold with the understanding that the manufacturer,

its agents, and representatives are not liable for injury or damage which may result from exposure to X-radiation.

Various protective material and devices are available. It is recommended that such materials and devices be used.

Digital Remote Controlled Table with dynamic flat panel detector

User’s Manual

In normal use, (detector integrated into the table as image receptor) the reference axis of the X-ray beam must

form an angle of 90 ° with the surface of the tabletop, so that the X-ray beam corresponds to the image area. There

is an indexing system, activated by the buttons on the tube cover that automatically positions the X-ray tube

assembly at 0°, + / -90° and 180°.

Be sure that in normal use (detector in the table) the X-ray tube assembly is well positioned at 0 ° with the indexing

system.

NOTE TO THE USER

Your X-ray department has just purchased a Digital Dynamic Remote System with flat panel detector.

We congratulate you on this choice, and are sure you will be fully satisfied with its use and diagnostic capabilities.

These radiology units offer high quality and advanced technology.

To become familiar with its operation and make the most of its performance, the use of this equipment is conditioned

by the initial training received during approximately 5 days, depending on the X-ray service requirements, provided

during entry into service as well as the careful reading and understanding of the full user manual.

Read all documentation before using the medical device.

Keep this manual with the others in a safe place so that you can easily refer to it in the future.

Thank you for your confidence.

Digital Remote Controlled Table with dynamic flat panel detector

User’s Manual

GUARANTEE CONDITIONS

It is the responsibility of the user to ensure that the government regulations respecting installation and operation of

the equipment are observed.

Incorrect operation or failure of the user to maintain the equipment in accordance with the schedule of maintenance

relieves the manufacturer or his agent from all responsibility for consequent non-compliance, damage, injury,

defects and/or other malfunction.

In normal use, the table must be fixed to floor by eight screws M8x120. Refer to Service manual, in « Mounting »

chapter in paragraph « Implementation to floor ». No specific foot exists for the control console: it must be layed on

the shelf behind the shield but it is not necessary to fix it.

Refer to Service manual for any question related to the installation of the remote controlled table.

In any case of trouble, please contact the authorized company in charge with the equipment.

Refer to Service Manual to obtain pieces of information retated to:

- functioning, transport, and to storage of the equipment,

- the conditions necessary for installation of the equipment,

- the preparation for use of the equipment,

- the replacement of fuses, power supply cords and other parts,

- the circuits diagrams, and to the list of components,

- mains isolation.

The installation and equipment must not be used if any mechanical, electrical or radiation-emitting component is

defective, or if the procedures described in the schedule of maintenance have not been carried out.

Changes and additions to the equipment may only be carried out by the manufacturer or by third parties expressly

authorized by the manufacturer to do so. Such changes must comply with local regulations and accepted standards

of good practice.

In case the power lines do not meet the specifications given in section A "Preinstallation" of the Service Manual, the

table cannot reach its maximum performance and the standard use cannot be guaranteed.

Technical files (diagrams, parts list, measurement procedure and so on...) are available on request to the

manufacturer.

Digital Remote Controlled Table with dynamic flat panel detector

User’s Manual

ENVIRONMENTAL PROTECTION

This equipment or system contains environmentally dangerous components and materials (electronic boards,

electronic components, lead, transformers, etc…) that, once the life-cycle of the equipment or system comes to

end, becomes dangerous and need to be considered as harmful waste according to the international, domestic and

local regulations.

Please, contact the manufacturer once the life-cycle of the equipment or system comes to end and before remove

this equipment or system.

Label in compliance with 2002 / 96 / EC European Directive

Digital Remote Controlled Table with dynamic flat panel detector

User’s Manual

SAFETY AND PROTECTION

X-rays are not innocuous and can be dangerous if used badly. You must, therefore, take precautions even when

following the instructions in this manual.

Are entitled to use the remote controlled table physicians specialized in radiology and medical imaging as well as

medical electroradiology operators, these users receive initial and ongoing training in radiation protection to

implement these measures.

X-rays units manufactured by the manufacturer comply with the strictest safety standards in force throughout the

world. They guarantee optimum protection against radiation risks.

Nonetheless, you are handling a unit specifically designed to generate X-rays to allow medical diagnosis on a film

or using a digital imaging system. Consequently, despite the inherent safety of our equipment, we recommend

using conventional commercially available equipment to protect yourself and your patient against scattered

radiation risks.

The following instructions must be strictly observed:

1- Safety:

Use only the following accessories supplied by the manufacturer:

- Remote control

- Compression band and compression winches

- Footrest

- Stool

- Handles

- Double pedal

OPTIONAL ACCESSORIES:

- Triple pedal

- Cup holder

- Pair of shoulder rests

- Pair of gynaecological stirrups

- Retaining bar

- Compression ladle

- Compression plexi

- IV-Pole

- Multi FPD lateral support

- 1m ruler for stitching

- Ruler support for stitching

- 10cm ruler for measuring

- Ruler support for measuring

- Secondary console

Note: applied parts, as defined in the general requirements for basic safety and essential performance are

tabletop, footrest, stool, handles, compression band, pair of shoulder rests, pair of gynaecological stirrups,

retaining bar, compression ladle, compression plexi.

Reminder: the applied part is defined as the part of the electromedical device (EM) which in normal use is

necessarily in physical contact with the patient so that the EM device or EM system performs its function.

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