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OPERA SYSTEM MANUAL

OPERA - SYSTEM MANUAL

CODE 62313 - REVISION 1.0

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OPERA - SYSTEM MANUAL

CODE 62313 - REVISION 1.0

R/F Remote Controlled System

OPERA MANUFACTURER

GENERAL MEDICAL MERATE S.p.A. Via Partigiani, 25 24068 Seriate (BG) – Italy Tel. +39 035 45 25 311 Fax +39 035 29 77 87 / 29 95 37 www.gmmspa.com - [email protected]

_______________________________________________________________________________________________ General diagnostic radiology Systems Intended use: _______________________________________________________________________________________________ The present documentation has been drawn up with the aim of illustrating OPERA System functioning. The original version of this publication was drafted in English and will be referred to for any controversy regarding interpretation. The contents of this publication may not be reproduced in any manner with any electronic or mechanical means. It cannot be distributed in any manner without written authorization issued by General Medical Merate S.p.A. All the images included in the present manual are protected by Copyright. Use and distribution of these images are forbidden without previous authorization by General Medical Merate S.p.A. General Medical Merate S.p.A. reserves the right to modify/update this document without prior notice. REVISION HISTORY Rev. 0 0.1 1.0

Date August 2010 December 2010 February 2011

OPERA - SYSTEM MANUAL

Notes Draft version First version First coded release

Code --62313

CODE 62313 - REVISION 1.0

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OPERA - SYSTEM MANUAL

CODE 62313 - REVISION 1.0

OPERA - SYSTEM MANUAL CODE 62313 - REVISION 1.0

GENERAL MEDICAL MERATE S.P.A.

Table of contents 1.

GENERAL NOTES ........................................................................................................ 3 1.1.

Typographic conventions............................................................................... 4

1.2.

Symbols of advice positioned on the equipment............................................. 5

1.3.

Directives and applicable standards ............................................................... 6

1.4.

Electromagnetic compatibility (EMC)............................................................. 6

2.

SYSTEM DESCRIPTION................................................................................................ 7

3.

FUNDAMENTAL COMPONENTS .................................................................................... 7 3.1. 3.1.1. 3.1.2. 3.1.3. 3.1.4. 3.1.5. 3.1.6. 3.1.7. 3.1.8. 3.1.9. 3.1.10. 3.1.11. 3.1.12. 3.1.13. 3.1.14. 3.1.15. 3.1.16. 3.1.17. 3.1.18. 3.1.19.

OPERA G RF: Radiographic high frequency generators ................................... 8 Main features .........................................................................................................8 Technology .............................................................................................................9 Operating radiographic techniques .........................................................................9 Focal spot selection ................................................................................................9 Kilovoltage (kV) selection in radiography.................................................................9 Milliampere (ma) selection in radiography...............................................................9 Milliampere-second (mAs) selection in radiography.................................................9 Time (ms) selection in radiography .......................................................................10 Automatic Exposure Control (AEC) .......................................................................10 Fluoroscopy..........................................................................................................10 KV transfer curves................................................................................................10 Anatomical programming (APR) ............................................................................10 DAP - Dose Area Product meter (optional).............................................................11 GenWareTM service software..................................................................................11 Examples of configurations...................................................................................11 Command panel - push button version.................................................................12 Command panel - touch screen version ................................................................13 Command panel - GMM touch screen version.......................................................14 Technical features ................................................................................................15

3.2. 3.2.1. 3.2.2. 3.2.3.

OPERA DFR: Digital imaging system ............................................................ 17 Main features .......................................................................................................17 Main applications .................................................................................................17 Performances .......................................................................................................17

3.3. 3.3.1. 3.3.2. 3.3.3. 3.3.4. 3.3.5. 3.3.6. 3.3.7. 3.3.8.

OPERA T: X-Ray remote controlled table (positioner) ................................... 20 OPERA T versions.................................................................................................20 Main features .......................................................................................................21 Main applications .................................................................................................21 Main options ........................................................................................................21 Performances .......................................................................................................21 Accessories...........................................................................................................27 Table overall dimensions ......................................................................................28 Technical features ................................................................................................34

3.4. 3.4.1. 3.4.2. 3.4.3. 3.4.4. 3.4.5. 3.4.6.

OPERA I: Analog imaging systems................................................................ 36 Main features .......................................................................................................36 Performances .......................................................................................................36 Intensifiers typical characteristics ........................................................................37 Cameras characteristics .......................................................................................37 TV monitor characteristics....................................................................................37 Monitor supports..................................................................................................37

4.

SAFETY RECOMMENDATIONS ................................................................................... 38

5.

PROTECTION MEASURES .......................................................................................... 39

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OPERA - SYSTEM MANUAL CODE 62313 - REVISION 1.0

5.1.

Safety.......................................................................................................... 39

5.2. 5.2.1. 5.2.2.

Safety devices ............................................................................................. 39 Dead man controls ...............................................................................................39 Electronic hardware protection functions .............................................................39

6.

IDENTIFICATION ....................................................................................................... 40

7.

ENVIRONMENTAL CHARACTERISTICS AND FUNCTIONING LIMITS ............................ 41 7.1.

Mains supply ............................................................................................... 41

8.

RISK RELATED TO WASTE DISPOSAL........................................................................ 42

9.

CLEANING AND DISINFECTION.................................................................................. 43 9.1.

Cleaning ...................................................................................................... 43

9.2.

Disinfection................................................................................................. 43

10. FUNCTIONING AND SAFETY CHECKS ........................................................................ 44 10.1.

Daily checks ................................................................................................ 44

10.2.

Periodical verification of the performance constancy................................... 44

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GENERAL MEDICAL MERATE S.P.A.

1.

OPERA - SYSTEM MANUAL CODE 62313 - REVISION 1.0

General notes

Warning X-RAY EQUIPMENTS CAN BE DANGEROUS TO THE HEALTH OF BOTH PATIENTS AND OPERATORS UNLESS PROPER SAFETY MEASURES ARE STRICTLY OBSERVED. Although this equipment was designed and manufactured according to the most up-to-date safety Standards, the X-ray beam always represents a danger, should not the operator be properly qualified and trained. Excessive exposures to X-rays cause damages to the human body: therefore, all the necessary precautions must be taken to prevent unauthorized or unskilled personnel from operating this equipment, thus jeopardizing themselves and other people. Before executing any operation, the person being qualified and authorized to operate this equipment, must be informed about the protection and safety measures established by the International Committee for the Radiological Protection, as well as any other relevant national Standards. For a proper use of this equipment, it is required that the operator should previously and carefully refer to the User’s manuals related to each component of the system. A special attention should be paid to the sections “Safety Recommendations”, “Protection Measures”, “Functioning and Safety Controls”. Note: This equipment is in compliance with the requirements established by the European Directive 2007/47CEE concerning medical devices that amends the former Directive 93/42CEE, thus it is provided with the EC mark stating the code number identifying the notified body responsible for carrying out the procedures foreseen for the compliance certification.

The original document was drawn up in English. General Medical Merate S.p.A. shall decline all responsibility with regard to the good functioning of the equipment should the installation and/or the maintenance of it be executed by unauthorized personnel.

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GENERAL MEDICAL MERATE S.P.A.

1.1.

OPERA - SYSTEM MANUAL CODE 62313 - REVISION 1.0

Typographic conventions

In order to facilitate the reading of the manual, different styles and types were used: please make reference to the following: Text identified by bullets Example: • Instructions to be executed according to the sequence specified. Text in italics accompanied by the symbol “i” (information) Example: Important information

Text in italics included within a frame Example: Useful supplementary information

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GENERAL MEDICAL MERATE S.P.A.

1.2.

OPERA - SYSTEM MANUAL CODE 62313 - REVISION 1.0

Symbols of advice positioned on the equipment Warning symbol to advise when a possible general danger for the equipment or the operator may occur. Invite the operator to check the equipment documentations

Hazard symbol to advise X-ray radiation exposition

Warning symbol to advise for electrical components that are sensitive to electrostatic discharge

Warning symbol to advise of live electrical parts with a possible risk of electric shock

Warning symbol to advise of possible fingers squashing

Protective earth (Ground)

Earth (Ground)

Type B Applied Part

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GENERAL MEDICAL MERATE S.P.A.

1.3.

OPERA - SYSTEM MANUAL CODE 62313 - REVISION 1.0

Directives and applicable standards

OPERA system complies with the following regulatory requirements and design standards: •

EC Directive 93/42/EEC concerning Medical Devices (European Community), and 2007/47/EC Directive that amends 93/42EEC

•

EN 60601-1/IEC 60601-1; EN 60601-1-2/IEC60601-1-2; EN 60601-1-3/IEC60601-1-3; EN 60601-2-7/IEC60601-2-7; EN 60601-2-28/IEC60601-2-28; EN 60601-232/IEC60601-2-32

•

CAN/CSA c22.2 No.601.1; UL60601.1

-

Type of protection against electric shock: Class I equipment

-

Degree of protection against electric shock: Type B

-

Degree of protection against harmful ingress of water: Ordinary equipment

-

Mode of operation: Continuous operation with intermittent loading (standby - exposure)

-

Equipment not suitable for use in presence of a flammable anaesthetic mixture with air or with oxygen or nitrous oxide

NOTE: All referenced standards are considered to be at the latest revision.

1.4.

Electromagnetic compatibility (EMC) GUIDANCE AND MANUFACTURE’S DECLARATION ELECTROMAGNETIC EMISSION

This manufacture declaration is suitable for all the OPERA SYSTEMS. All the systems are manufactured in the same way, by following the same production and using the same components related to electromagnetic emission. This declaration is based on the following documents: Test report IMQ 80SE00265 concerning the x-ray remote table Test report IMQ 80SH00402-1/-2 for compliance to IEC 60601-1-2 of the x-ray television system Test report UltraTech CPI064-EN1-2 for compliance to IEC 60601-1-2 of the x-ray generator In accordance with the intended use, OPERA system complies with the European Council Directive concerning medical Devices. The CE marking affixed to this product signifies this. One of the harmonized standards of this Directive defines the permitted levels of electromagnetic emission from this equipment and its required immunity from the electromagnetic emissions of other devices. It is not possible, however, to exclude with absolute certainty the possibility that other high frequency electronic equipment, which is fully compliant to the EMC regulations, will not adversely, affect the operation of this system. If the other equipment has a comparatively high level of transmission power and is in close proximity to the system, these EMC concerns (the risk of interference) may be more pronounced. It is therefore recommended that the operation of equipment of this type such as mobile telephones, cordless microphones and other similar mobile radio equipment be restricted from the vicinity of the R&F device. Important! For further information regarding this specific subject make reference to the current version of the operator’s manual and installation manual of each component of the system.

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OPERA - SYSTEM MANUAL CODE 62313 - REVISION 1.0

GENERAL MEDICAL MERATE S.P.A.

2.

System description

1)

OPERA G RF: radiographic High Frequency Generators (G500RF; G650RF; G800RF)

OPERA System is a high integration system consisting of four fundamental parts: OPERA T remote-controlled tables 2.4.2 (T30CS-CSX: 90°/30° tilting tables T90CS-CSX, 90°/90° tilting tables T90CE-CEX; variable height 90°/90° tilting tables)

2)

3)

OPERA DFR: digital imaging system, or

4)

OPERA I: analog imaging systems

3.

Fundamental components

2.4, 2.4.1

The following is a general description of the fundamental components of the OPERA System. For any further specifications, relative to the single components, make reference to the current version of the relative manual.

OPERA G RF

OPERA DFR

OPERA T30CS-CSX, OPERA T90CS-CSX; OPERA T90CE-CEX

OPERA I

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GENERAL MEDICAL MERATE S.P.A.

3.1.

OPERA G RF: Radiographic high frequency generators

3.1.1.

Main features y y y y y y y

Model G500RF G650RF G800RF

Full range of powers and configurations High frequency technology – output up to 400 kHz Console with push buttons or touch screen Powerful and flexible anatomical programming Advanced interface with remote-controlled table and digital system Extensive self-diagnostics with operator prompt messages Bult-in DAP device (option) Power KW 50 65 80

mA max 630 800 1000

Dual speed starter Opt. Opt. Opt.

X-ray tubes 1 (2opt.) 1 (2opt.) 1 (2opt.)

AEC

DAP

Opt. Opt. Opt.

Opt. Opt. Opt.

OPERA G generators are characterized by an advanced control through computer which assures: y minimum patient dose y excellent stability y high contrast The control functions for the operator are designed to be simple and easy to use. The automatic exposure meter and the anatomical programming provide controlled and automatically optimized exposure factors for the selected clinical application. The special TDI interface allows an high level integration with the remote-controlled table and the digital system.

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GENERAL MEDICAL MERATE S.P.A.

3.1.2.

Technology

3.1.3.

Operating radiographic techniques

OPERA G generators adopt an advanced high frequency technology with output up to 400 kHz to provide high quality performances in all the applications fields of the modern radio-diagnosis: y minimum residual ripple y high efficiency y minor absorbed dose by the patient y reduced weight and dimensions of the high voltage transformer The adopted innovative technical solutions, allow a complete functional control of the equipment able to assure: y reliability and operational safety y sophisticated operator interface y connection versatility with any X-ray tube y exposure parameters setting according to load ratings of the X-ray tube selected y possibility of modifying, at any time, the planned exams data according to user particular demands y estimation and check of the X-ray tube thermal load y self-diagnostics of breakdowns for a remarkable reduction of service times

Three factors

Milliampere (mA) selection Time (ms) selection Kilovoltage (kV) selection

Two factors

Milliampere-second (mAs) selection Kilovoltage (kV) selection

One factor

Automatic exposure control (AEC) activation Kilovoltage (kV) selection (Milliampere selection if required)

3.1.4.

Focal spot selection

3.1.5.

Kilovoltage (kV) selection in radiography

3.1.6.

Milliampere (ma) selection in radiography

3.1.7.

Milliampere-second (mAs) selection in radiography

Automatic: the equipment selects the focal spot according to preset milliampere limit. Manual: the operator selects the required focal spot. Focal spot change is not allowed unless the milliampere is within the X-ray tube limit.

From 40 to 150 kV with 1 kV increments.

G500: from 10 to 630 mA in 19 values; G650: from 10 to 800 mA in 20 values; G800: from 10 to 1000 mA in 21 values. The maximum milliampere value is limited to a level based upon X-ray tube focus emission levels.

Without AEC From 0.5 to 1000 mAs in 35 values. The limit value it is normally selected to 630 mAs, the maximum mAs value is limited by focal spot emission, by anode thermal load and by generator’s power limit. With AEC Exposure limit 500 mAs, the generator can be programmed also for lower values. Depending on the characteristics of X-ray tube and/or generator, the value can be lower than 500 mAs.

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GENERAL MEDICAL MERATE S.P.A.

3.1.8.

Time (ms) selection in radiography

3.1.9.

Automatic Exposure Control (AEC)

From 1 ms to 6.3 s in 39 values. Time selection values can be limited by the X-ray tube’s focal spot emission and anode thermal loading.

Up to four measure chambers can be connected to OPERA G. Any chamber has three fields. Each of the six accessories can be programmed to work with the automatic exposure control. Film-screen selection Are selectable three film-screen types applicable to all the accessories with automatic exposure control. Field selection The three fields of every measure chamber are selectable in various combinations: left ●

central

right

● ● ● ●

● ● ●

● ● ● ●

the central field is selected as default. Optical density selection Eight density levels resulting dose change from 50% to +100%. The levels are defined in installation set-up and are available also for the anatomical programming.

3.1.10.

Fluoroscopy

3.1.11.

KV transfer curves

3.1.12.

Anatomical programming (APR)

Fluoroscopy can be used both in manual mode and automatic (ABS) mode with the following possibilities: - Manual (automatic kV, manually controlled mA). - Low dose (automatic kV and mA). - Normal (automatic kV and mA). - High contrast (automatic kV and mA).

OPERA G owns a series of fluoro-rad kV transfer curves. This allows the operator to preselect automatically the rad kV in relation to the fluoro kV.

OPERA G allows the selection of automatic techniques. That is obtained selecting a body region and then a subset of individual studies. The APR may be operated in two modes: Automatic, in combination with AEC; Semiautomatic, with possibility of adjust the technique according to patient size.

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GENERAL MEDICAL MERATE S.P.A.

3.1.13.

DAP - Dose Area Product meter (optional)

The device is completely built-in and uses ionization chambers placed in the X-ray tube collimator. Data are shown on console. It can check two X-ray tubes and it can be completed with a label printer. Radiography mode It is measured and shown the accumulated dose (mGycm2) of every single X-ray tube or, alternatively, of the sum of both the X-ray tubes. Fluoroscopy mode It can be shown, alternatively, the accumulated dose (mGycm2) or the dose rate (mGycm2/s). If dose rate is selected, the value is shown during the exposure; at the end the accumulated dose is shown. Data print (optional) The printer produces labels with day/time and the datum concerning the accumulated dose (mGycm2). On the labels are printed headings to be manually compiled: name, sex, dates by birth, identification number.

3.1.14.

GenWareTM service software

3.1.15.

Examples of configurations

The powerful service software allows a quick and careful product set-up, in addition allows also simple and quick configuration related to a specific installation and customer's requirements.

Integrated console with push-buttons

February 2011

Single console with push-buttons

Touch screen console and digital system

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GENERAL MEDICAL MERATE S.P.A.

3.1.16.

OPERA - SYSTEM MANUAL CODE 62313 - REVISION 1.0

Command panel - push button version

This picture represents the main screen; there are some principal areas: 1) 2) 3) 4) 5) 6)

Power ON, power OFF buttons Radiography controls and display Image receptor buttons (accessories) Anatomical programming display and control Fluoroscopy controls and display Prep and exposure buttons and exposure indicator LED

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GENERAL MEDICAL MERATE S.P.A.

3.1.17.

OPERA - SYSTEM MANUAL CODE 62313 - REVISION 1.0

Command panel - touch screen version

This picture represents the main screen; there are some principal areas: 1) 2) 3) 4) 5) 6) 7) 8)

Tube 1 / tube 2 indicator, DAP display, anode heat indicator, cine runtime indicator, and back / main menu selector button Radiography controls and display Image receptor buttons (accessories) Anatomical programming selector Fluoroscopy controls and display X-Ray lock-out button AEC lock selector button DAP (Dose-Area Product) reset / test / print selection button

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GENERAL MEDICAL MERATE S.P.A.

3.1.18.

OPERA - SYSTEM MANUAL CODE 62313 - REVISION 1.0

Command panel - GMM touch screen version

This picture represents the main screen; there are some principal areas: 1) 2) 3) 4) 5)

Image display of TV patient visualization device Radiography commands and display Fluoroscopy commands and display Display area exposure, stand-by, selected tube, thermal units, DAP Accessory selection and APR commands/display

This version allows: - image visualization of the patient vision device - spectral filters insertion through APR

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OPERA - SYSTEM MANUAL CODE 62313 - REVISION 1.0

GENERAL MEDICAL MERATE S.P.A.

3.1.19.

Technical features

GENERAL PERFORMANCES Frequency Ripple

Output up to 400 kHz < 1 kV @ 100 kV G500: 50 kW G650: 65 kW G800: 80 kW

Power

Output parameters

Maximum exposure rate Image receptor buttons (accessories) RADIOGRAPHY kV range Current values (mA)

mAs values

Exposure times values (ms)

KV 80 100 150

G500 G650 mA mA 630 800 500 630 320 400 30im/s 6

G800 mA 1000 800 500

From 40 to 150 kV with 1 kV increments 10 - 12.5 - 16 - 20 - 25 - 32 - 40 - 50 - 63 - 80 - 100 - 125 - 160 - 200 - 250 - 320 400 - 500 - 630* - 800** - 1000*** * maximum value for G500 ** maximum value for G650 *** maximum value for G800 0.5 - 0.63 - 0.8 - 1.0 - 1.2 - 1.6 - 2.0 - 2.5 - 3.2 - 4.0 - 5.0 - 6.3 - 8.0 - 10 - 12.5 - 16 - 20 - 25 - 32 - 40 - 50 - 63 - 80 - 100 125 - 160 - 200 - 250 - 320 - 400 - 500 630 - 800 - 1000 Limitable to lower values 1.0 - 1.25 - 1.6 - 2.0 - 2.5 - 3.2 - 4.0 - 5.0 - 6.3 - 8.0 - 10 - 12.5 - 16 - 20 - 25 - 32 40 - 50 - 63 - 80 - 100 - 125 - 160 - 200 250 - 320 - 400 - 500 - 630 - 800 - 1000 - 1250 - 1600 - 2000 - 2500 - 3200 4000 - 5000 - 6300

AUTOMATIC EXPOSURE CONTROL (AEC) Selections Connectable chambers Post display of exposure time and mAs output.

February 2011

3 dominant areas 3 intensifying screens 11 density values Up to 4

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GENERAL MEDICAL MERATE S.P.A.

FLUOROSCOPY kV range Current values (mA) Acoustic signal Timer Automatic setting of rad kV in relation to fluoro kV ANATOMICAL PROGRAMMING (APR) Number of techniques DAP METER Displayed values Connectable chambers Data visualization Data printer (optional) X-RAY TUBES Connectable tubes One speed starter Dual speed starter Thermal status visualization POWER SUPPLY Voltage Automatic voltage stabiliser OPERATING AMBIENT CONDITIONS Environment temperature Relative humidity Atmospheric pressure

OPERA - SYSTEM MANUAL CODE 62313 - REVISION 1.0

From 40 to 125 kV with 1 kV increments From 0.5 to 10 mA After 5 exposure min After 5 exposure min Until 10 minutes

1024 exam techniques

2.2

Rad Dose (mGycm2) 2 On console On labels 1 or 2 3000 g/min anode rotation 3000/9000 g/min anode rotation

400-480 v, three-phase, 50/60 Hz +/-10% From 10 to 40 °C From 30 to 75 % From 500 to 1060 hPa

Important! For further information regarding this specific component make reference to the current version of the relative operator’s manual and installation manual.

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GENERAL MEDICAL MERATE S.P.A.

3.2.

3.2.1.

OPERA - SYSTEM MANUAL CODE 62313 - REVISION 1.0

OPERA DFR: Digital imaging system

Main features y y y y y y

12” and 16” I.I. 1024x1024 x 12 bit digital CCD camera Functions of customization and automatization for all the procedures Wide range of imaging-dedicated functions Full DICOM 3.0 interface DSA version

OPERA DFR is a new system conceived for digital image acquisition and processing ensuring the best diagnostic results in any X-ray application.

3.2.2.

Main applications y

y

3.2.3.

Standard dynamic exams: - Gastroenterology - Urology - Arteriography and flebography Angiographic exams: - Brain - Lungs - Legs - Coronaries - Kidneys - Liver

Performances

CCD Camera 1024x1024x12 bit-digital CCD camera. Tandem-coupling lens with iris. Acquisition in digital Fluoroscopy mode: up to 30 frames/s 1024x1024x12 bit. Acquisition in digital Fluorography mode: up to 15 frames/s 1024x1024x12 bit. Automatic Image Optimization with special Look Up Tables customizable by the user ensuring image utmost quality.

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GENERAL MEDICAL MERATE S.P.A.

OPERA - SYSTEM MANUAL CODE 62313 - REVISION 1.0

Processor configuration PC tower with CPU INTEL Core 2 Duo. 1 GB RAM. Generator interface. Keyboard and mouse. 160 GB HD allowing at least 55,000 image storage. 1280x1024, 19” LCD monitor. DVD-RW drive to record, re-write and read DICOM images on DVD. Windows 2000 operating system. Clinical applications Pulsed fluoroscopy with acquisition rates of 1 - 3.75 - 7.5 - 15 - 30 frames/s. Fluorography with acquisition rates of 0.5 - 1 - 2 - 3 - 4 - 5 - 6 - 7.5 - 10 – 15 frames/s. Digital tomography. Thumbnail viewing. Real time-edge 5 Level 13x13 Edge enhancement (Fluoroscopy, Radiography, Standard). Automatic adjustments based on selected image printing preference. Brightness/contrast control. Grey scale reversal. Electronic digital diaphragms. Zoom/Pan 2x. H/V reversal. Fluoroscopy acquisition for emergency. Store 100 images in Fluoro sequences (Fluoro Loop). Store Single Fluoro image. Automatic and manual LIH Multiple image display: 4 on 1 and 16 on 1. Export Image in JPEG file, BMP and AVI files. Annotation: text, line, arrow and pre-defined markers. Management of patient sub-groups images for ease of revision, transmission, printing. Memorization of the exams selections based on the user’s specific and individual preferences (Doctor Preferences). Measures: length, multi-segment length, angle, calibration. Reference images on the second monitor: - 14 image Storage viewable and selectable with thumbnails. - Multiple image display: 1 on 1, 2 on 1 horizontal, 2 on 1 vertical, 4 on 1. Scan converter (NTSC and PAL) for VCR images visualization. DICOM DICOM 3.0 kit interface including: - DICOM Print Class, - DICOM Storage Class, - DICOM Query, - DICOM Retrieve, - DICOM WorkList, - Modality Perform Procedure Step, - Storage Commitment Class. Optional DSA functions Two 1280x1024 LCD 19” in-room monitors. Real time subtraction. Roadmapping. Min/Max Opacification. Landmarking: 0%, 10%, 25%, 50%. Automatic DSA loop replay. Re-store subtracted images with partial or entire pixel. Percent Stenosis Vascular Measurement Package. Programmable sequences. Injector synchronization. February 2011

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OPERA - SYSTEM MANUAL CODE 62313 - REVISION 1.0

GENERAL MEDICAL MERATE S.P.A.

Image Intensifiers Two I.I. models available: 12" – three field 16" – four field. Both models are specifically suited for combination with Digital Systems. Particularly, the 16” I.I. extends the application field to areas normally reserved to film radiography.

Input field size Normal Magnification 1 Magnification 2 Magnification 3 Output screen size IEC Standard DQE Conversion factor Central resolution Normal Magnification 1 Magnification 2 Magnification 3 Contrast ratio 10% 10 mm diameter contrast ratio

12”

16”

31 23 16 // 25 65 300

40 31 23 16 35 65 300

cm cm cm cm mm % cdxm-2/mRxs-1

46 50 56 // 30:1 18:1

46 50 56 65 30:1 18:1

pl/cm pl/cm pl/cm pl/cm

Important! For further information regarding this specific component make reference to the current version of the relative operator’s manual and installation manual.

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OPERA - SYSTEM MANUAL CODE 62313 - REVISION 1.0

GENERAL MEDICAL MERATE S.P.A.

3.3.

OPERA T: X-Ray remote controlled table (positioner)

The remote-controlled tables of OPERA T family are backed up by an exclusive and advanced concept and thanks to the high modularity of their structures they can be configured according to the user's specific needs, thus ensuring the optimization of the performance-cost ratio.

3.3.1.

OPERA T versions

The OPERA T remote-controlled tables family includes the following models: Model

Table Tilting Angles

T30cs

+90° | 0 | -30° (Trendelenburg)

T30csx

+90° | 0 | -30° (Trendelenburg)

T90cs

+90° | 0 | -90°

T90csx

+90° | 0 | -90°

T90ce

+90° | 0 | -90° 2.4

T90cex

+90° | 0 | -90°

Tabletop height Spot film device from the floor 2.4.1 division Fixed Vertical divisions to 86 cm Fixed Vertical and to 86 cm crossed divisions Fixed Vertical divisions to 86 cm Fixed Vertical and to 86 cm crossed divisions Variable 2.4.1 Vertical divisions from 76 to 100 cm Variable Vertical and from 76 to 100 cm crossed divisions

- OPERA T30 can tilt from -30° to +90° while OPERA T90 can tilt from -90° to +90°. 2.4 - OPERA T90ce differs from OPERA T90cs for the elevation of tabletop. 2.4.1 - OPERA T30csx, T90csx and T90cex differ from OPERA T30cs, T90cs and T90ce for the SFD with crossed division.

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GENERAL MEDICAL MERATE S.P.A.

3.3.2.

Main features y y y y y y y y y

3.3.3.

Gastroenterology Myelography Skeleton Paediatrics Urology and gynaecology Emergency/traumatology Digital angiography

Main options y y y y y

3.3.5.

Advanced design and structure Outstanding compactness and light weight Total access to the patient from any side 9" to 16" I.I. Flat or concave tabletop Control panel integrated with both generator and digital system Retractable grid Visualization of tilting and incidence angles on the tabletop SFD with digital-controlled servo motors

Main applications y y y y y y y

3.3.4.

OPERA - SYSTEM MANUAL CODE 62313 - REVISION 1.0

SFD with vertical and crossed division (only for T30csx – T90csx – T90cex versions) I.I. elevation device Longitudinal tabletop movement Iris collimator Collimator with additional filters

Performances

Microprocessor control All the functions of OPERA T are controlled by microprocessor in order to ensure the greatest functioning safety, superior reliability and real time-check of the equipment, including the selfdiagnosis function. Examination table The table top size of 210x74 cm and the special tilting system considerably reduce the overall dimensions of the equipment. The table structure allows the operators to move easily towards the patient from any side. The patient gets up/down easily from the table both in horizontal and in vertical. Tabletop The tabletop can be opted with transversal profile either flat or concave (basin-shaped). With both solutions the profile ensures a reduced tabletop-to-film distance; furthermore, the lateral structures, in anodised aluminium, have the accessory-holder guides placed under the tabletop to avoid any possible accumulations of liquids. The tabletop movements are extremely ample: 35 2.4.4 2.4.4.2 cm in the transversal direction, 160 cm as an option for the fixed base longitudinal 2.4.4.1 direction. The optional longitudinal movement can be opted symmetrical +/- 80 cm or asymmetrical 100 cm head side and 20 cm foot side. The tabletop-to-floor distance is fixed to 86 cm for T30cs, T30csx, T90cs and T90csx versions. The tabletop-to-floor distance is variable from 2.4.1 76 to 100 cm for T90ce and T90cex versions. For patients with motion difficulties when the table is in vertical position, if there is the tabletop longitudinal movement, it is possible to low down the tabletop in order to ease rising on the footboard. For safety reasons the operation is possible only using the on-board console. The patient's maximum admitted weight is especially high: - 227 kg 2.4.3

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OPERA - SYSTEM MANUAL CODE 62313 - REVISION 1.0

X-ray tube stand The extended displacements of the stand make the OPERA T system very supple. Longitudinal displacement: - 124 cm, without longitudinal tabletop movement - 108 cm with longitudinal tabletop movement Focus-detector distance: 2.3.4 continuously variable focus-detector distance with preset positions at 115, 135 and 150 cm for very high quality degree in the execution of cardiac and lung examinations. Oblique incidences: +/-40° along a longitudinal displacement of 45 cm, ensuring the execution of complete examinations of the spine with different incidences; in addition, the capability of layer height selection allows the operator to maintain the object to be examined always centred on the image. X-ray tube assembly rotation: 270° with mechanical detents placed at 0°, +/-18°, +/-72°, +/-90° and +180° to allow easy execution of examinations with cassette outside SFD, on wall bucky stand and on stretcher. Minimum distance between X-ray beam and table edge: 43 cm, makes it easy to execute effective uro-gynaecological examinations. Due to its special structure, the table placed in vertical position ensures a great diagnostic efficiency: - extended and easy execution of examinations on charged legs, thanks to the reduced focusfloor distance - examinations on stretched patients proves to be very easy since, thanks to the ample longitudinal displacement and long focal distance, the operator can count on a large focus-floor distance and wider space for patient positioning Spot Film Device - SFD SFD is completely automatic and, thanks to its great versatility, can be used with any standard size cassette from 18x24 to 35x43 cm with 2-3-4 vertical division capability. Furthermore, the T30csx, T90csx and T90cex versions can be chosen enabling crossed division in 4 and 6 for 18x24, 24x24 and 24x30 cm cassettes.

The comprehensive program featuring the SFD

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SFD versatility is even enhanced by the retracting grid capability and by film marker (right/left).

The film marker Image Intensifier and TV Chain OPERA T can be equipped with Image Intensifier from 9" to 16" and high performance TV chains complete of automatic dose control device. The remote-controlled table can be configured for the application of digital imaging systems. A very important aspect is represented by the possibility (as option) of Image Intensifier elevation, since this allows setting its input surface at the same level of the X-ray film. This feature ensures exposure geometry optimization in fluoroscopy and digital fluorography.

The elevation system of the Image Intensifier

2.5

Homothetic tomography Normally tomography involves the movement of significant masses which is contradictory compared to accurate movements: with OPERA T, tomography takes a special advantage from the effort devoted to reduce the dynamic masses, besides the digital control ensures a high accuracy and precision of reproducibility. Main performances: - possibility of execution from -30° up to 90° with scan in both directions (T30cs and T30csx versions); from -90° up to 90°, with scan in both directions (T90cs, T90csx, T90ce and T90cex versions); - tomographic area extended up to the whole displacement of the SFD; - angles: 5º, 8°, 20°, 30º, 40°;2.5 - two speeds for each angle; - possibility to change from tomography to radiography on the same cassette; - selection of the layer height from 0 to 330 mm; - automatic increase of the layer height between 1 and 10 mm pre-arranged during installation.

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OPERA - SYSTEM MANUAL CODE 62313 - REVISION 1.0

Collimator The collimator, provided with luminous centering device, allows three adjustment modes: - manual; - remote-controlled from the control panel; - automatic, according to the cassette division, I.I. field, focus-to-film distance. The collimator can be a rectangular field type or a rectangular-iris fields type very useful with digital system applications. Other two models, rectangular or rectangular-iris type, are available complete of: - series of additional filters with manual insertion: position 1: 1mm Al + 0,1 mm Cu, position 2: 1mm Al + 0,2 mm Cu, position 3: 2 mm Al, position 4: empty; - rotation feature for easy collimation of contact radiographies with cassette out of SFD (eg.: extremities); - more powerful lamp for brightness compensation of the luminous field due to the DAP meter presence. Compressor 2.6 The remote-controlled compressor allows an effective though not traumatic palpation, the compression force can be adjusted from 50 to 200 N. A special consideration has been devoted to mechanical and electrical safeties, as well as safety against wrong manoeuvres. The compressor has a parking position from which it automatically moves in and out.

The compressor in working position

The compressor in parking position

Control panel The command console represents the main contact point between operator and system. Considerable care was therefore dedicated to this important element especially concentrating on integration of the various components commands: remote controlled table, generator and digital system. Various configurations are available: from the simplest with all commands fitted in a single console with identical functional logic and ergonomics, to the more technologically advanced and complete with touch screen panel for the generator, LCD monitor and specific supports for keyboard and mouse. All the solutions offer sure advantages in terms ease of use, space savings and aesthetics. These solutions are realized to be supported by a suitable floor support or disposed on desk.

Integrated console with push buttons

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Command functions The part of the control panel controlling the table is characterised by five joysticks and one series of light touch-keys, while large displays constantly describe the entire status of the equipment. Acquisition frequency or image review function

1-2-3-4 5-23 6-7-8-9-10-11-12 13-14 15-16 17 18 19-20-21 22 24-25-26-27-28 29 30 31 32 33 34-35 36-37-38 39-40-41-42 43-44-45-46-47-48 49 50-51 52 53-54 55 56 57-58-59 60 61 62 63 64 65 66 February 2011

Layer height

Adjustable tabletop height Tilting angle

Stand angle

Available exposures

I.I. magnification choice Layer height choice Tomography functions Conventional-digital radiography selection Accessory selection Turning on of the X-ray room’s light Emergency STOP push-button Dose in fluoroscopy Available function or Review/image memorization functions Angiography service Automatic sequencies in tomography Parking the grid Mixed programming Spot-filming Acquisition frequency or review function Image inversion on the monitor FFD choice AEC areas selection Size division choice Collimator Lamp Iris diaphragms (option) I.I. elevation Automatic collimation selection semiautomatic/bucky selection Stop in the horizontal position Stand vertical position Tabletop longitudinal displacement (option) Cassette in/out Diaphragms collimation Compressor Tilting movement X-ray tube stand incidences Patient scanning movements X-ray exposure Page 25/44

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The controls enabling the movements are also duplicated on the remote-controlled table.

2.4.2

T90ce T90cex only

An on-board console with joystick is furthermore available as option for longitudinal stand and lateral tabletop movements.

On-board console with joystick

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GENERAL MEDICAL MERATE S.P.A.

3.3.6.

OPERA - SYSTEM MANUAL CODE 62313 - REVISION 1.0

Accessories

The wide versatility of OPERA T is further enhanced by the availability of a complete series of accessories.

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GENERAL MEDICAL MERATE S.P.A.

3.3.7.

Table overall dimensions

T30cs T30csx - Front view

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T30cs T30csx - Side view

T30cs T30csx - Plan view

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GENERAL MEDICAL MERATE S.P.A.

T90cs T90csx - Front view

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T90cs T90csx - Side view

T90cs T90csx - Plan view

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T90ce T90cex - Front view

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T90ce T90cex - Side view

T90ce T90cex - Plan view

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3.3.8.

Technical features

EXAMINATION TABLE Tilting angles Tilting speeds Simultaneous movements

2.4.4

TABLETOP Dimensions Absorption Height from floor Maximum patient weight 2.4.3 Lateral displacement travel 2.4.4.2 Lateral displacement speed Longitudinal displacement travel 2.4.4.1 Longitudinal displacement speed STAND Focus-detector distance Longitudinal incidences Tube rotation Longitudinal displacement with detector Longitudinal displacement speed Minimum distance from table edge SPOT FILM DEVICE Minimum cassette format Maximum cassette format Vertical divisions Crossed divisions Tabletop-film distance Maximum applicable image intensifier Tabletop-intensifier distance Rapid spot filming Fluoro-radiography transition time Retractable grid

February 2011

O-T30cs csx O-T90cs csx +90/-30° +90/-90° variable up to 6°/s tilting longitudinal stand travel tabletop travel stand incidences

O-T90ce cex +90/-90°

O-T30cs csx O-T90cs csx O-T90ce cex 210x74 cm 0,7 mm Al eq 0,45 mm Al eq 0,45 mm Al eq variable from fixed to 86cm fixed to 86cm 76 to 100 cm 227 kg 35 cm variable up to 5 cm/s optional ±80 cm o +100/-20 cm 5 cm/s 2.4.4.1 from 115 to 150 cm (optional 180 cm) ± 40° 270° 124 cm 108 cm with tabletop longitudinal movement variable up to 20 cm/s from console 12 cm/s from SFD 43 cm 18x24 cm 35x43 cm 1 - 2 - 3 - 4 on all standard formats T30csx, T90csx, T90cex versions only: 4 - 6 formats: 18x24, 24x24 and 24x30 cm 78 mm with concave profile (+17 mm with flat profile) 40 cm 138 mm with concave profile option: 78 - 138 mm (+17 mm with flat profile) 4 images in 2 s 1s 110 lines/inch, R = 12:1, F = 120 cm option: 150 lines/inch, R=13:1, F=120 cm

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TOMOGRAPHY DEVICE Movement Tomographic area Angles/times Layer height selection

linear with execution in the two directions extended all over SFD displacement 8°/0.4 - 0.6 s 20°/0.6 - 1.2 s 40°/1.2 - 2.5 s 0 - 330 mm

COLLIMATOR Type of command Rectangular field Iris field Luminous centering device Series of filters with manual insertion

manual remote-controlled automatic standard optional standard optional 1 mm Al + 0.1 mm Cu 1 mm Al + 0.2 mm Cu 2 mm Al

COMPRESSOR Compression force Travel Parking

from 50 to 200 N 55 cm automatic

ELECTRICAL CHARACTERISTICS Nominal line voltage Mains frequency Current absorption Thermal dissipation Protection type Protection level

230 Vac +/- 10 % 50/60 Hz 15 A 500 W Class I Type B

ENVIRONMENT CHARACTERISTICS Relative humidity Temperature Atmospheric pressure WEIGHTS Equipment Command Console Cabinet

in in in in in

operation 30 – 75 % stock 10 – 90 % operation 10 – 40 ºC stock -20 – 70 ºC operation/in stock 700 – 1060 hPa

O-T30cs csx O-T90cs csx 660 kg - base 660 kg - base plate 1,00 m2 plate 1,00 m2 100 kg - base plate 0,20 m2 140 kg - base plate 0,21 m2

O-T90ce cex 790 kg - base plate 1,18 m2

Important! For further information regarding this specific component make reference to the current version of the relative operator’s manual and installation manual.

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3.4.

OPERA I: Analog imaging systems

3.4.1.

Main features y y y y y

9 “and 12” image intensifiers Two models of TV cameras with CCD sensor DRF dynamic recursive filter Last image hold LCD TV monitor Intensifier

TV camera

I9LT

9” (23 cm)

0.5 K

Noise reduction filter Recursive

I9HP

9” (23 cm)

0.5 K

DRF

17”

I12HP

12” (32 cm)

0.5 K

DRF

17”

I9HR

9” (23 cm)

1K

DRF

19”

I12HR

12” (32 cm)

1K

DRF

19”

3.4.2.

LCD monitor 17”

Performances

Image Intensifiers The 9" (23 cm) image intensifier is especially suitable for general diagnostic examinations with TV fluoroscopy. The 12" (32 cm) image intensifier represents the best available solution in this category. LT - Basic system Low cost configuration with performances suitable to satisfy basic fluoroscopic demands. It is proposed with 9" intensifier, CCD camera with 576x576 pixels sensor and 17" LCD monitor. HP - High performance system High performance solution thanks to the adoption of the Dynamic Recursive Filter (DRF). It is proposed with 9" and 12" intensifiers, CCD camera with 576x576 pixels sensor and 17" LCD monitor. HR - High resolution system Innovative and high resolution system thanks to a camera with 1024x1024 pixels and the adoption of the Dynamic Recursive Filter (DRF). It is proposed with 9" and 12" intensifiers, CCD camera with from 1kx1k pixels sensor and 19" LCD monitor. This version allows images acquisition also in pulsed fluoroscopy moreover the normal continuous fluoroscopy. The system is completed by a 99 images RAM memory. Dynamic Recursive Filter (DRF) DRF is a particular and innovative recursive filter capable to modify the filter factor dynamically pixel for pixel which, as well allowing an effective reduction of the noise, removes the persistence phenomena due to fast movements in the image. Pulsed fluoroscopy With this modality, typical of advanced digital systems, images of high quality, low noise are obtained with reduced doses. The acquisition rate ranges from 1 to 12 frames/s. Dose control device The system is complete of an automatic device for fluoroscopy dose control with kV/mA variation.

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3.4.3.

Intensifiers typical characteristics

Entrance field size Normal Zoom 1 Zoom 2 Output-image diameter DQE standard IEC Conversion factor Center resolution Normal Zoom 1 Zoom 2 Contrast ratio 10% Contrast ratio 10 mm

3.4.4.

9”

12”

23 16 12

31 23 16

cm cm cm

20

25

mm

65 240

65 300

% cdxm-2/mRxs-1

48 56 66 25:1 16:1

46 50 56 30:1 18:1

pl/cm pl/cm pl/cm

Cameras characteristics

Image matrix Aspect ratio Integrated high resolution optical system Gamma correction Bandwidth Recursive filter

LT/HP

HR

576 x576 4:3

1024 x1024 1:1

yes

yes

0,4 or 1 20 MHz+/-3dB LT: standard with factors 2, 4, 8, 16 HP: DRF

0,35 40 MHz+/-3dB

yes

yes

yes

yes

yes 1 Vpp

yes 1 Vpp

no

yes

yes no

yes yes

LT/HP

HR

17” (44 cm) 1280x1024 350 Cd/m2

19” (48 cm) 1280x1024 1000 Cd/m2

Automatic video level compensation Dynamic contrast compensation (shading) Electronic circle Video output signal Pulsed fluoroscopy (1, 3, 6, 12 frames/s) Last image hold (LIH) 99 images RAM memory

3.4.5.

TV monitor characteristics

Dimension Resolution Maximum luminance

3.4.6.

DRF

Monitor supports

Two types of TV monitor supports are available: - trolley - arm support for console

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4.

OPERA - SYSTEM MANUAL CODE 62313 - REVISION 1.0

Safety recommendations

It is the installer or operator's responsibility to observe all the governmental obligations and regulations in force applying to the installation and/or use of this equipment. The OPERA system must be checked and inspected every 12 months in order to maintain reliability and proper equipment functioning to ensure safe conditions for patients, personnel and third parties. Nonetheless, more frequent controls could be necessary should the equipment be used in particularly intense working conditions: in this regard, please contact our Service Department or our authorized Distributor for request necessary interventions. All the equipment parts that are subject to wear and tear and that may become a source of danger for people, must be controlled at regular intervals or at least once every 12 months by qualified personnel and replaced, if necessary. These inspections should be effected with the annual maintenance operation by our qualified personnel or our authorized Distributor. It is obligatory to comply with dispositions and/or prescriptions established by potential national regulations that require more frequent controls or maintenance operations. Before performing any exam, the operator must make sure that all the equipment safety devices work properly and the equipment is properly set up for use. Particular attention must be given to the verification of all display information (visual inspection). The X-ray exposure signal lamp should light up only for the time strictly required by the radiographic or radioscopic exposure: should it light up when no exposure command has been activated, the radiological generator must be immediately disengaged and our Service Department promptly notified. Any modifications and/or amplifications/additions to the equipment must always be authorized by GMM and must only be effected in compliance with the applicable design regulations and standards. As manufacturers and installers of this product we can not be held responsible with regard to equipment safety, reliability and performance in situations where: - installation, amplifications, resetting, modifications, repair work are performed by unqualified and/or personnel not authorized by GMM's Service Department to perform such activities; - in the event of breakage, components that are deemed important for proper system operation are not replaced by original spare parts; - the electrical wiring system in the X-ray room does not comply with the specifications established by IEC 364 series Standards or relevant national standards; - the equipment is not used according to the relative user instructions. Upon request, GMM will be happy to place the technical documentation at your disposal at the relative nominal cost, with the understanding that this documentation is not an authorization for technical interventions on the equipment. General Medical Merate S.p.A. is not responsible for any repair work done without its specific authorization in writing, demonstrating its consent. For each technical intervention effected by our Service Department's personnel, we recommend that you request a copy of the relevant testing report with the following specifications: type of the intervention, modifications of the rated parameters or value range, date, name, signature of the technician who carried out the intervention.

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GENERAL MEDICAL MERATE S.P.A.

5.

OPERA - SYSTEM MANUAL CODE 62313 - REVISION 1.0

Protection measures

5.1.

Safety

Before switching on the equipment, check for: - dangerous areas on the equipment, where there are potential risks of collision or crushing; - dangerous areas on the equipment where the patient or operator could get injured; - dangerous movements that might damage the equipment. Important! For further information regarding this specific subject make reference to the current version of the operator’s manual and installation manual of each component of the system. Warning It is the operator’s responsibility to activate equipment movements only after making sure that the patient or third parties cannot be harmed by these movements.

5.2.

Safety devices

The machine is equipped with different safety and protection devices, which act on different levels: mechanical and electrical . In order to guarantee patient safety, a camera has been fitted in the collimator which displays the patient's image, so the operator can always keep the patient under control by the display. This display appears on the remote touch screen or on the dedicated monitor. A machine pre-setting connected to the anatomical part to be analyzed can be selected on the touch screen. The table will move only after the "jolly" joystick on the console is activated by the operator. After positioning the machine, the operator can only move some of the parts so as to ensure total patient and operator safety.

5.2.1.

Dead man controls

5.2.2.

Electronic hardware protection functions

There are “dead man” controls on the console which require the continuous attention of medical personnel in order to move the machine. The operation mode of these controls guarantees that the machine cannot be casually or unknowingly made to move.

If an equipment malfunction creates a potential emergency situation threatening the patient or operator, equipment operation can be stopped immediately by pressing the EMERGENCY STOP push-button, or through automatic activation of the microswitches. Warning The EMERGENCY STOP push-button can be released (pulling the red push-button) only after identifying and eliminating the problem that caused the emergency. Should the stop not function, press the GENERAL EMERGENCY STOP push-button that is provided for stopping the electrical supply to the entire installation. In this case, the equipment must not be reactivated and Service Department must be informed immediately. Important! For further information regarding this specific subject make reference to the current version of the operator’s manual and installation manual of each component of the system.

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GENERAL MEDICAL MERATE S.P.A.

6.

OPERA - SYSTEM MANUAL CODE 62313 - REVISION 1.0

Identification

The OPERA SYSTEM is identified by an adhesive label placed on the rear side of the main console. This label (figure below) is applied to identify the product from a commercial point of view and to meet the requirements of the standards currently in force. Besides the brand mark, the company’s address and the manufacturer, the identification label includes the following information: • model and reference standards • serial number • date of production (month and year) • CE mark and cCSAus mark

Important! For further information regarding the electrical data of each system’s component make reference to the current version of the relative operator’s manual and installation manual.

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GENERAL MEDICAL MERATE S.P.A.

7.

Environmental characteristics and functioning limits

HUMIDITY NON CONDENSATION In use

In stock

TEMPERATURE In use

ALTITUDE

In stock

In use

In stock

Min.

Max.

Min.

Max.

Min.

Max.

Min.

Max.

Min.

Max.

Min.

Max.

30%

75%

10%

90%

10°C

40°C

-20°C

70°C

700hPa

1060hPa

700hPa

1060hPa

7.1.

Mains supply

All the equipments of any X-ray installation must be connected to the electrical mains by means of a contact or another multipolar sectioning device that has to be installed by the Customer. The room of the installation must be in compliance with the IEC/CEI or UL/CSA prescriptions in force. The national regulations applying to X-ray installations must be carried out in all the relevant countries. Anyway, the compliance with the above-mentioned Standards is strongly recommended, of course where these are not contradictory compared with the national regulations established in order to ensure safety for the operator, the patient and third parties. Important! For further information regarding this specific subject make reference to the current version of the operator’s manual and installation manual of each component of the system.

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GENERAL MEDICAL MERATE S.P.A.

8.

OPERA - SYSTEM MANUAL CODE 62313 - REVISION 1.0

Risk related to waste disposal

At the end of product life, the equipment and accessories must be disposed of in accordance with all the requirements of waste disposal rules. indicates that the equipment has electrical and electronic components. In The symbol accordance with the requirements of European directive 2002/96/EC on waste of electrical and electronic equipment (WEEE), equipment and accessories waste cannot be treated as solid urban waste, but must be collected separately. Please contact General Medical Merate S.p.A. or other firms authorized by the national authorities for the disposal of electrical and electronic equipment. Important! For further information regarding this specific subject make reference to the current version of the operator’s manual and installation manual of each component of the system.

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GENERAL MEDICAL MERATE S.P.A.

9.

OPERA - SYSTEM MANUAL CODE 62313 - REVISION 1.0

Cleaning and disinfection

Turn off the equipment and disconnect the electrical supply before starting any cleaning or disinfection operations.

9.1.

Cleaning

Clean the generator by means of a soft cloth or a cotton pad. Dampen the cloth or pad with a solution of tepid water and normal household liquid detergent. Do not use any abrasive detergents, organic solvents, or cleansers containing solvents (alcohol, ether). WARNING Do not use liquid sprays! Fluid cleansers must not under any circumstance penetrate the equipment!

9.2.

Disinfection

For disinfecting the surfaces we recommend using a liquid solution with aldehyde or amphoteric based water solution for disinfecting surfaces (such as Tego 103, Korsolin). Disinfectants containing phenolic substances or chlorine are partially abrasive and not recommended. These limitations are to be taken into account for agents with alcohol used in non-diluted form (ex.: for disinfecting hands). Disinfectant sprays must not be used: the spray could penetrate the equipment. Consequently, equipment safety cannot be guaranteed (possible damage to electronic components, formation of inflammable mixtures of air and solvent vapours). N.B. It is generally known that disinfectants can be hazardous to health. Concentrations of disinfectants in air that is breathed must not exceed specific legal limits. For this reason, it is important to follow instructions supplied by the manufacturer regarding their usage.

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10. Functioning and safety checks 10.1.

Daily checks

Before starting the examinations: • Clean any residual contrast mediums from the patient-tabletop. • Do a visual check of the equipment movement, the displays and the luminous signals. • Make sure that the necessary accessories for immobilizing the patient are properly fixed to the equipment, and particularly the handgrips. See also chapter 5 “Protection measures”. During the exam: • The X-ray indicator lights up only during X-ray exposure. • Check that the patient is immobilized using, for instance, the handgrips.. • Carry out equipment movement only after making sure not to damage the patient or other persons. Important! For further information regarding this specific subject make reference to the current version of the operator’s manual and installation manual of each component of the system.

10.2.

Periodical verification of the performance constancy

On a regular basis, at least every 12 months, it is suggested that functional performance constancy tests be run. Particularly, we recommend performing such tests immediately after preventative and corrective maintenance operations. The performance constancy tests should be run by the Diagnostics X-ray department staff. GMM Service Department ([email protected]).

offers

proper

support

to

customers

who

request

it

Important! For further information regarding this specific subject make reference to the current version of the operator’s manual and installation manual of each component of the system.

February 2011

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