Agfa and the Agfa rhombus are trademarks of Agfa-Gevaert N.V., Belgium or its affiliates. CR Reader, CR Advanced Reader, CR Multiformat Reader, NX, ADC QS and ADC VIPS are trademarks of Agfa NV, Belgium or one of its affiliates. All other trademarks are held by their respective owners and are used in an editorial fashion with no intention of infringement.
CR Reader, CR Advanced Reader, CR Multiformat Reader | Introduction to this Manual | 5 Introduction to this Manual Topics: • Scope • About the safety notices in this document • Disclaimer 2591D EN 20191028 1712...
6 | CR Reader, CR Advanced Reader, CR Multiformat Reader | Introduction to this Manual Scope This manual contains information for safe and effective operation of the CR Reader , CR Advanced Reader and CR Multiformat Reader digitizers, further referred to as the digitizer, unless the information applies to a specific type.
CR Reader, CR Advanced Reader, CR Multiformat Reader | Introduction to this Manual | 7 About the safety notices in this document The following samples show how warnings, cautions, instructions and notes appear in this document. The text explains their intended use.
8 | CR Reader, CR Advanced Reader, CR Multiformat Reader | Introduction to this Manual Disclaimer Agfa assumes no liability for use of this document if any unauthorized changes to the content or format have been made. Every care has been taken to ensure the accuracy of the information in this document.
10 | CR Reader, CR Advanced Reader, CR Multiformat Reader | Introduction to CR Reader, CR Advanced Reader and CR Multiformat Reader Intended Use The digitizer is part of a CR system, further containing a cassette, image plate and modality workstation. The CR system is used in a radiological environment by qualified staff to read-out, process and route static X-ray radiographic images.
CR Reader, CR Advanced Reader, CR Multiformat Reader | Introduction to CR Reader, CR Advanced Reader and CR Multiformat Reader | 11 Intended User This manual has been written for trained users of Agfa products and trained diagnostic X–ray clinical personnel who have received proper training.
12 | CR Reader, CR Advanced Reader, CR Multiformat Reader | Introduction to CR Reader, CR Advanced Reader and CR Multiformat Reader Configuration The system consists of: • the digitizer for scanning image plates retaining latent X-ray images. The digitizer accepts one cassette containing one image plate at a time.
CR Reader, CR Advanced Reader, CR Multiformat Reader | Introduction to CR Reader, CR Advanced Reader and CR Multiformat Reader | 13 Image Acquisition Software The digitizer can be used in combination with software for image acquisition, identification, image processing and image transmission of digitized images received from the digitizer.
14 | CR Reader, CR Advanced Reader, CR Multiformat Reader | Introduction to CR Reader, CR Advanced Reader and CR Multiformat Reader Cassette adapter The cassette adapter is required for using a 24 cm x 30 cm cassette, depending on the digitizer model.
CR Reader, CR Advanced Reader, CR Multiformat Reader | Introduction to CR Reader, CR Advanced Reader and CR Multiformat Reader | 15 Operation Controls The digitizer interfaces with the user via: • a power button, • an erase button, • a status indicator, •...
16 | CR Reader, CR Advanced Reader, CR Multiformat Reader | Introduction to CR Reader, CR Advanced Reader and CR Multiformat Reader The Erase Button Press the erase button to start the erasing cycle of an image plate. After pressing the erase button, the status indicator is continuously lighting up in blue and the digitizer starts erasing the image plate of the cassette inserted next.
CR Reader, CR Advanced Reader, CR Multiformat Reader | Introduction to CR Reader, CR Advanced Reader and CR Multiformat Reader | 17 Status Indicator The indicator informs the user by light signals about the status of the digitizer. It is positioned at the front of the digitizer, so that it is visible from a distance.
18 | CR Reader, CR Advanced Reader, CR Multiformat Reader | Introduction to CR Reader, CR Advanced Reader and CR Multiformat Reader System Documentation The documentation shall be kept with the system for easy reference. Technical documentation is available in the product service documentation which is available from your local support organization.
CR Reader, CR Advanced Reader, CR Multiformat Reader | Introduction to CR Reader, CR Advanced Reader and CR Multiformat Reader | 19 Training The user must have received adequate training on the safe and effective use of the system before attempting to work with it. Training requirements may vary from country to country.
20 | CR Reader, CR Advanced Reader, CR Multiformat Reader | Introduction to CR Reader, CR Advanced Reader and CR Multiformat Reader Product Complaints Any health care professional (for example a customer or a user) who has any complaints or has experienced any dissatisfaction with the quality, durability, reliability, safety, effectiveness, or performance of this product must notify Agfa.
CR Reader, CR Advanced Reader, CR Multiformat Reader | Introduction to CR Reader, CR Advanced Reader and CR Multiformat Reader | 21 Compatibility The equipment must only be used in combination with other equipment or components if these are expressly recognized by Agfa as compatible. A list of such equipment and components is available from Agfa service on request.
CR Reader, CR Advanced Reader, CR Multiformat Reader | Introduction to CR Reader, CR Advanced Reader and CR Multiformat Reader | 23 General • The digitizer has been designed in accordance with the MEDDEV Guidelines relating to the application of Medical Devices and have been...
24 | CR Reader, CR Advanced Reader, CR Multiformat Reader | Introduction to CR Reader, CR Advanced Reader and CR Multiformat Reader Equipment Classification This device is classified as following: Table 1: Equipment classification Class I equipment Equipment in which protection against electric...
CR Reader, CR Advanced Reader, CR Multiformat Reader | Introduction to CR Reader, CR Advanced Reader and CR Multiformat Reader | 25 Connectivity The digitizer is connected to the workstation via Ethernet connection and uses the DICOM protocol to communicate with the workstation.
26 | CR Reader, CR Advanced Reader, CR Multiformat Reader | Introduction to CR Reader, CR Advanced Reader and CR Multiformat Reader Installation WARNING: When using the power supply, care must be taken to ensure that there is either a mains plug or an all-cable disconnecting device in the internal installation fitted near the device and that it is easily accessible in case of emergency.
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CR Reader, CR Advanced Reader, CR Multiformat Reader | Introduction to CR Reader, CR Advanced Reader and CR Multiformat Reader | 27 The classification of this product according to the medical electrical equipment standard IEC 60601-1 requires installation outside the patient vicinity.
28 | CR Reader, CR Advanced Reader, CR Multiformat Reader | Introduction to CR Reader, CR Advanced Reader and CR Multiformat Reader Labels Always take into account the markings and labels provided on the inside and outside of the machine. A brief overview of these markings and labels and their meaning is given below.
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CR Reader, CR Advanced Reader, CR Multiformat Reader | Introduction to CR Reader, CR Advanced Reader and CR Multiformat Reader | 29 Type label This mark shows compliance of the equipment with Directive 93/42/EEC (for European Union). Date of manufacture...
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30 | CR Reader, CR Advanced Reader, CR Multiformat Reader | Introduction to CR Reader, CR Advanced Reader and CR Multiformat Reader This mark indicates how to insert the cassette in the slot, depending on the cassette size that is in- dicated in the mark (CR Multiformat Reader on- ly).
32 | CR Reader, CR Advanced Reader, CR Multiformat Reader | Introduction to CR Reader, CR Advanced Reader and CR Multiformat Reader Additional labeling of the casette adapter Type labels Figure 2: Example of type labels This mark shows compliance of the equip- ment with Regulation 2017/745 (for Euro- pean Union).
CR Reader, CR Advanced Reader, CR Multiformat Reader | Introduction to CR Reader, CR Advanced Reader and CR Multiformat Reader | 33 Cleaning and Disinfection All appropriate policies and procedures should be followed to avoid contamination of the staff, patients and device. All existing universal precautions should be taken to avoid that the digitizer and its accessories come into contact with potential contaminations.
34 | CR Reader, CR Advanced Reader, CR Multiformat Reader | Introduction to CR Reader, CR Advanced Reader and CR Multiformat Reader Patient data security The user must ensure that the patients’ legal requirements are met and that the security of the patient data is guarded.
36 | CR Reader, CR Advanced Reader, CR Multiformat Reader | Introduction to CR Reader, CR Advanced Reader and CR Multiformat Reader Preventive Maintenance No regular preventive maintenance is required other than described further in this chapter. The digitizer informs you when preventive maintenance is required and displays the following message "Maintenance interval expired.
CR Reader, CR Advanced Reader, CR Multiformat Reader | Introduction to CR Reader, CR Advanced Reader and CR Multiformat Reader | 37 Recurrent safety tests The device shall be tested according to IEC 62353* in a time interval of at least 36 months or less if local regulations are different.
38 | CR Reader, CR Advanced Reader, CR Multiformat Reader | Introduction to CR Reader, CR Advanced Reader and CR Multiformat Reader Environmental protection Figure 3: WEEE symbol Figure 4: Battery symbol WEEE end user notice The directive on Waste Electrical and Electronic Equipment (WEEE) aims to prevent the generation of electric and electronic waste and to promote the reuse, recycling and other forms of recovery.
CR Reader, CR Advanced Reader, CR Multiformat Reader | Introduction to CR Reader, CR Advanced Reader and CR Multiformat Reader | 39 Safety Directions WARNING: To avoid risk of electric shock, this equipment must only be connected to a supply mains with protective earth.
40 | CR Reader, CR Advanced Reader, CR Multiformat Reader | Introduction to CR Reader, CR Advanced Reader and CR Multiformat Reader WARNING: The user must be aware that any error (crash / lock up) leading to an image processing failure can cause loss of diagnostic information.
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CR Reader, CR Advanced Reader, CR Multiformat Reader | Introduction to CR Reader, CR Advanced Reader and CR Multiformat Reader | 41 • Do not apply excessive shock or vibration to the digitizer during operation (e.g. putting cassettes on top of the device). This may decrease the image quality.
42 | CR Reader, CR Advanced Reader, CR Multiformat Reader | Introduction to CR Reader, CR Advanced Reader and CR Multiformat Reader Quality Control Quality control can be performed by means of the Auto QC2 tool. WARNING: Unnoticed image quality degradation can cause false negative diagnosis.
44 | CR Reader, CR Advanced Reader, CR Multiformat Reader | Getting started Starting the Digitizer To start the Digitizer: 1. Make sure the digitizer is connected to the control PC and that the control PC is running the appropriate NX software.
CR Reader, CR Advanced Reader, CR Multiformat Reader | Getting started | 45 Basic Workflow The main functions of the system are digitizing image plates and transmitting the digital image data to the image processing station, where you can perform an image quality control.
46 | CR Reader, CR Advanced Reader, CR Multiformat Reader | Getting started Step 1: Select a patient and start the exam At the NX workstation: 1. Open the Worklist window of NX. In the Worklist window, you can view and manage the exams that are scheduled via the Worklist pane.
CR Reader, CR Advanced Reader, CR Multiformat Reader | Getting started | 47 Step 2: Digitize the image At the digitizer: 1. Check that the digitizer is ready for operation: The status indicator on the digitizer constantly lights up in green.
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48 | CR Reader, CR Advanced Reader, CR Multiformat Reader | Getting started Figure 7: Inserting 24 cm x 30 cm cassette using the cassette adapter Note: The cassette is unidentified, so the digitizer will send a request to the NX station. The NX software must be operational, otherwise the digitizer is locked and the status indicator is blinking red.
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CR Reader, CR Advanced Reader, CR Multiformat Reader | Getting started | 49 4. As soon as the digitizer has received the complete identification data from the NX station (via Ethernet) it will start digitizing the image plate. The digitizer converts the information of the latent image to digital data.
50 | CR Reader, CR Advanced Reader, CR Multiformat Reader | Getting started Step 3: Perform a quality control At the NX workstation: 1. Select the image on which quality control is to be performed. 2. Prepare the image for diagnosis by using e.g. L/R markers or annotations.
CR Reader, CR Advanced Reader, CR Multiformat Reader | Getting started | 51 Step 4: Remove the cassette and insert the next one At the digitizer: 1. When the digitizer has finished treating the cassette, the status indicator constantly lights up in green.
52 | CR Reader, CR Advanced Reader, CR Multiformat Reader | Getting started Stopping the Device Topics: • Before Switching Off • Switching Off 2591D EN 20191028 1712...
CR Reader, CR Advanced Reader, CR Multiformat Reader | Getting started | 53 Before Switching Off Check that the digitizer is not scanning an image plate. If the digitizer is scanning an image plate, the status indicator is blinking yellow.
54 | CR Reader, CR Advanced Reader, CR Multiformat Reader | Operating CR Reader, CR Advanced Reader and CR Multiformat Reader Operating CR Reader, CR Advanced Reader and CR Multiformat Reader This chapter provides information about functions that are available in operator mode.
CR Reader, CR Advanced Reader, CR Multiformat Reader | Operating CR Reader, CR Advanced Reader and CR Multiformat Reader | 55 Reading an Emergency Image Plate Note: Reading an emergency image plate is a licensed functionality, necessary to facilitate the emergency cases and to improve the workflow.
56 | CR Reader, CR Advanced Reader, CR Multiformat Reader | Operating CR Reader, CR Advanced Reader and CR Multiformat Reader Re-erasing an Image Plate At the end of a normal or emergency digitizing cycle, the digitizer returns an erased image plate. However, in the following cases, you must re-erase the...
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CR Reader, CR Advanced Reader, CR Multiformat Reader | Operating CR Reader, CR Advanced Reader and CR Multiformat Reader | 57 Figure 9: Inserting small cassette Figure 10: Inserting 24 cm x 30 cm cassette using the cassette adapter As a result, the digitizer starts erasing the image plate: the status indicator switches to the state “blue blinking”.
58 | CR Reader, CR Advanced Reader, CR Multiformat Reader | Operating CR Reader, CR Advanced Reader and CR Multiformat Reader Reading the Initialization Data of an Image Plate The initialization data stored in the IP barcode can be read via the digitizer.
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CR Reader, CR Advanced Reader, CR Multiformat Reader | Operating CR Reader, CR Advanced Reader and CR Multiformat Reader | 59 Make sure that the cassette is firmly pushed into the slot, so that it is locked (you should hear a click). Otherwise, the digitizer cannot read the image plate.
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60 | CR Reader, CR Advanced Reader, CR Multiformat Reader | Operating CR Reader, CR Advanced Reader and CR Multiformat Reader Note: You can only remove the cassette from the cassette slot when the cassette is unlocked. Related Links Cassette formats...
62 | CR Reader, CR Advanced Reader, CR Multiformat Reader | Operating CR Reader, CR Advanced Reader and CR Multiformat Reader Upcoming Expiry of the Image Plate The Digitizer Remote Display informs you about upcoming expiry of the image plate 90 and 30 days before the expiry date. Please replace the image plates before expiry to avoid reduced system performance.
CR Reader, CR Advanced Reader, CR Multiformat Reader | Operating CR Reader, CR Advanced Reader and CR Multiformat Reader | 63 Troubleshooting In case of a malfunction of the digitizer, consult the Digitizer Remote Display UI (User Interface) messages on the control PC.
64 | CR Reader, CR Advanced Reader, CR Multiformat Reader | Operating CR Reader, CR Advanced Reader and CR Multiformat Reader Digitizer Remote Display Digitizer Remote Display is an application running on the NX PC. To verify if Digitizer Remote Display is running, check if the Digitizer Remote Display icon is present in the Windows taskbar: To start the Digitizer Remote Display, go to the Windows Start menu >...
66 | CR Reader, CR Advanced Reader, CR Multiformat Reader | Operating CR Reader, CR Advanced Reader and CR Multiformat Reader Cassette Could Not Be Identified Details This error message is displayed on the NX PC: Cause A cassette has been inserted in the digitizer and the ID but- ton was clicked directly afterwards.
CR Reader, CR Advanced Reader, CR Multiformat Reader | Operating CR Reader, CR Advanced Reader and CR Multiformat Reader | 67 Cassette release button pressed before end of cycle Details The following error message is displayed in the Digitizer Re- mote Display: Do not press the cassette release button before end of cycle.
68 | CR Reader, CR Advanced Reader, CR Multiformat Reader | Operating CR Reader, CR Advanced Reader and CR Multiformat Reader Cannot read data on the image plate Details The following error message is displayed in the Digitizer Re- mote Display: Error during read out of data on the image plate.
CR Reader, CR Advanced Reader, CR Multiformat Reader | Operating CR Reader, CR Advanced Reader and CR Multiformat Reader | 69 Image Plate Transport Problems Details The following error message is displayed in the Digitizer Re- mote Display: Image plate is not erased! Remove the cassette and press the confirm button.
70 | CR Reader, CR Advanced Reader, CR Multiformat Reader | Operating CR Reader, CR Advanced Reader and CR Multiformat Reader Removing a Jammed Image Plate Note: The technical concept does not allow the user to remove the top cover.
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CR Reader, CR Advanced Reader, CR Multiformat Reader | Operating CR Reader, CR Advanced Reader and CR Multiformat Reader | 71 7. Slide out the cassette unit with the cassette attached. WARNING: The cassette unit and/or the cassette falling down can cause injury of the operator.
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72 | CR Reader, CR Advanced Reader, CR Multiformat Reader | Operating CR Reader, CR Advanced Reader and CR Multiformat Reader 2. Open the back of the device by turning the four fixation rings by 90 degrees: 3. Gently remove the image plate from the back of the digitizer.
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CR Reader, CR Advanced Reader, CR Multiformat Reader | Operating CR Reader, CR Advanced Reader and CR Multiformat Reader | 73 Note: After removing a jammed image plate, erase the image plate before the next exposure. 2591D EN 20191028 1712...
74 | CR Reader, CR Advanced Reader, CR Multiformat Reader | Operating CR Reader, CR Advanced Reader and CR Multiformat Reader Behavior in Case of Power Failure Note: The description below is only applicable if an uninterruptible power supply (UPS) is put into the CR system configuration.
CR Reader, CR Advanced Reader, CR Multiformat Reader | Operating CR Reader, CR Advanced Reader and CR Multiformat Reader | 75 Cleaning the Optical Unit The only maintenance action which you must perform is checking the image quality. Refer to the User Manual of the NX software.
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76 | CR Reader, CR Advanced Reader, CR Multiformat Reader | Operating CR Reader, CR Advanced Reader and CR Multiformat Reader Make sure to return the lever completely to the left, where it is locked in position. 3. Place back the cassette unit.
78 | CR Reader, CR Advanced Reader, CR Multiformat Reader | Technical Data Specifications Labelling 93/42 EEC 'Medical Devices' (Europe), EN 60601-1 c NRTL us NRTL us certified, UL 60601-1 (North America) c NRTL us c NRTL certified CSA 22.2 No 601.1...
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CR Reader, CR Advanced Reader, CR Multiformat Reader | Technical Data | 79 Standby CR Reader CR Advanced Reader CR Multiformat Reader 110 V - 240 V / max. 41 W max. 22 W 50-60 Hz configura- tion During operation...
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80 | CR Reader, CR Advanced Reader, CR Multiformat Reader | Technical Data In line with IEC721-3-2: class 2K2 and 2M3, with following restrictions: Temperature -25 °C - +55 °C Vibration 5-200 Hz (vertical, longitudinal, transversal axis) Environmental conditions for mobile installation (during transport)
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CR Reader, CR Advanced Reader, CR Multiformat Reader | Technical Data | 81 (not applicable for CR HD5.0S General image plate) 118 s 100 µm 88 s End of Life Estimated product 7 yrs. life (if regularly serv- iced and maintained...
CR Reader, CR Advanced Reader, CR Multiformat Reader | Remarks for HF-emission and immunity | 85 Remarks for HF-emission and immunity It is hereby certified that the digitizer has interference suppression according to the EN 55011 Class A as well as the FCC Rules CR47 Part 15 Class A.
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86 | CR Reader, CR Advanced Reader, CR Multiformat Reader | Remarks for HF-emission and immunity Harmonic emis- Class A might not offer adequate protection to radio- sion in accord- frequency communication services. The user ance with IEC might need to take mitigation measures, such 61000-3-2 as relocating or re-orienting the equipment.
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CR Reader, CR Advanced Reader, CR Multiformat Reader | Remarks for HF-emission and immunity | 87 interrupted, it is recommen- • 0% U for 250 pe- ded to use an energy supply riods free of interruptions or a battery. Magnetic field at the...
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88 | CR Reader, CR Advanced Reader, CR Multiformat Reader | Remarks for HF-emission and immunity FM radio transmitters, cannot be precisely predetermined theoretically. An investigation of the location is recommended, to ascertain the electromagnetic environment as a result of stationary high frequency transmitters. If the field strength of the device exceeds the test level given above, the device must be observed with regard to its normal operation at each place of use.
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CR Reader, CR Advanced Reader, CR Multiformat Reader | Remarks for HF-emission and immunity | 89 • Precautions on EMC • Cables, transducers and accessories • Maintenance on EMC relevant parts 2591D EN 20191028 1712...
90 | CR Reader, CR Advanced Reader, CR Multiformat Reader | Remarks for HF-emission and immunity Immunity to RF wireless communication equipment Service ISM Band Distance Immunity test level (MHz) (V/m) 300-390 TETRA 400 430-470 GMRS 460; FRS 460 704-787...
CR Reader, CR Advanced Reader, CR Multiformat Reader | Remarks for HF-emission and immunity | 91 Precautions on EMC WARNING: Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.
92 | CR Reader, CR Advanced Reader, CR Multiformat Reader | Remarks for HF-emission and immunity Cables, transducers and accessories Cables, transducers and accessories which were tested and found to comply with the collateral standard IEC60601-1-2 (EMC): CAUTION: Use of accessories, transducers and cables other than those...
CR Reader, CR Advanced Reader, CR Multiformat Reader | Remarks for HF-emission and immunity | 93 Maintenance on EMC relevant parts Concerning the EMC safety of the CR Reader, CR Advanced Reader and CR Multiformat Reader devices, no relevant parts could be inspected by the operator or by a service engineer before the end of the digitizer lifetime.
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