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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.
For a patient/user/third party in the European Union and in countries with

identical regulatory regimes (Regulation 2017/745/EU on Medical Devices);

if, during the use of this device or as a result of its use, a serious incident has

occurred, please report it to the manufacturer and/or its authorised

representative and to your national authority.
Manufacturer address:
Agfa Service Support - local support addresses and phone numbers are listed

on www.agfa.com
Agfa - Septestraat 27, 2640 Mortsel, Belgium
Agfa - Fax +32 3 444 7094

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| DR Generator Sync Box, DR Retrofit Solution | Introduction

0319D EN 20191031 1011

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Содержание 5400/516

Страница 1: ...DR Generator Sync Box DR Retrofit Solution 5400 516 5400 526 User Manual 0319D EN 20191031 1011 ...

Страница 2: ... 25 Safety 25 Electromagnetic Compatibility 25 Environmental Compliance 25 Connectivity 26 Connectivity requirements 26 Installation 27 Messages 28 Labels 29 Consulting the About box 30 Cleaning and Disinfecting 31 Patient data security 32 Requirements on the operating environment 32 Maintenance 34 Environmental protection 35 Safety Directions 36 Disconnecting the DR Generator Sync Box from the ma...

Страница 3: ...ng modality position selected 49 Exposure blocked after switching to CR 50 Panel status remains in error 51 Technical Data 52 DR Retrofit Solution Technical Data 53 DR Generator Sync Technical Data 54 Fixed DR Detector Technical Data 55 Remarks for HF emission and immunity 57 Immunity to RF wireless communication equipment 62 Precautions on EMC 63 Cables transducers and accessories 64 Maintenance ...

Страница 4: ...rpose Products and services may not be available for your local area Please contact your local sales representative for availability information Agfa NV diligently strives to provide as accurate information as possible but shall not be responsible for any typographical error Agfa NV shall under no circumstances be liable for any damage arising from the use or inability to use any information appar...

Страница 5: ...ntroduction to this Manual Topics Scope of this Manual Warnings Cautions Instructions and Notes Disclaimer DR Generator Sync Box DR Retrofit Solution Introduction to this Manual 5 0319D EN 20191031 1011 ...

Страница 6: ... for safe and effective operation of the DR Retrofit Solution further referred to as the system and the DR Generator Sync Box further referred to as the device 6 DR Generator Sync Box DR Retrofit Solution Introduction to this Manual 0319D EN 20191031 1011 ...

Страница 7: ...Cautions are directions which if they are not followed can cause damage to the equipment described in this manual or any other equipment or goods and can cause environmental pollution Instruction This sign is typically used in combination with the warning sign when providing a specific instruction If it is followed exactly it should avoid the subject of the warning Note Notes provide advice and hi...

Страница 8: ...appear in this document To improve reliability function or design Agfa reserves the right to change the product without further notice This manual is provided without warranty of any kind implied or expressed including but not limited to the implied warranties of merchantability and fitness for a particular purpose Note In the United States Federal law restricts this device to sale by or on the or...

Страница 9: ...ration Controls System Documentation Training Product Complaints Compatibility Compliance Connectivity Installation Messages Labels Cleaning and Disinfecting Patient data security Maintenance Environmental protection Safety Directions DR Generator Sync Box DR Retrofit Solution Introduction 9 0319D EN 20191031 1011 ...

Страница 10: ...The DR Retrofit Solution converts the screen film or CR system into a DR system The DR Retrofit Solution is not indicated for use in mammography The DR Generator Sync Box is indicated for use as a component of the DR Retrofit Solution The DR Generator Sync Box is making the connection between the DR detector the NX workstation and the X ray generator 10 DR Generator Sync Box DR Retrofit Solution I...

Страница 11: ...handle the equipment as well as the persons having authority over the equipment Before attempting to work with this equipment the user must read understand note and strictly observe all warnings cautions and safety markings on the equipment DR Generator Sync Box DR Retrofit Solution Introduction 11 0319D EN 20191031 1011 ...

Страница 12: ...ole on the NX workstation or the X ray generator console of the X ray system depending on the configuration The DR Generator Sync Box synchronizes the exposure signal between the DR detector the NX workstation and the generator Maximum three exposure buttons can be connected to the DR Generator Sync Box An exposure button can be a hand switch or a foot switch The Software Console is available on t...

Страница 13: ...kstation with NX application and DR Software Console or DR Detector Switch 3 DR Detector 4 Replacement exposure button 5 DR Generator Sync Box DR Generator Sync Box DR Retrofit Solution Introduction 13 0319D EN 20191031 1011 ...

Страница 14: ...atient does not get in contact with any part of the equipment Water ingress This device does not have protection against in gress of water Cleaning See section on cleaning and disinfecting Disinfection See section on cleaning and disinfecting Flammable anesthetics This device is not suitable for use in the presence of a flammable anesthetic mixture with air or in presence of a flammable anesthetic...

Страница 15: ...le DR Detectors on the labels a nickname is written to identify the DR Detector An identical label is attached to the bucky of the X ray system to identify the dedicated workspace of each DR Detector DR Generator Sync Box DR Retrofit Solution Introduction 15 0319D EN 20191031 1011 ...

Страница 16: ...posure button DR Detector Switch on the NX workstation Warning The exposure button of the original system should be disabled Topics Exposure button DR Software Console DR Detector Switch 16 DR Generator Sync Box DR Retrofit Solution Introduction 0319D EN 20191031 1011 ...

Страница 17: ...ettings displayed on the console are suitable for the exposure 2 Check the Ready for Exposure status Press the exposure button down fully and keep it pressed until the exposure has ended The radiation indicator on the control console lights up and a signal sounds to indicate the exposure Note Letting the exposure button go ends the exposure immediately and the exposure can be underexposed DR Gener...

Страница 18: ...orkstation It is displayed on the NX workstation next to the NX application The DR Software Console is used to control the X ray exposure settings The DR Software Console contains the DR Detector Switch Figure 1 DR Software Console 18 DR Generator Sync Box DR Retrofit Solution Introduction 0319D EN 20191031 1011 ...

Страница 19: ...n be used to activate another DR Detector Figure 2 DR Detector Switch Figure 3 DR Detector Switch in the title bar of the NX application DR Detector Status Battery status icon Meaning Full Medium Low Empty Connection status icon wifi wired Meaning Good Low Bad Wired DR Detector Panel status icon blinking blinking Meaning Ready Initializing exposure Starting up Error Sleep DR Generator Sync Box DR ...

Страница 20: ...edia User documentation for the supported DR Detectors The DR Generator Sync Box DR Retrofit Solution Documentation CD contains DR Generator Sync Box DR Retrofit Solution User Manual this document document 0319 DR Software Console User Manual document 0289 DR Detector Calibration Key User manual document 0134 20 DR Generator Sync Box DR Retrofit Solution Introduction 0319D EN 20191031 1011 ...

Страница 21: ... must make sure that training is received in accordance with local laws or regulations that have the force of law Your local Agfa or dealer representative can provide further information on training The user must note the following information in the system documentation Intended Use Intended User Safety Directions DR Generator Sync Box DR Retrofit Solution Introduction 21 0319D EN 20191031 1011 ...

Страница 22: ...th identical regulatory regimes Regulation 2017 745 EU on Medical Devices if during the use of this device or as a result of its use a serious incident has occurred please report it to the manufacturer and or its authorised representative and to your national authority Manufacturer address Agfa Service Support local support addresses and phone numbers are listed on www agfa com Agfa Septestraat 27...

Страница 23: ... is available from Agfa service on request Changes or additions to the equipment must only be carried out by persons authorized to do so by Agfa Such changes must comply with best engineering practice and all applicable laws and regulations that have the force of law within the jurisdiction of the hospital DR Generator Sync Box DR Retrofit Solution Introduction 23 0319D EN 20191031 1011 ...

Страница 24: ...Compliance Topics General Safety Electromagnetic Compatibility Environmental Compliance 24 DR Generator Sync Box DR Retrofit Solution Introduction 0319D EN 20191031 1011 ...

Страница 25: ...EC on Medical Devices The DR Generator Sync Box has been designed in accordance with Regulation EU 2017 745 on medical devices MDR IEC 62366 ISO 14971 Safety IEC 60601 1 AAMI ES 60601 1 CSA C 22 2 No 60601 1 Electromagnetic Compatibility IEC 60601 1 2 Environmental Compliance European Council Directive 1907 2006 REACH European Council Directive 2011 65 EU RoHS 2 European Council Directive 2012 19 ...

Страница 26: ... protocols DICOM IHE The NX workstation can be connected to a RIS system input scheduling a PACS system output image data management and to a hardcopy device output image Related Links Configuration on page 12 Connectivity requirements Warning Any kind of equipment connected to any interface must be certified according to the respective IEC standards e g IEC 60950 IEC 62368 for data processing equ...

Страница 27: ... labeling to the DR Detector containing a unique nickname for each DR Detector The nicknames must be configured on the NX Workstation The DR Detector Switch shows which DR Detector is active and shows its status by means of the nickname of the DR Detector An identical label is attached to the bucky of the X ray system to identify the dedicated workspace of each DR Detector DR Generator Sync Box DR...

Страница 28: ...d or that a requested action cannot be performed The user must read these messages carefully It will provide information on what to do from then on This will be either performing an action to resolve the problem or to contact the service organization Details on the contents of messages can be found in the service documentation which is available to service personnel 28 DR Generator Sync Box DR Ret...

Страница 29: ...in text format and in machine readable format The most recent version of this docu ment is available on http www agfa healthcare com global en library index jsp If the exposure button of the original sys tem is visible this label is attached The user manual this document in structs not to use the exposure button of the original system Functional earth Equipotential connector DR Generator Sync Box ...

Страница 30: ...the About box 1 Click About the solution in the Tools section of the Main Menu window on the NX workstation Figure 5 Main Menu window This will open the About box showing the current release and version details of the DR Retrofit solution Figure 6 DR Retrofit About box Displayed data may be different Note Always quote these details when you discuss any issues with Agfa service personnel 2 Click on...

Страница 31: ...with the device Details about cleaning can be found in the following pages To clean the exterior of the equipment 1 Switch off the device 2 Remove the power plug of the socket 3 Wipe the exterior of the device with a clean soft damp cloth Use a mild soap or detergent if required but never use ammonia based cleaner Caution Make sure no liquid gets in the device Note Do not open the equipment for cl...

Страница 32: ...stomer Agfa reserves the right to revise these ISP Operating Environment Requirements and to make changes to them at any time Possible revisions of the ISP Operating Environment Requirements will only be available in an electronic form on request via our website by using the user documentation request form http www agfahealthcare com global en library index jsp The information presented herein is ...

Страница 33: ...limited only to authorized individuals and that physical theft of the device is prohibited An incident response plan detailing responsibilities and how to react and recover from incidents shall be in place Staff involved in the incident response plan shall be trained to respond appropriately and effectively A formal user provisioning and de provisioning process shall be implemented to enable the a...

Страница 34: ...ce engineer for complete maintenance schedules Maintenance of the DR Detector The DR Detector requires regular calibration Calibration instructions are described in the DR Detector Calibration Key User Manual doc 0134 34 DR Generator Sync Box DR Retrofit Solution Introduction 0319D EN 20191031 1011 ...

Страница 35: ...n and or dealer By ensuring this product is disposed of correctly you will help prevent potential negative consequences for the environment and human health which could otherwise be caused by inappropriate waste handling of this product The recycling of materials will help to conserve natural resources Battery notice The battery symbol on the products and or accompanying documents means that the u...

Страница 36: ...ppropriate inspection and testing is required to ensure continued safe use of the equipment Warning To avoid risk of electric shock do not remove any covers Changes additions maintenance or repairs must be carried out by an Agfa certified field service engineer Warning To avoid risk of electric shock this equipment must only be connected to a supply mains with protective earth Warning Ionizing rad...

Страница 37: ...a free exposure is selected on the Generator console and yet the exposure will be allowed Warning To prevent unintended exposure the position of the exposure footswitch should be such that it cannot be accidentally stepped on Caution Excessive ambient temperature may impact performance of DR Detectors and cause permanent damage to the equipment If ambient temperature and humidity is outside the ra...

Страница 38: ...Getting started Topics Starting Basic Workflow Stopping 38 DR Generator Sync Box DR Retrofit Solution Getting started 0319D EN 20191031 1011 ...

Страница 39: ...re available on the NX workstation 3 Power on the DR Generator Sync Box Basic Workflow This section describes the workflow which will be followed when using the system for acquiring radiographic images Topics Step 1 retrieve the patient info Step 2 select the exposure Step 3 prepare the exposure Step 4 check the exposure settings Step 5 execute the exposure Step 6 perform a quality control DR Gene...

Страница 40: ...ieve the patient info At the NX workstation 1 When a new patient comes in define the patient info for the exam 2 Start the exam 40 DR Generator Sync Box DR Retrofit Solution Getting started 0319D EN 20191031 1011 ...

Страница 41: ...hows its status Red flashing starting up Green constant ready for exposure 2 At the X ray generator console or on the DR Software Console select the exposure settings suitable for the exposure On systems with integration of X ray exposure parameters the default X Ray exposure parameters for the selected exposure are sent to the modality and displayed on the DR Software Console DR Generator Sync Bo...

Страница 42: ...t to the DR Detector and the patient 5 Set the correct distance between DR Detector and X Ray tube 6 Switch on the light on the collimator Adapt collimation if required Take care that the collimated area is not larger than the detector WARNING Monitor the patient position hands feet fingers etc with special care to avoid injury to the patient caused by unit movements Patient hands must be kept awa...

Страница 43: ...r is ready for exposure On a DR Detector that has a status indicator Check if the status of the DR Detector is ready for exposure If the status is not ready for exposure the DR Detector cannot be used for making an exposure In the operator room at the X ray generator console or on the DR Software Console 1 Check if the exposure settings displayed on the console are suitable for the exposure 2 Chec...

Страница 44: ... in the active thumbnail In the operator room at the NX workstation The image is acquired from the DR detector and displayed in the thumbnail On systems with integration of X ray exposure parameters the actual X Ray exposure parameters are sent back from the console to the NX workstation and are shown in the Image Detail pane If collimation is applied the image is automatically cropped at the coll...

Страница 45: ...o a hardcopy printer and or PACS Picture Archiving and Communication System Stopping 1 Switch off the DR Generator Sync Box 2 Stop NX For detailed information about stopping NX refer to the NX User Manual document 4420 3 Switch off the DR Detector For detailed information about switching off the DR Detector refer to the DR Detector user manual DR Generator Sync Box DR Retrofit Solution Getting sta...

Страница 46: ...y pushing the exposure button NX receives black DR image when X ray system not ready for exposure Wrong modality position selected Exposure blocked after switching to CR Panel status remains in error 46 DR Generator Sync Box DR Retrofit Solution Problem solving 0319D EN 20191031 1011 ...

Страница 47: ...le This prevents the DR Detector to synchronize with the X ray system Depending on the X ray system two situations can oc cur The X ray system will not make the exposure and the DR Detector acquires an image without expo sure The X ray system will start the exposure with a de lay and the DR Detector cannot acquire the com plete dose Brief Solution To repeat the exposure workflow 1 On the NX workst...

Страница 48: ...he expo sure button was pushed while the X ray system was not ready for exposure Brief Solution To repeat the exposure workflow 1 On the NX workstation click Copy Exposure to create a new thumbnail 2 Repeat the steps described in the Basic Workflow Related Links Basic Workflow on page 39 48 DR Generator Sync Box DR Retrofit Solution Problem solving 0319D EN 20191031 1011 ...

Страница 49: ...odified on the gener ator console This situation applies only to Siemens generators Brief Solution To use another modality position for a scheduled expo sure 1 On the NX workstation click Edit in the Image De tail Pane and select an exposure type for the correct modality position 2 Continue the exposure workflow DR Generator Sync Box DR Retrofit Solution Problem solving 49 0319D EN 20191031 1011 ...

Страница 50: ...is blocked Cause The X ray generator console is not automatically set to free ex posure This situation applies only to Siemens generators Brief Solu tion On the X ray generator console select free exposure Perform the CR exposure 50 DR Generator Sync Box DR Retrofit Solution Problem solving 0319D EN 20191031 1011 ...

Страница 51: ...e panel status remains in error Cause The generator is in error state This situation applies only to Siemens generators Brief Solution Restart the generator DR Generator Sync Box DR Retrofit Solution Problem solving 51 0319D EN 20191031 1011 ...

Страница 52: ...hnical Data Topics DR Retrofit Solution Technical Data DR Generator Sync Technical Data Fixed DR Detector Technical Data 52 DR Generator Sync Box DR Retrofit Solution Technical Data 0319D EN 20191031 1011 ...

Страница 53: ...DR Retrofit Solution Technical Data Technical data is available in the relevant modules of the user documentation DR Generator Sync Box DR Retrofit Solution Technical Data 53 0319D EN 20191031 1011 ...

Страница 54: ...ax 0 4 A Environmental conditions operation al min max Temperature 5 C 35 C Relative air humidity 20 80 Altitude 0 m 102 kPa 3000 m 70 kPa Environmental conditions storage and transport min max Temperature 15 C 50 C Relative air humidity 20 80 Altitude 0 m 102 kPa 3000 m 70 kPa Estimated product life 7 years 54 DR Generator Sync Box DR Retrofit Solution Technical Data 0319D EN 20191031 1011 ...

Страница 55: ...65 W Environmental conditions during storage and transport Temperature ambient between 20 C and 70 C Humidity non condensing between 10 and 90 Atmospheric pressure between 500 hPa and 1100 hPa Environmental conditions during normal operation Room temperature between 15 C and 35 C Humidity non condensing between 30 and 75 Atmospheric pressure between 700 hPa and 1100 hPa Warming up time 30 minutes ...

Страница 56: ...number 7964 Maximum Linear Dose us ing RQA5 50 µGy 75 µGy Minimum Modulation Transfer Function MTF using RQA5 1 lp mm 0 45 0 45 2 lp mm 0 15 0 15 3 lp mm 0 05 0 05 Typical Detective Quantum Efficiency DQE using RQA5 at 2 1 µGy dose level at 4 0 µGy dose level 0 lp mm 0 59 0 25 1 lp mm 0 41 0 20 2 lp mm 0 23 0 10 3 lp mm 0 11 0 03 3 6 lp mm 0 06 0 01 Minimum Signal Noise Ratio for 1mR SNR 115 1 115...

Страница 57: ...re professionals only This device may cause radio interference or may disrupt the operation of nearby equipment It may be necessary to take mitigation measures such as re orienting or relocating the device or shielding the location WARNING The HF emission and immunity can be influenced by connected data cables depending on length and the manner of installation This device is intended for operation...

Страница 58: ... floor is made of synthetic material Fast transient electri cal disturbance varia bles bursts in accord ance with IEC 61000 4 4 2 kV mains 1 kV data lines The quality of the voltage supplied should correspond to a typical commercial or clinical environment Impulse voltages surges in accordance with IEC 61000 4 5 1 kV line line volt age 2 kV line ground voltage The quality of the voltage supplied s...

Страница 59: ...n vironment Recommended pro tective distance Conducted high frequen cy disturbance variables in accordance with IEC 61000 4 6 3 V 150 kHz to 80 MHz 6 V within ISM bands Radiated high frequency disturbance variables in accordance with IEC 61000 4 3 3 V m 80 MHz to 2 7 GHz RF communication Refer to the section Im munity to RF wireless communication equip ment Disruptions are possi ble near devices t...

Страница 60: ...th precautions on EMC Recommended Protective Distances between Portable and Mobile High Frequency Communication Equipment and the Device Rated Power of the Transmitter W Protective Distance in accordance with RF emission Fre quency m 150 kHz to 80 MHz d 1 0 80 MHz to 800 MHz d 0 3 800 MHz to 2 7 GHz d 0 3 0 01 0 1 0 05 0 05 0 1 0 32 0 1 0 1 1 1 0 0 3 0 3 10 3 2 1 0 1 0 The distance can be determin...

Страница 61: ... Maintenance on EMC relevant parts DR Generator Sync Box DR Retrofit Solution Remarks for HF emission and immunity 61 0319D EN 20191031 1011 ...

Страница 62: ...787 LTE Band 13 17 0 3 9 800 960 GSM 800 900 TETRA 800 IDEN 820 COMA 850 LTE Band 5 0 3 28 1700 1990 GSM 1800 COMA 1900 GSM 1900 DECT LTE Band 1 3 4 25 UMTS 0 3 28 2400 2570 Bluetooth WLAN 802 11 b g n RFID 2450 LTE Band 7 0 3 28 5100 5800 WLAN 802 11 a n 0 3 9 62 DR Generator Sync Box DR Retrofit Solution Remarks for HF emission and immunity 0319D EN 20191031 1011 ...

Страница 63: ...lly WARNING Portable RF communications equipment including peripherals such as antenna cables and external antennas should be used no closer than 30 cm 12 inches to any part of the system including cables specified by the manufacturer Otherwise degradation of the performance of this equipment could result WARNING The DR detectors might be interfered with by other equipment DR Generator Sync Box DR...

Страница 64: ...hielded 3 m mains supply cable Exposure button DR Generator Sync box AWG21 unshiel ded 1 5 m PC DR Generator Sync box CAT 5e shielded 5 m ethernet PC DR Generator Sync box USB shielded 5 m DR Detector DR Generator Sync box 10 0 25 mm2 AWG23 16 m extension ca ble for DR De tector X ray gener ator control box DR Generator Sync box 10 0 25 mm2 AWG23 5 m extension ca ble for the console X ray gener at...

Страница 65: ...EMC safety of the DR Generator Sync Box no relevant parts could be inspected by the operator or by a service engineer before the end of lifetime DR Generator Sync Box DR Retrofit Solution Remarks for HF emission and immunity 65 0319D EN 20191031 1011 ...

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