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Labels

Mark

Meaning

This mark shows compliance of the equipment with Regulation

2017/745 (for European Union).

Date of manufacture

Manufacturer

Medical device

Serial number

Unique device identifier, in text format and in machine readable

format

The most recent version of this document is available on

http://

www.agfahealthcare.com/global/en/library/index.jsp

Further labels are listed and explained in the relevant modules of the System

Documentation.

Labeling of the bucky

Figure 1: (Sample of subtype
5523/120)

The type label is located on the rear cov-

er of the bucky or on the bucky drawer

below the rotating platform.
The type label information for each

bucky model is available in the technical

data.

Bucky | Introduction |

3253F EN 20210312 1125

Содержание 5523/100

Страница 1: ...Bucky 5523 100 5523 110 5523 115 5523 120 5523 125 5523 200 5523 210 5523 215 5523 220 5523 225 5523 250 5523 260 5523 265 5523 270 5523 275 5523 300 5523 310 5523 320 User Manual 3253F EN 20210312 1125 ...

Страница 2: ...cky 23 Loading of the bucky in the Radiographic Table 24 Loading of the bucky in the Radiographic Wall Stand 25 Unloading of the bucky in the Radiographic Table 26 Unloading of the bucky in the Radiographic Wall Stand 27 Automatic Cassette Size Sensing 28 Centering and collimating 29 Bucky types 31 Cassette and detector formats 33 Standard cassette formats 34 DR Detector formats and orientation 35...

Страница 3: ...ntal Compliance 47 Equipment Classification 48 Product Complaints 49 Training 50 Technical Data 51 Bucky Unit Technical Data 51 Remarks for HF emission and immunity 54 Immunity to RF wireless communication equipment 59 Precautions on EMC 60 Maintenance on EMC relevant parts 61 Bucky Contents iii 3253F EN 20210312 1125 ...

Страница 4: ...vailable 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 apparatus method or process disclosed in this...

Страница 5: ...Introduction to this Manual Topics Scope of this Manual About the safety notices in this document Disclaimer Bucky Introduction to this Manual 5 3253F EN 20210312 1125 ...

Страница 6: ... 001 BT Cassette WS R 001 BT Cassette WS GSS R 001 BT Cassette WS ACSS R 001 BT Fixed T 001 BT Fixed WS L 001 BT Fixed WS R 001 CASS BUCKY TABLE W O ACSS INCL DET CHARG CASS BUCKY WS LL W O ACSS INCL DET CHARG CASS BUCKY WS RL W O ACSS INCL DET CHARG CASS BUCKY TABLE ACSS INCL DET CHARG CASS BUCKY WS LL ACSS INCL DET CHARG CASS BUCKY WS RL ACSS INCL DET CHARG This User Manual also describes the su...

Страница 7: ...r person CAUTION A caution safety notice indicates a hazardous situation which can lead to a potential minor injury to a user engineer patient or any other person An instruction is a direction which if it is not followed can cause damage to the equipment described in this manual or any other equipment or goods and can cause environmental pollution A prohibition is a direction which if it is not fo...

Страница 8: ...sions that may 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 on order...

Страница 9: ...Introduction Topics Intended Use Intended User Installation Labels Cleaning and Disinfecting Environmental protection Bucky Introduction 9 3253F EN 20210312 1125 ...

Страница 10: ... the equipment and those who have 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 Installation Installation and configuration is performed by an Agfa trained and authorized service engineer Contact your local support organization for more information HF emis...

Страница 11: ...his document is available on http www agfahealthcare com global en library index jsp Further labels are listed and explained in the relevant modules of the System Documentation Labeling of the bucky Figure 1 Sample of subtype 5523 120 The type label is located on the rear cov er of the bucky or on the bucky drawer below the rotating platform The type label information for each bucky model is avail...

Страница 12: ...ating platform Read the instructions in the user man ual The label is positioned on the lateral cover of the bucky or on the rotating platform Compliance with China RoHS SJ T11364 2006 Indication of the Environ ment Friendly Use Period EFUP as the period years during which the hazard ous substances do not leak or mutate under normal use The label is located on the rear cover of the bucky or on the...

Страница 13: ...t All existing universal precautions should be extended to avoid potential contaminations and to avoid patients coming into close contact with the device The user is responsible for selecting a disinfection procedure Topics Cleaning Disinfecting Disinfecting safety directions Approved disinfectants Bucky Introduction 13 3253F EN 20210312 1125 ...

Страница 14: ...nt with only a little moisture Do not spray disinfectants or detergents directly on the equipment Do not pour liquid directly on the equipment CAUTION Do not use solvents such as anhydrous or high solvency alcohols thinner or benzine Do not use any corrosive dissolving or abrasive cleaning or polishing detergents Doing so may damage the surface of the equipment Using unsuitable cleaning agents or ...

Страница 15: ...ants can damage the device UV disinfection is also not allowed Perform the procedure following the instructions for use the disposal instructions and the safety instructions of the selected disinfectants and tools and of the hospital Items contaminated with blood or body fluids which may contain blood borne pathogens should be cleaned and then receive intermediate level disinfection with a product...

Страница 16: ...t is noticed due to disinfection contact the medical device manufacturer To disinfect the device Do not use any corrosive soluble or gaseous disinfectants Consult the manufacturer s Material Safety Data Sheets MSDS and recommendations on the product label for additional information prior to use Use of spray disinfection can cause malfunctions due to ingress of the disinfectant into the equipment D...

Страница 17: ...tions on the disinfectants that have been found compatible with the cover material of the device and can be used on the outer surface of the device http www agfahealthcare com global en library overview jsp ID 41651138 Bucky Introduction 17 3253F EN 20210312 1125 ...

Страница 18: ...he WEEE symbol on the products and or accompanying documents means that used electrical and electronic products should not be treated as or mixed with general household waste For more detailed information about take back and recycling of this product please contact your local service organization and or dealer The recycling of materials will help to conserve natural resources c2 caution By ensurin...

Страница 19: ...uct WARNING The product must only be installed using released components and in released configurations CAUTION Strictly observe all warnings cautions notes and safety markings within this document and on the product CAUTION All Agfa medical products must be used by trained and qualified personnel Bucky Safety Directions 19 3253F EN 20210312 1125 ...

Страница 20: ...cassette size format The bucky functionalities can be configured according the customer needs 1 4 3 6 5 7 2 1 Bucky drawer 2 Button to release the brake 3 Bucky drawer handle 4 Carrier for the cassette or detector 5 Knob for rotating the cassette or detector 6 Clamps 7 Side clamps Figure 4 Bucky 1 2 3 4 5 1 Tabletop 2 Removable grid 3 Automatic exposure control AEC 4 Carrier for cassette or detect...

Страница 21: ...graphic Wall Stand Unloading of the bucky in the Radiographic Table Unloading of the bucky in the Radiographic Wall Stand Automatic Cassette Size Sensing Centering and collimating Bucky types Cassette and detector formats Standard cassette formats DR Detector formats and orientation Grids Bucky Bucky 21 3253F EN 20210312 1125 ...

Страница 22: ...e bucky provides a protection for double exposure by checking if the bucky is re armed after each exposure Fixed DR Detector configuration The bucky for the fixed DR detector has no clamping or rotation mechanism The detector is permanently fixed in the bucky and can not be removed The detector has a square format and requires no rotation Radiographic wall stand configuration The cassette or detec...

Страница 23: ...using the rotation knob Rotate clockwise to change from portrait to landscape position Rotate counterclockwise to change from landscape to portrait position Figure 6 Example rotate clockwise to change from portrait to landscape position Make sure the rotation is complete before closing the bucky drawer 3 Close the bucky drawer using the front handle and pushing the button to release the brake Make...

Страница 24: ...e The clamping mechanism may hurt your fingers therefore take special care 4 Align the cassette or detector center indication to the center mark on the clamp CAUTION When positioning the cassette or detector out of center The alignment to the X ray tube must be controlled manually The AEC sensors might not be covered or not covered completely causing wrong exposure dose Make sure that AEC sensors ...

Страница 25: ... are not between slider and cassette The clamping mechanism may hurt your fingers therefore take special care 6 Rotate the cassette or detector if needed to get the correct position for next exposure 7 Align the cassette or detector The alignment can be centered or out of center CAUTION When positioning the cassette or detector out of center The alignment to the X ray tube must be controlled manua...

Страница 26: ...TION Make sure your fingers are not between slider and cassette The clamping mechanism may hurt your fingers therefore take special care 3 Lift the cassette or detector and remove it from the clamping The openings in the carrier allow your fingers to grip the detector or cassette 4 Load the bucky with another cassette or detector Alternatively close the bucky drawer using the front handle and push...

Страница 27: ...pen the clamping mechanism CAUTION Make sure your fingers are not between slider and cassette The clamping mechanism may hurt your fingers therefore take special care 4 Remove the cassette or detector from the clamping The openings in the carrier allow your fingers to grip the detector or cassette 5 Load the bucky with another cassette or detector Alternatively close the bucky drawer using the fro...

Страница 28: ... detector is not in the center of the bucky the collimated area is automatically expanded to expose the whole surface of the cassette or detector Because automatic collimation is always symmetrical on one side the exposure will extend beyond the surface of the cassette or detector and the collimation must be corrected manually to apply an asymmetrical collimation area The collimator must not be ro...

Страница 29: ...just the position of the X ray tube The collimator light field contains center lines to check the alignment of the X ray field to the bucky The centering icon on the tube head display indicates the alignment of the X ray field to the bucky Table 1 Centering status on the radiographic table X ray tube is pointing towards table bucky X ray tube stand and bucky are mechanically coupled X ray tube arm...

Страница 30: ...set the X ray collimation area pull out the bucky drawer until the cassette or detector edge is visible Align the X ray collimation field to the size of the cassette or detector Figure 7 Center line and collimation area 30 Bucky Bucky 3253F EN 20210312 1125 ...

Страница 31: ... stand left loading 5523 200 5523 210 5523 215 5523 220 5523 225 5523 310 Radiographic wall stand right loading 5523 250 5523 260 5523 265 5523 270 5523 275 5523 320 Table 4 Bucky with tray for multiple cassette or detector formats Clamping mechanism Rotation mechanism Cassette or detector detection CR double exposure protection Grid type and status detection AEC All types Bucky Bucky 31 3253F EN ...

Страница 32: ...3 300 Radiographic wall stand left loading 5523 310 Radiographic wall stand right loading 5523 320 Grid type and status detection AEC All types ACSS requires the cassette to be positioned in the center of the bucky Additionally for the radiographic wall stand ACSS is supported if a large format cassette or detector 43 cm x 35 cm or 17 inch x 14 inch is aligned to the top of the bucky in landscape ...

Страница 33: ... cm or 17 inch x 14 inch can be positioned either centered or aligned to the top of the bucky in landscape position 1 2 1 Indicators for large format cassette or detector position to the top of the bucky 2 Large format detector positioned to the top of the bucky Figure 8 Wall stand bucky with large format detector positioned to the top of the bucky 1 1 Indicators for large format cassette or detec...

Страница 34: ...Standard cassette formats 35 cm x 43 cm 35 cm x 35 cm 24 cm x 30 cm 18 cm x 24 cm 15 cm x 30 cm 34 Bucky Bucky 3253F EN 20210312 1125 ...

Страница 35: ...the bucky refer to following sections and to the user manual of the DR Detector Topics Orientation of DR 10s in the bucky Orientation of DR 14s in the bucky Orientation of DX D 10C DX D 10G in the bucky Using DX D 45C DX D 45G only outside the bucky Bucky Bucky 35 3253F EN 20210312 1125 ...

Страница 36: ...c table To use the detector in portrait orientation insert the detector in portrait orientation To use the detector in landscape orientation 1 Insert the detector in portrait orientation 2 Rotate the detector in the bucky 1 2 Figure 10 Landscape orientation in the radiographic table Orientation in the radiographic wall stand left loading To use the detector in landscape orientation insert the dete...

Страница 37: ...ic wall stand right loading Orientation of DR 14s in the bucky If the bucky is equipped with an internal DR Detector connector the battery will be charged while the detector is in the bucky Topics Orientation in the radiographic table Orientation in the radiographic wall stand left loading Orientation in the radiographic wall stand right loading Orientation in the radiographic table To use the det...

Страница 38: ...ientation 1 Insert the detector in landscape orientation 2 Rotate the detector in the bucky 1 2 Figure 14 Portrait orientation in the radiographic wall stand left loading Orientation in the radiographic wall stand right loading To use the detector landscape orientation insert the detector in landscape orientation To use the detector in portrait orientation 1 Insert the detector in landscape orient...

Страница 39: ...arrier Topics Orientation in the radiographic table Orientation in the radiographic wall stand left loading Orientation in the radiographic wall stand right loading Orientation in the radiographic table To use the detector in landscape orientation insert the detector in landscape orientation with the cable at lower right hand side To use the detector in portrait orientation 1 Insert the detector i...

Страница 40: ...ll stand right loading To use the detector portrait orientation insert the detector in portrait mode with the cable at bottom right hand side To use the detector in landscape orientation 1 Insert the detector in portrait mode with the cable at bottom right hand side 2 Rotate the detector in the bucky 1 2 Figure 18 Landscape orientation in the radiographic wall stand right loading Using DX D 45C DX...

Страница 41: ...e to avoid damage 3 Insert the grid with labels facing up in the appropriate slit of the bucky Make sure the grid is pushed up to the end CAUTION Using a focused grid with the X ray source not centered or on a wrong distance may cause reduced image quality CAUTION Injury of the patient or damage to the equipment can be caused by the grid if it is not properly inserted in the bucky CAUTION Handle g...

Страница 42: ...age quality Grids are available as an option Refer to the Agfa website for specifications on the anti scatter grids that have been found compatible with the system and the DR Detectors http www agfahealthcare com global en library overview jsp ID 54332498 42 Bucky Bucky 3253F EN 20210312 1125 ...

Страница 43: ...tion The handle of the grid is visible when the grid is inserted and its color indicates the focal distance of the grid Focal Distance Color 100 cm red 150 cm green 180 cm blue Parallell grid gray Bucky Bucky 43 3253F EN 20210312 1125 ...

Страница 44: ...pe of the grid and if the grid is correctly inserted in the bucky The grid status reflects if the inserted grid is suitable for the selected exposure and the current SID and is displayed on the tube head display and on the Software Console 44 Bucky Bucky 3253F EN 20210312 1125 ...

Страница 45: ...duct Information Topics Compatibility Compliance Equipment Classification Product Complaints Training Technical Data Remarks for HF emission and immunity Bucky Product Information 45 3253F EN 20210312 1125 ...

Страница 46: ...ons 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 Compliance The system is compliant with specific directives and standards Topics General Safety Electromagnetic Compatibility Environmental Compliance 4...

Страница 47: ...tes uses and can radiate radio frequency energy and if not installed and used in accordance with the installation manual may cause harmful interference to radio communications Operation of this equipment in a residential area is likely to cause harmful interference in which case the user will be required to correct the interference at his own expense If required contact your local service organiza...

Страница 48: ...there being no provision for protec tive earthing or reliance upon installation conditions Ingress This device does not have protection against ingress of wa ter 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 flam mable anesthetic mixture with air or in presence o...

Страница 49: ...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...

Страница 50: ...ountry The user 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 50 Bucky Product Information 3253F EN 20210312 1125 ...

Страница 51: ...ACSS INCL DET CHARG 5523 125 BT Cassette WS L 001 5523 200 BT Cassette WS GSS L 001 5523 210 CASS BUCKY WS LL W O ACSS INCL DET CHARG 5523 215 BT Cassette WS ACSS L 001 5523 220 CASS BUCKY WS LL ACSS INCL DET CHARG 5523 225 BT Cassette WS R 001 5523 250 BT Cassette WS GSS R 001 5523 260 CASS BUCKY WS RL W O ACSS INCL DET CHARG 5523 265 BT Cassette WS ACSS R 001 5523 270 CASS BUCKY WS RL ACSS INCL ...

Страница 52: ...6 0 kg DX D Fixed DR Detector bucky 13 kg Electrical connection type 5523 100 5523 200 5523 250 Operating voltage 24 VDC Operating current 80 mA Electrical connection type 5523 110 5523 120 5523 210 5523 220 5523 260 5523 270 5523 300 5523 310 5523 320 Operating voltage 24 VDC Operating current 375 mA Electrical connection type 5523 115 5523 125 5523 215 5523 225 5523 265 5523 275 Operating voltag...

Страница 53: ...peration Temperature ambient between 10 and 35 Celsius Humidity non condensing between 30 and 75 relative humidity Atmospheric pressure between 70 and 106 kPa Maximum altitude 3000 m For overall system environmental conditions the environmental conditions of the DR Detector or image plate should be taken into account Refer to the related User Manual for environmental conditions for the DR Detector...

Страница 54: ...onals 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 in the ele...

Страница 55: ...kV air discharge Floors should consist of wood concrete or ceramic tiles The relative humidity must be at least 30 if the 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 surge...

Страница 56: ...ion Test level of professio nal medical equipment and basic EMC stand ards Electromagnetic En 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 sectio...

Страница 57: ...th the maximum output power of the communications equipment See also the section with 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...

Страница 58: ... Maintenance on EMC relevant parts 58 Bucky Product Information 3253F EN 20210312 1125 ...

Страница 59: ...MRS 460 FRS 460 0 3 28 704 787 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 Bucky Product Information 59 3253F EN 20210312 1125 ...

Страница 60: ...at they are operating normally 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 equipme...

Страница 61: ...elevant parts could be inspected by the operator EMC relevant parts will be inspected from AFGA service engineer within the regular service interval until the end of lifetime The needed verifications are described in the service manual Bucky Product Information 61 3253F EN 20210312 1125 ...

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