AGFA 5400/527 User Manual Download Page 14

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Equipment Classification

Per EN/IEC60601-1, Medical Electrical Equipment, General Requirements for

Safety 3rd Edition, this device is classified as following:

Table 1: Equipment classification

Class I equipment

Equipment in which protection against electric

shock does not relay on basic insulation only, but

includes a power supply cord with protective earth

conductor. For earth reliability always plug the

main power cord into an earthed mains power

outlet.

Type B equipment

A Type B piece of equipment is one that provides a

particular degree of protection against electric

shock particularly regarding allowable leakage

current and reliability of the protective earth

protection.

Water ingress

This device does not have protection against

ingress 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 mixture with

oxygen or nitrous oxide.

Operation

Continuous operation.

Non-medical equipment

Following components are classified as non-medical equipment:

• Workstation
• DR detector control unit

WARNING:

Do not use non-medical equipment in the patient’s vicinity.

| DR 18M, DR 24M | Introduction to the DR Detector

0380A EN 20180703 1429

Summary of Contents for 5400/527

Page 1: ...DR 18M DR 24M 5400 527 5400 528 User Manual 0380A EN 20180703 1429 ...

Page 2: ...Training 21 Product Complaints 22 Compatibility 23 Compliance 24 General 25 Safety 25 Electromagnetic Compatibility 25 X ray devices 25 Connectivity 26 Wired communication 26 Installation 27 Environment of Use 27 Messages 28 Labels 29 Additional Labeling of the DR detector 31 Additional Labeling of the DR detector control unit 32 Cleaning and Disinfecting 33 Cleaning 34 Disinfecting 35 Use of prot...

Page 3: ...out AEC 55 Verifying if an image is exposed correctly 57 Special mammography views 58 Automatic exposure detection 59 Automatic Exposure Control with DR 18M 60 Stopping the DR Detector 61 Problem solving 62 No image available after exposure 63 DR image is not displayed 64 Image shows artifacts 65 Technical Data 66 DR 18M DR 24M 67 DR 18M DR 24M control unit 70 Remarks for HF emission and immunity ...

Page 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...

Page 5: ...Introduction to this Manual Topics Scope About the safety notices in this document Disclaimer DR 18M DR 24M Introduction to this Manual 5 0380A EN 20180703 1429 ...

Page 6: ...tains information for the safe and effective operation of the DR 18M and DR 24M DR Detectors and peripheral equipment further referred to as the DR detector 6 DR 18M DR 24M Introduction to this Manual 0380A EN 20180703 1429 ...

Page 7: ...rson 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 follow...

Page 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 to sale ...

Page 9: ...fication Operation Controls System Documentation Training Product Complaints Compatibility Compliance Connectivity Installation Messages Labels Cleaning and Disinfecting Maintenance Patient data security Environmental protection Safety Directions DR 18M DR 24M Introduction to the DR Detector 9 0380A EN 20180703 1429 ...

Page 10: ...n seconds eliminating the need for an X ray film or an image plate as an image capture medium The DR 18M and DR 24M is intended for mammography application only The DR detectors are designed to be equivalent in size to a conventional film and CR image plate The DR 18M is the appropriate size for a small bucky of any mammography unit and the DR 24M is the appropriate size for a large bucky of any m...

Page 11: ...my for adult examinations The DX D Retrofit Packages system converts the screen film or CR Mammography system into a DR Mammography system If the X ray system contains preconfigured exposure settings they will be updated for use with the DR detector and the system can no longer be used together with screen film or CR systems DR 18M DR 24M Introduction to the DR Detector 11 0380A EN 20180703 1429 ...

Page 12: ... 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 Only a physician or a legally certified operator should use this product 12 DR 18M DR 24M Introduction to the DR Detector 0380A EN 20180703 1429 ...

Page 13: ...n be integrated in an X ray system and that communicates to a workstation A workstation can communicate to a single DR Detector A DR Detector can communicate to a single workstation DR 18M DR 24M Introduction to the DR Detector 13 0380A EN 20180703 1429 ...

Page 14: ... shock particularly regarding allowable leakage current and reliability of the protective earth protection Water ingress This device does not have protection against ingress 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 ...

Page 15: ...Operation Controls Topics DR 18M DR 24M DR Detector Switch on the NX Workstation DR detector cable and control unit DR 18M DR 24M Introduction to the DR Detector 15 0380A EN 20180703 1429 ...

Page 16: ... Effective imaging area border and center position indication 2 Chest wall 3 Shock indicator 4 DR Detector cable connector Figure 1 DR Detector operation controls 16 DR 18M DR 24M Introduction to the DR Detector 0380A EN 20180703 1429 ...

Page 17: ...n the title bar of the NX application Connection status icon empty Meaning Wired DR Detector DR Detector is off or disconnected DR Detector status icon blinking empty Meaning DR Detector is ready for exposure DR Detector is initializing for exposure DR Detector is off or disconnected or in error DR Detector is inactive no thumbnail selected DR 18M DR 24M Introduction to the DR Detector 17 0380A EN...

Page 18: ...1 Power switch Figure 2 Front view of the control unit 5 4 6 7 1 2 3 1 Indicator light is on when the DR detector is active 2 Indicator light is on when the DR detector is connected 3 Indicator light is on when the DR detector power supply is on 4 DR detector cable 5 Connector for the DR detector cable 6 Connector for the network cable to the workstation 7 Connector for the power cable Figure 3 Re...

Page 19: ...Related Links Non medical equipment on page 14 DR 18M DR 24M Introduction to the DR Detector 19 0380A EN 20180703 1429 ...

Page 20: ...nction option or accessory described may have been purchased or licensed on a particular piece of equipment Technical documentation is available in the product service documentation which is available from your local support organization The most recent version of this document is available on http www agfahealthcare com global en library index jsp 20 DR 18M DR 24M Introduction to the DR Detector ...

Page 21: ... 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 DR 18M DR 24M Introduction to the DR Detector 21 0380A EN 20180703 1429 ...

Page 22: ...duct must notify Agfa If the device malfunctions and may have caused or contributed to a serious injury Agfa must be notified immediately by telephone fax or written correspondence to the following 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 22 DR 18M DR 24M Introduction to the DR ...

Page 23: ...nents 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 18M DR 24M Introduction to the DR Detector 23 0380A EN 20180703 1429 ...

Page 24: ...Compliance Topics General Safety Electromagnetic Compatibility X ray devices 24 DR 18M DR 24M Introduction to the DR Detector 0380A EN 20180703 1429 ...

Page 25: ...t procedures required by 93 42 EEC Medical Device Directive European Council Directive 93 42 EEC on Medical Devices amended by European Directive 2007 47 CE Safety EN 60601 1 2006 A1 2013 IEC 60601 1 2015 A1 2012 Electromagnetic Compatibility IEC 60601 1 2 2005 EN 60601 1 2 2007 X ray devices EN 62220 1 2 2007 DR 18M DR 24M Introduction to the DR Detector 25 0380A EN 20180703 1429 ...

Page 26: ...gital interfaces must be certified according to the respective IEC standards All combinations of equipment must be in compliance with IEC 60601 1 1 system requirements Any person who connects additional equipment to the signal input or signal output ports configures a medical system and is therefore responsible for ensuring that the system complies with the requirements of the system standard IEC ...

Page 27: ...nstallation There must be no dripping water in the area The environment must be free of harmful elements such as humid or acidic air air with a saline or sulfur content poor ventilation or unusual air pressure or temperature The equipment must not be placed at an angle or subjected to vibration or shock including when it is transported The equipment must not be kept where chemical products are sto...

Page 28: ...ion cannot be performed The user must read these messages carefully They 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 local service organization Details on the contents of messages can be found in the service documentation which is available to local service personnel 28 DR 18M DR 24M Introduction to the DR De...

Page 29: ...ing instructions Do not immerse in liquids No serviceable component inside Do not attempt to open the case Explosive gas flammable Control unit mains power fuse 250VAC 2A Type T Alternating current Dangerous voltage Protective earth ground On power connection to the mains Off power disconnection from the mains Manufacturer DR 18M DR 24M Introduction to the DR Detector 29 0380A EN 20180703 1429 ...

Page 30: ...d electrical and electronic products should not be treated as or mixed with general household waste Read and understand all instructions and warning labels in the product documentation before using the equipment Keep manual for future reference Topics Additional Labeling of the DR detector Additional Labeling of the DR detector control unit 30 DR 18M DR 24M Introduction to the DR Detector 0380A EN...

Page 31: ...e label Type label on the back side of the DR detector Warranty sealing label Do not to press the detector surface or carry the panel gripping the surface Location of the internal shock sensor DR 18M DR 24M Introduction to the DR Detector 31 0380A EN 20180703 1429 ...

Page 32: ...dditional Labeling of the DR detector control unit Figure 6 Example of type label Type label on the bottom side of the control unit 32 DR 18M DR 24M Introduction to the DR Detector 0380A EN 20180703 1429 ...

Page 33: ...It is advisable to keep the detector in the mammography X ray modality bucky at all time and not to remove it without any reason It is advisable to disinfect or clean the detector only when needed and following the local regulations When disinfection or cleaning of the detector is necessary be sure to put the detector on a flat and rigid surface so it will not bend Topics Cleaning Disinfecting Use...

Page 34: ...the device CAUTION Clean the equipment with only a little moisture Do not spray disinfectants or detergents directly on the equipment Do not pour liquid directly on the equipment CAUTION Liquids ingressing the DR Detector may cause malfunction and contamination Take special care near the cable connector on the side of the DR Detector CAUTION Do not use abrasive brush and scraper to clean the produ...

Page 35: ...ectants approved by Agfa If you plan to use other disinfectants approval of Agfa is needed before use as most disinfectants can damage the device UV disinfection is also not allowed DR 18M DR 24M Introduction to the DR Detector 35 0380A EN 20180703 1429 ...

Page 36: ...or patient tissue the DR Detector must be wrapped in a protective plastic envelope while performing the examination It is considered good clinical practice to use a single use protective envelope in all cases where contact of the device or contaminants is expected to avoid contamination of others Make sure that the plastic envelope is not wrinkled to avoid the creases showing in the image 36 DR 18...

Page 37: ... DR 24M DR detector WARNING Use only disinfectants that comply with the allowed disinfection practices in your country WARNING Do not use disinfectants based upon gluteraldehyde formaldehyde bleach or peroxide as the exterior of the detector may be affected and or difficult to remove deposit may occur on the surface of the detector DR 18M DR 24M Introduction to the DR Detector 37 0380A EN 20180703...

Page 38: ...reuse wipes WARNING Perform the procedure following the instructions for use as provided wit the cleaning or disinfection product CAUTION Be sure that all surfaces are thoroughly dry before returning the equipment to use CAUTION Make sure that the equipment is properly decontaminated and disinfected before shipment or servicing CAUTION Be sure that all surfaces are thoroughly dry before returning ...

Page 39: ...ecommendations on the product label for additional information prior to use Disclaimer The selection and description of the appropriate disinfection procedure and policy is the responsibility of the user DR 18M DR 24M Introduction to the DR Detector 39 0380A EN 20180703 1429 ...

Page 40: ...rder to ensure that the equipment is used safely and normally be sure to inspect the equipment before use If any problem is found during the inspection and cannot be corrected please contact your sales representative or local dealer Topics Daily inspection Half yearly inspection 40 DR 18M DR 24M Introduction to the DR Detector 0380A EN 20180703 1429 ...

Page 41: ...he orange and green led lights next to the network connector are lit to indicate that the control unit is connected to the NX workstation The three led lights are lit to indicate that the self tests have been passed 6 Perform a test exposure Local procedures for mammography or the local Organisation for Quality Control for mammography can advise to expose a certain QC phantom Follow their instruct...

Page 42: ... message is displayed on the NX workstation Perform calibration half yearly or when exposure conditions have changed significantly For details refer to the DX D DR Detector Calibration Key User Manual 0134 42 DR 18M DR 24M Introduction to the DR Detector 0380A EN 20180703 1429 ...

Page 43: ... and that the security of the patient data is guarded The user must define who can access patient data in which situations The user must have a strategy available on what to do with patient data in case of a disaster DR 18M DR 24M Introduction to the DR Detector 43 0380A EN 20180703 1429 ...

Page 44: ...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 By ensuring this product is disposed of correctly you will help prevent potential negative conse...

Page 45: ... If chemicals are spilled or evaporate it may result in fire or electric shock through contact with electric parts inside the equipment Also some disinfectants are flammable Take care when using them WARNING The DR detector is not suitable for operation in the presence of a flammable anesthetic mixture containing air oxygen or nitrous oxide WARNING To avoid risk of electric shock this equipment mu...

Page 46: ...he patient take a fixed posture and do not let the patient touch parts unnecessarily If the patient touches connectors or switches it may result in electric shock or malfunction of the equipment CAUTION Placing any objects on top of the detector or pressing down on the detector with pressure is prohibited Such actions may cause the device not to operate or unexpected images may appear or there may...

Page 47: ... Turn OFF the power to each piece of equipment for safety when not being used CAUTION Handle the equipment carefully Do not submerge the equipment in water The internal image sensor may be damaged if something hits against it or if it is dropped or receives a strong jolt CAUTION Observe great care when handling the DR Detector The detector is shock sensitive and drops should be avoided Warranty wi...

Page 48: ...or Positioning the DR detector Manual exposure table for examinations without AEC Verifying if an image is exposed correctly Special mammography views Automatic exposure detection Automatic Exposure Control with DR 18M Stopping the DR Detector 48 DR 18M DR 24M Getting started 0380A EN 20180703 1429 ...

Page 49: ...ere is any indication that image quality is suboptimal It is advisable to keep the detector in the mammography X ray modality bucky at all time and not to remove it without any reason Make sure the fail safe mechanism of the X ray modality that detects cassette exchange between every exposure is switched off contact the X ray modality engineer for advise It is advisable not to use lead markers tha...

Page 50: ... power switch at the front of the control unit 4 Check the DR Detector status icon on the DR Detector Switch The connection indicator is lit The DR Detector is ready Before exposure make sure to check the equipment daily and confirm that it works properly Allow the DR detector to warm up for about 10 minutes before the system is used for clinical purposes The DR Detector status icon on the DR Dete...

Page 51: ...etector 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 DR 18M DR 24M Getting started 51 0380A EN 20180703 1429 ...

Page 52: ...atient Apply radiation protective measures for the patient if needed 2 Check if the X Ray system position is suitable for the exposure Step 4 check the exposure settings 1 On the DR Detector switch check the DR Detector status icon Do not execute the expose while the status icon indacates that the DR Detector is not ready The exposure will be not detected by the DR Detector 2 On the X ray system c...

Page 53: ...ator on the control console lights up during exposure release WARNING Do not select another thumbnail until the preview image is visible in the active thumbnail At the NX workstation The image is acquired from the DR detector and displayed in the thumbnail DR 18M DR 24M Getting started 53 0380A EN 20180703 1429 ...

Page 54: ...de chest wall side 2 1 Figure 8 Detector orientation aids 1 Tube side of the detector 2 Chest wall side of the detector CAUTION Take care not to bend or wind the cable too tightly Otherwise the cable may be damaged causing fire electric shock or a bad connection 54 DR 18M DR 24M Getting started 0380A EN 20180703 1429 ...

Page 55: ...unction of compressed thickness and breast density For X ray systems that do not have a read out of the compressed breast thickness a variant of the manual exposure table is available that is attached to the X ray system and acts as a ruler By positioning the compression paddle a row is indicated in the table with the applicable exposure settings If the compression paddle is positioned inbetween t...

Page 56: ...dense target mAs standard Target Filter mAs values 21 mm 32 mm 45 mm 53 mm 75 mm 60 mm 90 mm Figure 10 Template of the manual exposure table that can be attached to the X ray system 56 DR 18M DR 24M Getting started 0380A EN 20180703 1429 ...

Page 57: ... 1 Measure the PVIc Log of the image at the location of the AEC cells 2 Compare the result to the reference value that is defined during installation 3 Estimate the amount of overexposure or underexposure on the acquired image Table 2 Using the pixel value index PVI to estimate the exposure level Measured PVIc Log value compared to a reference value Estimated exposure level compared to a reference...

Page 58: ...is magnification bucky because only one size of detector is available at your mammography centre In this case we advise an alternative workflow 1 Use the spot compression paddle on the regular bucky instead of the magnification bucky of the modality 2 Use the software tools of the NX workstation or the diagnostic review station to enlarge the local area of interest on the standard MLO and CC exams...

Page 59: ...automatically perform the image acquisition The X ray system has to generate a minimum exposure dose to trigger the DR detector s automatic exposure detection Related Links No image available after exposure on page 63 DR 18M DR 24M Getting started 59 0380A EN 20180703 1429 ...

Page 60: ... compliant with the specifications in ISO 4090 with regard to positioning of the automatic exposure control AEC dose measuring cells in the X ray modality Internal electronic parts of the detector may cover part of the AEC cells During installation a test is performed to determine which AEC cells can be activated when using the DR 18M detector The user is responsible to select the proper AEC cells...

Page 61: ...Stopping the DR Detector To stop the DR Detector Power off the DR Detector using the power switch at the front of the control unit DR 18M DR 24M Getting started 61 0380A EN 20180703 1429 ...

Page 62: ...Problem solving Topics No image available after exposure DR image is not displayed Image shows artifacts 62 DR 18M DR 24M Problem solving 0380A EN 20180703 1429 ...

Page 63: ...the automatic exposure detection of the DR detector are blocked Solution Check both of following conditions 1 Check the output of the automatic exposure on the X ray console If the mAs value is low to your experience make sure to manually raise the mAs keep other settings instead of repeating in automatic mode 2 Check if no objects with a high attenuation are blocking part of the image area DR 18M...

Page 64: ...ost however and default data are used Brief Solution Refer to the NX user manual for more information about image recovery Note If the DR detector cable is disconnected the synchronization between the control unit and the NX workstation will be interrupted If the cable is reconnected within 30 seconds the recovery image will be transferred to the NX Workstation If the connection stays interrupted ...

Page 65: ...e problem take following measures 1 If this situation is exceptional and can be justified by the high compression thickness or by the type of examination try to reduce the exposure time on the X ray system 2 Perform a typical flat field exposure to check the general image quality 3 Contact your local service representative who can extend the integration time of the DR detector Related Links Daily ...

Page 66: ...Technical Data Topics DR 18M DR 24M DR 18M DR 24M control unit 66 DR 18M DR 24M Technical Data 0380A EN 20180703 1429 ...

Page 67: ...a Environmental conditions during storage Temperature ambient between 10 C and 40 C Maximum temperature change rate max 15 C hour Humidity non condensing between 5 and 95 non condensing Atmospheric pressure between 500 hPa and 1060 hPa Warming up time 5 minutes minimum 10 minutes recommended 30 minutes before calibration Dimensions Dimensions width x length x height DR 18M 267 5 x 194 5 x 14 2 mm ...

Page 68: ... per hour 120 images per hour Estimated product life if regularly serviced and maintained according to Agfa instructions 7 years Conversion screen CsI Pixel size 76 µm Pixel matrix DR 18M 3054 x 2295 DR 24M 3063 x 3822 Fill factor 80 Effective area size DR 18M 232 0 mm x 174 4 mm DR 24M 290 4 mm x 232 8 mm Typical Detective Quantum Efficiency DQE 0 5 lp mm 50 1 lp mm 45 2 lp mm 40 3 lp mm 35 4 lp ...

Page 69: ...Minimum Modulation Transfer Function MTF 1 lp mm 65 2 lp mm 55 3 lp mm 35 4 lp mm 25 5 lp mm 20 6 lp mm 10 DR 18M DR 24M Technical Data 69 0380A EN 20180703 1429 ...

Page 70: ...ave protection against ingress of water Dimensions Dimensions width x height x depth 170 0 mm x 60 5 mm x 170 0 mm Weight 1 23 kg Electrical connection Rated Power Supply 100 240 V AC 50 60 Hz 2 5 1 25 A Maximum power system prospective short circuit current 35 16 A 70 DR 18M DR 24M Technical Data 0380A EN 20180703 1429 ...

Page 71: ...nd immunity Topics EMC Electromagnetic Compatibility Statements Cables transducers and accessories Electromagnetic emissions Electromagnetic immunity DR 18M DR 24M Remarks for HF emission and immunity 71 0380A EN 20180703 1429 ...

Page 72: ...can be determined by turning the equipment off and on the user is encouraged to try to correct the interference by one or more of the following measures reorient or relocate the receiving device increase the separation between the devices connect the equipment into an outlet on a circuit different from that to which the other devices are connected If the problem cannot be solved with the above mea...

Page 73: ...d accessories not mentioned in this manual or spare parts not ordered from Agfa may cause a higher emission of electromagnetic phenomena and or may rise the susceptibility against it DR 18M DR 24M Remarks for HF emission and immunity 73 0380A EN 20180703 1429 ...

Page 74: ...with CISPR 11 Group 1 This DR Detector uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions in accordance with CISPR 11 Class A The DR Detector is suitable not only in non household facilities but can also be used by directly connecting it to the common low power network in a b...

Page 75: ...ed should correspond to a typical commercial or clinical environment Impulse voltages surges in accordance with IEC 61000 4 5 1 kV push pull voltage 2 kV common mode voltage 1 kV push pull voltage 2 kV common mode voltage The quality of the voltage supplied should correspond to that of a typical commercial or clinical environment Voltage breakthroughs short term interruptions and variations in the...

Page 76: ...t Electromagnetic Environment Use portable and mobile radio sets at a safe distance from the DR Detector including the leads not closer than the recommended protective distance which is calculated according to the equation suitable for the transmission frequency Recommended protective distance Conducted high frequency disturbance variables in accordance with IEC 61000 4 6 3 Veff 150 kHz to 80 MHz ...

Page 77: ...se Guidelines may not apply to all situations The dispersion of electromagnetic waves is influenced by absorption and reflections from buildings objects and people Note The field strength of stationary transmitters such as base stations of radio telephones mobile broadcasts for rural areas amateur stations and AM and FM radio transmitters cannot be precisely predetermined theoretically An investig...

Page 78: ...erformance characteristics it can be necessary to take additional measures such as the re orientation of the device for example Note The field strength will be lower than 3 V m above the frequency range from 150 kHz to 80 MHz 78 DR 18M DR 24M Remarks for HF emission and immunity 0380A EN 20180703 1429 ...

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