Varex Imaging Deutschland XRPAD2 802.11n 3T3R Mini PCIe Module User Manual

PerkinElmer Medical Imaging 802.11n 3T3R Mini PCIe Module Users Manual

Contents

Users Manual

DIGITAL IMAGING68153 01XRpad2 4336 Digital X-ray Detector System User ManualBefore using the X-ray detector, be sure to read this manual thoroughly along with any other manuals for the software and other system components. Keep this manual where it is easily accessible.
DIGITAL IMAGINGii www.perkinelmer.com 68153 01Before You Begin XRpad2 4336Before You Begin•To avoid personal injury or product damage, read the manual and all accompanying information carefully before installing and using the X-ray detector.•The X-ray detector is intended for use by trained and qualified professional personnel who are knowledgeable with the use of X-ray detectors, X-ray systems, and electrical equipment.•The user is responsible for using and maintaining the detector according to prescribed installation, usage, maintenance, handling, and storage specifications. To keep the detector and its accessories in a safe and proper condition, only trained and qualified professional person(s) shall be in charge of maintenance.•X-ray imaging, image processing, image acquisition, and data storage must be performed in accordance with the applicable laws. The user is also responsible for compliance to laws pertaining to the privacy of image data.•In no event is X-ray detector manufacturer liable for direct, indirect, or consequential injury, damage, or loss of equipment operation time or image data arising from the use of the X-ray detector, its components, and/or accessories.Protection Against Ionizing Radiation•Exposure of any part of the human body to X-radiation may be harmful to health. Whenever X-ray equipment or radioactive sources are in use, appropriate safety precautions and measures shall be instituted, and all regulatory requirements must be met. It is the responsibility of the X-ray system installer, operator, and user to comply with applicable requirements.•The X-ray detector is intended to be installed, maintained, and used by qualified professional personnel who are trained and qualified in the installation, maintenance, and use of X-ray equipment.•The X-ray detector does not contain a primary barrier for X-rays or Gamma rays. The X-ray system installer or X-ray system manufacturer must provide the necessary protection based on the X-ray system’s intended use.•For portable applications, the X-ray system installer or X-ray system manufacturer must provide the necessary training for operators to protect themselves, patients, and surrounding persons.
DIGITAL IMAGING68153 01 www.perkinelmer.com iiiXRpad2 4336 For Your SafetyFor Your SafetyTo avoid personal injury or product damage, read this manual and all accompanying informa-tion carefully before handling, installing, or using the X-ray detector. Follow all instructions, warnings, and cautions in this manual and all warnings and cautions printed on the warning label. Ignoring instructions, warnings, or cautions in the handling, installing, or using of the detector may result in personal injury, death, or product damage. Keep this manual for future reference.Meaning of Alerts and NotesDANGER This indicates a potentially hazardous situation which, if ignored, will result in severe personal injury, death, or substantial product damage. WARNING This indicates a potentially hazardous situation which, if ignored, may result in severe personal injury, death, or substantial product damage.Caution This indicates a potential hazardous situation which, if ignored, may result in minor or moderate personal injury or damage to the product.Note This emphasizes or supplements important information about the main text.
DIGITAL IMAGINGiv www.perkinelmer.com 68153 01For Your Safety XRpad2 4336Installation and Environment of UseWARNING Do not operate the X-ray detector in or around flammable gases, gas mixtures, liquids, chemicals, or other substances. Ignoring this warning may result in explosion, fire, or electric shock, which may result in severe personal injury, death, or substantial product damage.Caution Do not operate the X-ray detector in a location with the following conditions.•Close to fluid or places where fluid is used•Close to heat sources, such as a heater•High temperature environment•High humidity environment•High condensation environment•Extreme cold environment•Dusty environment•Salty or sulphurous environment•Near a vibrating environmentIgnoring this caution may result in personal injury or damage to the product.WARNING Do not connect the X-ray detector to any component or accessory other than the manufacturer’s specified components and accessories. Ignoring this warning may result in explosion, fire, or electric shock, which may result in severe personal injury, death, or substantial product damage.WARNING Do not modify or alter the X-ray detector, its components, or accessories. Ignoring this warning may result in explosion, fire, or electric shock, which may result in severe personal injury, death, or substantial product damage.WARNING The detector is not designed to control X-ray dose. The system integrator is responsible for controlling the X-ray radiation.
DIGITAL IMAGING68153 01 www.perkinelmer.com vXRpad2 4336 For Your SafetyInterface and Power Unit and CablesWARNING Be sure to turn OFF the power of the X-ray detector, including turning off the power supply or removing the battery (if applicable) before servicing, maintaining, connecting, or disconnecting the cables or accessories. Do not touch the power supply, Lithium Battery Pack, X-ray detector, cable, connector, or any other electrical component or equipment with wet hands. Ignoring this warning may cause electrical shock, which may result in severe personal injury, death, or substantial product damage.WARNING Disconnect the cables by pulling on the connector and not the cable itself. Ignoring this warning may cause electrical shock, which may result in severe personal injury, death, or substantial product damage.WARNING Do not modify the cables or subject the cable to external stress or damage. Avoid placing anything heavy, including the detector, on the cable, stepping on the cable, pulling the cable, or subjecting the cable to excessive bending or bundling. Ignoring this warning may cause cable failure resulting in electrical shock, which may result in severe personal injury, death, or substantial product damage.WARNING Do not turn ON the power supply or X-ray detector when condensation is on the X-ray detector or any of its components or accessories. Ignoring this warning may cause electrical shock, which may result in severe personal injury, death, or substantial product damage. WARNING To avoid risk of electric shock, this equipment must only be connected to a supply mains with protective earth.
DIGITAL IMAGINGvi www.perkinelmer.com 68153 01For Your Safety XRpad2 4336HandlingWARNING Never disassemble, modify, or alter the X-ray detector, its components, Lithium Battery Pack battery, battery charger, or accessories. Ignoring this warning may cause electrical shock and/or unknown hazards, which may result in severe personal injury, death, or substantial product damage.WARNING Do not touch the interface and power unit or cable and the patient at the same time. Do not let the patient touch the interface and power unit or cable. Ignoring this warning may cause electrical shock and/or unknown hazards, which may result in severe personal injury, death, or substantial product damage.Caution Place the X-ray detector horizontally on a flat, stable surface. If the X-ray detector is placed vertically or in any tilted position, the X-ray detector must be securely placed in the Bucky tray or securely fastened to the X-ray detector enclosure or support structure. Ignoring this caution may result in personal injury or damage to the product.Caution Do not exceed the maximum uniform load weight of 150 kg distributed across the surface of the X-ray detector.Caution Do not exceed the maximum load weight of 100 kg distributed on an area of 40 mm in a diameter of the X-ray detector surface.Caution Do not drop the X-ray detector. If the X-ray detector is dropped, remove the X-ray detector from service, and immediately ask your establishment’s safety representative to verify or re-validate the proper function of the X-ray detector prior to resuming use of the detector. Further use under abnormal conditions may result in severe personal injury, death, or substantial product damage.
DIGITAL IMAGING68153 01 www.perkinelmer.com viiXRpad2 4336 For Your SafetyBatteryWARNING Do not use the XRpad2 LBP (battery) if the casing is broken or if it emits an unusual odor, smoke, or excessive heat, or if it leaks any substance. Avoid contact with any substance seeping from the battery pack. If any fluid touches your skin or eyes, wash the affected area with clean, running water and immediately seek medical attention.WARNING The cells within the battery contain toxic substances. Do not attempt to open the battery. Do not insert any object into the battery pack or use any device to pry at the battery pack casing. Attempting to open the battery casing will damage the casing, which could cause the battery to release toxic and harmful substances causing injuries such as electric shock or burns, or cause a fire, and will render the pack unusable.WARNING Observe and follow all safety information in this manual and on the warning label found on the battery. Ignoring a warning may result in personal injury or damage to the product.WARNING Use only charging devices approved by device manufacturer, and never attempt to bypass or override their charging protection circuits.WARNING Keep out of reach of children.WARNING Remove the battery if the X-ray detector is not likely to be used for some time.WARNING Do not submerge the battery in water or other liquid.WARNING Do not charge the battery near flammable materials.WARNING Do not connect the battery to an electrical outlet directly, or to any other electrical source not described in the manual.
DIGITAL IMAGINGviii www.perkinelmer.com 68153 01For Your Safety XRpad2 4336WLANWARNING Do not drop or hit the battery against hard objects since this may cause damage to the battery and risk release of the battery toxic and harmful substances, causing injuries such as electric shock or burns or causing a fire, and will render the battery unusable.WARNING Do not use the battery charger in the patient environment.Caution There is a risk of explosion, personal injury, or damage to product if the battery is replaced by non-OEM approved components.WARNING Do not obstruct the detector antenna. If it is obstructed by metal, wood, or a human body, the wireless communication can be slowed down or disconnected.WARNING Follow the laws and regulations for each country, and select the regional code accordingly. WARNING Do not use the detector in aircraft because there is a potential affect to aviation systems.Caution Use WLAN access point devices to get the best communication performance.Caution The electromagnetic emission of the detector may influence implantable medical devices like pacemakers. Check the information for these devices.WARNING Do not modify or alter the detector as this can violate the certification of the Radio Law.
DIGITAL IMAGING68153 01 www.perkinelmer.com ixXRpad2 4336 For Your SafetyAutomatic Exposure Detection (AED) ModeIf a Problem OccursWARNING The AED mode requires a sufficient X-ray dose rate to the detector surface. The required dose rate can vary between X-Ray tube, generator, and X-ray voltage. The system integrator must evaluate the AED operation with the complete X-ray setup in order to secure a proper image acquisition in AED mode.WARNING The external sync mode is the default acquisition mode, and the detector needs to switch into the AED mode to use the Auto Exposure detection. It is important that a settling time for the AED is implemented by the system integrator. If the settling time is too short, the image can show artifacts.WARNING The AED on-time is limited and must be turned off directly after acquiring the image. Staying longer in AED mode will reduce the battery duty cycle and heat up the detector.WARNING Do not apply any, handling, loading, mechanical shock, or electronic noise to the detector while it is in AED mode. These actions can start an unwanted acquisition (false trigger). If a false trigger is applied to the detector, the detector will not be able to react on a real X-ray exposure until it has acquired the false trigger image. WARNING If any abnormal condition, such as smoke, fumes, or strange sounds, is evident, turn off the X-ray detector, turn off and unplug the power supply from the AC outlet, and immediately ask your establishment’s safety representative to contact your dealer, distributor, or device manufacturer. Further use under abnormal conditions may result in severe personal injury, death, or substantial product damage.WARNING When liquid has been spilled into or on any part of the X-ray detector or power supply (if applicable), or when the X-ray detector, its component, or accessory is dropped, unplug the power supply from the AC outlet, and immediately ask your establishment’s safety representative to contact your dealer, distributor, or device manufacturer. Further use under abnormal conditions may result in severe personal injury, death, or substantial product damage.
DIGITAL IMAGINGx www.perkinelmer.com 68153 01For Your Safety XRpad2 4336Maintenance and InspectionWARNING Turn off the power of the X-ray detector when the inspections indicated in this manual are going to be performed. Ignoring this warning may result in electric shock, which may result in severe personal injury, death, or substantial product damage.WARNING When the X-ray detector system is going to be cleaned, turn off the X-ray detector and remove the battery. If the X-ray detector is connected to a power supply, turn off the power switch and/or unplug the power supply cable from the AC outlet. If the X-ray detector is battery powered, remove the battery. Never use thinner, benzine, acetone, or other flammable cleaning agents. Ignoring this warning may result in explosion, fire, or electric shock, which may result in severe personal injury, death, or substantial product damage.WARNING The X-ray detector must be repaired by X-ray detector manufacturer-authorized personnel only. Ignoring this warning may result in explosion, fire, electric shock, or unknown hazards, which may result in severe personal injury, death, or substantial product damage.Caution Follow the manufacturer’s recommendations for inspecting the X-ray detector before use.
DIGITAL IMAGING68153 01 www.perkinelmer.com xiTable of Contents1.0 Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12.0 Usage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13.0 Audience. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14.0 Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25.0 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36.0 Definition of Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37.0 Standards and Regulations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58.0 Description of the X-ray Detector. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68.1 Overview of the X-ray Detector. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68.2 Environmental Considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88.3 X-ray Detector Specification. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98.4 X-ray Detector Dimensions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108.5 X-ray Detector Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118.5.1 Rechargeable Lithium Battery Pack (XRpad2 LBP) . . . . . . . . . . . . . . . . . 138.5.2 XRpad IPU-2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 188.6 Minimum System Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 218.7 Operating the X-ray Detector. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 228.7.1 Wired X-ray Detector Connection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 238.7.2 Wireless X-ray Detector Connection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 248.7.3 Before Using the X-ray Detector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 258.7.4 Powering On the X-ray Detector. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 268.7.5 Powering Off the X-ray Detector. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 278.7.6 General Workflow for Acquiring an Image. . . . . . . . . . . . . . . . . . . . . . . . 279.0 Inspection and Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 299.1 Daily Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 299.1.1 Before Turning On the Power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 299.1.2 After Turning On the Power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 319.1.3 After Turning Off the Power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 319.2 Monthly Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 329.3 Yearly Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 329.4 Calibrating the X-ray Detector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
DIGITAL IMAGINGxii www.perkinelmer.com 68153 01 Table of Contents XRpad2 43369.5 Cleaning the X-ray Detector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 339.6 Error Messages and Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3410.0 After-Sales Service for PerkinElmer Products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3411.0 Disposing of the X-ray Detector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3512.0 Declarations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3612.1 Guidance and Manufacturer’s Declaration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3612.2 Declaration of Conformity for European Union (and EEA) . . . . . . . . . . . . . . . . . . 4012.3 Federal Communication Commission Interference Statement (US) . . . . . . . . . . . 4212.4 Industry Canada Statement (English) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4312.5 Industrie Canada – Déclaration (Français) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4412.6 Korean. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
DIGITAL IMAGING68153 01 www.perkinelmer.com xiiiList of FiguresFigure 1 X-ray Detector (Front View) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6Figure 2 Dimensions for the X-ray Detector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10Figure 3 Patient Vicinity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12Figure 4 XRpad2 LBP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13Figure 5 Removing the XRpad2 LBP. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16Figure 6 XRpad IPU-2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18Figure 7 Wired Connection of the X-ray Detector. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23Figure 8 Wireless Connection of the X-ray Detector (Station/Client Mode) . . . . . . . . . . . . 24Figure 9 Wireless Connection of the X-ray Detector (WAP Mode) . . . . . . . . . . . . . . . . . . . . 25Figure 10 Workflow for Acquiring an Image . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
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DIGITAL IMAGING68153 01 www.perkinelmer.com xvList of TablesTable 1 Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2Table 2 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3Table 3 Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3Table 4 Standards and Regulations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5Table 5 Overview of the X-ray Detector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6Table 6 Environmental Considerations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8Table 7 X-ray Detector Specification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9Table 8 Accessories for the X-ray Detector. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11Table 9 Specification of the XRpad2 LBP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14Table 10 Overview of the XRpad IPU-2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19Table 11 Specification of the XRpad IPU-2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20Table 12 Guidance and Manufacturer’s Declaration of Electromagnetic Emissions . . . . . . 36Table 13 Guidance and Manufacturer’s Declaration of Electromagnetic Immunity . . . . . . 37Table 14 Recommended Separation Distance between Portable and Mobile RF-Communication Equipment and the X-ray Detector . . . . . . . . . . . . . . . . . . . . . 38Table 15 Guidance and Manufacturer’s Declaration of Electromagnetic Immunity (Portable Equipment). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
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68153 01 www.perkinelmer.com 1DIGITAL IMAGING1.0 ScopeThis document describes design elements and respective interfaces for the XRpad2 4336 detector. Applicable mechanical, electronic, and software interfaces are addressed. PerkinElmer digital X-ray Flat Panel Detectors and their accessories are components designed to be integrated into products by X-ray system manufacturers. Manufacturers are responsible for qualifying, validat-ing, and certifying their products for their intended uses and meeting all applicable regulatory requirements. Final application and intended use is based on the completed X-ray system design. It is the responsibility of the X-ray system manufacturer to confirm the efficacy and compliance of the X-ray system for its intended use, inclusive of the detector. The Digital Radiography Software referred to in this manual is medical imaging software for radiography, which is typically supplied by the X-ray system manufacturer or third-party provider and is not part of the XRpad2 4336 detector.2.0 UsageThe XRpad2 4336 detector is a component of a digital imaging system used for generating radiographic images of human anatomy for diagnostic X-ray procedures, wherever conventional Screen-Film (SF), Digital Radiography (DR), or Computed Radiography (CR) systems may be used. 3.0 AudienceThis document is for users of the X-ray detector and for X-ray system manufacturers and X-ray system installers who are responsible for installing the X-ray detector into an X-ray system.
XRpad2 4336268153 01DIGITAL IMAGING4.0 AbbreviationsTable 1 includes a list of abbreviations used in this manual and a description of each abbreviation.Table 1 AbbreviationsAbbreviation DescriptionAED Automatic Exposure DetectionAP Access PointCR Computed RadiographyDFS Dynamic Frequency SelectionDR Digital RadiographyESS Extended Service SetFoV Field of Viewfps Frames per secondGigE Gigabit EthernetI/F InterfaceIP Internet ProtocolIPU Interface and Power UnitLAN Local Area NetworkLBC Lithium Battery ChargerLBP Lithium Battery PackLED Light Emitting DiodeMDD Medical Device DirectiveOEM Original Equipment ManufacturerREF Radiated Electromagnetic FieldRx Caution: Federal law restricts this device to sale by or on the order of a licensed healthcare practitionerSELV Separated or Safety Extra-Low VoltageSF Screen FilmWAP Wireless Access PointWEEE Waste Electrical and Electronic EquipmentWi-Fi Wireless FidelityWLAN Wireless Local Area Network
68153 01 www.perkinelmer.com 3XRpad2 4336DIGITAL IMAGING5.0 ReferencesTable 2 includes a list of documents referred to in this manual. For access to the following references, contact your establishment’s representative or your dealer, distributor, or device manufacturer. 6.0 Definition of SymbolsTable 3 includes a list of symbols and a description of each symbol.Table 2 ReferencesDocument Name Document #1XRpad LBC Charger for Rechargeable Lithium-Ion Battery Pack487732XRpad LBP Rechargeable Lithium-Ion Battery Pack487723XRpad2 4336 Digital X-ray Detector System Reference Manual696524Digital Radiography Software Manual Supplied by X-ray system manufacturer or third-party provider5 Digital Radiography Software Supplied by X-ray system manufacturer or third-party provider6Access Point Manual Supplied by the Access Point Manufacturer or third-party providerTable 3 SymbolsSymbol DescriptionThis Way Up.Handle with Care.pKeep Dry.Reusable.Disposal (WEEE).Follow all local and regional disposal requirements.Refer to instruction manual/booklet.MManufacturer‘s name and address.NDate of Manufacture, YYYY-MM, YYYY=Year, MM=Month.hREF = Reference Number.PerkinElmer Catalog Number, Part Number, or Material Number.
XRpad2 4336468153 01DIGITAL IMAGINGSymbol DescriptionfSerial Number.~AC Input.D.C. Voltage.Temperature Limitation.Relative Humidity Limitation.Potential Equalization.Functional Earth Connection.Protection Class I.Protection Class II.Non-Ionizing Radiation.Battery charge condition.•Battery Charged (> 75%).•Battery ¾ (≤75%).•Battery Half (≤50%).•Battery Low (≤25%).•Battery Empty (≤10%).•No Battery. / Wireless Connectivity/No Wireless Connectivity. / LAN Connection/Missing LAN Connection.Access PointTrigger Connection.Push Button.Power Switch.Do not crush.Do not expose to fire.Table 3 Symbols (Continued)
68153 01 www.perkinelmer.com 5XRpad2 4336DIGITAL IMAGING7.0 Standards and RegulationsThe X-ray detector is designed to be compliant with the standards and/or regulations detailed in Table 4. The manufacturer’s certifications to standards and regulations are valid only if the original accessories (as listed in Table 8) are used according to prescribed instructions. Product certification and warranty are rendered void if any modification or alteration to the product is made, or any instruction, warning, or caution is not followed.Symbol DescriptionKeep away from children.Maximum Load.UL Recognized component mark for US and Canada. European Conformity markings for the product.Table 4 Standards and RegulationsStandards and Regulations DescriptionANSI/AAMI Std ES60601-1:2005 Medical electrical equipment Part 1: General Requirements for Basic Safety and Essential PerformanceEN IEC 60601-1:2006/AC:2010 General Requirements for Basic Safety for Medical Electrical EquipmentEN IEC 60601-1-2:2007 Medical Electrical Equipment, Part 1-2: General Requirements for Safety and Essential Performance – Collateral Standard: Electromagnetic CompatibilityCAN CSA C22.2 No 60601-1 08 Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Essential PerformanceFCC Part 15 subpart B/E Radio Frequency ExposureETSI EN 301 893 V.1.7.1 (2012) Broadband Radio Access Networks (BRAN); 5 GHz high performance RLANETSI EN 301 489-1 V1.9.2 (2011) Electromagnetic Compatibility and Radio spectrum Matters (ERM); Electromagnetic Compatibility (EMC) standard for radio equipment and services; Part 1: Common technical requirementsETSI EN 301 489-17 V2.2.1 (2012) Electromagnetic Compatibility and Radio spectrum Matters (ERM); Electromagnetic Compatibility (EMC) standard for radio equipment and services; Part 17: Specific conditions for 2.4 GHz wideband transmission systems and 5 GHz high performance RLAN equipment”EN ISO 10993-5:2009 Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicityTable 3 Symbols (Continued)
XRpad2 4336668153 01DIGITAL IMAGING8.0 Description of the X-ray Detector8.1 Overview of the X-ray DetectorThe XRpad2 4336 is a wireless, light weight, cassette-sized flat panel detector for digital radiography. It fits into a conventional table or wall-stand Bucky, just like a film-screen cassette. Figure 1 shows the front view of the X-ray detector, and Table 5 includes a brief description of each feature. Figure 1 X-ray Detector (Front View)Standards and Regulations DescriptionEN ISO 10993-10-2010-2013 Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitizationEN ISO 4090:2004 Photography – Medical Radiographic Cassettes/Screens/Films and Hard-Copy Imaging Films – Dimensions and SpecificationsEN 60529:1991 + A1:2000 Degrees of Protection Provided by Enclosures (IP-code)Table 5 Overview of the X-ray Detector1 Active Area with Markers: 1a) Top and 1b) Bottom Side of the Image2 Antenna. Make sure that they are not obstructed3 Power and communication tethered connectorTable 4 Standards and Regulations (Continued)1a23452621b
68153 01 www.perkinelmer.com 7XRpad2 4336DIGITAL IMAGING4DisplayBattery charge condition•Battery Charged (> 75%)•Battery ¾ (≤75%)•Battery Half (≤50%)•Battery Low (≤25%)•Battery Empty (≤10%)•No BatteryWireless Connectivity/No Wireless Connectivity / Access PointLAN Connection/No LAN Connection / 5 Push Button with a LED ☼ (blue light)Short press and LED OFF Power ON and LED flashes Short press and LED ON or flashes Switch On of the displayLong Press (4s) and LED ON or flashes Power OFFLED Status (blue light)LED OFF Detector is not poweredLED flashing (first instance) Detector is initializingLED flashing (second instance) Detector is ReadyLED ON Detector is not connected to the software6 Battery InsertTable 5 Overview of the X-ray Detector (Continued)
XRpad2 4336868153 01DIGITAL IMAGING8.2 Environmental ConsiderationsTable 6 includes a list of environmental considerations for the transport, storage, and operation of the X-ray detector.WARNING Storage or use of the X-ray detector and power supply in environmental conditions outside the specification may cause fire, electrical shock, and unknown hazards, which may result in severe personal injury, death, or substantial product damage or reduced product lifetime.Table 6 Environmental ConsiderationsEnvironment Transportation/Storageaa. In original transport container for 365 days.OperationAmbient Temperatureb (30d/365d)b. Temp. Gradient: max 4.5 K/hour.–10°C to 55°C/0°C to 55°C 10°C to 35°CRelative Humidity 5% to 90% 10% to 85%Atmospheric Pressure 520 hPa to 1070 hPa 690 hPa to 1070 hPaVibrationc (EN60068-2-64)c. Image quality cannot be guaranteed during shock or vibrations.5 m2/s3 (10 Hz to 100 Hz)1 m2/s3 (100 Hz to 2000 Hz)0.5 m2/s3 (10 Hz to 100 Hz)0.1 m2/s3 (100 Hz to 2000 Hz)Shockc (EN 60068-2-27) 25 g (duration 6 ms) 2 g (duration 6 ms)Ingress protection rating IPx4 rated (protection against splashing water)
68153 01 www.perkinelmer.com 9XRpad2 4336DIGITAL IMAGING8.3 X-ray Detector SpecificationTable 7 includes the specification for the X-ray detector.Table 7 X-ray Detector SpecificationSensorPanel Single substrate amorphous silicon active TFT/diode arrayScintillator Direct deposition CsI:TlPixel Matrix 3524 x 4288Pixel Pitch 100 μmElectronicsAmplifiers Low noise ASICs with user selectable gainsADC 16-bitImage Transfer Time Wired: 500 ms; Wireless: 3000 msOn-board Memory 1 GB DDR3, 4 GB SDHC cardMechanicalSize ISO 4090 for 35 cm × 43 cm (14” × 17”) cassette sizeActive Area 352.4mm x 428.8 mmExternal Dimensions 384 mm (w) × 460 mm (l) × 15 mm (h)Weight 3.1 kgHousing Aluminum frame with carbon-fiber entrance windowCommunicationStatus Display OLED display with Wi-Fi, LAN, battery, and sensor indicatorsWireless Data I/F 802.11n Wi-Fi standard @ 5 GHzChannel: WAP: 36-48, 149-165Stationary: 36-48, 149-165Stationary DFS:a52-64, 100-116, 132-140a. Country-dependent.Wired Data I/F GigE via optional power and communication tetherX-ray I/F Integrated X-ray trigger controlAutomatic Exposure DetectionImage PerformanceLimiting Resolution 5 cy/mmTypical MTF 70% (1 cy/mm), 40% (2 cy/mm), 15% (4 cy/mm) for RQA5Typical DQE 75% (0 cy/mm), 60% (1 cy/mm), 40% (3 cy/mm) for RQA5
XRpad2 433610 68153 01DIGITAL IMAGING8.4 X-ray Detector DimensionsFigure 2 shows the dimensions for the X-ray detector.Figure 2 Dimensions for the X-ray Detector00460383,615,541,8341,8219,961,95116,25230383,5
68153 01 www.perkinelmer.com 11XRpad2 4336DIGITAL IMAGING8.5 X-ray Detector AccessoriesThe X-ray detector shall only be used with its approved OEM Lithium Battery Pack XRpad2 LBP, cables, and connectors. Product certification and warranty are rendered void if any modification or alteration to the product is made, or any instruction, warning, or caution is not followed. It is important that the X-ray detector is not directly connected to the clinical network. Connection of the X-ray detector directly with the clinical computer network may disturb the IT environment. The imaging workstation and the Wi-Fi access point must comply with IEC 60601-1 and/or IEC 60950-1, depending on the usage and application.Table 8 includes a list of accessories for the X-ray detector.Table 8 Accessories for the X-ray DetectorPerkinElmer Article No. Description95510949H-01 XRpad2 LBP (Lithium Battery Pack)95510921H XRpad LBC (Lithium Battery Charger)95510928H XRpad IPU-2 (Interface Power Unit)95510970H XRpad2 LPT Detector Cable95510590H XRpad2 Protective Insert95510246H AC Cable IEC 60320 C13 DE95510249H AC Cable IEC 60320 C13 US95510256H Trigger Cable 5 m/16.5 ft95510257H Trigger Cable 20 m/65.5 ft95510621H XRD GigE Interface Cable 7.6 m/25 ft95510622H XRD GigE Interface Cable 15.25 m/50 ft95510623H XRD GigE Interface Cable 30.5 m/100 ft
XRpad2 433612 68153 01DIGITAL IMAGINGDo not use any non-medical equipment in the patient vicinity, as shown in Figure 3.Figure 3 Patient VicinityWARNING Connection of the X-ray detector directly to the clinical computer network may disturb the IT environment.WARNING Do not use any non-medical equipment, such as the Battery Charger or Wi-Fi access point, in the patient environment. 1.5m1.5m2.5m1.5m1.5m
68153 01 www.perkinelmer.com 13XRpad2 4336DIGITAL IMAGING8.5.1 Rechargeable Lithium Battery Pack (XRpad2 LBP)Figure 4 shows the XRpad2 LBP.Figure 4 XRpad2 LBPWARNING Storage or use of the Lithium Battery Pack environmental conditions outside the specification may cause fire, electrical shock, and unknown hazards, which may result in severe personal injury, death, or substantial product damage or reduced product lifetime.
XRpad2 433614 68153 01DIGITAL IMAGINGTable 9 includes the specification for the XRpad2 LBP. 8.5.1.1 Charging the XRpad2 LBP •A new rechargeable Lithium Battery Pack (XRpad2 LBP) comes in a discharged condition and must be charged using the dedicated lithium battery charger (XRpad LBC) before use. Refer to the XRpad LBC manual for more details.•The XRpad LBC will charge the XRpad2 LBP to a usable condition within three hours depending on the initial state of charge. The X-ray a detector, when connected to the XRpad Interface and Power Unit (XRpad IPU-2), can also charge the XRpad2 LBP, but the charge rate is much slower.•A charged battery will eventually lose its charge if unused. Upon initial use (or after a prolonged storage period), the battery may require three to four charge/discharge cycles before achieving maximum capacity.•The actual battery run-time will depend on the power demands made by the X-ray detector.•The XRpad2 LBP is keyed and can only be inserted into the XRpad LBC charger in one orientation.Table 9 Specification of the XRpad2 LBPGeneralREF 95510949H-01Voltage 11.1VAmp-hours 4.2AhCapacity 46.6WhCharging Time Within 3 hoursEnvironmentalRelative Humidity 35% to ~85%Operating (discharging) -10°C to 55°CCharging 0°C to 42°CTransportation -20°C to 45°CStorage (up to 3 months) 15°C to 35°CIngressIngress Protection Rating IP54LifetimeCharge-discharge Cycles 500 cycles on average under normal usage conditions.Battery should be discarded on or before five years from date of manufacture indicated on the battery label.
68153 01 www.perkinelmer.com 15XRpad2 4336DIGITAL IMAGING•Check to ensure the XRpad2 LBP is clean, dry, and free of foreign contamination or debris. If cleaning is necessary, see “Section 8.5.1.6, Cleaning the XRpad2 LBP” on page 17 for cleaning instructions.•Ensure the XRpad LBC charger is powered on.•Orient the XRpad2 LBP to match the orientation of the XRpad LBC Charger, and insert the XRpad2 LBP firmly into the XRpad LBC charger. Keep the XRpad LBP in the XRpad LBC charger until all the four charge status LEDs maintains a solid green, indicating a full charge. To remove, lift the battery out of the XRpad LBC charger.8.5.1.2 Installing the XRpad2 LBPWhen installing the XRpad2 LBP in the X-ray detector in place of the XRpad2 Protective Insert, or to change a used XRpad2 LBP, remove the XRpad Protective Insert or used XRpad2 LBP before installing the new XRpad2 LBP (see “Section 8.5.1.3, Removing the XRpad2 LBP” on page 16).To install the XRpad2 LBP:1Fully support the X-ray detector to prevent it from dropping or slipping.2Check to ensure the battery compartment of the X-ray detector is clean, dry, and free of foreign contamination or debris. If cleaning is necessary, see “Section 8.5.1.6, Cleaning the XRpad2 LBP” on page 17 for cleaning instructions.3Check to ensure the XRpad2 LBP is clean, dry, and free of foreign contamination or debris. If cleaning is necessary, refer to “Section 8.5.1.6, Cleaning the XRpad2 LBP” on page 17 for cleaning instructions.4The XRpad2 LBP is keyed and can only be inserted into the XRpad2 4336 detector in one ori-entation. Align the orientation of the XRpad2 LBP to match the orientation required on the X-ray detector.5Insert the charged XRpad2 LBP into the X-ray detector in the corresponding orientation, and gently press on the end cap until the latches secure the XRpad2 LBP inside the detector.WARNING Do not drop or hit the XRpad2 LBP against hard objects as this may cause a risk of damage to the XRpad2 LBP, which may result in exposure to the corrosive cell contents, fire, or explosion.WARNING There is risk of explosion, personal injury, or damage to the product if the Battery XRpad2 LBP is replaced by a non-OEM approved component.
XRpad2 433616 68153 01DIGITAL IMAGING6Push the Power button on the X-ray detector to power on.7Check the battery charge status on the X-ray detector. If the battery charge status shows sufficient battery charge is present, the X-ray detector is ready for use. If the battery charge status shows lower than desired battery charge level, replace the battery with a charged battery.8.5.1.3 Removing the XRpad2 LBPTo remove the XRpad2 LBP:1Fully support the X-ray detector and XRpad2 LBP before performing this task to prevent them from dropping or slipping.2Power off the X-ray detector by pressing the Power button on the X-ray detector.3Move the two sliding latches closer to the center to disengage the XRpad2 LBP from the X-ray detector (see Figure 5). Remove the XRpad2 LBP from the battery compartment of the X-ray detector using a slow and steady pulling motion, supporting both the X-ray detector and the XRpad2 LBP.4Store the XRpad2 LBP in a cool, dry, clean environment if not in use or when recharging the XRpad2 LBP for the next use.Figure 5 Removing the XRpad2 LBP8.5.1.4 Transportation and StorageWhen transporting and storing the XRpad2 LBP:•Follow all local, state, and federal/national regulations for handling, packaging, labeling, and transporting Lithium-Ion batteries.•Before transporting the battery, inspect it to confirm that there is no damage or leakage from the battery.•When possible, transport the battery in a discharged state.•Transport the battery in approved packaging only. Retain the original packaging, inclusive of the Safety Data Sheet (SDS), for transporting the battery.•Store the battery in a cool, dry, clean environment if not in use. Do not remove the battery from its original packaging until required for use.Caution Dispose of a used XRpad2 LBP according to the instructions in “Section 11.0, Disposing of the X-ray Detector” on page 35.
68153 01 www.perkinelmer.com 17XRpad2 4336DIGITAL IMAGING•Store within approved temperatures: -20°C to 45°C for short periods (less than one month). Recommended storage conditions are 15°C to 35°C, 85% RH Max.•Do not leave or store the battery in extremely hot or cold temperatures (for example, in direct sunlight, cars, or car trunks). The battery may overheat causing fire, or performance life will be shortened.•Do not short-circuit the battery or store the battery without sufficient packaging in a location where it may short-circuited. This may cause a risk of fire, an explosion, or a severe burn hazard.8.5.1.5 Maintaining the XRpad2 LBPTo maintain the XRpad2 LBP:•Before inserting the XRpad2 LBP into the X-ray detector or XRpad LBC, inspect the XRpad2 LBP for signs of damage, defects, or abnormalities. Do not use damaged, defective, or abnormal conditioned XRpad2 LBP.•Check to ensure the XRpad2 LBP is clean, dry, and free of foreign contamination or debris. If cleaning is necessary, see “Section 8.5.1.6, Cleaning the XRpad2 LBP” on page 17 for cleaning instructions.•The XRpad2 LBP has no repairable parts. Do not disassemble. No modification of this product is allowed.•If the XRpad2 LBP emits an odor or generates heat or in any way appears abnormal during use, recharging, or storing, immediately remove it from the device or battery charger, and stop using the XRpad2 LBP.•Using a damaged or defective XRpad2 LBP may reduce function time or cause the X-ray detector system to fail.•If an XRpad2 LBP leaks, do not touch the leaking fluid. If the fluid touches your skin or eyes, wash the affected area with clean, running water and immediately seek medical attention.•If the XRpad2 LBP has not been used or charged for an extended period of time (approximately 30 days), check the condition of the XRpad2 LBP, and recharge if necessary before using.8.5.1.6 Cleaning the XRpad2 LBPTo clean the XRpad2 LBP:•Avoid exposure of the XRpad2 LBP to liquids and solvents when possible.•Do not allow liquids or solvents to contact the electrical contacts on the XRpad LBP.•When necessary, clean the XRpad2 LBP using a lightly moistened cloth with 70% isopropyl alcohol or 3% hydrogen peroxide.•Never use thinner, benzene, acetone, or any other corrosive or flammable cleaning agents.•Ensure the XRpad2 LBP is completely clean and dry before storing inserting the XRpad2 LBP into the X-ray detector, or inserting the XRpad2 LBP into the XRpad LBC.
XRpad2 433618 68153 01DIGITAL IMAGING8.5.1.7 Disposing of the XRpad2 LBPTo dispose of the XRpad2 LBP:•The XRpad2 LBP shall not be disposed with other waste at the end of its working life.•Recycle or dispose the battery in accordance with local, state, and federal/national laws and environmental regulations.•Do not place the battery in fire or incinerate.•For transporting, follow the requirements in “Section 8.5.1.4, Transportation and Storage” on page 16.8.5.2 XRpad IPU-2The XRpad IPU-2 is an Interface and Power Unit. The XRpad IPU-2 combines the Power Supply Unit with additional communication and trigger interfaces. The tethered power and communica-tion cable is connected to the X-ray detector. The communication data are split inside the XRpad IPU-2 into Gigabit Ethernet Interface, Detector Trigger Interface, Hand Switch and Generator Interface, and Detector Push Button Interface. The Gigabit Ethernet Interface of the XRpad IPU-2 is connected to the Imaging Workstation using a Cat 5e/6 cable. The maximum cable length is 31m. The AC cable must be connected to a properly grounded receptacle. The AC cable is remov-able and will be plugged to an IEC connector. The XRpad IPU-2 must be connected with a ground by the functional ground connector (Figure 6 [13]) or with the potential of the hospital by the potential equalization connector (Figure 6 [12]). The socket outlet shall be near the XRpad IPU-2 and shall be easily accessible. To isolate the equipment electrically from supply main on all poles simultaneously, the supply main switch (Figure 6 [1]) must be used.Figure 6 XRpad IPU-2WARNING Connecting the XRpad IPU-2 LAN port directly to the clinical computer network may disturb the IT environment.Front Panel Rear Panel123 45678910111213 14 15 16 17 18
68153 01 www.perkinelmer.com 19XRpad2 4336DIGITAL IMAGINGTable 10 includes an overview of the XRpad IPU-2. I Table 10 Overview of the XRpad IPU-21XRpad Push Button ( )2 DC Output LED (Yellow) ( )LED Yellow DC Output OK, no output loadLED Green DC Output OK, output loaded3 Status LED (Yellow) ( )LED Yellow N/ALED Green N/A4 XRpad Interface and Power I/O (1)5 Trigger Out Signal to Generator6 Trigger In Signal from Hand Switch (Prep/Expose)7Trigger In/Out I/F8 XRpad Interface and Power I/O9TRIG IN Signal10 TRIG OUT Signal11 LAN Port to Imaging Workstation12 USB Connector13 Remote Detector Power14 Potential Equalization Connector15 Functional Ground Connector16 Power In17 AC Input LED (Green) ( )18 XRpad IPU-2 Power Switch
XRpad2 433620 68153 01DIGITAL IMAGINGTable 11 includes the specification for the XRpad IPU-2.Table 11 Specification of the XRpad IPU-2Electrical SpecificationAC Input Voltage [16] 100 V … 240 VAC Frequency [16] 50 Hz/60 HzDC Output [8] 12.5 V/5 A, 15 V/1 A (voltage level is dependent of load)Trigger In Signal from Hand Switch [6] 5 V … 24 V/10 mA (SELV)Trigger Out Signal to Generator [5] Same level as Trigger In SignalTrigger In Signal [7, 9] 3.3 V … 5 V (SELV)Trigger Out Signal [7, 10] 3.3 VDC Output 5PF [7] 5 V/100 mAMechanical SpecificationSize 260 mm (L) × 205 mm (W) × 50 mm (H)Temperature RangesOperating 10°C to 35°CTransportation/Storage –10°C to 70°CRelative HumidityOperating 10% to 90%Transportation/Storage 0% to 90%Ingress Protection RatingIP40 rated (protection against particles > 1 mm)WARNING All external signals that are connected to the IPU-2 (especially PREP/EXPOSE and Trigger signals) should be from a Separated or Safety Extra-Low Voltage (SELV) circuit. Ignoring this warning may result in electric shock, which may result in severe personal injury, death, or substantial product damage.
68153 01 www.perkinelmer.com 21XRpad2 4336DIGITAL IMAGING8.5.2.1 Cleaning the XRpad IPU-2If the XRpad IPU-2 (Interface and Power Unit) surface is dirty or dusty, clean it with a cleaning cloth dampened with ethanol or a diluted neutral detergent. If you are using a disinfectant other than those specified, we recommend you consult a specialist for the procedure for disinfection. Turn off the XRpad IPU-2, and disconnect the AC power cable, detector power, and detector communication tethered cables before cleaning.8.6 Minimum System RequirementsThe following are the minimum requirements for the host computer that controls the X-ray detector.1Gigabit Ethernet Infrastructure and a free Gigabit Ethernet Port or Wi-Fi Infrastructure.2Intel compatible Multi Core Processor (> 2 GHz).3RAM > 4 GB.4Windows 7 (32-bit/64-bit).5If a Firewall is used, make sure that it allows a connection to the detector.6Access Point:aWPA2 encryption support.b802.11n standard with 20 MHz channel bandwidth 36-48, 52-64, 100-116, 132-140, 149-165.cMIMO 3x3.dComplying with IEC 60601-1 or IEC 60950-1.WARNING When the Interface Power Unit is going to be cleaned, be sure to turn off the XRpad IPU-2 (Interface and Power Unit), and unplug all cables. Never use thinner, benzine, acetone, or other flammable cleaning agents. Ignoring this warning may result in explosion, fire, or electric shock, which may result in severe personal injury, death, or substantial product damage.
XRpad2 433622 68153 01DIGITAL IMAGING8.7 Operating the X-ray DetectorBefore connecting the X-ray detector, ensure that the Digital Radiography Software is installed as described in its manual. If not, install the software first. The X-ray detector can be used in different configurations depending on the desired application. The following sections describe the different use cases.WARNING Do not exceed the maximum uniform load weight of 150 kg distributed across the surface of the X-ray detector.WARNING Do not exceed the maximum load weight of 100 kg distributed at one location in a 40mm diameter of the X-ray detector surface.Caution Check the threshold of the auto trigger mode regularly.Caution Do not acquire images and calibration files while handling the detector. This can disturb the image quality and result in the wrong diagnosis.
68153 01 www.perkinelmer.com 23XRpad2 4336DIGITAL IMAGING8.7.1 Wired X-ray Detector ConnectionFigure 7 shows the wired connection of the X-ray detector in a clinical environment. In the wired application, the X-ray detector is connected to the XRpad IPU-2, which powers the X-ray detector and is responsible for the data transfer. The AC outlet should be installed near the XRpad IPU-2 and should be easily accessible. Figure 7 Wired Connection of the X-ray DetectorThe XRpad IPU-2 may be mounted in an equipment enclosure if there is adequate ventilation within the equipment enclosure. The XRpad IPU-2 is connected to the Imaging Workstation using a Cat 5e/6 cable. Make sure that the XRpad IPU-2 is not connected directly with the clinical network. The Trigger I/F of the XRpad IPU-2 must be connected with the Generator and with the Hand switch if the detector is used in external trigger mode.The XRpad IPU-2 communicates using a standard Gigabit Ethernet network Interface and comes equipped with an RJ45 interface port. Due to the overall network traffic, it is recommended that you use this interface in a direct (Point-to-Point) connection with the host computer in order to achieve optimal speed performance. The XRpad IPU-2 should be connected to the host computer by one of the PerkinElmer XRD GigE Interface Cables or a CAT5e/CAT6 (shielded twisted pair, stranded, or solid copper conductor) cable. The cable length can be up to 31 m.PatientX-Ray SourceInterface Power UnitGeneratorXRpadHand SwitchXRpad LPT Detector CableImaging WorkstationCat 5e/6Operator RoomExposure RoomBattery PackBattery Charger
XRpad2 433624 68153 01DIGITAL IMAGING8.7.2 Wireless X-ray Detector ConnectionFigure 8 shows the wireless connection of the X-ray detector in a clinical environment. The X-ray detector is connected using WLAN over a Wi-Fi Access Point with the Imaging Workstation. The Wi-Fi Access Point may be wall or ceiling mounted to maximize wireless signal strength. Make sure that the router is not connected directly to the clinical network. The detector can also be connected directly to the Imaging Workstation using WLAN with the WAP mode of the detector (see Figure 9).Before imaging, make sure that the XRpad2 LBP charge is sufficient and the X-ray detector antenna is not obstructed. Figure 8 Wireless Connection of the X-ray Detector (Station/Client Mode)
68153 01 www.perkinelmer.com 25XRpad2 4336DIGITAL IMAGINGFigure 9 Wireless Connection of the X-ray Detector (WAP Mode)8.7.3 Before Using the X-ray DetectorSudden cooling or heating of the room will cause condensation. In this case, wait until condensation disappears before powering on the X-ray detector.WARNING If the X-ray detector system is used under conditions where condensation can occur, problems in image quality or malfunction of the detector system may occur. In addition, this may cause fire, electrical shock, and unknown hazards, which may result in severe personal injury, death, or substantial product damage.Caution The X-ray detector should only be used with an inserted XRpad2 LBP or XRpad2 Protective Insert.
XRpad2 433626 68153 01DIGITAL IMAGING8.7.4 Powering On the X-ray DetectorThis section describes how to power on the X-ray detector. For more information, refer to the Digital Radiography Software Manual. Ensure that the IP setting on your network adapter is set to static IP and correlates to the X-ray detector. The default settings of the X-ray detector are 192.168.2.158 for the LAN connection and 192.168.22.1 for the WLAN connection with the submask 255.255.255.0. The X-ray detector must have an XRpad2 Protective Insert or an XRpad2 LBP inserted into battery compartment.8.7.4.1 Wired ModeTo power on the X-ray detector in wired mode:1Plug in the power cord to the XRpad IPU-2, and switch the power on. The AC Input LED turns on (green), and the DC Output LED turns on (yellow). 2To power on the X-ray detector, press the X-ray detector Power push button on the XRpad IPU-2, or press the push button on the X-ray detector for one second. The DC Output LED turns from yellow to green, and the detector push button LED turns ON for a few seconds.During the initialization of the detector, the detector push button LED starts flashing. Once the X-ray detector is powered on, the X-ray detector display is on and shows the current status of the X-ray detector. The X-ray detector LED will turn from flashing to constant on. After the Radiography Imaging Software has initialized the detector, the X-ray detector LED starts flashing. 8.7.4.2 Wireless ModeTo power on the X-ray detector in wired mode:1When the detector is not connected to the XRpad IPU-2, check the status of the XRpad LBP to ensure the charge of the battery is more than 50%. If the status is low, exchange the XRpad2 LBP with a charged one, or use the wired operation mode. 2Press the X-ray detector’s push button for one second, and the X-ray detector will be powered on, which is shown by the detector’s push button LED. During the initialization of the detector, the detector push button LED starts flashing. Once the X-ray detector is powered on, the X-ray detector display is on and shows the current status of the X-ray detector including battery status. The X-ray detector LED will turn from flashing to constant on. After the Radiography Imaging Software has initialized the detector, the X-ray detector LED starts flashing.
68153 01 www.perkinelmer.com 27XRpad2 4336DIGITAL IMAGING8.7.5 Powering Off the X-ray DetectorThe X-ray detector is powered off by holding down one of the following three push buttons for more than four seconds:•X-ray detector (Figure 1 [5]) (wireless and wired mode).•XRpad IPU-2 push button (Figure 6 [5]) (wired mode).•Extended hand switch push button (wired mode)8.7.6 General Workflow for Acquiring an ImageFigure 10 shows the procedure for acquiring a clinical image after starting the Radiography Imaging Software. Details of the Radiography Imaging Software and the X-ray generator are described in their corresponding operation manuals.
XRpad2 433628 68153 01DIGITAL IMAGINGFigure 10 Workflow for Acquiring an ImageStartCommunicationModeAttachafullychargedbatterypacktothedetectorStarttheInterfacePowerUnit(IPU)TurnonthedetectorRegisterthedetectortotheRadiographyImagingSoftwareSelectorregisterthepatientinformationPreparetheexaminationsetup:x Arrangethepatientx PositiontheXͲraycollimatorx Checkallconditionsx StarttheSoftwarecapturingbuttonConducttheexamination:x PressthePrepswitchx PresstheExposureswitchCheckthecapturedimagesTurnoffthedetectorCommunicationModeRemovethebatterypackforrechargingSwitchofftheInterfacePowerUnit(IPU)EndWireless WiredWireless WiredLoopbackprocedureforeachbodypartLoopbackprocedureforeachpatient
68153 01 www.perkinelmer.com 29XRpad2 4336DIGITAL IMAGING9.0 Inspection and MaintenanceIt is important that the X-ray detector is used safely and as intended. Inspect the detector and its accessories before use. If any problem is found during the inspection, correct the problem, and take the measures indicated in this section. The X-ray detector and the Interface and Power Unit do not have any internal exchangeable parts. Only the accessories listed inTable 8 can be changed after consulting your with establishment’s safety representative. If the problem cannot be corrected, contact your dealer, distributor, device manufacturer, or any PerkinElmer subsid-iaries (regional service headquarters) listed on the last page of this document.We recommend that records of the inspection be kept close to the detector. You can use copies of the checklist in this section, or you can make your own copies of the checklist.9.1 Daily InspectionPerform the following inspection daily. If there is any problem, immediately ask your establish-ment’s safety representative to contact your dealer, distributor, or device manufacturer.9.1.1 Before Turning On the PowerWARNING The X-ray detector must be repaired by PerkinElmer authorized personnel only. Ignoring this warning may result in explosion, fire, electric shock, or unknown hazards, which may result in severe personal injury, death, or substantial product damage.Caution Inspect the X-ray detector before use. In addition, carry out prescribed, regular inspections per the instructions in this manual.InspectionResultRemedyDate/Date/Date/CablesCheck all cables, if applicable, (Power and communication tethered cord, DC-cable, Ethernet cable, Sync cable) to ensure that they are not damaged and the insulation is not damaged.Good/Bad Good/Bad Good/Bad Contact your dealer, distributor, or device manufacturer if there is a problem.Check all connector plugs and locks to ensure they are not loose.Good/Bad Good/Bad Good/Bad Fully insert the cables and lock them.
XRpad2 433630 68153 01DIGITAL IMAGINGInspectionResultRemedyDate/Date/Date/DetectorCheck that the detector is not damaged.Good/Bad Good/Bad Good/Bad Contact your dealer, distributor, or device manufacturer if there is a problem.Check the manufacturing date of the Battery Pack to ensure that its age is not five years or older.Good/Bad Good/Bad Good/Bad Replace the Battery Pack with a new one and recycle the old one.Check that the Battery Pack (wireless mode) or the Protective Insert (wired mode) is in the battery compartment and the sliding latches are closed.Good/Bad Good/Bad Good/Bad Slide the Battery Pack or the Protective Insert into the battery compartment as described in “Section 8.5.1.3, Removing the XRpad2 LBP” on page 16. Check that the Battery Pack is not damaged.Good/Bad Good/Bad Good/Bad Replace the Battery Pack with a new one.Check that the detector is not loose and all screws are fixed.Good/Bad Good/Bad Good/Bad Contact your dealer, distributor, or device manufacturer if there is a problem.
68153 01 www.perkinelmer.com 31XRpad2 4336DIGITAL IMAGING9.1.2 After Turning On the Power9.1.3 After Turning Off the PowerInspectionResultRemedyDate/Date/Date/GeneralCheck that the wireless connectivity or the AP symbol ( )is shown in the display if wireless mode is used.Good/Bad Good/Bad Good/Bad Connect the X-ray detector and the Wi-Fi Access Point as described in the Access Point Manual.Check that the LAN connectivity symbol ( ) is shown in the display if the wired mode is used.Good/Bad Good/Bad Good/Bad Connect the Gigabit Ethernet cable and the tethered power and communication cable properly.Check the battery charge condition (Battery Half or better ( ).Good/Bad Good/Bad Good/Bad Exchange the Battery Pack with a charged one.Check that the detector LED is ON.Good/Bad Good/Bad Good/Bad Set the Detector to Exposure Ready as described in the Digital Radiography Software Manual.Perform test exposure as described in the Digital Radiography Software Manual.Good/Bad Good/Bad Good/Bad If any error messages appear, follow the instructions in the Digital Radiography Software Manual. If there is a problem, contact your dealer, distributor, or device manufacturer.InspectionResultRemedyDate/Date/Date/GeneralCheck that the X-ray detector is turned off normally and that all LEDs are OFF.Good/Bad Good/Bad Good/Bad See “Section 8.7.5, Powering Off the X-ray Detector” on page 27 for turning off the X-ray detector.Make sure that the X-ray detector is clean and disinfected.Good/Bad Good/Bad Good/Bad See “Section 9.5, Cleaning the X-ray Detector” on page 33 for cleaning the X-ray detector.
XRpad2 433632 68153 01DIGITAL IMAGING9.2 Monthly InspectionPerform the following inspection at least once a month. If there is a problem, immediately ask your establishment’s safety department to contact your dealer, distributor, or device manufacturer.9.3 Yearly InspectionPerform the following inspection at least once a year. If there is any problem, immediately ask your establishment’s safety department to contact your dealer, distributor, or device manufacturer.InspectionResultRemedyDate/Date/Date/GeneralExecute the Dark Noise and X-ray Uniformity tests (refer to the XRpad2 4336 Digital X-ray Detector System Reference Manual).Good/Bad Good/Bad Good/Bad If there are changes in performance, acquire new calibration files as described in the Digital Radiography Software Manual.Contact your dealer, distributor, or device manufacturer if there is any problem.Make sure that the XRpad IPU-2 is clean from dirt or dust.Good/Bad Good/Bad Good/Bad Use the instructions in“Section 8.5.1.6, Cleaning the XRpad2 LBP” on page 17 for cleaning.Check the manufacturing date of all Battery Packs to ensure that their age is not five years or older.Good/Bad Good/Bad Good/Bad Replace the Battery Pack with a new one and recycle the old one.InspectionResultRemedyDate/Date/Date/GeneralExecute the Dark Noise, X-ray Uniformity, Bad Pixel, and Resolution tests (refer to the XRpad2 4336 Digital X-ray Detector System Reference Manual).Good/Bad Good/Bad Good/Bad If there are changes in performance, acquire new calibration files as described in the Digital Radiography Software Manual.Contact your dealer, distributor, or device manufacturer if there is any problem.
68153 01 www.perkinelmer.com 33XRpad2 4336DIGITAL IMAGING9.4 Calibrating the X-ray DetectorWhen exposure conditions have changed significantly (for example, new energy settings, new X-ray tube, and new distances), acquire new gain calibration files. Follow the instructions in the Digital Radiography Software Manual for acquiring new calibration files. Never acquire calibration files while handling or transporting the detector.9.5 Cleaning the X-ray DetectorTo clean the X-ray detector:1Turn off the X-ray detector and the power and communication tethered cable, if applicable.2Insert the XRpad2 Protective Insert into the battery compartment before cleaning or disinfecting the detector.3If the detector surface is dirty, clean it with a cleaning cloth dampened with ethanol or a diluted neutral detergent. Do not allow any fluid, detergent, or solution to get inside the battery compartment of the X-ray detector.4Remove any excess detergent or solution.5Wipe the X-ray detector surface with a clean cloth to completely dry the X-ray detector.6Allow the X-ray detector to completely air dry before turning on or storing the X-ray detector.WARNING Do not acquire images and calibration files while handling the detector. This can disturb the image quality and result in the wrong diagnosis.WARNING When the detector system is going to be cleaned, be sure to turn off X-ray detector and remove the battery. If the detector is connected to a power supply, turn off the power switch and/or unplug the power and communication tethered cable, if applicable. If the X-ray detector is battery powered, remove the battery. Never use thinner, benzine, acetone, or other flammable cleaning agents. Ignoring this warning may result in explosion, fire, or electric shock, which may result in severe personal injury, death, or substantial product damage.Note If you are using a disinfectant other than those specified, we recommend you consult a specialist for the procedure for disinfection.
XRpad2 433634 68153 01DIGITAL IMAGING9.6 Error Messages and TroubleshootingIf any error messages appear, follow the instructions in the Digital Radiography Software Manual. If there is any problem that is not described in the manual, immediately ask your establishment’s safety representative to contact your dealer, distributor, or device manufacturer. Further use may result in severe personal injury, death, or substantial product damage.10.0 After-Sales Service for PerkinElmer ProductsContact your sales person, distributor, or device manufacturer for after-sales service (including warranty) or any other information. If information is not available, contact one of the Perkin-Elmer subsidiaries (regional service headquarters) listed on the last page of this document.Field service is limited to replacement of the detector or adding and replacing approved accesso-ries by authorized personnel. The detector and its accessories are not intended to be repaired in the field.For product returns, contact your distributor or device manufacturer for shipping and packaging instructions. Do not return products to PerkinElmer for repair or service without advance notifi-cation. Include all required papers in the shipment.If the X-ray detector or accessories have been contaminated with potentially harmful substances or activated by high energy X-rays, gamma rays, or neutrons, they cannot be accepted without written evidence of decontamination.To ship the XRpad2 LBP, follow the local and regional requirements for proper packaging and shipping of Lithium Batteries.WARNING If any abnormal condition, such as smoke, fumes, or strange sounds, is evident, turn off the X-ray detector, turn off and unplug the power supply from the AC outlet, and immediately ask your establishment’s safety representative to contact your dealer, distributor, or device manufacturer. Further use under abnormal conditions may result in severe personal injury, death, or substantial product damage.
68153 01 www.perkinelmer.com 35XRpad2 4336DIGITAL IMAGING11.0 Disposing of the X-ray DetectorIf the X-ray detector is activated by high energy X-rays, gamma rays, or neutrons follow the local radiation protection regulation.Contact your supplier or distributor, and check the terms of conditions of the purchase contract. This product should not be mixed with other commercial waste for disposal.A label with a crossed-out wheeled bin symbol and a rectangular bar indicates that the product is covered by the Waste Electrical and Electronic Equipment (WEEE) Directive and is not to be disposed of as unsorted municipal waste. Any products marked with this symbol must be collected separately, according to the regulatory guidelines in your area.The objectives of this program are to preserve, protect, and improve the quality of the environ-ment, protect human health, and utilize natural resources prudently and rationally. Specific treatment of WEEE is indispensable in order to avoid the dispersion of pollutants into the recy-cled material or waste stream. Such treatment is the most effective means of protecting the cus-tomer’s environment.Requirements for waste collection, reuse, recycling, and recovery programs vary by regulatory authority at your location. Contact your local responsible body (for example, your hospital, clinic, establishment, or site manager) or authorized representative for information regarding applicable disposal regulations. Contact PerkinElmer at the following web site for information specific to PerkinElmer products.Web Address:http://www.perkinelmer.com/pages/010/onesource/environmental-health-and-safety/environmental-directives-compliance.xhtmlThe PerkinElmer product may be attached as part of a component to other manufacturers’ systems. These other manufacturers are directly responsible for the collection and processing of their own waste products under the terms of the WEEE Directive. Contact these producers directly before discarding any of their products. Consult the PerkinElmer web site (above) for producer names and web addresses.
XRpad2 433636 68153 01DIGITAL IMAGING12.0 DeclarationsThis section includes the manufacturers’ declaration of standards and/or regulations for which the product complies.12.1 Guidance and Manufacturer’s DeclarationTable 12 Guidance and Manufacturer’s Declaration of Electromagnetic EmissionsGuidance and Manufacturer’s Declaration of Electromagnetic EmissionsThe X-ray detector is intended for use in the electromagnetic environment specified below. The installer, X-ray system manufacturer, or user of the X-ray detector is responsible for the usage condition of the detector to be within such environment.Emissions Test Compliance Electromagnetic Environment – GuidanceRF-emissions CISPR 11 Group 1 The X-ray 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. Should any interference (EMC) be detected with any other equipment, reposition the X-ray detector or the other equipment away from each other.RF-emissions CISPR 11 Class B (wireless)Class A (wired)The X-ray detector is suitable for use in industrial and clinical environments in the wired mode.In the wireless mode the X-ray detector is suitable for use in all environments within Class B.Should any interference (EMC) be detected with any other equipment, reposition the X-ray detector or the other equipment away from each other.Harmonic emissions IEC 61000-3-2Class B (wireless)Class A (wired)Voltage fluctuations/ flicker emissions IEC 61000-3-3Complies
68153 01 www.perkinelmer.com 37XRpad2 4336DIGITAL IMAGINGTable 13 Guidance and Manufacturer’s Declaration of Electromagnetic ImmunityGuidance and Manufacturer’s Declaration of Electromagnetic ImmunityThe X-ray detector is intended for use in the electromagnetic environment specified below. The installer, X-ray system manufacturer, or user of the X-ray detector is responsible for the usage condition of the detector to be within such environment.Immunity Test IEC 60601 Test Compliance Electromagnetic Environment – GuidanceElectrostatic Discharge (ESD) IEC 61000-4-2Contact: 6 kVAir: 8 kVContact: 6 kVAir: 8 kVFloors should be made of wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.Electrical fast transients (Burst) IEC 61000-4-40.5 kV (AC)1kV (DC)0.5 kV (AC)1kV (DC)Mains power quality should be that of a typical commercial and/or hospital environment.Transients-SurgesIEC 61000-4-51 kV /‘2 kV 1 kV /2 kV Mains power quality should be that of a typical commercial and/or hospital environment.Power frequency magnetic field IEC 61000-4-83 A/m 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial and/or hospital environment.Voltage dips and short interruptionsIEC 61000-4-11–95%/10 ms–60%/100 ms–30%/500 ms>–95%/5000 ms–95%/10 ms–60%/100 ms–30%/500 ms>–95%/5000 msMains power quality should be that of a typical commercial or hospital environment.If the user of the X-ray detector requires continued operation during power mains interruptions, we recommend that the X-ray detector be powered from an uninterruptible power supply or battery.
XRpad2 433638 68153 01DIGITAL IMAGINGTable 14 Recommended Separation Distance between Portable and Mobile RF-Communication Equipment and the X-ray DetectorRecommended Separation Distance between Portable and Mobile RF-Communication Equipment and the X-ray DetectorThe X-ray detector is intended for use in the electromagnetic environment specified below. The installer, X-ray system manufacturer, or user of the X-ray detector should assure that it is used in such an environment.Rated Maximum Output Power of the Transmitter (W)150kHz to 80MHz 80MHz to 800MHz 800MHz to 2.5GHz0.01 0.12 0.12 0.230.1 0.38 0.38 0.731 1.2 1.2 2.310 3.8 3.8 7.3100 12 12 23For a transmitter rated at a maximum output power not listed above, the separation distance can be estimated using the equation in the corresponding column, where P is the maximum output (power rating of the transmitter in watt [W]) according to the transmitter manufacture and d is the recommended separation distance in meter (m).Note: This guideline may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.Pd 2.1Pd 2.1Pd 3.2
68153 01 www.perkinelmer.com 39XRpad2 4336DIGITAL IMAGINGTable 15 Guidance and Manufacturer’s Declaration of Electromagnetic Immunity (Portable Equipment) Guidance and Manufacturer’s Declaration of Electromagnetic ImmunityThe X-ray detector is intended for use in the electromagnetic environment specified below. The installer, X-ray system manufacturer, or user of the X-ray detector should assure that it is used in such an environment.Immunity Test IEC 60601 Test Compliance Electromagnetic Environment – GuidanceConducted radio-frequency fields (CEF)IEC 61000-4-6Radiated electromagnetic field (REF)IEC 61000-4-33V150 kHz to 80 MHz3V/m80 MHz to 2.5 GHz[V1] 3 V150 kHz to 80 MHz[E1] 3 V/m80 MHz to 2.5 GHzPortable and mobile RF-communication equipment should not be closer to any part of the X-ray detector including the data cables, than the recommended separation distance calculated from the equation appropriate for the frequency of the transmitter., for 150 kHz to 80 MHz,, for 80 MHz to 800 MHz,, for 800 MHz to 2.5 GHz,where P is the maximum output of the transmitter in watt (W) according to the transmitter manufacturer and d is the recommended separation distance in meter (m).Field strengths outside the shielded location from fixed RF transmitters, as determined by an electromagnetic site surveya, should be less than 3V/m.Interference may occur in the vicinity of equipment marked with the following symbol.a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast, and TV broadcast, cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the mea-sured field strength in the location in which the X-ray detector is used exceeds the applicable RF compliance level above, the X-ray detector should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the X-ray detector.Note 1: These guidelines may not apply to all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.Note 2: It is essential that the actual shielding effectiveness and filter attenuation of the shielded location be verified to assure that they meet the minimum specification.Pd 2.1Pd 2.1Pd 3.2
XRpad2 433640 68153 01DIGITAL IMAGING12.2 Declaration of Conformity for European Union (and EEA) English Hereby, PerkinElmer Inc. declares that this XRpad2 4336 is in compliance with the essential requirements and other relevant provisions of Directive 1999/5/EC.Česky PerkinElmer Inc. tímto prohlašuje, že tento XRpad2 4336 je ve shodě se základními požadavky a dalšími příslušnými ustanoveními směrnice 1999/5/ES.Dansk PerkinElmer Inc. erklærer herved, at denne XRpad2 4336 overholder de væsentlige krav samt øvrige relevante bestemmelser i direktiv 1999/5/EF.Deutsch Hiermit erklärt PerkinElmer Inc., dass der XRpad2 4336 den grundlegenden Anforderungen und anderen einschlägigen Bestimmungen der Richtlinie 1999/5/EG entspricht.Eesti Käesolevaga kinnitab PerkinElmer Inc. seadme XRpad2 4336 vastavust direktiivi 1999/5/EU põhinõuetele ja nimetatud direktiivist tulenevatele teistele asjakohastele sätetele.Español Por medio de la presente, PerkinElmer Inc. declara que el XRpad2 4336 cumple con los requisitos esenciales y cualesquiera otras disposiciones aplicables o exigibles de la Directiva 1999/5/CE.Français Par la présente, PerkinElmer Inc. déclare que ce XRpad2 4336 est en conformité avec les exigences essentielles et autres dispositions pertinentes de la directive 1999/5/CE.Ελληνική ΜΕ ΤΗΝ ΠΑΡΟΥΣΑ Η PerkinElmer Inc. ΔΗΛΩΝΕΙ ΟΤΙ ΤΟ XRpad2 4336 ΣΥΜΜΟΡΦΩΝΕΤΑΙ ΠΡΟΣ ΤΙΣ ΟΥΣΙΩΔΕΙΣ ΑΠΑΙΤΗΣΕΙΣ ΚΑΙ ΤΙΣ ΛΟΙΠΕΣ ΣΧΕΤΙΚΕΣ ΔΙΑΤΑΞΕΙΣ ΤΗΣ ΟΔΗΓΙΑΣ 1999/5/ΕΚ.Italiano Con la presente, PerkinElmer Inc. dichiara che questo XRpad2 4336 è conforme ai requisiti essenziali ed alle altre disposizioni pertinenti della direttiva 1999/5/CE.Íslenska Her með lýsir PerkinElmer Inc. yfir þvi að XRpad2 4336 er í samræmi við grunnkröfur og aðrar kröfur, sem gerðar eru í tilskipun 1999/5/EC.Latviski Ar šo PerkinElmer Inc. paziņo, ka XRpad2 4336 atbilst Direktīvas 1999/5/EK būtiskajām prasībām un citiem ar to saistītiem noteikumiem.Lietuviu PerkinElmer Inc. patvirtina, kad šis XRpad2 4336 atitinka Direktyvos 1999/5/EB esminius reikalavimus ir kitas nuostatas.Malti Hawnhekk, PerkinElmer Inc., jiddikjara li dan XRpad2 4336 jikkonforma mal-ħtiġijiet essenzjali u ma provvedimenti oħrajn relevanti li hemm fid-Dirrettiva 1999/5/EC.Magyar Alulírott, PerkinElmer Inc. nyilatkozom, hogy az XRpad2 4336 megfelel a vonatkozó alapvető követelményeknek és az 1999/5/EK irányelv egyéb előírásainak.Nederlands Hierbij verklaart PerkinElmer Inc. dat het toestel XRpad2 4336 in overeenstemming is met de essentiele eisen en de andere relevante bepalingen van richtlijn 1999/5/EG.Norsk PerkinElmer Inc. erklærer herved at utstyret XRpad2 4336 er i samsvar med de grunnleggende krav og øvrige relevante krav i direktiv 1999/5/EF.
68153 01 www.perkinelmer.com 41XRpad2 4336DIGITAL IMAGINGThe XRpad2 4336 may be operated in the following countries:Polski Niniejszym PerkinElmer Inc. oswiadcza, ze XRpad2 4336 jest zgodny z zasadniczymi wymogami oraz pozostalymi stosownymi postanowieniami Dyrektywy 1999/5/EC.Português PerkinElmer Inc. declara que este XRpad2 4336 está conforme com os requisitos essenciais e outras disposicões da Directiva 1999/5/CE.Suomi PerkinElmer Inc. vakuuttaa taten etta XRpad2 4336 tyyppinen laite on direktiivin 1999/5/EY oleellisten vaatimusten ja sita koskevien direktiivin muiden ehtojen mukainen.Slovensko PerkinElmer Inc. izjavlja, da je ta XRpad2 4336 v skladu z bistvenimi zahtevami in ostalimi relevantnimi dolocili direktive 1999/5/ES.Svenska Härmed intygar PerkinElmer Inc. att denna XRpad2 4336 står I överensstämmelse med de väsentliga egenskapskrav och övriga relevanta bestämmelser som framgår av direktiv 1999/5/EG.AT BE BG CH CY CZ DE DK EE ES FIFR GB GR HU IE IT IS LI LT LU LVMT NL NO RO PL PT SE SI SK
XRpad2 433642 68153 01DIGITAL IMAGING12.3 Federal Communication Commission Interference Statement (US)1This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.1. Section is only applicable to the USCaution Any changes or modifications not expressly approved by PerkinElmer Medical Imaging could void the user’s authority to operate the equipment.Note This equipment has been tested and found to comply with the limits for a Class A digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instruction 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 or her own expense.The country code selection is for non-US models only and is not available to all US models. Per FCC regulation, all Wi-Fi products marketed in the US must be fixed to US operation channels only.IMPORTANT Radiation Exposure Statement: The product comply with the US portable RF exposure limit set forth for an uncontrolled environment and are safe for intended operation as described in this manual. The further RF exposure reduction can be achieved if the product can be kept as far as possible from the user body or set the device to lower output power if such function is available. This transmitter must not be co-located or operating in conjunction with any other antenna or transmitter.
68153 01 www.perkinelmer.com 43XRpad2 4336DIGITAL IMAGING12.4 Industry Canada Statement (English)2This device complies with RSS-210 of the Industry Canada Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.The product complies with the Canada portable RF exposure limit set forth for an uncontrolled environment and are safe for intended operation as described in this manual. The further RF exposure reduction can be achieved if the product can be kept as far as possible from the user body or set the device to lower output power if such function is available.2. Section is only applicable to Canada.Caution The device for operation in the band 5150-5250 MHz is only for indoor use to reduce the potential for harmful interference to co-channel mobile satellite systemsWARNING The maximum antenna gain permitted for devices in the bands 5250-5350 MHz and 5470-5725 MHz shall comply with the e.i.r.p. limit.WARNING The maximum antenna gain permitted for devices in the band 5725-5825 MHz shall comply with the e.i.r.p. limits specified for point-to-point and non-point-to-point operation as appropriate.WARNING Users should also be advised that high-power radars are allocated as primary users (for example, priority users) of the bands 5250-5350 MHz and 5650-5850 MHz and that these radars could cause interference and/or damage to LE-LAN devices.Note This equipment does not exceed the Class A limits for radiated emissions as described in the Radio Interference Regulations of the Canadian Department of Communications.
XRpad2 433644 68153 01DIGITAL IMAGING12.5 Industrie Canada – Déclaration (Français)3Le présent dispositif est conforme à la norme RSS-210 d'Industrie Canada. L'exploitation est autorisée aux deux conditions suivantes : (1) ce dispositif ne doit pas causer d'interférences nuisibles, et (2) ce dispositif doit accepter toute interférence reçue, y compris les interférences susceptibles de causer un dysfonctionnement.Le produit est conforme aux limites d'exposition pour les appareils portables RF pour les Etats-Unis et le Canada établies pour un environnement non contrôlé. Le produit est sûr pour un fonctionnement tel que décrit dans ce manuel. La réduction aux expositions RF peut être augmentée si l'appareil peut être conservé aussi loin que possible du corps de l'utilisateur ou que le dispositif est réglé sur la puissance de sortie la plus faible si une telle fonction est disponible.Remarque: Cet appareil numérique ne dépasse pas les limites de la classe A pour les émissions radio, telles que définies dans le Radio Interference Regulations du Département Canadien des Communications.Cet équipement ne dépasse pas les limites de la classe A pour les émissions rayonnées, telles que définies dans le règlement sur le brouillage radioélectrique édicté par le ministère des Communi-cations du Canada.CAN ICES-3 (A)/NMB-3 (A)/CAN NMB-3(A)3. Section is only applicable to Canada.Mise en garde Le dispositif fonctionnant dans la bande 5 150-5 250 MHz est réservé exclusivement à une utilisation en intérieur afin de réduire les risques d'interférences nuisibles pour les systèmes mobiles par satellite utilisant les mêmes canaux.Mise en garde Le gain maximal d’antenne permis pour les dispositifs utilisant les bandes 5 250-5 350 MHz et 5470-5 725 MHz doit se conformer à la limite de p.i.r.e.Mise en garde Le gain maximal d’antenne permis (pour les dispositifs utilisant la bande 5 725-5 825 MHz) doit seconformer à la limite de p.i.r.e. spécifiée pour l’exploitation point à point et non point à point, selon le cas.Mise en garde De plus, les utilisateurs devraient aussi être avisés que les utilisateurs de radars de haute puissance sont désignés utilisateurs principaux (c.-à-d., qu’ils ont la priorité) pour les bandes 5 250-5 350 MHz et 5 650-5 850 MHz et que ces radars pourraient causer du brouillage et/ou des dommages aux dispositifs LAN-EL.
68153 01 www.perkinelmer.com 45XRpad2 4336DIGITAL IMAGING12.6 KoreanType of Equipment User’s GuideA급 기기 (업무용 방송통신기자재 )이 기기는 업무용 (A 급) 전자파적합기기로서 판매자 또는 사용자는 이 점을 주의하시기 바라며, 가정외의 지역에서 사용하는 것을 목적으로합니다 . 주의 해당 무선설비는 전파혼신 가능성이 있으므로 인명안전과 관련된 서비스는 할 수 없음해당 무선 설비는 5150-5250MHz 대역에서 실내 에서만 사용할 수 있음 .
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DIGITAL IMAGING68153 01 www.perkinelmer.com 47IndexAabbreviations 2accessories for the X-ray detector 11acquiring an image, general workflow for 27AED mode safety note ixafterturning off the power 31turning on the power 31after-sales service for PerkinElmer products 34alerts and notes, meaning of iiiaudience 1Bbattery safety note viibeforeturning on the power 29using the X-ray detector 25you begin iiCcalibrating the X-ray detector 33charging the XRpad LBP 14cleaningX-ray detector 33XRpad IPU-2 21XRpad LBP 17connectionwired X-ray detector 23wireless X-ray detector 24considerations, environmental 8Ddaily inspection 29declarations 36Federal Communication Commission interface statement 42guidance and manufacturer’s 36Industrie Canada declaration 44Industry Canada statement 43Korean 45of conformity of European Union and EEA 40definition of symbols 3descriptionX-ray detector 6XRpad IPU-2 18dimensions for the X-ray detector 10disposing ofX-ray detector 35XRpad LBP 18Eenvironmental considerations 8FFederal Communication Commission interface statement 42for your safety iiiGgeneral workflow for acquiring an image 27guidance and manufacturer’s declaration 36Hhandling safety note viIif a problem occurs safety note iximage, workflow for acquiring 27Industrie Canada declaration 44Industry Canada statement 43inspectiondaily 29monthly 32yearly 32inspection and maintenance 29installation and environment of use safety note ivinstalling the XRpad LBP 15interface and power unit and cables safety note vionizing radiation, protection against iiIPU-2. see XRpad IPU-2KKorean declarations 45Llithium battery pack. see XRpad LBP
DIGITAL IMAGING48 www.perkinelmer.com 68153 01Index XRpad2 4336Mmaintaining the XRpad LBP 17maintenance and inspection 29maintenance and inspection safety note xmeaning of alerts and notes iiiminimum system requirements 21monthly inspection 32Nnotes and alerts, meaning of iiiOoperating the X-ray detector 22overviewX-ray detector 6XRpad IPU-2 19Ppatient vicinity 12PerkinElmer products, after-sales service for 34powerafter turning off 31after turning on 31before turning on 29powering off the X-ray detector 27powering onX-ray detector 26X-ray detector in wired mode 26X-ray detector in wireless mode 26products, after-sales service for 34protection against ionizing radiation iiRrechargeable lithium battery pack. see XRpad LBPreferences 3regulations and standards 5removing the XRpad LBP 16Ssafety noteAED mode ixbattery viihandling viif a problem occurs ixinstallation and environment of use ivinterface and power unit and cables vmaintenance and inspection xWLAN viiisafety, for your iiiscope 1service, after-sales for PerkinElmer products 34specificationX-ray detector 9XRpad IPU-2 20XRpad LBP 14standards and regulations 5storage and transportation 16symbols, definition of 3system requirements, minimum 21Ttransportation and storage 16turning off power, what to do after 31turning on powerwhat to do after 31what to do before 29Uusage 1using the detector, what to do before 25Vvicinity, patient 12Wwired modeconnection for 23powering on X-ray detector 26wireless modeconnection for 24powering on X-ray detector 26WLAN safety note viiiworkflow for acquiring an image 27XX-ray detectoraccessories 11before using 25calibrating 33cleaning 33description 6dimensions 10disposing of 35operating 22overview 6powering off 27powering on 26powering on in wired mode 26powering on in wireless mode 26specification 9wired connection 23wireless connection 24
DIGITAL IMAGING68153 01 www.perkinelmer.com 49XRpad2 4336 IndexXRpad IPU-2cleaning 21description 18overview 19specification 20XRpad LBP 13charging 14cleaning 17disposing of 18installing 15maintaining 17removing 16specification 14Yyearly inspection 32
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68153 01 www.perkinelmer.com 51XRpad2 4336DIGITAL IMAGINGUSAPerkinElmer Inc.2175 Mission College BlvdSanta Clara, CA 95054USAP: +1-844-726-8228F: +1 408-969-6493fpd@perkinelmer.comwww.perkinelmer.comGermanyPerkinElmer Technologies GmbH & Co. KGIn der Rehbach 2265396 WallufGermanyP: +49 6123 971-300F: +49 6123 971-600fpd@perkinelmer.comwww.perkinelmer.comFor a complete listing of our global offices, visit www.perkinelmer.com©2015 PerkinElmer, Inc. All rights reserved. The PerkinElmer logo and design are registered trademarks of PerkinElmer, Inc. or its subsidiaries, in the United States and other countries. All other trademarks not owned by PerkinElmer, Inc. or its subsidiaries that are depicted herein are the property of their respective owners. PerkinElmer reserves the right to change this document at any time without notice and disclaims liability for editorial, pictorial or typographical errors.

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