Perkin-Elmer XRpad2 4336 User Manual

Perkin-Elmer XRpad2 4336 User Manual

Digital x-ray detector system
Table of Contents

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XRpad2 4336 Digital X-ray
Detector System User Manual
Before 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.
68153 01

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Summary of Contents for Perkin-Elmer XRpad2 4336

  • Page 1 XRpad2 4336 Digital X-ray Detector System User Manual Before 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.
  • Page 2 Before You Begin XRpad2 4336 Before 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.
  • Page 3 XRpad2 4336 For Your Safety For Your Safety To 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.
  • Page 4 For Your Safety XRpad2 4336 Installation and Environment of Use Do not operate the X-ray detector in or around flammable gases, gas mixtures, WARNING 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.
  • Page 5 XRpad2 4336 For Your Safety Interface and Power Unit and Cables Be sure to turn OFF the power of the X-ray detector, including turning WARNING off the power supply or removing the battery (if applicable) before servicing, maintaining, connecting, or disconnecting the cables or accessories.
  • Page 6 For Your Safety XRpad2 4336 Handling Never disassemble, modify, or alter the X-ray detector, its components, WARNING 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.
  • Page 7 XRpad2 4336 For Your Safety Battery Do not use the XRpad2 LBP (battery) if the casing is broken or if it WARNING emits an unusual odor, smoke, or excessive heat, or if it leaks any substance. Avoid contact with any substance seeping from the battery pack.
  • Page 8 For Your Safety XRpad2 4336 Do not drop or hit the battery against hard objects since this may cause WARNING 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.
  • Page 9 XRpad2 4336 For Your Safety Automatic Exposure Detection (AED) Mode The AED mode requires a sufficient X-ray dose rate to the detector WARNING 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.
  • Page 10 For Your Safety XRpad2 4336 Maintenance and Inspection Turn off the power of the X-ray detector when the inspections WARNING 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.
  • Page 11: Table Of Contents

    Table of Contents Scope ............. . . 1 Usage .
  • Page 12 Table of Contents XRpad2 4336 Cleaning the X-ray Detector ..........33 Error Messages and Troubleshooting .
  • Page 13 List of Figures Figure 1 X-ray Detector (Front View) ..........6 Figure 2 Dimensions for the X-ray Detector .
  • Page 14 List of Figures XRpad2 4336 This page intentionally left blank. www.perkinelmer.com 68153 01...
  • Page 15 List of Tables Table 1 Abbreviations ............2 Table 2 References .
  • Page 16 List of Tables XRpad2 4336 This page intentionally left blank. www.perkinelmer.com 68153 01...
  • Page 17: Scope

    XRpad2 4336 detector. Usage The 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.
  • Page 18: Abbreviations

    XRpad2 4336 Abbreviations Table 1 includes a list of abbreviations used in this manual and a description of each abbreviation. Table 1 Abbreviations Abbreviation Description Automatic Exposure Detection Access Point Computed Radiography Dynamic Frequency Selection Digital Radiography Extended Service Set...
  • Page 19: References

    Document # XRpad LBC Charger for Rechargeable Lithium-Ion 48773 Battery Pack XRpad LBP Rechargeable Lithium-Ion Battery 48772 Pack XRpad2 4336 Digital X-ray Detector System 69652 Reference Manual Digital Radiography Software Manual X-ray system manufacturer or Supplied by third-party provider X-ray system manufacturer or...
  • Page 20 XRpad2 4336 Table 3 Symbols (Continued) Symbol Description Serial 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%).
  • Page 21: Standards And Regulations

    XRpad2 4336 Table 3 Symbols (Continued) Symbol Description Keep away from children. Maximum Load. UL Recognized component mark for US and Canada. European Conformity markings for the product. Standards and Regulations The X-ray detector is designed to be compliant with the standards and/or regulations detailed in Table 4.
  • Page 22: Description Of The X-Ray Detector

    Description of the X-ray Detector Overview of the X-ray Detector The 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...
  • Page 23 XRpad2 4336 Table 5 Overview of the X-ray Detector (Continued) Display Battery charge condition • Battery Charged (> 75%) • Battery ¾ (≤ 75%) • Battery Half (≤ 50%) • Battery Low (≤ 25%) • Battery Empty (≤ 10%) •...
  • Page 24: Environmental Considerations

    XRpad2 4336 Environmental Considerations Storage or use of the X-ray detector and power supply in WARNING 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.
  • Page 25: X-Ray Detector Specification

    XRpad2 4336 X-ray Detector Specification Table 7 includes the specification for the X-ray detector. Table 7 X-ray Detector Specification Sensor Panel Single substrate amorphous silicon active TFT/diode array Scintillator Direct deposition CsI:Tl Pixel Matrix 3524 x 4288 Pixel Pitch 100 μm...
  • Page 26: X-Ray Detector Dimensions

    XRpad2 4336 X-ray Detector Dimensions Figure 2 shows the dimensions for the X-ray detector. 219,9 383,6 15,5 383,5 116,25 61,95 Figure 2 Dimensions for the X-ray Detector 68153 01...
  • Page 27: X-Ray Detector Accessories

    XRpad2 4336 X-ray Detector Accessories The 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.
  • Page 28: Figure 3 Patient Vicinity

    XRpad2 4336 Do not use any non-medical equipment in the patient vicinity, as shown in Figure 1.5 m 2.5 m 1.5 m 1.5 m 1.5 m Figure 3 Patient Vicinity Connection of the X-ray detector directly to the clinical computer WARNING network may disturb the IT environment.
  • Page 29: Rechargeable Lithium Battery Pack (Xrpad2 Lbp)

    XRpad2 4336 8.5.1 Rechargeable Lithium Battery Pack (XRpad2 LBP) Figure 4 shows the XRpad2 LBP. Figure 4 XRpad2 LBP Storage or use of the Lithium Battery Pack environmental conditions WARNING 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.
  • Page 30: Table 9 Specification Of The Xrpad2 Lbp

    XRpad2 4336 Table 9 includes the specification for the XRpad2 LBP. Table 9 Specification of the XRpad2 LBP General 95510949H-01 Voltage 11.1V Amp-hours 4.2Ah Capacity 46.6Wh Charging Time Within 3 hours Environmental Relative Humidity 35% to ~85% Operating (discharging) -10°C to 55°C Charging 0°C to 42°C...
  • Page 31 “Section 8.5.1.6, Cleaning the XRpad2 LBP” on page 17 cleaning instructions. The 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.
  • Page 32: Figure 5 Removing The Xrpad2 Lbp

    XRpad2 4336 Push the Power button on the X-ray detector to power on. Check 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.
  • Page 33 XRpad2 4336 • 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).
  • Page 34: Xrpad Ipu-2

    XRpad2 4336 8.5.1.7 Disposing of the XRpad2 LBP To 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.
  • Page 35: Table 10 Overview Of The Xrpad Ipu-2

    XRpad2 4336 Table 10 includes an overview of the XRpad IPU-2. Table 10 Overview of the XRpad IPU-2 XRpad Push Button ( DC Output LED (Yellow) ( LED Yellow DC Output OK, no output load LED Green DC Output OK, output loaded...
  • Page 36: Table 11 Specification Of The Xrpad Ipu-2

    XRpad2 4336 Table 11 includes the specification for the XRpad IPU-2. Table 11 Specification of the XRpad IPU-2 Electrical Specification AC Input Voltage [16] 100 V … 240 V AC Frequency [16] 50 Hz/60 Hz DC Output [8] 12.5 V/5 A, 15 V/1 A...
  • Page 37: Minimum System Requirements

    XRpad2 4336 8.5.2.1 Cleaning the XRpad IPU-2 If 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.
  • Page 38: Operating The X-Ray Detector

    XRpad2 4336 Operating the X-ray Detector Before 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.
  • Page 39: Wired X-Ray Detector Connection

    XRpad2 4336 8.7.1 Wired X-ray Detector Connection Figure 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.
  • Page 40: Wireless X-Ray Detector Connection

    XRpad2 4336 8.7.2 Wireless X-ray Detector Connection Figure 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.
  • Page 41: Before Using The X-Ray Detector

    XRpad2 4336 Figure 9 Wireless Connection of the X-ray Detector (WAP Mode) 8.7.3 Before Using the X-ray Detector Sudden cooling or heating of the room will cause condensation. In this case, wait until condensation disappears before powering on the X-ray detector.
  • Page 42: Powering On The X-Ray Detector

    XRpad2 4336 8.7.4 Powering On the X-ray Detector This 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.
  • Page 43: Powering Off The X-Ray Detector

    XRpad2 4336 8.7.5 Powering Off the X-ray Detector The 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). •...
  • Page 44: Figure 10 Workflow For Acquiring An Image

    XRpad2 4336 Start Communication Wireless Wired Mode Attach a fully charged Start the Interface Power battery pack to the Unit (IPU) detector Turn on the detector Register the detector to the Radiography Imaging Software Select or register the patient information...
  • Page 45: Inspection And Maintenance

    XRpad2 4336 Inspection and Maintenance The X-ray detector must be repaired by PerkinElmer authorized WARNING 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.
  • Page 46 XRpad2 4336 Result Inspection Remedy Date Date Date Check that the detector is Good/Bad Good/Bad Good/Bad Contact your dealer, not damaged. distributor, or device manufacturer if there is a problem. Check the manufacturing Good/Bad Good/Bad Good/Bad Replace the Battery Pack with...
  • Page 47: After Turning On The Power

    XRpad2 4336 9.1.2 After Turning On the Power Result Inspection Remedy Date Date Date Check that the wireless Good/Bad Good/Bad Good/Bad Connect the X-ray detector connectivity or the AP and the Wi-Fi Access Point as symbol ( )is shown in...
  • Page 48: Monthly Inspection

    Date Execute the Dark Noise Good/Bad Good/Bad Good/Bad If there are changes in and X-ray Uniformity tests performance, acquire new (refer to the XRpad2 4336 calibration files as described Digital X-ray Detector in the Digital Radiography System Reference Manual). Software Manual.
  • Page 49: Calibrating The X-Ray Detector

    XRpad2 4336 Calibrating the X-ray Detector When 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.
  • Page 50: Error Messages And Troubleshooting

    XRpad2 4336 Error Messages and Troubleshooting If 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.
  • Page 51: Disposing Of The X-Ray Detector

    XRpad2 4336 11.0 Disposing of the X-ray Detector If 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.
  • Page 52: Declarations

    XRpad2 4336 12.0 Declarations This section includes the manufacturers’ declaration of standards and/or regulations for which the product complies. 12.1 Guidance and Manufacturer’s Declaration Table 12 Guidance and Manufacturer’s Declaration of Electromagnetic Emissions Guidance and Manufacturer’s Declaration of Electromagnetic Emissions The X-ray detector is intended for use in the electromagnetic environment specified below.
  • Page 53: Table 13

    XRpad2 4336 Table 13 Guidance and Manufacturer’s Declaration of Electromagnetic Immunity Guidance and Manufacturer’s Declaration of Electromagnetic Immunity The 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.
  • Page 54: Table 14 Recommended Separation Distance Between Portable And Mobile Rf-Communication Equipment And The X-Ray Detector

    XRpad2 4336 Table 14 Recommended Separation Distance between Portable and Mobile RF-Communication Equipment and the X-ray Detector Recommended Separation Distance between Portable and Mobile RF-Communication Equipment and the X-ray Detector The 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.
  • Page 55: Table 15 Guidance And Manufacturer's Declaration Of Electromagnetic Immunity

    XRpad2 4336 Table 15 Guidance and Manufacturer’s Declaration of Electromagnetic Immunity (Portable Equipment) Guidance and Manufacturer’s Declaration of Electromagnetic Immunity The 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.
  • Page 56: Declaration Of Conformity For European Union (And Eea)

    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...
  • Page 57 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.
  • Page 58: Federal Communication Commission Interference Statement (Us)

    XRpad2 4336 12.3 Federal Communication Commission Interference Statement (US) This 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.
  • Page 59: Industry Canada Statement (English)

    XRpad2 4336 12.4 Industry Canada Statement (English) This 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.
  • Page 60: Industrie Canada - Déclaration (Français)

    XRpad2 4336 12.5 Industrie Canada – Déclaration (Français) Le 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.
  • Page 61: Korean

    XRpad2 4336 12.6 Korean Type of Equipment User’s Guide A 급 기기 이 기기는 업무용 (A 급 ) 전자파적합기기로서 판 ( 업무용 방송통신기자재 ) 매자 또는 사용자는 이 점을 주의하시기 바라 며 , 가정외의 지역에서 사용하는 것을 목적으로 합니다 .
  • Page 62 XRpad2 4336 This page intentionally left blank. 68153 01...
  • Page 63 Index disposing of X-ray detector abbreviations XRpad LBP accessories for the X-ray detector acquiring an image, general workflow for AED mode safety note after environmental considerations turning off the power turning on the power after-sales service for PerkinElmer products alerts and notes, meaning of Federal Communication Commission interface audience statement...
  • Page 64 Index XRpad2 4336 specification X-ray detector maintaining the XRpad LBP XRpad IPU-2 maintenance and inspection XRpad LBP maintenance and inspection safety note standards and regulations meaning of alerts and notes storage and transportation minimum system requirements symbols, definition of monthly inspection...
  • Page 65 XRpad2 4336 Index XRpad IPU-2 cleaning description overview specification XRpad LBP charging cleaning disposing of installing maintaining removing specification yearly inspection 68153 01 www.perkinelmer.com...
  • Page 66 Index XRpad2 4336 This page intentionally left blank. www.perkinelmer.com 68153 01...
  • Page 67 XRpad2 4336 Germany PerkinElmer Inc. PerkinElmer Technologies GmbH & Co. KG 2175 Mission College Blvd In der Rehbach 22 Santa Clara, CA 95054 65396 Walluf Germany P: +1-844-726-8228 P: +49 6123 971-300 F: +1 408-969-6493 F: +49 6123 971-600 fpd@perkinelmer.com fpd@perkinelmer.com...

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