Varex Imaging XRpad2 4343 User Manual

Varex Imaging XRpad2 4343 User Manual

Digital x-ray detector
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XRpad2 4343 Digital X-ray
Detector 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.

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Summary of Contents for Varex Imaging XRpad2 4343

  • Page 1 XRpad2 4343 Digital X-ray Detector 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 4343 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 4343 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 4343 Installation and Environment of Use The X-ray detector is intended to be installed, maintained, and used by WARNING qualified professional personnel who are trained and qualified in the installation, maintenance, and use of X-ray equipment.
  • Page 5 XRpad2 4343 For Your Safety The detector is not designed to control X-ray dose. The system WARNING integrator is responsible for controlling the X-ray radiation. Connection of the X-ray detector to the installed IT network that WARNING includes other equipment could result in previously unidentified risk to patients, operators or third parties.
  • Page 6 For Your Safety XRpad2 4343 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 7 XRpad2 4343 For Your Safety Handling Never disassemble, modify, or alter the X-ray detector, its components, WARNING Battery Pack, 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 8 For Your Safety XRpad2 4343 Battery Do not use the battery pack if the casing is broken or if it emits an WARNING 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.
  • Page 9 XRpad2 4343 For Your Safety Do not drop or hit the battery against hard objects since this may cause WARNING damage to the LBP 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 pack unusable.
  • Page 10 For Your Safety XRpad2 4343 Automatic Exposure Detection (AED) Mode The AED mode requires a sufficient X-ray dose rate to the detector WARNING surface to trigger image acquisition. The required dose rate can vary at different use conditions. The system integrator must evaluate the AED operation with the complete X-ray setup in order to secure the proper image acquisition in AED mode.
  • Page 11 XRpad2 4343 For Your Safety If a Problem Occurs If any abnormal condition, such as smoke, fumes, or strange sounds, WARNING 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.
  • Page 12 For Your Safety XRpad2 4343 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 13: Table Of Contents

    Table of Contents Scope ............. . . 1 Detector Options .
  • Page 14 Table of Contents XRpad2 4343 11.1.3 After Turning Off the Power........36 11.2...
  • Page 15 List of Figures Figure 1 X-ray Detector (Front View) ..........9 Figure 2 Typical Detector Label .
  • Page 16 List of Figures XRpad2 4343 This page intentionally left blank. www.vareximaging.com...
  • Page 17 List of Tables Table 1 Abbreviations ............2 Table 2 References .
  • Page 18 List of Tables XRpad2 4343 This page intentionally left blank. xviii www.perkinelmer.com...
  • Page 19: Scope

    Scope This document describes design elements and respective interfaces for the XRpad2 4343 detector. The XRpad2 4343 X-ray detector series contain specific models for which the main difference is the scintillator. Applicable mechanical, electronic, and software interfaces are addressed. Varex digital X-ray Flat Panel Detectors and their accessories are components designed to be integrated into products by X-ray system manufacturers.
  • Page 20: Abbreviations

    XRpad2 4343 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 21: References

    Document # XRpad LBC Charger for Rechargeable 48773 Lithium-Ion Battery Pack XRpad LBP Rechargeable Lithium-Ion 48772 Battery Pack XRpad2 4343 Digital X-ray Detector Reference ##### Manual Digital Radiography Software Manual X-ray system manufacturer or Supplied by third-party provider X-ray system manufacturer or...
  • Page 22: Definition Of Symbols

    XRpad2 4343 Definition of Symbols Table 3 includes a list of symbols and a description of each symbol. Table 3 Symbols Symbol Description This Way Up Handle with Care Keep Dry Reusable Disposal (WEEE) Follow all local and regional disposal requirements...
  • Page 23 XRpad2 4343 Table 3 Symbols (Continued) Protection Class II Non-Ionizing Radiation Battery charge condition • Battery Charged (> 80%) • Battery ¾ (≤ 80%) • Battery Half (≤ 60%) • Battery Low (≤ 40%) • Battery Empty (≤ 20%) •...
  • Page 24 XRpad2 4343 Table 3 Symbols (Continued) UL Recognized component mark for US and Canada European Conformity marking for the product “0050” shows the notified body number for MDD Do not X-ray backside Environmental Friendly Use Period of 10 years Intertek ETL Classified Logo - United States 5005875...
  • Page 25: Standards And Regulations

    XRpad2 4343 Standards and Regulations The 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.
  • Page 26 XRpad2 4343 Table 4 Standards and Regulations (Continued) EN ISO 4090:2004 Photography – Medical Radiographic Cassettes/Screens/Films and Hard-Copy Imaging Films – Dimensions and Specifications EN 60529:1991 + A1:2000 Degrees of Protection Provided by Enclosures (IP-code) EN 50566:2013/AC:2014 Product standard to demonstrate compliance of radio frequency...
  • Page 27: Description Of The X-Ray Detector

    Description of the X-ray Detector 10.1 Overview of the X-ray Detector The XRpad2 4343 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 28: Figure 2 Typical Detector Label

    XRpad2 4343 Table 5 Overview of the X-ray Detector (Continued) Shock Sensor Temperature Warning Wireless Connectivity/No Wireless Connectivity Access Point LAN Connection/No LAN Connection Push Button with a LED ☼ (blue light) Short press and LED OFF Power ON and LED flashes...
  • Page 29: Environmental Considerations

    XRpad2 4343 10.2 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 30: X-Ray Detector Specification

    XRpad2 4343 10.3 X-ray Detector Specification Table 7 displays the specifications for the X-ray detector. In addition, Figure Figure 4, and Figure 5 below display the measured DQE (per the IEC 62220-1 Ed.1 standard at ~8 µGy), MTF, and characteristic curves of the X-ray detector.
  • Page 31: Figure 3 Dqe Vs Frequency

    XRpad2 4343 a. Country-dependent. Figure 3 DQE vs Frequency www.vareximaging.com...
  • Page 32: Figure 4 Mtf Vs Frequency

    XRpad2 4343 Figure 4 MTF vs Frequency Figure 5 Plot of Characteristic Curve (Signal vs Exposure) www.vareximaging.com...
  • Page 33: X-Ray Detector Dimensions

    XRpad2 4343 10.4 X-ray Detector Dimensions Figure 6 shows the dimensions (in mm) for the X-ray detector. Figure 6 Dimensions for the X-ray Detector www.vareximaging.com...
  • Page 34: X-Ray Detector Accessories And Replacement Parts

    XRpad2 4343 10.5 X-ray Detector Accessories and Replacement Parts The X-ray detector shall only be used with its approved Varex accessories and replacement parts. 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 installed network.
  • Page 35: Figure 7 Patient Vicinity

    XRpad2 4343 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 7 Patient Vicinity Connection of the X-ray detector directly to the installed computer WARNING network may disturb the IT environment.
  • Page 36: Rechargeable Battery Pack

    XRpad2 4343 10.5.1 Rechargeable Battery Pack Figure 8 shows the battery pack. Figure 8 XRpad2 LBP Contents on the label of the battery are for reference only and may be Note different or subject to change. Storage or use of the battery pack environmental conditions outside...
  • Page 37: Table 9 Specification Of The Battery Pack

    XRpad2 4343 Table 9 includes the specification for the battery pack. Table 9 Specification of the Battery Pack General 95510949H-01 Voltage 11.1 V Amp-hours 4.2 Ah Capacity 46.6 Wh  3 hours Charging Time Environmental Relative Humidity 35% to ~85% Operating (discharging) -10°C to 55°C...
  • Page 38 XRpad2 4343 • Ensure the battery charger is powered on. • Orient the battery pack to match the orientation of the battery charger, and insert the battery pack firmly into the battery charger. Keep the XRpad2 LBP in the battery charger until all the four charge status LEDs maintains a solid green, indicating a full charge.
  • Page 39: Figure 9 Removing The Battery Pack

    XRpad2 4343 10.5.1.3 Removing the Battery Pack Dispose of a used battery pack according to the instructions in the Caution “Section 13.0, Disposing of the X-ray Detector” on page To remove the battery pack: Fully support the X-ray detector and battery pack before performing this task to prevent them from dropping or slipping.
  • Page 40 XRpad2 4343 • 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. 10.5.1.5 Maintaining the Battery Pack To maintain the battery pack: •...
  • Page 41: Xrpad Ipu-2

    XRpad2 4343 10.5.1.7 Disposing of the Battery Pack To dispose of the battery pack: • The battery pack 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 42: Table 10 Overview Of The Xrpad Ipu-2

    XRpad2 4343 Table 10 includes an overview of the XRpad IPU-2. Table 10 Overview of the XRpad IPU-2 Detector Power Switch on IPU( DC Output LED (Yellow) ( LED Yellow DC Output OK, no output load LED Green DC Output OK, output loaded (Detector is powered on or Battery is...
  • Page 43: Table 11 Specification Of The Xrpad Ipu-2

    XRpad2 4343 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] 13.5 V/5 A, 15 V/1 A...
  • Page 44: Minimum System Requirements

    XRpad2 4343 10.5.2.1 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 45: Operating The X-Ray Detector

    XRpad2 4343 10.7 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 46: Wired X-Ray Detector Connection

    XRpad2 4343 10.7.1 Wired X-ray Detector Connection Figure 11 shows the wired connection of the X-ray detector in an installed 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 47: Wireless X-Ray Detector Connection

    XRpad2 4343 10.7.2 Wireless X-ray Detector Connection Figure 12 shows the wireless connection of the X-ray detector in an installed 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.
  • Page 48: Before Using The X-Ray Detector

    XRpad2 4343 Figure 13 Wireless Connection of the X-ray Detector (WAP Mode) 10.7.3 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 49: Powering On The X-Ray Detector

    XRpad2 4343 10.7.4 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 50: Powering Off The X-Ray Detector

    Extended hand switch push button (wired mode) 10.7.6 Temperature Warning Limits The XRpad2 4343 detector has two temperature limits that prompts the Digital Radiography Software and displays a temperature symbol on the detector display informing the user of the temperature.
  • Page 51: Figure 14 Workflow For Acquiring An Image

    XRpad2 4343 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 52: Inspection And Maintenance

    XRpad2 4343 11.0 Inspection and Maintenance The X-ray detector must be repaired by Varex authorized personnel WARNING 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 53 XRpad2 4343 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 54: After Turning On The Power

    XRpad2 4343 11.1.2 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 55: 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 4343 calibration files as described Digital X-ray Detector in the Digital Radiography Reference Manual). Software Manual.
  • Page 56: Calibrating The X-Ray Detector

    XRpad2 4343 11.4 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 57: Cleaning The X-Ray Detector

    XRpad2 4343 11.5.2 Cleaning the X-ray Detector To clean the X-ray detector: Turn off the X-ray detector and the power and communication tethered cable, if applicable. Insert the XRpad2 Protective Insert into the battery compartment before cleaning or disinfecting the detector.
  • Page 58: Error Messages And Troubleshooting

    XRpad2 4343 Ensure that the surfaces remain visibly wet for the maximum necessary disinfection time specified on the product label. If a disinfection time is not specified on chemical label for the concentration used, ensure that the surfaces remain visibly wet for a minimum of 10 minutes.
  • Page 59: Disposing Of The X-Ray Detector

    XRpad2 4343 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 battery pack, follow the local and regional requirements for proper packaging and shipping of Lithium Batteries.
  • Page 60: Declarations

    XRpad2 4343 14.0 Declarations This section includes the manufacturers’ declaration of standards and/or regulations for which the product complies. 14.1 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 61: Table 13 Guidance And Manufacturer's Declaration Of Electromagnetic Immunity

    XRpad2 4343 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 62: Table 14 Recommended Separation Distance Between Portable And Mobile Rf-Communication Equipment And The X-Ray Detector

    XRpad2 4343 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 63: Table 15 Guidance And Manufacturer's Declaration Of Electromagnetic Immunity

    XRpad2 4343 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 64: Declaration Of Conformity For European Union

    Directiva 2014/53/EU. Français Par la présente, Varex Imaging déclare que ce XRpad2 4343 est en conformité avec les exigences essentielles et autres dispositions pertinentes de la directive 2014/53/EU.
  • Page 65 Varex Imaging vakuuttaa taten etta XRpad2 4343 tyyppinen laite on direktiivin 2014/53/ EU oleellisten vaatimusten ja sita koskevien direktiivin muiden ehtojen mukainen. Slovensko Varex Imaging izjavlja, da je ta XRpad2 4343 v skladu z bistvenimi zahtevami in ostalimi relevantnimi dolocili direktive 2014/53/EU. Svenska Härmed intygar Varex Imaging att denna XRpad2 4343 står I överensstämmelse med de...
  • Page 66: Federal Communication Commission Interference Statement (Us)

    XRpad2 4343 14.3 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 67: Industry Canada Statement (English)

    XRpad2 4343 14.4 Industry Canada Statement (English) This device complies with Industry Canada’s license-exempt RSSs. Operation is subject to the following two conditions: This device may not cause harmful interference, and this device must accept any interference received, including interference that may cause undesired operation.
  • Page 68: Industrie Canada - Déclaration (Français)

    XRpad2 4343 14.5 Industrie Canada – Déclaration (Français) Le présent appareil est conforme aux CNR d'Industrie Canada applicables aux appareils radio exempts de license. L'exploitation est autorisée aux deux conditions suivantes: ce dispositif ne doit pas causer d'interférences nuisibles, et ce dispositif doit accepter toute interférence reçue, y compris les interférences susceptibles de...
  • Page 69 X-ray detector after disposing of turning off the power X-ray detector turning on the power XRpad LBP after-sales service for Varex Imaging products alerts and notes, meaning of audience environmental considerations battery pack. see XRpad2 LBP Federal Communication Commission interface...
  • Page 70 X-ray detector XRpad IPU-2 using the detector, what to do before patient vicinity power Varex Imaging products, after-sales service after turning off after turning on vicinity, patient before turning on powering off the X-ray detector powering on...
  • Page 71 XRpad2 4343 Index XRpad IPU-2 cleaning description overview specification XRpad LBP charging cleaning disposing of installing maintaining specification XRpad2 LBP yearly inspection www.vareximaging.com...
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  • Page 73 This page intentionally left blank.
  • Page 74 ©2017 Varex Imaging. All rights reserved. The Varex logo and design are registered trademarks of Varex Imaging or its subsidiaries, in the United States and other countries. All other trademarks not owned by Varex Imaging or its subsidiaries that are depicted herein are the property of their respective owners.

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