Varex Imaging Deutschland XRPAD4336 Digital X-Ray Detector System User Manual 1

PerkinElmer Medical Imaging Digital X-Ray Detector System 1

UserManual.wiki >

Varex Imaging Deutschland >

XRPAD4336 User Manual

Users manual

Document Title Document No. Version PUB XRPAD 4336 MED - USER MANUAL TBA 1 This document is confidential and proprietary to PerkinElmer The following pages contain the “User Manual” TBA, Ver.01 PUB XRpad 4336 MED User Manual Printed document is valid for use within the day printed. Use or verify the latest revision of document in Document Control Directory Page 0 of 34 REVISION SECTIONS CHANGED ORIGINATOR CN DATE 1 Initial release S. Arnold TBA 2013-11-29

www . p erk i n e l m e r . c o m DIGIT AL IM AGIN G U S E R M A N U A L XRpad™ 4336 MED Digital X-Ray Detector System Before using the 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.

www . p erk i n e l m e r . c o m XRpad™ 4 3 3 6 M E D 2 U S E R M A N U A L PLEASE NOTE To avoid personal injury or product damage, read the manual and all accompanying information carefully before installation or use of the XRpad™ 4336 MED detector. The 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 PerkinElmer 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 manufacturer must provide the necessary protection based on the x-ray system’s intended use. For portable applications the x-ray system installer or manufacturer must provide the necessary training for the operator to protect them self, the patient, or surrounding persons.

www . p erk i n e l m e r . c o m XRpad™ 4 3 3 6 M E D 3 U S E R M A N U A L FOR YOUR SAFETY To avoid personal injury or product damage, read this manual and all accompanying information carefully before handling, installing, or using the XRpad™ 4336 MED 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 Caution Signs DANGER 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. Installation and Environmental Use WARNING 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 environment Ignoring 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 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.

www . p erk i n e l m e r . c o m XRpad™ 4 3 3 6 M E D 4 U S E R M A N U A L Interface and Power Unit and Cables WARNING Be sure to turn OFF the power of the XRpad™ 4336 MED detector, including turning off the power supply and or removal of the XRpad™ LBP (Lithium Battery Pack) before servicing, maintaining, connecting, or disconnecting the cables or accessories. Do not touch the power supply, Lithium Battery Pack, 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 formed on the system. Ignoring this warning may cause electrical shock, which may result in severe personal injury, death, or substantial product damage. Handling WARNING Never disassemble, modify, or alter the x-ray detector, its components, Lithium 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. 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 detector is placed vertically or in any tilted position, the detector must be securely placed in the Bucky tray. Ignoring this caution may result in personal injury or damage to the product. Caution Do not exceed the maximum load weight of 150 kg distributed around the overall surface of the detector (Uniform Load). Caution Do not exceed the maximum load weight of 100 kg distributed on an area of 40 mm in a diameter of the detector surface (Local Load). Caution Do not drop the detector. If the detector is dropped, remove the detector from service and inform your establishment safety representative immediately to verify or re-validate the proper function of the detector prior to resuming use of the detector. Further use under abnormal conditions may result in severe personal injury, death, or substantial product damage.

www . p erk i n e l m e r . c o m XRpad™ 4 3 3 6 M E D 5 U S E R M A N U A L Battery WARNING Do not use the XRpad™ LBP (Lithium Battery Pack) 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 XRpad™ LBP contain toxic substances. Do not attempt to open the battery packs. Do not insert any object into the battery pack or use any device to pry at the battery pack casing. Attempting to open the XRpad™ LBP casing will damage the casing which could cause the LBP to release toxic and harmful substances, causing injuries such as electric shock, 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 XRpad™ LBP. Ignoring warning may result in personal injury or damage to the product. WARNING Use only charging devices approved by PerkinElmer and never attempt to bypass or override their charging protection circuits. WARNING Keep out of reach of children. WARNING Remove the XRpad™ LBP if the XRpad™ 4336 MED detector is not likely to be used for some time. WARNING Do not submerge the XRpad™ LBP in water or other liquid. WARNING Do not charge the XRpad™ LBP near flammable materials WARNING Do not connect the XRpad™ LBP to an electrical outlet directly, or to any other electrical source not described in the manual. WARNING Do not drop or hit the battery against hard objects since this may cause damage to the LBP and risk release of the battery toxic and harmful substances, causing injuries such as electric shock, burns, or cause a fire, and will render the XRpad™ LBP unusable. WARNING Do not use the Battery Charger in the patient environment Caution Risk of explosion, personal injury, or damage to product if the Battery XRpad™ LBP is replaced by non-OEM approved component.

www . p erk i n e l m e r . c o m XRpad™ 4 3 3 6 M E D 6 U S E R M A N U A L When a Problem Occurs WARNING If any abnormal condition is evident such as smoke, fumes, or strange sounds, unplug the power supply from the AC outlet, and inform your establishment safety representative immediately to contact your dealer, distributor, or PerkinElmer. 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, power supply, Lithium Battery Pack, battery charger, or when the detector, its component, or accessory is dropped, unplug the power supply from the AC outlet, and inform your establishment safety representative immediately to contact your dealer, distributor, or PerkinElmer. Further use under abnormal conditions may result in severe personal injury, death, or substantial product damage. Maintenance and Inspection WARNING Turn OFF the power of the 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 detector system is going to be cleaned, turn OFF the XRpad™ 4336 MED, remove the XRpad™ LBP, and or unplug the power supply cable from the AC outlet. 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 XRpad™ 4336 MED 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 Follow the manufacturer’s recommendation for inspecting the detector before use.

www . p erk i n e l m e r . c o m XRpad™ 4 3 3 6 M E D 7 U S E R M A N U A L Table of Contents 1 Scope ............................................................................................................. 9 2 Intended Use / Indication for Use .......................................................... 9 3 Audience ....................................................................................................... 9 4 Abbreviations .............................................................................................. 9 5 References .................................................................................................... 9 6 Definition of Symbols .............................................................................. 10 7 Regulations ................................................................................................ 11 8 Description of the XRpad™ 4336 MED .............................................. 12 8.1 Detector Overview ............................................................................................................................ 12 8.2 Main Detector Specification ............................................................................................................ 13 8.3 Environmental Considerations ...................................................................................................... 13 8.4 Detector Dimensions ........................................................................................................................ 14 8.5 Detector Accessories ......................................................................................................................... 15 8.5.1 Rechargeable Lithium Battery Pack XRpad™ LBP ......................................................... 16 8.5.2 Interface and Power Unit XRpad™ IPU ............................................................................. 19 8.6 Minimum Computer Requirements .............................................................................................. 21 8.7 Operation .............................................................................................................................................. 21 8.7.1 Wired Detector Operation ....................................................................................................... 22 8.7.2 Wireless Detector Operation ................................................................................................... 23 8.7.3 Before Using the X-ray Detector ........................................................................................... 23 8.7.4 Power Down the XRpad™ 4336 MED ................................................................................ 24 8.7.5 General Workflow ...................................................................................................................... 25 9 Inspection and Maintenance................................................................... 26 9.1 Daily Inspection ................................................................................................................................. 26 9.1.1 Before Turning ON the Power ............................................................................................... 26 9.1.2 After Turning ON the Power .................................................................................................. 26 9.1.3 After Turning OFF the Power ............................................................................................... 27 9.2 Monthly Inspection ........................................................................................................................... 27 9.3 Yearly Inspection ............................................................................................................................... 28 9.4 Calibration ........................................................................................................................................... 28 9.5 Cleaning the Detector ....................................................................................................................... 28 10 After-Sales Service for PerkinElmer Products ................................... 29 11 Disposal ...................................................................................................... 29 12 Declarations ............................................................................................... 30 12.1 Guidance and Manufacturer’s Declaration ................................................................................. 30

www . p erk i n e l m e r . c o m XRpad™ 4 3 3 6 M E D 8 U S E R M A N U A L 12.2 Industry Canada statement: ..................................................... Error! Bookmark not defined. 12.3 Declaration of Conformity for European Union (and EEA)Error! Bookmark not defined. 12.4 Federal Communication Commission Interference Statement (US)Error! Bookmark not defined. List of Figures Figure 1 Detector Overview (Front View) .................................................................................................. 12 Figure 2 Detector Dimensions ........................................................................................................................ 14 Figure 3 Patient Vicinity ................................................................................................................................... 15 Figure 4 Rechargeable Lithium Battery Pack XRpad™ LBP ................................................................ 16 Figure 5 Removal of the XRpad™ LBP ....................................................................................................... 18 Figure 6 XRpad™ IPU Overview .................................................................................................................. 19 Figure 7 Wired Connection of the XRpad™ ............................................................................................... 22 Figure 8 Wireless Connection of the XRpad™ .......................................................................................... 23 Figure 9 General Workflow ............................................................................................................................. 25 List of Tables Table 1 Abbreviations ......................................................................................................................................... 9 Table 2 References ............................................................................................................................................... 9 Table 3 Symbols ................................................................................................................................................. 10 Table 4 Standards and Regulations .............................................................................................................. 11 Table 5 Detector Overview ............................................................................................................................ 12 Table 6 Main Detector Specification ............................................................................................................ 13 Table 7 Environmental Considerations ...................................................................................................... 13 Table 8 Accessories for the XRpad™ 4336 ............................................................................................... 15 Table 9 Specification of the XRpad™ LBP ................................................................................................ 16 Table 10 XRpad™ IPU Overview .................................................................................................................. 19 Table 11 Specification of the XRpad™ IPU ................................................................................................ 20 Table 12 Guidance and Manufacturer’s Declaration of Electromagnetic Emissions ....................... 30 Table 13 Guidance and Manufacturer’s Declaration of Electromagnetic Immunity ........................ 30 Table 14 Recommended Separation Distance between Portable and Mobile RF-Communication Equipment and the X-Ray Detector ............................................................................................. 31 Table 15 Guidance and Manufacturer’s Declaration of Electromagnetic Immunity (Portable Equipment) .......................................................................................................................................... 31

www . p erk i n e l m e r . c o m XRpad™ 4 3 3 6 M E D 9 U S E R M A N U A L 1 Scope This document describes design elements and respective interfaces for the XRpad™ 4336 MED detector. Applicable mechanical, electronic, and software interfaces are addressed. PerkinElmer digital X-ray Flat Panel Detectors and accessories are designed to be integrated into products by x-ray system manufacturers. Manufacturers are responsible for qualifying, validating, and certifying their products for their intended uses and meeting all applicable regulatory requirements. 2 Intended Use / Indication for Use The XRpad™ 4336 MED detector, when used with a radiographic imaging system, is intended for use in 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. It is not intended for mammographic use. 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 PerkinElmer XRpad™ 4336 MED detector. 3 Audience This document is for professional users from Original Equipment Manufacturers (OEMs) and system installers who are responsible for installing the XRpad™ 4336 MED detector into an x-ray system. 4 Abbreviations Table 1 Abbreviations Abbreviation Description FoV Field of View fps Frames per second I/F Interface IP Internet Protocol LED Light Emitting Diode SF Screen Film CR Computed Radiography DR Digital Radiography OEM Original Equipment Manufacturer 5 References Table 2 References Document Name Document # 1 XRpad™ LBC Reference Manual 620-005121-002 2 XRpad™ LBP Reference Manual 620-005149-001 3 Digital Radiography Software Manual Supplied by OEM

www . p erk i n e l m e r . c o m XRpad™ 4 3 3 6 M E D 10 U S E R M A N U A L 6 Definition of Symbols Table 3 Symbols Symbol Description This Way Up Handle with Care Keep Dry Reusable Disposal (WEEE) Refer to Instruction Manual Caution Manufacturer‘s name and address. Date of Manufacture, YYYY=Year, MM=Month Authorized representative in the European Community Material Number Serial Number ~ AC Input D.C. Voltage Temperature Limitation Relative Humidity Limitation Potential Equalization Functional Earth Connection Protection Class I Protection Class II EMI Sensitive Component Battery charge condition • Battery Charged (> 75%) • Battery ¾ (<= 75%) • Battery Half (<= 50%) • Battery Low (<= 25%) • Battery Empty (<= 10%) • No Battery Wireless Connectivity / LAN Connection / Missing LAN Connection Trigger Connection Push Button Power Switch Do not crush Do not expose to fire Keep away from children. UL Recognized component mark for US and Canada 0050 Conformity European - Hereby, PerkinElmer Inc., declares that this XRpad™ 4336 MED is in compliance with the essential requirements and other relevant provisions of Directive 1999/5/EC and 93/42/EEC. “0050” shows the notified body number for MDD.

www . p erk i n e l m e r . c o m XRpad™ 4 3 3 6 M E D 11 U S E R M A N U A L 7 Regulations The XRpad™ 4336 MED is designed to be compliant with the standards and/or regulations detailed in Table 3. Manufacturer’s certifications to standards and regulations are valid only if the original accessories (as listed in Table 7) 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. Table 4 Standards and Regulations Standards and Regulations Description ANSI/AAMI Std ES60601-1:2005 Medical electrical equipment Part 1: General Requirements for Basic Safety and Essential Performance IEC 60601-1:2005, EN 60601-1:2006 General Requirements for Basic Safety for Medical Electrical Equipment IEC/EN 60601-1-2:2007 Medical Electrical Equipment, Part 1-2: General Requirements for Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility CAN CSA C22.2 No 60601-1 08 Medical electrical equipment Part 1: General Requirements for Basic Safety and Essential Performance FCC Part 15 subpart C Radio Frequency exposure ETSI EN 301 893 V.1.7.1 (2012) Broadband Radio Access Networks (BRAN); 5 GHz high performance RLAN ISO 10993-5 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization ISO 4090 Photography – Medical Radiographic Cassettes/Screens/Films and Hard-Copy Imaging Films – Dimensions and Specifications EN 60529:1991 Degrees of Protection Provided by Enclosures (IP-code)

www . p erk i n e l m e r . c o m XRpad™ 4 3 3 6 M E D 12 U S E R M A N U A L 8 Description of the XRpad™ 4336 MED 8.1 Detector Overview Figure 1 Detector Overview (Front View) Table 5 Detector Overview 1 Active Area with Markers; a) Top b) Bottom Side of the Image 2 Antenna; make sure that they is not obstructed 3 Display Battery charge condition • Battery Charged (> 75%) • Battery ¾ (<= 75%) • Battery Half (<= 50%) • Battery Low (<= 25%) • Battery Empty (<= 10%) • No Battery Wireless Connectivity LAN Connection/ No LAN Connection / 4 Power & communication tethered connector 5 Push Button with a LED ☼ (blue light) Short press & LED OFF Power ON & LED flashes fast Short press & LED flashes Switch on of the Display Long Press (4s) & LED flashes Power OFF LED Status (blue light) LED OFF Detector is not powered LED flashing fast Detector is powering on LED flashing slowly Detector is in IDLE Mode LED ON Detector is Ready 6 Battery Insert 7 Detector Label 2 3 1a 5 4 6 7 2 2 1b

www . p erk i n e l m e r . c o m XRpad™ 4 3 3 6 M E D 13 U S E R M A N U A L 8.2 Main Detector Specification Table 6 Main Detector Specification Purpose General Radiography Grey Scale 14-bit, 16384 gray values / 16-bit, 65535 gray values1 Image Transfer Time Wired: Wireless: 500 ms 3000 ms Maximum Frame Time 5000 ms +/- 1ms Scintillator CsI:Tl (direct deposition on aSi photodiodes) Radiation Energy 40 kV – 160kV Size 384 mm x 460 mm x 15 mm (ISO 4090) Weight 3.7 kg Housing Solid Carbon-Fiber Front & Back Interface Wireless data I/F (802.11n @ 5GHz) Gigabit Ethernet (1000BASE-T ) via power & communication tether Active pixel Number 3530 x 4290 Pitch 100 µm Total Area 355 mm x 430 mm Power Rating Wired: Wireless: Powered by the Interface & Power Unit XRpad™ IPU Powered by the battery pack XRpad™ LBP 8.3 Environmental Considerations WARNING Storage or use of the 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 7 Environmental Considerations Environment Transportation/Storage2 Operation Ambient Temperature43 (30d/365d) -10° to +55°C /0° to +55°C +10° to +35°C Relative Humidity 5% to 90% 30% to 70% Atmospheric Pressure 700 to 1250 hPa 800 to 1250 hPa Vibration4(EN60068-2-64) 5m2/s3 (10 Hz to 100 Hz) 1m2/s3 (100 Hz to 2000 Hz) 0.5m2/s3 (10 Hz to 100 Hz) 0.1m2/s3 (100 Hz to 2000 Hz) Shock4(EN 60068-2-27) 25g (duration 6 ms) 2g (duration 6ms) Ingress protection rating IP42 rated (protection against particles > 1mm and Splashing water) 1Firmware depending 2In original transport container for 365 days 3Temp. Gradient: max 4.5 K/hour 4Image quality cannot be guaranteed during shock or vibrations.

www . p erk i n e l m e r . c o m XRpad™ 4 3 3 6 M E D 14 U S E R M A N U A L 8.4 Detector Dimensions Figure 2 Detector Dimensions

www . p erk i n e l m e r . c o m XRpad™ 4 3 3 6 M E D 15 U S E R M A N U A L 8.5 Detector Accessories The XRpad™ 4336 MED shall only be used with its approved OEM Lithium Battery Pack XRpad™ 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. The wired or wireless connection must be applied to a workstation. It is important that the detector is not directly connected to the clinical network. Connection of the detector directly with the clinical computer network may disturb the IT environment. The imaging workstation and the WiFi access point must comply with IEC 60601-1 or IEC 60950-1. Table 8 Accessories for the XRpad™ 4336 PerkinElmer Article No. Description 95510920H XRpad™ LBP (Lithium Battery Pack) 95510921H XRpad™ LBC (Lithium Battery Charger) 95510922H XRpad™ IPU (Interface Power Unit) 95510931H XRpad™ LPT Detector Cable, 3m/10ft 95510923H XRpad™ Protective Insert 95510020H XRpad™ 4336 Connector Cover Set 95510256H Trigger Cable 16.5FT / 5M 95510257H Trigger Cable 65,5FT / 20M 95510621H XRD GigE Interface Cable 25ft - 7.6m 95510622H XRD GigE Interface Cable 50ft - 15.25m 95510623H XRD GigE Interface Cable 100ft - 30.5m Figure 3 Patient Vicinity WARNING Connection of the detector directly with the clinical computer network may disturb the IT environment. WARNING Do not use any non-medical equipment such as the Battery Charger, WiFi access point in the patient environment. 1.5 m1.5 m2.5 m1.5 m1.5 m

www . p erk i n e l m e r . c o m XRpad™ 4 3 3 6 M E D 16 U S E R M A N U A L 8.5.1 Rechargeable Lithium Battery Pack XRpad™ LBP Figure 4 Rechargeable Lithium Battery Pack XRpad™ LBP WARNING Storage or use of the Lithium Battery Pack (XRpad™ LBP) 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 9 Specification of the XRpad™ LBP Electrical specification Voltage 11.1V Amp-hours 4.8Ah Capacity 53.3Wh Charging time Approximately 3h Temperature ranges Operating (discharging) -10°C to 60°C Charging 0°C to 42°C Transportation - 20°C to 45°C Storage 15°C to 35°C Ingress protection rating IP54 Lifetime Charge-discharge cycles 500 cycles under normal usage conditions Battery should be discarded on or before 5 years from date of manufacture. 8.5.1.1 Lithium Battery Pack Charging Instructions  A new rechargeable Lithium Battery Pack (XRpad™ LBP) comes in a discharged condition and must be charged using the dedicated XRpad™ LBC battery charger before use. Please refer to the XRpad™ LBC battery charger manual for more details.  The XRpad™ LBC will charge the XRpad™ LBP to usable condition within three hours depending upon the initial state of charge. The XRpad™ 4336 MED detector when connected to the XRpad™ Interface and Power Unit (XRpad™ IPU) can also charge the XRpad™ 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 upon the power demands made by the XRpad™ 4336 MED detector.  The XRpad™ LBP is keyed and can only be inserted into the XRpad™ LBC charger in one orientation.

www . p erk i n e l m e r . c o m XRpad™ 4 3 3 6 M E D 17 U S E R M A N U A L  Check to ensure the XRpad™ LBP is clean, dry and free of foreign contamination or debris. If cleaning is necessary, refer to section 7.5.1.6 for cleaning instructions.  Ensure the XRpad™ LBC Charger is powered on.  Orient the XRpad™ LBP to match the orientation of the XRpad™ LBC Charger, and insert the XRpad™ LBP firmly into the XRpad™ LBC charger. Keep the XRpad™ LBP in the XRpad™ LBC charger until all the four charge status LEDs maintain a solid green, indicating a full charge. To remove, lift the battery out of the XRpad™ LBC charger. WARNING Do not drop or hit the XRpad™ LBP against hard objects, as this may cause a risk of damage to the XRpad™ LBP which may result in exposure to the corrosive cell contents, fire or explosion. 8.5.1.2 XRpad™ Lithium Battery Pack Installation When there is no XRpad™ LBP in the detector or to change a used XRpad™ LBP, perform XRpad™ LBP removal prior to installing the XRpad™ LBP. Caution Risk of explosion, personal injury, or damage to product if the Battery XRpad™ LBP is replaced by non-OEM approved component.  Ensure the XRpad™ 4336 MED detector is fully supported prior to performing this task to avoid drop or slip of the XRpad™ 4336 MED detector, or XRpad™ LBP.  Check to ensure the battery compartment of the XRpad™ 4336 MED detector is clean, dry and free of foreign contamination or debris. If cleaning is necessary, refer to section 8.1.5 for cleaning instructions.  Check to ensure the XRpad™ LBP is clean, dry and free of foreign contamination or debris. If cleaning is necessary, refer to section 7.5.1.6 for cleaning instructions.  The XRpad™ LBP is keyed and can only be inserted into the XRpad™ 4336 MED detector in one orientation.  Align the orientation of the XRpad™ LBP to match the orientation required on the XRpad™ 4336 MED detector.  Insert the charged XRpad™ LBP into the XRpad™ 4336 MED detector in the corresponding orientation and gently press on the end cap until the latches secure the XRpad™ LBP inside the detector.  Push the power button on the XRpad™ 4336 MED detector to power on.  Check the battery charge status on the XRpad™ 4336 MED detector. If the battery charge status shows sufficient battery charge is present, the XRpad™ 4336 MED 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 XRpad™ LBP Removal Caution Dispose of used XRpad™ LBP according to the instructions in the chapter 11  Ensure the XRpad™ 4336 MED detector is fully supported prior to performing this task to avoid drop or slip of the XRpad™ 4336 MED detector, or XRpad™ LBP.  Power off the XRpad™ 4336 detector by pressing the power button on the XRpad™ 4336 MED detector.  Move the two sliding latch closer to the center to disengage the XRpad™ LBP from the XRpad™ 4336 MED detector (see Figure 5). Remove the XRpad™ LBP out of the battery

www . p erk i n e l m e r . c o m XRpad™ 4 3 3 6 M E D 18 U S E R M A N U A L compartment of the XRpad™ 4336 MED detector using a slow and steady pull motion, supporting both the XRpad™ 4336 MED detector, and the XRpad™ LBP.  Store the XRpad™ LBP in a cool, dry, clean environment if not in use or during recharge of the XRpad™ LBP for the next use. Figure 5 Removal of the XRpad™ LBP 8.5.1.4 Transportation and Storage  Store the XRpad™ LBP in a cool, dry, clean environment when not in use. Do not remove the XRpad™ LBP from its original packaging until it is required for use.  Do not leave, expose or store the XRpad™ LBP in extremely hot or cold temperatures (e.g., in direct sunlight, nearby heat sources, in cars or car trunks). The XRpad™ LBP may overheat causing fire, or performance life will be shortened.  Do not short-circuit the XRpad™ LBP, or store the XRpad™ LBP without sufficient packaging in a location where it may be short-circuited. 8.5.1.5 Maintenance of the XRpad™ LBP  Before inserting XRpad™ LBP into the XRpad™ 4336 MED detector or XRpad™ LBC battery charger, inspect the XRpad™ LBP for sign of damage, defects or abnormality. Do not use damaged, defective or abnormal condition XRpad™ LBP.  Check to ensure the XRpad™ LBP is clean, dry and free of foreign contamination or debris. If cleaning is necessary, refer to section 7.5.1.6 for cleaning instructions.  The XRpad™ LBP has no repairable parts. Do not disassemble. No modification of this product is allowed.  If the XRpad™ LBP gives off an odor or generates heat or in any way appears abnormal during use, recharging or storage, immediately remove it from the device or battery charger and stop using the XRpad™ LBP.  Using a damaged or defective XRpad™ LBP may cut operating time or cause the XRpad™ 4336 MED detector system to fail.  If a XRpad™ 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 XRpad™ LBP has not been used or charged for an extended amount of time (approximately 30 days), check the condition of the XRpad™ LBP and recharge if necessary prior to use. 8.5.1.6 Cleaning of the XRpad™ LBP  Avoid exposure of the XRpad™ LBP to liquids and solvents when possible.  Do not allow liquids or solvents to contact the electrical contacts on the XRpad™ LBP.  When necessary, the XRpad™ LBP may be clean 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 XRpad™ LBP is completely clean and dry prior to storage, inserting into the XRpad™ 4336 MED detector or XRpad™ LBC battery charger.

www . p erk i n e l m e r . c o m XRpad™ 4 3 3 6 M E D 19 U S E R M A N U A L 8.5.2 Interface and Power Unit XRpad™ IPU The XRpad™ IPU is a Power Supply Unit with integrated additionally interfaces. The tethered power and communication cable is connected to the XRpad™ 4336 MED detector. The communication data are split inside the XRpad™ IPU 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 is connected via Cat 5e/6 with the imaging Workstation. The maximum cable length is 30m. The AC cable has to be connected to a properly grounded receptacle. The AC cable is removable and will be plugged to an IEC connector. The XRD IPU needs to 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)) To isolate the equipment electrically from supply mains on all poles simultaneously, the supply mains switch (Figure 6 (1)) must be used. Figure 6 XRpad™ IPU Overview Table 10 XRpad™ IPU Overview 1 XRpad™ IPU Power Switch 2 Power In 3 AC Input LED (Green) (~) 4 DC output LED (Yellow) ( ) LED Yellow DC Output ok, no output load LED Green DC Output ok, output loaded 5 XRpad™ Push Button ( ) 6 XRpad™ Hand Switch In (Extension of the Push Button) 7 XRpad™ Interface and Power I/O 8 Trigger Out Signal to Generator 9 Trigger In Signal from Hand Switch (Prep / Expose) 10 Trigger In/Out I/F ( ) 11 LAN port to Imaging Workstation 12 Potential Equalization Connector 13 Functional Ground Connector WARNING Connection of the XRpad™ IPU LAN port directly with the clinical computer network may disturb the IT environment. 1 2 3 4 5 6 8 9 10 13 7 11 12

www . p erk i n e l m e r . c o m XRpad™ 4 3 3 6 M E D 20 U S E R M A N U A L Table 11 Specification of the XRpad™ IPU Electrical specification AC Input Voltage [2] 100V .. 240V AC frequency [2] 50Hz / 60Hz DC output [7] 12.5V / 5A, 15V / 1A (voltage level is dependent of load) Trigger In Signal from Hand Switch [8] 5V .. 24V /10mA (SELV) Trigger Out Signal to Generator [9] Same level as Trigger In Signal Trigger In Signal [10] 3.3V ... 5V (SELV) Trigger Out Signal [10] 3.3V DC output 5PF [10] 5V / 100mA Trigger In Signal [10] 3.3V ... 5V (SELV) Mechanical Specification Size 311 mm x 230 mm x 60 mm Temperature ranges Operating +10° to +35°C Transportation/Storage -10° to 70°C Relative Humidity Operating 10% to 90% Transportation/Storage 0% to 90% Ingress protection rating IP40 rated (protection against particles > 1mm) WARNING All external signals which are connected to the IPU (especially PREP/EXPOSE and Trigger signals) should be from SELV (Separated or safety extra-low voltage) circuit. Ignoring this warning may result in electric shock, which may result in severe personal injury, death, or substantial product damage. 8.5.2.1 Cleaning of the XRpad™ IPU If the XRpad™ IPU surface is dirty or dusty, it should be cleaned with a commercial available ethanol papers or a cleaning cloth tightly wrung out of 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 and disconnect the AC power cable, the detector power, and detector communication tethered cables before cleaning. WARNING When the Power and Interface Unit is going to be cleaned, be sure to turn OFF the XRpad™ IPU, 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.

www . p erk i n e l m e r . c o m XRpad™ 4 3 3 6 M E D 21 U S E R M A N U A L 8.6 Minimum Computer Requirements 1. Gigabit Ethernet Infrastructure and a free Gigabit Ethernet Port or WiFi Infrastructure 2. Intel compatible Multi Core Processor (>2 GHz) 3. RAM > 4 GB 4. Windows Vista or Windows7 (32bit / 64bit) 5. If a Firewall is used make sure that it allows to connect the detector 6. Access Point a. WPA2 encryption support b. 802.11 AN MIMO 3x3 c. Complying with IEC 60601-1 or ICC 60950-1. 8.7 Operation Before connecting the XRpad™ 4336 MED detector, ensure that the Digital Radiography Software is installed as described in its manual. If not, install the software first. The 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 load weight of 150 kg distributed around the overall surface of the detector. WARNING Do not exceed the maximum load weight of 100 kg distributed at one location in a 40mm diameter of the detector surface. Caution Check the threshold of the auto trigger mode regularly.

www . p erk i n e l m e r . c o m XRpad™ 4 3 3 6 M E D 22 U S E R M A N U A L 8.7.1 Wired Detector Operation Figure 7 shows the wired connection of the XRpad™ 4336 MED detector in a clinical environment. The AC outlet shall be installed near the Interface and Power Unit XRpad™ IPU and shall be easily accessible. The XRpad™ IPU may be mounted in an equipment enclosure. In the wired application the XRpad™ 4336 MED detector is connected with the XRpad™ IPU which powers the XRpad™ 4336 MED detector and is responsible for the data transfer. The XRD IPU is connected via Cat 5e/6 with the Imaging Workstation. Make sure that the XRpad™ IPU is not connected directly with the clinical network. The Trigger I/F of the XRpad™ IPU need to be connected with the Generator and with the Hand switch. Figure 7 Wired Connection of the XRpad™ The XRpad™ IPU communicates via a standard Gigabit Ethernet network Interface, and comes equipped with an RJ45 interface port. Due to the overall network traffic it is recommended to use this interface in a direct (Point-to-Point) connection with the host computer in order to achieve optimal speed performance. The XRpad™ IPU 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 30m.

www . p erk i n e l m e r . c o m XRpad™ 4 3 3 6 M E D 23 U S E R M A N U A L 8.7.2 Wireless Detector Operation Figure 8 shows the wireless connection of the XRpad™ 4336 MED detector in a clinical environment. The XRpad™ 4336 MED detector is connected via WLAN over a WiFi Access Pointer with the Imaging Workstation. The WiFi Access Pointer may be wall or ceiling mounted to maximize wireless signal strength. Make sure that the Router is not connected directly with the clinical network. Before imaging make sure that the XRpad™ LBP charge is sufficient and that the XRpad™ 4336 MED detector antenna is not obstructed. Figure 8 Wireless Connection of the XRpad™ 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 detector. WARNING If the detector system is used under condensation conditions, 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 XRpad™ 4336 MED should only be used with an inserted XRpad™ LPB or XRpad™ Protective Insert PatientX-Ray SourceGeneratorHand SwitchImaging WorkstationWiFi Access Point [Router]Exposure RoomOperator RoomBattery PackBattery Charger

www . p erk i n e l m e r . c o m XRpad™ 4 3 3 6 M E D 24 U S E R M A N U A L 8.7.3.1 Power On the XRpad™ 4336 MED Detector This chapter describes the power up the XRpad™ 4336 MED. For more details check the Digital Radiography Software Manual. Please make sure that the IP setting on your network adapter is set to static IP and in correlation to the XRpad™ 4336 MED. The default settings of the XRpad™ 4336 MED are “192.168.2.158” for the LAN – connection and “192.168.22.1 for the wireless LAN – connection. It is required that the detector has an XRpad™ Protective Insert or an XRpad™ LPB inserted into battery compartment. 8.7.3.2 Wired Mode Plug in the power cord to the Interface and Power Unit XRpad™ IPU and switch the Power On. The AC Input LED will turn on (Green) and the DC Output LED will turn ON (Yellow). To power the XRpad™ 4336 MED detector, press the XRpad™ 4336 MED detector Power push button of the XRpad™ IPU or the push button at the XRpad™ itself for 1s. The DC Output LED will turn from Yellow to green. During the initialization of the detector the detector push button LED is flashing fast. Once the XRpad™ 4336 MED detector is powered, the XRpad™ 4336 MED detector LED will be flashing slowly and the Detector display is showing the current status. After preparing the Radiography Imaging Software for exposure the XRpad™ 4336 MED detector LED will turn in a continuously ON. The XRpad™ 4336 detector LED ON will indicate that the detector is ready for exposure. 8.7.3.3 Wireless Mode When the detector is not connected to the XRpad™ IPU then 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 XRpad™ LBP with a charged one or use the wired operation mode. Press the detector push button for 1s and the XRpad™ 4336 MED detector will be powered up. During the initialization of the detector the detector push button LED is flashing fast. Once the detector is powered the blue LED of the push button will be flashing slowly and the Detector display is showing the current status. After preparing the Radiography Imaging Software for exposure the XRpad™ 4336 MED detector LED will turn in a continuously ON. The XRpad™ 4336 MED detector LED ON will indicate that the XRpad™ 4336 MED detector is ready for exposure. 8.7.4 Power Down the XRpad™ 4336 MED The XRpad™ 4336 MED detector is powered OFF by holding down one of the three push buttons for more than 4 seconds. The following buttons can be used • XRpad™ 4336 MED detector (Figure 1 (5)) (wireless & wired mode) • XRpad™ IPU push button (Figure 6 (5)) (wired mode) • Extended hand switch push button (wired mode)

www . p erk i n e l m e r . c o m XRpad™ 4 3 3 6 M E D 25 U S E R M A N U A L 8.7.5 General Workflow The following Workflow indicates the procedure of acquiring a clinical image after startup of the Radiography Imaging Software. Details of the Radiography Imaging Software and the x-ray generator are described in their corresponding Operation Manuals. Figure 9 General Workflow

www . p erk i n e l m e r . c o m XRpad™ 4 3 3 6 M E D 26 U S E R M A N U A L 9 Inspection and Maintenance WARNING The XRpad™ 4336 MED 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 XRpad™ 4336 MED detector before use. In addition, carry out prescribed, regular inspections per the instructions in this manual. It is important that the 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 measurements indicated in this chapter. If the problem cannot be corrected, contact your dealer, distributor, or any PerkinElmer subsidiaries (regional service headquarters) listed on the last page of this document We recommend that you keep records of the inspection close to the detector. You can make copies of the checklist in this chapter or make your own checklist. 9.1 Daily Inspection Perform the following inspection daily. If there is any problem, inform your establishment safety representative immediately to contact your dealer, distributor, or PerkinElmer subsidiary. 9.1.1 Before Turning ON the Power Inspection Result Remedy Date / Date / Date / Cables Check all cables (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 any PerkinElmer subsidiaries 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. Detector Check that the detector is not damaged. Good/Bad Good/Bad Good/Bad Contact your dealer, distributor, or any PerkinElmer subsidiaries if there is a problem. 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 any PerkinElmer subsidiaries if there is a problem. 9.1.2 After Turning ON the Power Inspection Result Remedy Date / Date / Date / General Check that the wireless connectivity symbol ( ) is shown in the display if the Wireless Mode is used. Good Bad Good/Bad Good/Bad Connect the Detector and the WiFi Access Pointer as described in the Access Pointer 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.

www . p erk i n e l m e r . c o m XRpad™ 4 3 3 6 M E D 27 U S E R M A N U A L Check the Battery charge condition 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 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 any PerkinElmer subsidiary. 9.1.3 After Turning OFF the Power Inspection Result Remedy Date / Date / Date / General Check that the XRpad™ is turned off normally and that all LEDs are OFF Good Bad Good/Bad Good/Bad Check the chapter 8.7.4 for turning off the XRpad™. Make sure that the XRpad™ is clean and disinfected Good Bad Good/Bad Good/Bad Check the chapter 9.5 for cleaning the XRpad™. 9.2 Monthly Inspection Perform the following inspection at least once a month. If there is a problem, inform your establishment safety department immediately to contact your dealer, distributor, or PerkinElmer subsidiary. Inspection Result Remedy Date / Date / Date / General Execute an Image Performance Test, and compare the test results. Good/Bad Good/Bad Good/Bad Follow the instructions in the Digital Radiography Software Manual for the Performance Test procedure. If there are changes in the performance, acquire new calibration files as described in the Radiography Software Manual. Contact your dealer, distributor, or any PerkinElmer subsidiaries if there is any problem. Check the threshold of the auto trigger mode Follow the instructions in the Digital Radiography Software Manual for the threshold test and if the test fails inform your establishment safety representative immediately to contact your dealer, distributor, or PerkinElmer. Make sure that the XRpad™ IPU is clean from dirt or dust. Good/Bad Good/Bad Good/Bad Use the instructions of chapter 0 for cleaning.

www . p erk i n e l m e r . c o m XRpad™ 4 3 3 6 M E D 28 U S E R M A N U A L 9.3 Yearly Inspection Perform the following inspection at least once a year. If there is any problem, inform your establishment safety representative immediately to contact your dealer, distributor, or PerkinElmer subsidiary. Inspection Result Remedy Date / Date / Date / General Execute an Image Performance Test using a phantom, or an Image Quality Indicator (IQI). Good/Bad Good/Bad Good/Bad Follow the instructions in the Digital Radiography Software Manual and the manual of your IQI phantom for the Performance Test procedure. Contact your dealer, distributor, or any PerkinElmer subsidiaries if there is any problem. 9.4 Calibration When exposure conditions have changed significantly (e.g. new energy settings, new x-ray tube, new distances), acquire new gain calibration files. Follow the instructions in the Digital Radiography Software Manual for acquiring new calibration files. 9.5 Cleaning the Detector WARNING When the detector system is going to be cleaned, be sure to turn OFF the XRpad™ 4336 MED detector, remove the XRpad™ LBP and or unplug the power and communication tethered cable if applicable. 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. Turn OFF the detector, and the power and communication tethered cable if applicable and insert the XRpad™ Protective Insert into battery compartment before cleaning or disinfecting of the detector. If the detector surface is dirty, it should be cleaned with commercial available ethanol papers for disinfection or a cleaning cloth tightly wrung out of 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. To clean the XRpad™ 4336 MED detector: 1. Turn OFF the XRpad™ 4336 MED detector. 2. Unplug the power and communication tethered cable if applicable. 3. Insert the XRpad™ Protective Insert into battery compartment 4. Wipe the detector surface with a a commercial available ethanol papers for disinfection or a cleaning cloth tightly wrung out of ethanol or a diluted neutral detergent. Do not allow any fluid, detergent or solution to get inside the battery compartment of the XRpad™ 4336 MED detector. 5. Remove any excess detergent or solution. 6. Wipe the detector surface with a clean cloth to completely dry the detector. 7. Allow the detector to completely air dry before turning on detector, or storage.

www . p erk i n e l m e r . c o m XRpad™ 4 3 3 6 M E D 29 U S E R M A N U A L 10 After-Sales Service for PerkinElmer Products Contact your sales person or distributor for after-sales service (including warranty) or any other information. If information is not available, contact one of the PerkinElmer 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 accessories by authorized personnel. The detector and its accessories are not intended to be repaired in the field. For product returns, contact your distributor or PerkinElmer for shipping and packaging instructions. Do not return products to PerkinElmer for repair or service without advance notification. Include all required papers in the shipment. If the 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 XRpad™ LBP (Lithium Battery Pack), follow the local and regional requirements for proper packaging and shipping of Lithium Batteries. 11 Disposal If the 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 environment, 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 recycled material or waste stream. Such treatment is the most effective means of protecting the customer’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 Web site listed below for information specific to PerkinElmer products. Web Address: http://www.perkinelmer.com/pages/010/onesource/environmental-health-and-safety/environmental-directives-compliance.xhtml The 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.

www . p erk i n e l m e r . c o m XRpad™ 4 3 3 6 M E D 30 U S E R M A N U A L 12 Declarations 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. 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 – Guidance RF-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 e 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 61000-3-2 Class B (wireless) Class A (wired) Voltage fluctuations/flicker emissions IEC 61000-3-3 Complies 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. Immunity Test IEC 60601 Test Compliance Electromagnetic Environment – Guidance Electrostatic Discharge (ESD) IEC 61000-4-2 Contact: 6 kV Air: 8 kV Contact: 6 kV Air: 8 kV Floors 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 61000-4-4 0.5 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-Surges IEC 61000-4-5 1 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 61000-4-8 3 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 interruptions IEC 61000-4-11 -95% / 10 ms -60% / 100 ms -30% / 500 ms >-95% / 5000 ms -95% / 10 ms -60% / 100 ms -30% / 500ms >-95% / 5000 ms Mains 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.

www . p erk i n e l m e r . c o m XRpad™ 4 3 3 6 M E D 31 U S E R M A N U A L 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. Rated Maximum Output Power of the Transmitter (W) 150 kHz to 80 MHz Pd 2.1= 80 MHz to 800 MHz 800 MHz to 2.5 GHz Pd 3.2= 0,01 0.12 0.12 0.23 0,1 0.38 0.38 0.73 1 1.2 1.2 2.3 10 3.8 3.8 7.3 100 12 12 23 For 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 as the recommended separation distance in meter (m). Note: This guideline may not apply in all situations. Electromagnetic propagation is absorption and reflection from structures, objects, and people. 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 -ray detector should assure that it is used in such an environment. Immunity Test IEC 60601 Test Compliance Electromagnetic Environment – Guidance Conducted radio-frequency fields (CEF) IEC 61000-4-6 Radiated electromagnetic field (REF) IEC 61000-4-3 3 V 150 kHz to 80 MHz 3 V/m 80 MHz to 2.5 GHz [V1] 3 V 150 kHz to 80 MHz [E1] 3 V/m 80 MHz to 2.5 GHz Portable 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. , 150 kHz to 80 MHz ,for 80 MHz to 800 MHPd 3.2=,for 800 MHz to 2.5 GHz, where P is the maximum output of the transmitter in watt (W) according to the transmitter manufacture 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 survey10, should be less than 3 V/m. Interference may occur in the vicinity of equipment marked with the following symbol. 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. 10Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, armature 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 measured 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. Pd 2.1=Pd 2.1=Pd 2.1=

www . p erk i n e l m e r . c o m XRpad™ 4 3 3 6 M E D 32 U S E R M A N U A L 12.2 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. Caution 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 own expense. Operations in the 5150-5250 MHz band are restricted to indoor usage only. 12.3 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. 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 systems Caution 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. Caution 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. Caution Users should also be advised that high-power radars are allocated as primary users (i.e. 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. The product comply 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. CAN ICES-3 (*)/NMB-3(*) 12.1 Industrie Canada déclaration (français): Le présent appareil est conforme aux CNR d'Industrie Canada applicables aux appareils radio exempts de licence. L'exploitation est autorisée aux deux conditions suivantes : (1) l'appareil ne doit pas

www . p erk i n e l m e r . c o m XRpad™ 4 3 3 6 M E D 33 U S E R M A N U A L produire de brouillage, et (2) l'utilisateur de l'appareil doit accepter tout brouillage radioélectrique subi, même si le brouillage est susceptible d'en compromettre le fonctionnement. Avertissement Les dispositifs fonctionnant dans la bande 5 150-5 250 MHz sont réservés uniquement pour une utilisation à l’intérieur afin de réduire les risques de brouillage préjudiciable aux systèmes de satellites mobiles utilisant les mêmes canaux. Avertissement 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. Avertissement 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. Avertissement 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. 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. Note: 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. 12.2 Declaration of Conformity for European Union (and EEA) English Hereby, PerkinElmer Inc. declares that this XRpad 4336 MED is in compliance with the essential requirements and other relevant provisions of Directive 1999/5/EC. Česky PerkinElmer Inc. tímto prohlašuje, že tento XRpad 4336 MED je ve shodě se základními požadavky a dalšími příslušnými ustanoveními směrnice 1999/5/ ES. Dansk Undertegnede PerkinElmer Inc. erklarer herved, at folgende udstyr XRpad 4336 MED overholder de vasentlige krav og ovrige relevante krav i direktiv 1999/5/EF. Deutsch Hiermit erklärt PerkinElmer Inc. dass sich das XRpad 4336 MED in Übereinstimmung mit den grundlegenden Anforderungen und den übrigen einschlägigen Bestimmungen der Richtlinie 1999/5/EG befindet. Eesti Käesolevaga kinnitab PerkinElmer Inc. seadme XRpad 4336 MED vastavust direktiivi 1999/5/EU põhinõuetele ja nimetatud direktiivist tulenevatele teistele asjakohastele sätetele. Espanol Por medio de la presente PerkinElmer Inc. declara que el XRpad 4336 MED 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 l’appareil XRpad 4336 MED est conforme aux exigences essentielles et aux autres dispositions pertinentes de la directive 1999/5/CE. Ελληνική ΜΕ ΤΗΝ ΠΑΡ_ΥΣΑ PerkinElmer Inc. ∆ΗΛΩΝΕΙ _ΤΙ XRpad 4336 MED ΣΥΜΜ_ΡΦΩΝΕΤΑΙ ΠΡ_Σ ΤΙΣ _ΥΣΙΩ∆ΕΙΣ ΑΠΑΙΤΗΣΕΙΣ ΚΑΙ ΤΙΣ Λ_ΙΠΕΣ Σ_ΕΤΙΚΕΣ ∆ΙΑΤΑ_ΕΙΣ ΤΗΣ _∆ΗΓΙΑΣ 1999/5/ΕΚ. Italiano Con la presente PerkinElmer Inc. dichiara che questo XRpad 4336 MED è conforme ai requisiti essenziali ed alle altre disposizioni pertinenti stabilite dalla direttiva 1999/5/CE. Íslenska Her með lýsir PerkinElmer Inc. yfir þvi að XRpad 4336 MED er ísamræmi við grunnkröfur og aðrar kröfur, sem gerðar eru í tilskipun 1999/5/EC. Latviski Aršo PerkinElmer Inc. deklare, ka XRpad 4336 MED atbilst Direktivas 1999/5/EK

Navigation menu