Varex Imaging XRpad2 4343 User Manual Download

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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.

Version

2017-11-03

Summary of Contents for XRpad2 4343

Page 1: ...ser 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 accessib...

Page 2: ...laws pertaining to the privacy of image data In no event is Varex liable for direct indirect or consequential injury damage or loss of equipment operation time or image data arising from the use of t...

Page 3: ...ult in personal injury death or product damage Keep this manual for future reference Meaning of Alerts and Notes DANGER This indicates a potentially hazardous situation which if ignored will result in...

Page 4: ...ge acquisition must be assessed for the specific intended use and application For the most reliable image acquisition method use of the external or software trigger mode to synchronize with the X ray...

Page 5: ...nvironment Dusty environment Salty or sulphurous environment Near a vibrating environment Environment where there is insufficient air circulation to enable the X ray detector and power supply to dissi...

Page 6: ...al 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...

Page 7: ...X ray detector must be securely placed in the Bucky tray or securely fastened to the X ray detector enclosure or support structure Ignoring this caution may result in personal injury or damage to the...

Page 8: ...LBP to release toxic and harmful substances causing injuries such as electric shock or burns or cause a fire and will render the pack unusable WARNING Observe and follow all safety information in this...

Page 9: ...tructed by metal wood or a human body the wireless communication can be slowed down or disconnected WARNING Follow the laws and regulations for each country and select the regional code accordingly WA...

Page 10: ...he most reliable image acquisition method use of the external or software trigger mode to synchronize with the X ray source is recommended WARNING The external sync mode is the default acquisition mod...

Page 11: ...e under abnormal conditions may result in severe personal injury death or substantial product damage WARNING When liquid has been spilled into or on any part of the X ray detector or power supply if a...

Page 12: ...switch and or unplug the power supply cable from the AC outlet If the X ray detector is battery powered remove the battery Never use thinner benzine acetone or other flammable cleaning agents Ignorin...

Page 13: ...mensions 15 10 5 X ray Detector Accessories and Replacement Parts 16 10 5 1 Rechargeable Battery Pack 18 10 5 2 XRpad IPU 2 23 10 6 Minimum System Requirements 26 10 7 Operating the X ray Detector 27...

Page 14: ...Cleaning the X ray Detector 39 11 5 3 Disinfecting the X ray Detector 39 11 6 Error Messages and Troubleshooting 40 12 0 After Sales Service for Varex Products 40 13 0 Disposing of the X ray Detector...

Page 15: ...ure 14 Figure 6 Dimensions for the X ray Detector 15 Figure 7 Patient Vicinity 17 Figure 8 XRpad2 LBP 18 Figure 9 Removing the Battery Pack 21 Figure 10 XRpad IPU 2 23 Figure 11 Wired Connection of th...

Page 16: ...This page intentionally left blank xvi www vareximaging com List of Figures XRpad2 4343 V e r s i o n 0 1 2 0 1 7 1 1 0 3...

Page 17: ...able 9 Specification of the Battery Pack 19 Table 10 Overview of the XRpad IPU 2 24 Table 11 Specification of the XRpad IPU 2 25 Table 12 Guidance and Manufacturer s Declaration of Electromagnetic Emi...

Page 18: ...xviii www perkinelmer com List of Tables XRpad2 4343 This page intentionally left blank V e r s i o n 0 1 2 0 1 7 1 1 0 3...

Page 19: ...is the responsibility of the X ray system manufacturer to confirm the safety efficacy and compliance of the X ray system for its intended use inclusive of the detector The Digital Radiography Softwar...

Page 20: ...igabit Ethernet I F Interface IP Internet Protocol IPU Interface and Power Unit LAN Local Area Network LBC Lithium Battery Charger LBP Lithium Battery Pack LED Light Emitting Diode MDD Medical Device...

Page 21: ...e Document XRpad LBC Charger for Rechargeable Lithium Ion Battery Pack 48773 XRpad LBP Rechargeable Lithium Ion Battery Pack 48772 XRpad2 4343 Digital X ray Detector Reference Manual Digital Radiograp...

Page 22: ...ts Refer to instruction manual booklet Refer to Instruction Manual Caution Manufacturer s name and address Date of Manufacture YYYY MM where YYYY Year MM Month OR Date of Manufacture YYYY MM DD where...

Page 23: ...Temperature Warning Wireless Connectivity No Wireless Connectivity LAN Connection Missing LAN Connection Access Point Trigger Connection Detector Push Button Detector Power Switch on IPU Do not crush...

Page 24: ...king 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 Intertek ETL Cla...

Page 25: ...al electrical equipment Part 1 6 General requirements for basic safety and essential performance Usability Medical devices Part 1 Application of usability engineering to medical devices CAN CSA C22 2...

Page 26: ...held and body mounted wireless communication devices used by the general public 30 MHz 6 GHz EN 62209 02 2012 Human exposure to radio frequency fields from hand held and body mounted wireless communic...

Page 27: ...sette Figure 1 shows the front view of the X ray detector and Table 5 includes a brief description of each feature Figure 1 X ray Detector Front View Table 5 Overview of the X ray Detector 1 Active Ar...

Page 28: ...Long Press 4 s and LED ON or flashes Power OFF LED Status blue light LED OFF Detector is not powered LED flashing first instance Detector is initializing LED flashing second instance Detector is Ready...

Page 29: ...vironmental Considerations Environment Transportation Storagea a In original transport container for 365 days Operation Ambient Temperatureb 14 days b Temp Gradient max 4 5 K hour 10 C to 55 C 0 C to...

Page 30: ...s On board Memory 1 GB DDR3 8 GB SDHC card Mechanical Size ISO 4090 for 43 cm 43 cm 17 17 cassette size Active Area 426 mm 426 mm External Dimensions 460 mm w 460 mm l 15 5 mm h Weight 4 1 kg 9 03 lbs...

Page 31: ...www vareximaging com 13 XRpad2 4343 U SER M ANUAL Figure 3 DQE vs Frequency a Country dependent V e r s i o n 0 1 2 0 1 7 1 1 0 3...

Page 32: ...XRpad2 4343 14 www vareximaging com U SER M ANUAL Figure 4 MTF vs Frequency Figure 5 Plot of Characteristic Curve Signal vs Exposure V e r s i o n 0 1 2 0 1 7 1 1 0 3...

Page 33: ...ximaging com 15 XRpad2 4343 U SER M ANUAL 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 V e r s i o n 0 1 2 0 1 7...

Page 34: ...t must comply with IEC 60601 1 or IEC 60950 1 Table 8 includes a list of accessories and replacement parts for the X ray detector Table 8 Accessories and Replacement Parts for the X ray Detector Varex...

Page 35: ...7 Figure 7 Patient Vicinity WARNING Connection of the X ray detector directly to the installed computer network may disturb the IT environment WARNING Do not use any non medical equipment such as the...

Page 36: ...the battery are for reference only and may be different or subject to change WARNING Storage or use of the battery pack environmental conditions outside the specification may cause fire electrical sh...

Page 37: ...before achieving maximum capacity The actual battery run time will depend on the power demands made by the X ray detector The battery pack is keyed and can only be inserted into the battery charger i...

Page 38: ...ck is clean dry and free of foreign contamination or debris If cleaning is necessary refer to Section 10 5 1 6 Cleaning the Battery Pack on page 22 for cleaning instructions 4 The battery pack is keye...

Page 39: ...and federal national regulations for handling packaging labeling and transporting Lithium Ion batteries Before transporting the battery inspect it to confirm that there is no damage or leakage from t...

Page 40: ...the device or battery charger and stop using the battery pack Using a damaged or defective battery pack may reduce function time or cause the X ray detector system to fail If an battery pack leaks do...

Page 41: ...or Trigger Interface Hand Switch and Generator Interface and Detector Push Button Interface The Gigabit Ethernet Interface of the XRpad IPU 2 is connected to the Imaging Workstation using a Cat 5e 6 c...

Page 42: ...ow LED Yellow USB trigger function enabled LED Green Remote Detector Power via USB 4 XRpad Interface and Power I O 1 5 Trigger Out Signal to Generator 6 Trigger In Signal from Hand Switch Prep Expose...

Page 43: ...to 70 C Relative Humidity Operating 10 to 90 Transportation Storage 0 to 90 Ingress Protection Rating IP40 rated protection against particles 1 mm WARNING All external signals that are connected to t...

Page 44: ...ray detector 1 Gigabit Ethernet Infrastructure and a free Gigabit Ethernet Port or Wi Fi Infrastructure 2 Intel compatible Multi Core Processor 2 GHz 3 RAM 4 GB 4 Windows 7 32 bit 64 bit 5 If a Firew...

Page 45: ...tions installation method X ray system setup and subject to be imaged the use of AED mode may result in false trigger or no trigger of X ray image acquisition The risk of false trigger or no trigger o...

Page 46: ...kstation using a Cat 5e 6 cable Make sure that the XRpad IPU 2 is not connected directly with the installed network The Trigger I F of the XRpad IPU 2 must be connected with the Generator and with the...

Page 47: ...nt may be wall or ceiling mounted to maximize wireless signal strength Make sure that the router is not connected directly to the installed network The detector can also be connected directly to the I...

Page 48: ...on the X ray detector WARNING If the X ray detector system is used under conditions where condensation can occur problems in image quality or malfunction of the detector system may occur In addition...

Page 49: ...ing Once the X ray detector is powered on the X ray detector display is on and shows the current status of the X ray detector The X ray detector LED will turn from flashing to constant on After the Ra...

Page 50: ...a temperature symbol on the detector display informing the user of the temperature When the near thermal limit occurs typically 41 C immediately finish the exam and then power down the detector to re...

Page 51: ...rmation Prepare the examination setup x Arrange the patient x Position the X ray collimator x Check all conditions x Start the Software capturing button Conduct the examination x Press the Prep switch...

Page 52: ...11 1 Daily Inspection Perform the following inspection daily If there is any problem immediately ask your establishment s safety representative to contact your dealer distributor or device manufactur...

Page 53: ...ne Check that the battery pack wireless mode or the Protective Insert wired mode is in the battery compartment and the sliding latches are closed Good Bad Good Bad Good Bad Slide the battery pack or t...

Page 54: ...a charged one Check that the detector LED is ON Good Bad Good Bad Good Bad Set the Detector to Exposure Ready as described in the Digital Radiography Software Manual Perform test exposure as described...

Page 55: ...ibed in the Digital Radiography Software Manual Contact your dealer distributor or device manufacturer if there is any problem Make sure that the XRpad IPU 2 is clean from dirt or dust Good Bad Good B...

Page 56: ...Germicidal Disposable Wipes or Clinell Universal Wipes 1 4 Hydrogen Peroxide solution Commercial option Clorox Healthcare Hydrogen Peroxide Wipes All chemicals listed above as approved for use can be...

Page 57: ...opyl alcohol wipe and let air dry 11 5 3 Disinfecting the X ray Detector To disinfect the X ray detector 1 Turn off the X ray detector and the power and communication tethered cable if applicable 2 In...

Page 58: ...or substantial product damage 12 0 After Sales Service for Varex Products Contact your sales person distributor or device manufacturer for after sales service including warranty or any other informat...

Page 59: ...delines in your area The objectives of this program are to preserve protect and improve the quality of the environ ment protect human health and utilize natural resources prudently and rationally Spec...

Page 60: ...ssions 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 equip...

Page 61: ...Electrical fast transients Burst IEC 61000 4 4 0 5 kV AC 1 kV DC 0 5 kV AC 1 kV DC Mains power quality should be that of a typical commercial and or hospital environment Transients Surges IEC 61000 4...

Page 62: ...utput Power of the Transmitter W 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz 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 ma...

Page 63: ...ded separation distance in meter m Field strengths outside the shielded location from fixed RF transmitters as determined by an electromagnetic site surveya should be less than 3 V m Interference may...

Page 64: ...irective 2014 53 EU Varex Imaging XRpad2 4343 2014 53 EU Italiano Con la presente Varex Imaging dichiara che questo XRpad2 4343 conforme ai requisiti essenziali ed alle altre disposizioni pertinenti d...

Page 65: ...Rpad2 4343 v skladu z bistvenimi zahtevami in ostalimi relevantnimi dolocili direktive 2014 53 EU Svenska H rmed intygar Varex Imaging att denna XRpad2 4343 st r I verensst mmelse med de v sentliga eg...

Page 66: ...es 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...

Page 67: ...Canada Caution The device for operation in the band 5150 5250 MHz is only for indoor use to reduce the potential for harmful interference to co channel mobile satellite systems WARNING The maximum ant...

Page 68: ...nada Mise en garde Le dispositif fonctionnant dans la bande 5 150 5 250 MHz est r serv exclusivement une utilisation en int rieur afin de r duire les risques d interf rences nuisibles pour les syst me...

Page 69: ...stry Canada statement 49 of conformity of European Union and EEA 46 definition of symbols 4 description X ray detector 9 XRpad IPU 2 23 dimensions for the X ray detector 15 disinfecting and cleaning i...

Page 70: ...maintenance and inspection xii WLAN ix safety for your iii scope 1 service after sales for Varex Imaging products 40 specification X ray detector 12 XRpad IPU 2 25 XRpad LBP 19 standards and regulatio...

Page 71: ...4343 Index XRpad IPU 2 cleaning 26 description 23 overview 24 specification 25 XRpad LBP charging 19 cleaning 22 disposing of 23 installing 20 maintaining 22 specification 19 XRpad2 LBP 18 Y yearly in...

Page 72: ...This page intentionally left blank 54 www vareximaging com Index XRpad2 4343 V e r s i o n 0 1 2 0 1 7 1 1 0 3...

Page 73: ...55 This page intentionally left blank V e r s i o n 0 1 2 0 1 7 1 1 0 3...

Page 74: ...ffices visit www vareximaging com 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 countri...

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