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NCE

ANUAL

4343W/4336W-G5/2530W-G5 X-ray Detectors

9.0

Storage and Use Conditions

Environments outside the specification reduce the lifetime and may irreparably damage the
X-ray detector.

Table 5

Environmental Conditions

Category

Limits

Storage & Transport Temperature (ambient)

-20º C to +55º C

Operating Temperature (ambient)

10º C to 40º C

Storage and Operating Humidity Range (non-condensing)

10% to 90%

Atmospheric Pressure Range

70kPa to 106kPa

Shock (any direction no power applied)

20G

Vibration Tolerance (25Hz, 30 min each Axis, without power)

2.5G

Ingress Protection

IP68

Detector Altitude

Operates at

≤

3000m

Note

The X-ray detector is intended to be installed, maintained, and used in a
professional healthcare facility.

Summary of Contents for 2530W-G5

Page 1: ...530W G5 X ray Detectors Before using the X ray detectors 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 e...

Page 2: ...storage must be performed in accordance with all applicable laws The user is also responsible for compliance to laws pertaining to the privacy of image data In no event is the X ray detector manufactu...

Page 3: ...may result 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 r...

Page 4: ...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 p...

Page 5: ...ient contact device and the surface shall not exceed 42 C Internal temperature sensor data is provided in the diagnostic data attached to each image These temperature measurements are well correlated...

Page 6: ...X ray 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 substantial pro...

Page 7: ...nclosure or support structure Ignoring this caution may result in personal injury or damage to the product Caution Do not exceed the maximum uniform load weight of 300 kg distributed across the surfac...

Page 8: ...tery before servicing and maintaining Do not touch the battery pack X ray detector cable connector or any other electrical component or equipment with wet hands Ignoring this warning may cause electri...

Page 9: ...4336W G5 and 2530W G5 will not introduce noise An aftermarket power supply may not be used with the X ray detector WLAN WARNING Do not obstruct the X ray detector antenna If it is obstructed by metal...

Page 10: ...ccess to the X ray detector and the WLAN access point Unauthorized access may cause disruption to the normal operation of the X ray detector and access point vTrigger Mode Automatic Exposure Detection...

Page 11: ...on WARNING Turn off the power of the X ray detector see Section 11 7 when the inspections indicated in this manual are going to be performed Ignoring this warning may result in electric shock which ma...

Page 12: ...Before You Begin 4343W 4336W G5 2530W G5 X ray Detectors xii www vareximaging com This page intentionally left blank...

Page 13: ...s 13 11 0 Getting Started 16 11 1 Shipment Contents 16 11 2 Data Interface and Cables 16 11 2 1 Connecting the Service Cable for 4343W 17 11 2 2 Connecting the Tether Cable for 4336W G5 and 2530W G5 1...

Page 14: ...on 42 11 12 4 Gain Calibration Steps 44 11 13 Image Acquisition 47 11 13 1 Acquiring Radiography Images 48 11 13 2 Radiographic Acquisition Settings 51 11 14 ViVA Configuration Settings 51 11 15 Dynam...

Page 15: ...ions 69 16 2 Electromagnetic Immunity 70 16 3 Radio Frequency RF Compliance Information 76 16 3 1 United States FCC IC Compliance 76 17 0 Regulatory 79 17 1 Industry Canada Notice 79 17 2 Declaration...

Page 16: ...Table of Contents 4343W 4336W G5 2530W G5 X ray Detectors xvi www vareximaging com This page intentionally left blank...

Page 17: ...Acquisition 47 Table 15 Operational Mode Example 56 Table 16 Problems and Solutions 64 Table 17 4343W Radiated Conducted Emissions Harmonics Voltage Fluctuations Flicker 69 Table 18 4336W G5 and 2530...

Page 18: ...List of Tables 4343W 4336W G5 2530W G5 X ray Detectors xviii www vareximaging com This page intentionally left blank...

Page 19: ...Unlatch Battery 24 Figure 14 Battery Removal 24 Figure 15 Battery Charge Level 25 Figure 16 Varex Inductive Battery Charger Dimensions in mm and Mounting Hole Locations 4343W and 4336W G5 and 2530W G...

Page 20: ...Drop Down Menu 48 Figure 43 Acquire Image Button 49 Figure 44 Acquire Image 49 Figure 45 Start Acquisition 50 Figure 46 Image Acquisition Progress 50 Figure 47 Acquisition Type Drop Down Menu 51 Figu...

Page 21: ...Detector Dimensions in mm 84 Figure 64 4343W X ray Detector Dimensions in mm 84 Figure 65 4336W G5 X ray Detector Dimensions in mm 85 Figure 66 4336W G5 X ray Detector Dimensions in mm 85 Figure 67 2...

Page 22: ...xxii www vareximaging com List of Figures 4343W 4336W G5 2530W G5 X ray Detectors This page intentionally left blank...

Page 23: ...X ray system design It is the responsibility of the X ray system manufacturer to confirm safety efficacy and compliance of the X ray system intended for use inclusive of the X ray detector The Digita...

Page 24: ...EQ Request SDK Software Developer Kit ViVA Varex Imaging and Viewing Application VSP Varex Smart Panel vTrigger Automatic Exposure Detection WLAN Wireless Local Area Network 6 0 References Table 2 inc...

Page 25: ...l does not apply to model 2530W G5 IP68 The X ray detectors have an IP68 ingress protection rating It is completely protected against ingress of dust and has protection against full water immersion fo...

Page 26: ...R EFERENCE M ANUAL 4343W 4336W G5 2530W G5 X ray Detectors Table 3 Definition of Symbols Continued Symbol Description Type B Applied Part Underwriters Laboratory Safety Mark China RoHS environmentally...

Page 27: ...1 1 2008 Medical Electrical Equipment Part 1 General Requirements for Basic Safety and Essential Performance CAN CSA C22 2 No 601 1 M90 2005 Medical Electrical Equipment Part 1 General Requirements fo...

Page 28: ...torage Transport Temperature ambient 20 C to 55 C Operating Temperature ambient 10 C to 40 C Storage and Operating Humidity Range non condensing 10 to 90 Atmospheric Pressure Range 70kPa to 106kPa Sho...

Page 29: ...W G5 T2 Minimum 19 C T2 Maximum 47 C 2530W G5 T1 Minimum 19 C T1 Maximum 48 C Note The T1 4343W and T2 temperature sensors are used to monitor the internal temperature of the glass These are the only...

Page 30: ...tor and the imaging system and may be mounted in an equipment enclosure or it may also be wall or ceiling mounted to maximize wireless signal strength A Service Cable is supplied with the 4343W to all...

Page 31: ...16 bit 16 bit 16 bit Mechanical 4343W 4336W G5 2530W G5 Housing Plastic with Carbon Fiber entrance window Plastic with Carbon Fiber entrance window Plastic with Carbon Fiber entrance window Weight wit...

Page 32: ...e The 2 4GHz frequency is not available for use with these detectors Do not use the 2 4GH band setting with the router or access point being used with the detector UNII 1 5150MHz 5250MHz UNII 3 5725MH...

Page 33: ...1dBm 802 11n ac 40_5190MHz 9 1dBm 802 11n ac 40_5230MHz 9 1dBm 802 11n ac 40_5755MHz 5795MH z 9 1dBm 802 11ac 80 8 1dBm 802 11ac 80 10 5 1dBm 802 11ac 80 10 5 1dBm Transmit Power WIFI_Chain 1 802 11n...

Page 34: ...ensitivity 802 11a 70dBm 54Mbps 802 11a 70dBm 54Mbps 802 11a 70dBm 54Mbps 802 11n 5GHz HT20 60dBm MCS7 802 11n 5GHz HT20 60dBm MCS7 802 11n 5GHz HT20 60dBm MCS7 802 11n 5GHz HT40 60dBm MCS7 802 11n 5G...

Page 35: ...nd Features Number Description 1 Handles 2 Battery Alignment Marker 3 Battery and Battery Well 4 Replaceable Battery Latch 5 Antennas 6 Inductive Charging Receiver 7 Patient Contact Surface 8 Service...

Page 36: ...nd Features Number Description 1 Handles 2 Battery Alignment Marker 3 Battery and Battery Well 4 Replaceable Battery Latch 5 Inductive Charging Receiver 6 Antennas 7 Patient Contact Surface 8 Tether C...

Page 37: ...atures Number Description 1 Handle 2 Battery Alignment Marker and Contacts 3 Battery Well 4 Replaceable Battery Latch 5 Inductive Charging Receiver 6 Antennas 7 Tether Cable Connection 8 LED Status In...

Page 38: ...es WARNING For proper operation X ray detector antennas and access point antennas should be unobstructed WARNING Access point should not be installed next to power supply or generator equipment Please...

Page 39: ...g com 17 Figure 5 X ray Detector as Access Point Figure 6 X ray Detector with Router 11 2 1 Connecting the Service Cable for 4343W To connect the Service Cable 1 Pull back the USB door 2 Insert the Se...

Page 40: ...e workstation by providing a 100Mbp s Ethernet connection for set up of the wireless interface and as a last resort for retrieval of images from the X ray detector in case of wireless transmission fai...

Page 41: ...e for 4336W G5 and 2530W G5 To connect the Tether Cable 1 Remove the overlay to reveal the screw holding the USB door in place see Figure 8 Figure 8 Remove the Overlay 2 Completely remove the screw an...

Page 42: ...net connection for tether communication set up of the wireless interface and as a last resort for retrieval of images from the X ray detector in case of wireless transmission failure Note The Tether C...

Page 43: ...icrosoft Windows operating system Sample code C will also be provided to illustrate the sequence of API calls needed to acquire X ray images This will include sample code for the standard set of APIs...

Page 44: ...to transfer a configuration file to the X ray detector This is a service function and should not be used by OEM customers Additionally transferring a new file to the X ray detector is typically only...

Page 45: ...Chargers visit www vareximaging com 11 4 1 Battery Installation 1 Insert Battery at a slight angle so that the side with contacts sits over the adjoining contacts in the battery compartment Note When...

Page 46: ...ray Detectors 11 4 2 Battery Removal 1 Press in the battery latch until an audible click is heard The latch will stay in closed position 2 Place a finger in opening on either side of the latch and lif...

Page 47: ...ate Each LED illuminated represents 25 charge Figure 15 Battery Charge Level 11 4 4 Battery Hot Swap The X ray detectors are equipped with a hot swappable battery When a discharged battery is removed...

Page 48: ...he Varex Inductive Battery Charger and Detector Support into the bucky tray Use Figure 16 Figure 17 and Figure 18 for mounting locations 3 Route the USB C Cable from the Varex Inductive Battery Charge...

Page 49: ...343W 4336W G5 2530W G5 X ray Detectors www vareximaging com 27 Figure 16 Varex Inductive Battery Charger Dimensions in mm and Mounting Hole Locations 4343W and 4336W G5 and 2530W G5 R EFERENCE M ANUAL...

Page 50: ...2530W G5 X ray Detectors 28 www vareximaging com R EFERENCE M ANUAL Figure 17 VHB Tape Placement Locations on Varex Inductive Battery Charger Figure 18 VHB Tape Placement Dimension on Varex Inductive...

Page 51: ...ng a third party Inductive Battery Charger WARNING Third party Inductive Battery Chargers must not be used in the bucky tray Ignoring this warning may result in image artifacts or damage to the X ray...

Page 52: ...n battery is inserted Note When a Battery is inserted into the X ray detector the LED Status Indicator will turn orange as it boots After booting it connects to the configured wireless router and is i...

Page 53: ...To reboot 1 Remove the tether cable 2 Insert and remove the Battery 4 times within an 8 second window see Figure 20 Figure 20 Reboot Sequence WARNING The tether cable must be removed before attemptin...

Page 54: ...nge Solid 111111 Booting Green Blinking 100000 No connection to the detector blinks every 1 5 seconds Green Blinking 101010 Connected to the detector blinks twice 2 per second Green Solid 111111 Link...

Page 55: ...nge then begin to blink Green See Table 12 2 To link to the X ray detector click the ViVA icon to launch the application Figure 22 The ViVA Icon 3 The X ray detector will link automatically in ViVA Wh...

Page 56: ...odes file Reset software to Factory Image Note Control Panel screens will vary slightly for the type of detector WiFi related settings will only display for wireless detectors Note For best results on...

Page 57: ...er Name and Password 3 Enter the default user and password User Name admin Password password 4 Click Log In Note Once the X ray detector is configured the default password should be changed 5 The main...

Page 58: ...ings To modify the settings 1 Click Settings 2 The Settings content will load and any settings that are able to be modified 3 After inputting desired settings click Update The X ray detector will rebo...

Page 59: ...long with its matching confirmation click Change to confirm the new password 4 To clear the passwords entered in the forms click Reset Figure 27 Change Password Note Passwords must be at least 8 chara...

Page 60: ...are 1 Click Update Firmware This option is used to update all X ray detector software embedded software firmware etc 2 Select the Varex provided firmware image by clicking Browse 3 After selecting the...

Page 61: ...was successful At this point the X ray detector will apply the updated firmware Figure 29 Firmware Updated WARNING A fully charged battery should be used during firmware update Do not remove the batte...

Page 62: ...fixed pattern pixel intensity variations in the image associated with the dark current and electronic offsets The Offset reference image is an average of a series of frames acquired without X ray and...

Page 63: ...Calibration from the menu bar under Acquisition Figure 31 Initiate Offset Calibration 3 A Calibration Setting window appears 4 Enter the number of frames desired and click OK Figure 32 Calibration Se...

Page 64: ...ss will include automatically running an Offset calibration to ensure that the detector is properly calibrated Gain calibration is based upon the linear response of the X ray detector to dose Normaliz...

Page 65: ...usted under the Mode Settings pull down menu Note We recommend accumulating 32 frames for gain calibration and 8 frames for offset calibration for optimal image quality Note Gain calibration should be...

Page 66: ...referred to as dark field acquisition Note X rays must not be used for this part of the calibration Gain Calibration Multiple Gain frames taken Software pauses at each frame so that the operator can...

Page 67: ...tion Progress window will appear When prompted waiting for X ray perform exposure Figure 37 Gain Calibration Progress window 4 Once all X ray frames have been accumulated the calibration process will...

Page 68: ...L Figure 39 Gain Calibration Complete Note Gain calibration should be performed at regular intervals At least every twelve 12 months If the central beam of the X ray source has been moved relative to...

Page 69: ...applied during Acquisition Type Images transferred to Workstation Raw Exposed Frame and Post Offset Frame Corrected A single fully corrected frame Offset Corrected A single offset corrected frame with...

Page 70: ...es for diagnosis Note The OEM workstation should have the ability to employ the PREP and Expose_OK signals See Section 13 3 or Section VSPADU UTILITY in 03236 FP2032_VarexSmartPanel_SoftwareInterfaceS...

Page 71: ...4336W G5 2530W G5 X ray Detectors 3 Click Acquire Image button or click Acquire Image in the Acquisition menu under the Menu Bar to begin acquiring images Figure 43 Acquire Image Button Figure 44 Acq...

Page 72: ...appear Click Start Acquisition and initiate X ray exposure Figure 45 Start Acquisition 5 The Radiographic Acquisition Progress window will begin to show acquisition process with a blue status bar Fig...

Page 73: ...k the Acquisition Type Drop Down Menu to switch between Software or Hardware Acquisition vTrigger Figure 47 Acquisition Type Drop Down Menu 11 14 ViVA Configuration Settings This section describes the...

Page 74: ...ware Handshaking click Acquisition under the Menu Bar and select or de select Hardware Handshaking ViVA will remember your preferences for future launches Hardware Handshaking is needed for gain calib...

Page 75: ...e System Settings click Acquisition under the Menu Bar 4 Click on System Settings A System Settings window will appear Image and calibration settings may be turned On or Off in this window Figure 51 O...

Page 76: ...15 Dynamic Integration Settings Dynamic Integration allows the User to change the exposure time settings within ViVA 1 Click the desired mode from the Mode Drop Down Menu Figure 53 Select Mode 2 Click...

Page 77: ...is selected or the link has been closed 4343W 4336W G5 2530W G5 X ray Detectors 3 A message box will appear click OK to proceed Figure 55 Message Box 4 Enter the integration time exposure time in the...

Page 78: ...or more information on how to dynamically change the integration time The X ray detector supports Radiographic and vTrigger modes of operation see Table 15 for a typical mode example The sensitivity o...

Page 79: ...time is defined in the customer configuration file and may be different for each mode APIs can be used to obtain several of the configuration file mode settings When trigger is called the software se...

Page 80: ...EM the benefit of not requiring any hardware synchronization with the generator A vTrigger acquisition mode utilizes the X ray detector s hardware to sense when X rays are exposed to the X ray detecto...

Page 81: ...and hand switch and relay those signals to the various API calls in the VSP Library Upon receiving PREP signal the workstation software should call the Prepare API function upon receiving REQ signal...

Page 82: ...be transferred to a client PC later The detector can be armed in the autonomous mode and then taken to the patient s room In the process the detector link will be closed and remain in the armed state...

Page 83: ...X ray grade carbon fiber input window and housing WARNING When the X ray detector system is going to be cleaned or disinfected be sure to remove the battery pack Ignoring this warning may result in ex...

Page 84: ...ident after air drying remove the residue with a general Isopropyl Alcohol wipe and let air dry 14 1 3 Disinfecting the X ray Detector To disinfect the X ray detector 1 Remove the battery from the X r...

Page 85: ...RNING Do not use flowing liquid or immersion on the X ray detector battery battery compartment or battery charger 14 2 Field Replaceable Parts The X ray detector has been designed to allow for field r...

Page 86: ...nsure they match 5 If problem persists consult the manufacturer or field service technician for help Intermittent or slow WiFi connection or slow image transfer Check the router band setting band shou...

Page 87: ...oblem persists consult the manufacturer or field service technician for help Acquired image shows a white or a black channel 1 Let power off Section 11 7 or reboot the detector Section 11 8 re insert...

Page 88: ...al or horizontal lines 1 Let power off Section 11 7 or Reboot the detector Section 11 8 re insert the battery re establish the link 2 Ensure that the tube dose is set to the correct settings 3 Acquire...

Page 89: ...ame AppData Local crashdumps viva log Detector dropped 1 Power off the detector Section 11 7 and inspect for damage 2 If the battery does not appear damaged place into battery charger to see if batter...

Page 90: ...been exposed to high energies 8 5 MeV or higher Varex cannot accept any activated X ray detectors that have been used in environments 8 5 MeV or higher that exceed the local regulatory limits WARNING...

Page 91: ...and displayed is acceptable e g small amount of noise pixelation video artifact etc if the degradation would not affect the diagnosis or treatment Images acquired shall be normal when the immunity int...

Page 92: ...poses Voltage fluctuations flicker emissions IEC 61000 3 3 Complies Complies The detector is suitable for use in all establishments other than domestic and those directly connected to the low voltage...

Page 93: ...inued operation during power mains interruptions it is recommended that the system be powered from an uninterruptible power supply or a battery Power frequency 50 60 Hz magnetic field IEC 61000 4 8 30...

Page 94: ...1845 1970 1700 1990 GSM 1800 CDMA 1900 GSM 1900 DECT LTE Band 1 3 4 25 UMTS Pulse modulation b 217 Hz 2 0 3 28 2450 2400 2570 Bluetooth WLAN 802 11 b g n RFID 2450 LTE Band 7 Pulse modulation b 217 H...

Page 95: ...5 kV 1 kV 2 kV Line to Ground 0 5 kV 1 kV Line to Line 0 5 kV 1 kV 2 kV Line to Ground Mains power quality should be that of a typical professional healthcare environment Voltage dips short interrupti...

Page 96: ...m 80 MHz to 2 7 GHz 80 AM at 1 kHz E 6 P d Where P is the maximum power in W d is the minimum separation distance in m and E is the Immunity Test Level in V m If the X ray detector complies with Immu...

Page 97: ...duty cycle square wave signal As an alternative to FM modulation 50 pulse modulation at 18 Hz may be used because while it does not represent actual modulation it would be worst case Note These guide...

Page 98: ...quipment 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...

Page 99: ...table 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 b...

Page 100: ...4343W 4336W G5 2530W G5 X ray Detectors 78 www vareximaging com R EFERENCE M ANUAL Figure 61 4336W G5 Detector and Wireless Label Locations Figure 62 2530W G5 Detector and Wireless Label Locations...

Page 101: ...ette derni re n mette pas de champs radio lectriques sup rieurs aux limites specif es par Sant Canada pour le grand public consulter le Code de s curit 6 disponible sur le site Web de Sant Canada l ad...

Page 102: ...se requirements set a SAR limit of 1 6 W kg averaged over one gram of tissue The highest SAR value reported under this standard during product certification for use when properly worn on the body is 1...

Page 103: ...e el Radiolan cumple con los requisitos esenciales y cualesquiera otras disposiciones aplicables o exigibles de la Directiva 1999 5 CE Greek Varex Imaging Radiolan 1999 5 Fran ais French Par la pr sen...

Page 104: ...lo ili direktive 1999 5 ES Slovensky Slovak Varex Imaging t mto vyhlasuje e Radiolan sp a z kladn po iadavky a v etky pr slu n ustanovenia Smernice 1999 5 ES Suomi Finnish Varex Imaging vakuuttaa t te...

Page 105: ...ce Cable 149961 6 5 ft 2 2m Field Maintenance Kit 151236 N A Mains Hospital Grade 110V Cable 11616 6 5 ft 2m Mains European Cable 660 8 2 ft 2 5m Mains Chinese Cable 19045 8 2 ft 2 5m Note Accessory o...

Page 106: ...X ray Detectors 84 www vareximaging com R EFERENCE M ANUAL 19 0 Appendix B Mechanical Drawings All dimensions are measured in mm Figure 63 4343W X ray Detector Dimensions in mm Figure 64 4343W X ray D...

Page 107: ...4343W 4336W G5 2530W G5 X ray Detectors www vareximaging com 85 Figure 65 4336W G5 X ray Detector Dimensions in mm Figure 66 4336W G5 X ray Detector Dimensions in mm R EFERENCE M ANUAL...

Page 108: ...4343W 4336W G5 2530W G5 X ray Detectors 86 www vareximaging com R EFERENCE M ANUAL Figure 67 2530W G5 Detector Dimension in mm Figure 68 2530W G5 Detector Dimension in mm...

Page 109: ...Firmware 34 Firmware Update 38 G Gain Calibration 42 Gain Calibration Steps 44 H Hot Swap Battery 25 How To Access Control Panel 34 Acquire Image 47 Gain Calibration 44 Link 33 Offset Calibration 40...

Page 110: ...x Safety For Your iii Screws Inductive Charger 27 Sensor Temperature 7 Service Change Password 37 Firmware Update 38 In Warranty 68 Log In 34 Maintenance 61 Obtain RMA Number 68 Out of Warranty 68 Rep...

Page 111: ...4343W 4336W G5 2530W G5 X ray Detectors This page intentionally left blank 89...

Page 112: ...obal offices visit www vareximaging com 2021 Varex Imaging All rights reserved The Varex Imaging logo and design are registered trademarks of Varex Imaging or its subsidiaries in the United States and...

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