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

76 

www.vareximaging.com 

 

 

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ANUAL

 

 

 

 

 

 

16.3 

Radio Frequency (RF) Compliance Information 

This section describes RF Compliance information. 

 

16.3.1  United States FCC/IC Compliance

 

This device complies with Part 15 of the FCC Rules. Operation is subject to the following two 
conditions: 

•

 

This device may not cause harmful interference. 

•

 

This device must accept any interference received, including interference that may cause 
undesired operation. 

This transmitter must not be co-located or operating in conjunction with any other antenna or 
transmitter. This device meets all the other requirements specified in Part 15E, Section 15.407 of 
the FCC Rules. 

Transmission Band Frequencies: 5.2GHz and 5.8Ghz band ranges 

 

 

 

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 their own 
expense. 

 

FCC responsible

: Varex Imaging Corporation, 1678 South Pioneer Road, Salt Lake City, Utah 

84104, USA, Tel: + 801/972-5000, Website: www.vareximaging.com 

FCC Caution

: Any changes or modifications not expressly approved by the party responsible for 

compliance could void the user's authority to operate this equipment. 

4343W/4336W-G5: 

These 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 1.172 W/kg. 

2530W-G5: 

These 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 1.564 W/kg. 

Содержание 4343W

Страница 1: ...2530W 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 easily accessible ...

Страница 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 manufacturer 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...

Страница 3: ...r 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 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...

Страница 4: ...t 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 WARNING The X ray detector is not designed to control X ray dose The system integrator is responsible for controlling the X ray radiation WARNING The X ray detector is not intended to b...

Страница 5: ...tient 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 with the X ray detector external surface temperature It is advisable to monitor this diagnostic data as an additional safety precaution see document 03236 FP2032 VSP Software Interface Also see Table...

Страница 6: ...e 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 product damage WARNING The Service Cable 4343W does not support image acquisition It should only be used for the following to retrieve an orphaned image from the X ray detector when a wireless connectio...

Страница 7: ...enclosure 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 surface of the X ray detector Caution Do not exceed the maximum load weight of 150 kg distributed on an area of 40 mm in a diameter of the X ray detector surface Caution Do not drop the X ray detector If t...

Страница 8: ...ttery 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 electrical shock which may result in severe personal injury death or substantial product damage WARNING Do not insert the battery into the X ray detector when condensation is on the X ray detector or any of...

Страница 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 wood or a human body the wireless communication can be slowed down or disconnected WARNING Do not route Ethernet cables near or with power cables degradation of performance could result WARNING Follo...

Страница 10: ...access 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 WARNING The vTrigger mode requires a sufficient X ray dose rate to the X ray detector surface to trigger image acquisition The required dose rate can vary at different use conditions The system inte...

Страница 11: ...ion 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 may result in severe personal injury death or substantial product damage WARNING When the X ray detector system is going to be cleaned remove the battery pack cables and wait until the X ray detector p...

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

Страница 13: ...es 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 19 11 3 Software Installation 21 11 3 1 SDK Files 21 11 3 2 Bonjour Installation Files 21 11 3 3 Sample Code 22 11 3 4 Utility Software 22 11 3 5 ViVA installation 22 11 4 X ray Detector Battery 23 11...

Страница 14: ...ion 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 Dynamic Integration Settings 54 12 0 The Detector Configuration File 56 13 0 System Software 57 13 1 Radiography Acquisition 57 13 2 vTrigger Acquisition AED 58 13 3 X ray Generator Interface Signals 59 1...

Страница 15: ...sions 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 of Conformity for European Union 81 17 3 Korea Certification 82 18 0 Appendix A Accessories 83 19 0 Appendix B Mechanical Drawings 84 R EFERENCE MANUAL ...

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

Страница 17: ...g 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 2530W G5 Radiated Conducted Emissions Harmonics Voltage Fluctuations Flicker 70 Table 19 4343W ESD Transient Burst Surge Voltage Variation Magnetic Fields 70 Table 20 4343W Test Specs for Enclosure Port ...

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

Страница 19: ...3 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 G5 27 Figure 17 VHB Tape Placement Locations on Varex Inductive Battery Charger 28 Figure 18 VHB Tape Placement Dimension on Varex Inductive Battery Charger 28 Figure 19 Third party Inductive Battery ...

Страница 20: ...e 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 Figure 48 Mode Drop Down Menu 51 Figure 49 Hardware Handshaking Not Selected 52 Figure 50 Hardware Handshaking Selected 52 Figure 51 Open System Settings 53 Figure 52 System Settings window 53 Figure 53 ...

Страница 21: ...y 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 2530W G5 Detector Dimension in mm 86 Figure 68 2530W G5 Detector Dimension in mm 86 R EFERENCE M ANUAL ...

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

Страница 23: ...d 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 Digital Radiography Software referred to in this manual is intended to be used by system integrators to control and operate the X ray detector as well as for development testing and maintenance purposes on...

Страница 24: ...REQ 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 includes a list of documents referred to in this manual For access to the following refer ences contact your dedicated Varex representative Table 2 References References Document Number or Location Pane...

Страница 25: ...ol 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 for up to 60 minutes at depths up 1m Consult Instruction for Use Load Weight Restrictions Do Not Discard with Domestic Waste European Union Mark of Conformity to Applicable European Directives Note Thi...

Страница 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 friendly for 10 years ...

Страница 27: ...01 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 for Safety EN IEC 60601 1 2 Medical Electrical Equipment Part 1 2 General Requirements for Basic Safety and Essential Performance Collateral Standard Electromagnetic Compatibility 4th ed 93 42 EECa Eur...

Страница 28: ...orage 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...

Страница 29: ...6W G5 T2 Minimum 19º C T2 Maximum 47º C 2530W G5 T1 Minimum 19º C T1 Maximum 48º C Note The T1 4343W and T2 temperature sensors are used to monitor the internal temperature of the glass These are the only temperature sensors that need to be monitored by the OEM see Table 6 WARNING If the maximum temperature is reached the X ray detector must be turned off and allowed to cool Ignoring this warning ...

Страница 30: ...ctor 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 allow for set up of the wireless interface and to retrieve images from the X ray detector in case of failed wireless transmission A Tether Cable is provided with the 4336W G5 and 2530W G5 to provide pow...

Страница 31: ...C 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 without Battery DRZ 3 1 kg 6 83 lbs CsI 3 3 kg 7 27 lbs DRZ 2 65 kg 5 84 lbs CsI 2 85 kg 6 28 lbs CsI 2 3 kg 5 07 lbs Load Support 200 kg over diameter 40 mm at center 300 kg entire surface 150 kg over...

Страница 32: ...te 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 5725MHz 5850MHz Note Subject to local reg ulations Note 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 ...

Страница 33: ...3 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 ac 20_5180MHz 5240MH z 13 5 1dBm 802 11n ac 20_5180MHz 5240MH z 13 5 1dBm 802 11n ac 20_5180MHz 5240MH z 9 1dBm 802 11n ac 20_5745MHz 5825MH z 13 1dBm 802 11n ac 20_5745MHz 5825MH z 13 1dBm 802 11n ...

Страница 34: ...Sensitivity 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 5GHz HT40 60dBm MCS7 802 11n 5GHz HT40 60dBm MCS7 802 11ac VHT80 51dBm MCS9 802 11ac VHT80 51dBm MCS9 802 11ac VHT80 51dBm MCS9 ...

Страница 35: ...and 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 Cable Connection 9 LED Status Indicator 10 Top of X ray detector interior electronics location 11 Orientation Mark also indicates glass array coordinates X 0 Y 0 12 Orientation Mark R EFERENCE M ANUA...

Страница 36: ...and 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 Cable Connection 9 LED Status Indicator 10 Top of X ray detector interior electronics location 11 Orientation Mark also indicates glass array coordinates X 0 Y 0 12 Orientation Mark ...

Страница 37: ...eatures 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 Indicator 9 Top of X ray detector interior electronics location 10 Orientation Mark also indicates glass array coordinates X 0 Y 0 11 Orientation Mark R EFERENCE M ANUAL ...

Страница 38: ...les 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 contact your Varex representative for a list of approved access points WARNING Detector in Client Mode Varex strongly recommends disabling auto channel selection or roaming on the access point Auto ...

Страница 39: ...ng 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 Service Cable as indicated in Figure 7 R EFERENCE M ANUAL ...

Страница 40: ...he 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 failure Note The Service Cable does not support image acquisition Note The Service Cable does not provide power to the X ray detector when tethered Before servicing ensure that a fully charged battery i...

Страница 41: ...le 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 and remove the USB door see Figure 9 Figure 9 Remove the Screw and the USB Door R EFERENCE M ANUAL ...

Страница 42: ...rnet 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 Cable is verified for image acquisition Note The Tether Cable provides 19V to the X ray detector which allows it to run on tether power and charge the Battery Note The detector should be set to Statio...

Страница 43: ...Microsoft 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 as well as usage of the consolidated API methods For customers working in other operating environments source code for the VSP DLL may be licensed for re compilation It should be noted that correctio...

Страница 44: ...d 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 needed if modifications have been made to the configuration file vsp file exe 11 3 5 ViVA installation To install the ViVA application 1 Locate the Software Packageand click Setup Figure 11 Setup 2 F...

Страница 45: ...d 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 inserting the battery the angle of the battery should not be more than 20 degrees inserting a battery at a larger angle could cause damage to the battery contact pins 2 Lay the battery down with the...

Страница 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 lift the battery out Figure 13 Unlatch Battery Figure 14 Battery Removal ...

Страница 47: ...nate 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 from the X ray detector the User will have a set amount of time for the battery hot swap to occur Table 11 Battery Hot Swap Operation Time X ray Detector Operation Time 4343W 3 minutes 4336W G5 2530W...

Страница 48: ...the 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 Charger to the Power Supply in a way that the opening and closing of the bucky tray does not cause damage to the cable The USB C Cable can be replaced if damaged WARNING Alignment between the Varex Inducti...

Страница 49: ...4343W 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 ...

Страница 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 Battery Charger ...

Страница 51: ...ing 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 detector Caution Third party Inductive Battery Chargers do not support image acquisition while using the charger Note To support image acquisition while using the charger the Varex supplied Inductive...

Страница 52: ...en 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 in Standby Mode where the LED Status Indicator will blink twice 2 per second If the X ray detector does not connect to the configured wireless router it will blink slowly To Power off 1 Remove the bat...

Страница 53: ...d 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 attempting to reboot via the battery The battery reboot will not work if the tether cable is connected to the detector R EFERENCE M ANUAL ...

Страница 54: ...ange 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 Opened detector controlled remotely LED always on Green Blinking 110011 Connected to Service Cable 4343W or Tether Cable 4336W G5 2530W G5 blinks once 1 per second Yellow Solid 111111 Detector Error ...

Страница 55: ...ange 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 When the X ray detector is linked the Mode Drop Down Menu will become populated Figure 23 Detector Linked in ViVA Note Automatically linking to the X ray detector in ViVA will require that Bonjour is i...

Страница 56: ...Codes 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 only use Firefox or a Chrome browser window 11 11 1 Access the VSP Control Panel To access the Control Panel 1 Open a browser window and navigate to the IP Address of the X ray detector example http 19...

Страница 57: ...ser 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 VSP Control Panel screen displays links in the left pane When a link is clicked the content will show in the right pane Figure 25 VSP Control Panel R EFERENCE M ANUAL ...

Страница 58: ...tings 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 reboot and the new settings will updated on the X ray detector Figure 26 Modify VSP Control Panel Settings ...

Страница 59: ...along 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 characters in length WARNING There is no back door available to the User or Varex for password recovery If the password is mismanaged it will result in the return of the X ray detector for service R EFERE...

Страница 60: ...ware 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 desired firmware click Update Firmware to send the image to the VSP and start the upgrade process Figure 28 Updating the Firmware ...

Страница 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 battery during firmware update WARNING Do not remove the Service Cable until the X ray detector s LED is blinking Green R EFERENCE M ANUAL ...

Страница 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 referred to as dark fields Prior to acquiring images an offset calibration must be performed in each mode The Offset calibration file created by this calibration is used by the corrections module to ...

Страница 63: ...t 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 Setting window 5 An Offset Calibration Progress window appears Figure 33 Offset Calibration Progress R EFERENCE M ANUAL ...

Страница 64: ...ess 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 Normalization is achieved by applying the flat field image acquired during the gain calibration to all images corrected by the VSP Gain calibration should be performed in the range where the detector is line...

Страница 65: ...justed 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 performed at least once per year The actual number of calibration frames used is determined by the system integrator depending upon their specific performance requirements Note ViVA provides the con...

Страница 66: ...n 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 apply X ray exposure Note The exposure should ideally be at a level and technique representative of the typical exposure dose for the detector during procedures Repeat The above procedure must be rep...

Страница 67: ...ation 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 average the gain calibration image for the current mode Figure 38 Gain Calibration Updating 5 When complete an updated message and successfully finished calibration message will appear The calibratio...

Страница 68: ...AL 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 the X ray detector If the X ray tube is replaced If the X ray detector is dropped ...

Страница 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 without gain and defect correction Gain Corrected A single gain corrected frame without defect correction Note When acquiring Corrected Offset Corrected and Gain Corrected images if preview is enabled an...

Страница 70: ...ges 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_SoftwareInterfaceSpecification PDF for an example of controlling the X ray Generator 1 Choose the desired imaging mode from the Mode Drop Down Menu Figure 42 Mode Drop Down Menu 2 Make sure Hardware Handshaking is sel...

Страница 71: ...W 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 Acquire Image R EFERENCE M ANUAL ...

Страница 72: ...l 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 Figure 46 Image Acquisition Progress 6 The acquired image can be saved in the desired file format by clicking File Save As ...

Страница 73: ...ck 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 ways to view or change calibration and system settings that are currently used in ViVA 1 Choose the desired imaging mode from the Mode Drop Down Menu Figure 48 Mode Drop Down Menu R EFERENCE M ANUAL...

Страница 74: ...dware 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 calibration see Section 11 12 4 Figure 49 Hardware Handshaking Not Selected Figure 50 Hardware Handshaking Selected ...

Страница 75: ...ee 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 Open System Settings Figure 52 System Settings window R EFERENCE M ANUAL ...

Страница 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 Acquire Image Setup from the menu bar under Acquisition Figure 54 Acquire Image Setup ...

Страница 77: ...e 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 input box Only values from 350 4000 ms will be accepted Figure 56 Enter Integration Time Note R EFERENCE M ANUAL ...

Страница 78: ...for 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 of the X ray detector is optimized to match the X ray dose used in each mode Table 15 Operational Mode Example Characteristic 4343W 4336W G5 2530W G5 Modes Radiography or vTrigger Radiography or vTrig...

Страница 79: ...n 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 sends notifications indicating the begin and end of integration These signals are used to interface with the X ray generator The exposure on notification indicates that integration has started and expo...

Страница 80: ...OEM 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 detector i e Automatic Exposure Detection Once X rays have been detected vTrigger automatically begins integration followed by image readout For modes that use vTrigger only the Prepare command is used to a...

Страница 81: ...r 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 the workstation software should call the Trigger API function When exposure on event is received the workstation soft ware should turn on the EXP_OK signal and when exposure off event is received the...

Страница 82: ...o 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 ready for X ray After one or more images are acquired the detector can be synchronized again with a client PC and image s transferred so they can be associated with the patient study Refer to docume...

Страница 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 explosion fire or electrical shock which may result in severe personal injury death or substantial product damage 14 1 1 Material Compatible Chemicals for Cleaning and Disinfecting All chemicals listed...

Страница 84: ...vident 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 ray detector 2 Locate and read the cleaning instructions specified on the product label Follow the product instructions for cleaning Note If you are using a disinfectant other than those specified we ...

Страница 85: ...ARNING 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 replacement of parts that may wear out after repeated usage avoiding the need to return the X ray detector to Varex for repair Contact Varex customer support Section 15 1 for procedure to replace the ...

Страница 86: ...ensure 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 should be set to 5GHz The detector will not run on the 2 4GHz frequency Detector causes Electro Magnetic Interference 1 Reorient or relocate the receiving device 2 Increase the separation between the equ...

Страница 87: ...roblem 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 the battery re establish the link 2 Ensure that the tube dose is set to the correct settings 3 Acquire another image at the recommended median count as stated in Section 11 12 3 4 If problem persists...

Страница 88: ...cal 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 another image at the recommended median count as stated in Section 11 12 3 4 If the problem persists add the defects to the defect map and redo a gain calibration 5 Acquire another image 6 Move the ...

Страница 89: ...name 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 battery charger reports an error 3 Inspect the detector for any physical damage 4 Insert a charged battery into the detector and see if it powers on 5 Re establish a link 6 Acquire an image from the detect...

Страница 90: ...e 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 If the X ray detector or accessories have been contaminated with potentially harmful substances they cannot be accepted without written evidence of decontamination See Section 14 1 2 and Section 14 ...

Страница 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 interference stops May require User intervention to clear an error message or continue operation 16 1 Electromagnetic Emissions Table 17 4343W Radiated Conducted Emissions Harmonics Voltage Fluctuations...

Страница 92: ...rposes 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 power supply network that supplies buildings used for domestic purposes 16 2 Electromagnetic Immunity Table 19 4343W ESD Transient Burst Surge Voltage Variation Magnetic Fields Immunity test IEC 6060...

Страница 93: ...tinued 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 A m 30 A m Magnetic field should be that of a typical location in a typical professional healthcare environment IEC 61000 4 6 3 Vrms 150 kHz to 80 MHz 6V m in ISM bands between 0 15MHz and 80MHz 80 ...

Страница 94: ...0 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 Hz 2 0 3 28 5240 5500 5785 5100 5800 WLAN 802 11 a n Pulse modulation b 217 Hz 0 2 0 3 9 Note If necessary to achieve the Immunity Test Level the distance between the transmitting antenna and the X ra...

Страница 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 interruptions and voltage variations on power supply input lines IEC 61000 4 11 Voltage dips 0 UT 100 dip in UT for 0 5 cycle at 0 45 90 135 180 225 270 315 0 UT 100 dip in UT for 1 cycle at 0 70 UT 30 dip in ...

Страница 96: ...V 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 Immunity Test Levels for this test the 30cm minimum separation distance in 5 2 1 1 f may be replaced with minimum separation distances calculated from the higher Immunity Test Levels Table 22 4336W G5 an...

Страница 97: ...0 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 guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Note Field strengths from fixed transmitters such as base...

Страница 98: ...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 interfere...

Страница 99: ...rtable 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 The user may find the following booklet prepared by the Federal Communications Commi...

Страница 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 ...

Страница 101: ...que cette dernière n émette pas de champs radioélectriques supérieurs aux limites specifées par Santé Canada pour le grand public consulter le Code de sécurité 6 disponible sur le site Web de Santé Canada à l adresse suivante www hc sc gc ca rpb This device complies with ISED license exempt RSS standard s Operation is subject to the following two conditions this device may not cause interference t...

Страница 102: ... These 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 1 172 W kg Ces exigences établissent une limite SAR de 1 6 W kg en moyenne sur un gramme de tissu La valeur SAR la plus élevée déclarée selon cette norme lors de la certification du produit à utili...

Страница 103: ... otras disposiciones aplicables o exigibles de la Directiva 1999 5 CE Ελληνική Greek ΜΕ ΤΗΝ ΠΑΡΟΥΣΑ Varex Imaging ΔΗΛΩΝΕΙ ΟΤΙ Radiolan ΣΥΜΜΟΡΦΩΝΕΤΑΙ ΠΡΟΣ ΤΙΣ ΟΥΣΙΩΔΕΙΣ ΑΠΑΙΤΗΣΕΙΣ ΚΑΙ ΤΙΣ ΛΟΙΠΕΣ ΣΧΕΤΙΚΕΣ ΔΙΑΤΑΞΕΙΣ ΤΗΣ ΟΔΗΓΙΑΣ 1999 5 ΕΚ Français French Par la présente Varex Imaging déclare que l appareil Radiolan est conforme aux exigences essentielles et aux autres dispositions pertinentes de la di...

Страница 104: ...ovak Varex Imaging týmto vyhlasuje že Radiolan spĺňa základné požiadavky a všetky príslušné ustanovenia Smernice 1999 5 ES Suomi Finnish Varex Imaging vakuuttaa täten että Radiolan tyyppinen laite on direktiivin 1999 5 EY oleellisten vaatimusten ja sitä koskevien direktiivin muiden ehtojen mukainen Svenska Swedish Härmed intygar Varex Imaging att denna Radiolan står I överensstämmelse med de väsen...

Страница 105: ...ice 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 or optional equipment connected to the analog and digital interfaces must be certified to the respective IEC standards i e IEC 60601 1 for medical equipment Furthermore all configurations shall comply...

Страница 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 Detector Dimensions in mm ...

Страница 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 ...

Страница 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 ...

Страница 109: ...3 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 Power Off 30 Power On 30 Reboot 31 I Image Acquisition Auto Save 48 Corrected Image 48 Debug Verbosity 48 Loop 48 Imaging Mode 48 Inductive Charger Screws 27 Inductive Charging 26 Install Battery 23 ...

Страница 110: ...ix 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 Repair 68 Trouble Shooting 64 Specifications Active Area 9 Environmental Considerations 6 Load Support 9 Signal Strength 9 Weight 9 Standards and Regulations 5 Standards Regulatory Requirements 5 T Temp...

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

Страница 112: ...lobal 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 other countries All other trademarks not owned by Varex Imaging or its subsidiaries that are depicted herein are the property of their respective owners Varex Imaging reserves the right to change th...

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