Carestream Focus 35C User Manual Download

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Safety and Regulatory Information

AJ4309 | 2019-08-13

1–3

This indicates operational temperature limits.

This indicates storage temperature limits.

This indicates the product radiates a wireless signal.

Package symbol: Fragile

Package symbol: Keep away from sunlight.

Package symbol: Keep dry.

This indicates the humidity limits.

Summary of Contents for Focus 35C

Page 1: ...Publication No AJ4309 2019 08 13 User Manual for the CARESTREAM Focus 35C Detector...

Page 2: ...s reserved No part of this manual may be reproduced or copied in any form by any means graphic electronic or mechanical including photocopying typing or information retrieval systems without written p...

Page 3: ...cluding consequential or special damages even if loss or damage is caused by Carestream Health s negligence or fault Note Notes provide additional information such as expanded explanations hints or re...

Page 4: ...law restricts this device to sale by or on the order of a physician CAUTION If you witness or become aware of a potential safety issue with this equipment take the appropriate safety measures and rep...

Page 5: ...ing from the use of any options or consumable products other than those dedicated as original products by Carestream It is the responsibilities of the user or physician to maintain the privacy of imag...

Page 6: ...Notices and Conventions 1 iv AJ4309 2019 08 13...

Page 7: ...4 Intended Use and Essential Performance 1 25 2 Overview Components and Specifications 2 2 Product Components 2 2 Product Specifications 2 6 IT Network 2 11 Service Information 2 14 Disposal 2 15 3 In...

Page 8: ...Generation A 29 Gain Calibration Template Generation A 30 Defect Correction Template Generation A 32 Image Check and Upload A 35 Local Image Check A 35 Panel Image Upload A 35 Defect Template Check an...

Page 9: ...nventions Labels and Markings on the Equipment WARNING This is used to identify conditions under which improper use of the product may cause death or serious personal injury This is used to indicate a...

Page 10: ...of 19 digits as shown in the following example 1A2A3A4 B1B2 C1C2 L M1M2 D1D2 Y1Y2 X1X2X3X4 1A2A3A4 Product code B1B2 Derived classes C1C2 Version L Production site M1M2 Month D1D2 Day Y1Y2 Year X1X2X...

Page 11: ...s indicates operational temperature limits This indicates storage temperature limits This indicates the product radiates a wireless signal Package symbol Fragile Package symbol Keep away from sunlight...

Page 12: ...Safety and Regulatory Information 1 4 AJ4309 2019 08 13 Keep the product upright Do not roll the transportation packaging This indicates the stacking limit number This indicates a Type B applied part...

Page 13: ...benzene etc Chemicals that are spilled or evaporated may result in fire or electric shock through contact with electric parts inside the product Also some disinfec tants are flammable Be sure to take...

Page 14: ...ce such as a heater Where the power supply is unstable In a dusty environment In a saline or sulfurous environment Where temperature or humidity is high Where there is freezing or condensation In area...

Page 15: ...ock that could result in death or serious injury WARNING Do not place heavy object on cables and cords Co not pull bend bundle or step on them to prevent damage to the sheath Do not alter them Avoid d...

Page 16: ...onnect multiple portable socket outlets or extension cords to the system to avoid fire or electric shock WARNING Connect this product only to a power supply with protective earth to avoid fire or elec...

Page 17: ...ous injury WARNING Be sure to hold the plug or connector to disconnect the cord If you pull the cord the core wire may be damaged resulting in fire or electric shock Power Supply CAUTION Always connec...

Page 18: ...fall and cause an injury Metal objects such as needles or clips that fall into the product or spilled liquid may result in fire or electric shock WARNING Do not strike drop or cause a strong jolt to t...

Page 19: ...ectric shock In such a situation protect the equipment with a disposable cover as neces sary CAUTION For safety Turn OFF the power and remove the plug for all equipment when not used CAUTION Handle th...

Page 20: ...o the internal image sensor and an incorrect image Patients stand on the product temporarily and the intended weight can be 135 kg Based on the internal TFT character cannot load the dynamic forces du...

Page 21: ...m bending and doing damage to the internal image sensor Be sure to securely hold the product while using it in an upright positions to prevent the product from tipping or flipping over resulting in in...

Page 22: ...o not use the battery outside of the guidelines Do not dispose of the battery or change the inner structure Do not submerge the battery in water When in use do not allow the battery to have contact wi...

Page 23: ...hat the surface and connectors are dry before turning on the product to avoid fire or electric shock WARNING Clean the power cord connector periodically Disconnect the connector from the AC outlet Use...

Page 24: ...ect has entered through an opening When the product has been dropped and damaged Type of protection against electrical shock External electrical power source equipment Class I Equipment medical approv...

Page 25: ...fety requirements for portable sealed secondary lithium cells and for batteries made from them for use in portable applications Part 2 Lithium systems IEC 62220 1 1 2015 EN 62220 1 1 2015 Medical elec...

Page 26: ...01 1 14 Medical electrical equipment Part 1 General requirements for basic safety and essential perfor mance ISO 15223 1 2016 EN ISO 15223 1 2016 Medical devices Symbols to be used with medi cal devic...

Page 27: ...35C Detector is suit able for use in all establishments including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for d...

Page 28: ...ion 1 kHz sine 28 V m 710 704 787 Pulse modulation 217 Hz 9 V m 745 780 810 800 960 Pulse modulation 18 Hz 28 V m 870 930 1720 1700 1990 Pulse modulation 217 Hz 28 V m 1845 1970 2450 2400 2570 Pulse m...

Page 29: ...4 11 0 UT 1 cycle and 70 UT 25 30 cycles Single phase at 0 Voltage interruptions IEC 61000 4 11 0 UT 250 300 cycles Emissions Test EMC Standard Test Levels Professional healthcare facility environmen...

Page 30: ...the system and create a potentially unsafe situation The minimum distance between the panel and other equipment should be larger than 12 inch Focus 35C conforms to this EN60601 1 2 2015 standard for b...

Page 31: ...ause harmful interference to radio or television reception which can be determined by turning the panel off and on the user is encouraged to correct the interference by one or more of the following me...

Page 32: ...kaline or other non acid electrolytes Safety requirements for portable sealed secondary cells and for batteries made from them for use in portable applications First Edition UL 2054 Household and comm...

Page 33: ...panel is not intended for mammography and extra oral X ray applications Essential Performance For Focus 35C the intended use and the result of risk management getting imaging and function of data tran...

Page 34: ...Safety and Regulatory Information 1 26 AJ4309 2019 08 13...

Page 35: ...between the panel and the workstation and is powered by an internal battery Scope This manual contains information about the Focus 35C Information in the manual including the illustrations is based on...

Page 36: ...Overview 2 2 AJ4309 2019 08 13 Components and Specifications Product Components Component Description Detector Figure 1 External Signals Figure 2 Input Control Panel...

Page 37: ...ort For service C Detector indicator Detector indicator of control panel D Power button Power button of control panel E Mode button Mode switch F Antenna Item Description Notes A Battery label B Batte...

Page 38: ...Battery Interface A 8 pin battery connector B Battery Interface B Not used C Battery Interface C Not used D Indicator The indicator definition is as follow E The limit ball plug F Hand Pull Position...

Page 39: ...ted X Indicator Operating Status All off No power input A indicator on AC power input Multiple batteries inserted A indicator on B and C alternately blink 2 times Battery insertion self test A and B i...

Page 40: ...3 3 Lp mm Image Acquisition Time Wireless Both AP Mode and Client Mode Preview acquisition time 3 sec Processed acquisition time 5 sec Cycle Time Min 8 sec Power Consumption Max 18 W Dimension L W H...

Page 41: ...2C Nominal voltage 10 8 V Charge voltage 12 6 0 05 V Discharged end voltage 9 V Charging method CC CV Operating temperature Charge 0 60 C 32 140 F Discharge 0 60 C 32 140 F Storage temperature 3 month...

Page 42: ...ertificate number SG PSB MD 00191 Item Specifications Model Charger Combo Simultaneous Charging 1 Battery Pack Full Charging Time 3 hr Rated Power Supply 90 264 V ac Dimension L W H 240 0 x 184 0 x 38...

Page 43: ...745 5 85 GHz ch149 ch165 Data Transmission Rate 802 11b Max 11 Mbps 802 11a g Max 54 Mbps 802 11n Max 300 Mbps MIMO 2x2 802 11ac Max 867 Mbps MIMO 2x2 Modulation 802 11b CCK DQPSK DBPSK 802 11a g n 6...

Page 44: ...ure Pressure Change Operating 5 35 C 41 95 F 1k min 10 90 RH 700 1060 hPa 10 kp min 1 kp 1 0197E 5Pa Storage 20 55 C 4 131 F 1k min 5 95 RH 700 1060 hPa 10 kp min 1 kp 1 0197E 5Pa Focus 35C detectors...

Page 45: ...patibility of the operating system is not compatible Inability to update or change software Incompatibility of the interface Inconsistency of interface or format leads to data distortion Data transfer...

Page 46: ...r format leads to data distortion Data output failed Warning Connection of the main unit to an IT network that includes other equipment could result in previously unidentified risks The manufacturer o...

Page 47: ...Overview AJ4309 2019 08 13 2 13 Connection of additional items to the IT network Disconnecting of items from the IT network Update of equipment connected to the IT network...

Page 48: ...justments or replace consumables such as fuses etc There may be cases where an overhaul is recommended depending on conditions Contact Carestream service or your local dealer for regular inspection or...

Page 49: ...le electrical or electronic waste Contact your local authorities for information about dropping off waste products for recycling If collection systems are not available call Carestream Customer Servic...

Page 50: ...Overview 2 16 AJ4309 2019 08 13...

Page 51: ...etector Battery The detector can be powered by the battery package or DC power The detector will be activated as soon as power is supplied and will power off as soon as power is removed 1 Make sure th...

Page 52: ...toward the center of the detector Power on the Detector On the control panel the power button is used to power the detector on and off To power on the detector press and hold the power button for 4 s...

Page 53: ...ting up the user can check the status LED indicator Power Indicator Lighting Status Operating Status Operating Battery Capcity DC Input OFF Power OFF Orange ON Power ON 20 No Green ON Power ON Battery...

Page 54: ...rating Battery Capcity DC Input Power Indicator Lighting Status Description Off Shut down Wired connection broken and wireless connection not ready Green On Wired connection is built Blue On Client mo...

Page 55: ...Exposure prohibit Green On Exposure enable Green Blinking Exposure enable Orange On Error Orange Blinking Safety mode Power Indicator Lighting Status Description Off Shut down Wired connection is bui...

Page 56: ...Long hold Power button hold for 4 sec onds Mode button hold for 7 sec onds Forced restart Power ON Long hold No action Hold for more than 7 sec onds when the Power indica tor is OFF and then ON releas...

Page 57: ...2019 08 13 3 7 Install the Detector Battery Charger 1 Remove the battery from the battery charger 2 Insert battery into battery charger in the orientation shown below 3 Press the battery down into the...

Page 58: ...detector and power it on 2 Connect the other end of the adapter to the PC 3 Insert the battery into the detector 4 Open a web browser and enter the following address http 10 0 1 150 cgi bin ship mode...

Page 59: ...sert the battery into the detector 3 Press the power button for approximately 4 seconds to shut down the detector 4 In the shutdown state press the power button 3 times to exit ship mode Charger 1 Pow...

Page 60: ...Installation 3 10 AJ4309 2019 08 13...

Page 61: ...emperature gradually The product should be warmed up for 15 minutes before exposure or updating the gain map and defect map Make sure exposure rate is over 900 nGy s 70 KV Make sure the wave form of t...

Page 62: ...r details on how to sterilize consult a specialist CAUTION Do not spray disinfectants or detergents directly onto the detector To prevent damage to the surface of the detector wipe with a cloth slight...

Page 63: ...Operation AJ4309 2019 08 13 4 3 Detector Position To prevent abnormal light lines place the detector behind the patient in the orientation shown below...

Page 64: ...Operation 4 4 AJ4309 2019 08 13...

Page 65: ...ges free for use after connecting the detector 3 SDK Configure UI for SDK free for use after connecting the detector 4 Detector Configure UI for detector free for use after connecting the detector 5 C...

Page 66: ...ctor 10 Remove Delete the instance for one detector 11 Syncbox Manage the syncbox Item Description Function Tab Description SN Serial number of the detector Status Status of the detector busy or ready...

Page 67: ...acceptable Is not green while taking an x ray the image quality will be degraded General Settings Parameter Description Can be Modified Product No Type number of the detector No Sub Product No Sub ty...

Page 68: ...mode Yes Exp Window Time Exposure Window for Software Inner mode the value should not be larger than 10s Yes Acquire Delay Time Reserved Yes Integrate Time Should not be modified keep the original va...

Page 69: ...08 13 A 5 Hvg Prep On Reserved Yes Hvg XRay Enable Reserved Yes Hvg XRay On Reserved Yes Tube Ready Time Reserved Yes Image Pkg Gap Time Reserved Yes Out Mode Cap Trigger Reserved Yes Parameter Descri...

Page 70: ...Port Port of local workstation Yes Ftp Download Host IP FTP download server IP keep the same as Host IP Yes Ftp Download Host Port FTP download server Port keep the same as Host Port Yes Ftp Upload Ho...

Page 71: ...he AP Key Up Move up the AP information Down Move down the AP information Select Select the AP Read Config Read the parameters of the AP information when the detector is set as AP Write Config Write t...

Page 72: ...ays Work Flow 1 Workstation receives prep request and sends clear command to the panel 2 Panel receives clear from the workstation and starts clearing leakage from the panel Meanwhile the panel sends...

Page 73: ...libration is on Time Setting To set a clear scenario for programming see the diagram below Inner2 Mode Block Diagram The workstation is a host PC device installed with iDetector and SDK Installation d...

Page 74: ...ear scenario for program see the diagram below Freesync Mode Block Diagram The workstation is a host PC device installed with iDetector and SDK Installation describes how to establish connections betw...

Page 75: ...uploading Post dark image to the workstation If hardware offset is selected panel first performs correction and calibration and then uploads the processed image to the workstation 5 Workstation receiv...

Page 76: ...Installation Do the following if the iDetector application is not working 1 Install MICROSOFT NET Framework 4 5 2 Install vcredist_x86_2013 or vcredist_x64_vs2013 Important The iDetector application s...

Page 77: ...should be configured per site requirements Wireless Client Mode Wireless AP Mode Wireless Client Mode 1 Connect one end of the Gigabit Ethernet cable to the workstation 2 Connect another end to the LA...

Page 78: ...Appendix A 14 AJ4309 2019 08 13 4 In the Connections field click on Local Network 5 Open the IPV4 settings 6 For the IP and network mask setting select Obtain an IP address automatically...

Page 79: ...re 2 4 GHz wireless network SSID NETGEAR_BIG_24 Security WPA2 PSK Password 12345678 Channel Check the current Wi Fi environment and choose a relatively clean channel 10 Configure 5G Hz wireless networ...

Page 80: ...ddress 192 168 8 1 Subnet Mask 255 255 255 0 12 Do an external wireless AP reboot Apply the above settings and reboot your wireless router 13 Recover the local network IPV4 setting IP setting IP addre...

Page 81: ...Appendix AJ4309 2019 08 13 A 17 14 Connect the panel to the workstation with the Ethernet cable 15 Select Detector Wifi Read Config Client 16 Select Add and enter the SSID and Password Select Apply...

Page 82: ...s 18 Turn on the wireless router a Make sure there is a wired connection between the outer work station and IP 192 168 8 188 b Select Read Wifi Status to check wireless transmission status numerical v...

Page 83: ...d only be used by the service operator To start configuration with wired cable it is necessary to complete this procedure 1 Connect the panel to the workstation with the Ethernet cable 2 Select the De...

Page 84: ...rom others already used 6 In the Frequency field click on the arrow and select a value from the drop down list 7 In the Country field click on the arrow and select a country from the drop down list 8...

Page 85: ...remove the wired cable until the FPD status is Ready The detector will connect to the wireless AP the next time it is powered on 10 Configure the external wireless card a Open the local wireless signa...

Page 86: ...endix A 22 AJ4309 2019 08 13 c Open the wireless card configuration d Open the IPV4 setting and set the following values IP setting IP address 192 168 8 188 Network mask setting Subnet mask 255 255 25...

Page 87: ...Appendix AJ4309 2019 08 13 A 23 e Open SDK and select the detector f Select Connect...

Page 88: ...uble click the window using the right mouse but ton The window level and width are adjusted to WL 32767 WW 65535 Drag the left mouse button to move the displayed image Drag the right mouse button hori...

Page 89: ...the default of 28000 Note When the connection is changed to a different network card the user must reconnect the detector using a different IP address The rule of Multi Share control is based on the I...

Page 90: ...onfigure the Detector 1 From the iDetector menu select the Acquire tab 2 Acquire the module related setting such as loading correction and calibration template acquiring images 3 See the SDK module re...

Page 91: ...settings such as trigger module wireless signal 5 Calibrate the module related setting such as making correction and calibration template The template in the panel could be uploaded to a workstation a...

Page 92: ...Appendix A 28 AJ4309 2019 08 13 6 See the Local File module related setting such as import a Raw or DCM image...

Page 93: ...orm the new correction and calibration after any major change to the system settings and hardware configuration It is also recommended to do the correction and calibration every 6 months Pre offset Te...

Page 94: ...lete the screen will display Offset MAP Generated Gain Calibration Template Generation Before doing this procedure make sure SID1 2m no copper is required Actual screens may be different from those sh...

Page 95: ...en completed select Acquire to get the light image 5 If the value meets the expected value select Accept and then acquire the other four images If the value does not meet the expected value do not cli...

Page 96: ...template Defect Correction Template Generation Before doing this procedure make sure SID1 2m no copper is required Actual screens may be different from those shown in this procedure Note Use software...

Page 97: ...en completed select Acquire to get the light image 5 If the value meets the expected value select Accept and then acquire the other seven images If the value does not meet the expected value do not se...

Page 98: ...e to generate the gain template Note Make sure your x ray dose is correct If your dose is out of the range iDetector will remind you to adjust the dose Then you can select start creating and try again...

Page 99: ...ck images saved in the workstation Panel Image Upload is used to upload images stored in the panel Local Image Check 1 From the Local File tab select Load File Choose the specified file 2 Choose the i...

Page 100: ...etector will be listed 3 Select Upload Images and choose the specified image Select OK When the state changes to Success the image has been uploaded The upload process can be canceled by selecting Sto...

Page 101: ...ty to check the defect template If the template has updates the user can add and delete pixels or defective lines by modifying the opened defect template Defect Template Check 1 From the Local File pa...

Page 102: ...ate Modification 1 Open the specified defect template The defect management dialog box will be displayed 2 Locate the pixel that needs to be managed type the coordinates of the pixel and select Add Th...

Page 103: ...cted the information will be removed from the template 3 Select Save 4 It is similar to manage the defect pixel If the user needs to add the defect line type the coordinates of the line and select Add...

Page 104: ...ation The detector supports correction and calibration template storage Templates in the detector can be uploaded to a workstation and templates in a workstation can be downloaded to a detector 1 Afte...

Page 105: ...Appendix AJ4309 2019 08 13 A 41 3 Select Read Status 4 If the Activity column shows disable select the row and select Active to enable it...

Page 106: ...o correction and calibration In software correction and calibration the workstation completes all correction and calibration In hardware correction and calibration the panel completes all correction a...

Page 107: ...Appendix AJ4309 2019 08 13 A 43 2 Select HWPostOffset HWGain HWDefect Note The hardware based calibration is on 3 Select SWPostOffset SWGain SWDefect Note The software based calibration is on...

Page 108: ...net can be used to upgrade the detector firmware This procedure applies to MCU FPGA and ARM 1 Connect the panel to a PC 2 Open a browser type 192 168 8 8 in the search bar and then press Enter 3 Enter...

Page 109: ...uares located on the left side of the screen 5 Select Upgrade and then Browse 6 Select one the firmware files from the list and select Open MARS141V3TIS_IMAGE_MCU_xxxx_xx_15 ifm MARS141V3TIS_IMAGE_FPG...

Page 110: ...3TIS_IMAGE_ALL_xxxx_xx_15 ifm will allow all three versions of firmware to be updated at the same time 7 When the selected file name is displayed on the interface select Upgrade 8 Select Close when th...

Page 111: ...Appendix AJ4309 2019 08 13 A 47 9 If the upgrade is successful the following interface screen will be displayed Note If the screen is not displayed the upgrade has failed...

Page 112: ...Appendix A 48 AJ4309 2019 08 13...

Page 113: ...AJ4309 2019 08 13 I Publication History Version Date Changes A 2019 08 13 Initial release...

Page 114: ...estream Health Inc 150 Verona Street Rochester NY USA 14608 Carestream Health Inc 2019 Made in China for Carestream Health Inc CARESTREAM is a trademark of Carestream Health Pub No AJ4309 Rev A i3Y PO...

Page 115: ...eption which can be determined by turning the equipment off and on the user is encouraged to try to correct the interference by one or more of the following measures Reorient or relocate the receiving...

Page 116: ...r this device the highest FCC reported SAR value for usage against the head is 0 152W kg and for usage near the body is 0 137W kg the highest CE SAR value for usage against the body is 0 090W kg While...

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