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Notes on the user manual

000000-2227-967-GA-GB-281021

Notes on the user manual

Purpose and availability of the documentation

This user manual describes the safety precautions, functions, usage and

performance parameters, as well as care and maintenance measures for the

ZEISS VISUREF® 150 Autorefractor/Keratometer.

Correct operation of the device is imperative for safe and effective functioning.

You should therefore ensure that you are thoroughly familiar with this user

manual before setting up and using the device for the first time.

The user manuals and other documentation enclosed with the device should

be kept accessible to users at all times, to ensure that the information

required for using the device is readily available.

Questions and comments

If you have any questions or comments concerning this user manual or the

device, please contact ZEISS service or your local dealer. (Contact details see

reverse.)

Содержание VISUREF 150

Страница 1: ...ZEISS VISUREF 150 Autorefractor Keratometer Documentation set...

Страница 2: ...ks Carl Zeiss Meditec AG checks their content to ensure that it is not likely to result in civil or criminal liability It does not however continuously check for any changes which could form the basis...

Страница 3: ...000000 2227 967 Inhalt0 GB 281021 Contents User manual ZEISS VISUREF 150 Autorefractor Keratometer 000000 2227 967 GA GB 281021...

Страница 4: ......

Страница 5: ...ZEISS VISUREF 150 Autorefractor Keratometer User manual...

Страница 6: ...000000 2227 967 GA GB 281021...

Страница 7: ...duct 10 External labels 11 Performance specifications 14 Functional description 14 Service life 15 Description of the device 16 Installation 19 Notes on installation and use 19 Unpacking the device 19...

Страница 8: ...1 Preparation of the device for measurement 51 Positioning the patient and explaining the procedure to the patient 57 Performing a measurement 58 Data display in the review screen 61 Measurement of pu...

Страница 9: ...07 Care and cleaning 108 Cleaning and disinfection of painted surfaces 109 Safety inspections 110 Transport 111 Transport without packaging 111 Transport with packaging 111 Technical data 113 Electrom...

Страница 10: ...ve for safe and effective functioning You should therefore ensure that you are thoroughly familiar with this user manual before setting up and using the device for the first time The user manuals and...

Страница 11: ...mation in this user manual and on device labels WARNING Indicates a hazardous situation which may result in death or serious bodily injury if the appropriate safety precautions are not heeded CAUTION...

Страница 12: ...en delivered 4 Documentation set 5 Dust cover 6 2 fuses see Section Technical data page 113 7 Data carrier with source data of free software components optional 8 Network cable 9 USB storage device 10...

Страница 13: ...ent prevention regulations Further notes on classification are to be found in Section Technical data page 113 and following Device group 1 in accordance with ISO 15004 2 max radiation intensity 117 1...

Страница 14: ...ts who are unable to sit upright in front of the device Patients who have forehead or chin injuries that prevent the head from being supported on the forehead chin rest Patients whose eyes exhibit an...

Страница 15: ...d maintained by persons who have been properly trained or who have the required knowledge and experience to do so Please also adhere to the national qualification guidelines applicable in your country...

Страница 16: ...l of the product within the EU In accordance with applicable EU guidelines and national regulations at the time at which the product was brought onto the market the product specified on the consignmen...

Страница 17: ...Country specific information and labels 000000 2227 967 GA GB 281021 11 External labels Fig 2 External labels 7 2 18 14 4 1 6 5 17 8 9 10 16 15 11 12 13 19 3 20 21...

Страница 18: ...VISUREF 150 Catalogue number part number Serial number UDI Unique device identification code data matrix and plain text 3 Device identification code data matrix serial number and device name 4 Label...

Страница 19: ...l with fuse specifications 13 Information label Disconnect device from the power supply before opening 14 Not applicable Not applicable 15 Applied part type B 16 Applied part type B 17 Not applicable...

Страница 20: ...purpose of enhancing the visual inspection of the measured object and optimizing the measurement These include the intensity of the ambient light on the measured object reference illumination and ill...

Страница 21: ...directory on a network folder and or USB drive Furthermore the measured data can be sent to a network printer for printing or to the ZEISS subjective refraction system comprising the VISUSCREEN 100 50...

Страница 22: ...the device 1 Status LED illuminated device switched on flashing screen saver activated 2 LCD monitor 3 Printer cover 4 Stage locking lever 5 Buttons for chin rest height adjustment 6 Measuring button...

Страница 23: ...000000 2227 967 GA GB 281021 17 1 Forehead rest 2 Measurement window 3 Dust cap 4 Chin rest 5 Fixing pins for chin rest paper 6 Canthus markers Reference mark for optimum eye level of patient Fig 4 Pa...

Страница 24: ...00 2227 967 GA GB 281021 18 1 Clamping screw to lock the stage for transportation 2 Fuses 3 Power input socket 4 Monitor output 5 USB port with cover 6 Power switch 7 RS232 interface 8 Network connect...

Страница 25: ...store alcohol and other flammable vapors and liquids in the vicinity of this equipment CAUTION DANGER FROM FALLING PARTS When selecting a suitable table ensure that the combination of table and devic...

Страница 26: ...head or the patient We recommend the use of a height adjustable instrument table This facilitates the positioning of the patient in front of the device for achieving good measuring results Do not use...

Страница 27: ...data on the type label WARNING RISK OF ELECTRIC SHOCK Be sure to turn off the power switch before connecting to or disconnecting the device from a power supply grid Connect the power supply cable int...

Страница 28: ...g further equipment to medical device you are configuring a medical system and are thus responsible for ensuring compliance with the requirements for medical electrical systems Please observe that loc...

Страница 29: ...ronment Measures for reducing leakage current include using a medically approved isolation transformer If a non medical grade LCD monitor or PC is to be used with the autorefractor keratometer system...

Страница 30: ...If devices are used which do not comply with IEC 60601 1 an isolating transformer is required to power the device or connect the devices to additional protective grounding 3 2 1 5 4 6 1 Peripheral eq...

Страница 31: ...logical or physical network configuration New integration or removal of other network participants or network accessories Updates or upgrades of network participants CAUTION PROPERTY DAMAGE When conn...

Страница 32: ...ation The device does not require any special network settings for proper functioning If the network is incorrectly configured the basic functioning of the device will not be impaired although some of...

Страница 33: ...device has been started booted the start up screen will be displayed Fig 8 Start up screen During initial start up of the device or after a reset to factory settings an input mask will be displayed f...

Страница 34: ...alization Here you can set basic settings of your device These settings can be displayed and modified at any time using the Device settings symbol Select the desired language and tap on Next Fig 9 Dev...

Страница 35: ...ectivity Using the serial interface Switch off both devices and plug the RS 232 cable into the corresponding connecting ports of the ZEISS VISUREF 150 7 Fig 5 and the receiving device e g your i Com s...

Страница 36: ...ace enablement menu see Section Interface submenu page 95 Exit the device settings The SMB2 protocol is used for communication with the network server Direct data transmission via network Connect the...

Страница 37: ...ORUM user manual and the corresponding instructions Switch to device settings Enable the interface in the Interface Interface enablement menu see Section Interface submenu page 95 Open the Interface L...

Страница 38: ...Initial start up 000000 2227 967 GA GB 281021 32 Fig 11 Enter the peer address and select output format and protocol...

Страница 39: ...bmenu page 95 Open VISUCONSULT 500 and note the IP address of your i Com server Open the Interface LAN Network socket menu see Interface submenu page 95 Enter the IP address of your i Com server into...

Страница 40: ...n via web server is only possible if your EMR PMS system supports this data exchange service Connect the device to your network To do this plug the network cable 8 Fig 1 into the relevant socket 8 Fig...

Страница 41: ...are missing or damage is visible the device should not be used and should be taken out of service WARNING RISK OF ELECTRIC SHOCK Please take care that the following operational requirements are met b...

Страница 42: ...device if you do not know the user PIN Contact your device administrator Fig 13 Entering the user PIN Open the printer cover 3 Fig 3 and check that the printing paper is properly inserted and suffici...

Страница 43: ...hand or fingers under the chin rest This could result in damage or injury CAUTION RISK OF FALSE DIAGNOSIS Direct and lateral light incidence to the front of the device or eye being examined should be...

Страница 44: ...ng messages are displayed on the screen Fig 14 Error message example Operating concept Position the patient for measurement using the joystick 7 Fig 3 and buttons for chin rest height control 5 Fig 3...

Страница 45: ...screen contains measurement and review screens The device settings can also be changed see Section Device settings page 87 The different setting menus can be opened by tapping the Settings icon 7 Fig...

Страница 46: ...me 3 Refraction measurement mode Refraction 4 Pupil diameter measurement mode Pupil 5 Image capture mode Image 6 Contact lens measurement mode 7 Settings 8 Lock device 9 Upper navigation bar 10 Lower...

Страница 47: ...n be shown grey letters 5 Settings 6 Upper navigation bar 7 Display field for left eye measurement results OS 8 Navigation arrow to results of single measurements optional 9 Lower navigation bar 10 Se...

Страница 48: ...The Device settings window has up to three navigation levels consisting of an upper tab display 2 Fig 19 a lower tab display 4 Fig 19 and various detail pages 3 6 Fig 19 The selected upper and lower t...

Страница 49: ...cond navigation level 5 Number of detail pages on third Navigation level current selection is highlighted in black 6 Direction arrows for navigating through the detail pages third navigation level Fig...

Страница 50: ...s shown summarizing the information input field and input format 14 Fig 21 Capitals can be entered using the Cap button 12 Fig 21 or the Shift button 11 Fig 21 If these buttons are activated they appe...

Страница 51: ...input field 4 Delete the character before the current cursor position 5 Enter button for line break 6 OK button Save and close 7 Buttons for positioning the cursor 8 Access to punctuation marks long...

Страница 52: ...be identified by a device internal counter and not allocated to patient data The various options offered for linking measurement and patient data are explained in Section Patient selection page 47 Th...

Страница 53: ...to display the patient list as a pull down menu The list is not updated in the overview screen To update the list go back to the measurement screen 13 Fig 17 The user has now several options Select a...

Страница 54: ...ously selected from the patient list the device goes back to the unscheduled patient selection as the default setting Patients are displayed in the patient list in chronological order of assignment to...

Страница 55: ...exception of the family name all elements of the pattern are optional The different elements can only partially describe the searched data record The abbreviations m male f female or d diverse can be...

Страница 56: ...GB 281021 50 Fig 23 Text input field to define a patient search Select a patient from the displayed list Fig 24 Fig 24 Patient selection list In Russian Korean Japanese and Chinese languages the patie...

Страница 57: ...atient default setting Select the Refraction menu in the upper navigation bar As soon as the word Refraction is displayed in blue the Refraction measurement mode is enabled 1 Fig 25 Select the mode fo...

Страница 58: ...mode Checking the device settings Check the enabled device settings for refraction measurement Use the parameter control panel 4 Fig 25 on the measurement screen or the general access to device settin...

Страница 59: ...e parameter control panel are not to be edited with a single click this function can be disabled To do this select the Direct control parameter in the Interface User User interaction tabs of the Devic...

Страница 60: ...pathological finding the Standard mode illumination parameters can be retained Table 3 summarizes the illumination parameters of the device Illumination parameters Description Scale Reference Controls...

Страница 61: ...case of a user defined change of illumination parameters the device cannot perform keratometry Keratometry values can only be measured in Standard and IOL illumination mode Illumination mode Applicat...

Страница 62: ...u can also return to the pre set illumination modes by selecting Standard or IOL Table 4 If you use one of the pre set modes the illumination parameters are displayed in grey Fig 28 If you use the IOL...

Страница 63: ...tons 5 Fig 3 adjust the motorized chin rest so that the patient s eyes are set to the height of the Canthus marks 6 Fig 4 Disinfect the chin rest after each patient CAUTION RISK OF PINCHING The motori...

Страница 64: ...the pupil into the inner ring of the cross hairs move the joystick to the left or right For fine adjustment of the height rotate the joystick As soon as the eye is focused and centered the cross hair...

Страница 65: ...f measurement results for a measurement sequence of OD measurement screen without display of pupil distance Patient eye identified laterality displayed cross hairs displayed in yellow as eye is not ce...

Страница 66: ...results for a measurement sequence of OS measurement screen including display of pupil distance Now tap on Review to switch to the review screen in refraction mode and display the measurement results...

Страница 67: ...is SE Spherical equivalent Keratometry R1 Corneal curvature radius for flat meridian K1 k value for flat meridian R2 Corneal curvature radius for steep meridian K2 k value for steep meridian A Axis of...

Страница 68: ...es of each parameter and each measurement within this measurement sequence can be displayed The detailed display 7 Fig 33 can be opened by tapping on the desired measurement value in the corresponding...

Страница 69: ...onvert them on the basis of the selected parameters Depending on the selection of the output unit of keratometry the user interface shows the R1 or R2 corneal curvature values in mm or the K1 or K2 va...

Страница 70: ...nctions in Pupil mode Preparation of the device for measurement Selecting the measurement mode Select the desired patient from the patient list see Section Patient selection page 47 or start anonymize...

Страница 71: ...Pupil measurement mode enabled 3 Laterality display 4 Live image of the eye moving 5 Open the review screen 6 Confirmation disabled 7 Zoom disabled 8 Illumination Fig 38 User interface in Pupil measur...

Страница 72: ...e of the eye using the joystick Press the measuring button of the joystick 6 Fig 3 to capture an image As soon as the device has captured an image the moving live image 4 Fig 38 will be replaced by th...

Страница 73: ...etermined from the distance of the two measurement lines will be displayed below the laterality display 1 Fig 39 This value changes with each movement of the measurement line In order to perform a mea...

Страница 74: ...om function in Pupil mode Close the pop up window Zoom by tapping again on the Zoom button After closing the Zoom pop up window the selected magnifying factor is displayed beside the magnifying glass...

Страница 75: ...eturns to the live image mode see also Fig 36 and Fig 38 Now you can measure the diameter again Fig 42 Confirm image discard When both measurement lines are correctly positioned confirm the measuremen...

Страница 76: ...aragraph Data display in the review screen page 61 of Section Measurement of refraction and keratometry The image on which the measurement is based and the measurement lines are stored together with t...

Страница 77: ...st see Section Patient selection page 47 or start anonymized measurement default setting Select the Image menu in the upper navigation bar As soon as the word Image is displayed in blue the Image meas...

Страница 78: ...firmation 5 6 Fig 45 buttons are disabled 1 Image capture mode Image enabled 2 Laterality display 3 Live image of the eye moving 4 Open the review screen 5 Confirmation disabled 6 Zoom disabled 7 Sele...

Страница 79: ...take an image of the eye Focus and center the displayed live image of the eye using the joystick Press the measuring button of the joystick 6 Fig 3 to capture an image As soon as the device has captu...

Страница 80: ...measuring button on the joystick once 6 Fig 3 A query is displayed if you want to discard the image really This message can be suppressed by changing the device settings in the Interface User User in...

Страница 81: ...right eye OD Fig 47 Image review screen with 4 images When tapping on the displayed preview images 1 and 7 Fig 47 a pop up window will open to display the selected image in full screen mode Fig 48 Th...

Страница 82: ...ages in full screen mode Fig 48 Image capture in full screen mode Now finish the image capture by one of the following actions Save the images by tapping Finish Further notes on this are to be found i...

Страница 83: ...of the test eye and insert the contact lens 2 Fig 1 and insert the contact lens so that its convex side points downwards to the test eye surface Fig 49 Fig 49 Attaching the contact lens to the rear o...

Страница 84: ...to perform measurement Tap on the corresponding side of the two function button The activated measurement mode will be displayed in white on a blue background In Manual measurement mode measurement is...

Страница 85: ...reen 6 Parameter control panel disabled 7 Select the illumination parameters disabled Fig 51 User interface in contact lens measurement mode Focus and center the measuring head as described in Section...

Страница 86: ...esults in the measurement screen of contact lens mode To measure another contact lens release the test eye from the chin rest and carefully remove the contact lens Repeat the steps described in Sectio...

Страница 87: ...ry subsection Data display in the review screen page 61 Fig 53 Contact lens review screen with detailed display of a single measurement value Finish the measurement by one of the following actions Sav...

Страница 88: ...reselection of data to be deleted example for refraction keratometry data If you want to delete data of a certain single measurement and not all data of a selected type navigate to the display of the...

Страница 89: ...ed during measurement of the pupil diameter the corresponding measurement value will also be deleted Delete a selected patient from the current patient list of the device or delete the complete list D...

Страница 90: ...ough the various elements of the open measurement Output of measurement results Measurement results can be output using the Finish button This button has two functions On the left side the word Finish...

Страница 91: ...sh button By tapping on the corresponding line you can perform one of the options in the Finish pop up window During measurement result output details on the individual steps are displayed on the scre...

Страница 92: ...e device the next patient in the list will be selected Use the Patient ID context menu 1 Fig 22 to select another patient or anonymized measurement unscheduled patient option Configure the measurement...

Страница 93: ...f the access to device settings is protected by a PIN code see page 34 you will be asked to enter the administrator PIN code Fig 59 After you have entered the PIN code correctly the Device settings wi...

Страница 94: ...21 88 General submenu On the second navigation level in the General submenu you can find the Basic settings Administration and Service tabs Fig 60 Table 5 explains the user setting options in the Gene...

Страница 95: ...eric code Administration PIN protection for administration and configuration of the device Enabled Disabled Administrator PIN Define a PIN for administration configuration of the device Numeric code S...

Страница 96: ...e desired file can be selected Save log file Saves the log file of the device on a USB drive or network folder No selection possible Reset to factory settings Resets the device to factory settings All...

Страница 97: ...device Last mode Refraction Pupil Image Contact lens Trigger mode Select manual or automatic measurement triggering On manual triggering the user must release measurement by pressing the measurement b...

Страница 98: ...021 92 Output submenu On the second navigation level in the Output submenu you can find the Basic settings Format and Advanced settings tabs Fig 62 Table 7 explains the user setting options in the Out...

Страница 99: ...op up menu is shortened by one line Back Local printer Local printer template Network printer Network printer template No option Menu option 1 Menu option 2 Menu option 3 Menu option 4 Format Page 1 2...

Страница 100: ...ade in the recent past on neighboring devices only if web service is enabled see following parameters Consider allocations on neighboring devices Allows you to access the data of patients for whom mea...

Страница 101: ...Interface submenu On the second navigation level in the Interface submenu you can find the Basic settings User Printer Serial USB and LAN tabs Fig 63 Table 8 explains the user setting options in Inte...

Страница 102: ...etwork printer Enabled Disabled Folder Enabling data input output via network folder Enabled Disabled Socket Enabling direct data output on EMR PMS application within the network Enabled Disabled Web...

Страница 103: ...the second eye the device automatically switches to the review screen Standard Simplified User Page 3 3 Sound playback Monitor Sound playback upon tapping the screen No beep Low beep Loud beep Joysti...

Страница 104: ...rotocol of serial interface Blind transmission Other protocols depend on installation USB interface Output path 1 Definition of output path 1 for saving measurement data on a USB drive Text input of o...

Страница 105: ...the IP address or the network name of the domain controller Text input Example guest1 domain server1 Password Input of a user name and the corresponding password to get access to the file server Input...

Страница 106: ...User name Input of a user name and the corresponding password to access the EMR PMS application Text input Password Output format Selection of a communication protocol for data storage in the EMR PMS...

Страница 107: ...e device this can be found in the device settings in the Interface LAN submenu in the address line of your browser Use the Navigator menu 3 Fig 64 to comfortably access the web server outputs of the o...

Страница 108: ...tion of the device and its location In step 4 5 load a ppd file suitable for your printer and then tap Add printer In step 5 5 configure the added printer You can find ppd files for example at http ww...

Страница 109: ...c shock Penetration of substances Smoke sparks or strange noises Faults that cannot be remedied based on the information provided in this user manual Label the device clearly as out of service and rep...

Страница 110: ...note the information in section Replacing the printer paper roll page 107 and following The device displays the heading Error and the error message The operation failed due to an internal error Vario...

Страница 111: ...s with information on the update process Wait until the process is completed and the window closes again After the successful update remove the USB drive from the USB port of the device If required di...

Страница 112: ...e fuses disconnect the device from the power supply to prevent the risk of serious injury or death Replace the fuses in the power input module with fuses that conform with the specifications in Sectio...

Страница 113: ...he body case Open the printer cover Install the paper roll so that the printable side of the paper smoother and shinier than the other side faces upwards when fed through to the printer assembly Feed...

Страница 114: ...ol tested with isopropyl alcohol 60 For aldehyde tested with glutaraldehyde 2 For quaternary compounds tested with DDAC 0 2 CAUTION RISK OF FALSE DIAGNOSIS Use the supplied cover to protect the device...

Страница 115: ...tions on the cleaning cloth packaging This will enable you to maintain the high image quality of your product Cleaning and disinfection of painted surfaces All painted surfaces may be cleaned with a d...

Страница 116: ...ing device using the power cable To perform the measurement press the measuring tip against the metallic holding plate Fig 67 of the plugs on the bottom of the device The measured value may not exceed...

Страница 117: ...ith packaging Switch off the device at the power switch and disconnect the power cable from the device Lock the stage using the clamping screw 1 Fig 5 and lever 4 Fig 3 Use the supplied plastic bags a...

Страница 118: ...injure you Hold the ribbon on both sides of the cut Wear protective gloves when unpacking the device Unpack the device on a level surface to prevent slipping CAUTION PROPERTY DAMAGE Do not place heavy...

Страница 119: ...ustment max 65 mm Internal printer Type Thermal printer Printing paper Thermal paper width 57 mm external diameter of roll 50 mm surface weight 60 g m thickness 59 m Refractometry Corneal vertex dista...

Страница 120: ...3 mm 0 05 mm 4 2 Ambient conditions for intended use Temperature Relative humidity Atmospheric pressure Shock without packaging 10 C to 40 C 30 to 90 70 kPa to 106 kPa 10 g 6 ms Ambient conditions for...

Страница 121: ...EC 60601 1 Therefore no limitations on essential performance of ZEISS VISUREF 150 are to be expected due to electromagnetic interference CAUTION GENERAL HAZARDS If operation is required in the domesti...

Страница 122: ...uthorized by Carl Zeiss Meditec The use of accessories all types of transducers and cables not specified in this user manual or not sold by Carl Zeiss Meditec as replacement parts may result in higher...

Страница 123: ...at 1 kHz Electrical fast transient burst IEC 61000 4 4 2 kV 100 kHz repetition rate power cable 1 kV 100 kHz repetition rate data cable Surge voltage surges line to line IEC 61000 4 5 0 5 kV 1 kV pow...

Страница 124: ...y wireless communications equipment in accordance with IEC 60601 1 2 IEC 61000 4 3 385 TETRA 400 27 450 GMRS 460 FRS 460 28 710 LTE Band 13 17 9 745 780 810 GSM 800 900 TETRA 800 iDEN 820 CDMA 850 LTE...

Страница 125: ...trademarks of Apple Inc CUPS is protected by copyright 2007 2014 by Apple Inc all rights reserved D Diopter DDAC Quaternary ammonium compound for disinfection and cleaning EMR Electronic medical reco...

Страница 126: ...45 Fig 22 Unfolded patient list 48 Fig 23 Text input field to define a patient search 50 Fig 24 Patient selection list 50 Fig 25 User interface in Refraction measurement screen automatic measurement...

Страница 127: ...ed contact lens in front of the measuring head 78 Fig 51 User interface in contact lens measurement mode 79 Fig 52 View of measurement results in the measurement screen of contact lens mode 80 Fig 53...

Страница 128: ...s via long touch 44 Table 3 Description of illumination parameters 54 Table 4 Overview of illumination parameters in different illumination modes 55 Table 5 Parameters in the General submenu 90 Table...

Страница 129: ...ly startup 35 Description of the device 16 Device software 105 Disposal 10 E Electromagnetic compatibility 115 External labels 11 F Figures 120 Functional description 14 G Glossary 119 I Installation...

Страница 130: ...281021 124 P Package check list 6 Performance specifications 14 R Replacing the fuses 106 S Safety inspections 110 Service life 15 Shutting down 103 Switching off 103 Switching on 36 Symbols 5 T Techn...

Страница 131: ......

Страница 132: ...c AG G schwitzer Strasse 51 52 07745 Jena Germany Telephone 49 3641 220 333 Fax 49 3641 220 112 Email info meditec zeiss com Internet www zeiss com med 000000 2227 967 GA GB 281021 ZEISS VISUREF 150 S...

Страница 133: ......

Страница 134: ...rl Zeiss Meditec AG G schwitzer Strasse 51 52 07745 Jena Germany Telephone 49 3641 220 333 Fax 49 3641 220 112 Email info meditec zeiss com Internet www zeiss com med ZEISS VISUREF 150 Subject to chan...

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