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REP

USB

Indicates a USB connection port.

DIRECT CURRENT

[3] REF NO. 5031

Indicates the connection port for the power supply. Adjacent text indicates the input current
voltage and amperage.

WEEE SYMBOL

Indicates that the equipment consists of electronic components and other assemblies that must
not be disposed of as domestic refuse. Refer to the

Disposal

section of this manual for more

information.

AUTHORIZED REPRESENTATIVE IN THE EUROPEAN COMMUNITY

[4] REF NO. 5.1.2

Indicates the Authorized Representative in the European Community. Adjacent to the symbol is
the name and address of the Authorized Representative.

[1]

EN ISO 7000 (5th Ed) Graphical Symbols For Use On Equipment

[2]

EN ISO 7010 (2nd Ed) Graphical Symbols—Safety Color and Safety Signs—Registered Safety Signs

[3]

IEC 60417:2002 DB Graphical Symbols For Use On Equipment

[4]

ISO 15223

1:2012 Medical Devices—Symbols To be Used With Medical Devices Labels, Labeling, And Information To Be

Supplied—Part 1: General Requirements

Содержание SCANMATE FLEX

Страница 1: ...DOCUMENT FLEX INS OMENG R4 SCANMATE FLEX ULTRASOUND PLATFORM FOR USE WITH SCANMATE v4 2 SOFTWARE OPERATOR S MANUAL 0120...

Страница 2: ...CLEARSCAN COVERS WITH B SCAN PROBES FOR STERILE EXAMINATIONS 21 USING CLEARSCAN COVERS TO PERFORM UBM OR ANTERIOR SEGMENT EXAMINATIONS 22 PERFORMING B SCANS 24 PERFORMING UBM SCANS 26 REVIEWING B SCA...

Страница 3: ...CTION 50 ROUTINE MAINTENANCE VERIFYING A SCAN CALIBRATION 51 REPAIRS AND CUSTOMER SUPPORT 52 ULTRASONIC EMISSIONS INFORMATION 58 ELECTROMAGNETIC IMMUNITY AND EMISSIONS 61 ENVIRONMENTAL CONDITIONS 61 S...

Страница 4: ...y cause damage to the device excessive temperatures fire or explosion The battery is only to be serviced replaced by qualified service personnel WARNING Using non essential software in conjunction wit...

Страница 5: ...urer ATMOSPHERIC PRESSURE LIMITATION 1 REF NO 2621 Indicates the range of atmospheric pressure to which the medical device can be safely exposed HUMIDITY LIMITATION 1 REF NO 2620 Indicates the range o...

Страница 6: ...information AUTHORIZED REPRESENTATIVE IN THE EUROPEAN COMMUNITY 4 REF NO 5 1 2 Indicates the Authorized Representative in the European Community Adjacent to the symbol is the name and address of the A...

Страница 7: ...ower of the plano hard contact lens IOL Intraocular Lens IOP Intraocular Pressure Kcorr The corrected K value that should be used in IOL calculations for patients who have previously undergone refract...

Страница 8: ...10 32 bit 64 bit Microsoft Windows Server 2008 R2D 64 bit Microsoft Windows Server 2012 2012 R2D 64 bit Microsoft Windows Server 2016D 64 bit A The software can be operated using touch controls on sys...

Страница 9: ...order of a physician OPERATOR QUALIFICATIONS CAUTION Operators of the device should be trained medical professionals with knowledge of the use of ultrasonic imaging devices and imaging protocols ALARA...

Страница 10: ...ode PIXEL COUNT 512 x 512 4 1 oversampling SAMPLING FREQUENCY 80 MHz max PC CONNECTION USB 2 0 BATTERY PACK TYPE 10 8 V 3250 mAh Li Ion BATTERY LIFE Approximately 4 hours when fully charged INPUT VOLT...

Страница 11: ...OTE Probe may be completely submerged in liquid when disconnected from probe cable 1 2 3 4 A SCAN PROBE DGH 6006 1 Probe Lens w Fixation LED 2 Immersion Shell Stop 3 Probe Handle 4 Cord Strain Relief...

Страница 12: ...o ring is in complete firm contact NOTE Before reattaching the transducer be sure that the connector interior for both the probe and transducer are completely dry i e after cleaning Also ensure that t...

Страница 13: ...harge The green light on the front panel will illuminate indicating the device is powered The amber light will indicate active battery charging The blue Charge Status lights will become illuminated in...

Страница 14: ...e menus which are located above the Mode Tabs FILE MENU The File Menu allows the user to save measurements images and videos The File Menu also allows the user to import and export patient records The...

Страница 15: ...ithin the standard deviation thresholds for the system to automatically stop scanning MEASUREMENT DELAY The Measurement Delay is the amount of time after alignment is detected but before an A Scan mea...

Страница 16: ...IOL click the CALCULATE FROM MFG A CONST button to automatically calculate and display all constants needed for the SRK II SRK T Hoffer Q Holladay 1 and Haigis formulas These values can also be enter...

Страница 17: ...or deselected for use in personalized constant calculations OPERATOR PREFERENCES MENU The Operator Preferences Menu allows the user to create edit or delete individual operators for the device Operat...

Страница 18: ...E Changing the image reference setting will change the orientation of the images stored in the database If this reference is changed after images have been acquired any measurements overlaying the ima...

Страница 19: ...rch fields will be highlighted Type in the identifying information to perform the search Searches can also be performed by scrolling through the patient table Load Existing Patient To view an existing...

Страница 20: ...y Enabling the A Scan Overlay will superimpose an A Scan waveform over the B Scan image or video Use a left click to place the vector in the desired position Zoom Double click the left mouse button on...

Страница 21: ...with the ClearScan probe covers for more information USING CLEARSCAN COVERS TO PERFORM UBM OR ANTERIOR SEGMENT EXAMINATIONS WARNING Before each procedure the ultrasound probe and removable transducer...

Страница 22: ...e the Position Map to indicate the area of the eye being examined NOTE If the operator is not listed in the Operator drop down box add the new operator by selecting Preferences Operator and clicking t...

Страница 23: ...m by pressing and on the keyboard or by moving the slider below video display The exam video can also be replayed 10 To save images click the SAVE IMAGE button upper right hand corner or select File S...

Страница 24: ...ther or independently Refer to the B Scan Page Preferences section for more information 1 Create a new patient or select an existing patient on the Patient Screen 2 Select the B Scan UBM screen tab If...

Страница 25: ...software has recorded the number Video Buffer Frames specified in the Operator Preferences the scan will begin to overwrite itself 10 To Stop scanning Click the STOP SCAN button or Press the Space Bar...

Страница 26: ...e ANGLE TOOL Use single clicks of the right mouse button to designate three points to create the desired angle Area Calculation Click the AREA TOOL Use single clicks of the left mouse button to design...

Страница 27: ...ration USER VERBAL COMMANDS FLEX AUDIBLE RESPONSE FLEX COMMAND EXECUTED Hey Flex Tone Double Beep Voice control activated The software is ready to receive verbal commands Start Scan Verbal Starting Sc...

Страница 28: ...measurements to be entered into the measurement bank and manually stop the scan In Auto Measure Mode measurements that meet alignment criteria will automatically be entered into the measurement bank a...

Страница 29: ...t to obtain measurements NOTE Refer to Page 27 for more information on Corneal Compression Sensitivity 6 Seat or recline the patient in a position comfortable for both Patient and Operator Head moveme...

Страница 30: ...Manual Measurement Mode a measurement is only recorded in the measurement bank if the user presses the Enter key on the keyboard or Right Foot Pedal accessory Measurements manually placed in the meas...

Страница 31: ...d if the probe is not in the proper position 6 Connect the catheter tubing to the immersion shell filler port and to the saline reservoir either a syringe or bottle Place the saline reservoir in a con...

Страница 32: ...rmation on how measurements are evaluated during Auto Measurement Mode In Manual Measurement Mode a measurement is only recorded in the measurement bank if the user presses the Enter key on the keyboa...

Страница 33: ...ameters measurement will automatically stop The entries in the bank are used to calculate the measurement average If 3 star alignment is not achieved within the alignment timeout period a warning mess...

Страница 34: ...dditional arrow at the leftmost echo The red arrows can be moved horizontally by using the mouse to left click and hold on the arrow then sliding it to the desired position When a measurement arrow is...

Страница 35: ...e user must first say Hey Flex or press the ENTER key depending upon System Configuration USER VERBAL COMMANDS FLEX AUDIBLE RESPONSE FLEX COMMAND EXECUTED Hey Flex Tone Double Beep Voice control activ...

Страница 36: ...IOL calculation Target IOL Power Emmetropic Power and Range of IOL Power and Refractions are displayed for up to three 3 IOLs for each eye Post Refractive Data If the patient has previously undergone...

Страница 37: ...A Scan average A Scan Single Measurement and User Input If user input is selected complete the highlighted fields 6 The Corneal Refractive Index nc of the keratometer used to calculate the corneal pow...

Страница 38: ...sonal communication based on documents prepared July 2 2008 Received Feb 2 2009 HOFFER Q Hoffer K J The Hoffer Q formula A comparison of theoretic and regression formulas Journal of Cataract and Refra...

Страница 39: ...nly K1 and K2 are entered automatically into the Post Refractive Surgery section of the Post Refractive Calculator NOTE Deselecting the Post Refractive checkbox returns all fields to the original conf...

Страница 40: ...ver Correction and Double K methods These methods have been implemented as described by Shammas H John Intraocular lens power calculations Slack Incorporated 2004 HISTORY DERIVED The History Derived m...

Страница 41: ...Refraction S E DOUBLE K SRK T This method uses the pre refractive corneal power to estimate the post refractive anterior chamber depth also known as effective lens position The post refractive corneal...

Страница 42: ...tive Data used to perform the calculations by clicking the SAVE button 4 Perform the lens replacement surgery Record the actual lens model and power that was used 5 Enter the Stabilized Post Operative...

Страница 43: ...onalized Lens Constants calculation based on the Procedures that are currently selected in the table The Current Personalized Constants group box displays the lens constants that are currently being u...

Страница 44: ...ciated with the patient and then drag and drop the thumbnail onto the desktop or into the appropriate folder The report will be saved in a pdf format IMPORT A SCAN MEASURMENT FILE Select File Import A...

Страница 45: ...not be stored on the same physical drive that hosts the database DATABASE MANAGEMENT SQLITE DATABASE BACKUP If a Single PC installation was performed a SQLite database is used to store patient records...

Страница 46: ...2 benzenedicarboxaldehyde soak 1hr Isopropyl Alcohol 70 v v Isopropyl Alcohol soak 1hr soak d 5 10 min soak d 5 10 min Household Bleach 0 6 w w Sodium Hypochlorite soak 1hr soak d 5 min soak d xx 5 m...

Страница 47: ...h a water dampened cloth using distilled sterile or de ionized water to remove any residue and then wipe dry with a soft dry cloth DISINFECTION Immerse approximately 1 4 of the probe tip in a solution...

Страница 48: ...y be cleaned using a soft gauze while only applying light pressure When cleaning the rubber gasket use a soft cloth or soft bristle brush with light pressure Hard plastic surfaces of the probe may be...

Страница 49: ...ted before each use Remove the rubber o ring from inside the adapter Clean and disinfect both the adapter and o ring using FDA and EPA approved cleaning and disinfection products The solutions must be...

Страница 50: ...etween the transducer and probe should be checked for damage that may allow water ingress If the o ring is damaged it can be replaced with the manufacturer provided substitutes IMMERSION SHELL P 102 T...

Страница 51: ...for information on contacting DGH Technology REPAIRS AND CUSTOMER SUPPORT All repairs replacements modifications are to be performed by DGH Technology Inc If you feel there is a problem with the devic...

Страница 52: ...Data tables show the results of a statistical analysis was performed on the data to examine the upper output limits based on a one sided tolerance limit approach The mean and standard deviation of the...

Страница 53: ...pa 3 at max MI W cm2 7 09 Operating Control Conditions XMT 100V Note 1 Information need not be provided for any formulations of TIS not yielding the maximum value of TIS for that mode Note 2 Informati...

Страница 54: ...l Conditions 10 Hz scan rate 60 degree scan angle 256 lines per scan Note 1 Information need not be provided for any formulations of TIS not yielding the maximum value of TIS for that mode Note 2 Info...

Страница 55: ...Conditions 10 Hz scan rate 60 degree scan angle 256 lines per scan Note 1 Information need not be provided for any formulations of TIS not yielding the maximum value of TIS for that mode Note 2 Infor...

Страница 56: ...Conditions 10 Hz scan rate 20 degree scan angle 256 lines per scan Note 1 Information need not be provided for any formulations of TIS not yielding the maximum value of TIS for that mode Note 2 Infor...

Страница 57: ...l Conditions 10 Hz scan rate 20 degree scan angle 256 lines per scan Note 1 Information need not be provided for any formulations of TIS not yielding the maximum value of TIS for that mode Note 2 Info...

Страница 58: ...ity should be at least 30 Electric Fast Transient Burst Immunity IEC 61000 4 4 2 kV for AC Mains 1 kV for signal I O lines Complies Mains power quality should be that of a typical commercial or hospit...

Страница 59: ...e in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in...

Страница 60: ...of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not app...

Страница 61: ...t SHELF LIFE LIFETIME The shelf life lifetime indicated for this device is 10 years with proper care and maintenance The shelf life lifetime indicated for the 35 MHz UBM transducer element DGH1500 35...

Страница 62: ...er 2012 Configuration Tools SQL Server Configuration Manager 2 In the SQL Server Configuration Manager s left hand column select SQL Server Configuration Manager SQL Server Services 3 The software wil...

Страница 63: ...ters of high powered electromagnetic disturbances nearby i e HF surgical equipment MRI machines etc PATIENT DATA NOT LOADED Error Message Indicator Can not save No patient loaded message With no patie...

Страница 64: ...s to incorporate such changes in Equipment already completed on the effective date of any such changes The warranty provided with the device at the time of purchase is the only warranty of this produc...

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