DGH TECHNOLOGY SCANMATE FLEX Operator'S Manual Download Page 50

 

 50

 

DEVICE CORDS (FLEX

-

PCABLE)

 

All device cords (probe cords, power cords, USB cords, etc.) should be routinely inspected for 
bends, cuts, abrasions and other forms of damage. Cord connectors should be inspected for 
cracks, abrasions, deformation, damaged/bent pins, etc. 

 

 

A

-

SCAN PROBE (DGH6006)

 

The A

-

Scan probe housing should be routinely inspected of cracks, splitting, dents, sharp edges, 

projections, deformation and other forms of damage. Special attention should be paid to the 
probe tip that contacts the patient

s eye, ensuring that the surface is smooth and without cracks, 

dents or blemishes. 

 

 

B

-

SCAN PROBE (DGH1912, DGH1920)

 

The B

-

Scan probe housing should be routinely inspected for cracks, splitting, dents, sharp edges, 

projections, deformation and other forms of damage. B

-

Scan probes should also be inspected 

for leaks of the internal transmission fluid. Special attention should be paid to the probe tip that 
contacts the patient

s eye, ensuring that the surface is smooth and without cracks, dents or 

blemishes. 

 

 

UBM PROBE (DGH1500) AND TRANSDUCERS (DGH1500

-

35, DGH1500

-

50)

 

The  UBM  probe  housing  should  be  routinely  inspected  of  cracks,  splitting,  dents,  sharp  edges, 
projections, deformation and other forms of damage. Special attention should be paid to check 
for  damage/deformation  that  may  allow  water  ingress.  The  black  o

-

ring  seals  between  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) 

 

The A

-

Scan Immersion shell should be regularly checked for chips, cracks, abrasions, 

deformation and other physical damage. If damage is found, the shell should be discarded and 
replaced. 

 

 

 

ROUTINE MAINTENANCE —

 

VERIFYING A

-

SCAN CALIBRATION

 

WARNING: 

Verifying calibration should not be performed while the device is in use with the 

patient. Verifying calibration should be performed prior to use of the device. 

 

 

A

-

Scan calibration should be verified routinely. The software must be placed into a test mode to 

check calibration on a standardized polystyrene block (provided with unit). The following 
procedure describes entering test mode and verifying unit calibration.

 

 

1.

 

Navigate to the Patient Data Screen by selecting the 

Patient Data

” 

tab. In the 

Last Name

” 

 

drop

-

down box, select 

Test Block

”.  

 

 

2.

 

Navigate to the A

-

Scan Screen by selecting the 

A

-

Scan

” 

tab.  The current eye should be 

 

displayed as 

Test Block

” 

in the waveform display screen, and the lens type drop

-

down box 

 

should be frozen, displaying 

Test Block

”.

 

 

3.

 

Place the arm of the Flex unit in the down position. Apply a small drop of water to the top 

 

of the reference test block.

 

 

4.

 

Apply the probe tip to the center of the reference test block. 

 

 

5.

 

Measurement of the test block should begin almost instantaneously. If not, move the probe 

 

tip slightly until a measurement is obtained.

 

Summary of Contents for SCANMATE FLEX

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

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Reviews: