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EZER EUS-2600 Operation Manual

Ultrasonic a/b scanner
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  • Page 2: Table Of Contents

    CONTENTS CONTENTS IMPORTANT NOTICES ........................... III EXPLANATION OF LABELS AND SYMBOLS ON THE PRODUCT ............. IV EXPLANATION OF LABELS AND SYMBOLS ON THE PACKING BOX ..........V GENERAL INTRODUCTION ....................1 CHAPTER 1. : ......................1 TRUCTURE AND OMPONENTS ............................1 NTENDED ..........................1 PERATION ODES ..........................1 ONTRAINDICATIONS ..........................1 OFTWARE ERSION CHAPTER 2. TECHNICAL SPECIFICATIONS ..................2 ..................
  • Page 3 CONTENTS CHAPTER 6. MAINTENANCE, PRECAUTIONS FOR PROPER USE AND SIMPLE WAYS TO TROUBLESHOOT ............................. 36 ..........36 AINTENANCE AND RECAUTIONS FOR ROPER SE OF RODUCT ..........................36 IOMETRIC ..................... 37 IMPLE AYS TO ROUBLESHOOT 6.3.1 The power indicator light on the main unit is not on, and the product fails to start 6.3.2 The mouse or keyboard doesn’t work properly ..............

  • Page 4: ImportantNotices

    No individual or organization is allowed to copy, modify or translate any part of this User Manual without written consent of the manufacturer. All parts of the EUS-2600 that shall not be serviced or maintained while in use with a PATIENT.

  • Page 5: ExplanationOfLabelsAndSymbolsOnTheProduct

    EXPLANATIONOFLABELSANDSYMBOLSONTHEPRODUCT ExplanationofLabelsandSymbolsontheProduct PowerSwitch B-Scan Caution！PleaseRefertoaccompanyingdocuments PleaseRefertoUser’sManual ElectrostaticDischargeWarning Non-ionizingRadiation 10MHzA-Probe Socketfor10MHzA-ScanProbe 10MHzB-Probe Socketfor10MHzB-ScanProbe 20MHzB-Probe Socketfor20MHzB-ScanProbe USB USBPorts HDMI HDMIInterface VEDIOOUT VideoOutputInterface FootswitchInterface PowerInputSocket  DC-12V Manufacturer - IV -...

  • Page 6: ExplanationOfLabelsAndSymbolsOnThePackingBox

    EXPLANATIONOFLABELSANDSYMBOLSONTHEPRODUCT ExplanationofLabelsandSymbolsonthePackingBox This Way Up Fragile, Handle with Care Keep Dry Stacking Limit by 4 Temperature Limit Humidity limitation - V -...

  • Page 7: Chapter 1. General Introduction

    Chapter 1. General Introduction 1.1 Structure and Components EUS-2600 Ultrasonic A/B Scanner for Ophthalmology is an ultrasonic imaging instrument specialized in ophthalmological diagnosis. It consists of a main unit, application software, a 10MHz A-Scan probe, a 10MHz B-Scan probe, a 20MHz B-Scan probe, a footswitch, a keyboard, a mouse and a power adaptor.

  • Page 8: Chapter 2. Technical Specifications

    TECHNICALSPECIFICATIONS Chapter 2. Technical Specifications 2.1 Requirements for Working Conditions Working Temperature: 5℃-40℃; Relative Humidity: lower than 80%; Power Voltage: AC100-240V, 50Hz/60Hz; Atmospheric Pressure: 70-106kPa. 2.2 Basic Parameters Standard ultrasound frequency A-Scan Probe: 10MHz; B-Scan Probe: 10MHz and 20MHz. Grey Scale: 256 Levels Scanning Frame Rate: 10 fps B-scan Scanning Angle: 53...

  • Page 9: Safety

    TECHNICALSPECIFICATIONS a) 10MHz Probe: No more than 3mm; b) 20MHz Probe: No more than 3mm; A-Scan AL Biometric Measuring Range a) Axial Length (AL): 15mm-40mm; b) Anterior Chamber Depth (AC): 2.0mm-6.5mm; c) Lens Thickness (LEN): 2.0mm-6.5mm; d) Vitreous Body Thickness (VITR): 12mm-33mm. A-Scan AL Biometric Measuring Accuracy: No more than ±0.05mm.
  • Page 10 TECHNICALSPECIFICATIONS - Probe: IPX7. By disinfection and sterilization methods recommended by the manufacturer: - see <Section 5 Cleaning, Disinfection and Sterilization of Probes>; By safety when being used together with flammable anesthetic gases mixed with air, oxygen or nitrous oxide: this product doesn’t belong to AP/APG equipment. By working mode: Continuous.

  • Page 11: Chapter 3. Installation And Assembly

    INSTALLATIONANDASSEMBLY Chapter 3. Installation and Assembly 3.1 Structure and Components This product consists of a main unit, application software, a 10MHz A-Scan probe (Prb1000A/10-C), a 10MHz B-Scan probe (Prb2100B-10), a 20MHz B-Scan probe (Prb2100B-20), a footswitch, a mouse, a keyboard and a power adaptor (shown in Figure 3-1). The applied parts are 10MHz A-Scan probe, 10MHz B-Scan probe and 20MHz B-Scan probe.

  • Page 12: Start-Up And Shut-Down

    INSTALLATIONANDASSEMBLY HDMI Interface USB Ports Video Output Interface Footswitch Socket Stand DC Power Socket Figure 3-2 Left View Notes:The electrical equipment connected to the device (through HDMI and Video Out interface) shall pass IEC 60950 safety certification, to ensure that the safety performance of the device shall not be affected by the risks arising from the failure of external equipment under normal use.

  • Page 13: Routine Check Before Use

    INSTALLATIONANDASSEMBLY Check if there are devices that may interfere the product in its vicinity; Check if the site is dry.; Check if the appearance of the entire unit is good; Check if there are cracks on the outer casing and LCD of the product; Open the stand on the rear panel and place the product stably on a working platform.

  • Page 14: Assembly

    INSTALLATIONANDASSEMBLY The main unit and its supportive accessories of this product are applicable to patient environment. Notes: ① The operator shall check if the protective grounding wire in the single-phase, three-pole power socket on the wall or voltage stabilizer works well, to guarantee the safety. ②...

  • Page 15: Chapter 4. Operation Instructions

    Press the power switch to get direct access to the login interface of the program, as shown in Figure 4-1. Figure 4-1 Login Interface for EUS-2600 Ultrasonic A/B Scanner for Ophthalmology program Click “User Name” column, and select an Operator from its drop-down list; input its corresponding password in the “Password”...

  • Page 16: Creating A New Patient

    OPERATIONINSTRUCTIONS Figure 4-2 Main Interface of EUS-2600 Program 4.2 Creating a New Patient Click “New” on the main interface to access “New Patient” interface as shown in Figure 4-3; fill in (select from their drop-down list) the columns of “Name”, “ID”, “Sex” and “DOB” (Date of Birth);...
  • Page 17 OPERATIONINSTRUCTIONS operator wants to load saved records for further operation; and click “OK” to access the selected record. Click “Find” to search for history records, and a dialog box pops up (shown in Figure 4-5) for the operator to search patient records by keywords, including “All Patients”, “Today”, “Name”, “ID”, “Sex”, “DOB”, “Doctor”, and “Time”.

  • Page 18: B-Scan

    OPERATIONINSTRUCTIONS 4.4 B-Scan Click “B scan” on the main interface to access “B scan” interface shown in Figure 4-6. Figure 4-6 B scan Interface Click “OD” or “OS” to indicate whether a right eye or a left eye is scanned. “OD” (Oculus Dexter) stands for the right eye, and “OS”...
  • Page 19 OPERATIONINSTRUCTIONS into the area for displaying the scanned image, its cursor becomes cross-shaped. Left-click desired starting and finishing points in the area, and the reading of the distance can be automatically displayed (shown in Figure 4-7). Figure 4-7 Dist-2, Two-point Distance Measurement Dist-5: for 5-Point Marking Method under the B-Scan mode.
  • Page 20 OPERATIONINSTRUCTIONS Figure 4-9 Angular Measurement Area: for area measurement. Click “Area”; and drag your mouse along the boundary of an area to be measured while pressing the left button of the mouse down, and measured readings can be displayed on the screen by releasing the left button (shown in Figure 4-10). Figure 4-10 Area Measurement Text: for annotation.
  • Page 21 OPERATIONINSTRUCTIONS Figure 4-11 Annotation in the Image Undo: for undoing the last action. : Zoom-in & Zoom-out. Click “ ”, to zoom in; and click “ ”, to zoom out. Press the left button of the mouse down for drag-and-display (shown in Figure 4-12), when the product zooms Figure 4-12 Zoom-in &...

  • Page 22: Analysis On Scan Direction And Position

    OPERATIONINSTRUCTIONS Bright: for adjusting the brightness of the image (default setting: 50). Contrast: for adjusting the contrast of the image (default setting: 50) Color: for pseudo-color code, e.g., for switching among 8 groups of pseudo-color codes. Depth: for adjusting the scope of scan depth. Delay: for adjusting delayed depth.

  • Page 23: A-Scan Al Biometric Measurement

    OPERATIONINSTRUCTIONS adjustment may vary depending on patients and diagnosis conditions. However, it’s not suggested that the gain remains unchanged nor that the higher the better. Click “Snap” to save the current image. Cineloop: Click “Loop”, and drag the slider to replay the 100 images frame by frame. 4.5 A-Scan AL Biometric Measurement In A-Scan biometric AL (Axial Length) measurement, an ultrasound-based distance measurement method is used to measure the anterior chamber depth, lens thickness and vitreous length of an...

  • Page 24: Steps For Automatic Measurement

    OPERATIONINSTRUCTIONS Figure 4-13 A-Scan Interface Click “Mode” to access “A-Scan Mode Setup” interface (shown in Figure 4-14). Figure 4-14 A-Scan Mode Setup interface Click “Normal”, “Aphakic”, “Special” or “Cataract” under the “Mode” column, to select eye type; Click “Manual” under the “Mode” column, to select manual mode; Click “Contact”...
  • Page 25 OPERATIONINSTRUCTIONS Click “Mode” to access “A-Scan Mode Setup” interface (shown in Figure 4-14); Select the correct eye type from “Normal”, “Aphakic”, “Special” and “Cataract”; Tell the patient to lie face up, keep his/her eye open, and perform topical anesthesia on the eye to be scanned;...

  • Page 26: Steps For Manual Measurement

    OPERATIONINSTRUCTIONS Figure 4-15 Prompt Dialog Box for Clearing Measured Readings 4.5.2 Steps for Manual Measurement If it’s difficult for the operator to take readings through automatic measurement, or for a patient to follow the operator’s instructions due to his/her physical conditions, the operator may take manual measurement;...

  • Page 27: 5-Point Marking Method Under B+A Mode For Axial Length Measurement

    OPERATIONINSTRUCTIONS of axial length (AL) according to Formula 1.1. This is the so-called 5-Point Marking Method for AL measurement. 4.6.1 5-Point Marking Method under B+A Mode for Axial Length Measurement Use the Immersion Method for scanning; don’t freeze until satisfactory scanned images are acquired;...

  • Page 28: 5-Point Marking Method For Measuring Axial Length Under A-Scan Biometric Mode

    OPERATIONINSTRUCTIONS Figure 4-18 Setting Acoustic Velocities in 5-Point Marking Method under B-Scan Mode 4.6.2 5-Point Marking Method for Measuring Axial Length under A-Scan Biometric Mode Click A scan to access A-Scan biometric mode; Select the eye type from: “Normal”, “Aphakic”, “Special” and “Cataract”; Place the A-Scan probe on the cornea of a patient with proper care, and switch on the footswitch to conduct automatic measurement;...
  • Page 29 OPERATIONINSTRUCTIONS Figure 4-19 5-Point Marking Method under A-Scan Mode Note: Acoustic velocities under different measuring modes: Normal mode: Acoustic Velocity of Cornea: = 1620 m/s ① – ② Acoustic Velocity of Anterior Chamber: = 1532 m/s ② – ③ Acoustic Velocity of Lens: = 1641 m/s ③...

  • Page 30: Iol Calculation

    OPERATIONINSTRUCTIONS 4.7 IOL Calculation This product provides different calculation methods for patients who have undergone refractive surgery and for those who haven’t. 4.7.1 For patients who haven’t undergone refractive surgery Parameters for IOL Calculation For patients who haven’t undergone refractive surgery, the product provides 6 groups of IOL calculation formulas: SRK-II, SRK-T, BINK-II, HOLLADAY, HOFFER-Q and HAIGIS.
  • Page 31 OPERATIONINSTRUCTIONS Figure 4-20 IOL Interface (for Patient who haven’t Undergone Refractive Surgery) Automatically acquire AL (Axial Length) through measurement; See Annex F <IOL Formulas> for detailed information on selecting IOL calculation formulas and parameters; Click “AL Select”, and a dialog box for selecting AL value pops up. “A Scan” row shows the AL value acquired from measurement under A-Scan mode;...

  • Page 32: For Patients Who Have Undergone Refractive Surgery

    OPERATIONINSTRUCTIONS Click “A const” to set Constant A or ACD, shown in Figure 4-22. Figure 4-22 Dialog Box for Setting Constant A/ACD Click “Calculate” to perform IOL calculation and display IOL results; Click “Clear” to clear the current results. 4.7.2 For patients who have undergone refractive surgery Introduction to relevant parameters For patients who have undergone refractive surgery, the product provides 5 groups of IOL calculation formulas: History derived method, Double K/SRK-T method, Refraction derived...

  • Page 33: Setting Acoustic Velocity

    OPERATIONINSTRUCTIONS Figure 4-23 IOL Interface (for Patients who Undergone Refractive Surgery) Automatically acquire AL (Axial Length) through measurement; See Annex F <IOL Formulas> for detailed information on selecting IOL calculation formulas and parameters; Click “AL Select”, and a dialog box for selecting AL value pops up. “A Scan” row shows the AL value acquired from measurement under A-Scan mode;...

  • Page 34: User Setup

    OPERATIONINSTRUCTIONS Table 4-1 Reference Table for Acoustic Velocity Settings Unit: m/s SPEC NORM APHA CATA Anterior Chamber 1532 —— 1532 1532 V (AC) PMMA：2718 Lens 1641 —— 1629 Acrylic：1946 V (LEN) Silicone：1050 Vitreous Body 1532 1532 1532 V (VITR) * provided by IOL manufacturers Click the area for setting acoustic velocities in the A-Scan interface (e.g., a rectangular area for displaying acoustic velocities at the upper part of the A-Scan interface), and a dialog box for setting acoustic velocities pops up (shown in Figure 4-24);...

  • Page 35: Case Report

    OPERATIONINSTRUCTIONS Figure 4-25 User Setup Interface Use the left part of the interface for setting usernames and their corresponding passwords. Fill in the hospital name under the “Hospital Name”. Set the storage path of the system under the “Work Path”. 4.10 Case Report Click “Report”...
  • Page 36 OPERATIONINSTRUCTIONS Figure 4-26 Report Printing Interface Click an empty area of the report, and a command window pops up (shown in Figure 2-27). Figure 4-27 Report Management Interface Click “Select Image” in the Report Management Interface shown in Figure 4-27, and a dialog box for selecting images pops up (shown in Figure 4-28);...
  • Page 37 OPERATIONINSTRUCTIONS Figure 4-28 Dialog Box for Selecting Images Click “Print Report”, “Save Report”, “Load Report” and “Dictionary” in the report management interface shown in Figure 4-27, to perform corresponding operations; or right-click the report printing interface, and a right-click function menu pops up for corresponding operations (shown in Figure 4-29).
  • Page 38 OPERATIONINSTRUCTIONS The function menu includes: Print Report: for printing case reports; Save Report: for saving case reports in PDF format; Load Report: for opening saved PDF-format reports; Dictionary: a “Diagnosis Dictionary” dialog box pops up (shown in Figure 4-30). Figure 4-30 “Diagnosis Dictionary” Dialog Box Fill eye parts, such as “Ocular Fundus”...
  • Page 39 OPERATIONINSTRUCTIONS Figure 4-31 Right-Click Functions in “COMMENT” menu - 33 -...

  • Page 40: Chapter 5. Cleaning, Disinfection And Sterilization Of Probes

    CLEANING,DISINFECTIONANDSTERILIZATIONOFPROBES Chapter 5. Cleaning, Disinfection and Sterilization of Probes 5.1 Cleaning, Sterilization and Maintenance of Probes Always keep the probe clean, and clean the probe with soft paper after use. Rinse the front part of the probe with distilled water, physiological saline, disinfectant alcohol, or chloramphenicol eye drop when cleaning the probe.
  • Page 41 CLEANING,DISINFECTIONANDSTERILIZATIONOFPROBES off, in order to prevent damage on the cable; when plugging the probe, the operator shall align the red spot on the plug with that on the socket. Don’t soak the casing of the probe and its parts above the cable co Don’t nnector in water or any other form of liquid (see right drawing).

  • Page 42: Chapter 6. Maintenance, Precautions For Proper Use And Simple Ways To Troubleshoot

    MAINTENANCE,PRECAUTIONSFORPROPERUSRANDTROUBLESHOOTING Chapter 6. Maintenance, Precautions for Proper Use and Simple Ways to Troubleshoot 6.1 Maintenance and Precautions for Proper Use of Product The operator shall use a single-phase, three-pole power socket with good protective grounding. It is generally appropriate for continuous use of this product within 4 hours, but it will become inappropriate when use for a longer time than that.

  • Page 43: Simple Ways To Troubleshoot

    MAINTENANCE,PRECAUTIONSFORPROPERUSRANDTROUBLESHOOTING Initial Wave Reflected Waves from Interfaces Enter the mode selection interface again by pressing Mode, and select “Normal” to obtain the results of the staged target by automatic measurement. Press A scan and FRZ/SCN to repeat the measurement while keeping the probe still. It’s indicated that the biometric function of the product works well, if measured results show good repeatability.

  • Page 44: Chapter 7. Service And Support Information

    SERVICEANDSUPPORTINFORMATION Chapter 7. Service and Support Information 7.1 Warranty This product has a warranty of one year from the date of purchasing, on the premise of using in accordance with the User Manual. If the device does not work properly, please contact your local distributor or the manufacturer immediately with your warranty card.

  • Page 45: Annex A. Prudent Use Statement

    PRUDENTUSESTATEMENT Annex A. Prudent Use Statement A.1 Statement Although there is no evidence so far the diagnostic ultrasound instrument will lead to biological effects in humans, it is possible to prove the existence of biological effects in future applications. The radiated acoustic power of the instrument itself is very low; still we must use ultrasound prudently in clinical applications.

  • Page 46: Annex B. Acoustic Output Reporting Table

    ACOUSTIC OUTPUT REPORTING TABLE Annex B. Acoustic Output Reporting Table Transducer Model: Operating Mode: Prb1000A/10-C A-Mode Index Label Non-scan Non-sca Scan 1 cm >1 cm aprt aprt 0.119 Maximum index value (MPa) 0.366 (mW) min of [P ), I (mW) 　...
  • Page 47 ACOUSTIC OUTPUT REPORTING TABLE Transducer Model: Operating Mode: Prb2100B/10 B-Mode Index Label Non-scan Non-sca Scan >1 cm 1 cm aprt aprt 0.221 Maximum index value (MPa) 0.667 (mW) min of [P ), I (mW) 　 ta,　 (cm) (cm) Associated (cm) acoustic z at max.
  • Page 48 ACOUSTIC OUTPUT REPORTING TABLE Transducer Model: Operating Mode: Prb2100B/20 B-Mode Index Label Non-scan Non-sca Scan 1 cm >1 cm aprt aprt 0.118 Maximum index value (MPa) 0.484 (mW) min of [P ), I (mW) 　 ta,　 (cm) (cm) Associated (cm) acoustic z at max.

  • Page 49: Annex C. Iol Formulas

    IOL FORMULAS Annex C. IOL Formulas Parameters Refractive Formula Surgery? REFp ANTI/POST K1pr K2pr REFpr SRK_II × √ √ √ × × × × × × SRK_T × √ √ √ × × × × × × BINK_II × √ √...

  • Page 50: Annex D. Guidance And Manufacturer's Declaration

    Table 1 Guidance and Manufacturer’s Declaration - Electromagnetic Emission The EUS-2600 Ultrasonic A/B Scanner for Ophthalmology is intended for use in electromagnetic environment specified below. The customer or the user of EUS-2600 should assure that it is used in such an environment.
  • Page 51 Table 2 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity The EUS-2600 Ultrasonic A/B Scanner for Ophthalmology is intended for use in the electromagnetic environment specified below. The customer or the user of EUS-2600 should assure that it is used in such an environment.
  • Page 52 To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the EUS-2600 is used exceeds the applicable RF compliance level above, the EUS-2600 should be observed to verify normal operation.
  • Page 53 Note 2: These guidance may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. Note 3: EUS-2600 operates in compliance with its intended use in the presence of external electromagnetic disturbances.

  • Page 54: Annex E. Electromagnetic Compatibility

    AC-Depth、Lens-thickness、Vitr-length. B Mode: B Scan Mode is composed of 10MHz and 20MHz case and represents the reflected ultrasonic signal by gray level image. E.2 Product Components Description Model/Version EUS-2600 Main Unit 10MHz B-Scan Probe Prb2100B/10 20MHz B-Scan Probe Prb2100B/20...

  • Page 55: Notes For Product Installation

    ELECTROMAGNETIC COMPATIBILITY medical devices in IEC 60601-1-2: 2007. However, there is no guarantee that interference will not occur in a particular installation. If interference caused by this product (may be confirmed by turning on/off the product) is identified, the user (or qualified service personnel) shall try to take one or more of following measures to prevent the interference: Re-orienting or relocating affected devices;...

  • Page 56: General Notes

    ELECTROMAGNETIC COMPATIBILITY product equipped with a power plug shall be connected to a fixed power outlet with protective grounding. Don’t use any type of adaptors or converters (such as a three-phase to two-phase converter) to connect the power plug. Extend the product as far as possible from other electronic devices. Use the output cable and probe provided or designated by the company.
  • Page 57 ELECTROMAGNETIC COMPATIBILITY c) ESD training should include an introduction to the physics of electrostatic charge, the voltage levels that can occur in normal practice and the damage that can be done to electronic components if devices are touched by an operator who is electrostatically charged.

  • Page 58: Annex F. Instructions And Abbreviations

    Instructions and Abbreviations Annex F. Instructions and Abbreviations New — new a patient Load — Load case library B scan — enter B mode scanning interface A scan — enter A mode scanning interface Report — case report Setup — set up the user name、hospital name and work path etc. Exit —...

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