EZER EUS-2600 User manual

CONTENTS
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CONTENTS
IMPORTANTNOTICES ................................................................................................................................... III
EXPLANATIONOFLABELSANDSYMBOLSONTHEPRODUCT ..................................................... IV
EXPLANATIONOFLABELSANDSYMBOLSONTHEPACKINGBOX .............................................. V
CHAPTER 1. GENERAL INTRODUCTION ................................................................................................ 1
1.1 STRUCTURE AND COMPONENTS: .......................................................................................................... 1
1.2 INTENDED USE ....................................................................................................................................... 1
1.3 OPERATION MODES ............................................................................................................................... 1
1.4 CONTRAINDICATIONS ............................................................................................................................. 1
1.5 SOFTWARE VERSION ............................................................................................................................. 1
CHAPTER 2. TECHNICAL SPECIFICATIONS .......................................................................................... 2
2.1 REQUIREMENTS FOR WORKING CONDITIONS ....................................................................................... 2
2.2 BASIC PARAMETERS .............................................................................................................................. 2
2.3 SPECIFICATIONS ..................................................................................................................................... 2
2.4 SAFETY ................................................................................................................................................... 3
2.5 ENVIRONMENTAL REQUIREMENTS FOR STORAGE AND TRANSPORTATION .......................................... 3
2.6 CLASSIFICATION ..................................................................................................................................... 3
CHAPTER 3. INSTALLATION AND ASSEMBLY ..................................................................................... 5
3.1 STRUCTURE AND COMPONENTS ............................................................................................................ 5
3.2 START-UP AND SHUT-DOWN .................................................................................................................. 6
3.2.1 Checking before Start-up ........................................................................................................ 6
3.2.2 Routine Check before Use ...................................................................................................... 7
3.2.3 Shut-down ................................................................................................................................... 7
3.3 ENVIRONMENTAL REQUIREMENTS ......................................................................................................... 7
3.4 ASSEMBLY .............................................................................................................................................. 8
3.5 ASSEMBLY AND DISASSEMBLY OF ACCESSORIES AND REPLACEMENT OF CONSUMABLES ................ 8
CHAPTER 4. OPERATION INSTRUCTIONS ............................................................................................. 9
4.1 STARTING PROGRAM ............................................................................................................................. 9
4.2 CREATING A NEW PATIENT ................................................................................................................... 10
4.3 LOADING A PATIENT RECORD FROM DATA B AS E ................................................................................. 10
4.4 B-SCAN ................................................................................................................................................ 12
4.4.1 Analysis on Scan Direction and Position ......................................................................... 16
4.4.2 Steps for B-Scan ..................................................................................................................... 16
4.5 A-SCAN AL BIOMETRIC MEASUREMENT ............................................................................................ 17
4.5.1 Steps for Automatic Measurement ..................................................................................... 18
4.5.2 Steps for Manual Measurement ........................................................................................... 20
4.6 5-POINT MARKING METHOD ................................................................................................................ 20
4.6.1 5-Point Marking Method under B+A Mode for Axial Length Measurement .............. 21
4.6.2 5-Point Marking Method for Measuring Axial Length under A-Scan Biometric
Mode 22
4.7 IOL CALCULATION ............................................................................................................................... 24
4.7.1 For patients who haven’t undergone refractive surgery .............................................. 24
4.7.2 For patients who have undergone refractive surgery ................................................... 26
4.8 SETTING ACOUSTIC VELOCITY ............................................................................................................ 27
4.9 USER SETUP ........................................................................................................................................ 28
4.10 CASE REPORT ...................................................................................................................................... 29
CHAPTER 5. CLEANING, DISINFECTION AND STERILIZATION OF PROBES ............................. 34
5.1 CLEANING, STERILIZATION AND MAINTENANCE OF PROBES .............................................................. 34
5.2 PRECAUTIONARY NOTICES .................................................................................................................. 34

CONTENTS
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CHAPTER 6. MAINTENANCE, PRECAUTIONS FOR PROPER USE AND SIMPLE WAYS TO
TROUBLESHOOT ............................................................................................................................................. 36
6.1 MAINTENANCE AND PRECAUTIONS FOR PROPER USE OF PRODUCT ................................................. 36
6.2 BIOMETRIC TEST .................................................................................................................................. 36
6.3 SIMPLE WAYS TO TROUBLESHOOT ..................................................................................................... 37
6.3.1 The power indicator light on the main unit is not on, and the product fails to start
up. 37
6.3.2 The mouse or keyboard doesn’t work properly .............................................................. 37
6.3.3 The footswitch doesn’t work properly ............................................................................... 37
6.3.4 The main unit works, but the screen doesn’t work or work properly. ....................... 37
CHAPTER 7. SERVICE AND SUPPORT INFORMATION ..................................................................... 38
7.1 WARRANTY ........................................................................................................................................... 38
7.2 ACCESSORIES AND MATERIALS ........................................................................................................... 38
7.2.1 Detachable Parts ..................................................................................................................... 38
7.2.2 Consumables ........................................................................................................................... 38
ANNEX A. PRUDENT USE STATEMENT ................................................................................................ 39
A.1 STATEMENT .......................................................................................................................................... 39
A.2 ALARA PRINCIPLE (AS LOW AS REASONABLY ACHIEVABLE).......................................................... 39
ANNEX B. ACOUSTIC OUTPUT REPORTING TABLE ........................................................................ 40
ANNEX C. IOL FORMULAS ....................................................................................................................... 43
ANNEX D. GUIDANCE AND MANUFACTURER’S DECLARATION .................................................. 44
ANNEX E. ELECTROMAGNETIC COMPATIBILITY ............................................................................. 48
E.1 PRODUCT BASIC PERFORMANCE ........................................................................................................ 48
E.2 PRODUCT COMPONENTS ..................................................................................................................... 48
E.3 PRODUCT CABLES ............................................................................................................................... 48
E.4 EMC (ELECTROMAGNETIC COMPATIBILITY) PERFORMANCE ............................................................. 48
E.5 NOTES FOR PRODUCT INSTALLATION .................................................................................................. 49
E.6 GENERAL NOTES ................................................................................................................................. 50
ANNEX F. INSTRUCTIONS AND ABBREVIATIONS ............................................................................ 52

IMPORTANTNOTICES
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ImportantNotices
This product requires a power supply at a voltage of AC100-240V (50Hz/60Hz). It’s
suggested using a regulated power supply when the local power grid is unable to meet
the above standard; for guaranteed reliability of a workstation of the product, it’s
suggested using an uninterruptable power supply; and each device of the product shall be
properly grounded.
The customer is fully responsible for maintenance and management of the product after
the purchase of the product.
The user shall read this User Manual carefully prior to installation and use of this product.
This User Manual contains warnings against predicable potential hazards. Please remain
vigilant at any time to these hazards. The manufacturer is not responsible for any damage
or loss caused by negligence or ignorance of preventive actions in this User Manual.
This product shall be operated by trained medical staff.
The user shall prevent patients from cross-infection by cleaning, disinfecting and
maintaining probes (see <Chapter 5 Cleaning, Disinfection and Sterilization of Probes>).
Please unplug the power plug before cleaning this product!
Assembly, expansion, re-adjustment, improvement and repair of this product shall be
performed by personnel authorized by the manufacturer. Users are not allowed to open
the outer casing for unauthorized repair without permission by the manufacturer. The
manufacturer is not responsible for any consequences of safety and effectiveness caused
by unauthorized repair.
Users are not allowed to make any unauthorized modification to software and hardware of
this product.
This product is not intended for therapeutic use.
This product has no special protective action against discharging effect of cardiac
defibrillator; and it’s not suitable for use within the vicinity of high-frequency therapeutic
equipment.
The operator shall properly keep original packages, and pack detachable parts like probes
into their original packages for transportation when needed.
This product shall be discarded in accordance with local regulations for environmental
protection; this product can be discarded in the same way as electronic and information
products (such as computers and displays).
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.

EXPLANATIONOFLABELSANDSYMBOLSONTHEPRODUCT
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ExplanationofLabelsandSymbolsontheProduct
PowerSwitch

B-Scan

Caution！PleaseRefertoaccompanyingdocuments
PleaseRefertoUser’sManual
ElectrostaticDischargeWarning
Non-ionizingRadiation
10MHzA-Probe Socketfor10MHzA-ScanProbe
10MHzB-Probe Socketfor10MHzB-ScanProbe
20MHzB-Probe Socketfor20MHzB-ScanProbe
USB USBPorts
HDMI HDMIInterface
VEDIOOUT VideoOutputInterface
FS FootswitchInterface
 DC-12V PowerInputSocket
Manufacturer

EXPLANATIONOFLABELSANDSYMBOLSONTHEPRODUCT
- V -
ExplanationofLabelsandSymbolsonthePackingBox
This Way Up
Fragile, Handle with Care
Keep Dry
Stacking Limit by 4
Temperature Limit
Humidity limitation

GENERALINTRODUCTION
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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.
1.2 Intended Use
This product is intended for ophthalmological ultrasonic diagnosis and AL biometric measurement.
1.3 Operation Modes
This product supports operations by mouse, keyboard, touch screen and footswitch.
1.4 Contraindications
Patients with eyelid trauma and severe eye infection are prohibited from using B-Scan; and
patients with keratitis and cornea trauma are prohibited from using A-Biometric scan.
1.5 Software Version EUS-2600 V1.0.

TECHNICALSPECIFICATIONS
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Chapter 2. Technical Specifications
2.1 Requirements for Working Conditions
1. Working Temperature: 5℃-40℃;
2. Relative Humidity: lower than 80%;
3. Power Voltage: AC100-240V, 50Hz/60Hz;
4. Atmospheric Pressure: 70-106kPa.
2.2 Basic Parameters
1. Standard ultrasound frequency
a) A-Scan Probe: 10MHz;
b) B-Scan Probe: 10MHz and 20MHz.
2. Grey Scale: 256 Levels
3. Scanning Frame Rate: 10 fps
4. B-scan Scanning Angle: 53
5. Gain Control Range: 1-105dB
6. Image Pre-processing and Signal Post-processing: Frame-Averaging, Pseudo-Color Codes,
and Gamma Correction
7. Digital Scan Converter (DSC) Size: ≥4×512×512×8bit
8. Data processor OS: Windows
9. Net Weight: 5.5kg
10. Size: 34cm x 31cm x8cm
2.3 Specifications
1. B-Scan Scanning Depth
a) 10MHz Probe: No less than 60mm;
b) 20MHz Probe: No less than 20mm.
2. B-Scan Axial Resolution
a) 10MHz Probe: No more than 0.1mm;
b) 20MHz Probe: No more than 0.08mm,
3. B-Scan Lateral Resolution
a) 10MHz Probe: No more than 0.2mm;
b) 20MHz Probe: No more than 0.15mm.
4. B-Scan Geometric Location Precision:
a) Vertical: No more than 3%;
b) Horizontal: No more than 5%
5. B-Scan Blind Zone

TECHNICALSPECIFICATIONS
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a) 10MHz Probe: No more than 3mm;
b) 20MHz Probe: No more than 3mm;
6. 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.
7. A-Scan AL Biometric Measuring Accuracy: No more than ±0.05mm.
8. AC Error of Indication: No more than ±0.05mm;
LEN and VITR Error of Indication: No more than ±0.10mm.
2.4 Safety
1. The electrical safety of this product shall be in accordance with requirements of IEC60601-1
and IEC60601-2-37.
2. For information on Acoustic output parameters, please see Annex B.
2.5 Environmental Requirements for Storage and Transportation
1. Environmental Requirements for Storage
This product shall be stored in a well-ventilated room without any corrosive
gas. Temperature: -40C to 55C
Relative Humidity: no more than 80%
Atmospheric Pressure: 70-106kPa
2. Environmental Requirements for Transportation
General modes of transportation are allowed for packaged products. However, the products shall
be protected against severe impact, collision and exposure to rain and snow during
transportation.
Temperature: -40C to 55C
Relative Humidity: no more than 80%
Atmospheric Pressure: 70-106kPa
Notes: The operator shall pack detachable parts like probes into their original
packages for transportation when needed.
2.6 Classification
1. By type of protection against electric shock: Class I;
2. By degree of protection against electric shock: Type B;
3. By degree of protection against ingress of liquids:
- Main Unit: IPX0;
-Footswitch:IPX1;

TECHNICALSPECIFICATIONS
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- Probe: IPX7.
4. By disinfection and sterilization methods recommended by the manufacturer:
- see <Section 5 Cleaning, Disinfection and Sterilization of Probes>;
5. 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.
6. By working mode: Continuous.

INSTALLATIONANDASSEMBLY
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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.
Figure 3-1 Components of this Product
Main Unit
Keyboard
Power Adaptor
Footswitch
20MHz B-Scan Probe
10MHz B-Scan Probe
10MHz A-Scan Probe
Power Switch
Mouse

INSTALLATIONANDASSEMBLY
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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.
Figure 3-3 Right View
3.2 Start-up and Shut-down
3.2.1 Checking before Start-up
1. Check if the site is appropriate for the product;
Stand
USB Ports
HDMI Interface
DC Power Socket
Footswitch Socket
Video Output Interface
Socket for 10MHz A-Scan Probe
Socket for 10MHz B-Scan Probe
Socket for 20MHz B-Scan Probe

INSTALLATIONANDASSEMBLY
- 7 -
Check if there are devices that may interfere the product in its vicinity;
Check if the site is dry.;
2. Check if the appearance of the entire unit is good;
Check if there are cracks on the outer casing and LCD of the product;
3. Open the stand on the rear panel and place the product stably on a working platform.
4. Check if the probe is securely connected:
Check if the plug of the probe is loose, and if there are cracks on the part used on a patient;
Check if the cable of the probe is twined around other cables;
Check if there are cracks or damages on the surface of the probe and cables;
5. Check if the power connection is secured;
Check if the power adaptor and the DC power socket on the main unit are securely
connected;
Check if the power adaptor is securely connected with mains power;
6. The operator shall run the above-mentioned checks, and turn on the unit for further check
until everything is ok.
Press power switch on the front panel of the main unit, and the power indicator light is on
and turned blue, and the product starts up.
3.2.2 Routine Check before Use
Please run the routine check first after each start-up
1. Check if the power indicator light is on and turned blue;
2. Check if the mouse, keyboard or touch screen works;
3. Check the user setup (see <Section 4.9 User Setup>).
4. Sterilize and disinfect the probe.
3.2.3 Shut-down
Press the power switch on the front panel of the main unit, and the product shuts down; and
pressing and holding the power switch will lead to forced shut-down of the product.
After power off, please disconnect the device from the power supply”
3.3 Environmental Requirements
This product shall be placed on a flat surface, with an appropriate ambient temperature of
18℃-30 and an appropriate relative humidity of less than 80%. It’s suggested using the product℃
in an air-conditioning environment.
This product shall be powered by a single-phase, three-pole power socket with good protective
grounding, and its power supply voltage is AC100-240V, 50Hz/60Hz. This product shall be placed
where interference of a strong electromagnetic field can be avoided, kept away from equipment
with strong electromagnetic radiation (such as microwave, RF treatment equipment), and stored
away from direct exposure to sunlight.

INSTALLATIONANDASSEMBLY
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The main unit and its supportive accessories of this product are applicable to patient
environment.
Notes:
①The 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.
②This product is prohibited from being used together with a high-frequency surgical
device.
3.4 Assembly
1. Insert the 10MHz A-Scan probe, 10MHz B-Scan probe and 20MHz B-Scan probe into their
corresponding sockets respectively shown in Figure 3-3;
2. Insert the wireless receivers of peripherals (wireless mouse and keyboard) into the USB
ports shown in Figure 3-2;
3. Insert the plug of the footswitch into the footswitch socket shown in Figure 3-2;
4. Insert the power adaptor into the DC power socket shown in Figure 3-2.
3.5 Assembly and Disassembly of Accessories and Replacement of Consumables
There’s no dismountable part in the main unit, so users are not authorized and allowed to open
the outer casing.
Move the main unit and other components with proper care when necessary.
Two bottles of acoustic gel are provided for free, and water-based polymer gel type coupling
agent used for normal B-Scan shall also apply.
The bottle for acoustic gel is made of polyethylene, and residue of acoustic gel is a water-soluble
substance with its heavy metal content meeting standards for cosmetics. Therefore, the operator
shall dispose of the empty bottle in accordance with local regulations for environmental protection,
e.g., the operator may dispose of the bottom together with disposable plastic products
(disposable syringes and infusion sets).
This product shall be discarded in accordance with local regulations for environmental protection.

OPERATIONINSTRUCTIONS
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Chapter 4. Operation Instructions
4.1 Starting Program
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” column (supporting keyboard or virtual on-screen keyboard); and
press “OK” to access the main interface of the program, as shown in Figure 4-2; or press “Exit” to
exit. There are seven functions in the main menu on the left side of the interface. These functions
include “New”, “Load”, “B scan”, “A scan”, “Report” and “Exit”.

OPERATIONINSTRUCTIONS
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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);
and click “Ok” to confirm the creation of the new patient.
Figure 4-3 “New Patient” Interface
4.3 Loading a Patient Record from Database
Click “Load” on the main interface to access “Load Patient” interface (shown in Figure 4-4), if the

OPERATIONINSTRUCTIONS
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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”.
Click “Delete” to delete a selected patient record; and the operator’s discretion is required.
Figure 4-4 Load Patient Interface
Figure 4-5 Dialog Box for Searching for History Records

OPERATIONINSTRUCTIONS
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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” (Oculus Sinister) stands for the left eye.
Click “B 10MHz” or “B 20MHz” to select the B-scan probe, and the selected probe will be
highlighted.
Click “Scan” or use the footswitch to start or freeze the probe.
Click “Snap” or tread on “SAVE” treadle on the footswitch, to acquire the existing image or
dynamic images scanned, and the acquired images will be displayed in a list on the right side of
the B scan interface.
If “Image” is highlighted, acquired images can be saved in BMP format; and if “Cine” is
highlighted, dynamic images acquired 10 seconds before the probe freezes can be saved in AVI
format.
The acquired images can be processed under the B-Scan mode, using several function keys like
“Mark”, “Dist-2”, “Dist-5”, “Angle”, “Area”, “Text”, “Undo”, “ ” and “Clear”.
Mark: for marking positions of eye. Left-click “Mark” to change the marked position of the eye on
a picture .
Dist-2: for measuring the distance between two points. Click “Dist-2”, and when the mouse comes

OPERATIONINSTRUCTIONS
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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. Click “Dist-5”, and 5 movable
rectangular boxes and an area for displaying parameters appear in the image-displaying area.
Corresponding value varies when left-dragging one of the boxes. (shown in Figure 4-8, see
<Section 4.6.1, 5-Point Marking Method under B+A Mode for Axial Length Measurement>)
Figure 4-8 5-Point Marking Method for Axial Length Measurement under B-Scan mode
Angle: for angular measurement. Click “Angle”, and when the mouse comes into the area for
displaying the scanned image, its cursor becomes cross-shaped. Firstly, locate the cursor at a
vertex of an angle to be measured; and then, locate two sides of the angle by placing cursors,
and measured readings can be displayed on the screen (shown in Figure 4-9).

OPERATIONINSTRUCTIONS
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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. Click “Text”; further left-click in the image-displaying area, and the “Text
Input” dialog box pops up; input desired text to be annotated; click “OK”, and the annotated text
can be displayed in the image-displaying area; and the text can be dragged by using the left
button of the mouse (shown in Figure 4-11).