EZER EUS-2600 Manuale utente
CONTENTS
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CONTENTS
IMPORTANTNOTICES ................................................................................................................................... III
EXPLANATIONOFLABELSANDSYMBOLSONTHEPRODUCT ..................................................... IV
EXPLANATIONOFLABELSANDSYMBOLSONTHEPACKINGBOX .............................................. 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
IMPORTANTNOTICES
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ImportantNotices
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.
EXPLANATIONOFLABELSANDSYMBOLSONTHEPRODUCT
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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
FS FootswitchInterface
DC-12V PowerInputSocket
Manufacturer
EXPLANATIONOFLABELSANDSYMBOLSONTHEPRODUCT
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ExplanationofLabelsandSymbolsonthePackingBox
This Way Up
Fragile, Handle with Care
Keep Dry
Stacking Limit by 4
Temperature Limit
Humidity limitation
GENERALINTRODUCTION
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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.
TECHNICALSPECIFICATIONS
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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
TECHNICALSPECIFICATIONS
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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: -40C to 55C
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: -40C to 55C
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;
TECHNICALSPECIFICATIONS
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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.
Indice
