Sun Kingdom SK-3000A User manual

Instruction For Use
Ophthalmic Ultrasound
SK-3000A
Chongqing Sunkingdom Medical Instrument Co., Ltd
File No.: IFU- EN-OU-3000A
Version: V200518

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Content
PREFACE .......................................................................................................................3
CHAPTER 1 SUMMARY...............................................................................................4
1.1 Machinery Description...........................................................................................4
1.2 Usage Information.................................................................................................4
1.3 Structure Components...........................................................................................5
1.4 Applicability...........................................................................................................5
1.5 Product Contraindication.......................................................................................6
1.6 Points for Attention................................................................................................6
1.7 Operation Instruction Applicability .........................................................................7
1.8 Products Features.................................................................................................7
1.9 Size and Weight....................................................................................................8
1.10 Working Environment..........................................................................................8
1.11 Transportation & Storage ....................................................................................9
1.12 Symbolic Interpretation........................................................................................9
1.12 Label.................................................................................................................11
CHAPTER 2 INSTRUMENT INTRODUCTION............................................................12
2.1 Basic Performance and Parameters....................................................................12
2.2 Performance Requirements.................................................................................13
2.3 Theory.................................................................................................................14
CHAPTER 3 DEVICE INSTALLATION INSTRUCTION ..............................................17
3.1 Packing ...............................................................................................................17
3.2 Working Environment..........................................................................................17
3.3 Installation Environment......................................................................................17
3.4 Device Installation...............................................................................................18
3.5 Device Start-up and Termination.........................................................................21
CHAPTER 4 INTERFACE INTRODUCTION AND SETUP..........................................22
4.1 Main Screen Introduction.....................................................................................22
4.2 New Create Interface...........................................................................................23
4.3 Database Interface..............................................................................................24
4.4 A-scan Test Interface ..........................................................................................25
4.5 P-scan Test Interface ..........................................................................................27
4.6 B-scan Test Interface ..........................................................................................29
4.7 IOL Calculation Interface.....................................................................................30
4.8 B-scan Image Post-processing............................................................................31
4.9 Setting Interface..................................................................................................33
4.10 Print Selection Interface of PC...........................................................................38
CHAPTER 5 OPERATING INSTRUCTION ...................................................................39
5.1 Software Instruction.............................................................................................39
5.2 PC Software Installation......................................................................................39
5.3 IP Settings of Upper Computer Software.............................................................39

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5.4 A-Scan Measurement..........................................................................................46
5.5 IOL Calculation....................................................................................................47
5.6 Corneal Thickness Measurement........................................................................47
5.7 B-scan Measurement ..........................................................................................48
5.8 Use Of Calibration Cylinder.................................................................................49
CHAPTER 6 PRINTER INSTRUCTION & REPLACE PAPER ....................................50
6.1 Printer Button......................................................................................................50
6.2 Printing Paper Specification ................................................................................50
6.3 Method to Change Printing Paper .......................................................................50
CHAPTER 7 EQUIPMENT MAINTENANCE...............................................................52
7.1 Daily Maintenance...............................................................................................52
7.2 Maintenance in Process Of Working....................................................................52
7.3 Maintenance of Probe .........................................................................................52
7.4 Maintenance During Long-term Non-use.............................................................53
7.5 How to Prevent Cross Infection of Patients..........................................................53
7.6 Common Faulty Troubleshooting.........................................................................54
7.7 Parts Replacement..............................................................................................54
7.8 Waste Disposal ...................................................................................................55
7.9 Manufacturer Responsibility ................................................................................55
CHAPTER 8 ANNOUNCMENT OF PROBE SOUND WAVE OUTPUT.......................56
CHAPTER 9 EMC INFORMATION REQUIREMENTS................................................58
CHAPTER 10 WARRANTY STATEMENT ..................................................................63

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PREFACE
Dear User：
Thank you very much for choosing SK-3000A Ultrasound AB Scanner manufactured
by Chongqing Sunkingdom Medical Instrument Co.(hereinafter called Sunkingdom), We
feel deeply honored to get your trust. The operation instruction including the description,
installation, usage, notice for use, maintenance, transportation and storage .This is an
essential part to guide you use the instruments.
For your security and benefit, please read the operation instruction as well as the
datum of the instruments carefully before using it. If the instruments in this manual are
carefully followed , we are confident that this products will give you reliable and
trouble-free usage.
Registration information
◆P ro d u ct N a m e ：SK-3000A Ophthalmic Ultrasound
◆Product Model：SK-3000A
◆Operators Manual Model：SK-3000A
◆Manufacturer Name：Chongqing Sunkingdom Medical Instrument Co.,Ltd.
◆Manufacture Address：35-2, Yingtian Guangdian Gonggu, Caijiagang Industry
Zone,Beibei District,Chongqing, China.
◆Product registration address：No. 1 Xinmao Road, Beibei District, Chongqing (Free
Trade Zone)
◆Production license number of this product.：Chongqing Pharmaceutical Supervision
Equipment Production License No. 20160050
◆Afte r-sale service company name：Chongqing Sunkingdom Medical Instrument Co.,
Ltd
◆Afte r-sale service address：35-2, Yingtian Guangdian Gonggu, Caijiagang Industry
Zone,Beibei District,Chongqing, China.
◆Afte r-sale service phone No.：[phone]
◆Date of production: See nameplate
◆Product life circle 5 years
◆Date of preparation of instruction: 19 June 2018
Before use, you are advised to do the following carefully:
1. Check carefully whether the instrument and packing list are consistent, and whether
the instructions and accessories are complete.
2. Please read the random documents carefully and keep them properly.
The pictures in this instruction are the effect pictures. The specific configuration is based
on the packing list. If you have any details, please consult Sunkingdom Medical.
Consultation tel: [phone]

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CHAPTER 1 SUMMARY
1.1 Machinery Description
SK-3000A Ultrasound AB Scanner takes the advantage of the international advanced
model, have higher stability and reliability compare to similar products in domestics.
Apply to measuring the axial length to choose right IOL power, capturing eye(anterior &
posterior chamber) and orbit image to diagnosis eye disease. The instruments have a
low input power, even repeated irradiate a living organism, there is no accumulated
biological effect and mechanical effect.
1.2 Usage Information
1.2.1 For your security and benefit , please read the operation instruction and all the
datum of the instrument carefully before using it. If you do not operate the instrument
according to the operation instruction, Sunkingdom will not take any responsibilities.
1.2.2 The instrument cannot be used in conjunction with high frequency surgical
equipment.
1.2.3 The voltage must be up to the given standard. If the voltage is not steady, please
install a constant voltage regulator. We will not take responsibility for the damage caused
by the voltage.
1.2.4 Do not use in the inflammable ,hot, dusty and oxygen-enriched environment and
pay attention to keep it clean and dry; to avoid being damaged by the environment
(Damp, dusty, liquid, under the sun , and so on). Do not let the liquid or any other small
objects run into the instrument ,otherwise these objects may make the inner parts of the
instrument short-circuit , and even make the users get an electric shock or even cause a
fire hazard.
1.2.5 Without the permission of us or our authorized distributor , do not open the box of
the instrument, or we will not take the responsibility of consequence.
1.2.6 For better maintenance , please wait for at least 5 seconds to restart the device
after turn off.

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1.2.7 Turn off the main power when not using the instrument, do not being power-up
state over 4 hours. Please keep the instrument clean.
1.2.8 Environment protection clause :it will pollute the environment if you discard the
equipment and accessories which is breakdown . Recall or disposal according to the
local laws and regulations.
1.2.9 A-probe, B-probe both are high precision instrument, please clean , sterilize the
instrument and put it back to probe frame, and put the cable in a place to avoid
damaging, or we will not take the consequence.
1.2.10 The front surface and adjacent 2-3 mm of A- probe can be immersed into water
or other no-corrosive, no-poisonous liquid.
1.2.11 About the instrument operation instruction（hereinafter called “operation
instruction”）
1）the pictures given by the operation instruction are effect pictures, please in kind
prevail.
2）If you have unknown or objection to any content or terms in operation instruction,
or you experience technical problems in the process of using, please contact with the
local agent or call [phone]
3) Sunkingdom reserves the right to explanation and modification for the operation
manual.
1.3 Structure Components
Components includes main unit, A-Scan probe（10M Hz）, B-scan probe（10M Hz）,
pachymetry probe（20M Hz）, foot pedal, power cable, calibration cylinder.waterproofing
grade of main unit is IPX0, waterproofing grade of probe is IPX7, waterproofing grade of
foot pedal is IPX1.
1.4 Applicability
Apply to measuring corneal thickness, anterior chamber depth, lens thickness ,
vitreous depth，axial length for ophthalmology, Calculate the intraocular lens implanted
into the eye, and generate the ultrasound images of the eye and orbit to examine the
eye diseases.

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Ultrasound A is suitable for measuring axial length, anterior chamber depth, lens
thickness and vitreous length.
B-mode ultrasonography is suitable for examining eye diseases.
P-ultrasonography is suitable for measuring corneal thickness
1.5 Product Contraindication
[Product contraindication] Active ocular inflammatory lesions (such as acute
conjunctivitis, blepharitis, keratitis, corneal ulcer, dacryocystitis, iridocyclitis etc) and the
infants can not use the product.
1.6 Points for Attention
In order to avoid personal injury and other possible dangers, please read the
precautions carefully.
Warning: When measuring the length of the eye axis, be careful not to press the
cornea.
Warning: This device cannot be used for infants.
Warning: Before wiping the equipment, the external power supply should be
disconnected.
Warning: disconnect the external power supply after shutting down the
equipment each time.
Warning: All biometric probes are push-pull connectors with locking systems to
prevent incorrect installation. Do not forcibly install connectors.
When using, make sure the equipment is grounded reliably. In order to avoid the
damage of the equipment by the environment (humidity, dust, liquid, direct exposure to
sunlight, etc.), it should be placed in a dry place. Do not splash liquid or other sundries
into the equipment, otherwise it may cause short circuit of the internal components of the
equipment and then cause electric shock or fire.
The instrument is well grounded and can only be used by clinicians without
sensitivity test..
Installation of instruments should be carried out on flat and inclined ground.

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Keep the working environment clean and dry, avoid overheating and dusty
environment.
Use the special wires equipped with the instrument when it leaves the factory.
No sharp instruments or hard objects shall be used to mark or touch any
exposed part of the surface.
Warning: This device can not be used with high frequency surgical equipment.
Warning: Do not open the case without permission of the company, otherwise
the consequences are at your own risk.
Warning: Be sure to use grounded power plugs.
Federal law restricts this device to sale by or on the order of a physician or
licensed professional practitioner.
This device can be only operated by Medical Doctors, Nurse or Medical
Technicians who have been trained for diagnosing patients.
1.7 Operation Instruction Applicability
This operation instruction is a comprehensive version, apply to following models.
The instrument models：SK-3000A
1.8 Products Features
1) According to the types of electric shock protection: Class I equipment;
2) According to the degree of protection against electric shock: type B application
part;
3) According to the degree of protection against liquid intake: the main machine is a
common type of equipment; pedal switch: IPX1; probe: IPX7;
4) According to the degree of safety in the use of flammable anesthetic gas mixed
with air or flammable anesthetic gas mixed with oxygen or nitrous oxide: it should not be
used in the case of flammable anesthetic gas mixed with air or flammable anesthetic gas
mixed with oxygen or nitrous oxide;

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5) Classified by operation mode: intermittent loading and continuous operation;
6) rated voltage and frequency of equipment: ~100-240V 50/60Hz;
7) The input power of the equipment is 80VA;
8) Whether the equipment has the application part of protection against the effect of
defibrillation discharge: no;
9) Whether the equipment has the signal output or input part: Yes;
10) Permanent installation equipment or non-permanent installation equipment:
non-permanent installation equipment;
11) Equipment type: portable;
12) Safety Pipe Model: F1AH250V;
13) The biocompatibility of the equipment: the materials contacted with patients by
A-scan probe, B-scan probe and Pachymetry probe meet the following requirements;
① Cytotoxicity; should be≤ II.
②sensitization; there should be no skin sensitization.
③Stimulation; should be a very slight reaction.
14) Detection accuracy: average relative error ≤ 0.05 mm
15) Wastes such as A-scan probe, B-scan probe and Pachymetry probe and
infiltration accessories after the equipment is used shall be disposed of in accordance
with national and local environmental regulations
1.9 Size and Weight
Table 1 weight and size
1.10 Working Environment
General clinical work environment
Temperature：5℃～40℃
Model
size／weight SK-3000A
dimension
（
wide*height*length
）（
mm）
300*93*255
weight
（
kg
）
3.6

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Relative humidity：≤85%
Atmosphere pressure: 700hPa～1060hPa
Power supply：AC 100-240V 50/60Hz
1.11 Transportation & Storage
The packaged instrument can be transported by ordinary means of transportation.
Rain and snow splashing and mechanical collision should be avoided during
transportation. It should not be exposed to sunlight. Transportation ambient
temperature:-40。C -+70。C, atmospheric pressure: 500 hPa - 1060 hpa, relative humidity
10% - 95%.
The packaged instruments should be stored in clean rooms with good ventilation, dry
and non-corrosive gases at ambient temperatures ranging from 0℃～55℃, relative
humidity not more than 85%, atmospheric pressure ranging from 500 hPa to 1060 hPa.
1.12 Symbolic Interpretation
Instrument external marking instructions：
Type B Application Section
Dangerous voltage
Caution!
ISwitch on and off the power supply
A-scan probe socket
Pachymetry probe socket
B-scan probe socket
Pedal switch socket
USB interface
Network interface
Video output interface and printer interface

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Power jack
Should not be treated as household waste
Manual Instruction symbol
Manufacturer information
Manufacture date
European certificate of conformity
Series Number of products
Authorized representative in the European Community
Symbol Interpretation on packaging box：
It indicates that fragile articles are contained in transport
packages and should be handled with care.
It indicates that the transport package should be vertically
upward when it is transported.
It shows that the transport package is afraid of rain.
It shows that the transport package can be stacked up
to five layers.

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1.12 Label
This label information is stick on main body of Ophthalmic ultrasound

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CHAPTER 2 INSTRUMENT INTRODUCTION
2.1 Basic Performance and Parameters
No Category Technical index Parameters Note
1
A-Scan
and
Pachymet
ry
Ultrasonic
frequency
10MHz(20MHz) 20MHzis for
Pachymetry
2 Definition ≤0.05mm axial lengths
measurement
3
≤0.01mm
Cornea measurement
4 Display
resolution ≤0.01mm
5 Probing depth ≥40mm Limit Axis Range
13-39 mm
Gain 0-99db
6 Velocity Typical sound velocity
1640m/s，1532m/s
You can choose
manually or pre-set the
sound velocity
7 Data output Cornea,anterior
chamber,lens,vitreous body,axial
length
8 Sets of data
output 10 sets Average, standard
deviation calculate
9 Formula SRK-T,Hollady,Hoffer
Q,SRK-2,BinkhorstⅡ,Haigis 6 usually used formulas
10 Lens type Phakic,Dense,Aphakic,PMMA,
Acrylic,Silicone
Selection of Six
Common lensConditions
11 Measurement
method Auto and Manual
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Test mode
Immersion,Contact
13
B-scan
Probe frequency
10MHz
15 Scanning
resolution
axial direction ≤0.2,
side direction≤0.4 Standard B-scan
16 Display
resolution ≤0.06mm
17 Probing depth ≥60mm
18 Blind zone ≤ 4 mm
19
Lengthways
geometric
position
accuracy
≤5%
20 Horizontal
geometric
≤ 10 %

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position
accuracy
21 Gain range
0
～
99db
22
Scan angle
≥53°
21
Grey scale
256
22
fps
≥12 frames per second
2.2 Performance Requirements
(1) A/B Ultrasound Performance
The nominal frequency of A-scan probe is 10MHz and the error range is±15%.
The nominal frequency of B-scan probe is 10MHz, and the error range is±15%.
The nominal frequency of the Pachymetry probe is 20MHz, and the error range
is±15%.
B-scan detection depth: 10M B-mode ultrasound probe (≥50)
Lateral Resolution of B-scan: 10M B-mode Ultrasound Probe ≤ 0.4mm
Axial resolution B-scan: 10M B-mode probe≤0.2
Transverse Geometric Position Accuracy of B-scan: 10M B-scan Probe ≤ 10%
Longitudinal Geometric Position Accuracy of B-scan: 10M B-scan Probe≤ 5%
Blind zone of B-scan: 10M B-scan probe≤4
The measuring range of the length of A-scan eye axis should not be less than 15 mm
to 35 mm.
The error of measuring the length of A-scan eye axis should be no more than 0.05
mm.
The measurement range of Pachymetry corneal thickness should not be less than
0.3 mm to 1.2 mm.
The measurement error of Pachymetry thickness should be no more than 0.05 mm.
A-scan Axis length measurements should show two significant digits after decimal
points, and Pachymetry corneal thickness measurements should show three significant
digits after decimal points.
A-scan has two measuring modes, manual and automatic. The error of the two
measuring modes is not more than 0.2 mm.

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It has the function of calculating intraocular lens and the name of calculating formula
should be given in software settings and attached files.
(2) Appearance and structural requirements
The shell of the diagnostic instrument should be free from mechanical damage and
rust. The words and marks on the panel should be clearly visible and firm.
The plastic parts of the diagnostic instrument should be free from foaming, cracking,
deformation and overflow of fillings.
The operation and adjusting mechanism of the diagnostic instrument should be
flexible, reliable and the fastener should not be loosened.
The front side of the B-scan probe of the diagnostic instrument should be marked
correctly to indicate the scanning plane, and the marking should be on the scanning
plane.
(3) Foot pedal
The pedal switch shall meet the requirements of MEDICAL FOOT SWITCH.
(4) Safety requirements
General safety shall meet the requirements of EN 60601-1:2006/ A1:2013 or IEC
60601-1:2005 /A1:2012 and special safety shall meet the requirements of IEC/EN
60601-2-37 2015.
(5) EMC requirements
EMC shall comply with the relevant provisions of EN 60601-1-2:2015/ IEC
60601-1-2:2014 and IEC/EN 60601-2-37 2015.
(6) Environmental test requirements
The measuring instrument should meet the requirements of Climate Environment
Group II and Mechanical Environment Group II in EN ISO 14710-2009
2.3 Theory
A-scan theory

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A-scan ultrasound show reflected signal which is from interface in human body as
vertical peak, form an image. The ultrasonic wave transmission time represents distance
of reflecting interface, the further the distance, the later position of peak .the height of
peak represent echogenicity, the stronger of echo, the higher of peak. The echo
amplitude obtained is A-Scan ultrasound echogram.
B-scan theory
B-scan ultrasound send out a set of ultrasonic to human body, scanning according to
a certain direction, transfer the interface echo to echo spot in different brightness , all
these light spot form a 2D series section images.
Pachymetry theory
Pachymetry cornea thickness measurement :When the ultrasonic pulse strikes the
first interface, one part of the acoustic wave is reflected, the other part of the acoustic
wave penetrates the first interface and continues to move to the second interface, and
then another part of the ultrasonic wave is reflected by the second interface. The corneal
thickness can be calculated by measuring the distance between the two peaks produced
by the two reflections of ultrasound.
Velocity
Sound wave has different velocity in different medium, sound velocity is associated
with medium density and medium temperature. The velocity in anterior chamber and
vitreous body is 1532m/s，the velocity in lens range from 1590-1670m/s according to
different opacification degree, general use 1641m/s.
Detected results analysis
A-scan ultrasound allows for measuring the anterior chamber depth, lens thickness
and vitreous depth of eyes (corneal thickness included in anterior chamber).The visual
axis length from cornea to retina average in 22-24.5mm, age-related decreasing of
anterior chamber depth, thickness of lens between 3.5-4.5mm, lens thickness is

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proportional to increase of age. Behind lens is vitreous body section, most in 16-18mm,
but people who has high myopia usually larger than this range.
Important notes for A-scan：
1,placing the A-probe against patient eye lightly, and don’t press it;
2.The direction of acoustic must through axle center of eye, or obvious measure
errors will be made.
The mark on the B-probe represent the direction of sound beam and the upside of
image.B-scan ultrasound mainly do width scanning ,equivalently equatorial diameter, so
when you want to scan peripheral part, you must change the probe direction or patient
gaze direction , to make the lesion area in the center of image.
The method to get high definition B-scan image :
1. Lesion area located in the central zone;
2. Sound beam must perpendicular to detected interface;
3. Adjust the gain , keep enough strength and low decibel to get the best resolution
image.
Algorithm
The calculation of IOL powers be implanted，usually using SRKⅡfor calculation，
the formula as below:
P=A*L-2.5*L-0.9(K1+K2)/2
There into
P IOL degree
A IOL constant
L axial length
K1Horizontal corneal diopter
K2 Vertical corneal diopter
When 19≤L<20 then AL=A+3
20≤L<21 then AL=A+2
21≤L<22 then AL=A+1
22≤L≤24.5 then AL=A
L>24.5 then AL=A-0.5

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CHAPTER 3 DEVICE INSTALLATION INSTRUCTION
3.1 Packing
Open this instruments package carefully，outside packing is carton and inside
protection packing is Pearl wool .Please check all accessories according to packing list
before discarding the packing materials.
（1）SK-3000A Ultrasound AB Scanner main machine
（2）Accessories
Power line A-probe Foot pedal B-probe P-probe Calibration cylinder
3.2 Working Environment
（1）Environment temperature: -5℃～40℃
（2）Atmosphere :700hPa～1060h Pa
（3）Relative humidity: 45%～85%
（4）AC.100－240V 50/60Hz
（5）Input power: 80VA
3.3 Installation Environment
In order to ensure the safe and stable operation of the equipment, please ensure
good installation environment：
(1) Install this instrument on the flat surface.

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(2) This instrument must be installed in clean, quiet and dry environment.
(3) Must install special ground wire .
If the equipment encounters low temperature during transportation, it is not
recommended to open the switch immediately after unpacking.
Warning: Switching on the switch can cause serious damage if the equipment is
at a temperature close to 0 C。. Open the package and place the equipment at room
temperature for at least 8 hours to ensure that the internal parts are gradually warmed
up.
3.4 Device Installation
1) Front view of machine（pic 1）
2) Side view of machine（Pic2,Pic3,Pic4）
Pic 1
Display
screen
Indicator light
Gain knob
Probe
bracket

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Pic 2
P-probe
B-probe
A-probe
Printer port
Foot pedal port
Power
switch
Power plug
A-probe jack
P-probe jack
B-probe jack
USB Port
Network port
Pic 3