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CHAPTER 9 EMC INFORMATION REQUIREMENTS

For this equipment, special precautions concerning electromagnetic compatibility (EMC)

should be taken, and the equipment must be installed and used according to the EMC

information specified in this specification.

Portable and mobile radio frequency communication equipment may have an impact on

the equipment.

In addition to the cables (transducers) sold as spare parts of internal components, the

use of accessories and cables (transducers) other than those specified may lead to an

increase in equipment or system emission or a decrease in immunity.

Devices or systems should not be used close to or overlay other devices. If they must be

used close to or overlay, they should be observed and verified to operate normally under

the configuration they are using.

Guidelines and Manufacturers'Statements - Electromagnetic Launch
The equipment is expected to be used in the electromagnetic environment

specified below, and the purchaser or user shall ensure that it is used in such an
electromagnetic environment:

Launching

test

Conformit
y

Electromagnetic Environment - Guide

radio-frequency
emission
CISPR 11

1group

The AB-type ophthalmic ultrasound diagnostic
instrument (SK-3000A) uses radio frequency energy
only for its internal functions, so its radio frequency
emission is very low and the possibility of
interference to nearby electronic equipment is very
small

radio-frequency
emission
CISPR 11

A type

Ophthalmological AB-type ultrasound diagnostic
instrument (SK-3000A) is suitable for use in all
facilities which are not directly connected with the
public low-voltage power supply network of
household and non-household houses.

Harmonic radiation

IEC 61000-3-2

applicable

Voltage
fluctuation/scintillat
ion emission
IEC 61000-3-3

applicable

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Содержание SK-3000A

Страница 1: ...Instruction For Use Ophthalmic Ultrasound SK 3000A Chongqing Sunkingdom Medical Instrument Co Ltd File No IFU EN OU 3000A Version V200518 ...

Страница 2: ...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 sc...

Страница 3: ...ing 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 OUT...

Страница 4: ...tian 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 After sale service company name Chongqing Sunkingdom Medical Instrument Co Ltd After sale service address 35 2 Yi...

Страница 5: ...ties 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...

Страница 6: ...ction 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 86 023 68643990 3 Sunkingdom reserves the right to explanation and modification for the operation manual 1 3 Str...

Страница 7: ...not 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...

Страница 8: ...cal 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 ...

Страница 9: ...iocompatibility of the equipment the materials contacted with patients by A scan probe B scan probe and Pachymetry probe meet the following requirements Cytotoxicity should be II sensitization there should be no skin sensitization Stimulation 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 in...

Страница 10: ...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 I ...

Страница 11: ...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 ...

Страница 12: ...11 1 12 Label This label information is stick on main body of Ophthalmic ultrasound ...

Страница 13: ...e 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 12 Test mode Immersion Contact 1...

Страница 14: ...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...

Страница 15: ...e 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...

Страница 16: ... 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 veloc...

Страница 17: ... 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 I...

Страница 18: ... 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 install...

Страница 19: ...iately 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 G...

Страница 20: ...19 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 ...

Страница 21: ...and installation diagram Pic 5 A P and B ultrasonic probes can be installed in the direction of arrow in Pic 5 and disassembled in the opposite direction of arrow in Pic 5 Pic 5 Pic 4 Calibration cylinder of A scan Pachymetry ...

Страница 22: ...itch to position I and start the device Power supply 100 to 240V AC power switch On the front screen the touch screen will light up Displays the first screen Equipment termination Put the switch of the power switch next to the power line on the left side of the equipment to the position O and the operation of the equipment can be safely terminated ...

Страница 23: ...ace 8 IOL calculation Click to enter IOL calculation interface 9 B scan image post processing Click to enter B scan image post processing interface 10 Print Click to print the test result Click Print on PC one can preview test report 11 Setting Click to enter setting interface 12 Online state Blue means PC and PLC connect well blank means PC and PLC offline 13 System time display zone In PC softwa...

Страница 24: ...23 4 2 New Create Interface PLC new create patient information interface 1 Input patient basic information 2 New New create 3 Delete Delete doctor name PC new create patient interface ...

Страница 25: ...mplate you can choose preset diagnostic opinion from drop list menu 4 Diagnostic opinion edit area Note After checking save test data enter database interface Choosing a patient click Load then you can enter New create interface to input ultrasonography description and diagnostic opinion 4 3 Database Interface 1 Query condition selection in database 2 Keyword input box 3 Search Click to proceed qu...

Страница 26: ... imported data from database click copy selected data will be imported into USB disk now the data just can import to USB disk one by one Then Insert this U disk into PC click Copy on PC interface the data be imported into PC to check Just can import one by one 9 Patient test data list 4 4 A scan Test Interface 1 Eye Switch left eye and right eye 2 Gain value show the gain value of current test you...

Страница 27: ...ion and IOL calculation Click the ignore again the set of data recover to normal and participate in calculation If you need ignore multi group data select one set click ignore then select another set click ignore 9 Delete Delete selected test data 10 Enter shift under manual examination mode you can switch among A L V calibration point by pressing it 11 Left Right move icon move the calibration po...

Страница 28: ...27 4 5 P scan Test Interface 1 Eye Switch left eye and right eye ...

Страница 29: ...ng it 7 Pachymetry echogram display area 8 Average value show the average value of corneal thickness 9 Minimum show the minimum value of corneal thickness 10 SD show measured data s standard deviation 11 Map mode enter corneal multi point measurement mode 12 Start start corneal thickness data collection 13 Clear clear all corneal thickness data of current examination 14 Delete delete the selected ...

Страница 30: ...29 4 6 B scan Test Interface 1 Eye Switch left eye and right eye ...

Страница 31: ...ch between 10M and 20M 6 B scan echogram display area 7 Echogram storage area 8 Start Stop start collecting B scan data or stop collecting data by pressing it 9 Delete Delete the selected images 10 Paging turning Click to do page turning 11 B A echogram display area 12 In B A mode A scan echogram baseline adjust icon 4 7 IOL Calculation Interface 1 Postoperative desired value display D E M The pow...

Страница 32: ... axial length of the tested eye A Constant K1 K2 Corneal radius DR The value postoperative expected to retain ACD Anterior chamber depth used in HAIGIS determined according to measured data ACDB Anterior chamber depth after operation used in Binkhorst II given by the IOL manufacturers 5 Count icon Press the icon to perform calculation Note the calculation will not be performed automatically after ...

Страница 33: ...ch need to mark the angel locate the starting point accurately by adjust the direction icon then click the central button to fix the point b click the screen choose a point to draw one edge c click screen to choose another point to draw another edge d read the angel 4 Sharpen click to focus on the blurry edge to improve definition or focus degree of a certain part in the image 5 Area measurement c...

Страница 34: ...tion you can click this button to cancel the wrong mark 9 B scan scanning angle selection click the down arrow there is a drop down menu pop up for selection No Display means don t display 1 12 correspond to 1 12 o clock 10 Zoom in click to zoom in the image click one time get twice size at most make it three times larger 11 Image zoom in zoom out and gray adjustment 12 Delete Use for deleting sel...

Страница 35: ...34 ...

Страница 36: ...n different types of lens 2 IOL calculation preset parameters setting 3 System setting 4 Keyboard zone 5 Save can save parameter setting 6 Cancel 7 Tissue velocity versus different lens type and customize type display zone you can ...

Страница 37: ...ick the button to set the PCL IP address PLC and PC should be set in same network segment 15 Touch screen calibration 16 Database back up insert USB disk into PLC USB disk must be FAT32 click this button to back up the database into USB disk 17 Update User can put the upgrade file into the update folder then copy the folder into USB disk USB disk type must be FAT32 then insert the USB into PLC cli...

Страница 38: ... to enter IP setting of PC PLC and PC should be set in same network segment 3 Diagnostic template name edit 4 Diagnostic template type selection 5 Diagnostic template content edit 6 Input ultrasonography description list 7 Input diagnostic opinion list 8 Save button ...

Страница 39: ... selection if ticked is A4 paper if not ticked is A6 paper 5 Test mode selection tick to print the corresponding check results 6 Export the PDF option select the report that needs to be exported tick the PDF option click the print button you can export the check results to PDF format export the path to the pdfs folder in bin folder if there is no pdfs folder under bin file you can create a new pdf...

Страница 40: ...ion with AB scan ophthalmic ultrasound diagnostic instrument and is an embedded software component of the equipment 5 1 4 Software Support Chongqing Sunkingdom Medical Instrument Co Ltd provides technical support and training for software users while continuing to upgrade and optimize the operation software 5 2 PC Software Installation 1 Double click to install the software 2 Click Next follow the...

Страница 41: ...40 2 Click Properties 3 Double click Internet protocol version 4 ICP IPv4 ...

Страница 42: ...se the following IP address input the IP address PLC and PC should be set in same network segment check the IP address of PLC in IP setting of PLC 5 Open the PC software click Setup enter IP setup see in below image ...

Страница 43: ...42 6 Input the IP value Mask value Gate value DNS value in PLC IP setup to corresponding position in PC software click OK finish setting 5 3 2 IP Settings of PC and PLC Connected by Router ...

Страница 44: ...etting up IP connect the PC and PLC to the router with the network cable respectively 2 Open the computer s network and sharing center and click on the local connection as shown below 3 Click details as shown below ...

Страница 45: ...44 4 Record the values of IPv4 address IPv4 subnet mask IPv4 default gateway IPv4 DNS server 5 Open PLC click setup then click IP as show below ...

Страница 46: ...f IPv4 subnet mask Gate fills in the value of IPv4 default gateway DNS fills in the value of IPv4 DNS server click ok 7 Open PC software click setup enter IP as show below 8 Input the IP value Mask value Gate value DNS value in PLC IP setup to corresponding position in PC software click OK finish setting ...

Страница 47: ...usted according to waveform changes in process of measurement as needed 5 Take down A probe cap clean the surface of A scan probe tip with normal saline The patient is placed in a supine position on a flat examination table apply a drop of topical anesthetic to the eye that is to be measured prior to performing the A Scan 6 Separate patient eyelid instruct the patient focus on the red light in cen...

Страница 48: ... a cup to be placed on patient s eyeball probe to be placed in cup pic 1 Pic 1 Pic 2 b Contact mode probe need to be placed on cornea gently pressing in or out of the corneal apex will cause data inaccurate pic 2 5 5 IOL Calculation 1 When A scan measurement is completed click IOL to turn to calculation interface can also calculate artificial lens formula on IOL interface 2 Select the needed formu...

Страница 49: ...rior to performing the P scan 6 Separate patient eyelid instruct patient focus on red light in central probe or look upward step on foot pedal or press the Start icon then place the probe gently on the patient s cornea vertex single point mode or the corresponding corneal position versus the point display on the screen map mode start measuring 7 If echogram meets the criteria of the selected exami...

Страница 50: ...il capture perfect B scan ultrasonoscopy 9 After testing if you want playback the ultrasonoscopy just click Cineloop sequence to make it 10 If you want to do post processing please enter the B scan image post processing interface 5 8 Use Of Calibration Cylinder 1 Turn on main machine power supply 2 Enter main screen and select calibrate mode in lens type drop down menu when calibrate with p scan s...

Страница 51: ...nting Paper Specification Printing paper width is 110mm thermal printing paper 6 3 Method to Change Printing Paper 1 Press power switch button open the machine when there is no paper inside the LCD is in Orange and show message EMPTY 2 Press OPEN button to open the paper box ...

Страница 52: ...3 Tear off the printer paper s label reserve 15 20cm length paper out then roll the paper into paper repository notice keep the front side upward if not the print can t success 4 Pull the plate to close it ...

Страница 53: ...nd A B and P probe belong to high precision instruments After use they should be cleaned disinfected and put back into the probe rack Warning Touch screen is easily damaged Only use wet cloth to wipe Solvents or alcohol should not be used 7 2 Maintenance in Process Of Working When working there should be no interference from strong noise light electricity and magnetism Keep this device from this k...

Страница 54: ...polyethylene film wrapped or dismantled In order to protect the housing do not use friction cleaning tools If possible remove stains before drying 7 5 How to Prevent Cross Infection of Patients The probe must be cleaned between the two patients in order to prevent cross infection The probe can be cleaned with alcohol commonly used in hospitals When cleaning follow the label instructions Other FDA ...

Страница 55: ... or use function icon on the screen to collect No normal reflection echogram Probe not connected or damaged Re connected or replace probe For ordinary malfunction users can remove it by themselves If there are other malfunctions please contact our company to solve them 7 7 Parts Replacement Customerte can repair or replace the parts information by itself must use the specified model of our company...

Страница 56: ... not be discarded at will When the equipment reaches the end of its life it should be recycled according to the requirements of local laws and regulations In order to avoid causing environmental pollution 7 9 Manufacturer Responsibility The manufacturer is responsible for the safety and reliability of the equipment only in the following circumstances Assemblies additions commissioning modification...

Страница 57: ...sitivity test can determine the sensitivity of probes and should be performed before each use 2 The results of the sensitivity tst can not meet the requirements indicating it may not be sensitive enough to perform accurate scans Is general this is due to a loss of sensitivity in the probe If this is the case the probe should be replaced However in order to confirm that it is the probe which is the...

Страница 58: ... Iob mW cm2 0 94 4 Ispta mW cm2 4 79 4 Ispta mW cm2 1 12 5 System setup 5 System setup 6 Lp 30 6 Lp 5 7 Wpb6 5 2 2 8 7 Wpb6 1 59 3 05 8 prr kHz not applicable 8 prr kHz 0 6 9 srr Hz 14 28 9 srr Hz not applicable 10 Output wave beam size cm2 0 5024 10 Output wave beam size cm2 0 0962 11 fawf MHz 9 36 11 fawf MHz 8 5 12 APF not applicable 12 APF not applicable 13 Boot mode not applicable 13 Boot mod...

Страница 59: ...are using Guidelines and Manufacturers Statements Electromagnetic Launch The equipment is expected to be used in the electromagnetic environment specified below and the purchaser or user shall ensure that it is used in such an electromagnetic environment Launching test Conformit y Electromagnetic Environment Guide radio frequency emission CISPR 11 1group The AB type ophthalmic ultrasound diagnosti...

Страница 60: ...ical commercial or hospital environments Surge IEC61000 4 5 1kV cable to cable 2kV cable to ground 1kV Difference Patter ns Network power supply should have the quality to be used in typical commercial or hospital environments Voltage sags short interruptions and voltage variations on power input lines IEC61000 4 11 5 UT last 0 5 cycle on UT 95 sag 40 UT last 5cycle on UT 60 sag 70 UT last 25 cycl...

Страница 61: ...tromagnetic Environment Guide Radiofrequency conduction IEC61000 4 6 Radiofrequency radiation IEC61000 4 3 3 V Effective value 150kHz 80MHz 3 V m 80MHZ 2 5GHZ 3 V Effective value 3 V m Portable and mobile radio frequency communication devices should not be used closer to any part of the device including cables than recommended isolation distances The distance is calculated by a formula correspondi...

Страница 62: ...performance is observed supplementary measures may be necessary such as reorientation of the direction or position of the ophthalmic AB ultrasound diagnostic instrument SK 3000A b In the whole frequency range of 150 kHz 80 MHz the field intensity should be less than 3V M Recommended Isolation Distance between Portable and Mobile Radio Frequency Communication Equipment and Ophthalmic AB Ultrasound ...

Страница 63: ...ted output power of the transmitter provided by the transmitter manufacturer In Watt W units Note 1 At 80MHz and 800MHz frequencies higher frequency band formulas are used Note 2 These guidelines may not be suitable for all situations Electromagnetic propagation is affected by the absorption and reflection of buildings objects and human bodies The following cables must be used to meet electromagne...

Страница 64: ... product is guaranteed free of charge for one year from the date of purchase subject to the operation of this instruction 3 In accordance with the instructions and the operating precautions in the normal operation state once the machine breaks down please contact our company immediately 4 The following items are not included in the warranty Damage caused by failure to follow the instructions for u...

Страница 65: ...made ChongQing Sunkingdom Medical InstrumentCo Ltd No 1 Xinmao road Beibei district chongqing free trade zone 35 2 YingTian GuangDian GongGu CaiJiaGang Industry Zone BeiBei District ChongQing China Tel 86 23 68643990 Fax 86 23 68102805 MedNet GmbH Borkstrasse 10 48163 Muenster Germany Tel 49 251 322660 For more information please turn to us www cqsunkingdom com ...

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