Meditech C-Scan User Manual Download Page 9

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ONTENTS

Safety Specifications Volume

.............................................................................. 1

Chapter 1 Safety Specifications

.................................................................................. 1

1.1

The text used in this manual

............................................................................................. 3

1.2

A description of the safety symbol and the device label

............................................... 4

1.3

Identify the label

.................................................................................................................. 5

1.4

Safety classification

............................................................................................................ 6

1.5

Patient safety

....................................................................................................................... 6

1.6

Operator safety

................................................................................................................... 8

1.7

Safety of the Probe

............................................................................................................. 9

1.8

Electrical Safety

................................................................................................................ 10

1.9

EMC

.................................................................................................................................... 11

1.10

ALARA Principle (As Low As Reasonably Achievable)

.............................................. 16

1.11

Safety Statements

............................................................................................................ 17

1.12

Biological Effects

.............................................................................................................. 17

User's Manual Main Volume

.............................................................................. 18

Chapter 2 System composition and characteristics

.................................................. 18

2.1

System composition

......................................................................................................... 18

2.1.1

Specification of product specification and its division

............................................. 18

2.1.2

Performance

.................................................................................................................. 19

2.2

Intended use

...................................................................................................................... 22

2.3

Contraindications

.............................................................................................................. 23

2.4

Target population

.............................................................................................................. 23

2.5

Lifetime

............................................................................................................................... 23

Chapter 3 System Appearance

.................................................................................. 24

3.1

System Appearance

......................................................................................................... 24

3.2

Introduction to Parts

......................................................................................................... 25

Chapter 4 Operation Panel Function Introduction

..................................................... 26

Chapter 5 Storage and Transportation of the System

............................................... 28

5.1

Environment requirement

................................................................................................ 28

5.2

Power requirements

......................................................................................................... 29

5.3

Storage and transport conditions

................................................................................... 29

5.4

Mobile devices

.................................................................................................................. 30

Summary of Contents for C-Scan

Page 1: ...trasound System User s Manual Ver 1 2 49 PLEASE READ ALL OF THE INFORMATION IN THE PACKAGE INSERT BEFORE USING THE SPIROMETER IF YOU DO NOT UNDERSTAND THE INSTRUCTIONS CONSULT MEDITECH service meditec...

Page 2: ...ation of the equipment please read and understand the entire contents of this manual before using the ultrasonic equipment so that you can familiarize yourself with the device performance and operatio...

Page 3: ...lities enabling users to fully manage data which can exchange a variety of medical findings and these data will be open for future quantitative analysis The user friendly design and comfortable interf...

Page 4: ...ical scans for the purpose of medical diagnosis C The acoustical strengths shown in this manual are below the limits for medical applications D The formulas and databases in this manual are for refere...

Page 5: ...ranties of fitness for a particular purpose For the replaced defective parts and scrapped whole machine please do not discard as garbage They should be recycled or discarded according to local laws an...

Page 6: ...uipment co Ltd has the right of final interpretation of this manual Issued Date Warranty and maintenance services The warranty period of the purchased product shall be subject to the sales contract Co...

Page 7: ...ng the warranty period we may charge the costs for the maintenance and accessories if the malfunction is caused by the following reasons Man made damage Improper use The grid voltage is outside the pr...

Page 8: ...y regulations User Manual Main Volume Describes the system operating procedures maintenance checks basic functions system daily preparation work and instructions for using the system Probe and Consuma...

Page 9: ...12 Biological Effects 17 User s Manual Main Volume 18 Chapter 2 System composition and characteristics 18 2 1 System composition 18 2 1 1 Specification of product specification and its division 18 2 1...

Page 10: ...re 34 7 3 Check after booting 34 7 4 System Settings 35 7 5 Shut down the system 37 7 6 Software Update 38 Chapter 8 Clinical Application Types 38 8 1 B mode scanning 38 8 2 C mode scanning for convex...

Page 11: ...recautions 65 11 4 2 Clean the probe 66 11 4 3 Sterilization of the probe 67 11 5 Peripheral cleaning 69 11 6 Screen cleaning 69 11 7 SECURITY INSPECTION 70 11 8 Troubleshooting 70 11 9 List of access...

Page 12: ...system performance degradation All modifications must be made by our authorized personnel Do not use this unit where water may enter the machine Do not place the liquid above the device If the conduct...

Page 13: ...plug the power supply If flammable substances are detected ventilate the area before closing the unit Connect the power supply and the ground wire according to the correct method in the user manual ot...

Page 14: ...used in this manual Indicates a particularly hazardous situation which if not avoided could result in Severe or fatal injury Significant property damage Fire Indicates that a potential situation if u...

Page 15: ...other important matters This symbol indicates the B type application part This symbol indicates AC marking indicates AC power and rated current Non ionizing radiation Global Medical Devices term This...

Page 16: ...linear array probe All probes have the working frequency indication and a raised edge on the shell to designate the orientation The raised edge corresponds to mark on the scanning screen mark indicat...

Page 17: ...tion effect of the protection of the application of the discharge part no application part for the defibrillation discharge protection According to the work mode the device is divided into continuous...

Page 18: ...he sound beam through the eye The instrument should be used with caution to patients with burns or other external skin damage The device cannot be used for a long time to check the fetus This instrume...

Page 19: ...may perform the scanning for the patient unauthorized personnel shall not indiscriminately use the device Improper operation of this system may result in the risk of injury to the operator Only the q...

Page 20: ...f function this may cause an electric shock or malfunction of the probe Using the probe with caution damage to the probe may increase the risk of electric shock Always check for cracks or openings on...

Page 21: ...em must use the matching power adapter When the system is used in conjunction with a high frequency device such as a surgical electrode surgical instrument failure or damage to the probe lens may resu...

Page 22: ...or our company 1 9 EMC All types of electronic equipment may cause electromagnetic interference to other equipment through air or connecting cables The term electromagnetic compatibility EMC means the...

Page 23: ...e safety and electromagnetic compatibility performance will not be expected to decrease The manufacturer will not bear this risk Portable and mobile radio frequency communication equipment may affect...

Page 24: ...evices is very small Radio frequency emission IEC CISPR11 2010 A This equipment is suitable for use in all facilities that are not directly connected to the public low voltage power supply network for...

Page 25: ...mmended that the all digital hand held ultrasonic diagnostic apparatus be powered by an uninterruptible power supply or battery Power frequency magnetic field 50 60Hz IEC 61000 4 8 3A m 50Hz 3A m The...

Page 26: ...In order to assess the electromagnetic environment of fixed RF transmitters consideration should be given to the investigation of electromagnetic fields If the measured all digital portable diagnostic...

Page 27: ...und should obey the ALARA principle use the lowest level of energy that does not lead to biological effects provided that satisfactory diagnostic information is available Ultrasonic energy depends on...

Page 28: ...2 Biological Effects In recent years with the rapid development of ultrasonic diagnostic technology people are increasingly concerned that the application of ultrasound and diagnostic techniques may l...

Page 29: ...MHz the length of curvature is 40mm scanning mode is electronic linear array scanning The number of elements of the C5 2 probe is 128 elements the center frequency is 3 5MHz the radius of curvature is...

Page 30: ...100V 240V 50 60Hz output DC5V 2000mA B model Performance B mode Probe information Probe Type Convex array type C5 2 Linear array type L10 5 Radius of curvature 60mm Probe center frequency MHz 3 5 7 5...

Page 31: ...ness mm 8 5 Horizontal geometric position accuracy 15 10 Vertical geometric position accuracy 10 5 Area measurement error Within 15 Within 10 Color Flow Mode Repeatability Color images without overflo...

Page 32: ...c pressure 700hPa 1060hPa Functional requirements Touch screen capacitive touch screen control Imaging mode B mode and C mode Image format DICOM Image control depth adjustable gain adjustable color ga...

Page 33: ...equirements Charging time not more than 5 hours charging adapter output DC5V 2000mA Continuous working time not less than 1 hour 2 2 Intended use L The product is suitable for observation and diagnosi...

Page 34: ...r discrimination 2 3 Contraindications Do not apply to the eye 2 4 Target population Target population Adults adolescents pregnant women and fetuses not used for fetal sex examination 2 5 Lifetime Thi...

Page 35: ...rt of the scanning press the freeze start button once can freeze the current scanning interface press the freeze start button again can start scanning press the freeze start button in other applicatio...

Page 36: ...ed in the operator panel Control button Convenient and flexible use of the principles of design and layout allows the operator easy comfortable and efficient use The control buttons contain quick butt...

Page 37: ...ge information Freeze display The Undo key Undo the last action Restore key Restore Undo operation Single frame mode key Switch to multiframe mode Multi frame mode key Switch to single frame mode Slid...

Page 38: ...messages Camera key Scanned area shooting Record the current scan image of the scan site for reference Enter key Confirm the reference image of the scan site Add a key to the teaching pack Teaching f...

Page 39: ...he device for example portable telephones radio controlled toys and so on The person in charge of the device must inform the technician the patient and others who may be present around the device to c...

Page 40: ...ent damage we are not responsible for warranty maintenance caused by such situations To ensure stable operation of the instrument the C SCAN system should use a standard adapter ensuring that the powe...

Page 41: ...m Storage conditions 10 55 Storage humidity 90 No condensation Transport conditions 10 55 5 4 Mobile devices Avoid the operator s wet hands moving system Mobile Device Steps Turn off the system includ...

Page 42: ...speed limited and ensure that no debris on the road so as not to damage the equipment due to vibration When transporting this system the following precautions should be observed A Ensure that the syst...

Page 43: ...ea mainly displays the current scanning probe frequency current user ID current time patient ID information TI MI value 6 2 Image scanning area The image area displays the ultrasonic image the image s...

Page 44: ...ulation photos 6 5 System Setup Area The system setting area is used to check and set patient archive biopsy special settings and about parameters 6 6 System status area System status area is used to...

Page 45: ...he system is normal Battery power level 7 2 Turn on procedure Long press the power button Wait for the system to boot Start the display panel control system 7 3 Check after booting Checking after the...

Page 46: ...1 Click System Settings to enter the system settings Mainly to set the following parameters set the date and time WLAN settings screen brightness and so on Time display format is hour minute second M...

Page 47: ...d brightness of the display is one of the important factors in obtaining high quality images If these controls are not set correctly you may need to adjust the gain frequently to achieve the desired i...

Page 48: ...creen it indicates that the system is turned off Before shutdown it is recommended to freeze the image and save the useful images in case that the data are damaged or lost during the shutdown Shutdown...

Page 49: ...e fill in the blanks with your information The update will be initialized Chapter 8 Clinical Application Types 8 1 B mode scanning Linear The system has different scanning scenarios corresponding to d...

Page 50: ...array probe General Obstetrics Freeze the image Flip the image and probe orientation product name Thermal index Mechanical index End button Networking connected status and battery icon The number of i...

Page 51: ...umber can view the image list clicking the number again the list is hidden Figure 8 1 1 6 In the interface of scanning press the flip icon on the left side you can turn the image from left to right an...

Page 52: ...screen to enter the doctor information list interface It can add select modify the doctor information add to the Scanning Doctor of the main interface after selecting a doctor 12 Click Please select a...

Page 53: ...face of C mode scanning press to change from C mode Figure 8 2 1 into B mode Figure 8 1 1 the real time scanning mode will change from C mode to B mode color doppler Color gain index Wall filter Pulse...

Page 54: ...key is displayed when it is the real time scanning status Click the button to enter the frozen state or press the physical button on the left side of the system Adjusting gain in real time scanning m...

Page 55: ...er specified coordinate point to form a measurement line and mark the distance Maximum 4 length distance lines can be formed Undo function When problems occur during the measurement the user can undo...

Page 56: ...determine an oval area then the system automatically identifies the area of this selected region 9 5 Arrow Arrow function select the arrow mark on the image the first touch designates the location of...

Page 57: ...h finger use finger to determine another point the two point will be connected with a straight line then determine the third point with finger this point will be connected with the first point in anot...

Page 58: ...s to determine an oval area then the system automatically identifies the perimeter of this selected region 9 8 Text Select the text make a point at the scanning interface it will show an inputting int...

Page 59: ...48 9 9 IMT Select the IMT put the cube at the edge of the carotid it will automatically measure the thickness of intima...

Page 60: ...al option to enter the 2B mode selection interface Figure 9 9 1 The default display is None Click 2BL option to enter the 2BL interface Figure 10 9 2 Click the 2BR option to enter the 2BR interface Cl...

Page 61: ...ck biopsy to enter into the biopsy options interface Figure 9 10 1 The default display is none Click Degree A Degree B and Degree C to select different angles Click PICC to jump to the Superficial mea...

Page 62: ...in the patient details editing interface click on add can automatically create the patient information jump to the main interface of scanning 10 1 1 Click the Scan button in the Patient Details Editin...

Page 63: ...e 10 2 1 Input the relevant doctor information and click the Add button to save the doctor s information The added doctor is displayed in the doctor information list Figure 10 2 2 10 2 1 10 2 2 Select...

Page 64: ...isplay interface is shown below In the frozen state the real time scanning parameters are no longer displayed and display image parameters save length area arrows angle perimeter text and operation ke...

Page 65: ...g the system will automatically perform the latest 128 frame video caching Video playback when the frozen state click you can see the interface as shown below click the video can be suspended or playb...

Page 66: ...he scanning interface image is saved successfully press the end examination button to jump to the examination result interface Click the thumbnail image to enter the image details interface Click the...

Page 67: ...ient archive enter into the patient archive interface All scanned images of the same patient are saved in the same group The upper left corner of the list item displays the user description A local ic...

Page 68: ...earch by inputting date cloud unique ID T he date format is similar to 20150804 Click Edit button can pop up editing menu item it can delete images in batch in all select model Send means uploading th...

Page 69: ...he completed recording is displayed below the Recording button Click the play button to play the recording and click the Delete button to delete the recording Delete Press the Delete button and the im...

Page 70: ...mbnail on the left side of the image detail interface enter the image measure and play interface 10 7 1 10 7 2 Overlay information In the frozen state marked length area arrow angle perimeter text it...

Page 71: ...are not saved there is no overlay information in the image play detail interface after saving the images Overlay selected button will display on the list click to enter the overlay list can choose to...

Page 72: ...dy Marker icon to mark the current scanning position Drag enlarge narrow it can be dragged enlarged and narrowed the image by two finger the translation coefficient and magnification ratio are display...

Page 73: ...ed by the packing box The storage environment should be in accordance with the storage condition At the end of the day after cooling the instrument should be covered with protective cover to prevent d...

Page 74: ...and negative Put the battery in the liquid Put the battery in fire 11 2 Use of the probe The general procedure for probe operation is described below Operators should receive specialized training and...

Page 75: ...edures The probe sheath has to be used before the cavity check on the human body Use a protective cover approved by the market To avoid infection the probe guard can only be used once during the inspe...

Page 76: ...cal support for reparation If the probe lens cable or connector is cracked ruptured or damaged it may endanger the electrical safety of the probe Connector needle cannot bend If the needle is damaged...

Page 77: ...that the probe has not been damaged electrically Do not attempt to use an autoclave ultraviolet rays rays or gases steam or heat sterilization method toward the probe these methods may permanently da...

Page 78: ...be cable is not cracked or ruptured Wipe the dust from the cable with a soft cloth Gently wipe the probe and cable with a soft cloth soaked in an aqueous solution and a mild detergent Use a soft cloth...

Page 79: ...er s instructions for disinfectant concentration disinfection method and dilution method 2 Activators are used for glutaraldehyde solutions 3 Rinse thoroughly with sterile water to remove any residual...

Page 80: ...to the equipment Incorrect maintenance will compromise the stability of the equipment For any malfunction caused by failure to follow the procedure and instructions no warranty will be served Do not u...

Page 81: ...res Reasons and Handling No Failure phenomenon Method of exclusion 1 Press the power button to boot the motor does not vibrate the display has no signal Check whether the battery is intact Check wheth...

Page 82: ...e department of our company Our technician will be responsible for the replacement and it is strictly forbidden to replace the key components without permission 11 10 Disposal of the product When the...

Page 83: ...he probe center frequency Thermal sensitivity The thermal index TI is the ratio of power required to assess soft tissue or bone temperature rise by 1 C Peak expansion pressure The peak expansion press...

Page 84: ...r pressure 80kPa 106kPa A 3 A 3Sound output report form Linear array Depth mm MI TI 40 0 9 0 2 50 0 8 0 2 60 0 7 0 2 Convex array depth MI TI abdomen Maternity MI TI 140 1 0 0 2 1 1 0 1 160 0 9 0 2 1...

Page 85: ...oefficient 2 sound initial coefficient 3 power set every 3dB as a level can be controlled by the user Appendix B Type B imaging performance B type imaging performance indicators The basic performance...

Page 86: ...n mm 50 Geometric Accuracy Horizontal 10 vertical 5 Length and area measurement error 10 Slice thickness mm 3 Probe Type C2 5 Convex array Radius of curvature 60mm Probe center frequency MHz 3 5 Sound...

Page 87: ...target group B Blind target group C Longitudinal target group D Horizontal target group E Imitating Tumor F Imitating gallbladder diameter 10mm and stone G Imitating gallbladder diameter 6mm KS107BD...

Page 88: ...adjacent target line is 4 3 3 1mm respectively Blind target group the distance between the center of the adjacent target line are 10mm distance to the acoustic window are10 9 8 7 6 5 4 3 mm respective...

Page 89: ...78...

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