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Kaixin BVT02 User Manual

Bladder scanner
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KAIXIN
BVT02
Bladder Scanner
User's Manual
Xuzhou Kaixin Electronic Instrument Co., Ltd.

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  • Page 1 KAIXIN BVT02 Bladder Scanner User’s Manual Xuzhou Kaixin Electronic Instrument Co., Ltd.

  • Page 2: Warranty And Repair Service

    The qualified service personnel who get Kaixin written authorization can repair the instrument out of warranty by themselves. But this should be agreed by Xuzhou Kaixin Electronic Instrument Co., Ltd. We will provide circuit diagrams, component part lists or other information to assist service personnel to repair those parts of our equipment that are designated by our company as repairable by service personnel.

  • Page 3: Important Statement

    This user’s manual contains warnings for predictable dangers. Users shall also exercise care at any time to be aware of the dangers unforeseen in this manual. Kaixin shall not be liable for the damages and losses arising out of neglecting to follow the operation instructions herein described.

  • Page 4: Safety Cautions

    Bladder Scanner User’s Manual V1.22 Safety Cautions 1. Warning Symbols and Definitions The following warning symbols are used in this manual to indicate safety level and other important items. Please remember these symbols and understand the meaning as you read this user’s manual.
  • Page 5 Bladder Scanner User’s Manual V1.22 Keep dry Fragile Stacking limit by number Temperature limits (Storage and transportation) Humidity limitation (Storage and transportation) Atmospheric pressure limitation (Storage and transportation) Symbol for the marking of electrical and electronics devices according to Directive 2012/19/EU. The device, accessories and the packaging have to be disposed of waste correctly at the end of the usage.

  • Page 6: Table Of Contents

    Bladder Scanner User’s Manual V1.22 Contents Chapter One Overview....................- 1 - 1.1 Introduction.......................- 1 - 1.2 Intended Use....................... - 1 - 1.3 Prescription Statement....................- 1 - Chapter Two Technical Specifications................. - 2 - 2.1 Technical data......................- 2 - 2.2 Primary functions.......................- 2 - 2.3 Technical index......................
  • Page 7 Bladder Scanner User’s Manual V1.22 7.3.9 Storage path setting....................... - 12 - 7.3.10 Patient ID setting......................- 13 - 7.4 Image storage and viewing..................- 13 - 7.4.1 Image storage........................- 13 - 7.4.2 Image viewing......................- 14 - 7.5 Image transfer to PC workstation................- 14 - Chapter Eight Bladder volume measurement............

  • Page 8: Chapter One Overview

    B-mode image of section bladder and the projection of bladder; it is convenient for doctors to check the location and determine the measurement results. The expected service life of BVT02 Bladder Scanner is 7 years. Applied part is ultrasonic probe.

  • Page 9: Chapter Two Technical Specifications

    Bladder Scanner User’s Manual V1.22 Chapter Two Technical Specifications 2.1 Technical data 1. Monitor: 3.5” LCD 2. Main unit size: approx. 90 × 140 × 85 (Length × Width × Height, mm) 3. Weight of main unit: approx. 750g (including battery and probe) 2.2 Primary functions 1.

  • Page 10: Chapter Three System Outline

    User’s Manual V1.22 Chapter Three System Outline 3.1 Structure composition of the instrument The BVT02 Bladder Scanner is composed of main unit, probe, power adapter, etc. 3.2 Components name Fig. BVT02 sketch map 3.3 Parts of the probe Fig. Parts name of 2.5MHz probe SN.

  • Page 11: Chapter Four System Configuration

    Bladder Scanner User’s Manual V1.22  In the two-dimensional scan state, press the up direction key to select the desired patient type;  In the two-dimensional scan state, press the down direction key to adjust the contrast of the image; ...

  • Page 12: Chapter Five Operation Condition

    Bladder Scanner User’s Manual V1.22 Chapter Five Operation Condition 5.1 Power supply Adapter rating: 100-240V~, 1.2-0.6A, 50-60Hz Adapter model: BJE01-40-001M Output of adapter: DC12.8V 3.0A Main device rating: DC12.8V 3.0A Warning: AC/DC adapter is as a part of the equipment, please only use the AC/DC adapter provided by manufacturer.

  • Page 13: Chapter Six System Installation And Check

    6. The device is turned off completely only by disconnecting the power supply from the wall socket. Warning: The power adapter, power supply cord and battery as described in this section are replaced by operator. But these parts must be provided by KAIXIN or his authorized supplier. - 6 -...

  • Page 14: System Placement

    EQUIPMENT the place where it is difficult to operate the disconnection device. 2. Adapter is as a part of the device, please only use the adapter provided by Kaixin. Contact a local distributer or Kaixin for replacements. 3. To avoid damaging power adapter or harming people by unexpected fallen, make sure the power adapter is placed on the leveled desk.

  • Page 15: Ultrasonic Probe Check Before And After Operation

    Bladder Scanner User’s Manual V1.22 6.4 Ultrasonic probe check before and after operation Before and after ultrasonic diagnosis to check if there are any exceptionally on the surface of the probe or cable jacket, such as peeling, cracks, bulge, or if the acoustic lens is reliable, disinfected or cleaned.

  • Page 16: Inspection After Start-Up

    Bladder Scanner User’s Manual V1.22 6.5.2 Inspection after start-up Check the following items after starting the machine: 1. No abnormal voice, strange smell and overheating appear. 2. Check the machine to ensure a normal start-up: The power indication light is on; the machine starts work status.

  • Page 17: Chapter Seven Functional Operation

    Bladder Scanner User’s Manual V1.22 Chapter Seven Functional Operation 7.1 Startup and Shutdown In shutdown status, hold down key at the top of the screen, machine starts up, power supply indicator lights on green. In startup status, hold down key, machine shuts down, power supply indicator goes out.

  • Page 18: System Set

    Bladder Scanner User’s Manual V1.22 The three-dimensional scan interface displays the B-mode images of bladder section and measured results. The interface mainly is divided into image display area and measured result display area. The image display area displays the system time, the battery power, the number of frames of the 12 images and 12 sectional images of the bladder.

  • Page 19: Language Setting

    Bladder Scanner User’s Manual V1.22 1. Press key to enter “System Set” menu; 2. Press key to move the cursor to “Screensaver” item, and then press key to adjust the screensaver time; 3. Screensaver time is “0-99” minutes, “0” stands for turn off the screensaver; 4.

  • Page 20: Patient Id Setting

    3. If you want to obtain the U disk encryption folder; please contact International Trade Dept of Kaixin.  U disk encryption Copy the "KX" folder provided by our company to the root directory of the U disk, and the encryption is completed.

  • Page 21: Image Viewing

    2. After ensuring that the system can recognize the PC, connect one end of the USB cable to the computer and the other end to the Micro-USB interface of the BVT02 main unit, the upper left corner of the screen appears “PC” prompt;...
  • Page 22 Start using PC workstation software (kx_station_2)  The PC workstation software kx_station_2 is used to view images sent by the BVT02 main unit. 1. Click the left and right arrow keys in the lower right corner of the workstation software to browse the received images;...

  • Page 23: Chapter Eight Bladder Volume Measurement

    Bladder Scanner User’s Manual V1.22 Chapter Eight Bladder volume measurement 8.1 Scanning and positioning bladder 1. Hold down the power key , machine starts up, the power indicator lights; 2. Press the scanning key on the probe or press the key on the keyboard to enter two-dimensional scan state;...
  • Page 24 Bladder Scanner User’s Manual V1.22 (2) If the machine is set to Lite: the system will generate projection of top view of the bladder; the measured result display area shows the bladder volume and the volume tip. 5. Confirm the scanning results. (1) If the measured result shows “0000”, it indicates no detectable result, you need to re-measure.

  • Page 25: Chapter Nine Principle Of Acoustic Power

    Bladder Scanner User’s Manual V1.22 Chapter Nine Principle of acoustic Power 9.1 Biological effect It is generally recognized that ultrasonic diagnosis is safe for human’s health. So far, there has been no report on bodily harm done by ultrasound. Nevertheless it is also believed that not all types of ultrasound are absolutely safe. Relevant researches have already indicated that high-intensity ultrasound is harmful for human body.

  • Page 26: Chapter Ten System Maintenance

    Bladder Scanner User’s Manual V1.22 Chapter Ten System Maintenance The system maintenance should be performed by the user and service engineer. Users shall be in full charge of maintenance and operation of the system after purchasing the product. Under normal circumstances, a routine consideration of the general inspection for the probe and the functional verification is a good practice and may help to avoid major problems in the future.
  • Page 27 2. Clean the probe with sterile water to remove the residual chemicals after disinfection, because the residual chemicals may be harmful for humans. 3. Kaixin Company will not make any guarantee for the efficacy of disinfector. Please contact the appropriate manufacturer for details.

  • Page 28: Use And Maintenance For The Rechargeable Battery Pack

    10.3 Use and maintenance for the rechargeable battery pack 1. Only use the battery pack (model JQ0157-02L or JQ0157-02L1) provided by Kaixin Company; the battery pack can only be charged in the main unit. Service personnel or operator can replace the battery pack.
  • Page 29 Bladder Scanner User’s Manual V1.22 Attention: When the “ ” icon appears in the middle of the screen, the battery power is low and needs to be charged before continuing to use. Connect the main unit to external power supply and recharge the battery, or turn off the machine to recharge.

  • Page 30: Replace The Fuse

    10.5 Replacement of power adapter and power supply cord Before replacing the power adapter and power supply cord, please contact Kaixin Company; replace it under the guidance of Kaixin Company. Please use the power adapter and power supply cord provided by Kaixin Company.

  • Page 31: Periodic Safety Checks

    10.7 Periodic Safety Checks To ensure the system performance and safety, it must be checked after using 1 year. When check the instrument, please consult the International Trade Dept of Kaixin or its dealers, as they need to have professional technology engineers.

  • Page 32: Chapter Eleven Storage And Transportation

    Bladder Scanner User’s Manual V1.22 Chapter Eleven Storage and Transportation 1. If the instrument is stored over 3 months, take out the instrument from the packing case, connect it to power supply for 4 hours, and then disconnect the power and place it in the case again following the direction indicated by arrows on the package.

  • Page 33: Chapter Thirteen Safety Classification

    Bladder Scanner User’s Manual V1.22 Chapter Thirteen Safety Classification 1. Classified according to the type of protection against electric shock: Class I EQUIPMENT + internally power EQUIPMENT 2. Classified according to the degree of protection against electric shock: Type B applied part 3.

  • Page 34: Chapter Fourteen Guidance And Manufacturer's Declaration

    Bladder Scanner User’s Manual V1.22 Chapter Fourteen Guidance and Manufacturer’s Declaration This product complies with EMC test standard IEC 60601-1-2. Intended Environments: Professional healthcare facility environment (except for near active HF SURGICAL EQUIPMENT and the RF shielded room of an ME SYSTEM for magnetic resonance imaging).
  • Page 35 Bladder Scanner User’s Manual V1.22 Table 1: Compliance level for electromagnetic emission Emission test Compliance RF emissions Group 1 CISPR 11 RF emissions Class A CISPR 11 Harmonic emissions Class A IEC 61000-3-2 Voltage fluctuations/flicker emissions Complies IEC 61000-3-3 Note: The emissions characteristics of this equipment make it suitable for use in industrial areas and hospitals (CISPR 11 class A).
  • Page 36 Bladder Scanner User’s Manual V1.22 Table 2: Compliance level for electromagnetic immunity Immunity test Compliance level Electrostatic discharge (ESD) ± 8 kV contact IEC 61000-4-2 ± 15 kV air 80MHz-2.7GHz Radiated RF EM fields 3V/m IEC 61000-4-3 80% AM at 1kHz Electrical fast transients/bursts ±...

  • Page 37: Maximum Power

    Bladder Scanner User’s Manual V1.22 Table 3: Compliance level for enclosure port immunity to RF wireless communications equipment Maximum IMMUNITY Test frequency Band Service power TEST LEVEL 380 to 390 TETRA 400 430 to 470 GMRS 460, FRS 460 704 to 787 LTE Band 13, 17 GSM 800/900, TETRA 800, iDEN 820,...
  • Page 38 Bladder Scanner User’s Manual V1.22 Table 4: Compliance level for enclosure port immunity to proximity magnetic fields Test frequency Modulation IMMUNITY TEST LEVEL (A/m) Pulse modulation 134.2 kHz 2.1 kHz Pulse modulation 13.56 MHz 50 kHz - 31 -...

  • Page 39: Appendix A System Block Diagram

    Bladder Scanner User’s Manual V1.22 Appendix A System Block Diagram - 32 -...

  • Page 40: Appendix B Acoustic Output Data Disclosure

    In the acoustic output measurement data, the MI uncertainty is 12%, TI uncertainty is 23%. Manufacturer: Xuzhou Kaixin Electronic Instrument Co., Ltd. Product Name: Bladder Scanner Table 201.103 Transducer: 2.5S120M2...

  • Page 41: Appendix C Acoustic Output Reporting Table For Track1

    Bladder Scanner User’s Manual V1.22 Appendix C Acoustic Output Reporting Table for Track1 (Autoscanning Mode) Table 1 System Model: BVT02 SN:1715161 Transducer Model: 2.5S120M2 SN:1704005 Nominal Frequency: 2.5MHz Operating Model: B SPTA.3 SPPA.3 Acoustic Output (mW/cm (W/cm Global Maximum Value 0.3773...
  • Page 42 Bladder Scanner User’s Manual V1.22 Table 2 System Model: BVT02 SN:1715161 Transducer Model: 2.5S120M2 SN:1704004 Nominal Frequency: 2.5MHz Operating Model: B SPTA.3 SPPA.3 Acoustic Output (mW/cm (W/cm Global Maximum Value 0.5969 15.1300 29.1800 0.9567 (MPa) 2.1590 2.1590 (mW) 2.5680 2.5680 2.5680...
  • Page 43 Bladder Scanner User’s Manual V1.22 Table 3 System Model: BVT02 SN:1715161 Transducer Model: 2.5S120M2 SN:1704006 Nominal Frequency: 2.5MHz Operating Model: B SPTA.3 SPPA.3 Acoustic Output (mW/cm (W/cm Global Maximum Value 0.7537 26.6700 58.7000 1.2140 (MPa) 4.6080 4.6080 (mW) 2.5960 2.5960 2.5960...
  • Page 44 KAIXIN ELECTRONIC XUZHOU KAIXIN ELECTRONIC INSTRUMENT CO., LTD. Kaixin Mansion, C-01, Economic Development Zone, Xuzhou, Jiangsu, China Zip Code: 221004 Tel: +86-516-87732932/87733758 Fax: +86-516-87732932/87792848 Website: http://www.kxele.com E-mail: info@kxele.com Shanghai International Holding Corp. GmbH (Europe) Eiffestrasse 80, 20537 Hamburg, Germany Information contained in this manual is subject to change without further notice.

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