Table of Contents

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Contents ................................................................................................................................................................... i
Chapter One Summary ................................................................................................................................................... 1
1.1 Introduction ...................................................................................................................................................... 1
1.3 ALARA ............................................................................................................................................................ 2
1.4 Standards .......................................................................................................................................................... 2
1.5 Service life ........................................................................................................................................................ 4
1.6 Operating conditions ......................................................................................................................................... 4
1.7 Declaration of electromagnetic compatibility ................................................................................................... 4
1.8 Manufacturer declarations ................................................................................................................................ 5
1.9 Contraindications .............................................................................................................................................. 5
1.10 Promulgation of heat index and mechanical index ......................................................................................... 6
Chapter Two Cautions and Warnings .............................................................................................................................. 7
2.1 Pre-scan checks ................................................................................................................................................. 7
2.2 Safety preparation before operation .................................................................................................................. 7
2.3 Operation instructions ....................................................................................................................................... 7
2.4 Notice after operation ....................................................................................................................................... 7
2.5 Conditions to avoid ........................................................................................................................................... 8
2.6 Cautions when handling the device .................................................................................................................. 8
2.7 In case of device failure .................................................................................................................................... 8
2.8 Regular check and maintain .............................................................................................................................. 9
2.9 Do not disassemble the device and the probe at random .................................................................................. 9
2.10 Power on ......................................................................................................................................................... 9
2.11 Power off ......................................................................................................................................................... 9
Chapter Three System Introduction .............................................................................................................................. 10
3.1 Figuration ........................................................................................................................................................ 10
3.2 Specification ................................................................................................................................................... 11
3.3 Block diagram ................................................................................................................................................. 12
3.4 Basic Principle ................................................................................................................................................ 13
3.5 Device constituent .......................................................................................................................................... 13
Chapter Four Installation .............................................................................................................................................. 14
4.1 Unpacking inspection ..................................................................................................................................... 14
4.2 Installation ...................................................................................................................................................... 14
4.2.1 Battery installation and removal ............................................. 14
4.2.2 Base Placement Diagram ....................................................... 15
4.3 Power supply .................................................................................................................................................. 16
4.3.1 Battery power supply ......................................................... 16
4.3.2 Battery power charging ....................................................... 16
Chapter Five User Interface .......................................................................................................................................... 17
5.1 Expert mode .................................................................................................................................................... 17
5.2 Easy mode screen ........................................................................................................................................... 18
5.3 System settings ............................................................................................................................................... 19
Caresono Technology Co., Ltd
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Summary of Contents for Caresono PadScan HD2

  • Page 1: Table Of Contents

    4.3 Power supply ..............................16 4.3.1 Battery power supply ............16 4.3.2 Battery power charging ............16 Chapter Five User Interface ............................17 5.1 Expert mode ..............................17 5.2 Easy mode screen ............................18 5.3 System settings ............................... 19 Caresono Technology Co., Ltd...
  • Page 2 Chapter Night Checking and Troubleshooting ......................28 9.1 Checking ................................. 28 9.2 Troubleshooting .............................. 28 9.3 Contacting Caresono for support when fault of device unsolved ..............28 9.4 Maintenance ..............................28 Chapter Ten Acoustic Output ............................29 10.1 Concerns with Bioeffects ..........................29 10.2 Prudent Use Statement ..........................
  • Page 3: Chapter One Summary

    PadScan HD 2 Chapter One Summary Statement: The power of interpretation of this document is the property of Caresono Technology Co., Ltd. Without permission from our company, this document must not be photocopied, reproduced or translated into other languages. We preserve the right of revising the content and items on this document without any further notice.
  • Page 4: Intended Use & Indicatioins For Use

    1.3 ALARA Users can not adjust the acoustic output energy of the PadScan HD2 Bladder Scanner. And the output level is below than the levels which were referred in AIUM remarks in 1992 and there were no reported biological effects under the level.
  • Page 5 0482 CE mark and code of certification body Consult instructions for use Manufacturer Manufacturing date Serial number Recycled separately from other household waste under the WEEE directive Package and transportation symbols: Handle with care Temperature limit Upwards Limited layers of storage Keep dry Caresono Technology Co., Ltd...
  • Page 6: Service Life

    Stop using the PadScan HD 2 until removal of the electromagnetic interference. Warning: Shared power supply may appear abnormal images. Eliminate the interference of electromagnetic coupling by means of test and verification. Caresono Technology Co., Ltd...
  • Page 7: Manufacturer Declarations

    Warning: The contacted material has been pass the ISO 10993 certificated. There is no any hazard for patient. 1.9 Contraindications Do not use the PadScan HD2 Bladder Scanner on following cases: a) Fetal use or pregnant patients. b) Patients with ascites.
  • Page 8: Promulgation Of Heat Index And Mechanical Index

    PadScan HD 2 1.10 Promulgation of heat index and mechanical index Heat index: PI<0.1。 Mechanical index: MI<0.1。 Caresono Technology Co., Ltd...
  • Page 9: Chapter Two Cautions And Warnings

    (3)Patients must not touch the device or any other electrical equipment during examination. (4)Do not cover the air vent of the device. 2.4 Notice after operation (1)Turn off the power. (2)Clean the device and the probe. (3)Place the device on the instrument stand. Caresono Technology Co., Ltd...
  • Page 10: Conditions To Avoid

    (2)Must not drop, vibrate and hit the device. 2.7 In case of device failure If it is suspected that the device is not working properly, turn off the power and remove the battery. Contact qualified technician for support. Caresono Technology Co., Ltd...
  • Page 11: Regular Check And Maintain

    (approximately 2 seconds) to turn on the device and enter the user interface. 2.11 Power off After finishing the operation for the device, long press the power key (approximately 2 seconds) to turn off the device. Caresono Technology Co., Ltd...
  • Page 12: Chapter Three System Introduction

    PadScan HD 2 Chapter Three System Introduction 3.1 Figuration Power Key Setting Key Recording Key Figure 3-1 PadScan HD 2 front Figure 3-2 PadScan HD 2 side connection ports Caresono Technology Co., Ltd...
  • Page 13: Specification

    ● Voice recording function ● Multi-language selection ● Volume setting and remind alarm function ● Device Mode: expert mode and easy mode ● SD card information storage ● Monitor size:2.5 inch TFT-LCD ● Consumption:10VA ● Dimensions:203﹡213﹡55mm Caresono Technology Co., Ltd...
  • Page 14: Block Diagram

    LCD drive port screen system Power Power detection consumption Language Buzzer system Drive of the motor Drive of bus Probe Signal process of A/D transform FPGA SRAM B ultrasonic SDRAM Figure 3-4 PadScan HD 2 electricity principle diagram Caresono Technology Co., Ltd...
  • Page 15: Basic Principle

    ● A main unit (including the 2D mechanical sector scanning probe: 3.5MHZ) ● Battery Charger: Model: HXY-084V1500A, input: 100-240Va.c., 50/60Hz, 0.5A ,Output: DC8.4V – 1.2A ● An user manual ● Li-ion battery: model: UR18650ZY-2600mAH(SNLB-178) ● Card: 8G ● A packing list ● A carrying Bag ●Base Caresono Technology Co., Ltd...
  • Page 16: Chapter Four Installation

    Figure 4-1 PadScan HD 2 battery installation diagram Battery removal: ● Slide the cover plate of battery  according to the direction of arrow. ● Take out the battery from the battery slot according to the direction of arrow Caresono Technology Co., Ltd...
  • Page 17: Base Placement Diagram

    PadScan HD 2 Shown as figure 4-2 Figure 4-2 PadScan HD 2 battery removal diagram 4.2.2 Base Placement Diagram Figure 4-3 PadScan HD2 base placement diagram Caresono Technology Co., Ltd...
  • Page 18: Power Supply

    (2)Insert the AC plug of the charger into the power supply socket. (3)When the battery is being charged, the indicator light on the charger turns red. When the battery is fully charged, the indicator light turns green. Caresono Technology Co., Ltd...
  • Page 19: Chapter Five User Interface

    PadScan HD 2 Chapter Five User Interface 5.1 Expert mode Figure 5-1 PadScan HD 2 expert mode screen A:Company logo B:Ultrasonic image outlining C:Bladder ultrasonic image D:Battery status indicator E:Bladder volume value Caresono Technology Co., Ltd...
  • Page 20: Easy Mode Screen

    PadScan HD 2 5.2 Easy mode screen Figure 5-2 PadScan HD 2 easy mode screen A: Section diagram of the bladder B: Circle of Easy Mode Caresono Technology Co., Ltd...
  • Page 21: System Settings

    PadScan HD 2 5.3 System settings Figure 5-3 PadScan HD 2 system setup A:Mode selection E:Device Calibration B:Sound Volume F:Firmware Update Update C:Remind G:Version Display D:Language Caresono Technology Co., Ltd...
  • Page 22: Chapter Six Operation

    ” on the screen indicates the device is storing the information. “ ” will disappear when device finishes storing the information. Tips: 1. The screen will show the warning as below picture shown if there is no SD card in the device. Caresono Technology Co., Ltd...
  • Page 23: Parameter Setup

    3. The level 400 means the patient’s bladder volume value is higher than 400ml, the buzzer will alarm, otherwise it won’t alarm. The level 500 means the patient’s bladder volume value is higher than 500ml, the buzzer will Caresono Technology Co., Ltd...
  • Page 24: Language Setup

    If the update succeeds, the alert box will be displayed on the screen as follows: If update fails, the alert box will be displayed on the screen as follows, and do not turn off the power moment, Update the device again until the update is successfully completed. Caresono Technology Co., Ltd...
  • Page 25: Version Number Display

    6.4 View patient information Remove the SD card from the device and insert it to the computer, there is a corresponding folder including ultrasonic images of bladder (BMP format), bladder volume value (TXT format), and record contents (WAV format) Caresono Technology Co., Ltd...
  • Page 26: Chapter Seven Cleaning And Maintenance

    (3)When the device is not used for a long time, pack the device and store in the environment as specified in “8.2”. 7.2 Probe cleaning and maintenance Please keep the probe clean to ensure the probe work normally and prolong its service life. Caresono Technology Co., Ltd...
  • Page 27: Probe Cleaning

    (1)Check the probe for signs of damage, such as leaking. If any sign of damage appears, stop using the probe and contact CARESONO for service immediately. (2)Use a soft cloth dampened with isopropyl alcohol (or an appropriate hospital cleaning agent) to wipe the probe until it is thoroughly cleaned.
  • Page 28: Treating And Disposing Of Products After Use

    PadScan HD 2 7.4 Treating and disposing of products after use The disposal of the waste product and battery should be accord with the local environmental protection regulations. Or contact with our after-sale service department. Caresono Technology Co., Ltd...
  • Page 29: Chapter Eight Transportation And Storage

    Do not place any objects on the package, and do not place it against floors, walls, or roof.  Keep it in a well-ventilated place and keep away from sunlight or caustic gases. Caresono Technology Co., Ltd...
  • Page 30: Chapter Night Checking And Troubleshooting

    Check the surroundings and whether there is the electromagnetic interference. 9.3 Contacting Caresono for support when fault of device unsolved 9.4 Maintenance ●Please perform maintenance in specified departments ●Please contract manufacturers for maintenance information...
  • Page 31: Chapter Ten Acoustic Output

    ALARA (as low as reasonably achievable) principle. Read this information carefully before using the PadScan HD2 Bladder Scanner. 10.1 Concerns with Bioeffects Diagnostic ultrasound is recognized as being safe. In fact, there have been no reports of injuries to patients caused by diagnostic ultrasound.
  • Page 32: Acoustic Output

    AIUM (American Institute of Ultrasound Medicine) title “Medical Ultrasound Safety”. Users can not adjust the acoustic output energy of the PadScan HD2 Bladder Scanner. And the output level is below than the levels which were referred in AIUM remarks in 1992 and there were no reported biological effects under the level.
  • Page 33: Appendix A: Labeling

    PadScan HD 2 Appendix A: Labeling HD 2 Main unit labeling Caresono Technology Co., Ltd...
  • Page 34 PadScan HD 2 Caresono Technology Co., Ltd...
  • Page 35: Appendix B: Acoustic Output Report

    PadScan HD 2 Appendix B: Acoustic Output Report Caresono Technology Co., Ltd...
  • Page 36: Appendix C: Definitions And Symbols

    Dim. of Aaprt the active aperture dimensions for the azimuthal and elevational planes (centimeters). the pulse duration (microseconds) associated with the transmit pattern giving rise to the reported value of MI. Caresono Technology Co., Ltd...
  • Page 37 Scan Repetition Rate is the rate of the same identical point of successive frames, sectors, or scans and applies to automatic scanning systems (modes) only. Output beam Output beam dimensions are the dimensions of the ultrasound Caresono Technology Co., Ltd...
  • Page 38 (usually the lens thickness) Transducer Standoff distance is the shortest distance between the transducer output face and the patient entry plane. The term “contact” is used to connate direct contact between the transducer output face and the patient. Caresono Technology Co., Ltd...

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