PadScan HD 2
Caresono Technology Co., Ltd
31
Appendix A: Labeling
HD 2 Main unit labeling
Page 1: ...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...
Page 2: ...maintenance 25 7 4 Treating and disposing of products after use 26 Chapter Eight Transportation and Storage 27 8 1 Transporting the system 27 8 2 Transportation and storage conditions 27 8 3 Transpor...
Page 3: ...aging and measuring and also provides non invasive volume measurement of the bladder It is a handheld bladder scanner the main unit and the probe are all in one It features Expert operating mode and E...
Page 4: ...ce The PadScan HD2 Bladder Scanner projects ultrasound energy through the lower abdomen of the patient to obtain images of the bladder which is used to calculate bladder Volume noninvasively The PadSc...
Page 5: ...ain unit Symbols Type B Device Power switch Signal output 0482 CE mark and code of certification body Consult instructions for use Manufacturer Manufacturing date Serial number Recycled separately fro...
Page 6: ...rly under specified electromagnetic environment Warning The disposal of the products should comply with the local regulations Warning Use of the PadScan HD 2 under strong electromagnetic environments...
Page 7: ...permission from CARESONO may cause unintended electromagnetic compatibility problems Only CARESONO trained technicians can service the system Warning Modifications must be inspected and tested by appr...
Page 8: ...PadScan HD 2 Caresono Technology Co Ltd 6 1 10 Promulgation of heat index and mechanical index Heat index PI 0 1 Mechanical index MI 0 1...
Page 9: ...device During operation pay attention to the main parts of the device If there is strange sound or smell stop using the device until the authorized engineer solves the problem 2 3 Operation instructio...
Page 10: ...ay from heat sources 12 Only use the ultrasound gel which FDA listed or cleard The use of gel is recommend We recommend an ultrasonic gel which is manufactured by echo med pharmaceuticals Inc echo gel...
Page 11: ...ssemble the device and the probe at random 2 10 Power on Long press the power key approximately 2 seconds to turn on the device and enter the user interface 2 11 Power off After finishing the operatio...
Page 12: ...dScan HD 2 Caresono Technology Co Ltd 10 Chapter Three System Introduction 3 1 Figuration Figure 3 1 PadScan HD 2 front Figure 3 2 PadScan HD 2 side connection ports Setting Key Recording Key Power Ke...
Page 13: ...me measure range 0ml 999ml Volume measure accuracy 15 15ml Volume display resolution 1ml Battery capacity 2600mAh Tissue Harmonic Imaging Voice recording function Multi language selection Volume setti...
Page 14: ...gress of Water IPX1 for probe Mode of operation Continuous Applied part probe Battery Charger Model HXY 084V1500A input 100 240Va c 50 60Hz 0 5A Max Output 8 4Vd c 1 2A It is considered as a part of M...
Page 15: ...form one section The ultrasonic wave transmits or scatters a wave through the body and sends the received reflected signal to the DSC via the transducer and proceeds with a serials of signal processi...
Page 16: ...installation and removal Battery installation Slide the cover plate of the battery according to the reverse direction of arrow Insert the battery into the battery slot according to the direction of ar...
Page 17: ...PadScan HD 2 Caresono Technology Co Ltd 15 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...
Page 18: ...turn on the device and enter the working state 4 3 2 Battery power charging Battery is charged by charger 1 Remove the battery from the main unit and connect it to the socket of the charger 2 Insert t...
Page 19: ...hnology Co Ltd 17 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 indicat...
Page 20: ...PadScan HD 2 Caresono Technology Co Ltd 18 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...
Page 21: ...HD 2 Caresono Technology Co Ltd 19 5 3 System settings Figure 5 3 PadScan HD 2 system setup A Mode selection B Sound Volume C Remind D Language E Device Calibration F Firmware Update Update G Version...
Page 22: ...r the sectional image of the bladder is located in the indicated center of the screen If not move the probe to locate the sectional image of bladder in the indicated center After that move the probe r...
Page 23: ...volume setup item Then press recording key to set the sound volume level it divides into Max Medium and Min levels 6 3 3 Remind setup Enter the parameter setup interface Press setup key to select the...
Page 24: ...bration mode it divides into two modes they are Calibration and Normal mode 6 3 6 Firmware update setup Enter the parameter setup interface Press the setup key to select Firmware update setup item The...
Page 25: ...face Press setup key to display the version number on the screen 6 4 View patient information Remove the SD card from the device and insert it to the computer there is a corresponding folder including...
Page 26: ...tructions of the detergents and the interval time should also meet the clinical requirements 5 Dry the system s surface naturally or dry it with clean cloth according to the instructions of the deterg...
Page 27: ...a new battery two to three times before first use 2 The battery can be charged and discharged for hundreds of times When the work time shortens apparently please replace it with a new one 3 Do not use...
Page 28: ...logy Co Ltd 26 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 a...
Page 29: ...The label of the packing box for the device meets the requirements of ISO780 Packaging Pictorial marking for handling of goods The packing box contains simple shockproof packing making it suitable fo...
Page 30: ...le 1 Check whether or not the battery is well installed to the device 2 Check whether or not the battery is working 2 Screen display shows snow like images or mesh interference appears on the screen 1...
Page 31: ...ing the last several years This rapid advance has generated concerns about the potential risk of bioeffects when new applications or diagnostic technologies become available 10 2 Prudent Use Statement...
Page 32: ...t from the 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 bel...
Page 33: ...PadScan HD 2 Caresono Technology Co Ltd 31 Appendix A Labeling HD 2 Main unit labeling...
Page 34: ...PadScan HD 2 Caresono Technology Co Ltd 32...
Page 35: ...PadScan HD 2 Caresono Technology Co Ltd 33 Appendix B Acoustic Output Report...
Page 36: ...coustic power emitted from the central 1 cm2 of the active non scanned aperture through which the highest acoustic power is being transmitted W 3 z1 the derated ultrasonic power at axial distance z1 m...
Page 37: ...y period during which scanning may not be taking place System settingsa User selectable system settings which may include Application SV and Focal Length Ip mm This is the distance from the transducer...
Page 38: ...or any system settings of a specified mode of operation This ratio is determined from measurements made at the position which yields the maximum pulse pressure squared integral or maximum mean square...
