FCC ID: 2AUG5-HD5PLUS Bladder Scanner

PadScan HD 5 Plus Bladder Scanner Users Manual EC-RepresentativeMEQUIPEX Bernhardt Kern AddressFeldstrasse 39, 4813 Altmuenster Austria Phone0043-650 735 2000 TRADEMARKS are

, PadScan trademarks, registered or otherwise, of CARESONOTechnology Co., Ltd. Other names may be trademarks of their respective owners. COPYRIGHT All rights reserved. No part of this publication may be reproduced in any form whatsoever without the prior written permission of CARESONO. Copyright 2019-2020CARESONO Version Number: HD5.V1.1.1.Caresono Release Date: 2019.9.27 Manufacturer Caresono Technology Co., Ltd Address4th Floor, N0.11Building, Initiating Zone, Instruments and Meters Industry Base, Near Port Industry Zone, Dandong, Liaoning, China Tel+86 415 6279782Fax: +86 415 3191279 ALL RIGHTS RESERVED. NO PART OF THIS PUBLICATION MAY BE REPRODUCED IN ANY FORM WHATSOEVER WITHOUT THE PRIOR WRITTEN PERMISSION OF CARESONO. ................................................................................................ II INTRODUCTION .................................................................................................................................................... 1 Intended Use ............................................................................................................................................................. 1 Contraindications ...................................................................................................................................................... 1 Declaration of electromagnetic compatibility ........................................................................................................... 1 CAUTIONS AND WARNINGS .................................................................................................................................. 3 Equipment Checks ..................................................................................................................................................... 3 Pre-scan Checks ......................................................................................................................................................... 3 Scanning Checks ........................................................................................................................................................ 3 Post-scan Checks ....................................................................................................................................................... 3 Maintain Device Safety .............................................................................................................................................. 3 Maintain Probe Safety ............................................................................................................................................... 4 Handling the Device .................................................................................................................................................. 4 In Case of Device Failure ............................................................................................................................................ 4 Manufacturer Declarations ....................................................................................................................................... 4 EQUIPMENT UNPACKING AND INSTALLATION ........................................................................................................ 5 Unpacking .................................................................................................................................................................. 5 Installation ................................................................................................................................................................. 6 Battery Charging and Status ...................................................................................................................................... 8 Power Supply ............................................................................................................................................................. 8 By AC Adapter ........................................................................................................................................................... 8 By Battery ................................................................................................................................................................. 8 POSITIONING THE PROBE AND OBTAINING OPTIMAL IMAGES ................................................................................ 9 PADSCAN HD 5 PLUS SCANNER SCREENS AND BUTTONS ...................................................................................... 11 Login Screen ............................................................................................................................................................ 11 Home Screen ........................................................................................................................................................... 11 Expert Mode ........................................................................................................................................................... 11 Easy Mode .............................................................................................................................................................. 12 Patient Information Screen ..................................................................................................................................... 13 Setup Screen ............................................................................................................................................................ 22 A: General ............................................................................................................................................................... 22 B. Service ................................................................................................................................................................ 23 C. Operator ............................................................................................................................................................. 24 D. Print .................................................................................................................................................................... 25 E. Power .................................................................................................................................................................. 26 F. Display ................................................................................................................................................................. 26 G. WiFi .................................................................................................................................................................... 27 H. Play ..................................................................................................................................................................... 28 QUICK GUIDE ON HOW TO PERFORM THE PADSCAN HD 5 BLADDER SCANNER ...................................................... 29 1. Login .................................................................................................................................................................... 29 NOTE: If you tap OFF to disable Operator Login under Setup screen, the login procedure through password will be canceled................................................................................................................................................................... 29 2. Add Patient Information ...................................................................................................................................... 29 3. Prepare Patient and Position Probe ..................................................................................................................... 30 4. Pre-Scan and Scan ............................................................................................................................................... 30 5. Re-aim and re-scan .............................................................................................................................................. 31 6. View the scanned images .................................................................................................................................... 31 7. Save Information ................................................................................................................................................. 32 8. Print ..................................................................................................................................................................... 32 CALIBRATION ...................................................................................................................................................... 33 TROUBLESHOOTING ............................................................................................................................................ 34 CLEANING AND PREVENTIVE MAINTENANCE ....................................................................................................... 35 System Cleaning and Maintenance ......................................................................................................................... 35 System Cleaning ...................................................................................................................................................... 35 System Maintenance .............................................................................................................................................. 35 Probe Cleaning and Maintenance ........................................................................................................................... 35 Cleaning the Probe ................................................................................................................................................. 35 Probe Maintenance ................................................................................................................................................ 35 Battery Use and Maintenance ................................................................................................................................. 35 Treating and Disposing of Products After Use ......................................................................................................... 36 TECHNICAL SPECIFICATIONS AND GENERAL SYSTEM INFORMATION ...................................................................... 37 Component Specifications* ..................................................................................................................................... 37 Operating Conditions............................................................................................................................................... 37 Transportation and Storage Conditions ................................................................................................................... 37 Transporting the System ......................................................................................................................................... 37 System Storage ....................................................................................................................................................... 38 Declaration of Electromagnetic Compatibility ........................................................................................................ 38 Promulgation of Heat Index and Mechanical Index ................................................................................................ 38 Standards ................................................................................................................................................................. 38 Symbols ................................................................................................................................................................... 39 APPENDIX A:LABELING ........................................................................................................................................ 40 Main Unit Labeling .................................................................................................................................................. 40 Probe Labeling ......................................................................................................................................................... 40 Adapter Labeling ..................................................................................................................................................... 41 Package labeling ...................................................................................................................................................... 41 APPENDIX B: ACOUSTIC OUTPUT REPORT ............................................................................................................ 43 APPENDIX C: RE-AIMING GUIDE .......................................................................................................................... 44 INTRODUCTION The PadScan HD 5 Plus developed and manufactured by Caresono Technology Co., Ltd. Provides noninvasive real-time measurement of urinary bladder volume. The device calculates the bladder volume by using patented ultrasound imaging and measuring technology. When the scan is complete, multiple 2D plane ultrasonic images are acquired in several seconds. It features:

Expert and Easy operating modes. Correct, reliable, fast, and simple operation. Printouts of ultrasound images with many parameters. Portable 8-inch LCD screen(800x600pixels) Power supply available by AC adapter and a built-in battery. Intended Use The PadScan HD 5 Plus is used for measuring the urine volume in the bladder noninvasively by projecting ultrasound energy through the lower abdomen of the patient to obtain images of the bladder. Contraindications The PadScan HD 5 Plus is contraindicated for any patient who is not a candidate for ultrasound scanning. To prevent cross-infection, do not use on patients with open skin or wounds in the suprapubic region. This device is not intended for fetus use or for use on pregnant patients. Do not use on patients with ascites If you scan a patient with a catheter in his/her bladder, the catheter may affect measurement accuracy. However, the information obtained from the measurement and real-time ultrasound image could still be clinically useful for detecting problems such as a blocked catheter. Declaration of electromagnetic compatibility Warning: Use of the PadScan HD 5 Plus under strong electromagnetic environments, close to generator, X-ray device, dental and physical therapy equipment, broadcasting stations, or buried cables, etc... may appear signal interference in the image. Stop using the PadScan HD 5 Plus until removal of the electromagnetic interference. PadScan HD 5 Plus in use will not interfere with other wired, wireless equipment and/or other electrical equipment. And it works properly under specified electromagnetic environment. Warning: Users replacing the equipment without prior permission from CARESONO may cause unintended electromagnetic compatibility problems. Only CARESONO-trained technicians can service the system. Warning: Shared power supply may appear abnormal images. Eliminate the interference of electromagnetic coupling by means of test and verification. CARESONO PadScan HD 5 Plus Users Manual 1 The PadScan HD 5 Plus Bladder Scanner has been tested and found to comply with the electromagnetic compatibility (EMC) limits for medical devices to IEC 60601-1-2:2014, IEC 60601-1-2-37:

2007 + A1: 2015. These limits are designed to provide reasonable protection against harmful interference in a typical medical installation. CARESONO PadScan HD 5 Plus Users Manual 2 CAUTIONS AND WARNINGS Read carefully before use Only trained technicians should operate this device. The operator must read the Owners manual entirely and refer to any additional training materials before using the device. Check and maintain the device regularly. Do not disassemble or attempt to repair the device and the probe. ONLY CARESONO-trained technicians may service the unit. Equipment Checks 1. Make sure all cables are properly connected. 2. Make sure the device is properly functioning. 3. Keep the device away from sunlight and keep dry. Warning: Do not use if any part of the device or if cables display any signs of damage. Pre-scan Checks 1. Make sure the probe is properly connected. 2. Make sure no water, chemicals, or other materials are on the device. Scanning Checks Warning: Do not plug or unplug the probe into the system while the power is ON. Connecting the probe while the power is ON may cause damage to the probe and the main unit. 1. Do not drop the probe. Always use ultrasound gel with the probe to ensure proper contact. 2. Pay attention to the main parts of the device. If strange noises or smells are emitted from the device, stop the operation at once, unplug all cables, and power OFF. Contact CARESONO technical support for help. 3. Patients must not touch other electrical equipment during examination. 4. Do not cover the air vent of the device. Post-scan Checks 1. Turn OFF the power. 2. Pull out the power plug from the power sockets. 3. Clean the device and the probe. Maintain Device Safety This device should avoid the following:

Spraying water High humidity Poor ventilation Direct sunlight Dust Gas with salt or sulfur CARESONO PadScan HD 5 Plus Users Manual 3 Chemical medicines or gas Sudden shaking of the device or drops Maintain Probe Safety Do not immerse the probe in water or any other liquids. Keep probe away from heat sources. To avoid damaging the cable or transducer connector, handle them with care. Do not bend or pull probe cable. It is recommended to use standard ultrasound gel only. Other substances may damage the probe and the probe cable. A dirty probe may decrease the accuracy of the system. Keep the probe clean. Use standard detergent or clean water to clean the ultrasound gel off the probe. The probes are not interchangeable between units. They are calibrated to specific main units. If changing the probe associated with a machine, it is necessary to calibrate the machine before using. Confirm that the probe and cable are normal before and after each examination. A defective probe may cause electric shock to the patient. Handling the Device Always pull out the power plug. Drop, shake, or hit the probe may cause malfunction or inaccuracy. Do not drop, shake, orhit the probe or the device. In Case of Device Failure If it is suspected that the device is not operating properly, turn OFF the power and unplug the power. Contact CARESONO technical support for help. Warning: Users will assume responsibility of the risks associated with the use of the device after recommended service life. Manufacturer Declarations WARNING! Changes or modifications not expressly approved by CARESONO could void the users authority to operate the equipment. Warning: It is strictly prohibited to perform any modifications to the device without prior permission. Warning: To ensure the continued safe use of the equipment, modifications must be inspected and tested by approved departments. Warning: This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. CARESONO PadScan HD 5 Plus Users Manual 4 EQUIPMENT UNPACKING AND INSTALLATION Unpacking When you receive a PadScan HD5 plus, perform a full visual inspection of the device for any obvious physical damage that may have occurred during shipment, and then check the components and accessories against the packing list. A standard PadScan HD 5 Plus system is included with:

1 main unit 1 N2/2.5MHz 3-D Mechanical sector scanning probe 1 docking station 1 Li-ion battery: Model: SNLB-159 1 probe cup 2 keys of the carry case 1 thumb screws M3*6 2 socket head cap screws M3*6 1 USB data line 1 power line 1 U-Disk 1 printer paper 1 user manual 1 Packing list 1 Carry case Screwdriver probe cup scan screen power button PadScan HD 5 Plus front CARESONO PadScan HD 5 Plus Users Manual 5 PadScan HD 5 Plus side connection ports USB slot for flash disk probe connection port printer paper dispenser PadScan HD 5 Plus back Installation 1. Battery Insertion and Removal Slide the battery lock downward. Insert the battery into (or remove it from) the battery compartment, and then slide the lock back into the place. battery lock CARESONO PadScan HD 5 Plus Users Manual 6 2. Probe Cup Installation and Removal Align the screw hole of probe cup with the one on main unit as shown in the figure, then tighten the two M3*6 screws using a screwdriver. probe cup M3*6 screws 3. Connect the main unit to the docking station As shown in the figure, gently slide the main unit along the entry on the docking station until the main unit clicks in place, taking the positioning column as reference. Secure the main unit by fixing its pendant slides into the slot on the docking station with the thumbs screws. thumbs screws pendant slides positioning column CARESONO PadScan HD 5 Plus Users Manual 7 4. Attach the probe to the main unit Align the red dot on the main unit with the black dot on the probe, and gently insert the probe into the main unit. red dot red dot 5. Plug the AC input plug of the adapter into a power outlet. when the indicator light on the DC output turns green, it indicates it is working properly. Battery Charging and Status 1. Insert the battery into the main unit. 2. Place the main unit securely onto the docking station. 3. Plug the power supply into the power outlet to start charging. 4. Turn on the scanner. NOTE: The orange light on the main unit indicates that the battery requires charging, while the green light indicates that it is fully charged. Power Supply PadScan HD 5 Plus is powered by two interchangeable methods: AC adapter and a built-in battery. By AC Adapter 1. Before each use, inspect the adapter for damage; verify the EPS is in the specified range. 2. Connect the adapter to the docking station. 3. Place the main unit onto the docking station. 4. The light indicator turning green indicates that it is functioning. 5. Turn on the main unit. Warning: Use only CARESONO supplied power adapters.Ensure a tight connection between the power cord and the connectors. By Battery 1. Insert the battery into the main unit as described on page 9. 2. Press the power button to turn on the main unit. CARESONO PadScan HD 5 Plus Users Manual 8 POSITIONING THE PROBE AND OBTAINING OPTIMAL IMAGES Locating the position of the bladder is the first and the most important step in obtaining correct volume measurements. The bladder is located in the lower abdomen, below the navel while approximately 3 cm above the pubic bone. Place an ample quantity of ultrasound gel on the patients abdomen and the probe before each scan. Press the probe as below onto the lower abdomen through the gel. NOTE: the probe button should always be pointed toward the patients head. In order to correctly measure the volume of the bladder, grasp the probe shown as below:

A green guideline visible on screen helps center the bladder. ((You can enable/disable this function from SETUP menu>Display>Central guide line ON/OFF) CARESONO PadScan HD 5 Plus Users Manual 9 In expert mode, center the bladder area (dark area within green outlines) relative to the vertical green line. It indicates that the bladder is centered if the center line is green or it is off centered if orange. Figure 1:correct position (expert mode) Figure 2:incorrect position (expert mode) In easy mode, center the bladder area relative to the vertical center line. If the bladder area is green, the scan is on target and successful; while if the bladder area is orange, the scan is off target and unsuccessful. Figure 3: correct position (easy mode) Figure 4: incorrect position (easy mode) If the bladder is off centered to the right relative to the center line, move the probe toward the left slowly;

if the bladder is off centered to the left relative to the center line, move the probe toward the right slowly;

In both Expert and Easy modes, a projection of the bladder in the crosshair is displayed at the right side on the screen. It helps re-aim and re-scan. (You can enable/disable this function from SETUP menu>Display>Projection ON/OFF) Please refer to APPENDIX C: RE-AIMING GUIDE for more information about how to re-aim and re-scan. CARESONO PadScan HD 5 Plus Users Manual 10 PADSCAN HD 5 PLUS SCANNER SCREENS AND BUTTONS Login Screen A B A B C Home Screen C Operator: Tap to select user ID Password: Tap to type password Keyboard:use for typing Tap when ID and password are complete Expert Mode Under this mode, the device is tended to use for locating the bladder through a real-time 2D ultrasound image scanned by a technician. D A B C E P F G O CARESONO H I J K PadScan HD 5 Plus Users Manual L M N Q 11 Hospital/Clinic and Department Admin User Date and Time Battery status indicator Ultrasound Image displayed area Scan icon Tap to add new or review patient data (see page 14) Tap to enter Setup menu Tap to print current scan Tap to save current scan Patient information A:

B:

C:

D: WiFi E:

F:

G:

H:

I:

J:

K:

L:

M: Current Volume N:

O: Maximum Volume displayed (Optional) P:

Q:

Caresono company logo Tap to enter instructional video Projection of probe aiming (Optional) Easy Mode It is designed to provide the guidance to help find the correct location of the bladder, but not to provide a real-time 2D scanned image. A B A: Crosshair Profile of the urine bladder B:

CARESONO PadScan HD 5 Plus Users Manual 12 Patient Information Screen A B C D A:

B:

C:

D:

E:

F:

G:

H:

I:

E F G H I Tap Mode and then icon [male

, female

, female with hysterectomy

,

(under 120cm tall and weighing less than 25kg)]

or child Tap to add Patient Age Tap to add Patient ID Tap to add Patient Name Keyboard for typing age Tap to clear content Tap to enter Patient data management Tap to confirm content entered Tap to cancel screen CARESONO PadScan HD 5 Plus Users Manual 13 Virtual keyboard to enter Patient ID A C E A:

B:

C:

D:

E:

F:

Input patient ID Virtual keyboard Caps lock Confirm the content entered Switch between words and numbers Backspace Virtual keyboard to enter patient Name B F D CARESONO PadScan HD 5 Plus Users Manual 14 NOTE: The patient information must be entered correctly and completely, otherwise the following dialog box will appear if any of it is not entered:

A. On the Patient Information screen, there are four options available in the Mode icon; It is required to tap one of them or the following dialog box will appear on the screen;

Null: No Mode entered B. On the Patient Information screen, age can be entered at a maximum of 3-digit number; It is required to enter or the following dialog box will appear on the screen;

Null: No Age entered CARESONO PadScan HD 5 Plus Users Manual 15 C. On the Patient Information screen, ID can be entered at a maximum of 12-digit number; It is required to enter or the following dialog box will appear on the screen;

Null: No ID entered D. On the Patient Information screen, Name can be entered at a maximum of 12-digit number; It is required to enter or the following dialog box will appear on the screen;

Null: No name entered NOTE: If you want to go to the Home screen, tap the OK after you are finished entering all information requested. CARESONO PadScan HD 5 Plus Users Manual 16 Save and Review Patient Data Tap to save current patient scan to the Patient Data Management. NOTE: If you want to save the scan results to Patient Data Management, you must select the patient mode at least in the Patient Information screen before scan. Then you can review the saved exam in the Patient Data Management. Tap on the Home screen and then tap to enter Patient Data Management screen. Tap the line in the patient list then tap to review the data. Tap or to move through the pages of patient information. I A B C D E F G H O N J K L M Q P A: Sequence Number Patient ID or tap it to search for the specific patient through ID entered B:

Patient Name or tap it to search for the specific patient through Name entered C:

Patient Age D:

Patient Mode E:

F:

Time and Date G: Urine Volume H: Operator Name I:

J:

K:

L:

M: Clear the scan result N:

O: Next page P Back to the previous screen Q:

Selected Patient Review more details about the selected patient Upload through WIFI or USB Rescan or modify the selected patient Tap to enter instructional video Previous page CARESONO PadScan HD 5 Plus Users Manual 17 Load Patient Data If you want to review all scanned results and records for one patient, select the patient and tap Load to enter the Patient Data Management screen If you havent selected or select two or more patients, the following dialog will appear on the screen. Null:please select one single patient Upload patient data through USB or WIFI Insert the USB flash disk to the USB slot on the main unit Tap in the Patient Management screen to export the selected patient data/all patient data to the USB flash disk. NOTE: It takes about 1 seconds to export the scan results for one patient to the USB flash disk. NOTE: Do not remove the USB flash disk while the export is in process. NOTE: If you want to export the patient data through WiFi, ensure that the WiFi network is reliable CARESONO PadScan HD 5 Plus Users Manual 18 and connected well with the device. NOTE: Do not turn off the device while the export through WiFi is in process; The time that is needed to complete the process depends on the local network. Import Patient Data If you want to modify the patient information that has been stored, or to rescan the patient, select the patient record on the list and tap Import. NOTE: If you want to modify the patient information that has been stored, tap Modify. If you want to rescan the patient whose information has been stored, tap Rescan to clear patient data. Tap Tap Clear to clear up the selected or all patients scan results. CARESONO PadScan HD 5 Plus Users Manual 19 ID and Name Search Tap ID or Name to enter the Search screen; The following Search as example is performed through ID. D C Input the ID to be Searched Common virtual keyboard Arrow to turn pages Display area for the Search results A:

B:

C:

D:

A B NOTE: On the Search screen, you may upload or delete patient scans on a batch basis If you enter the ID to be Searched, the display area on the left side will appear all patient data that satisfies your request. CARESONO PadScan HD 5 Plus Users Manual 20 Patient Data Management Connect to PC Install HD 5 Pluss software in the PC. Connect HD 5 Plus with a computer through the USB cable, whose one end inserting the mini USB port of HD5 Plus. Tap in the Home screen and then tap to enter Patient Data Management screen. Run <Patient Data Management> software in the PC. Do not remove the USB cable while the export is in process. HD 5 Plus USB Cable PC Patient Data Management Select [Tools]->[Sync Data] to upload the patient data from HD 5 Plus to <Patient Data Management>. Add the Hospital Name, Department Name and Physician Name from [Tools]->[Option]. Review the ultrasound images of selected patient by click<Previous> and <Next>. Print the Bladder Scanner Report from [Tools]->[Print]. Patient Data Management interface Report printout CARESONO PadScan HD 5 Plus Users Manual 21 Setup Screen Tap on the Home screen to configure the system. A: General Tap to add basic information and to start probe calibration if necessary (see page 33 for calibration information). A B C D E A: Tap to add the clinic/hospital name. A maximum of 12 letters can be added. B:

C:

D:

E:

Tap to add the department name. A maximum of 12 letters can be added. Tap to add date and time. Tap to start calibration (see page 24 for more information on how to calibrate) Tap for Language selection. CARESONO PadScan HD 5 Plus Users Manual 22 B. Service Tap password is required before any changes are made on these settings. to select the operation mode (Expert or Easy) or to restore all settings to default . A C A:

B:

C:

D:

E:

F:

Tap name for Easy mode Tap name for Expert mode Tap [PRINT] to print a self-test report Tap[START] to enter firmware update Tap name for Built in printer Tap name for External printer A B D E NOTE: If you perform the System Recovery, the following settings will get back to defaults:

Hospital Name, Department Name, Calibration Value, Exam mode (Expert Mode), Screen off time, Shutdown time, Operators name and password, and screen Display options. CARESONO PadScan HD 5 Plus Users Manual 23 C. Operator Tap to enter the system Administrators Access screen. A maximum of 10 users can be added in this field with user names and passwords. Administrators can modify uses passwords and names in this screen. Tap Operator Login: ON / OFF to turn ON or OFF the procedure of logging in the entire system through passwords. If its turned off, the access is granted for all users without passwords. A B C A:

B:

C:

Operator log in (ON/OFF) Users Name Users Password Tap User and the Name Input screen appears. Input the operators name in this field. Input the users password in this field. CARESONO PadScan HD 5 Plus Users Manual 24 NOTE: The device is configured with default administrator password: 123456 and user password is:

000000. NOTE: If you tap OFF to disable Operator Login under Setup screen, the login procedure through password will be canceled when you start the device. D. Print to perform the Print settings and pick up one from 6 image groups to print out. (example:

Tap Image 1&7, Image 2&8, etc). Each group contains two cross-sectional images. CARESONO PadScan HD 5 Plus Users Manual 25 E. Power Tap to perform the Power settings for the system. Input the time (in minutes) in the Screen Off Time field to place the whole system in standby mode input the screensaver activation time (in minutes). Input the time (in minutes) in the Shut Down Time field to automatically power off the whole system. F. Display Tap features. to perform the Display settings on Home screen. Tap ON or OFF to enable or disable the A B C A: Display the largest volume obtained for the patient on Home screen. B: Display crosshair of project icon guide on Home screen C: Display central guide line in Expert mode CARESONO PadScan HD 5 Plus Users Manual 26 G. WiFi Tap to perform the Wifi settings. A B C D A: Turn on/off WiFi B: Tap to search for WiFi signals C: Perform the configurable settings to connect with WiFi successfully D: Tap to connect the WiFi after the WiFi is settled with account number E: WiFi signals refreshed area Set up WiFi A B C A: add the WiFis account number B: add the WiFis password C: add the devices IP address, net_mask, gateway by hand D: add the hosts IP address CARESONO PadScan HD 5 Plus Users Manual E D 27 H. Play Tap to display onboard tutorial about installation, setup, operation and data transmission. A B C D Tutorial 1 Installation Tutorial 2 Scan Tutorial 3 Setup Tutorial 4 Data Transmission and Management CARESONO PadScan HD 5 Plus Users Manual 28 QUICK GUIDE ON HOW TO PERFORM THE PADSCAN HD 5 BLADDER SCANNER More details about screens can be found on page 13. 1. Login Press the power button to turn on the scanner. Tap Login and type the access code. NOTE: If you tap OFF to disable Operator Login under Setup screen, the login procedure through password will be canceled 2. Add Patient Information Tap Patient to add patient information. Tap Mode and select the appropriate icon. Tap ID, Age, Name to add corresponding information about the patient. Tap OK when you are finished. CARESONO PadScan HD 5 Plus Users Manual 29 3. Prepare Patient and Position Probe Let the patient lie in a supine position with abdominal muscle relaxed. Place an ample quantity of ultrasound gel on the patients abdomen, approximately 3cm above the pubic bone, and on the probe. lower Gently press abdomen through the gel and ensure the probes button is oriented at the patients head. the probe onto the 4. Pre-Scan and Scan Pre-Scan in Expert mode:

Press and release the button on the probe to start the Pre-scan process ( you could view a real-time ultrasound image of the bladder once the process begins). Angle the probe along the bodys middle line and tilt it slightly side to side to ensure the bladder area at maximum is centered. Once the bladder is located, press and release the button on the probe again to start the automatic scanning and calculation. Lift the probe once you hear it sounds beep tone. The bladder volume will be displayed on the screen is complete in around 5 seconds. immediately after the scan Pre-Scan in Easy Mode:

ress and release the button on the probe to start the Pre-scan process ( you could view a real-time sectional image of the bladder once the process begins) Angle the probe along the bodys middle line and tilt it slightly side to side to ensure the bladder area at maximum is centered relative to the vertical line.Once the bladder is located, press and release the button on the probe again to start the automatic scanning and calculation. Lift the probe once you hear it sounds beep tone. The bladder volume will be displayed on the screen is complete in around 5 seconds. immediately after the scan Scan analysis in progress Scan analysis complete Scan analysis in progress Scan analysis complete CARESONO PadScan HD 5 Plus Users Manual 30 NOTE: Hold the Probe steady while the scan is in process. Any movement of the probe during the scan will impair the accuracy of the measurement. 5. Re-aim and re-scan If the scan was on target, the bladder projection will appear in the center of the crosshairs shown as the top right picture. If the scan was off target, the bladder projection will appear not in the center of the crosshairs shown as the right bottom picture. Please refer to Appendix C. of re-aiming. 6. View the scanned images Once the scan is finished, the measurement volume and six groups of sectional images of bladder will be displayed. Tap the LEFT or RIGHT arrows to view the six groups of images. or CARESONO PadScan HD 5 Plus Users Manual 31 7. Save Information Tap SAVE to save the exam data and results. 8. Print Tap PRINT to print the scan results. The printout contains the patients name,ID code, age, scan mode, scan time, bladder volume, and two ultrasound images. CARESONO PadScan HD 5 Plus Users Manual 32 CALIBRATION 1. Prepare the Dansk Tissue Equivalent Phantom for calibration. 2. Place the probe head into the phantom holder firmly. 3. Align the probe button with the red arrow on the phantom. 4. In the main PadScan HD 5 Plus screen, tap SETUP>GENERAL>

CALIBRATION to enter the calibration screen. 5. Tap to start auto calibration. It takes about 2 minutes to finish the calibration. 6. Do not remove the probe during the calibration. 7. The default calibration value is 24. 8. A last calibration date and time will be displayed on the screen after the calibrations succeed. 9. Tap to exit. NOTE:

You may take a normal scan on the phantom in the calibration mode to verify the calibration result. (Compare the scan volume with the phantom labeling volume.)If the volume values deviate greatly from the acceptable calibration range, perform another calibration. The calibration can only be done on Dansk Tissue Equivalent Phantom. The Dansk Phantom should be equipped with the probe holder made by Caresono. The probe head should be immersed by the water on the phantom surface completely; the probe head should touch the phantom surface. The calibration should be done when the main unit is powered on at least 40 minutes. The calibration should be done when the AC power is on. (Shouldnt on battery only.) CARESONO PadScan HD 5 Plus Users Manual 33 TROUBLESHOOTING Check if the power supply is functioning properly, and the power cord of the main unit is connected and is plugged into the power adapter. Check if the probe and main unit are connected correctly. Symptom Check/Corrective Action(s) When power button pressed, the indicator does not turn on and no signal on the display screen visible. 1. Check the power supply;

2. Check the power cord and the plug;

3. Check if the power adapter is functioning. Screen display shows snow-like images or mesh interference appears on the screen 1. Check the power supply and whether it is interfered by other devices;

2. Check the environment and whether it is the electromagnetic field interfering with the device;

3. Check if the power, the plug of the probe and the sockets are connected well. If problems continue, please contact Caresono technical support. CARESONO PadScan HD 5 Plus Users Manual 34 CLEANING AND PREVENTIVE MAINTENANCE The PadScan HD 5 Plus is non-immersible. It should be wiped down with a soft, clean cloth dampened with a cleaning solution such as soap and water, or a mild detergent solution, or as per hospital/clinic cleaning instructions. Performing regular maintenance will reduce the need for costly repairs. Check the system and calibration every 24 months or whenever you suspect the system is off calibration. System Cleaning and Maintenance System Cleaning Turn OFF the system power. Unplug the power supply from the system. Use a soft, clean cloth dampened with isopropyl alcohol (or an appropriate hospital cleaning agent), to clean the devices surface. If you use a detergent solution to clean the instrument, remove all residual detergent. Let air dry or use a clean soft cloth to wipe dry. System Maintenance Operate the system in the environment as outlined on page 32. After shut down, wait five minutes before restarting the system. When the device is not used for a long time, pack the device and store in the environment outlined on page 33. Probe Cleaning and Maintenance Always clean the probe after use. Cleaning the Probe Check the probe and other cables for signs of damage, such as cracking and/or leaking. If any sign of damage appears, stop using the probe and contact CARESONOs technical support department. Use a soft cloth dampened with isopropyl alcohol (or an appropriate hospital cleaning agent) to wipe the Probe until it is thoroughly cleaned. Probe Maintenance Do not scratch the probe. Do not drop or bang the probe. Use only standard medical ultrasound gel. Battery Use and Maintenance For optimum performance, it is recommended to charge and completely discharge a new battery two to three times before first use. Do not step on, drop, drop in water, or puncture the battery. If misuse, abuse, or damage is suspected, or any form of mechanical damage to the casing is visible, then discontinue use and return the battery to CARESONO. If a sudden change in the batterys ability to hold a charge or a sudden change in battery life time is noticed, discontinue use and return the battery to CARESONO. Keep away from fire. The battery should be charged and completely discharged once every two to three months. NOTE: Always charge a battery that has been in storage for an extended period of time. CARESONO PadScan HD 5 Plus Users Manual 35 Treating and Disposing of Products After Use For end of life product, waste electrical and electronic equipment should be collected separately and returned to the designated local recycling service. Packaging waste should be collected separately for available national packaging collection and recycling services. CARESONO PadScan HD 5 Plus Users Manual 36 TECHNICAL SPECIFICATIONS AND GENERAL SYSTEM INFORMATION Component Specifications*

Probe: 3D mechanical sector Standard ultrasonic frequency of operation: 2.5MHz Volume measure range: 0ml - 999ml. Volume measure accuracy: 15%, 15ml (On Caresono tissue equivalent phantom) Scan time: 7second Operation methods: touchscreen Tissue Harmonic Imaging (THI) Mode of the device: Two modes: expert mode and easy mode Patient data storage Information print Socket of USB flash disk Dimensions of the display: 8-inch TFT-LCD Power consumption: <120VA Dimensions: 220x280x68mm Weight: approximately 2600g (including the probe) Battery capacity: 2600mA Battery charge time: 2 hours;

Battery life: 2hours continuous scanning, 5 hours standby. Languages: English

*Specifications are subject to change without prior notice. Operating Conditions Temperature: +5 to +40 Relative humidity: 30% to 75%

Pressure: 70kPa to 106kPa Transportation and Storage Conditions Temperature: -40 to +55 Relative humidity: 10% to 80%

Pressure: 50kPa to 106kPa Transporting the System 1. Unplug the power cord and put it in the carrying case. 2. Carefully place the main unit into the corresponding slot of the carrying case. Do not drop, shake or bang the probe or the device. 3. Carefully place the probe into the corresponding slot in the carrying case. 4. Cover the bottle of ultrasound gel tightly to prevent leaks and place it into the corresponding slot in the carrying case. Simple shockproof materials are equipped in the carrying case, which are suitable for aviation, railway, highway, or steamship transportation. Keep dry, avoid inversion and collision. CARESONO PadScan HD 5 Plus Users Manual 37 System Storage System should be unpacked when storage time exceeds six months. Power it on for four hours, and then re-pack it. Do not place any objects on the package, and do not place it against floors, walls, or roof. Keep it in a well-ventilated area away from sunlight or caustic gases. Declaration of Electromagnetic Compatibility PadScan HD 5 Plus in use will not interfere with other wired, wireless equipment and/or other electrical equipment. Warning: Use of the PadScan HD 5 Plus under strong electromagnetic environments, close to generators, X-ray devices, broadcasting stations, or buried cables, etc... may introduce interference signals in the image. It is recommended to correct this by repositioning the PadScan HD 5 Plus, or increasing the separation between the PadScan HD 5 Plus and the interfering equipment. Warning: Shared power supplies may produce distorted images. Eliminate the interference of electromagnetic coupling by means of test and verify. Warning: Users replacing the equipment without prior permission from CARESONO may cause unintended electromagnetic compatibility problems. Only CARESONO-trained technicians can service the system Promulgation of Heat Index and Mechanical Index Heat index: TI0.1;

Mechanical index: MI0.5. Standards This device is designed and manufactured in strict accordance with:

EN 60601-1-1:2006+A1:2013/IEC 60601-1-1:2005+A1:2012 Medical electrical equipment - Part 1: Ge neral requirements for basic safety and essential performance EN 60601-1-2:2015/IEC 60601-1-2:2014 Medical electrical equipment-Part 1-2:General requirements for basic safety and essential performance-Collateral Standard Electromagnetic disturbances-Requirements and tests IEC 60601-2-37:2007+A1:2005 Medical electrical equipment-Part 2-37:Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment Type B, Class II protection to the risk of electric shock Degree of protection against ingress of water: IPX7(probe), IPX0 (main unit) CARESONO PadScan HD 5 Plus Users Manual 38 Symbols Type B device AttentionConsult accompanying documents Switch ON the general power Switch OFF the general power Signal output 0482 CE mark and code of certification body Class II Electrical Equipment Not for general waste. Dispose of in accordance to local regulations. Manufacturer Manufacture Date Handle with care Temperature limit Upwards Keep dry Reference user's manual CARESONO PadScan HD 5 Plus Users Manual Limited layers of storage Keep away from sunlight 39 APPENDIX A:LABELING Main Unit Labeling Probe Labeling FCC Statement This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:

-- Reorient or relocate the receiving antenna.

-- Increase the separation between the equipment and receiver.

-- Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.

-- Consult the dealer or an experienced radio/TV technician for help. 15.21 Information to user. Any Changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment. This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. CARESONO PadScan HD 5 Plus Users Manual 40 The antenna(s) used for this transmitter must be installed to provide a separation distance of at least 20 cm from all persons and must not be co-located or operating in conjunction with any other antenna or transmitter. Adapter Labeling Package labeling CARESONO PadScan HD 5 Plus Users Manual 41 CARESONO PadScan HD 5 Plus Users Manual 42 APPENDIX B: ACOUSTIC OUTPUT REPORT CARESONO PadScan HD 5 Plus Users Manual 43 APPENDIX C: RE-AIMING GUIDE The above crosshair diagram shows the four points to consider when scanning the bladder. The projection guiding icon shows the bladder position after scanning. If the orange icon is not centered, you may need to re-aim and re-scan. The following images show how to re-aim. Move the probe to down to the left Move the probe to down to the right Move the probe to up to the left Move the probe to up to the right CARESONO PadScan HD 5 Plus Users Manual 44 Move the probe to the right Move the probe to the left Move the probe down Move the probe up CARESONO PadScan HD 5 Plus Users Manual 45

External Photo Adapter 1(JD-05) Adapter 2(JD-06)

Internal Photo RF Antenna Adapter 1(JD-05) Adapter 2(JD-06)