Caresono PadScan HD 5 Plus User manual

PadScan HD 5 Plus
Bladder Scanner
User’s Manual

TRADEMARKS
, PadScan are 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
EC-Representative：MEQUIPEX
Bernhardt Kern
Address：Feldstrasse 39, 4813
Altmuenster Austria
Phone：[phone]
Version Number: HD5.V1.1.1.Caresono
Release Date: 2019.9.27
Manufacturer：Caresono Technology Co., Ltd
Address：4th Floor, N0.11Building, Initiating Zone, Instruments and Meters
Industry Base, Near Port Industry Zone, Dandong, Liaoning, China
Tel：[phone]Fax: [phone]

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

CARESONO PadScan HD 5 Plus User’s Manual
1
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
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: 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.
Warning: Shared power supply may appear abnormal images. Eliminate the interference of
electromagnetic coupling by means of test and verification.
Warning: Users replacing the equipment without prior permission from CARESONO may
cause unintended electromagnetic compatibility problems. Only CARESONO-trained
technicians can service the system.

CARESONO PadScan HD 5 Plus User’s Manual
2
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 User’s Manual
3
CAUTIONS AND WARNINGS
Read carefully before use
Only trained technicians should operate this device. The operator must read the Owner’s 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.
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
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
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.
Warning: Do not use if any part of the device or if cables display any signs of damage.

CARESONO PadScan HD 5 Plus User’s Manual
4
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.
Manufacturer Declarations
WARNING! Changes or modifications not expressly approved by CARESONO could void the user’s
authority to operate the equipment.
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.
.
Warning: To ensure the continued safe use of the equipment, modifications must be inspected
and tested by approved departments.
Warning: It is strictly prohibited to perform any modifications to the device without prior
permission.
Warning: Users will assume responsibility of the risks associated with the use of the device after
recommended service life.

CARESONO PadScan HD 5 Plus User’s Manual
5
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
PadScan HD 5 Plus front
scan screen
power button
probe cup

CARESONO PadScan HD 5 Plus User’s Manual
6
PadScan HD 5 Plus side connection ports
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.
probe connection port
USB slot for flash disk
printer paper
dispenser
battery lock