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.

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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.

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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

CARESONO PadScan HD 5 Plus User’s Manual
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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.
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.
probe cup
M3*6 screws
thumbs screws
pendant slides
positioning column

CARESONO PadScan HD 5 Plus User’s Manual
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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.
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.
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.
Warning: Use only CARESONO supplied power adapters.Ensure a tight connection between
the power cord and the connectors.
red dot
red dot

CARESONO PadScan HD 5 Plus User’s Manual
9
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 patient’s 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 patient’s 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 User’s Manual
10
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 User’s Manual
11
PADSCAN HD 5 PLUS SCANNER SCREENS AND BUTTONS
Login Screen
A
Operator: Tap to select user ID
B
Password: Tap to type password
C
Keyboard:use for typing
Tap when ID and password are complete
Home Screen
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.
A
B
C
D
M
I
H
G
P
J
K
L
O
N
F
A
C
B
E
Q

CARESONO PadScan HD 5 Plus User’s Manual
12
A:
Hospital/Clinic and Department
B:
Admin User
C:
Date and Time
D:
WiFi
E:
Battery status indicator
F:
Ultrasound Image displayed area
G:
Scan icon
H:
Tap to add new or review patient data (see page 14)
I:
Tap to enter Setup menu
J:
Tap to print current scan
K:
Tap to save current scan
L:
Patient information
M:
Current Volume
N:
Projection of probe aiming (Optional)
O:
Maximum Volume displayed (Optional)
P:
Caresono company logo
Q:
Tap to enter instructional video
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:
Crosshair
B:
Profile of the urine bladder
B
A

CARESONO PadScan HD 5 Plus User’s Manual
13
Patient Information Screen
A:
Tap Mode and then icon [male , female , female with hysterectomy ,
or child (under 120cm tall and weighing less than 25kg)]
B:
Tap to add Patient Age
C:
Tap to add Patient ID
D:
Tap to add Patient Name
E:
Keyboard for typing age
F:
Tap to clear content
G:
Tap to enter Patient data management
H:
Tap to confirm content entered
I:
Tap to cancel screen
I
G
D
B
A
E
F
C
H

CARESONO PadScan HD 5 Plus User’s Manual
14
Virtual keyboard to enter Patient ID
A:
Input patient ID
B:
Virtual keyboard
C:
Caps lock
D:
Confirm the content entered
E:
Switch between words and numbers
F:
Backspace
Virtual keyboard to enter patient Name
A
D
E
F
C
B

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15
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 User’s Manual
16
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.