Caresono PadScan HD2 User manual

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

PadScan HD 2
Caresono Technology Co., Ltd ii
Chapter Six Operation ..................................................................................................................................................20
6.1 Bladder scanning ............................................................................................................................................20
6.2 Store information............................................................................................................................................20
6.3 Parameter setup...............................................................................................................................................21
6.3.1 Mode selection setup .........................................................21
6.3.2 Sound volume setup ...........................................................21
6.3.3 Remind setup .................................................................21
6.3.4 Language setup ...............................................................22
6.3.5 Device calibration setup .....................................................22
6.3.6 Firmware update setup ........................................................22
6.3.7 Version number display .......................................................23
6.4 View patient information ................................................................................................................................23
Chapter Seven Cleaning and Maintenance ...................................................................................................................24
7.1 System cleaning and maintenance ..................................................................................................................24
7.1.1 System cleaning ..............................................................24
7.1.2 System maintenance ...........................................................24
7.2 Probe cleaning and maintenance.....................................................................................................................24
7.2.1 Probe cleaning ...............................................................25
7.2.2 Probe maintenance ............................................................25
7.3 Battery usage and maintenance.......................................................................................................................25
7.4 Treating and disposing of products after use ..................................................................................................26
Chapter Eight Transportation and Storage....................................................................................................................27
8.1 Transporting the system..................................................................................................................................27
8.2 Transportation and storage conditions ............................................................................................................27
8.3 Transportation.................................................................................................................................................27
8.4 System storage................................................................................................................................................27
Chapter Night Checking and Troubleshooting .............................................................................................................28
9.1 Checking.........................................................................................................................................................28
9.2 Troubleshooting..............................................................................................................................................28
9.3 Contacting Caresono for support when fault of device unsolved ...................................................................28
9.4 Maintenance....................................................................................................................................................28
Chapter Ten Acoustic Output........................................................................................................................................29
10.1 Concerns with Bioeffects..............................................................................................................................29
10.2 Prudent Use Statement..................................................................................................................................29
10.3 ALARA Principle (As Low As Reasonably Achievable)..............................................................................29
10.4 Acoustic Output ............................................................................................................................................30
10.4.1 Derated Ultrasonic Output Parameters ........................................30
10.4.2 Limits of Acoustic Output ...................................................30
Appendix A: Labeling ..................................................................................................................................................31
HD 2 Main unit labeling.......................................................................................................................................31
HD 2 Outer Package labeling ...............................................................................................................................31
Appendix B: Acoustic Output Report...........................................................................................................................33
Appendix C: Definitions and Symbols .........................................................................................................................34

PadScan HD 2
Caresono Technology Co., Ltd 1
Chapter One Summary
Statement:
The power of interpretation of this document is the property of Caresono Technology Co., Ltd.
Without permission from our company, this document must not be photocopied, reproduced or
translated into other languages.
We preserve the right of revising the content and items on this document without any further notice.
Some operations on this document are explained by pictures and these pictures are used only for
indicating without any other purpose.
Any abuse of these trademarks without permission will be sued to assume legal responsibility
according to laws.
1.1 Introduction
The PadScan HD 2 by Caresono Technology Co., Ltd. provides real-time ultrasound imaging and
measuring, and also provides non-invasive volume measurement of the bladder. It is a handheld bladder
scanner; the main unit and the probe are all-in-one.
It features:
Expert operating mode and Easy operating mode. In the expert mode, real-time 2-dimensional
ultrasound image will be displayed. Doctors can decide if the location and the measurement result
are right according to the cross-section image of the bladder. In the easy mode, 2-dimensional
ultrasound image will not be displayed. The device instructs the operator to move the probe to find
the right location. (It is not necessary for the operator to have professional ultrasonic knowledge
during Easy operating mode.)
Non-invasive, comfortable, correct, reliable, fast and simple operation. When the operator releases
the scanning button, the bladder volume will be calculated and the value of the bladder volume will
be displayed.
SD card storage
Voice recording function

PadScan HD 2
Caresono Technology Co., Ltd 2
Urine volume setting and alarm setting
Multi-language selection
Injection olded shell, the main unit and the probe are all-in-one, 2.5-inch LCD screen(240x320pixels)
Power supply with built-in battery.
1.2 Intended use & Indicatioins for use
Intended use:
The Bladder Scanner(model: PadScan HD2) projects ultrasound energy through the lower
abdomen of the patient to obtain images of the bladder which is used to calculate bladder volume
noninvasively. The PadScan HD2 Bladder Scanner is intended to be used only by qualified medical
professionals.
Indicatioins for use:
The Bladder Scanner(model: PadScan HD2) is B-mode pulsed-echo ultrasound device. It intended
as a handheld battery-operated device. The PadScan HD2 Bladder Scanner projects ultrasound energy
through the lower abdomen of the patient to obtain images of the bladder which is used to calculate
bladder Volume noninvasively. The PadScan HD2 Bladder Scanner is intended to be used only by
qualified medical professionals.
1.3 ALARA
Users can not adjust the acoustic output energy of the PadScan HD2 Bladder Scanner. And the
output level is below than the levels which were referred in AIUM remarks in 1992 and there were no
reported biological effects under the level. However, to minimize exposure, measurements should be
kept as short as possible. Refer to the acoustic output section for more information.
1.4 Standards
This device is designed and manufactured in strict accordance with:
● AAMI / ANSI ES60601-1:2005/(R)2012 And A1:2012,, C1:2009/(R)2012 And
A2:2010/(R)2012 Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And
Essential Performance

PadScan HD 2
Caresono Technology Co., Ltd 3
● Type B, Class II protection to the risk of electric shock
● Degree of protection against ingress of water: IPX1(probe), IPX0 (main unit)
● Symbols：
Type B Device
Power switch
Signal output
0482 CE mark and code of certification body
Consult instructions for use
Manufacturer
Manufacturing date
Serial number
Recycled separately from other household waste under the WEEE directive
Package and transportation symbols：
Handle with care
Temperature limit
Upwards
Limited layers of storage
Keep dry

PadScan HD 2
Caresono Technology Co., Ltd 4
Keep away from sunlight
1.5 Service life
Product life service: Six years. Continuing using the device after service life will increase the risk
of failure and unpredictable risks.
1.6 Operating conditions
Temperature：+5℃ to +40℃
Relative humidity：30% to 75%
Pressure：70KPa to 106KPa
1.7 Declaration of electromagnetic compatibility
The operation of PadScan HD 2 will not interfere with other wired, wireless equipment and/or
other electrical equipment. And it works properly under specified electromagnetic environment.
Warning：The disposal of the products should comply with the local regulations.
Warning: Use of the PadScan HD 2 under strong electromagnetic environments, 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 2
until removal of the electromagnetic interference.
Warning: Shared power supply may appear abnormal images. Eliminate the interference of
electromagnetic coupling by means of test and verification.
Warning：Users will assume responsibility of the risks associated with the use of the device
after recommended service life.

PadScan HD 2
Caresono Technology Co., Ltd 5
1.8 Manufacturer declarations
The users will assume all the risks of changes or modifications of the device without the
manufacturer’s permission.
1.9 Contraindications
Do not use the PadScan HD2 Bladder Scanner on following cases:
a) Fetal use or pregnant patients.
b) Patients with ascites.
c) Patients with open or damaged skin.
d) Wounds in the suprapubic region
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：Modifications must be inspected and tested by approved departments.
Warning: It is strictly prohibited to perform any modifications to the device without the
manufacturer’s permission.
Warning：Do not allow service or maintenance the equipment while used in patient.
Warning：Direct plug-in plug is considered as disconnect device, please do not place the
equipment in a difficultly operation position
Warning： The contacted material has been pass the ISO 10993 certificated. There is no any
hazard for patient.

PadScan HD 2
Caresono Technology Co., Ltd 6
1.10 Promulgation of heat index and mechanical index
Heat index: PI＜0.1。
Mechanical index: MI＜0.1。

PadScan HD 2
Caresono Technology Co., Ltd 7
Chapter Two Cautions and Warnings
To ensure safety, please read the following contents before the operation. The device shall be
operated only by the professional appointed or authorized by relevant medical institutions.
2.1 Pre-scan checks
（1）The device is normal.
（2）Keep the device away from the hot and wet things; put the device in place to ensure the safety
of operation.
2.2 Safety preparation before operation
Check if the device is intact; make sure no water, chemicals or other material spattered on the
device. During operation, pay attention to the main parts of the device. If there is strange sound or smell,
stop using the device until the authorized engineer solves the problem.
2.3 Operation instructions
（1）During the operation, protect the surface of the probe and do not knock it. Always use
ultrasound gel with the probe to ensure proper contact.
（2）Keep an eye on the operation of the device and also the patients. If a device failure occurs,
please turn off the power of the device immediately.
（3）Patients must not touch the device or any other electrical equipment during examination.
（4）Do not cover the air vent of the device.
2.4 Notice after operation
（1）Turn off the power.
（2）Clean the device and the probe.
（3）Place the device on the instrument stand.

PadScan HD 2
Caresono Technology Co., Ltd 8
2.5 Conditions to avoid
This device should avoid the following:
（1）Spraying water
（2）High humidity
（3）Poor draught
（4）Strong sunlight
（5）Dust environment
（6）Gas with salt or sulfur
（7）Chemical medicine or gas
（8）Strong vibration and crash
（9）Our company takes no responsibility for the risk of disassembling, refitting without our
permission.
（10）Do not immerse the probe in water or any other liquids.
（11）Keep probe away from heat sources.
（12）Only use the ultrasound gel which FDA listed or cleard. The use of gel is recommend. We
recommend an ultrasonic gel, which is manufactured by echo-med pharmaceuticals, Inc. echo gel
200(K#955246). Other substances may damage the probe and the probe cable.
（13）Keep the probe clean. Use neutral detergent or clean water to clean the ultrasound gel on
the probe.
2.6 Cautions when handling the device
（1）Turn off the power.
（2）Must not drop, vibrate and hit the device.
2.7 In case of device failure
If it is suspected that the device is not working properly, turn off the power and remove the battery.
Contact qualified technician for support.

PadScan HD 2
Caresono Technology Co., Ltd 9
2.8 Regular check and maintain
2.9 Do not disassemble the device and the probe at random
2.10 Power on
Long press the power key (approximately 2 seconds) to turn on the device and enter the user
interface.
2.11 Power off
After finishing the operation for the device, long press the power key (approximately 2 seconds) to
turn off the device.

PadScan HD 2
Caresono Technology Co., Ltd 10
Chapter Three System Introduction
3.1 Figuration
Figure 3-1 PadScan HD 2 front
Figure 3-2 PadScan HD 2 side connection ports
Setting Key
Recording Key
Power Key

PadScan HD 2
Caresono Technology Co., Ltd 11
Figure 3-3 PadScan HD 2 back
3.2 Specification
● Probe：Mechanical sector probe
● Standard ultrasonic frequency of operation: 3.5MHz
● Volume measure range： 0ml-999ml
● Volume measure accuracy：±15％, ±15ml
● Volume display resolution：1ml
● Battery capacity：2600mAh
● Tissue Harmonic Imaging
● Voice recording function
● Multi-language selection
● Volume setting and remind alarm function
● Device Mode: expert mode and easy mode
● SD card information storage
● Monitor size：2.5 inch TFT-LCD
● Consumption：10VA
● Dimensions：203﹡213﹡55mm
Scan Key

PadScan HD 2
Caresono Technology Co., Ltd 12
● Weight：about 500g
● Power supply：Battery DC7.4V±0.5V
● Battery time for scanning：>3.5 hours
● Battery stand by time：>8 hours
●Type of Protection Against Electric Shock： Class II for approved adapter or internally
powered
● Degree of Protection Against Electric Shock: Type B applied part
● Degree of Protection Against the Ingress of Water: IPX1 for probe
● Mode of operation: Continuous
● Applied part: probe
●Battery Charger: Model: HXY-084V1500A，input: 100-240Va.c., 50/60Hz, 0.5A Max. Output:
8.4Vd.c. 1.2A. It is considered as a part of ME equipment.
3.3 Block diagram
Figure 3-4 PadScan HD 2 electricity principle diagram
Main control
system LCD drive port 2.5 inch display
screen
Buzzer Language
system
Drive of the motor
Signal process of
B ultrasonic A/D transform
Probe
Drive of bus
FPGA
SDRAM
SRAM
Key SD card
management
Power supply
management
Power
detection Power consumption
Battery

PadScan HD 2
Caresono Technology Co., Ltd 13
3.4 Basic Principle
The device utilizes a 2D Mechanical sector scanning probe to provide ultrasonic scans of the
bladder and calculates the volume of the bladder through complicated computations.
Operating principle: 1. Transmits the pulse signal to the 2D probe. Launch the ultrasonic wave to
the human body via the transducer of the probe (such pulses can only acquire one signal of one plane,
meaning to produce a 2D image section it needs to send ultrasonic waves at least 96 or 128 times to
form one section.) The ultrasonic wave transmits, or scatters, a wave through the body, and sends the
received reflected signal to the DSC via the transducer, and proceeds with a serials of signal processing
methods: logarithms compression, detection, dynamic filter, edge enhancement, frame relevance, line
relevance, etc., to form one high-definition section image to display on the screen. Then it processes the
image to figure out the volume of the bladder.
3.5 Device constituent
● A main unit (including the 2D mechanical sector scanning probe: 3.5MHZ)
● Battery Charger: Model: HXY-084V1500A, input: 100-240Va.c., 50/60Hz, 0.5A ，Output:
DC8.4V – 1.2A
● An user manual
●Li-ion battery: model: UR18650ZY-2600mAH(SNLB-178)
●SD Card: 8G
● A packing list
● A carrying Bag
●Base

PadScan HD 2
Caresono Technology Co., Ltd 14
Chapter Four Installation
4.1 Unpacking inspection
After unpacking, first affirm that there is no shipping damage, then check the device according to
"Packing List" and install it according to the requirements and methods described in "4.2".
4.2 Installation
4.2.1 Battery installation and removal
Battery installation：
● Slide the cover plate of the battery according to the reverse direction of arrow.
●Insert the battery into the battery slot according to the direction of arrow.
● Push the cover plate of battery according to the direction of arrow.
Shown as figure 4-1
Figure 4-1 PadScan HD 2 battery installation diagram
Battery removal：
● Slide the cover plate of battery  according to the direction of arrow.
●Take out the battery from the battery slot according to the direction of arrow

PadScan HD 2
Caresono Technology Co., Ltd 15
Shown as figure 4-2
Figure 4-2 PadScan HD 2 battery removal diagram
4.2.2 Base Placement Diagram
Figure 4-3 PadScan HD2 base placement diagram

PadScan HD 2
Caresono Technology Co., Ltd 16
4.3 Power supply
The power supply: battery.
4.3.1 Battery power supply
（1）Install the battery into the main unit as described in “4.2”.
（2）Press the power button to turn on the device and enter the working state.
4.3.2 Battery power charging
Battery is charged by charger.
（1）Remove the battery from the main unit and connect it to the socket of the charger.
（2）Insert the AC plug of the charger into the power supply socket.
（3）When the battery is being charged, the indicator light on the charger turns red. When the
battery is fully charged, the indicator light turns green.

PadScan HD 2
Caresono Technology Co., Ltd 17
Chapter Five User Interface
5.1 Expert mode
Figure 5-1 PadScan HD 2 expert mode screen
A：Company logo
B：Ultrasonic image outlining
C：Bladder ultrasonic image
D：Battery status indicator
E：Bladder volume value

PadScan HD 2
Caresono Technology Co., Ltd 18
5.2 Easy mode screen
Figure 5-2 PadScan HD 2 easy mode screen
A: Section diagram of the bladder
B: Circle of Easy Mode