PeakSonic M4-HD User manual

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Bladder Scanner
Model: M4-HD
User Manual
Version: M4-HD_V1.0.0.1
Product standard: XXX/J XXXX-2018
Production license No.: YSYJXSCX No. XXXXXXX
Registration certificate No.: JSYJX (Z) ZI 2014 No. XXXXX
Suzhou PeakSonic Medical Technology Co.Ltd.

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Contents
User Manual..................................................................................................................................................................1
Version: M4-HD_V1.0.0.1...........................................................................................................................................1
Contents ................................................................................................................................................................2
Chapter I Overview......................................................................................................................................................1
1.1 Introduction.....................................................................................................................................................1
1.2 Intended use ..................................................................................................................................................2
1.3 Executive standards......................................................................................................................................2
1.4 Service life......................................................................................................................................................4
1.5 Operating environment requirement...........................................................................................................4
1.6 Statement on electromagnetic compatibility..............................................................................................5
1.7 Statement of the manufacturer....................................................................................................................6
1.8 Contraindications...........................................................................................................................................7
1.9 Release of heat index and mechanical index ...........................................................................................7
Chapter II Precautions ................................................................................................................................................1
2.1 Inspection before operation .........................................................................................................................1
2.2 Safety preparation before operation...........................................................................................................1
2.3 Operating instructions...................................................................................................................................1
2.4 Instructions after operation ..........................................................................................................................2
2.5 Situations shall be avoided ..........................................................................................................................2
2.6 Relevant matters concerning moving the instrument...............................................................................3
2.7Operations in case of fault ............................................................................................................................3
2.8 Inspect and maintain the instrument regularly ..........................................................................................3
2.9 Do not disassemble the instrument and probe arbitrarily........................................................................3
2.10 Startup...........................................................................................................................................................3
2.11Poweroff.........................................................................................................................................................3
Chapter III System Introduction .................................................................................................................................4
3.1 Profile of scanning device ............................................................................................................................4
3.2 Technical specifications................................................................................................................................5
3.3 Block diagram ................................................................................................................................................7
3.4 Basic principle................................................................................................................................................8
Chapter IV Instrument Installation ...........................................................................................................................11
4.1 Unpacking inspection..................................................................................................................................11
4.2 Installation.....................................................................................................................................................11
4.2.1Schematic diagram of the base for the scanning device of the instrument......................................11
4.2.2Installation and disassembly of Bluetooth printer.................................................................................11
4.3 Power supply................................................................................................................................................12
4.3.1 Battery powered ...............................................................12
4.3.2 Battery charging ...............................................................12
Chapter V Instrument Interface................................................................................................................................14
5.1 Startup interface...........................................................................................................................................14
5.2 Main interface of the expert mode ............................................................................................................14

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5.3 Main interface of the easy mode...............................................................................................................15
5.4 Main interface of the intelligence mode ...................................................................................................16
5.5 Scanning under the expert mode..............................................................................................................16
5.5.1 Pre-scanning interface of the expert mode..........................................................................................16
5.5.2 Scanning start interface of the expert mode ........................................................................................17
5.5.3 Scanning end interface of the expert mode .........................................................................................17
5.6 Scanning under the easy mode ................................................................................................................18
5.6.1 Pre-scanning interface of the easy mode.............................................................................................18
5.6.2 Scanning start interface of the easy mode...........................................................................................18
5.6.3 Scanning end interface of the easy mode............................................................................................18
5.7 Scanning under the intelligence mode.....................................................................................................19
5.7.1 Pre-scanning interface of the intelligence mode .................................................................................19
5.7.2 Scanning start interface of the intelligence mode ...............................................................................19
5.7.3 Scanning end interface of the intelligence mode ................................................................................20
5.8 Bladder projection interface of the expert mode.....................................................................................20
5.9 Bladder 3D interface of the easy mode....................................................................................................20
5.10 Bladder 3D interface of the intelligence mode......................................................................................21
5.11 Saved patient information browsing........................................................................................................21
5.11.1 Patient history information view login interface .................................................................................21
5.11.2 Main interface of patient history information ......................................................................................22
5.11.3 Editing interface of patient history information...................................................................................23
5.11.4 Interface of patient history information and 3D model......................................................................23
5.11.5 Projection interface of patient history information .............................................................................24
5.11.6 Batch delete and upload selection interface of patient history information ...................................24
5.11.7 Upload login interface of patient history information.........................................................................25
5.11.8 Upload prompt interface of patient history information.....................................................................25
5.11.9 Single delete confirmation interface of patient history information .................................................26
5.11.10 Batch delete confirmation interface of patient history information................................................26
5.12 System setting interface...........................................................................................................................27
5.12.1 Operation mode setting interface ........................................................................................................27
5.12.2 Calibration setting interface..................................................................................................................28
5.12.3 Interface language setting interface....................................................................................................29
5.12.4 Automatic poweroff time setting interface ..........................................................................................29
5.12.5 Volume alert preset setting interface ..................................................................................................30
5.12.6 Password management ........................................................................................................................31
5.12.6.1 Password management login interface...........................................................................................31
5.12.6.2 Password management interface ....................................................................................................31
5.12.6.3 wifi auto connect interface..............................................................................................................32
5.12.7 System information view interface ......................................................................................................32
5.12.7.1 Software version upgrade interface.................................................................................................33
5.13 Printer Bluetooth scanning interface ......................................................................................................33
5.14 Bluetooth auto connect interface ............................................................................................................34
5.15 Battery power identifier.............................................................................................................................34
Chapter VI Operation Procedures...........................................................................................................................35
6.1 Instrument startup and shutdown..............................................................................................................35

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6.2 wifi connection of tablet computer .................................................................................................................35
6.3 Bladder scanning........................................................................................................... 错误!未定义书签。
6.3.1 Gender selection ...............................................................36
6.3.2 Bladder pre-scanning ...........................................................36
6.3.3 Bladder scanning ..............................................................37
6.3.3.1 Bladder scanning under the expert mode ........................................37
6.3.3.2 Bladder scanning under the easy mode..........................................38
6.3.3.3 Bladder scanning under the intelligence mode ....................................38
6.4 View ultrasound image of bladder scanning or section diagram, projection and 3D image ............39
6.5 Patient information input.............................................................................................................................39
6.6 Patient information saving..........................................................................................................................40
6.7 Printer Bluetooth connection .....................................................................................................................40
6.8 Patient information printing ........................................................................................................................40
6.9 History information browsing .....................................................................................................................41
6.9.1 Patient history information view login....................................................................................................42
6.9.2 Main interface of patient history information .................................................................................42
6.9.3 Editing interface of patient history information.............................................................................42
6.9.4 Delete patient history information.....................................................................................................43
6.9.5 Upload patient history information ...................................................................................................44
6.9.6 Browse scanned images, 3D images and projection positioning images of the bladder..............45
6.10 Settings.......................................................................................................................................................45
6.10.1 Mode selection setting .........................................................46
6.10.2 Calibration setting.............................................................47
6.10.3 Interface language setting ......................................................47
6.10.4 Automatic poweroff time setting .................................................48
6.10.5 Volume alert preset setting .....................................................48
6.10.6 Password management ........................................................48
6.10.7 System information view .......................................................50
6.10.7.1 App upgrade ..............................................................50
6.11 Host computer transmission and functions............................................................................................50
6.11.1 Login host computer software..............................................................................................................51
6.11.2 Main interface of host computer...........................................................................................................51
6.11.3 Import Data..............................................................................................................................................52
6.11.4 Host computer option interface............................................................................................................53
6.11.5 Host computer print interface ...............................................................................................................54
6.11.6 Save to PDF............................................................................................................................................56
6.11.7 Host computer password change ........................................................................................................57
6.12 Battery power identifier.............................................................................................................................57
6.13 Scanning operation and bladder positioning.........................................................................................58
Chapter VII Maintenance and Care.........................................................................................................................60
7.1 Cleaning and maintenance of the system ...............................................................................................60
7.1.1 Cleaning and disinfection steps .................................................60
7.1.2 Maintenance .................................................................60
7.2 Cleaning and maintenance of the probe...............................................................................................61
7.2.1 Cleaning and disinfection steps .................................................61

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7.2.2 Maintenance ..................................................................61
7.3 Battery use and maintenance.................................................................................................................61
7.4 Disposal of electronic waste ...................................................................................................................62
Chapter VIII Transportation and Storage................................................................................................................63
8.1 Precautions for handling instrument......................................................................................................63
8.2 Requirements for transportation and storage environment................................................................63
8.3 Transportation ...........................................................................................................................................63
8.4 Storage.......................................................................................................................................................63
Chapter IX Simple Fault Inspection and Elimination ............................................................................................65
9.1 Inspection .....................................................................................................................................................65
9.2 Simple fault elimination...............................................................................................................................65
9.3 If the fault cannot be eliminated, please contact Suzhou PeakSonic Medical Technology Co.Ltd. 65
9.4 Maintenance instructions............................................................................................................................65
Appendix A Schematic Diagram of the Complete Machine Identification..........................................................66
Schematic diagram of the nameplate of M4-HD complete machine..........................................................66
Schematic diagram of the nameplate on M4-HD outer packaging box .....................................................66
Schematic diagram of the nameplate of M4-HD base .................................................................................67
Schematic diagram of the nameplate of M4-HD charger.............................................................................67
Appendix B Ultrasound Output Report ...................................................................................................................68
Appendix C Technical Specification for Electromagnetic Compatibility .............................................................71
Attached page to the Specification..................................................................................................................77

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Chapter I Overview
Instructions: The right of interpretation of the document belongs to Suzhou PeakSonic
Medical Technology Co.Ltd.
No unit or individual may photocopy, copy or translate the document into other
languages without the permission of the company.
The rights to revise and modify the contents and terms of the document belong to the
company. The revision and modification of the document will not be separately notified.
Some operations in the document are illustrated with pictures, which are simply
schematic diagrams of the operations and do not mean anything else.
is the registered trademark of Suzhou PeakSonic Medical Technology
Co.Ltd. In accordance with laws, unauthorized use of the above trademark will be
investigated for legal responsibility.
1.1 Introduction
The M4-HD bladder scanner manufactured by Suzhou PeakSonic Medical Technology
Co.Ltd. provides non-invasive measurement of urinary bladder volume using ultrasonic
imaging and measurement principle. This instrument is composed of a handheld wireless
scanning device and a tablet computer. It has the following characteristics:
This instrument has three operation modes: The expert mode, the easy mode and the
intelligence mode. Under the expert mode, the real-time 2D B-ultrasound image can be
displayed. The operator can determine whether the position and the result of the
measurement are correct based on the bladder section image displayed. Under the
easy mode, there is no real-time 2D scanning image, and the operator is guided by the
instrument to move the probe to find the correct position for measurement (the operator
doesn’t need to have expertise in ultrasonic diagnosis). Under the intelligence mode, in
the pre-scanning stage, it only displays the real-time projection position map of the

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scanning surface of the bladder. The position of the bladder shall be found before
scanning (the operator does not need to have medical background, and moves the
probe according to the real-time projection position). Position before scanning.
During measurement, the instrument is non-invasive and comfortable to patients. It is
accurate, reliable, rapid and simple in operation. When the user releases the scan key,
within several seconds, it can get several 2D ultrasound images. It adopts complex
image processing technology to restore them to 3D images, and adopts complex
algorithm to calculate the bladder volume and display the results.
Two orthogonal images, patient information and volume value can be printed.
Adopt touch screen keyboard on tablet computer for operation.
Multi-language selection.
Volume preset alert
Bluetooth wireless print report
Information management, storage and printing
The instrument is composed of a handheld wireless scanning device with an injection
molding case and a tablet computer.
Adopt built-in battery for power supply.
1.2 Intended use
The 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 Bladder Scanner is
intended to be used only by qualified medical professionals.
1.3 Executive standards
The instrument shall be designed and manufactured strictly according to national
standards IEC/EN 60601-1 Medical Electrical Equipment Part 1: General Requirements for
Safety, IEC/EN 60601-1-2 Medical electrical equipment - Part 1-2: General requirements
for safety - Collateral standard Electromagnetic compatibility - Requirements and tests and
IEC/EN 60601-2-37 Medical electrical equipment - Part 2-37: Particular requirements for

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the safety of ultrasonic medical diagnostic and monitoring equipment. The protection type of
electric shock hazard is: Type B of Class II.
●The environment test of the instrument shall meet the requirements of climate
environment test Group II and mechanical environment test Group II of GB/T14710-2009
The environmental requirements and test methods for medical electrical equipment.
●Description of instrument nameplate and identification:
Product serial No.
Follow the
instructions
Production date of the
product
Type B equipment
Authorized
representative
information of the
European Union
Notice! Look up
random files
Manufacturer
information
IPX7
Waterproofing grade
The waste electrical
and electronic
equipment shall be
recycled according to
the regulations
CE identifier and code
of the certification
body
2AT6UM4-HD
Wireless certification
code
Prescription use only
Description of packing and transportation identification of the instrument:
Handle with care

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Limit of temperature
Upward
Limit number of stacking layer
Keep dry
Avoid heat
1.4 Service life
The service life of the product is 6 years. Continued use of this product after its service
life will lead to increased fault rate of the product and unexpected risks.
Warning: All risks arising from the continued use of this product after
its service life shall be borne by the user.
Note: Scrapping disposal of the product shall be in compliance with
local regulations. Don't scrap with household garbage.
1.5 Operating environment requirement
a) Ambient temperature range: +5℃～+40℃
b) Relative humidity range: 30%～75%
c) Atmospheric pressure range: 70KPa～106KPa

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1.6 Statement on electromagnetic compatibility
The use of M4-HD equipment will not affect the normal wired and wireless information transmission
and the performance of other electronic equipment. It can work normally in the specified electromagnetic
environment.
Warning: When the instrument is operated in strong electromagnetic
environment, such as close to the motor, x-ray device, dental and
physiotherapy equipment, broadcasting station or underground
cable, there will be interference signals on the image, affecting the
measurement. At this time, the instrument shall be stopped to prevent
mismeasurement and can be reused after the electromagnetic
interference is eliminated.
Warning: If the user replaces with non-conforming equipment parts
voluntarily, there may be unforeseen electromagnetic compatibility
problems which interfere with the measurement position resulting in
mismeasurement. Therefore, replacement of parts must be carried out
by the unit and department designated by the manufacturer.
Warning: If the user doesn’t use the battery of the model specified by
the manufacturer, there may be unforeseen electromagnetic
compatibility problems which prevent the instrument from working
normally. Therefore, the battery of the model specified by the

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manufacturer must be used.
Warning: When charging the battery when it is in the instrument, the
power supply of the instrument shall be disconnected, therefore, the
instrument cannot be used during battery charging.
1.7 Statement of the manufacturer
Responsibility of the manufacturer
Suzhou PeakSonic Medical Technology Co.Ltd. only considers itself responsible for the
safety, reliability and performance of the instrument in case of the following circumstances,
namely:
The assembly operation, expansion, re-adjustment, improvement and repair are carried
out by personnel approved by Suzhou PeakSonic Medical Technology Co.Ltd.;
Relevant electrical equipment complies with national standards;
The instrument is used according to operation guidance.
In case of the following circumstances, Suzhou PeakSonic Medical Technology Co.Ltd. is not
responsible for the safety, reliability and operation of the product:
 The components are disassembled, stretched and re-debugged;
 The product is not correctly used according to the Operating Specification.
Warning: Without the permit of the manufacturer, the equipment shall
not be modified.
Warning: If the equipment is modified, corresponding inspection and
tests must be carried out in the department designated by the state to
ensure that the equipment can be used continuously and safely.

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1.8 Contraindications
Do not use the 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.
1.9 Release of heat index and mechanical index
Heat index TIS: <0.042
TIB：＜0.042
Mechanical index MI: <0.38

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Chapter II Precautions
In order to ensure safety, during the operation of the equipment, the following contents
must be read first. This instrument is only allowed to be operated by a person confirmed or
authorized by relevant medical institution.
2.1 Inspection before operation
(1) The instrument is normal.
(2) Do not keep the instrument close to hot or wet articles. Keep the instrument in place
to ensure safe operation.
Warning: Please install and use the battery that is provided with the
instrument by the company to carry out the work. If the user arbitrarily
uses the battery of other specifications and models, it may cause
safety hazards to the user or the instrument.
2.2 Safety preparation before operation
Check whether the instrument is in good condition. Make sure that no water, chemicals
or other substances have been spilled on the instrument. If there is any strange noise or
smell during the operation, the instrument shall be stopped immediately, until the authorized
engineer resolves the problems.
2.3 Operating instructions
(1) During operation, the surface of the probe shall be well protected to prevent
collision, and the surface of the probe shall be applied with coupling agent to enable better
contact between the human body and the probe.
(2) Closely monitor the operation of the instrument and the patient. If the instrument

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fails, turn off the power immediately.
(3) The patient is prohibited from touching the instrument or other electric appliances.
(4) The vent of the instrument shall not be closed
2.4 Instructions after operation
(1) Switch off the power.
(2) Clean the instrument and the probe.
(3) Place the instrument on the base.
2.5 Situations shall be avoided
With respect to the instrument, the following situations shall be avoided as far as
possible:
(1) Water splashing
(2) Too high humidity
(3) Poor ventilation
(4) Straight sunshine
(5) Dust environment
(6) Saliferous or sulfurous gas
(7) Chemical medicine or gas
(8) Strong vibration and collision
(9) The company is not liable for any risks arising from the disassembly or modification
of the instrument by the user voluntarily.
(10) Strictly forbid to dip the instrument probe which contacts with the patient into any
liquid.
(11) Strictly forbid to heat the instrument probe which contacts with the patient.
(12) Use the ultrasonic coupling agent which meets the national standard
requirements. Other materials (such as: oil) will damage the probe.
(13) The instrument probe which contacts with the patient shall be kept clean. After
each use, wipe off the ultrasonic coupling agent on the probe with neutral detergent or fresh

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water.
2.6 Relevant matters concerning moving the instrument
(1) Turn off the power supply.
(2) Drop, vibration and collision of the instrument are strictly prohibited.
2.7Operations in case of fault
In case of malfunction of the instrument, turn off the power supply immediately, and
contact with qualified maintenance personnel.
2.8 Inspect and maintain the instrument regularly
2.9 Do not disassemble the instrument and probe arbitrarily
2.10 Startup
Long press (about 2 seconds) the power button of the scanning device to start it, click
the App icon of the tablet computer to enter the startup interface.
2.11Poweroff
After the operation of the device is completed, long press (about 2 seconds) the power
button of the scanning device again to turn off the scanning device. The power supply of
the scanning device of the instrument is turned off. Press the exit button of the tablet
computer to exit the App.

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Chapter III System Introduction
3.1 Profile of scanning device
Figure 3-1 Front schematic diagram of M4-HD scanning device
Figure 3-2 Left schematic diagram of M4-HD scanning device
Power switch
and scan key

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Figure 3-3 Rear schematic diagram of M4-HD scanning device
3.2 Technical specifications
●Probe: 3D mechanical sector-scanning
●Nominal ultrasonic operating frequency: 2.5MHz±15%
●Volume measurement range: 0ml-999ml
●Volume measurement accuracy: Error of ±7%, ±7ml
●Volume display resolution: 1ml
●Scanning time: < 5 seconds
●Battery capacity: 2400mAh
●Operation mode: Touch keys on the tablet computer
●Have 2D tissue harmonic imaging image
●3D scanning display: Real-time scanned image, volume value, outline information,
projection information, 3D graphics
●Information storage: Images, results and other information of the patient can be
stored
●Information printing: Print the measurement results and pictures through Bluetooth
control
●Information management: Call out patient information for viewing (playback of original
Charging socket

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database information), storage, printing, deletion and other operations
●Information input: Enter the gender, number, name and age of the patient
●Wifi wireless two-way transmission: The patient information is uploaded to the tablet
computer for display, storage and printing. At the same time, a mutual transmission
command is needed between the scanning device and the tablet computer.
●System setting: Including (calibration, mode, volume alert, automatic poweroff,
interface language, password management, version number view, software update)
●Multi-language selection
●The instrument has three operation modes: Expert mode, easy mode and intelligence
mode
●Display screen: Display on the tablet computer
●Power: 13VA
●Instrument size Host size: 215﹡56﹡45mm±0.6mm；Boundary dimension with the
base: 260﹡120﹡223mm±0.6mm
●Instrument weight: About 500g ±50g (including battery)
●Power supply mode: Battery powered: DC7.4V±0.5V
●Continuous scanning time of battery powered instrument: > 2 hours and 20 minutes
●Continuous electrification time of battery powered instrument: > 4 hours and 20
minutes
●The waterproofing grade of the front end of the probe is IPX7
●The instrument is composed of a handheld wireless scanning device and a tablet
computer.

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3.3 Block diagram
Figure 3-4 Block diagram of electrical principle of M4-HD

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3.4 Basic principle
This product is a non-invasive bladder scanner. On account of that ultrasonic diagnosis
is a non-invasive examination method, this device first uses the principle and technology of
ultrasonic imaging and obtains 12 images by using the 3D ultrasonic probe. It measures the
bladder volume with the technology of drawing the bladder boundary points and conducting
point integral operation at the same time. The method is as follows. According to the
gradient value of the image, rapidly outline to obtain the boundary data of each section of
the bladder, while obtaining key data of bladder boundary segment points. For the 12
images obtained through bladder scanning according to the bladder boundary segment
points, the curve at the right of the bladder boundary in each image is divided to 5 segments:
L1, L2, L3, L4 and L5. According to the divided segments of the curve, calculate the integral
value of one section in integral values of L1 first. The sum of the area values corresponding
to all points of L1 is the volume value of L1. And then the positive and negative judgment
shall be conducted to the volume value according to key points of L1, L2, L3, L4 and L5.
The volume of the right part of the bladder scanning section is the sum of the volume values
corresponding to L1, L2, L3, L4 and L5. The volume of the left part shall be calculated with
the same method as that of the right part. The volume value of one scanning section is the
sum of the volume values of the right and the left parts. The volume of the whole bladder is
the sum of 3-dimensional volume of 12 scanning sections. The instrument adopts a 3D
mechanical sector-scanning probe to conduct ultrasonic detection and scanning of the
bladder, and then performs complex operation to calculate the bladder volume. The
operating principle of the instrument is as follow: Firstly, the instrument sends pulse signal
to the 3D probe, and transmits ultrasonic wave to the human body through the energy
converter in the probe. The ultrasonic wave generates reflected or scattered wave in the
human body as it passes through tissue planes, and the tissue and organ can be positioned
according to its return time. According to its strength, tissue characteristics can be detected.
Sending such a set of pulses can only capture one piece of information on a plane of the
tissue, i.e., usually one 2D sectional tissue image needs it to be transmitted at least 96 or
128 times (for a 2D ultrasound device), so as to form a section. And then transmitted and