Youkey D8 User manual

1
Pocket ultrasound system
Instruction manual
Model：D8
WuHan Youkey Bio-Medical Electronics Co., Ltd.
IMPORTANT！
Read and understand this manual before operating
the equipment. After reading, keep this manual in an
easily accessible place.

2
Contents
Maintenance and repair service.................................................................................................5
Intellectual Property Statement..................................................................................................6
Version information....................................................................................................................... 6
Product Information...................................................................................................................... 7
After-sales service unit:............................................................................................................... 7
1 Safety precautions....................................................................................................................... 8
1.1 Security classification....................................................................................................... 8
1.2 Symbol definition..............................................................................................................8
1.3 Security symbol................................................................................................................ 8
1.4 Safety warning information.............................................................................................. 9
1.5 WARNING Labels.......................................................................................................... 11
2 Product overview........................................................................................................................... 12
2.1Intended use......................................................................................................................... 12
2.2 Contraindication..................................................................................................................12
2.3 Product specifications......................................................................................................... 12
2.3.1 Imaging mode....................................................................................................... 12
2.3.2 Software version information............................................................................... 12
2.3.3Software running IT environment............................................................................ 12
2.3.4 Power condition.................................................................................................... 13
2.3.5 environment condition.......................................................................................... 13
2.3.6 Probe outline dimensions and weight...................................................................14
2.4 system configuration........................................................................................................14
2.4.1 Standard configuration..........................................................................................14
2.4.2 Components.......................................................................................................... 15
2.5 Symbols description.........................................................................................................16
2.6 Introduction of each component of the system................................................................17
2.7 Control panel....................................................................................................................18
2.8 Basic interface..................................................................................................................19
2.8.1 Android application interface............................................................................... 19
2.8.2 Windows application interface............................................................................. 21
2.9 Information security............................................................................................................23
2.9.1 Forget password....................................................................................................... 23
2.9.2 User classification....................................................................................................23
Permission division...........................................................................................................23
2.9.3 Password setting...................................................................................................... 23
2.10 Indicator light....................................................................................................................23
3 Basic introduction.......................................................................................................................... 25
3.1 Working power supply..................................................................................................... 25
3.2 Turn on / off probe........................................................................................................... 25
3.2.1 Turn on probe................................................................................................................25
3.2.2 Turn off the probe................................................................................................. 26
3.2.3 Change the detachable transducer........................................................................ 26

3
3.3 Connection....................................................................................................................... 27
3.3.1 Wifi Connection....................................................................................................27
3.3.2 USB Connection................................................................................................... 27
4 Detailed operation introduction..............................................................................................27
4.1 Image mode......................................................................................................................27
4.2 Image parameter adjustment............................................................................................27
4.3 Parameter adjustment about B mode............................................................................... 28
4.3.1 B mode image parameter...................................................................................... 28
4.3.2 B mode image optimization..................................................................................29
4.4 Parameter adjustment about M mode.............................................................................. 31
4.4.1 M mode image parameter..................................................................................... 31
4.4.2 M mode image optimization.................................................................................32
4.5 Parameter adjustment about Color mode.........................................................................34
4.5.1 Color mode image parameter................................................................................34
4.5.2 Color mode image optimization........................................................................... 34
4.6 Parameter adjustment about Power mode....................................................................... 36
4.6.1 Power mode image parameter.............................................................................. 36
4.6.2 Power mode image optimization.......................................................................... 37
4.7 Parameter adjustment about PW mode............................................................................38
4.7.1 PW mode image parameter...................................................................................38
4.7.2 PW mode image optimization.............................................................................. 38
5 Measure.......................................................................................................................................... 41
5.1 Conventional measure......................................................................................................42
5.1.1 2D Conventional measure.....................................................................................42
5.1.2 Conventional measure in M mode........................................................................42
5.1.2 Conventional measure in Doppler mode.............................................................. 43
5.2 Special measuring package............................................................................................43
6 Cineloop/annotation/body mark.................................................................................................... 43
6.1 Cineloop......................................................................................................................... 43
6.1.1 Cineloop playback................................................................................................ 44
6.1.2 Save Cineloop....................................................................................................... 44
6.2 Annotation......................................................................................................................44
6.3 Body mark (for Windows version)................................................................................ 44
7 Probe...............................................................................................................................................44
7.1 Probe description........................................................................................................... 44
7.1.1 Probe type............................................................................................................. 44
7.1.2 Probe composition................................................................................................ 44
7.1.3 Probe performance index......................................................................................45
7.2 Probe cover.................................................................................................................... 47
7.3.1 Check up............................................................................................................... 47
7.3.2 Service life............................................................................................................ 47
7.3.3 Probe maintenance................................................................................................48
7.4 Cleaning and disinfection.............................................................................................. 48
8 Puncture guide................................................................................................................................51

4
8.1 Enter or exit puncture mod.............................................................................................. 51
8.2 Puncture lead calibration................................................................................................. 51
9 Acoustic output description.........................................................................................................52
9.1 biological effect................................................................................................................52
9.2 Caution use declaration....................................................................................................52
9.3 ALARA principle(As Low As Reasonably Achievable)................................................. 52
9.4 MI/TI description............................................................................................................. 53
9.4.1 Basic knowledge of MI and TI............................................................................. 53
9.4.2 MI/TI display instructions.................................................................................... 54
9.5 Sound power setting.........................................................................................................55
9.6 Acoustic power control.................................................................................................... 56
9.7 Acoustic output description............................................................................................. 56
9.7.1 Damping output parameter................................................................................... 56
9.7.2 Acoustic output limit.............................................................................................57
9.7.3 The difference between the actual MI/TI value and the display value................ 57
9.8 Uncertainty of measurement............................................................................................58
9.9 Reference literature for sound power and its safety........................................................ 58
9.10 Transducer surface temperature.....................................................................................58
10 Electromechanical safety standards............................................................................................. 60
Appendix A Names and contents of toxic and hazardous substances or elements.......................... 66
Appendix B Acoustic output data..................................................................................................... 66

5
Introduction
This manual describes the operation of the ultrasonic diagnostic equipment. In order to ensure the
safe operation of the system, please read and understand the contents of the manual before using
the system
This specification is formulated and explained by the company
The company reserves the right to change the contents of the instruction manual without prior
notice
Important statement!
1. The part or all of the contents of this manual shall not be copied or copied prior to the written
permission;
2. It is forbidden to modify the software or hardware of this product;
3. The scanner can provide the doctor with the image and data needed for clinical diagnosis, and
the doctor is responsible for the diagnosis process;
4. Quality assurance does not include the following, even within the warranty period：
(1) Damage or loss caused by improper installation or environmental conditions that do not
meet the requirements;
(2) Damage or loss caused by the supply voltage exceeding the specified range;
(3) Damage or loss of equipment or components purchased from the company or its
authorized distributor or agent;
(4) Damage or loss caused by using the scanner in different countries.
(5) Damage or loss caused by maintenance of non authorized personnel of the company;
(6) Damage or loss caused by force majeure such as fire, earthquake, flood or lightning;
(7) Damage or loss caused by error or rough use;
(8) Failure caused by other things, not the product itself.
5. Part of the waste or vulnerable parts may be produced when the product is in use or after the
service life is exceeded, which will cause serious pollution to the environment or
cross-infection if discarded at will, It shall be regulated and handled in accordance with local
laws and regulations and other relevant provisions. It cannot be dealt with in the same way that
normal waste is disposed of.
Maintenance and repair service

6
The standard warranty period of this product is 2 years, and the main warranty period is about 1
years. The warranty period from the product warranty card fill in the attached "date of installation"
date, the warranty card is the only certificate calculation warranty period.
Within the warranty period, the product is provide with free customer service; but please note that
even in the warranty period, due to the reasons on the page "important statement" caused by the
products need maintenance, the company will charge maintenance services, you need to pay the
cost of maintenance and spare parts costs.
After the expiration of the warranty, the company can provide maintenance services.
It should be noted that if you do not pay or delay the payment of maintenance costs, the company
will temporarily suspend maintenance services until you pay
We hereby declare that you must familiarize yourself with the operating instructions
before use and operate and use it in strict accordance with the requirements and methods
of operation of the operating instructions. The Company does not assume any
responsibility for safety, reliability and performance assurance due to any abnormality
caused by operation, use, maintenance and storage in accordance with the requirements of
this manual.
Operation taboo:
Danger ※Do not modify this equipment, including equipment components,
software, cables and so on. User modifications may result in security problems or reduced system
performance. All modifications must be completed by the personnel approved by the company.
Intellectual Property Statement
This specification and the intellectual property rights of the products are owned by the company.
No individual or organization may copy, modify or translate any part of this manual without the
written consent of the company
Version information
The version of this instruction is as follows:
Version number: 1.1
Issue date: June 2020

7
Product Information
Product name:Pocket ultrasound system
Product Model: D8
Name of the registrant: WuHan Youkey Bio-Medical Electronics Co., Ltd
Registered address：No.1, Floor 2, Building 7, Block B, No.818, High-tech Avenue, Donglaxin
Technical Development Zone, Wuhan City, China
Production enterprise name: WuHan Youkey Bio-Medical Electronics Co., Ltd
Production address (residence): 2nd Floor, Dingxin Industry park, Jiayuan Road, East Lake
Development Zone, 430074 Wuhan, PEOPLE’S REPUBLIC OF CHINA
Contact: 027 / 87797167
After-sales service unit:
Company Name: WuHan Youkey Bio-Medical Electronics Co., Ltd.
Address: 2nd Floor, Dingxin Industry park, Jiayuan Road, East Lake Development Zone, 430074
Wuhan, PEOPLE’S REPUBLIC OF CHINA
After-sales service Tel: 027 / 87797167
other:
Company website: www.youkeymedical.com
WeChat public number: Youkey

8
1 Safety precautions
1.1 Security classification
According to the type of anti electric shock：
Internal power supply, where the adapter is Class 1;
According to the degree of anti electric shock：
Type BF application part;
According to the protection degree of harmful liquid：
The Main unit is IPX4, transducer is IPX7
According to the degree of safety in the presence of flammable anesthetic gas mixed with air
(or oxygen, nitrous oxide two):
According to the working mode:
Continuous working equipment.
1.2 Symbol definition
In this manual，“ DANGER”“ WARNING”、“CAUTION”is used to indicate the safety
and other important matters, and their specific meanings are as follows.
Symbols and
vocabulary
Meaning
DANGER
Indicates that a hazardous situation may occur and, if not avoided,
may result in death or serious injury.
WARNING
Indicates that a potentially hazardous situation may occur and,
if not avoided, may result in death or serious injury.
CAUTION
Indicates that the risk may occur, if not avoided, may cause
property damage.
1.3 Security symbol
Security
symbol
Detailed description
Type BF application part
Description: all the ultrasonic probes connected to the system are part
of the BF application.
"Be careful" indicates what should be noted. Be sure to read the
instructions carefully before using the system.
IPX
Degree of protection against harmful intake

9
Security
symbol
Detailed description
Nonionizing radiation
1.4 Safety warning information
In order to ensure the safety of the patient and the operator, the following safety rules should be
strictly observed in the use of the wireless ultrasonic probe.
DANGER：
Do not use the scanner in an environment containing combustible gas,
such as an anesthetic gas, hydrogen, or flammable liquid, such as
ethanol. It may cause an explosion.
WARNING:
1
.
Do not disassemble the ultrasonic probe, which may cause electric shock.
2
.
Use the original power cable, or charging the scanner may cause electric
shock.
3
.
Use the probe carefully, if the probe is scratched with the contact surface of
the human body, immediately stop using the probe and contact the service
representative. If you use a scratched probe, there is a risk of electric shock
4
.
Every time you use the instrument must be checked for safety, do not let the
probe by the impact of damaged ultrasound probe may cause the patient to be
shocked.
5
.
Before performing an ultrasound check, check the surroundings to ensure safe
use within the environment. Do not operate the unit in an environment with
flammable or explosive liquids, vapors or gases such as oxygen or hydrogen.
6
.
Use sterilized ultrasound cover when doing gynecology exam.
7
.
Do not immerse the ultrasonic probe Type-C interface or above in water or
disinfectant. Because the Type-C interface of the ultrasonic probe does not
have a waterproof function, this may cause an electric shock or a probe
malfunction.
8
Make sure the transducer is in good status before and after each exam. The
defective transducer may cause electric shock.
9
Choose different transducer based on the exams. You can only use the
transducer provided by the manufacturer.
1
0
In order to ensure safety, the charging of the system can only be carried out in
the state of shutdown, and the charging is not allowed under the power-on
state.
CAREF
1.
Matters needing attention in clinical examination technology：
This equipment can only be operated by qualified medical
personnel.

10
UL：
This manual does not introduce a clinical examination
technique. It is necessary to select the correct
inspection techniques according to the professional
training knowledge and clinical experience.
2.
Do not scan fetal, newborn baby or pregnant woman for a long time.
3.
Please follow the ALARA principle during ultrasonic diagnosis,
especially in the examination of pregnant women, fetuses and
newborns. The sound power can be reduced as much as possible when
satisfactory clinical images can be obtained.
4.
If the APP software fails during installation or use, please
promptly provide feedback to the after-sales maintenance
personnel to avoid misdiagnosis.
5.
The APP software will be upgraded from time to time, and new
updates will be submitted by the developer. If you want a better
experience, please pay attention to download and upgrade.
6.
Do not use incompatible coupling agents, disinfectants, probe
protective cover, probe, puncture rack.
7.
Sterile gloves must be worn to prevent infection when using
ultrasonic probes.
8.
You must use a sterile ultrasound coupling agent. Use a coupling
agent that is in compliance with local regulatory requirements.
In addition, it is necessary to properly manage and use the
ultrasonic coupling agent to ensure that it does not become a
source of infection.
9.
Normal ultrasound does not cause burns at room temperature;
however, if the probe is placed in the same position for a long
time, the patient may be burned.
10.
The probe cover is made of natural rubber and is used with caution
for natural rubber allergy.
11.
During the examination, the temperature of the Transvaginal
transducer lens surface should be lower than 43°C.

11
1.5 WARNING Labels
The system has a variety of identification to cause the user to pay attention to the potential danger.
The symbol on the warning sign indicates the precautions for system security.
The instructions explain in detail the meaning of these warning signs. Read the instructions
carefully before using the system.
CAU
TIO
N：
1
In order to prevent abnormal probe function, read the following safety
precautions:
After each ultrasonic examination, the ultrasonic coupling agent on
the surface of the probe should be thoroughly cleaned. Otherwise, the
ultrasonic coupling agent will be solidified on the probe head, which
will affect the quality of the ultrasound image.
The probe should be cleaned and disinfected before and after each
ultrasonic examination。
2
Ambient environmental requirements:
Please use the ultrasonic probe in the specified environment：
ambient temperature：0℃～ 32℃
relative humidity：30% ～ 85%（No condensation）
Atmospheric pressure：70KPa ～ 106KPa。
To prevent damage to the ultrasonic probe, do not expose the probe to
the following environment：
Place where the sun shines
A place where the temperature changes dramatically.
A place filled with dust
Easy to vibrate place
Place near the heat source
3
Repeated disinfection will lead to the safety and performance of the
probe, the performance of the probe should be regularly checked.

12
2 Product overview
2.1Intended use
Pocket Ultrasound System is intended for use by a qualified physician for ultrasound evaluation.
Specific clinical applications and exam types include: Abdominal, Obstetrics, Gynaecology, Small
Parts (breast, thyroid, etc), Peripheral Vascular, Urology.
2.2 Contraindication
Pocket Ultrasound System is not intended for ophthalmic use or any use causing the acoustic
beam to pass through the eye.
2.3 Product specifications
2.3.1 Imaging mode
B mode
M mode
C mode
PW mode
Power mode
2.3.2 Software version information
a) Embedded software(Firmware) release version：1.3.18.
b) Controlled software(APP) release version：
—Android platform Software version：V2.1.7；
—Windows Platform software version：V2.3.19.
—Get software at this link: http://www.youkeymedical.com/
2.3.3Software running IT environment
Software Environment
Network
bandwidth
＜500KBbps

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Port
8080-8084
IP range
192.168.254.10-192.168.254.200
Operating
system
WindowsXP、7、8、10 or Android5.0 or above
Antivirus
software
1.Windows system is recommended to install the top anti-virus
software, such software takes up less resources, runs smoothly,
and does not conflict, enough to protect system security.
2.The general Android system brand equipment has built-in
security procedures, no need to download; if the original
system does not have its own security software, it is
recommended to download some of the top anti-virus software
to ensure system software security.
Antivirus
frequency
It is recommended to perform anti-virus once a week to protect
the system.
2.3.4 Power condition
Internal Battery(7.4V 2600mAh)
Charging power input: DC 5V 2A
Can not work when charging.
2.3.5 environment condition
work environment
Storage and transportation
environment
ambient
temperature
0℃～32℃
-20℃～+55℃
relative
humidity
30%～85%
（No condensation）
30%～95%
（No condensation）
atmospheric
pressure
700hPa～1060hPa
700hPa～1060hPa
WARNING：
Transport:
1. Do not use or store the system outside the specified
environmental conditions.
Working:
1. Make sure the scanner is been held firmly, or it will drop and
hurt the patient.
2. Use the scanner in a dry environment, the operation of
environmental temperature and humidity changes, may lead to liquid

14
2.3.6 Probe outline dimensions and weight
Convex array size: 166mm (L) * 58mm (W) * 24mm (thickness)
Net weight: 235g (R50) (C5-2Fs)
Convex array size: 167mm (L) * 58mm (W) * 24mm (thickness)
Net weight: 260g (R60) (C5-2Ks)
Linear array size: 159mm (L) * 58mm (W) * 24mm (thickness)
Net weight: 225g (L40) (L11-4Ks)
Linear array size: 159mm (L) *58mm (W) * 24mm (thickness)
Net weight: 220g (L25) (L11-4Gs)
Slightly Convex array size: 160mm (L) * 58mm (W) * 24mm (thickness)
Net weight: 230g (R15) (C8-5Ks)
2.4 system configuration
The system is mainly composed of main unit equipment, transduser and application
(Android/Windows platform )
The configurable probe model is:C5-2Fs(Convex array)，C5-2Ks(Convex array)，L11-4Ks(Linear
array)，L11-4Gs(Linear array)，C8-5Ks(Slightly Convex array)
2.4.1 Standard configuration
Main unit: 1 set
Appendix
condensation in the circuit board, there is the risk of short
circuit.
3. Do not operate the unit in an environment with flammable or
explosive liquids, vapors or gases such as oxygen or hydrogen. Do
not use the scanner in an environment containing combustible gas,
such as an anesthetic gas, hydrogen, or flammable liquid, such as
ethanol. It may cause an explosion..
A. If there are flammable substances in the environment, do not
use the scanner.
B. Use the real-time detection environment to detect flammable
substances after the system is turned on. Do not attempt to turn
off the device or unplug the power supply. First empty the air in
the area and ensure a smooth ventilation and then turn off the
power.
4. If the system fails, please do not disassemble the scanner,
please contact the service center or your sales representative.

15
Application
Operation manual
2.4.2 Components
2.4.2.1 Optional Transducer
Transducer
model
Type of
Transducer
Intended
use
Applicable
site
Center
frequency
Frequency
range
C5-2Fs
Large convex
transducer
Gynecology
and
obstetrics,
abdominal
kidney
body
surface
3.5MHz
2.0~5.0MHz
C5-2Ks
Large convex
transducer
Gynecology
and
obstetrics,
abdominal
kidney
body
surface
3.5MHz
2.5~5.0MHz
C8-5Ks
Slightly
convex
transducer
Gynecology
and
obstetrics,
abdominal
kidney
body
surface
6.5 MHz
5.0~8.0MHz
L11-4Ks
Linear array
transducer
Small organ
carotid artery
body
surface
7.5 MHz
6.0~11.0MHz
L11-4Gs
Linear array
transducer
Small organ
carotid artery
body
surface
7.5 MHz
6.0~11.0MHz

16
2.5 Symbols description
This device uses the following symbol identification, the following list shows its meaning.
No.
Symbols
Description
1
Type BF application part
explain：All ultrasonic probes are part of the BF
application.
2
Please refer to the instruction manual for this symbol to
avoid accidents
3
This symbol represents the product serial number
4
This symbol represents the date of production
5
IPX 4
This symbol product as the IPX4 grade
6
Safety mark on behalf of the product has been in line with
European standards for safety / health / environmental /
health and other standards and directives

17
2.6 Introduction of each component of
the system
Serial
number
Name
Function
1
Transducer
Transmit and receive ultrasound
2
Main Device
Scanning control and data processing
3
Control Panel
Operation control
4
Type-Cinterface
USB-C port for charging and data transferring

18
2.7 Control panel
2.7.1 Control area schematic
Serial
number
Button
icon
Key name
Function
1
Power switch /
freeze / thaw
button
1. Short press: power on / freeze / unfreeze scanner
2. Long press >=3s: power off the scanner.
3. Blue blinking, the scanner is in freezing status.
4. Blue solid, the scanner is in scanning status.
2
Main menu
button
1. Change scan mode.
2. Save image in freezing status
3. Battery light indication
3
（Depth）
“ ”button
Increase Depth / Switch Parameters.
4
（Depth）
“ ”button
Decrease Depth / Switch Parameters.
5
（Gain）
“+”button
Increase Gain and Parameters
6
（Gain）
“-”button
Decrease Gain and Parameters

19
2.8 Basic interface
2.8.1 Android application interface
The interface layout diagram for the Android application is as follows:
2.8.1 Interface layout diagram
Status and information display area
The status and information display area includes system menu, WiFi/USB connection
sign, patient information management, probe type, inspection type, puncture line, battery
charge and system time.
System menu
Contains pre-set, version information, operation manual.
WiFi/USB connection sign
Displays the current probe connection.When connected to a WIFI, the flag indicates
signal strength，and you can also click to pop up the probe selection dialog box
Probe type
Displays the currently used probe model or the default probe model.
Inspection type
Displays the type of examination currently in use, such as abdomen, heart, etc., click to
select the check mode.
Guide line
The system support 2 guide lines, when you toggle it on, you can adjust the position and
angle of the guide line.
Battery charge
Probe battery power (upper): after the probe is connected, the current probe is displayed.
Device battery power (below): the display device opens the application and displays the
current power of the display device (mobile phone / tablet).
IM
1.1
TIS
0.4
Freq
4.0
Gain
60
Dep
16.cm
Status and information display area
Menu and Parameters display area
Image area
IM
1.1
TIS
0.4
Freq
4.0
Gain
60
Dep
16.cm
Function keys
Image area
Gain
Depth

20
System time
Displays the current system time. Check time as the image freezes when the system
freezes.
Menu and Image Parameter display area
The areas can be divided into two parts : image mode switching area and image
parameter adjustment area.
B mode,click to switch to M mode, click back to B mode;
Color mode，Click to enter Color mode, click again to enter Power mode;
PW mode，Click to enter the pre-startup status of PW mode and click again to
start / pause to get the spectrum.. It's the same function as update.
Drop-down menu flag, click to enter the corresponding image mode of all
parameters adjustment.

Image parameter adjusting pulley：Slide up and down or click on the pulley to adjust the
corresponding parameters.
Function shortcut key area
Contains freeze/unfreeze /saves image buttons
Freeze and unfreeze the clinical images
Save image button.
Image area
The image area displays images of each mode and probe direction markers, time lines (in
M mode), PW sampling lines (PW mode), axes (including depth axes, time axes), etc.,
while annotating information and measuring, The gray bar also appears here
Gain
Depth