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.

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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

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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

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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

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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

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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

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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

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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.
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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.

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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.