Youkey P50 User manual

Pocket Ultrasound System
Instruction manual
Model: P50
GuangDong Youkey Medical 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 ....................................................................................................................6
After-sales service unit: .............................................................................................................7
1Safety 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
2Product overview ....................................................................................................................11
2.1 Intended use ..................................................................................................................11
2.2 Contraindication............................................................................................................11
2.3 Product specifications ...................................................................................................11
2.3.1 Imaging mode .....................................................................................................11
2.3.2 Software version information..............................................................................12
2.3.3 Software running IT environment .......................................................................12
2.3.4 Power condition ..................................................................................................12
2.3.5 Environment condition........................................................................................12
2.3.6 Probe outline dimensions and weight..................................................................13
2.4 system configuration .....................................................................................................14
2.4.1 Standard configuration........................................................................................14
2.4.2 Components ........................................................................................................14
2.5 Symbols description......................................................................................................15
2.6 Introduction of each component of the system .............................................................16
2.7 Control panel.................................................................................................................17
2.8 Basic interface...............................................................................................................18
2.8.1 Android application interface..............................................................................18
2.8.2 Windows application interface............................................................................20
2.9 Information security......................................................................................................22
2.9.1 Forget password ..................................................................................................22
2.9.2 User classification ...............................................................................................22
2.9.3 Password setting..................................................................................................22
2.10 Indicator light................................................................................................................22
3Basic introduction ...................................................................................................................23
3.1 Working power supply ..................................................................................................23
3.2 Turn on / off probe ........................................................................................................24
3.2.1 Turn on probe......................................................................................................24
3.2.2 Turn off the probe................................................................................................25
3.2.3 Change the detachable transducer.......................................................................25
3.3 Connection ....................................................................................................................25

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3.3.1 Wifi Connection ..................................................................................................25
3.3.2 USB Connection .................................................................................................25
4Detailed operation introduction...............................................................................................26
4.1 Image mode...................................................................................................................26
4.2 Image parameter adjustment .........................................................................................26
4.3 Parameters adjustment for B mode ...............................................................................27
4.3.1 B mode image parameter ....................................................................................27
4.3.2 B mode image optimization ................................................................................27
4.4 Parameters adjustment for M mode ..............................................................................30
4.4.1 M mode image parameter....................................................................................30
4.4.2 M mode image optimization ...............................................................................30
4.5 Parameters adjustment for Color mode.........................................................................32
4.5.1 Color mode image parameter..............................................................................32
4.5.2 Color mode image optimization..........................................................................33
4.6 Parameters adjustment for Power mode........................................................................34
4.6.1 Power mode image parameter.............................................................................34
4.6.2 Power mode image optimization.........................................................................35
4.7 Parameters adjustment for PW mode ............................................................................35
4.7.1 PW mode image parameter .................................................................................36
4.7.2 PW mode image optimization .............................................................................36
5Measurements .........................................................................................................................40
5.1 Conventional measurements .........................................................................................40
5.1.1 2D Conventional measurements..........................................................................40
5.1.2 Conventional measurements in M mode.............................................................41
5.1.3 Conventional measurements in Doppler mode ...................................................41
5.2 Special measuring package ...........................................................................................41
6Cineloop/annotation/body mark..............................................................................................42
6.1 Cineloop........................................................................................................................42
6.1.1 Cineloop playback...............................................................................................42
6.1.2 Save Cineloop .....................................................................................................42
6.2 Annotation.....................................................................................................................42
6.3 Body mark.....................................................................................................................42
7Probe .......................................................................................................................................43
7.1 Probe description...........................................................................................................43
7.1.1 Probe type ...........................................................................................................43
7.1.2 Probe composition...............................................................................................43
7.1.3 Probe performance index ....................................................................................43
7.2 Probe cover ...................................................................................................................46
7.3 Check up and maintenance............................................................................................46
7.3.1 Check up .............................................................................................................46
7.3.2 Service life ..........................................................................................................47
7.3.3 Probe maintenance ..............................................................................................47
7.4 Cleaning and disinfection..............................................................................................48
7.5 Disassembly and assembly...........................................................................................51

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8Puncture guide.........................................................................................................................52
8.1 Enter or exit puncture mode..........................................................................................52
8.2 Puncture lead calibration...............................................................................................52
9Acoustic output description.....................................................................................................53
9.1 Biological effect ............................................................................................................53
9.2 Caution use declaration.................................................................................................53
9.3 ALARA principle(As Low As Reasonably Achievable)...............................................53
9.4 MI/TI description ..........................................................................................................54
9.4.1 Basic knowledge of MI and TI............................................................................54
9.4.2 MI/TI display instructions...................................................................................55
9.5 Sound power settings ....................................................................................................55
9.6 Acoustic power control .................................................................................................56
9.7 Acoustic output description...........................................................................................57
9.7.1 Damping output parameter..................................................................................57
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 ...................................................................................59
10 Electromechanical safety standards ........................................................................................60
Appendix A Names and contents of toxic and hazardous substances or elements.........................66
Appendix B Acoustic output data ..................................................................................................67

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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.
The company reserves the right to change the contents of the instruction manual without
prior notice.
Important statement!
1. Any part 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 diagnostic 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 caused by components purchased from other company or its
unauthorized distributor;
(4) Damage or loss caused by using the scanner not in the original purchased place.
(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 misuse;
(8) Failure caused by other things, not the product itself.
Maintenance and repair service
Main unit is 2 years, and the probe head is 1 year. 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.

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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: 1.0
Issue date: January 2021
Document No: JL-YF-57-1000-A(EN)-1.0
Product Information
Product name:Pocket ultrasound system
Product Model: P50
Name of the registrant: GuangDong Youkey Medical Co., Ltd.

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Registered address: Unit 601,6/F,Block B,Building 1,B1 District,Hantian Technology
City,Dongping Road,Pingxi Shanghai Village,Guicheng Street,Nanhai District,Foshan
City,Guangdong Province,528200,China
Production enterprise name: GuangDong Youkey Medical Co., Ltd.
Production address (residence): Unit 601,6/F,Block B,Building 1,B1 District,Hantian
Technology City,Dongping Road,Pingxi Shanghai Village,Guicheng Street,Nanhai
District,Foshan City,Guangdong Province,528200,China
Contact photo: 0757-86258600
After-sales service unit:
Company Name: GuangDong Youkey Medical Co., Ltd.
Address: Unit 601,6/F,Block B,Building 1,B1 District,Hantian Technology City,Dongping
Road,Pingxi Shanghai Village,Guicheng Street,Nanhai District,Foshan City,Guangdong
Province,528200,China
After-sales service Tel: [phone]
other:
Company website: www.youkeymedical.com
WeChat public number: Youkey

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1Safety 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;
⚫According to the working mode:
Continuous working equipment.
⚫According to the degree of safety in the presence of flammable anesthetic mixture
with air or oxygen or nitrous oxide:
Equipment not suitable for use in the presence of a flammable anesthetic mixture
with Air or with Oxygen or Nitrous Oxide.
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.
IPX4
There is no harmful effect if the liquid is splashed into the shell from
any direction.
Non-ionizing electromagnetic radiation.

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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.
10.
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.
11.
The Pocket ultrasound system does not support the contrast
- enhanced sonography

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CAREFUL
1.
Matters needing attention in clinical examination
technology：
➢This equipment can only be operated by qualified
medical personnel.
➢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.
CAUTION
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.