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Pocket Size Ultrasound Dianogsis unit

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Pocket Size Ultrasound Dianogsis unit
Description

Details

Pocket ultrasound system
Instruction manual
ModelQ7

   

IMPORTANT
Read and understand this manual before operatingthe equipment. After reading, keep this manual in an easily accessible place.

 

  

WuHan Youkey Bio-Medical Electronics Co., Ltd.

Contents

Maintenance and repair service.-- P.5

Intellectual Property Statement.-- P.5

Version information.-- P.5

OPI.---------------------- P.6

After-sales service unit.-- P.6

1 Safety precautions.-- P.7

1.1 Security classification.-- P.7

1.2 Symbol definition.-- P.7

1.3 Security symbol.-- P.7

1.4 Safety warning information.-- P.8

1.5 WARNING Labels.-- P.11

2 Product overview.-- P.13

2.1 Intended use.-- P.13

2.2 Contraindication.-- P.13

2.3 Product specifications.-- P.13

2.3.1  Imaging mode.-- P.13

2.3.2  Software version information.-- P.13

2.3.3Software running IT environment.-- P.13

2.3.4  Power condition.-- P.14

2.3.5  environment condition.-- P.14

2.3.6  Probe outline dimensions and weight.-- P.15

2.4  system configuration.-- P.16

2.4.1  Standard configuration.-- P.16

2.4.2  Components.-- P.16

2.5  Symbol description.-- P.18

2.6  Introduction of each component of the system.-- P.19

2.7  Control panel..-- P.20

2.8  Basic interface.-- P.20

2.8.1  Android application interface.-- P.20

2.8.2  Windows application interface.-- P.23

2.9 Information security.-- P.25

2.9.1 Forget password.-- P.25

2.9.2 User classification.-- P.25

Permission division.-- P.25

2.9.3 Password setting.-- P.25

2.10 Indicator light.-- P.25

3 Basic introduction.-- P.27

3.1  Working power supply.-- P.27

3.2  Turn on / off probe.-- P.27

3.2.1  Turn on probe.-- P.27

3.2.2  Turn off the probe.-- P.28

3.2.3  Loading and unloading the probe.-- P.29

3.3  Connection.-- P.29

3.3.1  Wifi Connection.-- P.29

3.3.2  USB Connection.-- P.29

4  Detailed operation introduction.-- P.29

4.1  Image mode.-- P.29

4.2  Image parameter adjustment.-- P.30

4.3  Parameter adjustment about B mode.-- P.30

4.3.1  B mode image parameter.-- P.31

4.3.2  B mode image optimization.-- P.31

4.4  Parameter adjustment about M mode.-- P.34

4.4.1  M mode image parameter.-- P.34

4.4.2  M mode image optimization.-- P.35

4.5  Parameter adjustment about Color mode.-- P.37

4.5.1  Color mode image parameter.-- P.37

4.5.2  Color mode image optimization.-- P.37

4.6  Parameter adjustment about Power mode.-- P.39

4.6.1  Power mode image parameter.-- P.39

4.6.2  Power mode image optimization.-- P.40

4.7  Parameter adjustment about PW mode.-- P.41

4.7.1  PW mode image parameter.-- P.41

4.7.2  PW mode image optimization.-- P.41

5 Measure.--------------- P.45

5.1  Conventional measure.-- P.45

5.1.1  2D Conventional measure.-- P.45

5.1.2  Conventional measure in M mode.-- P.46

5.1.2  Conventional measure in Doppler mode.-- P.46

5.2   Special measuring package.-- P.46

6 Cineloop/annotation/body mark.-- P.47

6.1   Cineloop........................................................................................................ 47

6.1.1  Linkage movie playback........................................................................... 47

6.1.2  Store Movie............................................................................................ 47

6.2   Annotation..................................................................................................... 47

6.3   Body mark (for Windows version)..................................................................... 47

7 Probe........................................................................................................................... 48

7.1   Probe description............................................................................................. 48

7.1.1  Probe type.............................................................................................. 48

7.1.2  Probe composition................................................................................... 48

7.1.3  Probe performance index.... エラー! ブックマークが定義されていません。

7.2   Probe description............................................................................................. 48

7.3.1  Inspect................................................................................................... 49

7.3.2  Life cycle............................................................................................... 49

7.3.3  Probe maintenance................................................................................... 49

7.4   Cleaning and disinfection................................................................................. 50

8 Puncture guide.............................................................................................................. 53

8.1  Enter or exit puncture mod................................................................................. 53

8.2  Puncture lead calibration.................................................................................... 53

9  Acoustic output description.......................................................................................... 54

9.1  biological effect................................................................................................ 54

9.2  Caution use declaration...................................................................................... 54

9.3  ALARA principle(As Low As Reasonably Achievable).......................................... 54

9.4  MI/TI description.............................................................................................. 55

9.4.1  Basic knowledge of MI and TI.................................................................. 55

9.4.2  MI/TI display instructions......................................................................... 56

9.5  Sound power setting.......................................................................................... 57

9.6  Acoustic power control...................................................................................... 58

9.7  Acoustic output description................................................................................ 58

9.7.1  Damping output parameter........................................................................ 58

9.7.2  Acoustic output limit................................................................................ 59

9.7.3  The difference between the actual MI/TI value and the display value.............. 59

9.8  Uncertainty of measurement............................................................................... 60

9.9  Reference literature for sound power and its safety................................................ 60

9.10  Transducer surface temperature......................................................................... 60

10 Electromagnetic compatibility statement......................................................................... 61

Appendix A Names and contents of toxic and hazardous substances or elements...................... 68

Appendix B Acoustic output data....................................................................................... 68


Introduce

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 utility model 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)    There is no damage or loss caused by the use of this instrument in the initial purchase area;

(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 non product itself

  1. 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

 

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 can enjoy 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:

l  Version number: 1.0

l  Issue date: Oct. 2019

 

 

 

OPI

Product name:Pocket Ultrasound System

Product Model: Q7

 

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

 

1          Safety precautions

1.1        Security classification

l According to the type of anti electric shock:

Internal power supply, where the adapter is Class 1;

l According to the degree of anti electric shock:

Type BF application part;

l According to the protection degree of harmful liquid:

The Host is IPX4, probe is IPX7

l According to the degree of safety in the presence of flammable anesthetic gas mixed with air (or oxygen, nitrous oxide two):

l 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

 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 a probe in an environment where a combustible gas, such as an anesthetic gas, hydrogen, or the like, or a flammable liquid, such as ethanol, may cause an explosion.

 

WARNING:

1.

Do not disassemble the ultrasonic probe, which may cause electric shock.

2.

Use the power cord supplied with this unit; use only the power supply provided by the company to supply power, the use of other specific power supply (such as UPS, etc.) on the ultrasonic probe power supply may bring the risk of 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.

Be sure to wear a sterile probe case on the probe when performing an ultrasonic chamber check.

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

Before and after each inspection, you must ensure that the ultrasound sound normal. A defective ultrasonic probe may cause the patient to be shocked.

 

9

Please select the correct type of probe head according to the different parts of the inspection. Do not use any probe provided by our company. Otherwise, it will damage the machine and the probe.

 

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.

 

 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.

The equipment can not be checked 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 diagnostic maps 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.

For in vivo transducers in a single fault condition, the surface temperature rise shall not exceed 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 erased. 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 temperature0 32
  • relative humidity30% 85%No condensation
  • Atmospheric pressure70KPa 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.

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.

 

 

 

 

 

2 Product overview

2.1 Intended 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:1.1.19.

b)       Controlled software(APP) release version:

—         Android platform Software version:V2.0.3;

—         Windows Platform software version:V2.1.4.

2.3.3Software running IT environment

Software Environment

Network bandwidth

<500KBbps

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 1300mAh)

Charging power input: DC 5V 2A

Can not work when charging.

 

2.3.5  environment condition

 

work environment

Storage and transportation environment

ambient temperatue

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. Please ensure that the use of the equipment to master a solid, otherwise, equipment may hurt the patient fall.

2. To ensure that the equipment in a dry environment, the operation of environmental temperature and humidity changes, may lead to liquid 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. Equipment failure or fan motor sparks may be electronically detonated of these substances.

   A. Please ensure that the environment before use, if the detection of flammable substances in the environment, please do not plug in the power or open the system.

     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 view, please contact the service center or your sales representative.

2.3.6  Probe outline dimensions and weight

Convex array size: 148mm (L) * 73mm (W) * 26mm (thickness)

Net weight: 170g (R50) (C5-2Ks)

Convex array size: 148mm (L) * 53mm (W) * 26mm (thickness)

Net weight: 180g (R60) (C5-2Fs)

Linear array size: 140mm (L) * 55mm (W) * 26mm (thickness)

Net weight: 140g (L40) (L11-4Ks)

Linear array size: 140mm (L) * 41mm (W) * 26mm (thickness)

Net weight: 135g (L25) (L11-4Gs)

Slightly Convex array size: 142mm (L) * 41mm (W) * 26mm (thickness)

Net weight: 140g (R15) (C8-5Ks)

Endocavitary array size:325mm(L)*41mm(W)*26mm(thickness)

Net weight:160g (R10) (E10-4Ks)

2.4  system configuration

The system is mainly composed of host equipment, probe 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),E10-4Ks(Endocavitary array).

2.4.1  Standard configuration

  • Main unit: 1 set
  • Appendix

   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

E10-4Ks

Cavity transducer

Department of Obstetrics and Gynecology, urinary system

Via vagina

6.5 MHz

5.0~8.5MHz

 

 

2.5  Symbol description

This device uses the following symbol identification, the following list shows its meaning.

 

Serial number

Symbol

Explain

Type BF application part

explain:All ultrasonic probes are part of the BF application.

Please refer to the instruction manual for this symbol to avoid accidents

This symbol represents the product serial number

This symbol represents the date of production

IPX 4

This symbol product as the IPX4 grade

Safety mark on behalf of the product has been in line with European standards for safety / health / environmental / health and other standards and directives

2.6  Introduction of each component of the system

           

Serial number

Name

Function

1

Transducer

Transmit ultrasound

2

Main Device

Control transducer operation

3

Control Panel

Operation control

4

Type-C Port

External adapter power supply

2.7  Control panel

2.7.1 Control area schematic

Serial number

Button icon

Key name

Function

1

Power switch / freeze / thaw button

1, long press: power off

2, press: power on / freeze / thaw image

2

(Gain)

 “+”button

Gain increase

3

 (Gain)

 “-”button

Gain reductio

4

Main menu button

1、 Long press: one key optimization

Press short: toggle image mod

5

 (Depth)

 “”button

Depth increase

6

(Depth)

“”button

Depth reduction

 

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.

  • Puncture line

Piercing line switch symbol, this system supports two puncture guide wire, open can carry on piercing line position, angle preset.

  • 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).

  • System time

Displays the current system time. Check time as the image freezes when the system freezes.

Menu and Image Parameter display area

The region can be divided into two regions: 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 statu of PW mode and click again to start / pause to get the map.It's the same 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 / active buttons and saves image button icons.

In the active state for the white icon, click to enter the frozen state, the icon appears blue;

Save a single frame image button, suitable for freeze / active two states.

Image area

图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

 

2.8.2  Windows application interface

The interface layout diagram for the Windows application is as follows:

2.8.1 Interface layout diagram

Information area

The information area includes manufacturer identification, patient information, hospital name, probe type, current inspection type, date, inspection time, freezing mark, etc.

  • Manufacturer identification

Show the manufacturer's identity in the upper-left corner of the screen.

  • Hospital name

Show the hospital name. The hospital name setting path is [preset] [system preset][Hospital Information].

  • Time

Show the time, that is, the date and time of the system. The date and time and display format preset path is "[preset] [system preset] [composite preset]".  Time as the image freezes when the system freezes.

  • Freezing mark

Freezing mark,Indicates that the current image is frozen.

  • Patient information

Show patient name, ID, sex, age. Patient information is entered through the “patient Information” dialog box or imported locally stored patient information data in the patient list page.

  • Probe type

Show the currently used probe model or the default probe model.

  • Current inspection type

Shows the type of examination currently in use, such as the ABD.

Image parameters and menu area

Image parameters share this area with the menu. When a menu is not displayed on the screen, the area displays the image parameters of the current imaging modes.

  • Menu area

Menu pop-up overrides image parameters.

Menu operation can be done by touch screen, cursor and multi-function knob.

The opening and closing of the menu is controlled by the [function]à [measure] button.

The menu is divided into menu title bar, menu item and page turn button and so on.

  • Image area

The image area displays images of each mode and probe directi