Samsung MYSONO U6 ユーザーマニュアル

Samsung Medison provides the following warranty to the purchaser of this unit. This warranty is valid for

a period of one year from the date of installation and covers all problems caused by faulty workmanship

or faulty material. Samsung Medison will, as sole and exclusive remedy and at no charge, replace any such

defective unit returned to Samsung Medison within the designated warranty period.

The warranty does not cover damages and loss caused by outside factors including, but not limited to,  re,

 ood, storm, tidal wave, lightning, earthquake, theft, abnormal conditions of operation, and intentional

destruction of the equipment. Damage caused by equipment relocation is not covered.

The warranty is void in cases where the equipment has been damaged as a result of an accident, misuse,

abuse, dropping, or when attempts to modify or alter any part or assembly of the equipment have taken

place.

Parts with cosmetic defects or deterioration will not be replaced. Replacement of batteries, training

materials, and supplies are not covered.

Samsung Medison will not be responsible for incidental or consequential damages of any kind arising

from or connected with the use of the equipment.

Samsung Medison will not be responsible for any loss, damage, or injury resulting from a delay in services

rendered under the warranty

This limited warranty is in lieu of all other warranties expressed or implied, including warranties of

merchant ability or  tness for any particular use. No representative or other person is authorized to

represent or assume for Samsung Medison any warranty liability beyond that set forth herein.

Defective equipment shipped from you to Samsung Medison must be packed in the replacement

cartons. Shipping and insurance costs are the responsibility of the customer. To return defective material

to Samsung Medison contact the Samsung Medison Customer Service Department.

Samsung Medison or a local distributor will make available, upon request, circuit diagrams, a component

parts list, descriptions, calibration instructions and other information which will assist your appropriately

quali ed technical personnel to repair those parts of the equipment which are designed by Samsung

Medison as repairable.

CAUTION: United State federal law restricts this device to sale by or on the order of physicians.

WARRANTY

MANUFACTURER’S ADDRESS

3366, Hanseo-ro, Nam-myeon, Hongcheon-gun, Gangwon-do, Korea

ADDRESS OF MANUFACTURING SITE

3366, Hanseo-ro, Nam-myeon, Hongcheon-gun, Gangwon-do, Korea

SAMSUNG MEDISON CO., LTD. Customer Service Department

TEL : 82-2-2194-1234 FAX : 82-2-2194-1071

Website: www.samsungmedison.com

诊断超声系统

M359-C10000-01

使用说明书

版本

1.00.00

中文

专有信息和软件许可

客户应该对

Samsung Medison

提供或透漏的所有专有信息实施保密，除非此信息已并非由于客户

的过错而成为公开信息。

未经

Samsung Medison

的事先书面同意，客户不可将此专有信息用于保养、

修理或操作设备之外的用途。

Samsung Medison

的系统包含有机器可读的

Samsung Medison

专有软件。

Samsung Medison

保留

对此软件的全部权利、所有权和利益，除非购买本系统时含有一份用于使用其中的机器可读软件

的许可。

客户不可复制、复写、分解或修改此软件。

客户在转让此系统时须转让此软件许可，否

则不得转让此软件许可。

如果客户取消或终止合同或因为修理或修改之外的原因而送返本品，客

户应将这些专有信息返还给

Samsung Medison

。

安全要求





分类：

X

防电击保护类型：

I

类

X

防电击保护等级（患者连接）：

BF

型设备

X

防有害水浸入保护等级：普通设备

X

在有可燃性麻醉剂与空气或与氧气或一氧化二氮混合物场所内使用时的安全等级：设备不

适合于在有可燃性麻醉剂与空气或与氧气或一氧化二氮混合物场所内使用。

X

工作模式：连续工作





符合机电安全标准：

X

医用电气设备：第

1

部分：基本安全性和主要性能的通用要求

[IEC 60601-1:2005]

X

医用电气设备：第

1-2

部分：基本安全性和主要性能的通用要求

-

并列标准：电磁兼容性

—

要

求和测试

[IEC 60601-1-2:2007]

X

医用电气设备：第

1-6

部分：基本安全性和主要性能的通用要求

-

并列标准：适用性

[IEC

60601-1-6:2006]

X

医用电气设备：第

2-37

部分：医疗超声诊断与监护设备的基本安全性和主要性能的专门要求

[IEC6

0601-2-37:2007]

X

医用电气设备：第

1

部分：通用安全要求

[IEC 60601-1:1988

以及

A1:1991

和

A2:1995]

X

医用电气设备：第

1

部分：通用安全要求

– 1

并列标准：医用电气系统安全要求

[IEC 60601-1-

1:2000]

X

医用电气设备：第

1

部分：通用安全要求

- 2

并列标准：电磁兼容性

-

要求和测试

[IEC 60601-1-

2:2001, A1:2004]

X

医用电气设备：第

1

部分：通用安全要求

- 4

并列标准：程序可控的医用电气系统

[IEC 60601-1-

4: 1996, A1:1999]

X

医用电气设备：第

2

部分：特殊安全要求

- 37

医疗超声诊断和监护设备

[IEC60601-2-37: 2001

以及

A1:2004

、

A2:2005]

X

医疗器械

–

医疗器械风险管理的应用

[ISO 14971:2007]

X

医用电气设备：第

1

部分：通用安全要求

[UL60601-1:2003]

X

医用电气设备

-

第

1

部分：通用安全要求

[CAN/CSA 22.2 No.601.1-M90:1990

，以及

R2003

、

R2005]

X

医疗器械的生物学评定

[ISO10993 : 2009]

X

医疗诊断超声设备的超声输出的标准报告方法

[IEC61157:2007]





声明

这是适用于加拿大和美国的

CSA

标志。

这是制造商的产品声明，声明该产品符合适用

EEC

指令和欧洲认证机构的要求。

这是制造商的产品声明，声明该产品符合适用

EEC

指令。

这是表示符合韩国良好作业规范质量体系条例的

GMP

符号。

使用本系统之前

使用此说明书或超声系统之前，您应该掌握以上内容。





使用此系统时，请把使用说明书放在附近，以便随时参考。





尤其是“第一章

-

安全性”和“第八章

-

维护”，其中包含了重要的安全信息，必须彻底了解。





此说明书不包括诊断结果或观点。

另外，在使用应用程序的测量结果进行任何诊断前，请查看所

测量的身体部位的参考信息。





本系统为超声诊断设备，不能从用户的个人电脑上使用。

当用户在其个人电脑上运行此系统时，

我们对由此产生的错误概不负责。





只有医生或在医生监督下的人员可使用此系统。

不符合要求的人员不得操作本系统。





制造商对由于用户粗心和

/

或疏忽而对本系统造成的任何损坏概不负责。





本说明书中所述的内容和规格可能会随时更改，恕不另行通知。





非

Samsung Medison

产品名称可能是其各自所有者的商标。





以下词语用于强调用户必须了解的安全注意事项：

危险：忽略危险警告将有可能带来危及生命的伤害。

警告：必须遵守随附的信息，以防发生严重意外和

/

或财产损毁。

小心：必须遵守随附的信息，以帮助避免发生意外和

/

或财产损毁。

注意：随附的信息介绍需要用户小心注意，但很少直接导致危险情况的安装、操作或维护

步骤。

若需协助

如果您在使用设备时需要维修说明书或任何协助，例如需要维修说明书，请立即联系

Samsung

Medison

客户服务部门或该公司分布在世界各地的客户服务代表。

若需协助

如果您在使用设备时需要维修说明书或任何协助，请立即联系

Samsung Medison

客户服务部门或

该公司分布在世界各地的客户服务代表。

韩国

SAMSUNG MEDISON CO., LTD.

1003 Daechi-dong, Gangnam-gu, Seoul 135-280, Korea

电话：

82-2-2194-1234

美国

Samsung Medison America, Inc.

11075 Knott Ave. Cypress, CA90630, USA

电话：

1-714-889-3000

荷兰

Samsung Medison Europe B.V.

Parellaan 10, 2132 WS Hoofddorp, The Netherlands

电话：

31-23-564-9020

德国

SONOACE Deutschland GmbH

Elbestrasse 10, 45768 Marl, Germany

电话：

49-2365-924-3825

法国

Samsung Medison France S.A.S.

30 rue Mozart, 92110, Clichy, France

电话：

331-4756-1291

意大利

Samsung Medison Italia S.r.l.

2, Via Galileo Galilei, Bresso 20091 MI, Italy

电话：

39-02-8739-2344

电话：

81-3-5805-7631

俄罗斯

MEDIACE., LTD

1 Timirazevskaya, Build 3, 125422

127422 Moscow, Russia

电话：

7-095-211-42292

巴西

Samsung Medison BRASIL COMERCIO IMPOTACAO EXPOTACAO DE EQUIPMENTOS MEDICOS LTDA.

Centro Empresaial de Sao Paulo, Rua Maria Coelho Aguiar, No. 215-Bloco C-40 Andar, Jd. Sao Luis, Sao Paulo,

SP-Brazil

电话：

55-11-3747-7102

迪拜

Dubai Branch

ROOM 906, Sheikh Essa Tower, Sheikh Zayed Road,

P.O. Box 66547, Dubai, U.A.E

电话：

971-4-323-0334

印度

Samsung Medison India Private Ltd.

303, Ring Road Mall, Mangalam place, Rohini, Sector 3, New Delhi 110085, India

电话：

91-11-2794-1286

中国

三星麦迪逊（上海）医疗器械有限公司

中国上海浦东张江高科技园区蔡伦路

720

弄

7

号，

210203

电话：

86-21-5031-7887

麦迪逊（上海）有限公司

中国上海浦东张江高科技园区蔡伦路

720

弄

7

号，

210203

电话：

86-21-5079-0230

日本

Samsung Medison Japan Co., Ltd.

Kashiwaya bldg. 6F 3-40-11 Hongo Bunkyo-ku Tokyo, Japan 113-0033

修订历史记录

本说明书的修订历史记录如下所示。

文档日期注意

M359-C10000-01 2012-05-15

初始发行版

系统升级和说明书更新

对本系统的升级指升级其硬件和

/

或软件。

升级本系统时会发布经过更新的使用说明书，以反映系统

的更改。

请确保本说明书的修订版本与其随附的系统相匹配。

如果不一致，请联系

Samsung Medison

客户服

务部门。

17

第

1

章

安全性

适用范围

..........................................................................................................................................................1-3

禁用范围

...............................................................................................................................................................................1-3

安全信息

..........................................................................................................................................................1-4

安全性符号

.......................................................................................................................................................................... 1-4

标签

....................................................................................................

.....................................................................................1-5

电气安全性

.....................................................................................................................................................1-7

防止电击

.....................................................................................................................................................

..........................1-7

心电图相关信息

................................................................................................................................................................1-8

静电放电

...............................................................................................................................................................................1-8

电磁干扰

............

...................................................................................................................................................................1-9

电磁兼容性

.......................................................................................................................................................................... 1-9

机械安全性

.................................................

................................................................................................. 1-16

安全性注意事项

..............................................................................................................................................................1-16

移动设备

............................................................................................................................

.................................................1-17

生物安全性

.................................................................................................................................................. 1-18

ALARA

原则

........................................................................................................................................................................1-18

培训

.......

................................................................................................................................................................................1-29

环境保护

....................................................................................................................................................... 1-30

电池组

........................................................

.................................................................................................... 1-31

第

2

章

简介

规格

....................................................................................................................................................................2-3

系统配置

...................................................................................................................

.......................................2-5

监视器

.................................................................................................................................................................................... 2-6

控制面板

......................................................................................................................................................................

.........2-8

控制台

..................................................................................................................................................................................2-13

外围设备

.............................................................................................................................................................................2-15

电池组

................

..................................................................................................................................................................2-17

探头

.......................................................................................................................................................................................2-19

MySono U6

手推车（单独出售）

........................

....................................................................................................2-20

附件

.......................................................................................................................................................................................2-21

可选功能

.....................................................................................................

........................................................................2-21

18

使用说明书

第

3

章

开始诊断

电源

....................................................................................................................................................................3-3

交流适配器连接

................................................................................................................................................................3-3

接通电源

.........................................

...................................................................................................................................... 3-4

断开电源

...............................................................................................................................................................................3-4

监视器和音频

.........................................................................

.......................................................................3-5

监视器亮度调整

................................................................................................................................................................3-5

音量调整

......................................................................................................................................................

.........................3-5

探头和应用

.....................................................................................................................................................3-6

探头连接

...............................................................................................................................................................................3-7

应用选择

..........................

..................................................................................................................................................... 3-8

更改探头预设

.....................................................................................................................................................................3-8

患者信息

....................................................................

......................................................................................3-9

基本患者信息输入

...........................................................................................................................................................3-9

特定于应用的患者信息

.....................................................................................................................................

..........3-11

搜索患者信息

...................................................................................................................................................................3-19

管理患者检查

...................................................................................................................................................................3-21

更改测量

.................................

............................................................................................................................................3-28

节能模式

....................................................................................................................................................... 3-31

第

4

章

诊断模式

信息

.....................................................................................

...............................................................................4-3

诊断模式的类型

................................................................................................................................................................4-3

基本操作说明

............................................................................................................................................

.........................4-4

基本模式

..........................................................................................................................................................4-6

2D

模式

..................................................................................................................................................................................4-6

M

模式

..................

................................................................................................................................................................4-13

彩色多普勒模式

..............................................................................................................................................................4-16

能量多普勒模式

..........................................................

....................................................................................................4-20

PW

频谱多普勒模式

......................................................................................................................................................4-23

CW

频谱多普勒模式

........................................................................................................................

..............................4-29

组织多谱勒成像模式

....................................................................................................................................................4-31

组织多普勒模式

..............................................................................................................................................................4-33

19

复合模式

....................................................................................................................................................... 4-35

2D/C/PW

模式

...................................................................................................................................................................4-35

2D/PD/PW

模式

................................................

................................................................................................................4-35

2D/C/CW

模式

...................................................................................................................................................................4-35

2D/PD/CW

模式

..............................................................................................

..................................................................4-35

2D/C/M

模式

......................................................................................................................................................................4-36

2D/C

实时模式

............................................................................................................................................

......................4-36

双幅模式

....................................................................................................................................................... 4-37

3D/4D

模式

................................................................................................................................................... 4-38

3D Stand by

（

3D

待命）

.............................................................................................................................................4-39

3D

视图

—

MPR ................................................................................................................................................................4-42

3D XI ............................................................................................................

..........................................................................4-58

第

5

章

测量和计算

测量准确度

.....................................................................................................................................................5-3

测量误差原因

....................................................................................................................................................

................. 5-3

测量准确度优化

................................................................................................................................................................ 5-5

基本测量

..........................................................................................................................................................5-7

距离测量

..........................................

...................................................................................................................................5-10

周长和面积测量

..............................................................................................................................................................5-15

体积测量

..........................................................................................

...................................................................................5-17

按应用计算

.................................................................................................................................................. 5-20

注意事项

........................................................................................................................................................

.....................5-20

常用测量方法

...................................................................................................................................................................5-24

产科计算

.............................................................................................................................................................................5-29

妇科计算

..............

...............................................................................................................................................................5-37

心脏计算

.............................................................................................................................................................................5-41

颈动脉计算

.................................................

.......................................................................................................................5-64

下肢动脉计算

...................................................................................................................................................................5-70

上肢动脉计算

................................................................................................

...................................................................5-72

下肢静脉计算

...................................................................................................................................................................5-74

上肢静脉计算

....................................................................................................................................................

...............5-76

胎儿超声计算

...................................................................................................................................................................5-78

泌尿科计算

........................................................................................................................................................................5-83

腹部计算

........................

.....................................................................................................................................................5-86

小器官计算

........................................................................................................................................................................5-90

20

使用说明书

经颅多普勒计算

..............................................................................................................................................................5-95

肌肉骨骼计算

...................................................................................................................................................................5-97

小儿髋骨计算

............................................

.......................................................................................................................5-98

报告

...............................................................................................................................................................5-100

查看报告

.........................................................................................................

................................................................. 5-100

编辑报告

..........................................................................................................................................................................5-102

添加评论

.................................................................................................................................................

.........................5-104

打印报告

..........................................................................................................................................................................5-104

输出报告

..........................................................................................................................................................................5-105

传送报告

.....

..................................................................................................................................................................... 5-106

图表屏幕

..........................................................................................................................................................................5-106

关闭报告

.............................................

.............................................................................................................................5-110

第

6

章

图像管理

电影回放

/

线回放

..........................................................................................................................................6-3

标注

.............................................................................................................

.......................................................6-6

Text

（文字）

....................................................................................................................................................................... 6-6

体标

................................................................................................................................................................

.......................6-10

指示箭头

.............................................................................................................................................................................6-12

保存和播放图像

........................................................................................................................................ 6-14

保存图像

......................................

.......................................................................................................................................6-14

播放图像

.............................................................................................................................................................................6-15

传送和打印图像

.......................................................................

................................................................. 6-16

传送图像

.............................................................................................................................................................................6-16

打印图像

................................................................................................................................................

.............................6-17

SONOVIEW .................................................................................................................................................... 6-18

检查模式

.............................................................................................................................................................................6-18

对比模式

...................

..........................................................................................................................................................6-20

检查图像管理

...................................................................................................................................................................6-21

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