Amoul E6 User manual

文件类型
技术文件
项目编号
202
文件编号
H-1.601.00224
打印要求
彩色 □黑白
202-英文说明书
制定
审核
批准
日期
日期
日期
参 考 资 料
文件编号
说明
修 订 记 录
版本
ECR/PCN
TCN
更 改 内 容
制 定
批准日期
A1.0
ECR20200915
新增
谢荣锋
2020.09.22
A2.0
ECR20201223
封面修改；6.2 内容调整。
谢荣锋
2020.12.20
A3.0
ECR20210726
修改 1.5、3.2、7.3 和 9.1 章节内容。
骆万锟
2021.07.26
A4.0
ECR20220310
修改供货配置,更换 UI
韦雪雪
2022.1.19
2.0
ECR20220318
公司名称、官网、邮箱变更
邓伟良
发放部门
生产部 采购部 品质部 □ 市场部 研发系统
存档方式
电子文档 纸文档 □其它：

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H-1.601.00149-2.0
I
Contents
Contents................................................................................................................................................ I
1 Safety Instructions..........................................................................................................................1
1.1 Warning、Attention and tips....................................................................................................1
1.2 Overview................................................................................................................................... 1
1.3 Software.................................................................................................................................... 2
1.4 Accessories / spare parts.......................................................................................................... 2
1.5 Symbol Description................................................................................................................... 3
1.6 Battery....................................................................................................................................... 3
1.7 Operation.................................................................................................................................. 4
2 Device Description......................................................................................................................... 6
2.1 Scope of application..................................................................................................................6
2.2 Contraindications...................................................................................................................... 6
2.3 Side effects................................................................................................................................ 6
2.4 User Qualification......................................................................................................................6
2.5 Structural composition..............................................................................................................7
2.6 Components description...........................................................................................................7
2.7 E6 host description....................................................................................................................8
3 Interface.......................................................................................................................................... 11
3.1 Main interface......................................................................................................................... 11
3.2 Function Menu Description.................................................................................................... 12
3.3 Alarm information bar............................................................................................................ 18
4 Installation...................................................................................................................................... 20
4.1 Packing list...............................................................................................................................20
4.2 Battery installation.................................................................................................................. 21
4.3 Fixing belt install..................................................................................................................... 22
4.4 Stabilizing belt install.............................................................................................................. 22
4.5 EtCO2install (optional)............................................................................................................ 23
5 Operation........................................................................................................................................24
5.1 Arrive at the scene.................................................................................................................. 24
5.2 Unpacking................................................................................................................................24
5.3 For patients............................................................................................................................. 24
5.4 Adjust and start pressing........................................................................................................ 28
5.5 Use stabilizing belt.................................................................................................................. 31
5.6 Move patient........................................................................................................................... 33
5.7 Change battery during operation........................................................................................... 35
5.8 Charging battery......................................................................................................................37
5.9 Battery management.............................................................................................................. 38
5.10 Adjuvant treatment...............................................................................................................39
5.11 Remove E6 from patient....................................................................................................... 40
6 Sanitary treatment....................................................................................................................... 41
6.1 General cleaning procedures.................................................................................................. 41
6.2 Removing and installing the suction cup................................................................................ 41
7 Faults and trouble shooting...................................................................................................... 42
7.1 Technical faults........................................................................................................................ 42
7.2 Physiological Alarm................................................................................................................. 42
7.3 System Alarm.......................................................................................................................... 42
7.4 System prompts...................................................................................................................... 43

H-1.601.00149-2.0
II
8 Maintainance................................................................................................................................. 45
8.1 Regular check.......................................................................................................................... 45
8.2 Uninstall and install patient fixing belt................................................................................... 45
8.3 Uninstall and install patient stabilizing belt............................................................................46
8.4 Remove battery and charge....................................................................................................46
9 E6 Packing.......................................................................................................................................47
9.1 Standard configuration........................................................................................................... 47
9.2 Optional...................................................................................................................................47
10 Technical parameters................................................................................................................ 48
10.1 Medical Devices Management Category.............................................................................. 48
10.2 Physical Specifications.......................................................................................................... 48
10.3 Environmental specifications................................................................................................ 48
10.4 Power speficications............................................................................................................. 48
10.5 Patient................................................................................................................................... 49
10.6 Pressing parameters..............................................................................................................49
10.7 Battery physical specification............................................................................................... 49
10.8 Battery environment specs................................................................................................... 50
11 EMC................................................................................................................................................ 51
12 Warranty....................................................................................................................................... 56
13 Classification of Toxic/Harmful Substances........................................................................57
14 Storage and transport.............................................................................................................. 58

H-1.601.00149-2.0
III
Product Information
Thank you for purchasing E6 Cardiopulmonary Resuscitator.
Before using the equipment, please read this manual carefully and
understand the information contained in it so as to operate it properly. Keep
this manual properly in any accessible place.
Product name：Cardiopulmonary Resuscitator
Model：E6
Manufacturer：Ambulanc (Shenzhen) Tech. Co., Ltd.
Manufacturer address：3rd Floor, Block C, Building #5, Skyworth
Innovation Industry Park, Tang Tou 1st Road, Shiyan Town, Baoan District,
Shenzhen 518108, China
Tel: [phone] Fax:[phone]
Website: www.amoulmed.com E-mail: manage[email protected]om
Product date：See host
Service life：8 years
Revision date：2020-12
Attention：
This instrument is not intended for any family purpose.
EC-Representative
EC-Representative：Shanghai International Holding Corp. GmbH(Europe)
Eiffestrasse 80 20537,Hamburg,Germany
Contact pers：Qiming Cheng
Telephone: [phone] Fax: [phone]

H-1.601.00149-2.0
IV
Intellectual Property Right
© 2020 Ambulanc (Shenzhen) Tech. Co., Ltd. All rights reserved
This product and its operating manual are the intellectual property of
Ambulanc (Shenzhen) Tech. Co. Ltd., including but not limited to patent right,
trademark right and copyright.
Ambulanc has the final right to interpret this manual.
Ambulanc has the right to handle this manual as confidential material.
Without Ambulanc's prior written approval, any individual or organization
shall not disclose nor access all or part of the information in this manual in
any way, nor handle this manual in any other way, including but not limited
to, publishing, modifying, copying, issuing, leasing, recomposing and
translating.
is the registered trademark or trademark of Ambulanc
(Shenzhen) Tech. Co. Ltd., and these trademarks and related Ambulanc logo
are intangible property owned by Ambulanc (Shenzhen) Tech. Co. Ltd. Use of
any other trademarks or logos in this manual is for edition only, rather than
any other purpose, and they are owned by their respective owners.

H-1.601.00149-2.0
V
Statement
Ambulanc reserves the right to modify this manual without prior notice.
Ambulanc reserves the right to change related technology without prior
notice.
Ambulanc reserves the right to alter product specification without prior
notice.
Ambulanc makes no warranty in any form concerning this manual, including
(but not limited to) guarantee for implied marketability and adaptability for a
specific purpose.
Ambulanc will, at its own discretion, take responsibility for safety, reliability
and performance of the instrument in one of the following cases：
• any assembly, expansion, readjustment, improvement and repair
operations are performed by any professional approved by Ambulanc;
• related electrical equipment is in compliance with national standards;
• the instrument is used in accordance with the operation instructions.
Ambulanc will not be responsible for safety, reliability and operation
condition of the product in one of the following cases：
• any component is dismantled, expanded or re-adjusted;
• the instrument is repaired or changed not by any personnel approved by
Ambulanc;
• the product is not used correctly in compliance with this Operating
Manual.

H-1.601.00149-2.0
VI
Maintenance Service
Scope of Charge-Free Service：
• Charge-free service is provided for any equipment in the range of
Ambulanc's warranty terms.
Scope of Paid Service：
• Paid service is provided for any equipment beyond the range of
Ambulanc's warranty terms.
As well as in one of the following cases even during the warranty period:
• Damage caused by personal fault;
• Improper use;
• Grid voltage beyond the limits;
• Irresistible natural disaster;
• Use of spare part/ consumables not approved or machine service
performed by personal not authorized by Ambulanc.
Warning：
Failure to implement a set of satisfactory service/maintenance plan by any
hospital or institute responsible for using this instrument may cause
malfunction of it or even endanger body health.
Warranty
Manufacturing Process and Raw Material：
Ambulanc warrants that no failure will be resulted from any defect in
manufacturing process or raw material when this instrument is used and
serviced correctly.
After-Sales Service Unit
After-Sales Service Dept., Ambulanc (Shenzhen) Tech. Co. Ltd.
Address: 3rd Floor, Block C, Building #5, Skyworth Innovation Industry Park,
Tang Tou 1st Road, Shiyan Town, Baoan District, Shenzhen 518108, China
Service Hot Line：
Tel：[phone] Fax：[phone]
Web site: http://www.amoulmed.com
E-MAIL: [e-mail]

H-1.601.00149-2.0
VII
Return
Return Procedure
Any return as necessary shall comply with the following procedure:
• Acquire right of return: Contact Ambulanc's customer service, and provide
the product ID labeled on external packaging of the instrument, which
must be legible for return approval. Indicate product model and describe
the reason for return.
• Freight: Any expenses (including customs fee) incurred in transporting the
instrument to Ambulanc shall be paid by the user.
Important Information
1. After purchase of the product, the customer shall take full responsibility
for maintenance and management of it.
2. Quality assurance will not cover the following even during the warranty
period：
• any damage or loss resulted from improper use or misuse of the product;
• any damage or loss caused by force majeure such as fire, earthquake,
flood or lightning;
• any damage or loss attributed to failure to meet any operating condition
required for the system, such as insufficient power supply, improper
installation or unfavorable environmental conditions;
• any damage or loss incurred due to use of the system in the region not
initially intended for it; and
• any damage or loss caused due to purchase from any unauthorized dealer
or agent.
3. This equipment can be used only by certified medical staff.
4. Any software or hardware of this product must not be changed or
modified without authorization.
5. In any case Ambulanc will take no responsibility for problem, damage or
loss resulted from re-installation, change or repair of the system
performed not by personnel authorized by Ambulanc.
6. This system is intended to provide the data required for clinical diagnosis
for physicians. The physician takes responsibility for diagnosis process.
Ambulanc takes no responsibility for any diagnosis process.
7. Be sure to back any key data to external storage medium, such as
clinography and notes.
8. Ambulanc takes no liability for loss of data stored in the system due to