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
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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

H-1.601.00149-2.0
VIII
the operator's fault or any exceptional condition.
9. This manual contains warnings for foreseeable potential hazards. User
shall keep watch at any time for any hazard not stated in the manual.
Ambulanc takes no responsibility for damage or loss resulted from
negligence or failure to observe the preventive measures stated in this
manual.
10. This manual must be handed over to the successor when the system
administrator is changed.

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IX
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1 Safety Instructions
Please read these safety instructions carefully. These safety instructions are
an integral part of the equipment and must be kept accessible for review
whenever necessary. For purpose of safety, the following information must
be paid attention to.
1.1 Warning、Attention and tips
The following safety marks are used in this manual:
Warning：
Indicating any risk of harm to patient and/or user.
Attention：
Indicating potential equipment damage and undesired treatment effect.
Tips：
Giving useful indicative information.
1.2 Overview
• A functional inspection must be performed before use of the equipment
(refer to Section 8.1 - Regular check).
• Please observe the instructions in Section 6 - Sanitary treatment to
prevent infection or bacillosis.
Warning：
• 【After the training】You can operate E6 only after you have been
provided with proper medical training and technical guidance on
cardiopulmonary resuscitation equipment. Improper use of it may cause
serious injury to body.
• [Fire] Do not use E6 in an oxygen-rich environment or with flammable or
flammable anesthetics.
• [Scope of Application] Only use E6 for the intended purpose (see "2.1

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Page 2
Scope of Applicaion").
• [Maintenance Qualification] Only the manufacturer Ambulanc (Shenzhen)
Tech. Co., Ltd. or its authorized professionals can perform maintenance
measures.
• [Do not open] Do not open the E6 shield. Do not replace or modify the
external or internal parts of the E6.
Note:
• [Other devices] When E6 is used simultaneously with devices that emit
high-frequency radiation, (for example, mobile phones, radios) must be
kept at a distance of more than 1 m, otherwise it may cause dysfunction.
• [External Power Supply] When using an external power supply to power
the cardiopulmonary resuscitation machine, always connect it to a
simple-swap interface so that it can be quickly removed in the event of a
malfunction.
• [External Power Supply] When using an external power supply to power
the cardiopulmonary resuscitation machine, make sure that the power
cord is not caught or obstructed. Do not use an external power source
when it is not necessary, but use the battery inside the cardiopulmonary
resuscitation machine.
• [Liquid] Do not immerse the E6 in a liquid. If liquid enters the hood, it will
cause damage to the equipment.
1.3 Software
• A large number of quality assurance measures have been taken in the
development of the device software, and the risk due to software defects
is minimal.
1.4 Accessories / spare parts
Note:
• [Preventing exposure] Take measures to prevent silica gel and rubber
parts from being exposed to ultraviolet light and long-term direct
sunlight, otherwise these parts will be embrittled.
• [Use only approved accessories] Using accessories from other
manufacturers can cause malfunctions and incompatibilities. Please keep
in mind that in these cases the rights and responsibilities of the warranty

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will be void: using the accessories not recommended in the instructions or
not using the original spare parts.
1.5 Symbol Description
Description ICONS and symbols
SYMBOL DESCRIPTION SYMBOL DESCRIPTION
Refer to the document Refer to the operating
attached for more details instructions for more
details
Date of production BF type applications
Do not reject into dustbin Degrees of protection
provided by enclosures
Refer to the document Non-ionizing radiation
attached/manual
Power supply by adapter Main Unit Switch
battery
Battery level indication Power supply by
The product contains some hazardous substance. Use it at ease
in the eco-friendly service life but put it in the recovery cycle
system after it is beyond the eco-friendly service life which is 20
years.
It conforms to EU Medical Devices Directive 2007/47/EC and
meets CE symbol in basic requirements in Appendix I of the
Directive.
1.6 Battery
Warning:
• [Battery Low] When a low battery alarm occurs, do one of the following:
• Replace the battery with a fully charged battery.
• Connect an external E6 power supply.
Note:

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• Please pause or turn off the machine when replacing the battery
1.7 Operation
Warning:
• [Unsatisfactory position] If the E6 cannot be safely and correctly placed on
the patient's chest, perform an manual cardiopulmonary resuscitation
again.
• [Incorrect position on the chest] If the relative position of the compression
pad to the sternum is incorrect, it will increase the risk of damage to the
chest and internal organs. It also affects the patient's blood circulation.
• [Change in position during operation] If the position of the pressing disc
changes during operation or defibrillation, adjust the patient position and
reposition it. Always use the E6 stabilizer strap to help ensure the correct
position.
• [ECG interference] Chest compression can interfere with ECG analysis.
Press Pause first before starting the ECG analysis. Reduce interruption
time as much as possible. Press Start to restart pressing.
• [Electric Shock] If the external power cord (optional accessory) is
damaged, remove it and replace it immediately to avoid electric shock or
fire hazard.
• [Keeping Care] Never leave the patient or E6 machine during
cardiopulmonary resuscitation. Only then can you respond quickly when
the patient's condition deteriorates or the cardiopulmonary resuscitation
machine fails or alarms. A slow response from a medical professional can
result in serious bodily injury.
• [Fault] If an interruption occurs during operation, or the press becomes
insufficient, or an abnormal condition occurs: Press the On/Off key for 3
seconds to stop E6 working and remove the device from patient. Begin
manual chest compressions.
Note:
• [Defibrillation Electrodes] Position the defibrillator electrodes and wires so
that they are not under the suction cup. If the electrode already exists on
the patient, make sure it is not under the suction cup. If it is under the
suction cup, a new electrode must be used.

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Page 5
• [Gel is present on the chest] If there is a gel on the patient's chest (for
example, when used for an ultrasound examination), the position of the
pressing disc changes during use. Remove all gels before placing the
suction cup.
• [Application Stabilizer] If the E6 Stabilizer Band is used to prevent or delay
any treatment for the patient, the device should be deferred.
• [Auxiliary Therapy] Using other medical devices or drugs with E6 will
affect the treatment. For other devices and/or drugs, be sure to refer to
their Instructions for Use to ensure they are suitable for use with CPR.
• [Keep your hands away] Do not place your hands on or under the press
pad while the E6 is running. Keep your hands away from the lock when
attaching the upper part or lifting the patient.
• [Vein Path] ensures unobstructed venous access.
• [Do not block the vent hole] Do not block the vent hole under the hood,
as this may cause the device to overheat.
• [Device Alarm] If any malfunction occurs during operation, the alarm light
will illuminate and an alarm will sound. See section 7.3 for
troubleshooting.
• [Do not use the strap to lift the patient] Do not use the strap to lift the
patient. The strap is only used to secure the patient to the E6.
• [Skin burns] The temperature of the cover and battery may rise above
118°F / 48°C. If it is too hot, do not touch it for a long time to prevent skin
burns. The patient strap is removed from the patient's hands.

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2 Device Description
2.1 Scope of application
The E6 cardiopulmonary resuscitation machine is used for chest
compressions in patients with acute cardiac arrest (ie, loss of spontaneous
breathing and pulse beats and loss of consciousness).
2.2 Contraindications
Do not use the E6 cardiopulmonary resuscitator machine when:
• E6 machine cannot be placed safely or correctly on the patient's chest.
• Patient is too small: E6 can not complete auto positioning, or after
positioning completed when pressing starts, the machine alarms
“insufficient pressing depth” by message and voice prompts.
• The patient is too large: The upper part of the E6 cannot be locked to the
back panel without pressing the patient's chest.
When using E6, be sure to follow local and international guidelines for
cardiopulmonary resuscitation.
2.3 Side effects
The International Resuscitation Liaison Committee (ILCOR) stated that
cardiopulmonary resuscitation has the following side effects:
“In view of death from cardiac arrest, rib fractures and other injuries are
common and acceptable outcomes of cardiopulmonary resuscitation.
After resuscitation, all patients should be reassessed to determine if there
is any recovery-related injury.”
In addition to the above symptoms, chest embolism and pain are
common in the use of the E6 cardiopulmonary resuscitation machine.
2.4 User Qualification
Persons using E6 must be verified to have the following conditions:
• Operators with medical technology, such as: first responders, rescuer,
nurses, physicians or medical staff;

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• Trained for clinical application of E6 approved by Ambulanc (Shenzhen)
Tech. Co., Ltd.;
• Learned CPR courses in accordance with the guidelines of American Heart
Association, the European Resuscitation Council, or similar guidelines
Improper use can cause serious injury to people (operators and patients).
2.5 Structural composition
The main structural components of the E6 cardiopulmonary resuscitation
machine include:
• Back plate, located under the patient to support chest compression
• The upper part, which includes a rechargeable E6 battery and a
compression mechanism with a single suction cup
• Stabilizing belt, to help secure the unit to the patient
• Carrying case
Ambulanc (Shenzhen) Tech. Co., Ltd. has designed the E6 as a complete
component for cardiopulmonary resuscitation.
2.6 Components description
Fig. 1 E6 Components
Components
1 Carrying bag 2 Host

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3 External battery charger (optional) 4 Battery
5 Power adapter
2.7 E6 host description
2.7.1 Host – front view
Fig. 2 Host (front view)
Parts
1 Host shell 2 The top-loading section
3 Bellow 4 Suction cup
5 Machine leg 6 Lock catch
7 Back plate