Amoul i5 User manual

User Manual of i5 Automatic external defibrillator
Release Version：A2.2
Revision date：2022.10.12
User Manual
Automatic External Defibrillator

User Manual of i5 Automatic external defibrillator
Contents
Contents .................................................................................................................................................. 1
Product information ................................................................................................................................2
Intellectual Property Right ..................................................................................................................... 3
Statement ................................................................................................................................................ 4
Return ......................................................................................................................................................6
Equipment Description ........................................................................................................................... 8
Warning、Attention and tips ..................................................................................................................8
1 Equipment description ....................................................................................................................11
1.1 Purpose ....................................................................................................................................11
1.2 Indication ................................................................................................................................ 11
1.3 Contraindication ..................................................................................................................... 11
1.4 Application ..............................................................................................................................11
1.5 User qualification ....................................................................................................................11
2 Installation and setting ....................................................................................................................12
2.1 Setting i5 .................................................................................................................................12
2.2 CPR setting ............................................................................................................................. 12
3 Defibrillation .................................................................................................................................. 13
3.1 CPR guide ..............................................................................................................................13
3.2 Preparation for rescue .............................................................................................................13
3.3 Main rescue sequence .............................................................................................................13
3.4 CPR guide ...............................................................................................................................14
3.5 Data storage ............................................................................................................................ 14
4 Sanitary treatment ...........................................................................................................................16
5 Maintenance ....................................................................................................................................17
5.1 Battery .....................................................................................................................................17
5.2 Battery replacement ................................................................................................................17
5.3 Defibrillator electrode ............................................................................................................ 17
6 Technical parameter ........................................................................................................................18
6.1 Management category of medical equipment ........................................................................ 18
6.2 Physical specification ............................................................................................................. 18
7 EMC ................................................................................................................................................18
7.1 Declaration of magnetic radiation .......................................................................................... 18
7.2 Declaration of electromagnetic immunity - Requirements for all equipment systems ......... 19
7.3 Declaration on guide and manufacturer - Electromagnetic immunity ...................................20
7.4 Recommended isolation distance ........................................................................................... 21
8 Storage and transportation ..............................................................................................................22

User Manual of i5 Automatic external defibrillator
JG-205-3-SP031(2.2) 2
Product information
Thanks for purchasing i5 Automatic external defibrillator.
To use the instrument correctly, please carefully read and understand the Manual before using. Keep
the manual properly after reading and put it in an accessible position.
Product name: Automatic external defibrillator
Specification and model: i5
Name of registrant: AMBULANC (SHENZHEN) TECH. CO., LTD.
Domicile of registrant: 3rd Floor, Block C, Building #5 Skyworth Innovation Industry Park
Tang Tou 1st Road, Shiyan, Baoan District 518108 Shenzhen PEOPLE’S REPUBLIC OF
CHINA
Name of manufacturer: AMBULANC (SHENZHEN) TECH. CO., LTD.
Address of manufacturing site: 3rd Floor, Block C, Building #5 Skyworth Innovation Industry
Park Tang Tou 1st Road, Shiyan, Baoan District 518108 Shenzhen PEOPLE’S REPUBLIC OF
CHINA
EU representative: Shanghai International Holding Corp. GmbH (Europe)
Eiffestraße 80, D-20537 Hamburg, Germany
Date of manufacturing: See label on main unit
Service life: 8 years
Software release: V1.0
Revision date: 2022-10
Notes:
The instrument is not designed for family use.

User Manual of i5 Automatic external defibrillator
JG-205-3-SP031(2.0) 3|
Intellectual Property Right
© 2022 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 technology company has the final right to interpret this manual.
Ambulanc technology company has the right to handle this manual as confidential material.
Without prior written approval of Ambulanc technology company, any individual or organization
shall not disclose nor access all or parry 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.
This is the registered trademark or trademark of AMBULANC(SHENZHEN) TECH.CO.,LTD., and
these trademarks and related Ambulanc technology company 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.

User Manual of i5 Automatic external defibrillator
JG-205-3-SP031(2.2) 4
Statement
Ambulanc technology company reserves the right to modify this manual without prior notice.
Ambulanc technology company reserves the right to change related technology without prior notice.
Ambulanc technology company reserves the right to alter product specification without prior notice.
Ambulanc technology company 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 technology company 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 technology company;
• Related electrical equipment is in compliance with national standards;
• The instrument is used in accordance with the operation instructions.
Ambulanc technology company 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 technology
company;
• The product is not used correctly in compliance with this Operating Manual.
Basic UDI-DI is the main key in the database and relevant documentation (e.g. certificates,
declaration of conformity, technical documentation and summary of safety and clinical performance)
to connect devices with same intended purpose, risk class and essential design and manufacturing
characteristics.
Links to the summary of safety and clinical performance:
https://ec.europa.eu/tools/eudamed
A notice to the user and/or patient：Any serious incident that has occurred in relation to the device
should be reported to the manufacturer and the competent authority of the Member State in which
the user and/or patient is established.

User Manual of i5 Automatic external defibrillator
JG-205-3-SP031(2.0) 5|
Maintenance Service
Scope of Charge-Free Service：
•Charge-free service is provided for any equipment in the range of Ambulanc technology
company warranty terms.
Scope of Paid Service：
•Paid service is provided for any equipment beyond the range of Ambulanc technology company
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 technology company.
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.

User Manual of i5 Automatic external defibrillator
JG-205-3-SP031(2.2) 6
Warranty
Manufacturing Process and Raw Material：
Ambulanc technology company 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: 3th Floor, Block C, Building #5, Skyworth Innovation Industry Park, Tang Tou 1st
Road, Shiyan Town, Baoan District, Shenzhen 518108, P.R.China
Service Hot Line：400-9969-120
Tel：[phone] Fax：[phone]
Web site: http://www.amoulmed.com
E-MAIL: [e-mail]
Return
Return Procedure
Any return as necessary shall comply with the following procedure:
•Acquire right of return: Contact Ambulanc technology company 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
Ambulancanc shall be paid by the user.

User Manual of i5 Automatic external defibrillator
JG-205-3-SP031(2.0) 7|
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 caused by improper packaging when returning to Ambulanc technology company;
•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 technology company 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 technology company.
6. This system is intended to provide the data required for clinical diagnosis for physicians. The
physician takes responsibility for diagnosis process. Ambulanc technology company 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 technology company takes no liability for loss of data stored in the system due to 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.
10. The Ambulanc technology company is not responsible for damage caused by defects in the
equipment itself or damage caused by mistakes made by the user.
11. The Ambulanc technology company will not be responsible for any damage caused by the use
of this equipment after the service life of the equipment is exceeded.

User Manual of i5 Automatic external defibrillator
JG-205-3-SP031(2.2) 8
12. Ambulanc technology company will not bear the cost of transportation if the warranty request is
rejected.
13. Ambulanc technology company takes no responsibility for damage or loss resulted from
negligence or failure to observe the preventive measures stated in this manual.
14. This manual must be handed over to the successor when the system administrator is changed.
Equipment Description
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.
Warning、Attention and tips
The following safety marks are used in this manual:
Danger：
Warn the patient and the user of the risk of serious personal injury or even death.
Warning：
Warn of the danger of potential personal injury or even death to patients and users.
Attention：
Indicating potential equipment damage and undesired treatment effect.
Tip：
Giving useful indicative information.
Danger：
•This device emit high energy during defibrillation. This electrical energy can cause serious
personal injury or death if not used correctly in accordance with the operating instructions in
this manual. Observe all operating instructions in this manual when using this device. Do not
operate this equipment until you are familiar with all operating instructions.
•If this equipment is used near a flammable agent or in an oxygen-rich environment, an
explosion or fire may occur as the equipment may cause an arc discharge during a defibrillation
shock.

User Manual of i5 Automatic external defibrillator
JG-205-3-SP031(2.0) 9|
•During defibrillation, keep a sufficient distance from the patient and the metal objects
connected to the patient to avoid electric shock.
Warning:
•Check that the equipment, cables and accessories are working properly before use. Do not use
this device if you find a problem.
•This device can only be used with disposable batteries supplied by the company.
•Do not disassemble the defibrillator, otherwise there is a danger of electric shock. This device
does not contain any parts that can be removed by the user.
•The electrode sheet needs to be closely adhered to the patient's skin, and there is no gap left. If
necessary, the patient's chest hair should be scraped off with a tool.
•If you would like to use this device with equipment not mentioned in this manual, please consult
the manufacturer.
•Keep i5 away from sources of electromagnetic interference (such as motors, generators, X-ray
equipment, radio transmitters, cellular mobile phones, nuclear magnetic resonance, and other
equipment) as it may interfere with the signals being collected and analyzed during operation. .
For details, see Chapter 9, "EMC".
•Do not immerse any part of the device in water or other liquids. Also avoid spilling any liquid
on the device or accessories. Do not use formaldehyde or other flammable reagents for cleaning,
as this may cause an explosion or fire. Do not autoclave or disinfect this equipment or
accessories unless otherwise stated.
•Always have a spare battery that is fully charged and properly maintained. When the device
displays a low battery warning, replace the battery, as this may cause the device to shut down.
•Disconnect all other devices without defibrillation protection from the patient during
defibrillation.
•Do not modify this device.
•Only the manufacturer Shenzhen Ambulanc Technology Co., Ltd. or its authorized professionals
can perform maintenance measures such as inspection and maintenance work.
Attention：
•Please keep this equipment in a safe place to prevent it from falling, colliding, being subjected to
strong shocks or other mechanical external forces.
•Do not mix electrodes of different types and brands. Mixing electrodes can cause large baseline
drift or lead to longer baseline recovery time after defibrillation。

User Manual of i5 Automatic external defibrillator
JG-205-3-SP031(2.2) 10
•In order to avoid contamination or infection of personnel, the environment or other equipment,
equipment and its accessories that meet the service life must be disposed of in accordance with
relevant local regulations or hospital systems
Tip：
•Keep this manual near the equipment and make it easy to get it when you operate the equipment.
•When operating this device, the user should stand in front of the device.
•In order to prepare the equipment for use at any time, please install the battery in advance and
connect the electrode plug.
•User detection should be performed once the device has been dropped or improperly operated. If
any malfunction is detected, do not use the equipment and contact the designated service
personnel for repairs.
Residual risk
Even if we've figured out a lot of ways to prevent risk, it could happen:
•Instrument batteries may fail
•The instrument itself may fail to work
•May burn skin during use
Software
Since a lot of quality assurance measures were taken during equipment and software
development, the risk caused by software defects is negligible.
Accessories/spare parts
Attention:
• Maintenance measures can only be taken by manufacturer (AMBULANC (SHENZHEN)
TECH.CO.,LTD.) or its authorized professionals, such as inspection and overhaul.
• Use of accessories of other manufacturers may result in faults and incompatibility. Please
remember the warranty right and responsibility will be invalid in the following cases: not using
the accessories recommended in the Manual or the original spare parts.

User Manual of i5 Automatic external defibrillator
JG-205-3-SP031(2.0) 11|
1 Equipment description
1.1 Purpose
i5 is an Automatic external defibrillator. Simple and direct voice prompt and indication are
provided for direct rescue operation. The equipment is light, powered by battery and convenient to
carry. i5 aims to treat ventricular fibrillation (VF) and ventricular tachycardia, and these two
symptoms are the most common cause for sudden cardiac arrest (SCA). When SCA occurs, the
patient's heart will stop beating suddenly, and such situations will suddenly appear in any age group
and there is no sign of it. Defibrillation is the only effective treatment for this symptom.
1.2 Indication
To treat people who have cardiac arrest(SCA). The following are the symptoms of SCA:
•No activity or reaction during shaking
•inability to breathe normally
The defibrillator may be used with standard defibrillation pads only on adults and children who
are 8 years old or more or who weigh more than 25 kg (55 lbs). The defibrillator may be used on
children who are less than 8 years old or weigh less than 25 kg (55 lbs) with Infant/Child Reduced
Energy Defibrillation Electrodes.
1.3 Contraindication
Please don't use i5 when the patient has the following signs:
•Able to move and react when shaking
•Able to breathe normally
1.4 Application
i5 for emergency responders, medical staff, or trained non-professional in or outside the
hospital.
1.5 User qualification
The user of i5 shall be proved to satisfy the following conditions:
• Received training on equipment.
• Received training on cardiopulmonary resuscitation or other physician-authorized emergency
response programs.

User Manual of i5 Automatic external defibrillator
JG-205-3-SP031(2.2) 12
2 Installation and setting
Warning:
• Using of accessories not specified in the manual may increase electromagnetic radiation or
reduce the electromagnetic immunity of i5. Use the alternative accessories and
consumables of Ambulanc or those supplied by its authorized representatives.
2.1 Setting i5
Notes:
Please don't open the sealing electrode container if you don't plan to use it, to prevent drying of
AED electrode.
2.2 CPR setting
Tips:
i5 provides voice prompt (1min and 30s, 1min, 40s and 20s) of rest time under the pause time
countdown mode till the next cycle of defibrillation (start from ECG analysis).
Under the pause time countdown mode, press the flashing blue "i" within 20s after CPR start to
start the CPR voice guide mode.

User Manual of i5 Automatic external defibrillator
JG-205-3-SP031(2.0) 13|
3 Defibrillation
3.1 CPR guide
Warning:
Please don't use i5 for children below 1 year old.
Tips:
i5 can be used for children at the age of 1-8.
• Please use the pediatric low-energy defibrillator electrode supplied by Ambulanc
technology company for children at the age of 1-8 or the weight is less than 25Kg. (Please
don't use the pediatric low-energy defibrillator electrode supplied by Ambulanc
technology company for adult patients.)
• For the children above 8 years old, American Heart Association (AHA) suggests the
application of adult "Life chain" and resuscitation sequence (2010 AHA guide for
cardiopulmonary resuscitation and emergency cardiac care).
3.2 Preparation for rescue
Tips:
Please don't waste time on taking off the patient's clothes. Please tear or shear off the patient's
clothes when necessary.
Warning:
Check whether the electrode is damaged and whether the gel is dried.
If the electrode is damaged or the gel is dried, please change a new electrode.
3.3 Main rescue sequence
Warning:
• Please don't put the electrode (defibrillation pole) on the implanted pacemaker or
cardioverter-defibrillator. Keep the electrode away from the implanted equipment.
•The electrode piece needs to be closely attached to the patient's skin, and there is no gap left. If
necessary, use a tool to scrape the patient's chest hair.
• Please don't put the electrode (defibrillation pole) on the transdermal drug patch directly,
otherwise, it may result in skin burn.

User Manual of i5 Automatic external defibrillator
JG-205-3-SP031(2.2) 14
• During ECG signal collection and analysis, the patient shall keep static and reduce the motion
artifact to the maximum.
• When using i5, disconnect the connection between the patient and the medical electrical
equipment without the defibrillation parts.
• Keep the electrode far away from the other electrodes or metal parts.
• Prevent the patient's body (such as the head or the naked skin of limbs) and conducting flow
(such as gel, blood or saline) from contacting with metal (such as bedstead or stretcher), and
residual channels will be provided for defibrillation current.
• Excessive Energy Delivery.
For children less than 8 years of age or 55 lbs (25 kg), use child electrodes. Do not use Adult
electrodes; these electrodes do not attenuate the energy.
Tips:
Though i5 is charging after detecting the shockable rhythm, it can collect and analyze the ECG
of patient continuously. If the ECG heart rhythm is changed into non-shockable rhythm, i5 will
release automatically.
Warning:
After pressing "shock", no one should touch the patient. The defibrillation shock will result in
injury of operator or bystander.
3.4 CPR guide
Warning:
• i5 will stop analyzing the patient's ECG during CPR.
• It will recover the ECG analysis automatically after CPR.
• If it is necessary to use other defibrillators for the patient, please disconnect i5 from the patient.
Before using other defibrillators, please disconnect the connection between i5 and the patient.
3.5 Data storage
Warning:
• Please don't remove the battery when i5 collects data, otherwise, you will lose the special rescue

User Manual of i5 Automatic external defibrillator
JG-205-3-SP031(2.0) 15|
data. If it is necessary to remove the battery, please shut down i5 correctly before removal by
pressing "Start/shutdown".
• i5 has≥16G memory capacity for recording ECG and rescue data. If the collected data exceeds
the capacity during rescue, it will cover the earlier data automatically.

User Manual of i5 Automatic external defibrillator
JG-205-3-SP031(2.2) 16
4 Sanitary treatment
Notes:
• Please don't soak the parts of i5 in the liquid.
• If i5 is soaked in water, please contact with Ambulanc technology company or its
authorized representative to provide maintenance service.
• Please prevent liquid from entering the equipment box.
• Please prevent liquid from splashing on the equipment box.
• Please don't use powerful acetone cleaner when cleaning the equipment.
• Please don't use rough materials when cleaning the device (especially the infrared optical
filter at IrDA port).
• Please don't disinfect i5.

User Manual of i5 Automatic external defibrillator
JG-205-3-SP031(2.0) 17|
5 Maintenance
5.1 Battery
Warning:
• Only the battery recommended and supplied by the manufacturer can be used. Use of
battery not recommended and supplied by the manufacturer may result in abnormal
operation.
5.2 Battery replacement
Warning:
•Please don't open or remove the battery case.
•Please prevent battery from contacting with open fire and other heat sources, and don't
discard it in the fire.
•Please prevent terminal short circuit of battery.
•Please prevent the battery from serious physical influence, and prevent hammer from
knocking.
•If there is leakage or abnormal odor, please keep the battery away from the fire so as to
prevent fire of leaked electrolyte.
•Please put battery in the place inaccessible to children.
•If the battery leaks or the leaked liquid enters the eyes, please wash with clean water and
consult a doctor.
•Please don't put battery in direct sunlight pace or high-temperature area.
•Please prevent battery from contacting with water.
•Put battery in the place far away from direct sunlight, high temperature and humidity.
•Please dispose battery according to the local laws and regulations.
•Please don't put i5 battery in unsafe environment.
5.3 Defibrillator electrode
Warning:
•Only the electrodes supplied by the manufacturer can be used for supporting i5. Use of

User Manual of i5 Automatic external defibrillator
JG-205-3-SP031(2.2) 18
electrodes not specified by the manufacturer may affect the defibrillation effect.
6 Technical parameter
6.1 Management category of medical equipment
Management category of medical equipment
Category
Class III medical equipment according to Regulation EU 2017/745
6.2 Physical specification
Dimension of complete machine
Outline
dimension
Length: 289mm
Width: 217mm
Height: 91mm
Weight
About 2.5Kg
Display screen
Type
Color screen TFT
Size
7-inch
Resolution
Pixel: 800 x 480
7 EMC
7.1 Declaration of magnetic radiation
i5 can be used for the following specific electromagnetic environment, and the user shall
use the equipment in the following specified electromagnetic environment.
Radiation test
Compliance
test
Electromagnetic environment guide
RF radiation (CISPR
11)
(GB4824)
(GB4824)
First group
i5 only uses the RF energy when running the
internal functions.
Therefore, the RF radiation is extremely low
and has little electromagnetic interference on
the electronic equipment nearby.
RF radiation (CISPR
11)
(GB4824)
Class B
i5 is applicable to all facilities, including the
household and the residential public LV supply
network directly connected with the house.
Harmonic radiation
(IEC 61000-3-2)
N/A