Ambul T5 User manual

密级：★ ABMOBAN0001(A1.0)
保密文件，知识产权归安保科技公司所有
文件类型
技术文件
项目编号
609
文件编号
H-1.601.00137
打印要求
彩色 □黑白
609 用户使用说明书（英文）
参考资料
文件编号
说明
修订记录
版本
ECR/PCN
TCN
更改内容
制订
批准日期
A1.0
ECR20171163
新增
胡国权
2017.12.20
A2.0
ECR20180118
1）更新 11.8 节的“ FIGURE 43”图
2）更新 2.1、2.2 关于设备预期用途的说明。
胡国权
2018.01.28
A3.0
ECR20190207
新增第 16 章。
施丽迪
2019.02.28
A4.0
ECR20200407
修改 2.1 关于设备预期用途的说明
陈德伟
2020.05.08
A5.0
ECR20200609
优化呼吸模式介绍。
罗妙
2020.07.02
B1.0
ECR20201119
根据 ISO10651-3 标准新增 3.6 参数关联；修改地址信息、增加报
警优先级说明等
谢荣锋
2020.11.02
B2.0
ECR20210102
修改 2.8.3 和2.8.4 描述
陈德伟
2021.01.22
B3.0
ECR20210311
封面增加 CE0123 标示
谢荣锋
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：
制订
审核
批准
日期
2021.03.25
日期
2021.03.25
日期
2021.03.25

blank page

H-1.601. 00137-B3.0
I
Contents
Contents............................................................................................................................................. I
1 Equipment Description ...............................................................................................................1
1.1 Warning、Attention and tips ........................................................................................1
1.2 Overview.......................................................................................................................1
1.3 Safe Use of Oxygen ......................................................................................................3
1.4 Ventilation/Operation....................................................................................................4
1.5 Patient Respiratory Hose Assembly..............................................................................4
1.6 Software........................................................................................................................4
1.7 Accessories/Spare Parts ................................................................................................5
1.8 Battery...........................................................................................................................5
1.9 Symbols that..................................................................................................................6
2 Equipment Description...............................................................................................................7
2.1 Purpose..........................................................................................................................7
2.2 Contraindications:.........................................................................................................7
2.3 Scope of Application.....................................................................................................7
2.4 User Qualification.........................................................................................................8
2.5 The main composition of ..............................................................................................8
2.6 Main Unit......................................................................................................................8
2.7 Patient Respiratory Hose and Accessories....................................................................9
2.8 T5 Main Unit instruction...............................................................................................9
3 Interface description..................................................................................................................14
3.1 Composition of main interface....................................................................................14
3.2 Main menu instruction................................................................................................15
3.3 Alarm Message ...........................................................................................................20
3.4 Review Events ............................................................................................................25
3.5 Setting of Alarm Limits...............................................................................................26
3.6 Ventilation mode Parameter linkage relationship: ......................................................27
4 Installation....................................................................................................................................29
4.1 Overview.....................................................................................................................29
4.2 Boxed object ...............................................................................................................29
4.3 Install the battery.........................................................................................................29
4.4 Connection of Oxygen Cylinder .................................................................................30
4.5 Removal of Empty Cylinder .......................................................................................30
4.6 Connection of New Cylinder ......................................................................................30
4.7 Patient Respiratory Hose Assembly and Its Connection........................................30
4.8 Patient Breathing Valve...............................................................................................32
5 Ventilation Operation................................................................................................................34
5.1 Calibration of Touch Screen........................................................................................34
5.2 Startup-Self-Checking.................................................................................................35
5.3 Select Ventilation Mode..............................................................................................36
5.4 Main Ventilation Parameters Setting...........................................................................37
5.5 Details on Ventilation Modes......................................................................................38
5.6 Execution of Ventilation..............................................................................................43
5.7 Monitoring of Respiration...........................................................................................45
5.8 CPR Ventilation...........................................................................................................46
5.9 End Ventilation............................................................................................................48
5.10 Calculation of Storage Capacity/Operation.................................................................49
5.11 Alternative Breathing Apparatus.................................................................................50
5.12 Battery Management...................................................................................................50
6 Sanitization...................................................................................................................................52
6.1 T5 Main Unit...............................................................................................................52

H-1.601. 00137-B3.0
II
6.2 Respiratory Hose Assembly........................................................................................52
6.3 Components andAccessories......................................................................................52
6.4 Valve Fittings ..............................................................................................................53
6.5 Sanitization Methods...................................................................................................53
7 Functional Inspection................................................................................................................54
7.1 Inspection Cycle..........................................................................................................54
7.2 Inspect SystemAir-Tightness......................................................................................55
7.3 Examine Patient Breathing Valve................................................................................55
7.4 Machine Function Inspection......................................................................................55
8 Trouble Shooting........................................................................................................................58
8.1 Technical Failure.........................................................................................................58
8.2 Physiological Alarm....................................................................................................58
8.3 SystemAlarm..............................................................................................................59
8.4 Power failure alarm.....................................................................................................59
8.5 Abnormal power failure alarm....................................................................................60
9 Maintenance................................................................................................................................61
9.1 Routine inspection ......................................................................................................61
9.2 Battery.........................................................................................................................61
9.3 Accessories .................................................................................................................62
9.4 Replace Filter..............................................................................................................62
9.5 Storage ........................................................................................................................63
9.6 Disposal of Waste Equipment.....................................................................................63
10 T5 Supplies Configuration.....................................................................................................64
10.1 Standard Components .................................................................................................64
10.2 Optional Components .................................................................................................64
10.3 Ventilation Mode Configuration List..........................................................................65
11 Technical Parameters..............................................................................................................66
11.1 Medical Devices Management Category....................................................................66
11.2 Physical Specifications ...............................................................................................66
11.3 Environmental specifications......................................................................................66
11.4 Power Specifications...................................................................................................66
11.5 Ventilation mode.........................................................................................................67
11.6 Supply specifications ..................................................................................................67
11.7 Ventilator specifications..............................................................................................67
11.8 T5 Product Structure Diagram....................................................................................69
11.9 Available Minimum Oxygen Concentration...............................................................69
12 EMC..............................................................................................................................................71
12.1 EMR Statement...........................................................................................................71
12.2 EMI Statement - Requirements for All .......................................................................71
12.3 Guide and Manufacturer Statement –EMI.................................................................73
12.4 Recommended isolation distance................................................................................74
12.5 Information on T5 Patient's Physiological..................................................................75
12.6 Basic EMC Properties of T5 Emergency....................................................................76
13 Warranty.....................................................................................................................................77
14 Classification of Toxic/Harmful Substances ......................................................................78
15 Storage and Transport............................................................................................................80
16 Transient operating conditions............................................................................................81

H-1.601. 00137-B3.0
III
Product Information
Thank you for purchasing T5 Emergency Ventilator.
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：Emergency and Transport Ventilator
Model：T5
Manufacturer：Ambulanc (Shenzhen) Technology Co. Ltd.
Manufacturer address：3rd Floor, Block C, Building #5, Skyworth
Innovation Industry Park, Tang Tou 1st Road, Shiyan , Baoan District,
Shenzhen 518108, China
Tel: [phone] Fax:[phone]
Website:www.ambulgroup.com E-mail:man[email protected]om
Product date：See host
Service life：8 years
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]
Revision date：2021-03

H-1.601. 00137-B3.0
IV
Intellectual Property Right
© 2017 Ambulanc (Shenzhen) Technology Co. Ltd. All rights reserved
This product and its operating manual are the intellectual property of
Ambulanc (Shenzhen) Technology 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 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.
is the registered trademark or trademark of Ambulanc
(Shenzhen) Technology Co. Ltd., and these trademarks and related Ambulanc
logo are intangible property owned by Ambulanc (Shenzhen) Technology 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. 00137-B3.0
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 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. 00137-B3.0
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) Technology Co. Ltd.
Address: 3rd Floor, Block C, Building #5, Skyworth Innovation Industry Park,
Tang Tou 1st Road, Shiyan, Baoan District, Shenzhen 518108, China
Service Hot Line：400-9969-120
Tel：[phone] Fax：[phone]
Web site: http://www.ambulgroup.com
E-MAIL: [e-mail]

H-1.601. 00137-B3.0
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. 00137-B3.0
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.

H-1.601. 00137-B3.0
IX
blank page

H-1.601. 00137-B3.0
Page 1 of 81
1 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.
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.
Tip：
Giving useful indicative information.
1.2 Overview
•A functional inspection must be performed before use of the equipment
(refer to Section 7 - Functional Inspection).
•Please observe the instructions in Section 6 - Sanitization to prevent
infection or bacillosis.
Warning：
•【After the training】You can operate T5 only after you have been
provided with proper medical training in and technical guidance on
respiration equipment. Improper use of it may cause serious injury to
body.
•【Do not leave T5 in ventilation】Do not leave a patient or respirator in
ventilation to respond in time to any emergency (such as patient's
worsening state of an illness or machine fault) to minimize the patient's
injury.
•T5 can be used for the intended purpose (refer to Section 2.1 - Purpose

H-1.601. 00137-B3.0
Page 2 of 81
for more details).
•【Hyperbaric chamber】Do not use T5 in hyperbaric application
(hyperbaric chamber).
•【Danger】Do not use T5 in any explosive or toxic environment.
•【Fire】Do not use T5 in any oxygen-rich or inflammable environment.
•【Maintenance personnel qualification】This equipment can be repaired
and maintained only by Amoul or any professionals authorized by it.
•【Please do not open】Only maintenance personnel can open the cover,
replace or modify spare parts outside and inside T5.
Caution：
•【Other equipment】Any device or equipment emitting high-frequency
radiation (e.g. cell phone, radio) must be kept a minimum distance of 1
meter from T5 to prevent any malfunction in it.
•【The power converter】When the respirator is powered by any external
power supply, the power supply shall be connected to a pluggable
interface so that it can be disconnected quickly in case of failure.
•【External power supply】When the respirator is powered by an external
power supply, please ensure that the power line shall not hinder. If not
necessary (when battery capacity is lower than 20% or T5 is used in an
uninterrupted way for a long time), please do not use any external power
supply; instead, please give priority to power T5 by internal battery.
•【The standby】An alternative secondary respiration device must be
provided in case of failure of the primary equipment.
•【Replace Filter】After the equipment is used in any dusty environment,
replace the filter in accordance with Section 9.4 - Replace Filter.
•【Liquid】Please do not immerse T5 in any liquid. If liquid penetrates
into cover, it shall lead to damage of equipment.

H-1.601. 00137-B3.0
Page 3 of 81
1.3 Safe Use of Oxygen
Warning：
•High-pressure oxygen and combustible (lubricating grease, engine oil,
alcohol, etc.) may give rise to an explosion when they meet each other.
•Supply of oxygen in high concentration to a patient for a long time may
generate toxic effect. Patients differ in bearing duration due to age,
physical condition, etc. So please adopt proper way of ventilation
according to a patient's condition.
•Keep equipment and all joints clean and free from any engine oil or
lubricating grease.
•Before operating oxygen supply device, please wear a clean pair of
medical gloves.
•No open flame nearby equipment and related supporting facilities
Caution：
•While installing and replacing an oxygen cylinder, please manually screw
down knob switches on the oxygen cylinder and reducing valve. Do not
use any tool to prevent overexerting yourself from damaging thread and
sealing materials and leading to leakage.
•Please take measures to prevent an oxygen cylinder from toppling and
falling. A toppling and falling oxygen cylinder may damage reducing
valve or oxygen valve and even lead to an explosion in serious condition.
•Slowly open oxygen cylinder valve because it may give rise to sharp rise of
pressure to impact valve parts and result in their damage by opening
oxygen cylinder valve too intensely and quickly.
•Do not completely use up oxygen in the oxygen cylinder to prevent humid
air in surrounding environment from flowing into the oxygen cylinder to
corrode the oxygen cylinder.

H-1.601. 00137-B3.0
Page 4 of 81
1.4 Ventilation/Operation
•During ventilation, uninterrupted observation of both the patient and
respiratory equipment must be performed.
•Prolonged breathing through respirator may result in atrophy of patient's
respiratory muscles.
•Lengthy ventilation may cause patient's respiratory tract dry. Make sure
sufficient natural air is available for adjustment of respiration.
•Make high-pressure ventilation in a short time under instruction of an
physician. Because uninterrupted high-pressure ventilation for a long
time may injure a patient. Guarantee unimpeded respiratory hose of
patient to prevent influencing ventilation function of equipment.
1.5 Patient Respiratory Hose Assembly
Warning：
•Those using patient's respiratory hose assembly must have taken
professional medical training and technical instruction on respiratory
equipment for improper use may lead to serious physical injury.
•Please refer to related contents in the manual and make functional test
and visual inspection before using respiratory hose assembly.
•Before connecting to patient, please check whether direction of oxygen
flow transported to patient is correct and whether the respiratory hose is
unimpeded.
•Patient respiratory hose assembly can be used only for the intended
purpose.
•Patient respiratory hose assembly is unsuitable for high pressure
applications (hyperbaric chamber).
1.6 Software
Many quality assurance measures have been taken in development of
equipment software to minimize the risks potentially caused by software
defect.

H-1.601. 00137-B3.0
Page 5 of 81
1.7 Accessories/Spare Parts
Caution：
•【To prevent the sun】Proper measures shall be taken to prevent
prolonged exposure of any rubber parts to UV or direct sun and
brittleness caused thereby.
•【Use approved accessories only】Use of accessories of other
manufacturers may give rise to fault due to incompatibility. Please bear in
mind that warranty rights and liabilities shall be invalidated in such
cases: do not use accessories recommended in the manual or original
spare parts.
1.8 Battery
Warning：
【Low battery】When T5 alarms in low battery, please make any of the
following operations:
•Replace battery by fully charged battery.
•Connect T5 with external T5 power supply.
Attention:
[Keep battery installation] In order to enable T5 to make sustainable
operation, it is advised to always install fully charged battery (even though
when T5 is powered by external power supply).

H-1.601. 00137-B3.0
Page 6 of 81
1.9 Symbols that
Description ICONS and symbols
SYMBOL DESCRIPTION SYMBOL DESCRIPTION
Refer to the document Refer to the document
attached for more details attached/manual
Date of production BF type applications
Waterproof level Do not reject into dustbin
Adapter off Non-ionizing radiation
Power supply by adapter Main Unit Switch
Power supply by battery Battery level indication
menu Alarm mute
Lock/unlock Manual ventilation
Air inlet PEEP control
Manufacturers
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.

H-1.601. 00137-B3.0
Page 7 of 81
2 Equipment Description
2.1 Purpose
The T5 ventilator is intended to provide continuous ventilation for patients
who require invasive or non-invasive respiratory support (Infants, children,
adults), with a tidal volume greater than 50ml. The T5 ventilator is intended
for use in out-of-hospital emergency treatment (first aid treatment on the
ground or at sea) and in-hospital transportation run under the central
oxygen supply of the hospital or an oxygen cylinder pressure greater than
2.7Bar.
2.2 Contraindications:
Bullae of lung, pneumothorax, hemoptysis, active tuberculosis,
bronchopleural fistula, pleural effusion, acute myocardial infarction.
Warning：
T5 is suitable for patient’s tidal volume more than 50ml, offering A/C,
invasive and noninvasive ventilation support.
2.3 Scope of Application
T5 can be applied in the following cases:
Emergencies
•First-aid resuscitation on the site;
•Ongoing emergency lasting for a long time (e.g. fire); and
•Temporary oxygen uptake via respiratory mask and ventilation via
tracheal cannula.
Transfer of patient
•During first-aid treatment on surface or at sea;
•During transfer from ward to treatment room in hospital;
•During transfer from hospital to any other location.
•Use in other situations according to medical advice of physician.

H-1.601. 00137-B3.0
Page 8 of 81
Temporary ventilation in hospital
•Recovery room;
•ICU;
•Preparation for operation and the stage subsequent thereto;
•Emergency room.
2.4 User Qualification
The person operating T5 must be qualified and meet the following
conditions:
•Provided with proper medical training in and technical guidance on
respiration equipment.
•Provided with training in clinical application with T5 by Shenzhen Amoul
Technology Limited.
•Improper operation of the equipment may cause serious injury to persons
(the operator and patient).
2.5 The main composition of
T5 Emergency Ventilator The main composition of
consists of a main unit, respiratory valve, and rechargeable lithium battery.
All components necessary for T5 operating as a ventilation system have been
designed by Amoul.
2.6 Main Unit
T5 can be used for treatment of breathlessness and to provide breathing
support. By means of adjustable respiration parameter, you can keep
ventilation through the respirator consistent with patient's own breath.
•This unit provides two ventilation control modes, pressure control and
volume control.
•Inspiration triggering mode for this unit is pressure activation.
•This equipment provides electronic PEEP function.
•This unit allows ten respiration modes (IPPV/ V-A/C /V-SIMV/ P-A/C
/P-SIMV/PCV/CPAP/CPR/Manual/HFNC) which can be selected to meet
patient's breathing in various states.