Amoul T6 User manual

文件类型
技术文件
项目编号
624
文件编号
H-1.601.00313
打印要求
彩色 □黑白
624 - User Manual
制定
审核
批准
日期
2022.03.21
日期
2022.03.21
日期
2022.03.21
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
New
Jiying Wu
2021.07.19
A2.0
修改 UI 等内容
韦雪雪
2022.3.15
2.0
ECR20220318
公司官网、邮箱变更
邓伟良
2022.03.21
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：

I
Table of Contents
Table of Contents ..........................................................................................................................................I
1 Safety instructions.....................................................................................................................................1
1.1 Overview ...........................................................................................................................................1
1.2 Safe use of oxygen........................................................................................................................2
1.3 Ventilation/operation......................................................................................................................3
1.4 Patient ventilation line components.............................................................................................3
1.5 Software ..........................................................................................................................................4
1.6 Accessories/spare parts................................................................................................................4
1.7 Battery .............................................................................................................................................4
1.8 Description of symbols..................................................................................................................4
2 Device Overview........................................................................................................................................6
2.1 Intended use...................................................................................................................................6
2.2 Contraindications ...........................................................................................................................6
2.3 Intended operating environment..................................................................................................6
2.4 User qualification............................................................................................................................6
2.5 Product description ........................................................................................................................6
2.6 Appearance description ................................................................................................................7
2.6.1 Mainframe - front view.........................................................................................................7
2.6.2 Mainframe - Rear view........................................................................................................9
2.6.3 Mainframe - left view .........................................................................................................10
2.6.4 Mainframe –right view...................................................................................................... 11
2.6.5 T6 component diagram.....................................................................................................12
3 Installation.................................................................................................................................................13
3.1 Packing items ...............................................................................................................................13
3.2 Installation of battery ...................................................................................................................13
3.3 Connection of oxygen source.....................................................................................................14
3.4 Power supply connection............................................................................................................15
3.4.1 Connect AC power supply................................................................................................ 15
3.4.2 Connect DC power supply................................................................................................15
3.5 Install the mainframe ...................................................................................................................16
3.6 Install support arm .......................................................................................................................17
3.7 Patient respiratory line assembly and its connection .............................................................17
3.8 Install humidifier ...........................................................................................................................19
3.9 Infant invasive pipeline connection............................................................................................20
3.10 Infant noninvasive pipeline connection...................................................................................21
3.11 Install nebulization .....................................................................................................................22
3.12 Install EtCO2...............................................................................................................................22

II
3.13 Patient breathe valve.................................................................................................................23
3.13.1 Patient inspiratory valve..................................................................................................23
3.13.2 Patient expiratory valve...................................................................................................23
4 Interface description................................................................................................................................24
4.1 Main interface components ........................................................................................................24
4.2 Waveform interface......................................................................................................................26
4.2.1 Monitor waveform switching.............................................................................................26
4.3 Loops interface.............................................................................................................................27
4.4 Monitoring value interface...........................................................................................................27
4.5 Trend diagram interface..............................................................................................................28
4.6 Mechanics interface.....................................................................................................................28
4.7 Freeze............................................................................................................................................28
4.8 Events............................................................................................................................................28
4.9 Settings..........................................................................................................................................29
4.9.1 System.................................................................................................................................29
4.9.2 General................................................................................................................................31
4.9.3 Maintenace .........................................................................................................................31
4.9.4 About ...................................................................................................................................32
5 Special functions......................................................................................................................................33
5.1 Lung recruitment ..........................................................................................................................33
5.2 CPR................................................................................................................................................33
5.3 PEEPi.............................................................................................................................................34
5.4 P0.1................................................................................................................................................34
5.5 NIF..................................................................................................................................................35
5.6 Dynamic lung................................................................................................................................35
5.7 Suction...........................................................................................................................................36
5.8 Insp. holding..................................................................................................................................36
5.9 Exp.holding ................................................................................................................................... 37
5.10 Manual.........................................................................................................................................37
5.11 Nebulization................................................................................................................................37
5.12 P-V tool........................................................................................................................................38
6 Alarm .........................................................................................................................................................40
6.1 Alarm message ............................................................................................................................40
6.2 Alarm priority.................................................................................................................................40
6.3 Technical Alarm............................................................................................................................41
6.4 Physiological alarm......................................................................................................................44
6.5 Battery alarms ..............................................................................................................................44
6.6 Communication Alarms...............................................................................................................45
6.7 Alarm rules....................................................................................................................................45

III
6.8 Alarm mode...................................................................................................................................46
6.9 Setting of alarm limits..................................................................................................................47
6.10 Alarm parameter range.............................................................................................................47
7 Operations ................................................................................................................................................49
7.1 Power-on .......................................................................................................................................49
7.2 Self Check and calibration..........................................................................................................49
7.3 Select the patient .........................................................................................................................50
7.4 Ventilation type.............................................................................................................................51
7.4.1 Invasive ventilation ............................................................................................................51
7.4.2 Non-invasive ventilation....................................................................................................52
7.5 Ventilation settings.......................................................................................................................52
7.5.1 Ventilation parameter setting ...........................................................................................52
7.5.2 Ventilation parameters in each mode .............................................................................53
7.5.3 IPPV and PCV.................................................................................................................... 55
7.5.4 V-A/C and P-A/C................................................................................................................56
7.5.5 V-SIMV and P-SIMV..........................................................................................................57
7.5.6 CPAP/PSV..........................................................................................................................58
7.5.7 BiPPV ..................................................................................................................................59
7.5.8 APRV...................................................................................................................................60
7.5.9 PRVC...................................................................................................................................60
7.5.10 PRVC-SIMV......................................................................................................................61
7.5.11 CPAP .................................................................................................................................61
7.5.12 HFNC.................................................................................................................................62
7.5.13 Apnea ventilation .............................................................................................................63
7.5.14 Sigh....................................................................................................................................63
7.5.15 Intubation/Automatic tube compensation.....................................................................63
7.5.16 Compliance compensation.............................................................................................64
7.6 Standby..........................................................................................................................................64
7.7 End ventilation..............................................................................................................................64
7.8 Oxygen consumption...................................................................................................................65
7.8.1 Oxygen consumption.........................................................................................................65
7.8.2 Oxygen consumption zeroing ..........................................................................................65
7.9 Data Export...................................................................................................................................66
8 CO2monitoring.........................................................................................................................................67
8.1 Overview........................................................................................................................................67
8.2 CO2monitoring setting ................................................................................................................68
8.3 Measurement influencing factors...............................................................................................68
8.4 EtCO2zero calibration.................................................................................................................68
9 Cleaning and disinfection .......................................................................................................................69

IV
9.1 T6 mainframe................................................................................................................................69
9.2 Respiratory line components......................................................................................................69
9.3 Parts and accessories.................................................................................................................69
9.4 Valve accessories........................................................................................................................70
9.5 Replacement of filter cotton........................................................................................................70
9.6 Handling method..........................................................................................................................71
10 Faults and troubleshooting methods................................................................................................... 73
10.1 Technical faults ..........................................................................................................................73
10.2 Physiological alarm....................................................................................................................73
10.3 System alarms............................................................................................................................74
10.4 Abnormal power failure alarms................................................................................................75
11 Maintenance and inspection ................................................................................................................76
11.1 Routine inspections ...................................................................................................................76
11.2 Check air tightness of the system ...........................................................................................76
11.3 Check patient respiratory valve ...............................................................................................77
11.4 Functional inspection of machine............................................................................................ 77
11.5 Touch screen calibration...........................................................................................................79
11.6 Calibrate oxygen concentration sensor.................................................................................. 79
11.7 Flow sensor ................................................................................................................................80
11.8 Hose compliance .......................................................................................................................80
11.9 Hose resistance .........................................................................................................................80
11.10 Self-check and zeroing ...........................................................................................................81
11.11 Gas line self-inspection...........................................................................................................81
11.12 Battery management...............................................................................................................81
11.12.1 Battery inspection ..........................................................................................................81
11.12.2 Battery storage ...............................................................................................................82
11.12.3 Battery replacement ......................................................................................................82
11.12.4 Battery status description .............................................................................................83
11.13 Accessories ..............................................................................................................................84
11.14 Storage...................................................................................................................................... 84
11.15 Disposal of abandoned device ..............................................................................................84
12 T6 accessories.......................................................................................................................................85
13 Product specifications........................................................................................................................... 86
13.1 Safety specifications..................................................................................................................86
13.2 Physical specifications ..............................................................................................................86
13.3 Environmental specifications ...................................................................................................87
13.4 Power supply specifications.....................................................................................................87
13.5 Gas supply specifications.........................................................................................................88
13.6 Parameter specification ............................................................................................................89

V
13.7 CO2 specifications......................................................................................................................92
13.8 Gas line diagram........................................................................................................................93
13.9 Parts list.......................................................................................................................................93
13.10 Principle Description ...............................................................................................................94
14 EMC......................................................................................................................................................... 95
14.1 Electromagnetic radiation declaration ....................................................................................95
14.2 Battery immunity declaration - requirements for all devices and systems........................96
14.3 Guidelines and manufacturer's statement - electromagnetic immunity..............................98
14.4 Recommended isolation distance .........................................................................................100
14.5 Basic EMC performance of T6 ventilator .............................................................................101
15 Product warranty..................................................................................................................................102
16 Classification details of toxic and harmful substances...................................................................103
17 Storage and transportation.................................................................................................................105

VI
Product information
Thank you for purchasing the T6 ventilator.
To use this device correctly please read and understand the contents of this Device
manual carefully before use. After reading, keep this manual at a proper place
where it is easy to access.
Product name: ventilator
Model: T6
Production license number: GDFDA Medical Device Production License No.20020533
Registrant name: Ambulanc (Shenzhen) Tech. Co., Ltd.
Registrant domicile: A1302, Shenzhen National Engineering Laboratory Building, No.20,
Gaoxin South 7th Road, High-Tech Zone Community, Yuehai Street,
Nanshan District, Shenzhen
Manufacturer name: Ambulanc (Shenzhen) Tech. Co., Ltd.
Manufacturer address: Floor 3, Building C, Skyworth Innovation Valley #5, No.1 Tangtou
Road, Shiyan Street, Bao'an District, Shenzhen
Manufacturing Date: See the mainframe
Usage period: 8 years
Revision date: 12-2021
Version: A2.0
Notices: This instrument is not designed for household purposes.

VII
Intellectual property rights
@2021 Ambulanc (Shenzhen) Tech. Co., Ltd., All rights reserved
The intellectual property rights of this product and its operation manual belongs to
Ambulanc (Shenzhen) Tech. Co., Ltd., including but not limited to the patent right,
trademark right, and copyright, etc.
Ambulanc (Shenzhen) Tech. Co., Ltd. reserves the right for final interpretation of
this Operation Manual.
Ambulanc (Shenzhen) Tech. Co., Ltd. reserves the right to treat this Operation
Manual as confidential information. Without written permission of Ambulanc
(Shenzhen) Tech. Co., Ltd., no individual or organization shall disclose all or part of
the information of this Operation Manual by any means, nor allow others or
organizations to obtain all or part of the information of this Operation Manual by
any means.
Without written permission of Ambulanc (Shenzhen) Tech. Co., Ltd., no individual
or organization shall publish, modify, copy, distribute, rent, adapt or translate all or
part of this Operation Manual into other languages.
is the registered trademark or trademark of Ambulanc (Shenzhen)
Tech. Co., Ltd. These trademarks and related Ambulanc marks are the intangible
property of Ambulanc (Shenzhen) Tech. Co., Ltd. The use of trademarks or logo
other than those of Ambulanc (Shenzhen) Tech. Co., Ltd. in this manual is only for
editing and has no other purpose. Their rights belong to their respective rights
owners.

VIII
Statement
Ambulanc (Shenzhen) Tech. Co., Ltd. reserves the right to modify contents of this
Manual without prior notice.
Ambulanc (Shenzhen) Tech. Co., Ltd. reserves the right to change the technology
without prior notice.
Ambulanc (Shenzhen) Tech. Co., Ltd. reserves the right to modify the product
specifications without prior notice.
Ambulanc (Shenzhen) Tech. Co., Ltd. makes no guarantee of any kind with
respect to this information material, including (but not limited to) its implied
guarantee of marketability and suitability for a specific purpose.
Ambulanc (Shenzhen) Tech. Co., Ltd. considers itself responsible only for the
safety, reliability and performance of the instrument under the following
circumstances:
•Assembly operation, expansion, readjustment, improvement and repair which
are carried out by the personnel approved by Ambulanc (Shenzhen) Tech. Co.,
Ltd.
•The relevant electrical equipment meets the national standards;
•The instrument is operated in accordance with the operation instructions.
Ambulanc (Shenzhen) Tech. Co., Ltd. will not be responsible for safety, reliability
and operating conditions of the product if:
•Any component is disassembled, stretched, or readjusted;
•The instrument is repaired or modified by the personnel not authorized by
Ambulanc (Shenzhen) Tech. Co., Ltd.;
•The product is not operated correctly according to the Operation Manual.

IX
Maintenance service
Free maintenance range:
•All devices in line with warranty service regulations of Ambulanc (Shenzhen)
Tech. Co., Ltd. can enjoy free service.
Charged maintenance range:
•Any equipment beyond the range of warranty services regulations of Ambulanc
(Shenzhen) Tech. Co., Ltd. will be charged by Ambulanc for services;
•Within the warranty period, no warranty shall be granted under the following
circumstances:
1. Man-made damages;
2. Improper use;
3. Power grid voltage exceeds the specified range of equipment;
4. Irresistible natural disasters;
5. The machine is replaced with the parts and consumables that are not approved
by the Ambulanc (Shenzhen) Tech. Co., Ltd., or the machine is repaired by the
personnel not authorized by the Ambulanc (Shenzhen) Tech. Co., Ltd.
Warning:
If the hospital or institution responsible for use of the instrument does not
implement a satisfactory repair/maintenance plan, it may result in abnormal
instrument failure and may endanger human health.
Guarantee
Manufacturing process and raw materials:
Ambulanc (Shenzhen) Tech. Co., Ltd. guarantees that the instrument will have no
production process or raw material fault during the warranty period under normal
use and maintenance.
After-sales service unit
After-sales service department of Ambulanc (Shenzhen) Tech. Co., Ltd.
Address: Floor 3, Building C, Skyworth Innovation Valley #5, No.1 Tangtou Road,
Shiyan Street, Bao'an District, Shenzhen
Postal code: 518108 Toll-free service hotline: [phone]
Tel.: [phone] Fax: [phone]
Website: http://www.amoulmed.com
E-mail: [e-mail]

X
Return
Return procedures
Please follow the following steps if you do need to return the goods to Ambulanc
(Shenzhen) Tech. Co., Ltd.:
•Obtain the right of return: Contact the after-sales service department of
Ambulanc (Shenzhen) Tech. Co., Ltd. to inform serial number of Ambulanc
product, which has been marked on the outer packing box. If the serial number
is not clearly identifiable, the return will not be accepted. Please specify the
product model and briefly describe the reason for return.
•Freight: the user shall bear the freight (including customs charges) when the
instrument is transported to Ambulanc (Shenzhen) Tech. Co., Ltd. for repair.
Important information
1. After purchasing this product, the customer is fully responsible for maintenance
and management of the product.
2. During the warranty period, the following conditions are not covered by the
warranty:
•Damage or loss caused by wrong or rough use;
•Damage or loss caused by force majeure, such as fire, earthquake, flood or
lightning.
•Damage or loss caused by failure to meet the specified operating conditions of
the system, such as insufficient power supply, incorrect installation or
non-conforming environmental conditions.
•Damage or loss caused by not operating the system in the area where the
system is initially purchased.
•Damage or loss caused by the system which is not purchased from Ambulanc
or its authorized dealers or agents.
3. The equipment can only be operated by qualified medical personnel with
professional qualification certificate.
4. Software or hardware or any other parts of the product are forbidden to be
modified without authorization.
5. Ambulanc shall not be responsible for any problems, damage or loss arising
from the re-installation, modification or repair of the system by the personnel

XI
not designated by Ambulanc.
6. This system is designed to provide doctors with the auxiliary tools needed for
clinical treatment.
7. The doctors are responsible for the course of treatment.Ambulanc has no
responsibility for the course of treatment.
8. Important data should always be backed up to external storage media, such as
clinical records, notebooks, etc.
9. Ambulanc shall not be held responsible for the loss of data stored in the system
due to operator error or abnormal circumstances.
10. This Operation Manual contains warnings about potential hazards that can be
foreseen. Unstated dangers shall be kept on high alert at all times. Ambulanc
shall not be responsible for any damage or loss caused by negligence or
disregard of the preventive measures specified in this Operation Manual.
11. This Operation Manual must be handed over whenever a system administrator
changes.

1
1 Safety instructions
Please read these safety instructions carefully. These safety instructions are an integral
part of the equipment and must be accessible at all times. For the sake of safety, please
note the followings:
The safety instructions are marked in this Operation Manual as follows:
Warning:
Make a warning for the conditions that may cause a risk of harm to patients and users.
Caution:
Warn about the conditions that can cause equipment damage and may have incorrect
treatment effects
Hint:
Information alerts based on the contents of this user instruction.
1.1 Overview
Warning:
•A functional check must be performed before using this equipment (see "11
Maintenance and Inspection").
•Follow the instructions in "9 Cleaning and Disinfection" to prevent infection or
bacterial infection.
•T6 can only be used after getting the proper medical training and technical guidance
on ventilator usage as improper use may lead to death of the patient.
•It is strictly forbidden to leave the patient or the ventilator during ventilation, so as to
make timely response to emergencies (such as deterioration of the patient's condition
or machine failure), and to minimize the patient's injury.
•T6 may only be used for the specified purposes (see "2.1 Intended use").
•T6 is strictly prohibited in high-pressure applications (hyperbaric chamber).
•The use of T6 is strictly prohibited in explosive or toxic environments.
•The use of T6 is strictly prohibited in oxygen-rich or flammable environments.
•The device is not intended for use in a magnetic resonance imaging (MRI)
environment.
•Use of antistatic or conductive masks or ventilator lines when using high-frequency
surgical equipment may cause burns, so do not use antistatic/conductive masks or

2
ventilator lines.
•This equipment cannot be used with nitric oxide.
•This equipment cannot be used with helium or mixtures containing helium.
•In case of ventilator failure, if other ventilation methods cannot be applied
immediately, it may result in patient death.
•Non-maintenance personnel are prohibited to open the T6 cover to change or
replace any external or internal parts of T6.
Caution:
•When T6 is used together with devices that emit high-frequency radiation (e.g.
mobile phones, radios), a distance of more than 1m must be maintained, otherwise it
may cause dysfunction.
•When an external power supply is used to supply power to T6, always connect it to
an easily pluggable interface so that it can be quickly unplugged in case of failure.
•When an external power supply is used to supply power for T6, ensure that the power
cord does not form an obstruction. Please do not use the external power supply when
it is not necessary (i.e,. battery power is less than 20% or the battery power is used
uninterruptedly for a long time). Battery power is preferred.
•An alternative backup ventilator must be available in case of equipment failure.
•If the device is used in dirty environment, the filter should be replaced as described in
"11.14 Replace of filter cotton ".
•Do not immerse T6 in any liquid. If any liquid gets into the cover, it can cause damage
to the device.
1.2 Safe use of oxygen
Warning:
•When the high-pressure oxygen meets with any combustibles (grease, oil, and
alcohol, etc.)it can cause explosion.
•Long-term supply of high-concentration oxygen to the patient can have toxic
effects.The endurance of patients will vary due to their age and physical conditions.
Please use appropriate ventilation method according to patient's condition.
•The device and all joints shall be kept clean, and no oil or grease is allowed.
•Please wear clean medical gloves before operating the oxygen supply unit.
•No smoking or open flame is allowed near the device and related supporting facilities.

3
Caution:
•When installing and replacing oxygen cylinders, please manually tighten relevant
knob switches on oxygen cylinders and pressure reducing valves. It is strictly
prohibited to use any tools, so as not to damage the thread and sealing material due
to excessive force, resulting in leakage.
•Please take measures to prevent dumping of oxygen cylinders. The dumping of
oxygen cylinders would cause damage of the pressure reducing valve or oxygen
valve, or even cause an explosion.
•The valve of the cylinders shall be opened slowly. Opening the valve too aggressively
and too quickly will cause a sudden rise in pressure, which will impact the valve
fittings and cause damage.
•The oxygen cylinders shall not be completely used up to avoid corrosion of cylinders
caused by intrusion of moist air in surrounding environment.
1.3 Ventilation/operation
•The patient and ventilator must be continuously observed during ventilation.
•Prolonged reliance on T6 for breathing may cause respiratory muscles of the patient
to atrophy.
•Ventilation for a long time can dry out the respiratory tract.
•Ensure that the patient breathing tube and inspiratory end are connected smoothly,
otherwise the ventilation function of the equipment may be affected.
•The ventilator should not be placed next to a barrier as this will impede the flow of
cold air and cause the device to overheat.
1.4 Patient ventilation line components
Warning:
•Professional medical training and technical guidance on the ventilator usage must be
provided during use of the patient ventilation line assembly, as improper use may
result in serious physical injury.
•Before use, please refer to the relevant contents in the manual for functional and
visual inspection of the ventilation line components.
•Before connecting it with the patient, check that flow direction of the oxygen provided
to the patient is correct and the ventilation line is smooth.
•The patient’s ventilation line components can only be used for the specified
purposes.

4
•The patient ventilator line components are not suitable for high-pressure applications
(e.g. hyperbaric chamber).
1.5 Software
Extensive quality assurance measures have been taken during development of device
software, so the risk arising from software defects is minimal.
Software version:V1.
1.6 Accessories/spare parts
Notices:
•[Prevention of exposure] Measures shall be taken to protect silicone and rubber parts
from being exposed to ultraviolet light and long hours of direct sunlight, which would
otherwise cause brittleness of these parts.
•[Only use the approved accessories] Using accessories from other manufacturers
may cause malfunctions due to incompatibility.Please remember that the rights and
obligations of the warranty will expire if: do not use the accessories recommended in
the operation manual or do not use the original spare parts.
1.7 Battery
Warning:
[Low battery power] In case of low battery power alarm, please do any of the followings:
•Replace the battery with a fully charged battery.
•Connect the external power supply of T6.
Caution:
[Maintaining of battery installation] In order to enable continuous operation of T6, it is
recommended to use a fully charged battery for the whole time (even when an external
power supply is connected to supply power).
1.8 Description of symbols
The symbols used on this device or in this Manual are described in following table.
Symbol
Description
Symbol
Description
Caution, please refer to attached
documents
Refer to the
Operation Manual
Manufacturing Date
BF type

5
application part
Equipotential
Protection level
Do not discard in an ordinary trash
bin
Power cord
disconnection
Refer to the manual provided with
the device together/Operation
Manual
On/Off switch of
main unit
AC power supply
Battery power
supply
Clearing alarms other than
Advanced Alarms
Nebulization
Function menu
Lock/unlock
Muted alarm
Inspiratory
interface
Expiratory interface
USB port
Oxygen inlet
Battery capacity
state
Non-invasive
Invasive
Adult
Pediatric
Infant
Patient trigger
The product contains some harmful substances, so it can be safely
used within the environment-friendly use period, but it shall be put into
recycling system after exceeding the environment-friendly use period.
The product has an environment-friendly service life of 20 years.
It is in compliance with the European Union Medical Devices Directive
2007/47/EC, and meets the basic requirements for CE mark in Annex
I of the Directive.