Amoul T6 User manual

Confidential level: ★ABMOBAN0003(A1.0)
Document type Technical documents Process code 624
Document No. H-1.601.00313 Printing requirements □Colour□Black and white
624- User Manual
Reference materials
Document No. Explanation
Revise record
Version ECR/PCN
TCN Change content Prepared by Date of
approval
A1.0 New Jiying Wu
Distributed to □ Production
department
Purchasing
department
Quality
department
□ Marketing
department
R&D system
Archive method □ Electronic documents Paper documents □ Others:
Prepared
by Reviewed by Approved by
Date 7/19/2021 Date Date

I
Table of Contents
Table of Contents ..........................................................................................................................................I
1Safety instructions ................................................................................................................................... 13
1.1 Overview .............................................................................................................................. 13
1.2 Safe use of oxygen............................................................................................................. 15
1.3 Ventilation/operation........................................................................................................... 15
1.4 Patient ventilator line components................................................................................... 16
1.5 Software ............................................................................................................................... 16
1.6 Accessories/spare parts .................................................................................................... 16
1.7 Battery .................................................................................................................................. 17
1.8 Description of symbols....................................................................................................... 17
2Overview ................................................................................................................................................... 19
2.1 Intended use........................................................................................................................ 19
2.2 Contraindications................................................................................................................ 19
2.3 Intended operating environment....................................................................................... 19
2.4 User qualification ................................................................................................................ 19
2.5 Product description............................................................................................................. 19
2.6 Appearance description..................................................................................................... 20
2.6.1 Mainframe - front view................................................................................................ 20
2.6.2 Mainframe - rear view ................................................................................................ 22
2.6.3 Mainframe – right view............................................................................................... 23
2.6.4 Mainframe - left view .................................................................................................. 24
2.6.5 T6 component diagram.............................................................................................. 25
3Installation................................................................................................................................................. 26
3.1 Packing items...................................................................................................................... 26
3.2 Installation of battery.......................................................................................................... 26
3.3 Connection of oxygen source ........................................................................................... 27
3.4 Power supply connection................................................................................................... 28
3.4.1 Connect AC power supply......................................................................................... 28
3.4.2 Connect DC power supply......................................................................................... 28
3.5 Install support arm .............................................................................................................. 29
3.6 Patient respiratory line assembly and its connection .................................................... 29
3.7 Install humidifier.................................................................................................................. 31
3.8 Infant invasive pipeline connection .................................................................................. 32
3.9 Infant noninvasive pipeline connection............................................................................ 33
3.10 Install nebulization .............................................................................................................. 33
3.11 Install EtCO2 ....................................................................................................................... 34

II
3.12 Patient breathe valve ......................................................................................................... 35
3.12.1 Patient inspiratory valve............................................................................................. 35
3.12.2 Patient expiratory valve.............................................................................................. 35
4Interface description................................................................................................................................ 37
4.1 Main interface components............................................................................................... 37
4.2 Waveform interface ............................................................................................................ 39
4.2.1 Monitor waveform switching...................................................................................... 39
4.3 Loops interface.................................................................................................................... 40
4.4 Monitoring value interface ................................................................................................. 41
4.5 Trend diagram interface..................................................................................................... 42
4.6 Big fonts interface............................................................................................................... 42
4.7 Freezing ............................................................................................................................... 43
4.8 Events................................................................................................................................... 43
4.9 Settings ................................................................................................................................ 44
4.9.1 System.......................................................................................................................... 44
4.9.2 General......................................................................................................................... 46
4.9.3 Service.......................................................................................................................... 47
4.9.4 About............................................................................................................................. 47
5Special functions...................................................................................................................................... 48
5.1 Lung recruitment................................................................................................................. 48
5.2 CPR ...................................................................................................................................... 48
5.3 PEEPi ................................................................................................................................... 49
5.4 P0.1....................................................................................................................................... 50
5.5 NIF ........................................................................................................................................ 50
5.6 Dynamic lung....................................................................................................................... 50
5.7 Sputum Suction................................................................................................................... 51
5.8 Inspiratory holding .............................................................................................................. 52
5.9 Expiratory holding............................................................................................................... 52
5.10 Manual.................................................................................................................................. 53
5.11 Nebulization......................................................................................................................... 53
5.12 P-V tool................................................................................................................................. 54
6Alarm ......................................................................................................................................................... 55
6.1 Alarm message ................................................................................................................... 55
6.2 Alarm priority ....................................................................................................................... 55
6.3 Technical Alarm .................................................................................................................. 56
6.4 Physiological alarm............................................................................................................. 58
6.5 Battery alarms ..................................................................................................................... 59
6.6 Communication Alarms...................................................................................................... 60
6.7 Alarm rules........................................................................................................................... 60

III
6.8 Alarm mode ......................................................................................................................... 61
6.9 Setting of alarm limits......................................................................................................... 62
6.10 Alarm parameter range...................................................................................................... 62
7Operations ................................................................................................................................................ 64
7.1 Power-on.............................................................................................................................. 64
7.2 Self-inspection and calibration.......................................................................................... 64
7.3 Select the patient................................................................................................................ 65
7.4 Ventilation type.................................................................................................................... 67
7.4.1 Invasive ventilation ..................................................................................................... 67
7.4.2 Non-invasive ventilation............................................................................................. 67
7.5 Selection of ventilation mode............................................................................................ 67
7.6 Set ventilation control parameters.................................................................................... 68
7.6.1 Ventilation parameter setting .................................................................................... 68
7.6.2 Ventilation parameters in each mode ...................................................................... 69
7.6.3 IPPV and PCV............................................................................................................. 71
7.6.4 V-A/C and P-A/C......................................................................................................... 72
7.6.5 V-SIMV and P-SIMV................................................................................................... 73
7.6.6 CPAP/PSV ................................................................................................................... 74
7.6.7 BiPPV ........................................................................................................................... 75
7.6.8 APRV ............................................................................................................................ 76
7.6.9 PRVC............................................................................................................................ 76
7.6.10 PRVC-SIMV................................................................................................................. 77
7.6.11 CPAP ............................................................................................................................ 78
7.6.12 PCV............................................................................................................................... 78
7.6.13 HFNC............................................................................................................................ 79
7.6.14 Sigh............................................................................................................................... 80
7.6.15 Apnea ventilation ........................................................................................................ 80
7.6.16 Automatic tube compensation................................................................................... 80
7.6.17 Compliance compensation........................................................................................ 81
7.7 Standby ................................................................................................................................ 81
7.8 End ventilation..................................................................................................................... 81
7.9 Oxygen consumption ......................................................................................................... 82
7.9.1 Oxygen consumption.................................................................................................. 82
7.9.2 Oxygen consumption zeroing ................................................................................... 82
7.10 Data Export.......................................................................................................................... 83
8CO2monitoring......................................................................................................................................... 84
8.1 Overview .............................................................................................................................. 84
8.2 CO2monitoring setting....................................................................................................... 85
8.3 Measurement influence factors ........................................................................................ 85

IV
8.4 EtCO2 zero calibration....................................................................................................... 85
9Cleaning and disinfection ....................................................................................................................... 86
9.1 T6 mainframe ...................................................................................................................... 86
9.2 Respiratory line components ............................................................................................ 86
9.3 Parts and accessories........................................................................................................ 86
9.4 Valve accessories............................................................................................................... 87
9.5 Handling method................................................................................................................. 87
10 Faults and troubleshooting methods .................................................................................................. 89
10.1 Technical faults ................................................................................................................... 89
10.2 Physiological alarm............................................................................................................. 89
10.3 System alarms..................................................................................................................... 90
10.4 Abnormal power failure alarms......................................................................................... 91
11 Maintenance and inspection ................................................................................................................ 92
11.1 Routine inspections............................................................................................................ 92
11.2 Check gas tightness of the system .................................................................................. 92
11.3 Check patient respiratory valve ........................................................................................ 93
11.4 Functional inspection of machine..................................................................................... 93
11.5 Touch screen calibration ................................................................................................... 95
11.6 Calibrate oxygen concentration sensor........................................................................... 95
11.7 Flow sensor calibration ...................................................................................................... 96
11.8 Line compliance .................................................................................................................. 96
11.9 Line resistance .................................................................................................................... 97
11.10 Gas line zero calibration .................................................................................................... 97
11.11 Gas line self-inspection...................................................................................................... 97
11.12 Battery management.......................................................................................................... 97
11.12.1 Battery inspection ....................................................................................................... 98
11.12.2 Battery storage............................................................................................................ 98
11.12.3 Battery replacement ................................................................................................... 98
11.12.4 Battery status description .......................................................................................... 99
11.13 Accessories ....................................................................................................................... 100
11.14 Replacement of filter cotton ............................................................................................ 100
11.15 Storage............................................................................................................................... 101
11.16 Disposal of abandoned device........................................................................................ 101
12 T6 accessories..................................................................................................................................... 102
13 Product specifications ......................................................................................................................... 103
13.1 Safety specifications......................................................................................................... 103
13.2 Physical specifications..................................................................................................... 103
13.3 Environmental specifications .......................................................................................... 104
13.4 Power supply specifications............................................................................................ 104

V
13.5 Gas supply specifications................................................................................................ 105
13.6 Parameter specification ................................................................................................... 106
13.7 CO2 specifications............................................................................................................. 109
13.8 Gas line diagram............................................................................................................... 110
13.9 Parts list.............................................................................................................................. 110
13.10 Principle Description......................................................................................................... 111
14 EMC....................................................................................................................................................... 112
14.1 Electromagnetic radiation declaration ........................................................................... 112
14.2 Battery immunity declaration - requirements for all devices and systems............... 113
14.3 Guidelines and manufacturer's statement - electromagnetic immunity.................... 115
14.4 Recommended isolation distance .................................................................................. 117
14.5 Patient physiological signal information of T6.............................................................. 118
14.6 Basic EMC performance of T6 ventilator ...................................................................... 118
15 Product warranty.................................................................................................................................. 120
16 Classification description of toxic and harmful substances........................................................... 122
17 Storage and transportation................................................................................................................. 124

VI
Product information
Thank you for purchasing the T6 ventilator.
Before using the device, please read and understand contents of this Manual carefully, in
order to use this instrument correctly. Please keep this Manual properly after reading and
place it in an accessible location.
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
Date of manufacture: see the mainframe
Service life: 8 years
Revision date: 7-2021
Version: H-1.601.00313-A1.0
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 belong 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 trademarks or marks not belonging to
Ambulanc (Shenzhen) Tech. Co., Ltd. is only used for the purpose of editing, cannot be
used for other purposes, and their rights belong to their respective right 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. does not guarantee the information in any form,
including (but not limited to) the implied guarantee liability of merchantability and
appropriateness for a particular purpose.
Ambulanc (Shenzhen) Tech. Co., Ltd. considers itself responsible for the safety,
reliability and performance of the instrument only under the following circumstances:
•Assembly operation, expansion, readjustment, improvement and repair are all 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 service scope:
•All devices in line with warranty service regulations of Ambulanc (Shenzhen) Tech.
Co., Ltd. can enjoy free service.
Charged service scope:
•Any equipment beyond the scope of warranty service 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 in normal use and
maintenance state will not appear any manufacturing process and raw materials failure
during the warranty period.
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.ambulgroup.com

X
E-mail: [e-mail]
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 with 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 explain 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 purchase of the 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 be operated by only 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
reinstallation, modification or repair of the system by the personnel not designated by
Ambulanc.
6. This system aims to provide doctors with the auxiliary tools needed for clinical

XI
treatment.
7. The doctors are responsible for the course of treatment. Ambulanc has no
responsibility for the course of treatment.
8. Important data shall 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 in the event of a change in the system
administrator.

XII
Blank page

13
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.
Notice:
Make a warning for the conditions that may cause damage to the device and may
result in incorrect treatment.
Hint:
Information alerts 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 shall only be used after you are subjected to medical training and technical
instructions on ventilator as improper use can cause serious bodily injury.
•Do not leave the patient or the ventilator during ventilation, so as to be able to
make a timely response in the event of an emergency (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).
•T6 is strictly prohibited in explosive or toxic environments.
•T6 is strictly prohibited in oxygen-rich or flammable environments.
•The device is not intended for use in a magnetic resonance imaging (MRI)

14
environment.
•Use of antistatic or conductive masks or ventilator lines when using
high-frequency surgical equipment may cause burns, so do not use antistatic or
conductive masks or ventilator lines.
•This equipment cannot be used with nitric oxide.
•This equipment cannot be used with helium or mixtures containing helium.
•In case of respirator 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
modify any external or internal parts of T6.
•To avoid the risk of electric shock, the device can only be connected to a power
socket with protective grounding. Do not use a power socket that is not
connected with a grounding conductor.
•Do not open the enclosure of the equipment, otherwise there may be a risk of
electric shock.
•Maintenance or upgrade of the equipment can only be carried out by the
maintenance personnel trained and authorized by the company.
•When used outside the healthcare facility, T6 should be fixed on the road
vehicle and operated by EMS personnel with a basic knowledge of mechanical
ventilation.
Notices:
•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 for 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 (the 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.
•After the device is used in a dirtier environment, the filter shall be replaced as
described in "11.14 Replace of filter cotton ".

15
•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:
•An explosion will be caused when the high-pressure oxygen meets any
combustibles (grease, oil, and alcohol, etc.).
•Toxic effects may be caused when a patient is provided with the oxygen of high
concentration for a long period of time. 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.
Notices:
•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. Excessive opening of the
valve 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 of surrounding environment.
1.3 Ventilation/operation
•The patient and ventilator must be observed continuously during ventilation.
•Long-term 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.

16
•Make sure that the patient breathing tube and inspiratory end are connected
smoothly, otherwise the ventilation function of the equipment may be affected.
•The ventilator shall 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 ventilator line components
Warning:
•Professional medical training and technical guidance on the ventilator must be
provided during use of the patient ventilator line assembly, as improper use may
result in serious bodily injury.
•Relevant contents in the Operation Manual shall be referred to, and functional
inspection and visual inspection shall be carried out before use of the ventilator
line components.
•Before connecting it with the patient, check that flow direction of the oxygen
provided to the patient is correct and the ventilator line is smooth.
•The patient ventilator line components can only be used for the specified
purposes.
•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] Failure may be caused due to
incompatibilities arising from using of accessories from other manufacturers.
Please keep in mind that the rights and obligations of the warranty will expire if:
any accessories not recommended in the Operation Manual or any non-original

17
spare part is used.
1.7 Battery
Warning:
[Low battery power] When there is a low battery power alarm, please do any of the
followings:
•Replace the battery with a fully charged one.
•Connect the external power supply of T6.
Notices:
[Maintaining of battery installation] In order to enable continuous operation of T6, it
is recommended that a fully charged battery shall be installed at all times (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
Notice, please refer to attached
documents
Refer to the
Operation Manual
Date of manufacture
BF type
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
Host switch
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

18
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
the recovery and circulation system after 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.

19
2 Overview
2.1 Intended use
T6 is suitable for providing ventilation assistance and respiratory support to adults,
children and infants in and out of the hospital. It is also suitable for all types of
ambulance for emergency transport.
The T6 may be operated only if it is securely mounted and fixed or placed on a
licensed carrier platform.
Warning:
The ventilator shall not be covered or placed in a position that affects operation
and performance of the ventilator.
2.2 Contraindications
The patients with pulmonary bullae, pneumothorax, massive hemoptysis, active
tuberculosis, bronchopleural fistula, massive pleural effusion, acute myocardial
infarction or other diseases, or the patients who cannot use the ventilator
according to clinical experiences.
2.3 Intended operating environment
ICU, EICU, NICU, recovery room, operating room, intra-hospital and out-hospital
emergency transport, etc.
2.4 User qualification
The personnel operating T6 must meet the following conditions:
•Has received medical training and technical guidance on the ventilator;
•Has received the training on clinical application of T6 approved by Ambulanc
(Shenzhen) Tech. Co., Ltd.
Improper use may cause serious injury to personnel (operators and patients).
2.5 Product description
Main components of the T6 ventilator include:
Mainframe (including oxygen line, electronic system, mechanical structure, display,