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Amoul T6 Operation Manual

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文件类型
文件编号
制定
日期
2022.03.21
文件编号
ECR/PCN
版本
TCN
A1.0
A2.0
2.0
ECR20220318
发放部门
存档方式
技术文件
H-1.601.00313
624 - User Manual
审核
日期
参 考 资 料
修 订 记 录
更 改 内 容
修改 UI 等内容
公司官网、邮箱变更
生产部
采购部
电子文档
项目编号
打印要求
2022.03.21
说明
New
品质部
□ 市场部
□
纸文档
其它：
624
□
彩色
批准
日期
2022.03.21
制 定
Jiying Wu
韦雪雪
邓伟良
研发系统
黑白
批准日期
2021.07.19
2022.3.15
2022.03.21

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  • Page 1 文件类型 技术文件 项目编号 H-1.601.00313  □ 文件编号 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 ECR/PCN 版本 更 改 内 容 制...

  • Page 4: Table Of Contents

    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.....................
  • Page 5 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......................
  • Page 6 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 ......................
  • Page 7 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 ....................
  • Page 8 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...
  • Page 9 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.
  • Page 10 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.
  • Page 11 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.
  • Page 12 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; •...
  • Page 13 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.
  • Page 14 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.

  • Page 16: Safety Instructions

    • 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.

  • Page 17: Safe Use Of Oxygen

    • 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.

  • Page 18: Ventilation/Operation

    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.

  • Page 19: Software

    • 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).
  • Page 20 application part Equipotential Protection level Do not discard in an ordinary trash Power cord disconnection Refer to the manual provided with On/Off switch of the device together/Operation main unit Manual Battery power AC power supply supply Clearing alarms other than Nebulization Advanced Alarms Function menu...

  • Page 21: Device Overview

    It is used for ventilation assistance and respiratory support for adults, children and infants. The T6 may be operated only if it is safely installed 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.

  • Page 22: Appearance Description

    Ambulanc (Shenzhen) Tech. Co., Ltd. has designed all components required for the T6 ventilation system. Appearance description 2.6.1 Mainframe - front view Fig. 2-1 Mainframe (front view) Components Description 1 Alarm light In case of an alarm, the display turns into red, yellow...
  • Page 23 4 Battery sign Battery indicator. 5 Battery The indicator will flash during charge, and will stay on indicator untill the battery is fully charged or in use. Tip: To indicate the ventilator is powered by an internal battery or an external power supply during operation. 6 On/off key If it is in the shutdown state, click this button to turn on,if it is in standby state, click this button to turn off, and if it is in...

  • Page 24: Mainframe - Rear View

    sensor interface 16 Nebulizer Used to connect the nebulizer. interface 17 Leak test Used to calibrate compliance plug 18 Inspiratory Used to connect the inspiratory line. branch 2.6.2 Mainframe - Rear view Fig. 2-1 Mainframe (rear view) Components Description 1 DC power input port Used to connect to the vehicle power supply.

  • Page 25: Mainframe - Left View

    upgrade. 6 Hook Hook width: 45mm. 7 Gas supply Connect to high pressure gas supply port(high pressure) 8 Gas supply port(low Connect to low pressure gas supply. pressure) 用于连接外部校准设备，活可以连接医疗级外部 设备。 Used to remove and replace the rechargeable built in 9 Battery latch 支持与...

  • Page 26: Mainframe - Right View

    2.6.4 Mainframe – right view Fig. 2-3 Mainframe (right view) Components Description 1 Handle Handle height: 27mm. 2 Speaker Speaker of alarms, hints and alarms. 3 Exhalation valve exhaust Used to discharge gas.

  • Page 27: T6 Component Diagram

    2.6.5 T6 component diagram Fig. 2-2 T6 component diagram Components Description 1 Support arm Used to support and suspend respiratory line of patients. Include the oxygen line, electronic system, mechanical 2 Mainframe structure, display, and carbon dioxide module. 3 Trolley Used to support the mainframe, support arm, oxygen cylinder and humidifier, etc.

  • Page 28: Installation

    ⚫ After installation, you must do functional inspection (please refer to the "11 Maintenance and inspection") to ensure that the device works properly. Packing items T6 ventilator is packed in a single box. Please refer to "12 T6 accessories" for packing items. Installation of battery The battery used in T6 is a rechargeable lithium battery.After insertion, push it by hand,...

  • Page 29: Connection Of Oxygen Source

    Connection of oxygen source Fig. 3-2 Oxygen source interface The ventilator can provide two gas source interfaces: high-pressure oxygen and low-pressure oxygen. When the ventilator is connected with the high-pressure oxygen gas source, the normal working gas source pressure is 300-600kPa. If pressure of gas source is lower than 300kPa, performance of the ventilator will be affected, or even the ventilation may be disabled.

  • Page 30: Power Supply Connection

    interface shall be pressed, and then the gas source hose shall be pulled out. Power supply connection The ventilator can be connected to DC power supply and AC power supply. 3.4.1 Connect AC power supply Fig. 3-3 AC power interface 1.

  • Page 31: Install The Mainframe

    Insert the DC power cord directly into the DC power input interface, and then rotate clockwise until a "Pop" sound is heard which shows that it has been installed in place. Install the mainframe Fig. 3-5 Mainframe installation diagram ①Mainframe ②Positioning columns ③...

  • Page 32: Install Support Arm

    2. Tighten knob of the fixing block. Patient respiratory line assembly and its connection Respiratory line assembly of T6 is divided into repetitive respiratory line assembly and disposable respiratory line assembly. And connection mode of the line is: double-line connection mode. Following steps shall be followed in the connection mode (as shown...
  • Page 33 Components Components 1 Expiratory branch filter 7 Humidifier 2 Expiratory line 8 Humidifier gas inlet 3 Flow sensor 9 Humidifier gas outlet 4 Simulated lung (patient) 10 Inspiratory line 5 Seeper trap in expiratory 11 Inspiratory branch filter branch 6 Seeper trap in inspiratory branch Caution: 1.

  • Page 34: Install Humidifier

    Install humidifier Fig. 3-8 Humidifier installation diagram 1. Align humidifier pulley with the humidifier support mounting seat and slide into it, and then tighten the screws. 2. Install the filter to the inspiratory and expiratory interface. 3. Connect the filter in inspiratory branch to the humidifier inlet via the line. 4.

  • Page 35: Infant Invasive Pipeline Connection

    Infant invasive pipeline connection Fig. 3-9 Schematic diagram of infant invasive pipeline connection Parts Parts ①Infant flow sensor ②Expiratory line ③Humidifier...

  • Page 36: Infant Noninvasive Pipeline Connection

    3.10 Infant noninvasive pipeline connection Fig. 3-10 Schematic diagram of noninvasive pipeline connection for infants parts parts ①Infant nasal oxygen tube ② pressure pipeline tube ③Expiratory line ④Humidifier Warning: Infant patients: •You can only select CPAP, PCV mode or switch from CPAP, PCV mode to other modes during standby.

  • Page 37: Install Nebulization

    3.11 Install nebulization Nebulization refers to the atomization of medicines into aerosols, which are then inhaled into the patient's body for the purpose of treatment. Connect the nebulizer to the machine correctly, as shown in the figure below: Fig. 3-11 Nebulizer installation diagram Parts Parts 1 Nebulization port...

  • Page 38: Patient Breathe Valve

    3.13 Patient breathe valve Patient inspiratory valve 3.13.1 Fig. 3-13 Patient inspiratory valve Components Description Can be used to replace diaphragm of the safety valve. 1 Safety valve cover Used to connect to patient inspiratory line, and is 2 Gas outlet provided with a Φ15mm/22mm coaxial interface.

  • Page 39: Interface Description

    4 Interface description Main interface components Fig. 4-1 Main interface Components Description 1 System date and time Display current time and date. 2 Power supply service state Display battery power and charging status. 3 Adapter state Show whether the adapter is in place. Indicate that current respiration is triggered by 4 Patient trigger the patient...
  • Page 40 8 Screen lock Display locking status of screen 9 USB Display that the USB is connected now 10 Freezing mode Displays the waveform freeze status. 11 Alarm mute prompt icon Display current alarm mute state. 12 Patient type icon Display current patient type (adult/Pediatric). 13 Ventilation mode Display current mode.

  • Page 41: Waveform Interface

    Waveform interface Select the [Waveforms] button on the main interface screen to open the interface as shown in the figure below Fig. 4-2 Waveform interface 4.2.1 Monitor waveform switching In the main interface, click the waveform to be switched, double click to pop up the switching options, and then select to switch Fig.

  • Page 42: Loops Interface

    Loops interface Select the [Loops] button on the main interface to open the interface as shown in the figure below. This interface can display the combination of 2 loops and 1 waveform on the same screen Fig. 4-4 Loops interface Monitoring value interface Select the [values] on the main interface to open the interface as shown in the figure below...

  • Page 43: Trend Diagram Interface

    Trend Chart interface In the main interface, select the [Trends] option to pop up the trend setting interface. Enter the trend interface. You can set up the trend Chart or view trend data and trend waveforms in this interface. And view the 30min, 60min, 2h ,6h,12h or 24h trend charts.The trend chart can be saved for a maximum of 168 hours.

  • Page 44: Settings

    storage of up to 5,000 messages. When the maximum number of log messages is reached, the newer event will overwrite the older ones. The following points shall be noted when viewing the logs: Events structure: time + type + message. •...
  • Page 45 Fig. 4-7 System settings Keys Description 1 Time setting Year, month, day, hour, minute 2 Language Chinese (default). Adjustable range: Chinese, English 3 Sound Type Beep(default) 4 Volume Level 1 by default. Adjustable level 1-3 5 Luminance Level 5 (default). Adjustable range: level 1-8 6 style Night (default).

  • Page 46: General

    4.9.2 General Fig. 4-8 General setting Keys Description 1 Nebu time 1-90 min (adjustable) 2 Nebu Position Inhalation pipe/ patient end optional 3 Hold Time 1-40s (adjustable) 4 Gas ATPD, STPD, BTPS (adjustable) 5 Humidifying Artificial nose and humidifier (optional) 6 LPO Open and close optional 7 Oxygen sensor...

  • Page 47: About

    1 、 For user maintenance function, in the standby interface, click [Settings] → [Maintenance] → [User maintenance] (for the maintenance operation, please refer to 11 “Maintenance and inspection”): EtCO Zeroing (8.4 EtCO zeroing） ⚫ Calibrate oxygen concentration sensor (错误!未找到引用源。 Oxygen ⚫...

  • Page 48: Special Functions

    5 Special functions Lung recruitment maneuver(RM) Lung recruitment maneuver is a pulmonary protective ventilation strategy. The applying of a pressure higher than the normal mean airway pressure and maintaining it for a certain period of time during mechanical ventilation can enable reexpansion of more collapsed alveoli on one hand, and prevent secondary atelectasis caused by small tidal ventilation on the other hand.

  • Page 49: Peepi

    Step 2: Start CPR by following the voice prompts and the "Dong Dong Dong..."beat Caution： ⚫ Continuous mode It's not available in infant types. PEEPi PEEPi (intrinsic PEEP) refers to the positive end-expiratory alveolar pressure in the absence of extrinsic PEEP 1.

  • Page 50: Nif

    5.5 NIF NIF means the maximum negative pressure generated by the patient breathing spontaneously over a period of time. 1. Select [Tools] button → [Diagnostics] → [NIF]. 2. After pressing the [Exp Hold] button, the system will start the measurement. 3.

  • Page 51: Suction

    Suction Sputum suction is the process during which ventilator is used to assist the user to suck sputum of the patient. The ventilator automatically detects the action of the user disconnecting and connecting the patient's tube, applies oxygenated ventilation before and after sputum suction, and block relevant alarms during the process of sputum suction.

  • Page 52: Exp.holding

    Caution： ⚫ Not available in HFNC, CPR and CPAP mode. ⚫ You can not activate Insp Hold function in CPAP/PSV ventilation mode. If apnea ventilation occurs, the Inspiration Hold function is supported. Exp.holding Expiratory holding is the practice of artificially prolonging the patient's expiratory stage and preventing the patient from inspiration for a certain period of time.

  • Page 53: P-V Tool

    After clicking the → [General] → [Nebu time], and selecting the [Save] button after setting, and the ventilator will work according to the set nebulization time. After the nebulization function is enabled, remaining time of this function will be displayed in the system prompt message area.
  • Page 54 ⚫ It is not available in CPAP/PSV, non-invasive and apnea ventilation modes. ⚫ It is not available during the process of sputum suction and within 1 minute after the process, and not available within 1 minute after the last P-V test.

  • Page 55: Alarm

    6 Alarm Alarm message The alarm messages with the highest priority at present will be displayed in the alarm prompt bar on the main interface. If there are multiple alarms, you can click the alarm prompt message bar in the main interface, and the alarm message interface will be brought up to view other alarm messages (as shown below).

  • Page 56: Technical Alarm

    Type Voice alarm displayed!!! time. |0.1s|0.1s|0.5s|0.1s|, the duration of pulse is 0.2s, and the interval of pulse group is 7s. Medium-priority alarms The alarm area on The yellow 1. Three continuous the main interface light flashes “beep--beep--beep” will turn red and Flash sounds will be heard, corresponding...
  • Page 57 Alarm code Alarm name Alarm description Priority 1011 Failure 1011! Motor temperature read failure High Oxygen supply pressure 1012 Failure 1012! High sensor failure Ambient pressure sensor 1 1013 Failure 1013! High failure Ambient pressure sensor 2 1014 Failure 1014! High failure Incorrect ambient pressure...
  • Page 58 Alarm code Alarm name Alarm description Priority Patient side pressure Patient side pressure sensor 1031 High sensor failure!!! failure 1032 No pressure sensor!!! No pressure sensor High Input gas temperature greater 1033 High temp of input gas!!! High than 50°C Output gas temperature is 1034 High temp of output gas!!!

  • Page 59: Physiological Alarm

    Alarm code Alarm name Alarm description Priority Oxygen concentration is 2005 Low FiO2!!! High below lower limit 2006 High EtCO EtCO is above upper limit High 2007 Low EtCO EtCO is below lower limit High 2008 High PEEP!!! PEEP is above upper limit High 2009 Low PEEP!

  • Page 60: Communication Alarms

    High temperature during Battery temp is too high, battery discharge, and the 1051 High may turn off!!! system is about to shut down. (>75 °C) Battery temp high, High temperature during 1052 connect external Medium battery discharge (≥ 65 °C) power!! External power External power supply...

  • Page 61: Alarm Mode

    Condition Horn alarm messages are displayed in the alarm interface. Multi-ple Only the alarm The yellow light If it is a beep low-priority messages with the is always on alarm, it will be alarms are given highest priority will be given with low synchronously displayed in the...

  • Page 62: Setting Of Alarm Limits

    Alarm cancellation: ⚫ When the alarm limit is set to [OFF], the system will turn off the physiological alarm of the corresponding parameters. Namely, the text message, visual alarm, audible alarm and parameter flashing of the physiological alarm are all canceled. Setting of alarm limits Alarm limits can be set according to physiological characteristics of the patient's breathing.
  • Page 63 Alarm parameter Alarm range Lower limit of positive end Closed, 1cmH2O-40 cmH2O expiratory pressure Upper limit of airway pressure 12cmH O～100 cmH Lower limit of airway pressure Closed, 1cmH O-90 cmH Apnea 5s～60s Gas source pressure is Pressure of oxygen source is insufficient below 250 kPa Pressure of oxygen source is...

  • Page 64: Operations

    Power-on Plug the power cord into power outlet. Make sure the external power indicator is on. 1. Press the [ON/OFF] button to turn on T6. 2. At this time, a progress bar indicating that the ventilator is subjected to self-inspection will appear on the screen.

  • Page 65: Select The Patient

    System calibration includes: Self check and zeroing ⚫ Hose resistance ⚫ Hose compliance ⚫ Flow sensor ⚫ Caution: The automatic self-inspection function is not intended as a substitute for function ⚫ inspection. When using the machine, function inspection of the machine shall be carried out according to the contents described in "10 Maintenance and inspection".

  • Page 66: Ventilation Type

    Fig. 7-3 Patient setting Caution: ⚫ Each time you switch patient types, a system calibration must be performed to initiate ventilation. ⚫ If you select the previous patient’s ventilation, the machine will use the previous patient ventilation settings and alarm settings by default. Ventilation type This ventilator has two ventilation types: invasive ventilation and non-invasive ventilation.

  • Page 67: Non-Invasive Ventilation

    intubation. 7.4.2 Non-invasive ventilation(NIV) Non-invasive ventilation refers to the fact that the ventilation of patient is enabled by a nasal mask or respiratory mask without endotracheal intubation or tracheotomy intubation. In non-invasive ventilation mode, the following is available for adult and pediatric types: P-A/C, P-SIMV, APRV, BiPPV, CPAP/PSV, and in infant types: CPAP, PCV.

  • Page 68: Ventilation Parameters In Each Mode

    save, or [×] to cancel the operation. 4. Follow the same method to set other parameters that needs to be set. Fig. 7-4 Ventilation parameter setting 7.5.2 Ventilation parameters in each mode Ventilation mode Set parameters Tidal volume/inspiratory time/breath rate/PEEP/oxygen IPPV concentration/upper pressure limit/inspiratory pause/sigh Tidal volume/inspiratory time/breath rate/PEEP/oxygen...
  • Page 69 time/breath rate/PEEP/oxygen concentration/sigh/inspiratory trigger mode/inspiratory trigger threshold/upper pressure limit/sigh Inspiratory pressure/inspiratory time/pressure rise time/SIMV frequency/PEEP/oxygen concentration/sigh/ flow rate trigger / pressure trigger /inspiratory trigger P-SIMV mode/inspiratory trigger threshold/expiratory switching sensitivity/trigger window/support pressure/upper pressure limit/sigh PEEP/oxygen concentration/low pressure time/high APRV pressure time/high airway pressure/upper pressure limit Support pressure/inspiratory trigger mode/inspiratory trigger threshold/expiratory switching sensitivity/PEEP/oxygen BiPPV...

  • Page 70: Ippv And Pcv

    Oxygen therapy flow/oxygen concentration/upper pressure HFNC limit 7.5.3 IPPV and PCV • Intermittent positive pressure ventilation: IPPV During mechanical ventilation of IPPV (Intermittent Positive Pressure Ventilation), the ventilator always provides intermittent positive pressure ventilation. The pressure rise during inhalation/inspiration is manifested as positive pressure, while during exhalation/expiration the pressure returns to baseline pressure .

  • Page 71: V-A/C And P-A/C

    ratio imbalance caused by ARDS or COPD. Even when the respiratory line leaks, it can also ensure the supply of tidal volume. PCV should be used when the trachea is leaking. Typical pressure waveform of PCV is as follows: Fig. 7-6 PCV typical pressure waveform 7.5.4 V-A/C and P-A/C •...

  • Page 72: V-Simv And P-Simv

    Fig. 7-8 P-A/C typical pressure waveform The [Sigh] is a deep inspiration greater than current tidal volume/pressure at every other set ventilation times on the basis of the specified ventilation frequency, and is applicable for the patients who need mechanical ventilation for a long time. 7.5.5 V-SIMV and P-SIMV Synchronized intermittent mandatory ventilation: SIMV SIMV (Synchronized intermittent Mandatory Ventilation) is a ventilation technology...

  • Page 73: Cpap/Psv

    P-SIMV (pressure-limited synchronized intermittent mandatory ventilation) refers that the machine provides support pressure if the patient is able to trigger the ventilator outside the trigger window during mechanical ventilation. In a specific trigger window, the ventilator detects the patient's inspiratory effort according to setting of trigger sensitivity and immediately gives forced ventilation once according to the preset pressure, so that supply of the mandatory ventilation is synchronized with the patient's inspiratory force.

  • Page 74: Bippv

    The typical pressure waveform of CPAP/PSV is shown below: Pressure Apnea ventilation Pressure support ventilation Apnea pressure Support pressure Inspiratory trigger Rise time Time Fig. 7-11 CPAP/PSV typical pressure waveform 7.5.7 BiPPV bilevel positive airway pressure BiPPV means that during mechanical ventilation or autonomous breathing, the ventilator alternately provide two different levels of positive airway pressure.

  • Page 75: Aprv

    7.5.8 APRV APRV mode is known as the airway pressure release ventilation mode, which can be viewed as giving periodic and transient airway pressure release in CPAP mode. The typical pressure waveform of APRV: Fig. 7-13 APRV typical pressure waveform 7.5.9 PRVC In PRVC mode, volume control is carried out in the manner of pressure-controlled ventilation.

  • Page 76: Prvc-Simv

    Time Time Fig. 7-14 PRVC mode controlled typical pressure and velocity waveforms PRVC-SIMV 7.5.10 PRVC-SIMV mode known pressure-regulated volume control-synchronous intermittent mandatory ventilation mode, and is a ventilation mode that ensures the lowest preset ventilation frequency. The mechanical ventilation mode provided is the volume mode (PRVC mode).

  • Page 77: Hfnc

    The typical pressure and flow velocity waveforms controlled by CPAP mode are as shown below: Positive airway Pressure pressure Time Flow rate Time Fig. 7-16 CPAP mode controlled typical pressure and flow velocity waveform 7.5.12 HFNC HFNC is the high flow oxygen therapy function. This mode is indicated for the patient who has autonomous respiration.

  • Page 78: Apnea Ventilation

    Caution: ⚫ HFNC can only be used for the patients with autonomous respiration. ⚫ Patients must be given oxygen therapy under the supervision of medical care professional. If something goes wrong or the patient does not have enough autonomous respiration, the medical care professional can help immediately. ⚫...

  • Page 79: Compliance Compensation

    automatically adjust the gas supply pressure so that the pressure at intubation end is as consistent as possible with set value of the ventilator pressure. Once you select the ventilation mode, select [Compensate] → [ATC] in the parameter setting screen. When it is activated, you can perform corresponding parameter setting. After clicking [Save] button, the system will activate the intubation Compensation function;...

  • Page 80: Oxygen Consumption

    there is residual gas pressure in the cylinder when you return it to refill, which will prevent moist/humid air in the surrounding environment from intruding and causing corrosion/rust. 1. Please check the barometer on the pressure reducing valve that shows the pressure of the cylinder to check the gas storage condition of the cylinder.

  • Page 81: Data Export

    7.9 Data Export This machine provides the patient data export function, you can use it to export the current patient’s log information and trend information, etc. 1. Insert the USB drive into the USB port of the ventilator. Click → [Maintenance] → [User Maintenance] → [Data Export] in Standby screen 3.

  • Page 82: Co Monitoring

    8 CO monitoring Overview The CO module of this ventilator uses infrared absorption technology to measure the concentration in patient’s respiratory line.The principle is based on the fact that molecules can absorb infrared light energy of a specific wavelength, and the amount of energy absorbed is directly related to the concentration of CO .

  • Page 83: Co Monitoring Setting

    monitoring setting 1. Connect the sensor to CO module. 2. The CO module is the measurement mode by default. After connecting the CO module, the machine will automatically start CO monitoring. 3. The zeroing calibration operation shall be carried out as described in Section 8.4 (EtCO zero calibration).

  • Page 84: Cleaning And Disinfection

    9 Cleaning and disinfection The T6 mainframe and its accessories must be cleaned and disinfected after each use to keep it in a good standby state, to avoid cross-infection. Functional inspection should be carried out after each cleaning and disinfection (see the "11 Maintenance and inspection"...

  • Page 85: Valve Accessories

    4. Check the mask and replace it immediately if there are any damaged parts. 5. Re-useable respiratory hoses, patient respiratory valves, silicon parts and respiratory masks can also be sterilized/disinfected with high temperature. Valve accessories Warning: Risk of explosion! It is strictly forbidden to put valve accessories (pressure reducing valves, oxygen cylinders, etc.) in disinfectants or other similar liquids.

  • Page 86: Handling Method

    Warning: Use of the ventilator without a filter shall be prohibited, in order to avoid affecting performance of the machine, or even cause damage to the machine. Handling method Parts Cleaning Disinfection Rinsing in a Sterilization washer Use a piece Wipe to disinfect Not allowed Not allowed...
  • Page 87 Medical alcohol(75%) Disinfectant Isopropyl alcohol Disinfectant glutaraldehyde Disinfectant Phthalaldehyde disinfectant Disinfectant Soap water(pH from 7.0 to 10.5) Detergent clean water Detergent...

  • Page 88: Faults And Troubleshooting Methods

    10.1 Technical faults Faults Causes Remedies Deliver to the manufacturer or T6 malfunction/fault seller for repair T6 cannot be started The battery is used Recharge the battery The gas supply line Identify and correct gas Obvious oxygen loss leakage leakage points T6 cannot be shut Press and hold the "ON/OFF"...

  • Page 89: System Alarms

    limit is reasonable or not apnea apnea The apnea time Check condition of the exceeds the set patient time value Check that the set time value is reasonable or The set upper limit Check condition of the is exceeded patient Check condition of the Airway obstruction patient...

  • Page 90: Abnormal Power Failure Alarms

    10.4 Abnormal power failure alarms T6 has the function of shutdown alarm caused by abnormal power failure of the system. The alarm will be triggered when the mainframe is shut down due to the power failure caused by any abnormality, and the alarm duration is not less than 15 seconds;...

  • Page 91: Maintenance And Inspection

    11 Maintenance and inspection 11.1 Routine inspections Before each use: • Functional inspection shall be carried out once. After each use: • The reusable respiratory hoses and patient respiratory valves must be cleaned and disinfected once according to the instructions for use in Chapter 6. After each use or removal: •...

  • Page 92: Check Patient Respiratory Valve

    Relieve pressure from the system: for this, it is necessary to close the oxygen cylinder. Turn on T6 for a while until reading of pressure gauge of the oxygen cylinder is "0". Then turn T6 off again.
  • Page 93 When T6 is connected for self-inspection, the low battery power alarm will be inspected automatically. If T6 works normally and no alarm is given after the T6 is powered on when the oxygen cylinder is opened, it shows that the voltage is normal.

  • Page 94: Touch Screen Calibration

    7. Trigger pressure function test. The specific steps are as follows: a) The ventilation mode is set to CPAP/PSV ventilation mode, and CPAP pressure is set to 0. b) The trigger pressure is set to -3mbar. c) Inhale through the mask. The ventilator shall supply gas when the inspiratory negative pressure reaches to -3mbar, and will stop supplying gas when the support pressure reaches to the target pressure.

  • Page 95: Flow Sensor

    11.7 Flow sensor calibration Calibration of flow sensor shall be carried out when error of flow monitoring value is large or the flow sensor is replaced. Calibration of flow sensor can be performed according to the following steps: 1. Connect respiratory line and flow sensor. 2.

  • Page 96: Self-Check And Zeroing

    The T6 is equipped with a rechargeable lithium-ion battery, which is powered by a built-in battery through the T6 mainframe. The charging time shall not be less than 8 hours, and the working time under standard conditions shall not be less than 6 hours after full charging.

  • Page 97: Battery Storage

    40%-60%. The battery shall be fully charged before use. Battery replacement 11.12.3 Make sure the T6 mainframe is in shutdown state; Open the battery lock in the direction of the arrow (see Fig. 57); Remove the dead battery from battery case (see Fig. 58);...

  • Page 98: Battery Status Description

    Fig. 11-2 Placement with a new battery Battery status description 11.12.4 The user can view whether the battery is connected, whether the battery is charging, the battery power and other information in the interface. Status of the battery is described as follows: Components Description The battery is not connected...

  • Page 99: Accessories

    11.14 Storage If T6 is not used for a long period of time, following measures are recommended: Clean and disinfect (see Section 6 "Cleaning and disinfection").

  • Page 100: T6 Accessories

    12 T6 accessories Name/model Function Manufacturer Remarks Mainstream carbon Support CO Witleaf Purchased dioxide module M401B monitoring part Notices: ⚫ The accessories listed in this section are applicable to the ventilator. The hospital shall be responsible for ensuring the compatibility between ventilator and accessories.

  • Page 101: Product Specifications

    13 Product specifications 13.1 Safety specifications Medical device management category Category Category III medical devices Electric shock protection Category I device, including internal power supply type Electric shock protection Defibrillation-proof BF type class Operating mode Continuous operation It shall not be used in the presence of flammable Degree of safety for anesthetic gas mixed with air or with oxygen or flammable anesthetic gas...

  • Page 102: Environmental Specifications

    Function With touch screen Interface Network interface Support to connect to PC for software upgrade function Software of the ventilator can be upgraded via USB port, USB interface configuration information and historical data (e.g., trend data, logs, etc.) can also be exported via USB port, and configuration can be transferred between the machines with the same model via USB flash disk drive.

  • Page 103: Gas Supply Specifications

    Battery type Lithium-ion battery Battery capacity 9600mAh Rated battery voltage DC 14.8V Minimum power supply 6h (a new fully charged battery operated in standard time operating conditions) 13.5 Gas supply specifications Gas supply specifications Gas supply Medical oxygen High-pressure gas 3.0-6.0 bar source pressure High-pressure pipe input...

  • Page 104: Parameter Specification

    L/min; No more than 6 cmH2O (adult) at a flow rate of 60 L/min; Expiratory pressure No more than 6 cmH2O (pediatric) at a flow rate of 30 L/min; No more than 6 cmH2O (infant ) at a flow rate of 5 L/min; Trigger mode Trigger mode Pressure trigger, flow trigger...
  • Page 105 2:1～1:4：±10% of set value； 4：1～1：10 Others：±15% of set value Upper pressure 10-100 cmH ± (2cmH O+ 5% of set value) limit ± (0.4 cmH2O + 10% of the setting Pressure trigger -20～-0.5 cmH value) Positive end 0-40cmH ± (0.9cmH2O + 5% of the setting expiratory value) pressure...
  • Page 106 Inspiratory pause 0%-60% Monitored parameters ±2bpm or ±5% of actual reading, Respiratory rate 0～250bpm whichever is greater Inspiratory tidal 0-3,000ml ± (2mL+ 15% of actual reading) (infant volume mode); ± (3mL+ 15% of actual reading) (pediatric mode); ±15% actual reading (adult mode) Expiratory tidal ±...

  • Page 107: Specifications

    Notices: ⚫ When the ventilator is operated beyond the range specified by the manufacture, it may malfunction. Please ensure that the ventilator works under the specified working conditions, so as to maintain stable operation. ⚫ The total system response time of CO concentration is 1 sencond.

  • Page 108: Gas Line Diagram

    13.8 Gas line diagram F ig. 13-1 T6 Product Structure Diagram 13.9 Parts list Symbol NAME Symbol NAME Air filter cartridge Air inlet flow sensor Temperature sensor Primary acoustic box Turbine Secondary acoustic box Temperature sensor Check valve Fresh gas flow sensor...

  • Page 109: Principle Description

    13.10 Principle Description There are two types of oxygen supplies, including high pressure oxygen supply and low pressure oxygen supply: high pressure oxygen is connected via high pressure oxygen inlet 13; and low pressure oxygen is connected via low pressure oxygen inlet 14. Select one oxygen supply type: High pressure oxygen supply or low pressure oxygen supply.

  • Page 110: Emc

    ⚫ The guidelines and manufacturer's statements are detailed in the annexes. Warnings: ⚫ The T6 ventilator shall not be used near or stacked with other devices. If it must be used near or stacked with any other devices then it should be observed to verify that it can operate normally under the configuration used.

  • Page 111: Battery Immunity Declaration - Requirements For All Devices And Systems

    14.2 Battery immunity declaration - requirements for all devices and systems Electromagnetic immunity declaration - requirements for all devices and systems The T6 ventilator can be used in following specific electromagnetic environments, and users shall ensure to use the device in following specified electromagnetic environments. Electromagnetic...
  • Page 112 Common mode: Common mode: ±2kV ±2kV Power frequency 3A/m 3A/m The power magnetic field frequency 50/60Hz magnetic field (50/60Hz) shall have the (GB/T 17626.8) level characteristics of power frequency magnetic field at a typical location in a typical commercial or medical environment.

  • Page 113: Guidelines And Manufacturer's Statement - Electromagnetic Immunity

    14.3 Guidelines and manufacturer's statement - electromagnetic immunity Guidelines and manufacturer's statement - electromagnetic immunity The T6 ventilator is intended to be used in the electromagnetic environment specified below and the purchaser or user shall ensure that it is used in this electromagnetic environment.
  • Page 114 If the measured field intensity at the location of the T6 ventilator is higher than the applicable RF compliance level mentioned above, the T6 ventilator shall be observed to verify its normal operation.

  • Page 115: Recommended Isolation Distance

    Recommended isolation distance between portable and mobile radio frequency communication device and T6 ventilator The T6 ventilator is intended to be used in an electromagnetic environment in which the radio frequency radiation disturbance is controlled. The purchaser or user, depending on...

  • Page 116: Basic Emc Performance Of T6 Ventilator

    14.5 Basic EMC performance of T6 ventilator Basic EMC performance of T6 ventilator The T6 ventilator can work normally according to the parameter settings. For details, please see Chapter 11 of the Manual. The alarms can be given according to real-time monitoring on status of the T6 ventilator.

  • Page 117: Product Warranty

    15 Product warranty Ambulanc (Shenzhen) Tech. Co., Ltd. can carry out free of charge maintenance for the product quality problems occurred during normal use, based on product instructions within two years from the date of purchase. If the warranty period indicated on the product is less than two years, the warranty will expire at the end of the expiration date indicated on the package or in the Operation Manual.

  • Page 118: Classification Details Of Toxic And Harmful Substances

    16 Classification details of toxic and harmful substances Name and content of toxic and harmful substances or elements Hexaval Polybro Polybrominat Mercu minated Lead ed diphenyl Part name mium chromiu bipheny (Pb) ethers (Cd) (Hg) (PBDE) Cr(VI) (PBB) Display screen ×...
  • Page 119 ○ ○ ○ ○ ○ ○ pocket Power ○ ○ ○ ○ ○ ○ cord Connector ○ ○ ○ × ○ ○ Flow ○ ○ ○ ○ ○ ○ sensor Oxygen ○ ○ × ○ ○ ○ sensor ○ ○ ×...

  • Page 120: Storage And Transportation

    17 Storage and transportation The pack products are allowed to be transported by road, air or rail. Shock and violent vibration shall be prevented during transportation. See the description in the table below: Graphic symbols Description Graphic symbols Description This side up Handle with care Stacking layer limit: Keep dry...

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