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NIV BPAP HE User Manual
NIV BPAP HE User Manual
Noninvasive Ventilator
R
Tel:0086-024-31682686
233020021Rev 1.0 2020-02-17
Symbols
C ontents
RoHS
Warnings
01 02
● Do not place this instrument near to or stacked with other equipment. If it is necessary to place this instrument
Preface
near to or stacked with other equipment, inspection and observation must be conducted to ensure that it can
operate normally in such location.The instrument should be placed in a well-ventilated area and not on the soft
surface. BPAP H series ventilator is a breathing ventilation device that can use both non-invasivemask ventilation
and high-flow humidified airflow. Please read and understand thismanual carefully before use.
● Do not use the instrument when it is surrounded by flammable and/or anesthetic gases.
● Stop using the instrument if it has visible external damage, a liquid has entered into the instrument or the outlet
The non-invasive ventilator must be set and used for treatment parameters under theguidance of a
gas is over-temperature or there is abnormal noise. professional doctor.
● The over-use of Heated breathing tubeand nasal cannula can cause infections and other injuries.
● When the instrument is used under specified ambient temperature and humidity conditions, the temperature of
outlet gas isless than 43℃.。 Medical information
● In ventilation mode, the outlet gas may be harmful to the human body, when the room temperature exceeds 35°C.
● In humidification mode, the temperature and humidity will be affected when the ambient temperature exceeds
the specified temperature range of 18 ° C ~ 28 ° C.
This product's non-invasive positive pressure ventilation mode (Ventilation mode for short) can be used
● When the instrument is used beyond the specified ambient conditions (temperature, humidity etc.), the instrument for adult patients with insufficiency of breathing, such as those who do not rely on invasive ventilation
performance will be affected and even damaged and may cause body injuries. support, to provide ventilation assistance and respiratory support; has a high-flow heating and
● When the atmospheric pressure exceeds the specified range, using the ventilator may cause the set pressure to humidification mode (high flow mode for short) The product can be usedfor humidification and oxygen
therapy in adults with spontaneous breathing.
differ from the actual pressure
● AC input should be within ±10% of the rated voltage. AC input beyond this range may cause damage to the This product is not intended for life support, can be used in home environments, and can also be used in
medical institutions. This product needs to be used under the guidance of a professional doctor.
instrument.
● When exposed in an environment of electrocautery, electrosurgery, defibrillation, X-rays (γ-rays), infrared radiation
andtransient electromagnetic fields, including magnetic resonance (MRI) and radio interference, the instrument
★ Heartbeat or breathing stops;
may be interfered.
★ Weak spontaneous breathing and coma;
● When the instrument is blocking, covering or heating the outlet tube,air inlet port may cause overheating or even ★ High risk of aspiration, inability to remove oropharyngeal and upper respiratory secretions,and poor
damage to the instrument. respiratory protection;
● When the instrument is connected to oxygen,it may cause higher output oxygen concentration if the output tube ★ Combined with other organ failure (unstable hemodynamic indicators, unstable arrhythmia,perforation
/ hemorrhage of digestive tract, severe brain disease, etc.)
is blocked.
● The ventilation holes are at the bottom of the water chamber. When moving the humidifier, do not touch the ★ Undrained pneumothorax;
bottom to prevent body injuries. ★ Neck and facial trauma, burns and deformities;
★ Recent face, neck, oral cavity, pharyngeal cavity, esophagus and stomach surgery;
● Pressure and differential pressure sensors are installed inside the device. Pay attention to prevent water from
★ upper airway obstruction;
flowing backwards and causing damage.
★ Obviously uncooperative or extremely nervous;
● Do not move the instrument, place it upside down or tilt it when there is water in the humidification cup, so as to
★ Severe hypoxemia (PaO2 <45mmHg), severe acidosis (pH ≤7.20);
prevent water from flowing back into the instrument which will cause damages to the instrument. Above the
★ severe infection;
humidification cup, label awarning label “Do not Tilt the Instrument When There is Water!” to have attentions.
★ Airway secretions or sputum disorders;
● When the instrument is not in use, pull the plug.
★ Not recommended by other clinicians.
● Do not open the inside of instrument,should be repaired by the authorized maintainer.
Note: It is a relative contraindication. In such patients, the pros and cons of NPPV (non-invasivepositive
● When the treatment instrument is beyond its service life, please contact your dealer or RMS Medical for pressure ventilation) need to be carefully weighed, then decide whether to apply NPPV;
disposition instead of discarding it arbitrarily.
● Adding other components to the respiratory ventilation system will cause the exhalation pressure at the ->Adverse reactions
connection port of the patient to increase. If the patient has abnormal chest pain, dyspnea or severe headache or other adverse reactions,please
● Do not use antistatic or conductive hoses or tubes. contact the clinician immediately.
● The sensor's raw data collected by the ventilator is anti-interference processed by the median average filtering During the use of the ventilator, the following adverse reactions may occur:
method.
● The high-pressure gas must be connected to medical oxygen, and fresh gas cannot be used.
● It is recommended to measure the oxygen concentration at the patient's delivery end.
● The nasal cannula, Heated breathing tube, water chamber, mask, etc. equipped with the ventilator are products
registered separately by manufacturers with medical device qualifications. When using them, please refer to their
own instructions.
● Note:Above mentioned are general warnings and precautions.Detailed special warnings,notes and remarks are
shown in the manual.
03 04
Instrument Information ->Connect the water bag
Hang sterile water bag onto the instrument's high position whenuse the Water
chamber, insert the inlet needle into the rubber plug of water bag, and open the
->Instrument Components
bag's vents. The Water chamber will be added with water automaticallyaccording
to a fixed level.
Instrument.Water chamber.Heated breathing tube.mask or nasal cannula. The instrument
->Warnings:
Please use a medical treatment and no more than 2000ml of sterilized water.
->Components and Functions
After connecting into the water bag, check whether the water is flowing into the
Water chamberand kept below the water line. In case of any problem, replace
the Water chamber.
Make sure water in the Water chamber and water bag will not run out during
use. Otherwise it will cause the Water chamber to run dry and affect the
humidification effect.
When the Water chamber run dry,please replace Water chamber to avoid
Water chamberdamage.
->Warnings:
Please check the Heated breathing tube before connection. If it is damaged or bent, please replace the Heated
breathing tube.The human body should not be in contact with the Heated breathing tube for a long time,
/ otherwise it may cause danger or personal injury.
The Heated breathing tube should not be close to any heating body, and should not cover anything,
otherwise it may cause danger or personal injury.
Display screen The Heated breathing tube should be kept away from all kinds of objects with electronic radiation, as
Buttons
well as various wires and wires to prevent interference.
Oxygen Inlet
->Connect to the oxygen source
System Assembly
! Warnings: when the Water chamber and Heated breathing tube are not installed well, do not open
the
BPAP HF/BPAP HE/BPAP HO BPAP HP/BPAP H
05 06
Operation Panel
->Buttons RATE VT
● The shuttle has three basic operations: confirm(Press down), turn left, turn right.
Mode->S/T
● The shuttle confirm button: In the setting status, press down this button to selector exit
the current function.
● Turn left/right: To realize switching options in the setting mode. To increase ordecrease
data under data-modifying status in the setting mode.
Setting parameters
->Operation method
In the monitoring status, Press this button to enter the setting status.
In the setting interface, when the interface is switched, turn left the
shuttle to exit.
07 08
Tidal volume :200~2000ml ;
Press the shuttle confirmation key to enter the state of parameter IPAP Max: 0.4~4.0kPa(BPAP HF) 0.4~3.0kPa (BPAP HE / BPAP HO / BPAP H) ;
modification after switching to a parameter item, and then the MVAPS IPAP Min: 0.4~4.0kPa(BPAP HF) 0.4~3.0kPa (BPAP HE / BPAP HO / BPAP H) ;
anti-display dialog box of the selected parameter item will lighten. Tidal volume control mode EPAP:0.4~2.0 kPa; Risingtime : 0.1~0.6s, auto Frequency:2-40Bpm
Press the shuttle key to modify the parameter, and then press the Insp. Time:0.5-3s I-trigger:1~6,auto E-trigger: 1~6, auto
Ramp time:0~3min Temperature : 29~34 ℃ off ;
s h u t t l e ke y t o r e t u r n t o t h e s t a t e of o p t i o n s w i t c h i n g
FiO2 :21~100%(BPAP HF / BPAP HE / BPAP HO) ;
Note: when the parameter bit is in gray state, this function is not
available in the current state; when setting clinical parameters such Lflow mode Flow:2~25L/Min ; Temperature:34℃.
as mode, the clinical setting item in the system configuration is (BPAP HF/BPAP HE) FiO2 :21~100% ;
closed (see the icon in the upper right corner of the mode setting
window), and the clinical parameters such as mode cannot be
changed Hflow mode Flow:10~80L/Min ; Temperature:29-37℃.
(BPAP HF/BPAP HE) FiO2:21~100% ;
Note: in breathing mode, the inspirator y and respirator y transitions are triggered by time or by
When the interface changes state, press the left key of shuttle to
Return to menu the exit icon to return to the monitoring interface. At this time, the the patient. According to the patient's respirator y velocity and pressure, the inspirator y triggering
changes made to parameters are automatically stored. sensitivity and expirator y switching sensitivity were set at 1~6 levels. The sensitivity gradually
decreased, which was related to the treatment of diseases and the comfort level of patients, and
must be adjusted by professional doctors according to the specific treatment conditions of
When the ventilator detects In low flow mode and high flow Confirm that the Heated
1.Check the ventilator
that the temperature at the mode, if the ventilator does not breathing tube is not
for malfunction
connection port of the patient detect the heated breathing damaged and inser ted
2. Check whether theuse Middle
(breathing mode is the end of - tube af ter star ting up, the correctly. If the alarm still
environment meets the
the respirator y pipeline, while breathing tube alarm and e x i s t s , p l e a s e re p l a c e
requirements
Overtemperature - humidification mode is the Middle sound alarm shall be displayed t h e H e a te d b re a t h i n g
3. Check whether the
alarm endof the nasal plug catheter) within 5 seconds. tube
breathing line is
exceeds 43℃, an
damaged
overtemperature alarm and an
4. Please contact the
audible alarm shall be 1.Check whether the water
supplier or RMS In low flow mode and high flow
displayed within 15 seconds. chamber is installed inplace
mode, if the ventilator detects
Leakage alarm abnormal air leakage in the 2. Check whether the
- breathing circuit is Middle
system, it shall display the air
leakage alarm and generate the damaged and inserted
S/T、S、T、CPAP、PC、MVAPS 1.Check whether the sound alarm within 5 seconds. correctly
at S/T, S, CPAP, PC, MVAPS tubeis blocked
modes, the pressure atthe 2.Check whether the
Highinspirator y
junction of the patient ventilator is out oforder
pressure alarm Middle In low flow mode and high flow 1.Check for obstruction
(breathing mode is the end 3.Check the patient's mode, if the ventilator detects of water tank, respirator y
of the tube) is 3kPa higher, respirator y status Obstruction - that the system is blocked, it tube or nasal cannula Middle
which should show high 4.Please contact the alarm shall display the blocking alarm 2.Check whether the inlet
inspirator y pressure and supplier or RMS and generate the sound alarm hood and filter cotton are
generate sound alarm.
within 10 seconds. blocked
Check whether the oxygen 1.When the room
When the measured oxygen
source is properly temperature exceeds the
concentration is lower than the In low flow mode and high flow
connected to the oxygen range of 10~30℃, please
limit value, the low oxygen Middle mode, when starting up, when
i n l e t of t h e v e n t i l a t o r do not use the low flow
concentration alarm and sound the pipeline temperature
Adjust the flow of the mode or high flow mode
alarm shall be displayed within Check the exceeds the range of 10~30℃ ,
oxygen source as needed of the ventilator, which
20 seconds ser vice 60 seconds (± 6 seconds) shall Middle
- may not reach the set
situation display the working
temperature
environment alarm and
2.When the use
generate the sound alarm.
environment suddenly
changes, may cause alarm,
When the measured oxygen
1. Adjust the flow of oxygen please start again at room
c o n c e n t r a t i o n e xc e e d s t h e
source as needed temperature for 30 minutes
limit value, a high oxygen Middle
concentration alarm and a 2. Check the oxygen source
sound alarm shall be displayed
within 20 seconds In the startup state, the external 1 Check if power is
power is disconnected and the connected properly
- sound alarm is generated 2 Check whether the Middle
within 10 seconds, lasting for network power supply is
more than 120 seconds. normal
When the breathing mode and the humidification mode switch each other, the "check patient
When the water in the interface" is prompted to remind the correct use of the mask or nasal cannulathe mode switch
Check whether the water
humidifying tank is used up, the in the chamber is boiled
check water volume alarm and up, which may damage
sound alarm shall be displayed t h e c h a m b e r. P l e a s e Middle
- within 20 minutes (flow rate ensure that the water in
higher than 20 l/min) or within the chamber will not be
40 minutes (flow rate lower used up
than 20 l/min)
If you want to force dr y mode off, press the start/stop button for another 3 seconds,
.
but the stored wet gas in the tube may affect the next operation.
. ->Warning
★ After usage, be sure to turn off the oxygen to avoid the accumulation of oxygen in the ventilator.
.
★ In the drying process, do not wear a nasal cannula, so as not to cause damage to the body.
★
★ Heated breathing tube make sure that the instrument is powered off.
-Clean or replace filter cotton
★ Heated breathing tube is unblocked.
and clean vent
★
-Change mask or Heated
->Replacement of parts breathing tube
-Please Water chamber
-Check that the connection is
correct and reliable
-Use only the equipment
recommended and provided
by RMS
Service and Repair -Wait for the pressure to rise or
cancel, shorten the pressure
ramp time
When the warranty ser vice is required, if necessar y, the product circuit diagram and repairable
component information can be provided to the qualified technicians identified by us.
->Ventilation mode
175 SLPM
Pain in the nose -Consult a doctor
-Inflammation
or ears
≥90mL(HC-B1)
>45dB(A)(1m distance)
2~80 L/min;
Lflow mode:2~25 L/min,34℃;
230V~, 50Hz
Hflow mode:10~80L/min,29℃~37℃
Maximum temperature 2.0Kg(BPAP H/BPAP HP); 2.5Kg(BPAP HF/ BPAP HE/ BPAP HO)
of deliver yed gas
Classification of equipment : II BF Grade of waterproof : IP21
10 minutes to 31℃ , 30 minutes to 37℃ Running mode : continuous operationIn the case of Flammable
(water chamber( HC-B1 ),flow35L/min initial temperature 23±2℃) anesthetic gas mixed with air or with oxygen or nitrous oxide,
the device do not use .
Air pressure 70~106kPa
Operating temperature in high flow mode 18℃~28℃
Operating temperature in respiratory mode 5℃~35℃
service temperature 10~95%、 No condensation
10L/min,<20dB(A) (Hflow mode) Storage temperature -20~60℃
Storage humidity 10~95%、 No condensation
Air Circuit Diagram
Appendix A: Electromagnetic Compatibility
Fresh air / medical oxygen
Inlet filtration Fan
Guidelines and manufacturer's declaration - electromagnetic emissions:
The Noninvasive ventilator is intended for use in the electromagnetic environment s pecified as below and
User the purchasers and users should ensure that it is used in such an electromagnetic environment.
Instrument
Electric Circuit Diagram operation panel The Noninvasive ventilator is suitable for use in all facilities,
(display and buttons)
including residential facilities and direct connection to public
low-voltage power supply network for residential buildings.
230L
Turn on/off Main control Flow and oxygen
power supply panel concentration detection Guidelines and manufacturer's declaration - electromagnetic immunity:
The Noninvasive ventilator is intended for use in the electromagnetic environment specified as below and
230N the purchasers and users should ensure that it is used in such an electromagnetic environment.
Fan
Packing list
Recommended separation distance between the portable and mobile RF communication equipment and the
Noninvasive ventilator:
The Noninvasive ventilator is intended for use in an electromagnetic environment with a controlled radio
frequency radiation disturbance. According to the maximum rated output power of communication equipment,
the purchaser or the user can prevent electromagnetic interference by adopting the following recommended
minimum distance between the portable and mobile RF (transmitters) communication devices and the
Noninvasive ventilator.
For maximum rated output power of transmitters not listed in the above table, the recommended separation
distance d, in meters (m), can be determined by use of the formula in corresponding transmitter frequency
column, where P is the max rated output power in watts (w) of transmitter, provided by the manufacturer.
Note 1: at the 80MHz and 800MHz frequencies, formula of the higher frequency band will be used.
Note 2: these guidelines may not apply in all cases. Electromagnetic propagation will be affected
by absorption and reflection of buildings, objects, and human bodies.