Professional Documents
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Ventilator Machine
Service Manual
Shenzhen Northern Meditec Limited (“Northern Meditec”) owns the copyright of this
Manual, which is intended for internal use and shall be regarded as confidential
information. This Manual is provided only as a reference document for the servicing of the
vent.
This Manual and all of its intellectual property rights (including the copyright) are
owned by Northern Meditec. No one is allowed to use, disclose or allow any other person
to get access to this Manual by any means in whole or in part, nor shall anyone
photograph, duplicate, copy this Manual or translate it into any other language in whole or
in part without the prior written permission of Northern Meditec.
Northern Meditec reserves the right to the final interpretation of this Manual. This
Manual, the product technologies and the product specifications are subject to change
without further notice.
Statement
Northern Meditec shall provide no warranty for this Manual, including but not limited
to the implied warranty of merchantability and fitness for a particular purpose.
Northern Meditec shall be held liable for the safety, reliability and performance of
Crius V6 only if:
Northern
The related electrical equipment complies with the applicable national standard;
Northern Meditec shall not be held liable for the safety, reliability and working
condition of Crius V6 if:
Warranty
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Servicing
Free service: applicable to all of the products within the warranty of Northern Meditec.
Paid service:
1) Applicable to all of the products beyond the warranty of Northern Meditec;
2) Applicable to faulted product caused by man-made damage, grid voltage beyond the
specified range or force majeure (like natural disasters) in the warranty period.
Northern Meditec shall not be held liable for any direct, indirect or final damage or delay
caused by improper use, use of any accessory unapproved by Northern Meditec or any
servicing conducted by any person unauthorized by Northern Meditec.
Contact
Manufacturer: Shenzhen Northern Meditec Co., Ltd.
Website: www.northernmeditec.com
Website: http://www.obelis.net
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Chapter 1 Safety.............................................................................................................................5
1.1 Safety Information.............................................................................................................5
1.1.1 Dangers.......................................................................................................................6
1.1.2 Warnings.....................................................................................................................6
1.1.3 Cautions......................................................................................................................8
1.1.4 Notes........................................................................................................................10
1.2 Equipment Symbols..........................................................................................................10
Chapter 2 Structure installation..................................................................................................12
Chapter 3 Theory of Operation...................................................................................................14
3.1. System chart.....................................................................................................................14
3.2. Each board card function.................................................................................................14
3.2.1 AC Power board........................................................................................................14
3.2.2 DC Power board........................................................................................................15
3.2.3 Main control Board...................................................................................................16
3.2.4 Monitor(VCM) board................................................................................................17
3.2.5 Alarm lamp board.....................................................................................................18
3.3. Pneumatic Circuit.............................................................................................................19
Northern
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Chapter 1 Safety
1.1 Safety Information
DANGER
Indicates an imminent hazard that, if not avoided, will result in death or serious injury.
WARNING
Indicates a potential hazard or unsafe practice that, if not avoided, could result in death or
serious injury.
Northern
CAUTION
Indicates a potential hazard or unsafe practice that, if not avoided, could result in minor
personal injury and/or product/property damage.
NOTE
Provides application tips or other useful information to ensure that you get the most from
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your product.
Northern
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1.1.1 Dangers
There are no dangers that refer to the product in general. Specific “Danger” statements may
be given in the respective sections of this manual.
1.1.2 Warnings
WARNING
The ventilator must only be operated and used by authorized medical personnel well
trained in the use of this product. It must be operated strictly following the Operator’s
Manual.
Before putting the system into operation, the operator must verify that the equipment,
connecting cables and accessories are in correct working order and operating condition.
To avoid the risk of electric shock, this equipment must be connected to a properly
installed power outlet with protective earth contacts only. If the installation does not
provide for a protective earth conductor, disconnect it from the power line.
Use external power source (AC power or DC power) before the batteries are depleted.
To avoid explosion hazard, do not use the equipment in the presence of flammable
anesthetic agent, vapors or liquids. When O2 is used, keep the ventilator away from any
fire sources.
Do not place the ventilator adjacent to any barrier, which can prevent cold air from
flowing, resulting in equipment over heat.
Do not open the equipment housings. All servicing and future upgrades must be carried
out by the personnel trained and authorized by us only.
Do not rely exclusively on the audible alarm system for patient monitoring. Adjustment of
alarm volume to a low level may result in a hazard to the patient. Remember that alarm
settings should be customized according to different patient situations and always
keeping the patient under close surveillance is the most reliable way for safe patient
monitoring.
The physiological parameters and alarm messages displayed on the screen of the
equipment are for doctor’s reference only and cannot be directly used as the basis for
clinical treatment.
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To dispose of the package material, observe the applicable waste control regulations. And
keep the package material out of children’s reach.
All staff should be aware that disassembling or cleaning some parts of the ventilator can
cause risk of infection.
Maintenance menu can only be accessed when the equipment is disconnected from the
patient.
Do not use antistatic or conductive masks or patient tubing. They can cause burns if they
are used near high frequency electrosurgery equipment.
Do not use the ventilator in a hyperbaric chamber to avoid potential fire hazard due to an
oxygen-enriched environment.
All analog or digital products connected to this system must be certified to the specified
IEC standards (such as IEC 60950 for data processing equipment and IEC 60601-1 for
medical electrical equipment). All configurations shall comply with the valid version of IEC
60601-1. The personnel who are responsible for connecting the optional equipment to the
I/O signal port shall be responsible for medical system configuration and system
compliance with IEC 60601-1 as well.
Do not touch the patient when connecting the peripheral equipment via the I/O signal
ports or replacing the oxygen cell, to prevent patient leakage current from exceeding the
requirements specified by the standard.
When the ventilator’s gas supply input system fails or has faults, please contact us
immediately for service by specified personnel.
The ventilator shall not be used with helium or mixtures with Helium.
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Do not move the ventilator before removing the support arm from it, in order to avoid the
ventilator getting tilted during the movement.
To prevent possible personal injury and equipment damage, ensure that the ventilator is
secured to the trolley or placed on the safe and smooth surface.
To prevent possible equipment damage, avoid tipping over the ventilator when crossing
thresholds.
To prevent possible equipment damage, push the brake down when parking the
ventilator.
Avoid the use of polluted air. When the equipment uses air as gas source for ventilation, if
the air is polluted, harmful substance may enter the patient tubing
To prevent patient injury caused by equipment malfunction, when the alarm [Technical
Error**] occurs, remove the equipment immediately, record failure code, and contact the
Customer Service Department.
To prevent possible ventilator malfunction, do not spill liquid onto the ventilator.
A turbine can cause gas to be heated. To reduce the temperature of gas inside the tubing
and prevent patient injury accordingly, ensure that the length of patient tubing from the
humidifier to Y piece is greater than 1.2m.
The internal electrical power source is to be used if the integrity of the protective earth
conductor or the protective grounding system in the installation is in doubt.
Nebulization or humidification can increase the resistance of breathing system filters, and
that you need to monitor the filter frequently for increased resistance and blockage.
The ventilation accuracy can be affected by the gas added by use of a nebulizer.
For non-invasive ventilation, the exhaled volume of the patient can differ from the
measured exhaled volume due to leaks around the mask.
Check if the alarm limit settings are appropriate before taking measurement.
When operating the unit with the power supply unit, always connect the unit to an easily
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Stop using the ventilator and contact us immediately when the buzzer sounds.
Under the ambient temperature of 40ºC, the inspiratory pressure of the ventilator
exceeds 60 cmH2O, and the maximum temperature on the surface of breathing mask may
exceed 41ºC but does not exceed 43ºC
1.1.3 Cautions
CAUTION
The ventilator must be inspected and serviced regularly by trained service personnel.
Always have a special person attend and monitor the operation of the equipment once
the ventilator is connected to the patient.
During the operation of the ventilator, do not disassemble the inspiration safety valve and
expiration valve unless in standby status.
To ensure patient safety, use only parts and accessories specified in this manual.
At the end of its service life, the equipment, as well as its accessories, must be disposed of
in compliance with the guidelines regulating the disposal of such products.
Magnetic and electrical fields are capable of interfering with the proper performance of
the equipment. For this reason, ensure that all external devices operated in the vicinity of
the equipment comply with the relevant EMC requirements. Mobile phone, X-ray
equipment or MRI devices are a possible source of interference as they may emit higher
levels of electromagnetic radiation.
This system operates correctly at the electrical interference levels identified in this
manual. Higher levels can cause nuisance alarms that may stop mechanical ventilation.
Pay attention to false alarms caused by high-intensity electrical fields.
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CAUTION
Before connecting the equipment to the power line, check that the voltage and frequency
ratings of the power line are the same as those indicated on the equipment’s label or
specified in this manual.
Always install or carry the equipment properly to avoid damage caused by dropping down,
impact, strong vibration or other mechanical force.
To electrically isolate the ventilator circuits from all poles of the supply mains
simultaneously, disconnect the mains plug.
To minimize the risk of fire, do not use low-pressure gas tubes that are worn or
contaminated with combustible materials like grease or oil.
It is the clinician’s responsibility to ensure that all ventilator settings are appropriate.
To prevent possible patient injury, ensure the ventilator is set up for appropriate patient
type with the appropriate patient tubing. Ensure the System Check is performed before
each patient.
Perform Flow Sensor Calibration before the first use, or when the measured values have
deviations.
To prevent possible patient injury, ensure the ventilation parameters are set up properly
before ventilating the patient.
To ensure the accuracy of oxygen monitoring, replace an exhausted oxygen cell as soon as
possible or use an external monitor that complies with ISO 80601-2-55.
A fan failure could result in oxygen enrichment inside the ventilator and a subsequent fire
hazard.
To reduce the risk of explosion, do not burn the O2 cell or force the cell open.
When ventilating with a mask, avoid high airway pressures. High pressures may cause
gastric distension.
Peak pressures, exceeding 33 cmH2O, may increase the risk of aspiration due to gastric
insufflation. When ventilating with such pressures, consider using an invasive mode.
To reduce the risk of fire, use only tube systems approved for medical purposes and for use
with oxygen between the oxygen source and ventilator.
To reduce the risk of fire, ensure adequate ventilation at the rear of the ventilator.
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To reduce the risk of fire, switch off the oxygen source when the ventilator is not in a
ventilating mode.
Avoid putting the ventilator in the storage environment of more than 50℃ for a long time.
Such environment may damage or shorten the battery lives of internal battery and oxygen
sensor.
To prevent fire hazard, use only specified fuses or fuses with the same type, rated voltage,
and rated current as the existing fuses. When it is necessary to replace fuses, contact the
Customer Service Department.
Additional MULTIPLE SOCKET- OUTLET or extension cord shall not be connected to the
system.
Before moving the ventilator, ensure that the casters and brakes can work properly, and
the main unit is locked on the trolley.
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1.1.4 Notes
NOTE
Put the ventilator and its accessories in a location where you can easily see the screen and
access the operating controls.
Keep this manual close to the equipment so that it can be obtained conveniently when
needed.
The software was developed in compliance with IEC 62304. The possibility of hazards arising
from software errors is minimized.
This manual describes all features and options. Your equipment may not have all of them.
Degree of protection
CE mark
Protective earth ground
Recyclable
The following definition of the WEEE label applies to EU member states only.
This symbol indicates that this product should not be treated as household waste. By
ensuring that this product is disposed of correctly, you will help prevent bringing
potential negative consequences to the environment and human health. For more
detailed information with regard to returning and recycling this product, please
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B
Air Mixed case valve Turbine us
in
te keyboard plate
rf
Monitor board ac
e
bo
ar
d
Exhalation valve
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图 1AC/DC Board
Port connection function:
No. Name Function
1 TB1 TBH1 Connect To AC Power
2 TB2 TBH2 to J3(DC/DC Board)
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图 2 DC/DC Board
Port connection function:
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17 J61 No use
18 J62 J62 To Display Line(Connect To Touch)
19 J63 No use
20 J71 J71 To Plug-board J12
21 J73 No use
22 J76 J76 To Plug-board J10
23 BAT71 BST71 To Battery
图 4 VCM Board
Port connection function:
No. Name Function
1 J1 Connect oxygen battery
2 J3 Connect proportional valve
3 J4 Connect safety valve
4 J6 Reserved for communication between main
control board and monitoring MCU
5 J7 Connect inspiration valve
6 J8 Connect exhalation valve
7 J9 Connect 18V power supply from DC power
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board J4
8 J11 Turbine motor wiring base
9 J12 Solenoid valve connector
10 J13 Oxygen flow sensor connector
11 J14 inspiration flow sensor connector
12 J15 Turbine temperature sensor connector
13 J18 The main control board communicates with
the control MCU
14 J19 Reserved for debugging
15 J20 12v,5v input from DC power board J5
16 J21 Reserved for debugging
J1
图 5 Lighting Board
Port connection function:
No. Name Function
1 J1 J1 is connected to the key control board J4
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F1 Filter (O2) R3 Nebulizer resistor
REG Regulator Nebulizer Nebulizer
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Note:
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3) Select the [OK] button to enter the factory settings menu options interface,
as shown in the figure
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5) Pressure to zero calibration, zero need not make any preparations, start
with [Start]
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6) Calibrate the inhalation flow, you need to open the air path, pull out the
suction pipe, and press [Start] When ready to start calibration. The school
needs to wait patiently for a long time.
7) Calibrate the exhalation flow, need to close the air path, the operation
method is the same as the leak test.
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8) Oxygen sensor calibration, the need to open the air path, the operation
method is the same as the calibration inhalation flow, but the time is relatively
short.
9) Calibration of PEEP pressure requires closure of the air path, and the
operation method is the same as the leak test.
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Note:
Before the upper computer software is upgraded, it must be turned off first. Inserts a USB
drive and starts boot.
1) If the current system is activated, press the system to open the key, pop the
prompt box to select [OK], and enter the shutdown countdown window. After
3) Insert the USB disk into the USB interface, press the system boot key, and
4) Screen prompt upgrade status, and at the same time show the percentage
of progress, such as the upgrade end of the system automatically into the
checking the software version and hardware is correct with the burn program.
Hardware Flash has 64MB and 128MB. If the program update fails, it will stay
1) Do not use this equipment if there are signs of damage to the function of
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3) The maintenance personnel must be familiar with the power supply index,
the polarity Mark and the requirements of the company's products on the
ground line.
5) Be able to pay attention to their own safety and avoid the risk of infection
or infection in construction or maintenance.
7) During site maintenance, the parts and screws that can be removed can be
properly placed and kept in order.
8) Maintenance staff to ensure that the tools in their kit are complete and
well-organized.
9) Are the spare parts packing in good condition? Do not use packaging
defects or accessories if there are signs of damage.
10) After the repair is completed, please clean up the scene and leave.
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