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USER NOTICE
Dear users, thanks for purchasing the Oxygen Concentrator (hereinafter referred to as
machine).
This Manual is written and compiled in accordance with the council directive
IEC 60601-1:2020 and ISO 80601-2-69:2020. The information contained in this document is
subject to change without notice.
The Manual describes, in accordance with the machine’s features and requirements, main
structure, performance, specifications, correct methods for transportation, installation, usage,
operation, repair, maintenance and storage,etc. As well as the safety procedures to protect both
the user and machine. Refer to the respective chapters for details.
Please read the Manual carefully before using this machine. These instructions describe the
operating procedures to be followed strictly. This Manual will tell you the operating
procedures, possible abnormal operation, possible damage to this machine and danger to
personal injury which must be noticed during using this machine. Our company is not
responsible for the safety, reliability and performance issues and any monitoring abnormality,
personal injury and equipment damage due to user’s negligence of the operation instructions.
The manufacturer’s warranty service does not cover such faults.
Owing to the forthcoming renovation, the machine you received may not be totally in
accordance with the description of this Manual. We would sincerely regret for that.
This machine is a medical device, which can be used repeatedly.
Warning:
This Manual only provides technical instruction, please follow doctor's advice for
oxygen healthcare.
The machine doesn't suit for surgery or the salvage of no spontaneous respiratory.
Keep the machine away from strong magnetic field or electromagnetic interference
source.
Open flames during oxygen therapy are dangerous and is likely to result in fire or death.
Do not allow open flames within 2 m of the machine or any oxygen carrying accessories.
Avoid placing the machine in environment with contaminants or fumes.
Please refer to the correlative medical literature about the clinical restrictions and
contraindications.
The machine is only used for supplying oxygen, don't use it for first-aid treatment or
sustaining life.
There is a risk of fire associated with oxygen enrichment during oxygen therapy. Do not
use the oxygen concentrator or accessories near sparks or open flames.
To ensure receiving the therapeutic amount of oxygen delivery according to your medical
condition: the machine must be used only after one or more settings have been
individually determined or prescribed for you at your specific activity levels.And the
machine must be used with the specific combination of parts and accessories that are in
line with the specification of the concentrator manufacturer and that were used while
your settings were determined.
Our company reserves the final elucidative right.
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Contents
IMPORTANT INFORMATION ............................................................................................... 1
CHAPTER 1 OVERVIEW ........................................................................................................ 6
1.1
FEATURES .......................................................................................................................... 6
1.2
APPLIED RANGE ................................................................................................................. 6
1.3
ENVIRONMENT................................................................................................................... 6
CHAPTER 2 PRINCIPLE ........................................................................................................ 7
2.1
BASIC PRINCIPLES .............................................................................................................. 7
2.2
OXYGEN SWING ABSORBERS(PSA) .................................................................................... 7
2.3
UNCERTAINTY OF PARAMETER MEASUREMENT ................................................................. 7
CHAPTER 3 TECHNICAL CHARACTERISTIC ................................................................. 8
3.1
MAIN PERFORMANCE ......................................................................................................... 8
3.2
MAIN PARAMETERS............................................................................................................ 8
3.3
SAFETY CATEGORIES .......................................................................................................... 9
CHAPTER 4 INTRODUCTION FOR PARTS AND FUNCTIONS .................................... 10
4.1
PARTS NAME .................................................................................................................... 10
4.2
ALARM ............................................................................................................................. 11
4.3
FUNCTIONS FOR ACCUMULATING TIME ............................................................................ 12
4.4
FILTER .............................................................................................................................. 13
4.5
FUNCTION OF TIMING SHUTDOWN ................................................................................... 13
4.6
ACCESSORIES ................................................................................................................... 13
4.7
SOFTWARE INFORMATION ................................................................................................ 13
CHAPTER 5 OPERATION..................................................................................................... 14
CHAPTER 6 MAINTENANCE, TRANSPORTATION AND STORAGE ........................ 16
6.1
CLEANING AND DISINFECTION ......................................................................................... 16
6.2
MAINTENANCE ................................................................................................................ 17
6.3
TRANSPORTATION AND STORAGE ..................................................................................... 18
CHAPTER 7 TROUBLESHOOTING ................................................................................... 19
CHAPTER 8 SY MBO L MEANINGS .................................................................................... 21
APPENDIX 1 ALARM INFORMATION .............................................................................. 23
APPENDIX 2 EMC GUIDANCE AND MANUFACTURER’S DECLARATION ............. 24
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loss to property.
Important information
Please read the Manual carefully before using the machine.Do not use this product or any
available optional equipment without first completely reading and understanding these
instructions. If you are unable to understand the warnings, cautions or instructions, contact a
healthcare personnel before attempting to use this equipment-otherwise,injury or damage may
occur.
The safety prompt symbols(such as warning, attention, etc.) described in the Manual apply to
all dangerous operations which may result in the loss of personal property, as defined below:
Symbol
Warning: high hazard, improper operation may cause injury and death to person
or loss to property.
Attention: potential hazard, improper operation may cause injury to person or
Warning:
No modification of this equipment is allowed.
Do not modify this equipment without authorization of the manufacturer.
If this equipment is modified, appropriate inspection and testing must be conducted to
ensure continued safe use of the equipment.
Additional monitoring or attention may be required for patients using this device who are
unable to hear or see alarms or communicate discomfort.
Meanings
The machine is only applicable for use following the applied range described in the
Manual, it can't be used for first-aid treatment or sustaining life.
Oxygen therapy in certain circumstances can be hazardous, seeking medical advice before
using the machine is advisable.
The concentrator should always be kept in the upright position to prevent cabinet damage
while being transported .
Avoid severe vibration and lying upside down during transportation.
To avoid electroshock hazard, maintenance to the machine only can be performed by the
personnel appointed or authorized by manufacturer. Users are not permitted to maintain it by
themselves.
Such as power supply voltage instability, beyond AC220 V±22 V range, please install the
regulator before use.
Do not lubricate fittings, connections, tubing, or other accessories of the oxygen
concentrator to avoid the risk of fire and burns.
The oil, grease or such substances contacted with oxygen at a certain pressure may
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produce strong self-ignition. So they should be placed far away from the machine, pipeline,
connector and other equipment related to the oxygen. No lubricant can be used in the machine
without prior written consent of the manufacturer.
Oxygen is a kind of combustion-supporting material, so don't use the machine in
environment with inflammable and explosive goods. And smoking or naked flames (including
the electrostatic spark caused by friction) is prohibited during using.
Don't place the machine in wet environment, and avoid dripping water or other liquid into
the machine.
Don't immerse the machine into any liquid. If the machine is splashed or coagulated by
water, please stop operating.
Avoid using it during bathing. If the patient needs to be provided oxygen continuously,
please use it in the other room which is far away from the bathroom at least 2.5 m.
If the machine drops into water or other liquid carelessly, please don't touch, shut off
the power immediately and contact the authorized dealer or manufacturer.
The machine should be used in a well-ventilated room, and it should be placed far away
from the wall, furniture or similar goods for more than 10 cm.
NEVER block the air opening of the product or place it on a soft surface,such as a bed or
couch, where the air opening may be blocked.Keep the opening free from lint,hair and the
like.
Keep the machine clean, and don't drip or insert any substance into the outlet.
To reduce the accidental risk, please obey the following operations:
Don't move the machine under the state of working.
After connecting to the power, the machine needs to be looked after always.
Keep the power cord away from the objects generated heat or heating objects.
When the machine is not used, please cut off power. Don’t use the device in a place
where it is difficult to disconnect the power supply.
In order to cut off from the network power supply, the plug must be unplugged when
the device is not used.
Don't drag the power cord to avoid electric shock hazard.
It may influence the machine performance when using it near the portable communication
equipment.
Do not use the machine near the device with the frequency of 430 MHz~470 MHz, such
as wireless intercom equipment, or it may cause an unexpected interference to the machine
and once occurred, the machine need a restart.
There is a risk of inaccurate results or unexpected interference to use the machine during
specific investigations or treatments.
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Please operate the machine following doctor's advice or operation steps described in the
Manual, if lack of oxygen or insufficient oxygen concentration, please contact the doctor or
dealer immediately, don't adjust it by yourselves.
Check the machine periodically to make sure that there is no visible damage that may
affect patient’s safety or monitoring performance. It is recommended that the machine should
be inspected weekly at least. When there is obvious damage, or any one of the following
situations appears: (1)the power cord or the plug is broken, (2)the machine can't work
normally, (3)the machine is broken, please contact the engineer for maintaining.
Please don't connect the machine with other concentrator or oxygen therapeutic
equipment in series or parallel.
Use only spare parts recommended by the manufacturer to ensure proper function and to
avoid the risk of fire and burns.
It is recommended by the manufacturer that keep the machine working for thirty minutes
at least after switching on it, and avoid switching on/off the machine frequently, otherwise it
will shorten the life of the machine.
The oxygen delivery settings of the oxygen concentrator should periodically reassessed
for the effectiveness of the therapy.
Medical disposable nasal cannula is sterilized by ethylene oxide gas. Please don't use it if
the package is damaged.
DO NOT use the machine while examining by MRI and CT, as the induced current may
cause burn.
The device cannot be used in the MRI environment.
The disposal of scrap machine and its accessories, packings, wastes and residue should
comply with the corresponding national laws and regulations, to avoid polluting to the local
environment. And the packaging materials must be placed in the region where the children are
out of reaching.
Smoking during oxygen therapy is dangerous and is likely to result in facial burns or
death. Do not allow smoking within the same room where the oxygen concentrator or any
oxygen carrying accessories are located. If you intend to smoke, you must always turn the
oxygen concentrator off, remove the cannula and leave the room where either the cannula or
mask or the oxygen concentrator is located. If unable to leave the room, you must wait 10
minutes after you have turned the oxygen concentrator off before smoking.
Use only water-based lotions or salves that are oxygen-compatible before and during
oxygen therapy. Never use petroleum or oil-based lotions or salves to avoid the risk of fire
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and burns.
Oxygen makes it easier for a fire to start and spread.Do not leave the nasal cannula or
mask on bed coverings or chair cushions, if the oxygen concentrator is turned on, but not in
use; the oxygen will make the materials flammable. Turn the oxygen concentrator off when
not in use to prevent oxygen enrichment.
Geriatric, paediatric or any other patient unable to communicate discomfort can require
additional monitoring and or a distributed alarm system to convey the information about the
discomfort and or the medical urgency to the responsible care giver to avoid harm.
If you feel discomfort or are experiencing a medical emergency while undergoing oxygen
therapy, seek medical assistance immediately to avoid harm.
The oxygen delivery setting has to be determined for each patient individually with the
configuration of the equipment to be used, including accessories.
The proper placement and positioning of the PATIENT interface is critical to the
effectiveness of the therapy.
It is dangerous for children to play with the accessories, ensure the accessories are
placed where the children are out of reaching.
Attention:
Keep the machine away from dust, vibration, corrosive or flammable substances, and
higher or lower temperature and humidity.
The person who is allergic to silicone, PVC, TPU, TPE or ABS can not use this machine.
Accessories must be routed and secured properly. Don’t position the tubes or cords
around the neck. Ensure the patient can move freely while wearing the cannula. Ensure
the tiny parts be placed away from children to avoid accident swallow.
Keep children and pets away from nasal cannula and tubing to avoid choking or
strangulation or in case they may cause an unexpected change on the controller.
Please check the packing before use to make sure the machine and accessories are totally
in accordance with the packing list, or else the machine may have the possibility of
working abnormally.
Please use the accessories properly, for example, use of a paediatric cannula on an adult
patient may cause adverse effect on the therapy.
Ensure the oxygen concentrator, its parts and accessories are specified for use at rated
flowrate.
Incompatible parts or accessories can result in degraded performance.
The responsible organization can be accountable for ensuring the compatibility of the
oxygen concentrator and all of the parts or accessories used to connect to the patient
before use.
When the machine is carried from cold environment to warm or humid environment,
please do not use it immediately, wait four hours at least is recommended.
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Never try to sterilize the machine by high temperature or high pressure or steam
sterilizing process, please refer to relative chapters in the Manual for cleaning and
disinfection.
The machine doesn't suit all users, if you can't get satisfactory result, please stop using it.
Date of manufacture: see the label.
During the test normal operation of the OXYGEN CONCENTRATOR will deplete the
ambient oxygen inside the environmental chamber if the gas output leaves the
environmental chamber. An external air source is required to compensate and monitoring
of the oxygen concentration inside the chamber is recommended.
Any serious incident that has occurred in relation to the device should be reported to the
manufacturer and the competent authority of the Member State in which the user and/or
patient is established.
If necessary, our company can provide some information(such as circuit diagrams,
component lists, illustrations, calibration methods, etc.), so that the qualified technical
personnel of the user can repair the machine components designated by our company.
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Chapter 1 Overview
The machine is a small and mobile Oxygen Concentrator which is consisted of main unit,
humidifier bottle, flowrate controller, etc. It takes the molecular sieve as the adsorbent, adopts
pressure swing absorbers(PSA) directly concentrate the medical oxygen from the air.
The machine takes the advantages of small in volume, light in weight, convenient in
moving(as it has the turning truckle), stable in performance, high in safety, easy in operating,
low in noise, safe in working, which complies with requirements of medical device.
1.1 Features
a. Easy and convenient to operate.
b. Small in volume, light in weight and low in power consumption.
c. Concentrate the oxygen with high concentration from the air directly, easy to operate.
1.2 Applied range
1.2.1 Intended use / intended purpose
The device can be used in medical institutions for supplying oxygen for hypoxia patients.
1.2.2 Patient Population
Adult and child.
1.2.3 Intended users
Professional medical staff.
1.2.4 Medical indications
The device can be used for adjuvant therapy of diseases (including cardiovascular disease,
respiratory system disease, hypoxic disease).
1.2.5 Contraindications
Patients with oxygen poisoning or oxygen allergy.
1.3 Environment
a. Temperature: 10 ℃~40 ℃
b. Relative humidity: ≤80 %
c. Atmospheric pressure: 860 hPa~1060 hPa
d. Power supply: AC220 V ~ 50 Hz
e. Input power: 450 VA
Attention:
① If stored or used the machine outside the temperature and humidity specified by the
manufacturer, the system may not achieve the performance standards declared.
② The temperature and atmospheric pressure range of oxygen concentration status
indicator(OCSI) is consistent with the machine.
③ Use of this device at an altitude above 1900m is expected to adversely affect the flowrate
and the percentage of oxygen and consequently the quality of the therapy.
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Chapter 2 Principle
2.1 Basic principles
The device takes air as the material, adopts pressure swing adsorption (PSA) to generate the
oxygen (concentration 90 % ~ 96 %, oxygen 93 percent for short).
2.2 Oxygen swing absorbers(PSA)
Pressure swing adsorption, atmospheric pressure desorption. The compressed air passed the
air filter respectively enters the separated electromagnetic valve, then the nitrogen, carbon
dioxide, vapour in air is selectively adsorbed by the molecular sieve, and oxygen enrichment
passed the separation unit of nitrogen and oxygen to form product gas. When the molecular
sieve in the separation unit of nitrogen and oxygen adsorbs near the status of saturation, the
compressed air enters the other molecular sieve regenerated to continue adsorbing oxygen.
The saturated tower makes the molecular sieve desorb and regenerate by decompressing to
atmospheric pressure and introducing some oxygen for cleaning the beds of molecular sieve,
to prepare for next adsorption. The separation unit of nitrogen and oxygen consisted in series
or parallel achieves the purpose of getting continuous production of oxygen through the PLC
system controlling.
Sieve is a porous filtering material and is considered a wear item. Some factors that could
affect sieve material life include humidity, temperature, particulates, air contaminates, air
intake, vibration and other environmental conditions. The frequency or intensity of use may
also affect the effective service life.
Figure 1
2.3 Uncertainty of parameter measurement
Serial
number
1
2 concentration 93% ±3 % ±0.4%
Note: The tolerances declared in the documents include the uncertainty of the measurement.
test parameter value Device error
Maximum recommended
flowrate
5 L/min ±10% ±2%
measurement
uncertainty
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Chapter 3 Technical characteristic
3.1 Main performance
1) With turning truckle, easy to move.
2) Remove the impurity by built-in filter.
3) OCSI function.
4) Function of accumulating time.
5) Function of timing shutdown.
6) Alarm for power failure.
7) Alarm for low power supply.
8) Alarm for high/low pressure protection.
9) Alarm for low flowrate.
10) Alarm for high temperature.
11) With working indicator.
3.2 Main parameters
1) Maximum recommended flowrate: 5 L/min
2) Flowrate range: 0.5 L/min~5 L/min
3) Oxygen concentration(reach the stated oxygen concentration after turning on the machine
for about 30 minutes): 93 %±3 % (percentage of volume) when the flowrate at the range
of 0.5 L/min~5 L/min.
4) Flowrate range when the outlet nominal pressure is 0 and 7 kPa: 0.5 L/min ~ 5 L/min
5) Flowrate change in maximum recommended flowrate when back pressure of 7 kPa is
applied: <0.5 L/min.
6) Outlet pressure: 20 kPa~50 kPa
7) Input power: 450 VA
8) Working voltage: AC220 V±10 % ~ 50 Hz±1 Hz
9) Operating noise: ≤55 dB(A), at the flowrate of 5 L/min
10) When the outlet nominal pressure is 0, the function diagram for oxygen concentration
and flowrate is shown as Figure 2:
Figure 2
11) The relationship between oxygen concentration and altitude
In the plateau environment, with the increase of altitude, the atmospheric pressure
gradually decreases, the oxygen intake rate also decreases. At the same flowrate, the
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Altitude: m
Oxygen concentration: %
output oxygen concentration in the plateau environment is lower than that in the plain
environment.
Figure 3
12) Dimension: 508 mm×260 mm×530 mm
13) Weight: 21 kg
3.3 Safety categories
a. Device class: class Ⅱ equipment
b. The degree of protection against electroshock: type BF applied part(medical disposable
nasal cannula)
c. The degree of protection against ingress of water: IP21
d. Operation mode: continuous operation
e. Applied part for protecting defibrillator discharge effect: no
f. Signal input/output parts: no
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4.1 Parts name
Chapter 4 Introduction for parts and functions
Figure 4 Front panel view
Figure 5 Rear panel view
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Flowrate controller: anti-clockwise rotate the knob to increase the oxygen flowrate(the
maximum recommended is 5 L/min); clockwise rotate it to decrease the oxygen
flowrate(the minimum recommended is 0.5 L/min). And the LCD displays the flowrate
value.
Note:There will be a delay in the flow of electronic display. Please adjust the flow after
the display is stable.
Power switch: switch on the power to open the machine, then it can work normally,
switch off the power, then it stops working. The concentrator is isolated from the
SUPPLY MAIN by the Power switch.
Overload protector: when the operating current exceeds the current value limited by the
overload protector, the overload protector disconnects and the machine turns off, then
turn off the power switch and cut off the power immediately, after excluding the
over-current reasons, press it, the machine will return to normal.
Power indicator: it is green when the power is turned on; in power failure state, switch on
the power switch, the indicator is not light.
Low concentration indicator: the yellow indicator is light when the oxygen concentration
is below 82 %(+3 %), and the red indicator is light when the oxygen concentration is
below 60 %(±5 %).
Setting button for timing shutdown: press “+”, “-” to adjust the time for timing shutdown,
range: 0~120 minutes, step: 5 minutes.
Oxygen outlet: when the machine starts working, it exports high-concentration oxygen
with constant speed from this outlet.
Over-pressure relief valve: when the pressure in the humidifier bottle is too high which is
arisen from occlusion or bending of nasal oxygen cannula, the over-pressure relief valve
will reduce the pressure in the bottle by releasing the oxygen in the humidifier bottle, to
ensure that the machine can work normally.
Humidifier bottle: connect the top screw cap with the oxygen outlet of the machine. The
oxygen entered into the humidifier bottle is humidified, then output the oxygen from the
oxygen outlet.
Air intake filter: be used to purify the air inhaled by the machine, and it is placed in air
intake filter box.
Power socket: the power cord connects with the machine by this socket, to provide stable
AC for the machine. Plug power cord to an electrical outlet otherwise you can not use the
concentrator.
Exhaust port: be used for ventilation, heat radiation and waste gas output. It should be
kept smooth.
Use the accessories not specified by the manufacturer may affect the machine
performance.
4.2 Alarm
A. Alarm for power interruption
When the machine works normally, cut off the mains power, the machine gives an auditory
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alarm, which will stop after continuing for a moment.
When the alarm occurs, turn off the machine at first. Then make sure the power plug is
connected well and there is no power failure. Turn on the machine again, if alarm still exists,
please turn off and contact the dealer.
This alarm can be triggered by unplugging the power cord during normal operation.
B.Alarm for low power supply
When the power supply falls below the value necessary to maintain normal operation of the
concentrator, it will give a visual (the red indicator flashing (frequency:2 Hz) for alarm) and
auditory alarm.
When alarm occurs, better to use a voltage regulator as power supply to the concentrator.
C. Alarm for high/low pressure protection
When the abnormalities(the pressure in the oxygen tank is too low or high) appear, the
machine will give a visual (the red indicator flashing (frequency:2 Hz) for alarm) and auditory
alarm.
When the alarm occurs, make sure the flowrate is adjusted within normal range. Rolling the
knob clockwise to decrease it or anti-clockwise to increase it. Once corrected, turn it off for
60 seconds and then turn power back on.
D. Alarm for low flowrate
When the machine works normally, if the flowrate is lower than 0.5 L/min, the machine will
give a visual (the red indicator flashing (frequency:2 Hz) for alarm) and auditory alarm.
When the alarm occurs, rolling the knob anti-clockwise to increase it, and wait with a few
minutes.
This alarm can be triggered by setting the flowrate below 0.5 L/min.
E. Alarm for high temperature
When the machine works abnormally, and the air temperature is higher than default setting,
the machine will give a visual (the red indicator flashing (frequency:2 Hz) for alarm) and
auditory alarm.
When the alarm occurs, check if the cabinet filters requires replacement. Make sure the
oxygen concentrator is at least three inches away from walls,draperies or furniture. And don’t
use it within a short time to make sure the machine cools down adequately.
F. Alarm for low oxygen concentration
When the machine works normally, if the oxygen concentration is less than 82 %(+3 %), the
yellow indicator is light, then please contact the suppliers, users can continue to use it, but
make sure that there is spare oxygen nearby. When the oxygen concentration is less than
60 %(±5 %), the red indicator flashes, please turn it off immediately, use the spare oxygen and
contact the suppliers in time.
This alarm can be triggered by setting the flowrate to maximum, the yellow indicator light
illuminates first, and then the red .
4.3 Functions for accumulating time
When the machine works normally, the LCD displays the accumulated time, unit is hour,
when it arrives 99999, the machine stops accumulating.
When using the function of timing shutdown, the LCD can't display the accumulated time.
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Turn it on again, the LCD will accumulate the time automatically.
4.4 Filter
A filter is placed between the oxygen tank and oxygen outlet, it can filter such particles whose
diameter is more than 1 μm, which ensures the oxygen quality.
4.5 Function of timing shutdown
The machine has the function of timing shutdown, user can set the working time (range:
0~120 minutes) according to requirements.
4.6 Accessories
a. A humidifier bottle(M14×1.5)
b. A User Manual
c. A power cord (HSC-401+HSC-406)
d. A medical disposable nasal oxygen tube(gift for test machine)
4.7 Software information
Software name:
CONTEC21/OC5B
Software model: no
Version: V1
Naming rule for version: <Major enhancive software upgrade>.<Minor enhancive software
upgrade>
The software version can be found in the machine.
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Oxygen outlet
The screw cap of top cover
Top cover
Over-pressure safety valve
Chapter 5 Operation
A. Check the filter sponge
Before turning on the machine, please check the intake filter sponge to make sure that it is
clear and dry. Refer to section 6.1 for its maintenance.
B. Connect with humidifier bottle
Figure 6 Humidifier bottle
1) Clockwise screw the knob on the top cover of the humidifier bottle, to take out the
humidifier bottle.
2) Remove the top cover of the humidifier bottle. Inject distilled water or cold water to the
humidifier bottle to the position between "MINIMUM" and "MAXIMUM", then
tighten the top cover of humidifier bottle.
3) Connect the humidifier bottle to the oxygen outlet of the machine in counter clockwise
direction.
4) Connect the oxygen tube to the oxygen outlet of the machine.
Please inject water to the humidifier bottle following the Manual, the water volume
should not exceed the maximum scale marked on the humidifier bottle, otherwise it may
spilled over from the cannula which can cause the user choked.
C. Connect the power cord
Turn off the power switch, connect the machine to the power socket by the power cord.
D. Startup for the machine
Turn on the power switch, the power indicator is light, then the machine can work normally.
After the the start-up interface showed as figure 7, it enters the main interface, as figure 8. It
displays the status “Normal” and the accumulation time(as “00004h”) normally.
Adjust the flow controller clockwise to decrease it or anti-clockwise to increase it, to make it
in the location recommended by the medical personnel, then the machine will export
Figure 7 start-up interface Figure 8 main interface
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continuous and stable oxygen.
When it is abnormal, the status displayed in the screen would change, like “EL” “EH” “ELL”
“ET”“EP”. And other visual and auditory alarm could occur in the meantime.
E. Start absorbing oxygen after connecting the oxygen tube
Place the cannula over your ears and position the prongs in your nose as instructed.
Figure 9
Gas flow at the outlet of the cannula can be checked while the concentrator is warming up.
Wave your hand in front of the nasal prongs. You should be able to hear and feel the flow of
gas. If you do not feel the gas flow, check the cannula connection for leaks. Or place the end
of the nasal cannula under the surface of half-full cup of water and look for the bubbles.
F. Setting for timing shutdown
After turning on the machine, the accumulated time displays on the LCD, press “+” or “-” to
enter timing interface, the original value is 30 minutes, it increases five minutes each pressing
“+” once, the maximum is 120 minutes. The timing time decreases five minutes each pressing
“-” once, 0 minutes at least. Set a value as medical personnel recommend, when the machine
runs to the set time, it will turn off automatically.
Figure 10 original timing time Figure 11 after pressing button“-”
G. Finish absorbing oxygen
After stopping absorbing oxygen, turn off the power switch, pull out the power plug to cut off
the power.
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Chapter 6 Maintenance, transportation and storage
Don’t maintain the machine when operating.
6.1 Cleaning and disinfection
Please cut off the power before cleaning or disinfection.
A. Cleaning for the humidifier bottle
1) Take off the humidifier bottle.
2) Unscrew the bottle cap, Remove the small cap at the end of the air duct on the bottle cap,
immerse the removed cap, cup body and cap in 3 L of 1:270 (detergent to water ratio) Ruhof
cleaning solution for 10 minutes.
3) Soak the cleaning cloth with cleaning solution until it drips water.
4) Scrub the cup body and bottle cap part with a cleaning cloth, especially the rotating thread
of the cup cap, the cavity and the hose connected with the cup cap, and scrub each part for 2
minutes.
5) Use a small brush to soak the cleaning solution in the above steps to brush the cap, inner
wall of the air duct, threads and small holes on the bottle cap, and each part shall be brushed
for 1 minute.
6) Rinse the cup and cap with running water for 1 minute per section.
7) Dry the cup and cap with a clean soft cloth or air dry.
8)Please carry out visual inspection for the bottle and cover after above operations.Repeat the
operation 2-8) if there is still visible impurity remained.
B. Cleaning/replacement for the intake filter sponge
Figure 12 Figure 13
1) Remove the grid, take out the sponge.
2) Soak the sponge in 1:270 Ruhof cleaning solution (the ratio of detergent to water) for 5
minutes.
3) Rub the sponge in the cleaning solution for 2 minutes.
4) Rinse the foam on the sponge with running water for 2 minutes until there is no foam.
5) Dry it for future use.
6) Please carry out visual inspection for the sponge after above operations. Repeat the
operation 2-5) if there is still visible impurity remained.
Note: it is recommended that the filter sponge should be cleaned once per 100 hours, clean it
with water, reinstall it to the machine after fully drying. Please replace another new filter
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sponge if the one cleaned is not completely dry if the device need to be used immediately.
It may cause harm to the machine if the intake filter sponge is not installed to the machine
or turning on the machine when the intake filter sponge is not fully dried.
C. Replacement for the intake filter
Figure 14 Figure 15
Check the internal filter material by the plastic shell of the intake filter, it is recommended to
replace it when the black area reaches 80% or more. Press the filter cover by hand, open the
cover after unlocking, then unplug the intake filter to replace it.
It is recommended that the intake filter should be replaced once per 1000 hours at most. Or
the lifetime of the machine could be influenced to a certain degree, even the oxygen
concentration could be reduced when the filter is clogged severely.
The intake filter is a dissipative part which is not applicable for long-term use.
D. Replacement of nasal oxygen tube
The nasal oxygen tube is a sterile and disposable product, do not use it repeatedly or
crosswise, or it will be insanitary and may be harmful to your health. User can purchase the
nasal oxygen tube certificated by self.
To avoid cross-infection, it is recommended that each person uses the oxygen tube solely.
The oxygen tube is disposable, repeated use have a risk of infection.
The nasal oxygen tube is the only parts or accessories of the oxygen concentrator intend for
single use.
Cannula requirements: length of 4-25 ft including all oxygen tubing, with crush-proof and
single lumen tubing. For example, adult standard flow (rated for up to 6L/min continuous
flow) for lengths up to 7 ft.
Note: The nasal oxygen tube may become contaminated with body fluids or expired gases
during both NORMAL CONDITION and SINGLE FAULT CONDITION.
Note: Patients should use disposable nasal oxygen tubes of appropriate specificaations. The
following action is prohibited: Use of a paediatric cannula on an adult patient.
6.2 Maintenance
1) Please cleaning and disinfection refer to relative chapters (6.1) in the Manual.
2) The machine has 3-year service life, and sieve beds for a period of one year. It is
recommended to replace the molecular sieve when it reaches up to the expected hours
or the low oxygen concentration alarm appears. Keep the machine working for 30
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18
minutes at least after switching it on, and avoid switching on/off the machine frequently,
otherwise it will shorten the life of the machine.
Note: No lubricants other than those recommended by the manufacturer are to be used.
6.3 Transportation and storage
1) The packed machine can be transported by ordinary conveyance or according to
transport contract. During transportation, avoid strong shock, vibration and splashing
with rain or snow, and to avoid damage, please keep upright, no turning over.
2) The packed machine should be stored in room with no corrosive gases and good
ventilation. Temperature:-20 °C ~ +55 °C; Relative Humidity: ≤95 %.
3) Unpackaged machine should be stored in a dry area, humidity of 40 % or below is
recommended. High humidity may influence the life of the sieve beds.
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19
light.
the machine is broken.
replace the molecular sieve.
4) The machine failure.
2) Please contact the dealer.
Chapter 7 Troubleshooting
Trouble Possible Reason Solution
Turn on the
power switch, the
machine doesn't
work or the
indicator isn't
The machine
stops after
working for a
period of time, or
the oxygen
concentration
descends.
1) The power plug is not
inserted well.
2) No live with the power
socket.
3) The control board of
1) Occlusion for the air
intake or exhaust port
2) The intake filter
sponge is dirty.
3) The air intake filter is
dirty.
4) Too high temperature.
5) Too low voltage of the
machine.
6) The fan doesn't work.
7) The molecular sieve
failure.
1) Check the power plug.
2) Check the power.
3) Please contact the dealer.
1) Place the machine to the clear
location in room, or check the
air intake or exhaust port.
2) Install the intake filter sponge
via cleaning and drying.
3) Replace the filter.
4) Place the machine to the
ventilated location.
5) Collocate the manostat to
ensure the voltage is in the
range of 220 V±10 %.
6) Replace the fan.
7) Contact the suppliers to
The machine
can't export
oxygen, and
there is no
bubble in the
humidifier bottle.
Big noise with
abnormal sound.
LCD display
"ELL"
1) The knob of flow
controller is close.
2) The oxygen tube is
kinked or damaged.
3) The top cover of
humidifier bottle is not
screwed.
The machine failure. Please contact the dealer.
low flow alarm:
kinked or blocked tubing,
cannula or humidifier.
1) Open the flow controller and
check.
2) Unwrap the knot or replace the
oxygen tube.
3) Screw down the top cover of
the humidifier tube.
4) Please contact the dealer.
1) Inspect for kinks or
blockages.Correct,clean or
replace item.Inspect the
flowrate controller and LCD,if
it is lower than 0.5 L/min,
rolling the knob anti-clockwise
to increase it.
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20
LCD display
2) Please contact the dealer.
2) Please contact the dealer.
machine off, then turn on again.
4) Please contact the dealer.
normal operation.
"EL"
LCD display
"EH"
LCD display
"ET"
System low pressure
System high pressure
Overheat alarm:
unit overheating due to
blocked air intake.
1) Inspect the flowrate controller
and LCD,if it is higher than 5
L/min,rolling the knob
clockwise to decrease it.
1) Inspect for kinks or
blockages.Inspect the flowrate
controller,if it is lower than 0.5
L/min,rolling the knob
anti-clockwise to increase it.
1) Remove and clean cabinet
filters.
2) Ensure oxygen concentrator at
least three inches away from
walls, draperies or furniture.
3) Wait at least an hour with the
LCD display
"EP"
Power supply falls below the
value necessary to maintain
A voltage regulator is suggested
when the power supply is not stable.
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21
Chapter 8 Symbol Meanings
Symbol Meanings
Follow instructions for use
between 60 % to 82 %
O
2
Alarm
Do not smoke
No open flame: Fire, open ignition source and smoking prohibited
Power indicator
Power ON Switch
Power OFF Switch
Decrease the time for timing shutdown
Increase the time for timing shutdown
Timing range: 0 ~ 120 minutes, step: 5 minutes
+ Increase the flowrate
- Decrease the flowrate
Overload protection（250V, 3A）
Type BF applied part
Class II applied
IP21
Covering Protection rate
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22
Manufacturer
Serial Number
STERILE|EO Sterilized using ethylene oxide
Disposable device, do not re-use
Lot number
This way up
Fragile, handle with care
Keep in a cool, dry place
Stacking layers limit
Atmospheric pressure limit
Temperature limit
Humidity limit
WEEE disposal
Expiration date
Date of manufacture
Authorized representative in the European community
Product code
Imported by
Medical Device complies with Directive 93/42/EEC
Page 28
23
delay
supply
Appendix 1 Alarm information
State Screen display
1 Power failure —— Technical alarm
2
3 High temperature
4 High pressure EH Technical alarm 8 s High
5
6 Low flowrate ELL Technical alarm 10 s High
7 Low pressure EL Te c hnical alarm 8 s High
Audio characteristic for alarm:
High-level alarm: pulse burst composed of 10 pulses, interval: 3 s, fundamental frequency:
750 Hz.
Low-level alarm: single pulse, non-repetitive, fundamental frequency: 750 Hz.
Response frequency for buzzer in power interruption: about 0.32 Hz.
Verification of the functionality of the Alarm system:
Operator can verify the functionality of the Alarm system until oxygen concentrator
stabilizes(2 minutes or more after machine starts).
For example, to trigger the alarm for low flowrate, operator can adjust the flowrate of the
oxygen concentrator below 0.5 L/min, and this will cause a high-level alarm with “ELL”
display, as indicated above or in chapter 4.2. Another example, alarm for low oxygen
concentration can be triggered by setting the flowrate to maximum, the yellow indicator light
will illuminates after several seconds(low-level alarm), and it may become a high-level one if
the oxygen concentrate is low enough, that’s depend on the actual situation of the machine.
Low power
Low oxygen
concentration
EP Technical alarm 10 s Low
ET Technical alarm 1 s High
Normal Technical alarm 10 s High
Normal Technical alarm 10 s Low
Grouping of
alarm conditions
Delay
time
No
Priority
Low
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24
Appendix 2 EMC guidance and manufacturer’s declaration
Warnings
The machine is subject to special EMC precautions and it must be installed and used in
accordance with these guidelines.
The electromagnetic field can affect the machine performance, so other equipment used
near the machine must meet the corresponding EMC requirements. Mobile phones,
X-rays or MRI devices are possible interference source, as they can emit high-intensity
electromagnetic radiation.
The use of ACCESSORIES, transducers and cables other than those specified, with the
exception of transducers and cables sold by the MANUFACTURER of the ME
EQUIPMENT or ME SYSTEM as replacement parts for internal components, may result
in increased EMISSIONS or decreased IMMUNITY of the ME EQUIPMENT or ME
SYSTEM.
The following cable types must be used to ensure that they comply with interference radiation
and immunity standards:
Name Cable length(m)
Power cord 1.8 m
Cable introduction
The machine should not be used adjacent to or stacked with other equipment and that if
adjacent or stacked use is necessary, it should be observed to verify normal operation in
the configuration in which it will be used.
Active medical devices are subject to special EMC precautions and they must be
installed and used in accordance with these guidelines.
Portable and mobile RF equipment may affect the use of medical electrical equipment.
Operation of the machine or system below the minimum amplitude or minimum value
may result in inaccurate results.
Devices or systems may still be interfered by other equipment, even if other equipment
meets the requirements of the corresponding national standard.
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25
such an environment.
Guidance and manufacturer’s declaration -electromagnetic emissions
and Immunity
Table 1
Guidance and manufacturer’s declaration - electromagnetic emissions
The Oxygen Concentrator is intended for use in the electromagnetic environment specified
below. The customer or the user of the Oxygen Concentrator should assure that it is used in
Emissions test Compliance
RF emissions CISPR 11 Group 1
RF emissions CISPR 11 Class A
Harmonic emissions IEC 61000-3-2 Not applicable
Voltage fluctuations / flicker emissions IEC 61000-3-3 Not applicable
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26
such an environment
IEC 61000-4-2
Electrical fast
IEC 61000-4-4
IEC 61000-4-5
±2 kV common mode
Not Applicable
Voltage dips, short
interruptions and
voltage variations on
power supply input
0 % UT; 250/300 cycle
At 0°, 45°, 90°, 135°, 180°,
0 % UT; 250/300 cycle
Power frequency
IEC 61000-4-8
Table 2
Guidance and manufacturer’s declaration - electromagnetic Immunity
The Oxygen Concentrator is intended for use in the electromagnetic environment specified
below. The customer or the user of the Oxygen Concentrator should assure that it is used in
Immunity Test IEC 60601 Test level Compliance level
Electrostatic discharge
(ESD)
±8 kV contact
±15 kV air
±8 kV contact
±15 kV air
transient/burst
Surge
lines
IEC 61000-4-11
(50Hz)
magnetic field
NOTE UT is the a.c. mians voltage prior to application of the test level.
±2 kV for power supply lines
±1 kV signal input/output
±1 kV differential mode
0 % UT; 0,5 cycle
At 0°, 45°, 90°, 135°, 180°,
225°, 270° and 315°.
0 % UT; 1 cycle and 70 % UT;
25/30 cycles;
Single phase: at 0°.
30 A/m
50Hz
±2 kV for power supply lines
Not Applicable
±1 kV differential mode
0 % UT; 0,5 cycle
225°, 270° and 315°.
0 % UT; 1 cycle and 70 % UT;
25/30 cycles;
Single phase: at 0°.
30 A/m
50Hz
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27
such an environment
0,15 MHz and 80 MHz
0,15 MHz and 80 MHz
IEC61000-4-3
80 MHz – 2,7 GHz
80 MHz – 2,7 GHz
lectromagnetic site survey should be
Table 3
Guidance and manufacturer’s declaration - electromagnetic Immunity
The Oxygen Concentrator is intended for use in the electromagnetic environment specified
below. The customer or the user of the Oxygen Concentrator should assure that it is used in
Immunity Test IEC 60601 Test level Compliance level
3 V
0,15 MHz – 80 MHz
Conduced RF
IEC61000-4-6
3 V
0,15 MHz – 80 MHz
6 V in ISM bands between
6 V in ISM bands between
Radiated RF
3 V/m
3 V/m
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV
broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic
environment due to fixed RF transmitters, an e
considered. If the measured field strength in the location in which the Oxygen Concentrator
is used exceeds the applicable RF compliance level above, the Oxygen Concentrator should
be observed to verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as re-orienting or relocating the Oxygen Concentrator.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
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28
(V/m)
sine
217 Hz
LTE Band 5
4, 25; UMTS
Table 4
Guidance and manufacturer’s declaration - electromagnetic Immunity
The Oxygen Concentrator is intended for use in the electromagnetic environment specified
below. The customer or the user of the Oxygen Concentrator should assure that it is used in
such an environment
nce
(m)
IMMUN
ITY
TEST
LEVEL
Radiated
RF
IEC6100
0-4-3
(Te s t
specificat
ions for
ENCLOS
URE
PORT
IMMUNI
TY to
RF
wireless
communi
cations
equipme
nt)
Test
Freque
ncy
(MHz)
385
450
710
745
780
810
870
930
Band
a)
(MHz
)
380
–390
380
–390
704 –
787
800 –
960
Service a)
TETRA 400
GMRS 460,
FRS 460
LTE Band
13,
17
GSM
800/900,
TETRA 800,
iDEN 820,
CDMA 850,
Modul
ation
b)
Pulse
modula
tion b)
18 Hz
FM c)
± 5
kHz
deviati
on
1 kHz
Pulse
modula
tion b)
Pulse
modula
tion b)
18 Hz
Modul
ation
(W)
1,8 0,3 27
0,2 0,3 9
Dista
b)
2 0,3 28
2 0,3 28
1720
1845
1970
1 700
–
1 990
GSM 1800;
CDMA 1900;
GSM 1900;
DECT;
LTE Band 1,
3,
Pulse
modula
tion b)
217 Hz
2 0,3 28
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29
LTE Band 7
using higher IMMUNITY TEST LEVELS that are
P
d
6
E =
Bluetooth,
2 400
2450
5240
5500
5785
NOTE If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the
transmitting antenna and the ME EQUIPMENT or ME SYSTEM may be reduced to 1 m.
The 1 m test distance is permitted by IEC 61000-4-3.
a) For some services, only the uplink frequencies are included.
b) The carrier shall be modulated using a 50 % duty cycle square wave signal.
c) As an alternative to FM modulation, 50 % pulse modulation at 18 Hz may be used
because while it does not represent actual modulation, it would be worst case.
The MANUFACTURER should consider reducing the minimum separation distance, based
on RISK MANAGEMENT, and
appropriate for the reduced minimum separation distance. Minimum separation distances
for higher IMMUNITY TEST LEVELS shall be calculated using the following equation:
Where P is the maximum power in W, d is the minimum separation distance in
m, and E is the IMMUNITY TEST LEVEL in V/m.
–
2 570
5 100
–
5 800
WLAN,
802.11 b/g/n,
RFID 2450,
WLAN
802.11
a/n
Pulse
modula
tion b)
217 Hz
Pulse
modula
tion b)
217 Hz
2 0,3 28
0,2 0,3 9
Page 35
30
such an environment
fields)
Level (A/m)
Table 5
Guidance and manufacturer’s declaration - electromagnetic Immunity
The Oxygen Concentrator is intended for use in the electromagnetic environment specified
below. The customer or the user of the Oxygen Concentrator should assure that it is used in
Radiated fields in close
proximity
IEC61000-4-39
(Test specifications for
ENCLOSURE PORT
IMMUNITY to
proximity magnetic
Warning
Don’t near active HF SURGICAL EQUIPMENT and the RF shielded room of an ME
SYSTEM for magnetic resonance imaging, where the intensity of EM DISTURBANCES is
high.
Use of this equipment adjacent to or stacked with other equipment should be avoided
because it could result in improper operation. If such use is necessary, this equipment and
the other equipment should be observed to verify that they are operating normally.
Use of accessories, transducers and cables other than those specified or provided by the
manufacturer of this equipment could result in increased electromagnetic emissions or
decreased electromagnetic immunity of this equipment and result in improper operation.
Portable RF communications equipment (including peripherals such as antenna cables and
external antennas) should be used no closer than 30 cm (12 inches) to any part of the
Oxygen Concentrator, including cables specified by the manufacturer.Otherwise,
degradation of the performance of this equipment could result.
：
Note
The EMISSIONS characteristics of this equipment make it suitable for use in industrial
areas and hospitals (CISPR 11 class A). If it is used in a residential environment (for which
CISPR 11 class B is normally required) this equipment might not offer adequate protection
to radio-frequency communication services. The user might need to take mitigation
measures, such as relocating or re-orienting the equipment.
When the device is disturbed, the data measured may fluctuate, please measure repeatedly
or in another environment to ensure its accuracy.
Test Frequency Modulation
134.2 kHz
13.56 MHz
Pulse modulation
2.1 kHz
Pulse modulation
50 kHz
IMMUNITY Test
65
7.5
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31
Disposal: The product must not be disposed of along with other
domestic waste. The users must dispose of this equipment by
bringing it to a specific recycling point for electric and electronic
equipment.
GIMA WARRANTY TERMS
The Gima 12-month standard B2B warranty applies
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