OPERATION MANUAL

                                             Medical Oxygen Therapy Concentrator Model：RE-M10L

BRAND INTRODUCTION 

RESPIREASY Oxygen Concentrator is designed and manufactured by Shenzhen Jiaxing Technology Innovation Co., Ltd.

RESPIREASY has specialized in oxygen concentrators for over 15 years. We provide 1–60 LPM portable, home, and medical-grade devices with original accessories, serving 400,000+ users in 60+ countries.

Germany R&D Based & Shenzhen Factory 

Backed by German respiratory experts in Germany R&D Based, we hold 100+ patents and focus on PSA efficiency, AI adaptive flow, and IoT monitoring. Our ISO 13485-certified Shenzhen factory (CE/ISO/NMPA) has a 2M annual capacity, with strict 7-step testing ensuring 93% purity and <0.5% failure rate in 2 years.

RESPIREASY delivers reliable, affordable, and smart oxygen therapy solutions for home, travel, and clinical care.

--RESPIREASY, easy respiratory care, smart oxygen therapy solutions

                              Contents

1 Foreword-------------------------------------------2
2 Symbols--------------------------------------------2
3 Safety notice---------------------------------------3
4 Product introduction------------------------------4
5 Operation condition-------------------------------5
6 Scope of application-------------------------------5
7 Technical parameter--------------------------------5
8 Structures and Functions---------------------------6
9 Operation instructions-----------------------------8
10 Alarms and safety devices------------------------11
11Maintenance---------------------------------------12
12 Troubleshooting----------------------------------14
13 EMC Declaration----------------------------------16
14 Accessories----------------------------------------19
15 Condition for transportation and storage--------20
16 Quality warranty-----------------------------------20
17 Contact us-----------------------------------------20

                                                                         1

1  Foreword

Thank you for purchasing our products, hoping you will be satisfied with our products.
This operation manual contains function, operation steps, basic trouble solution and so
on.
To ensure your efficient use of the oxygen concentrator, please have a close read of this operation manual before operating it.

2  Symbols

The following table is a list of symbols and definitions that used with the RespirEasy RE-M10L Oxygen Concentrator.

 

Symbol	Description	Symbol	Description
	Warning - Describes a hazard or unsafe practice that  can result in severe bodily injury or death	(∈0197	Indicating its conformity with the Medical Devices Directive 93/42/EEC.The 0197 is the number of the Notified Body.
	Caution - Describes a hazard or unsafe practice  that can result in property  damage		"ON"(power)
	Follow User's Manual		"OFF"(power)
	CLASS Il equipment	SN	Serial  number
	Authorised Representative in the European Community		Separate collection for electrical and electronic equipment
	Type BF Applied Part, F-TYPE APPLIED PART complying with the specified requirements of this standard to  provide a higher degree of protection against electric  shock than that provided by TYPE B APPLIED PARTS.The symbol of Type BF Applied Part will be pasted on the outlet of oxygen.		Variability, rotational adjustment. To identify the control  by means of which a quantity is controlled. The controlled quantity increases/decreases by rotation with the figure width
	Date of manufacture		Alternating current
	Manufacturer	F6.3AL/250V	Type and rating of fuse
	Fragile, handle with care		Keep dry
	This way up		Stacking limit by number
	No open flame; Fire, open ignition source and smoking prohibited		No smoking

                                                                            2

3 Safety notice

1. This unit is not a life-support device , and in certain circumstances oxygen therapy can be hazardous, it is suggested that if any patient who needs oxygen treatment, please follow doctor's advice to choose the right flow and period for oxygen before using the oxygen concentrator.
2. The device was expected to use in a health care environment and only trained Medical staff can operate the device
3. In the event of an alarm, you observe your oxygen concentrator not working properly, or if you feel discomfort, consult your Equipment Provider and /or your physician immediately.
4. Use only voltage specified on rating label.
5. This device manufactures high concentration oxygen, which promotes rapid burning. Keep oxygen concentrator far away from open flames and no smoking around the patient.
6. Do not leave a nasal oxygen cannula under bed coverings or chair cushions. If the unit is turned on without use, the oxygen will help the flammable material get fire. :Use no lubricants, grease, or petroleum-based products on or near your oxygen concentrator.
7. Electrical shock hazard. Do not remove covers while the unit is plugged in. Only your Equipment Provider or a qualified service technician should remove the covers or service the unit.
8. Care should be taken to prevent the unit from getting wet or allowing water to enter the unit.
9. 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.
10. 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 RespirEasy RE-M10L medical oxygen concentrator, including  cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
11. The oxygen concentrator should be set to use in an environment without dust, corruption or toxicological harm gas.
12. Do not place the oxygen concentrator in surroundings where its airflow is obstructed.
13. Do not place items on top of the concentrator.
14. This unit is not a life-support device , and in certain circumstances oxygen therapy can be hazardous, it is suggested that if any patient who needs oxygen treatment, please follow doctor's advice to choose the right flow and period for oxygen before using the oxygen concentrator.
15. The device was expected to use in a health care environment and only trained Medical staff can operate the device
16. In the event of an alarm, you observe your oxygen concentrator not working properly, or if you feel discomfort, consult your Equipment Provider and /or your physician immediately.
17. Use only voltage specified on rating label.
18. This device manufactures high concentration oxygen, which promotes rapid burning. Keep oxygen concentrator far away from open flames and no smoking around the patient.
19. Do not leave a nasal oxygen cannula under bed coverings or chair cushions. If the unit is turned on without use, the oxygen will help the flammable material get fire. :Use no lubricants, grease, or petroleum-based products on or near your oxygen concentrator.
20. Electrical shock hazard. Do not remove covers while the unit is plugged in. Only your Equipment Provider or a qualified service technician should remove the covers or service the unit.
21. Care should be taken to prevent the unit from getting wet or allowing water to enter the unit.
22. 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.
23. 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 RespirEasy RE-M10L medical oxygen concentrator, including  cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
24. The oxygen concentrator should be set to use in an environment without dust, corruption or toxicological harm gas.
25. Do not place the oxygen concentrator in surroundings where its airflow is obstructed. :Do not place items on top of the concentrator.
26. Always place the concentrator on a hard surface. Never place the concentrator on a surface such as bed or couch, where the concentrator may tip or fall.
27. NEVER leave the concentrator unattended when plugged in.
28. Ensure the bottom smooth exhaustion during operating, or else the oxygen concentrator will be over-heated.
29. 5 minutes are needed from oxygen concentrator from warming up to reach regular function and nominal performance.

                                                                 3

NOTE: If oxygen does not seem to flow, first verify that the flowmeter ball is registering a flow. Then, place the tip of the cannula into a glass of water; if bubbles come out of the cannula, oxygen is flowing. If bubbles do not appear, turn off the oxygen concentrator immediately and refer to Troubleshooting.
NOTE: There is never a danger of depleting the oxygen in a room when you use your oxygen concentrator.

Radio Frequency Interference

Most electronic equipment is influenced by Radio Frequency Interference (RFI). When there is strong electromagnetic interference, maybe the LCD will be slightly affected, but the oxygen concentrator is still running. ALWAYS exercise CAUTION with regard to the use of portable communications equipment in the area around such equipment.

Requirement of environment protection

The materials used in the system won't create environment hazard. The packing materials of the system are recyclable, and they must be collected and disposed according to the related regulation in the country or region where the package of the system or its accessories is opened. The nasal oxygen tube is made of medical PVC, and if it is thrown away, it could not be bio-degradable, so it will cause the pollution. Any material of the system, that may cause pollution in the environment, must be collected disposed strictly complied with the local rules and requirements.

Contraindication
None.

4 Product  introduction

RespirEasy RE-M10L medical oxygen concentrator is a device that extracts oxygen
from atmospheric air.

It will typically be an electrically-powered molecular sieve (artificial zeolite) used to separate nitrogen from ambient air.

It could be applied widely in the hospitals at all different level, clinics, health centers and family nursing, health care for the old person, mental workers and students, etc..

 Whether the user is professional or not, &nbsp;the users could operate the oxygen concentrator by themselves after reading this user's manual.

 The oxygen concentrator can supply 1-2 patients simultaneously, with steady oxygen flowing out, safe and reliable, low cost, adjustable flow.

The key parts of the concentrator adopt anti-tiring and anti-aging design, and the planned life of the whole concentrator reaches up to 20,000 hours or 5 years, whichever comes first.

                                                                    4

5 Operation conditions and Environment

1. Ambient temperature: 10 ℃-40 ℃
2. Relative humidity: 30%-85%
3. Air pressure: 700 hPa-1060 hPa
4. Altitude: Up to 2286m without degradation; Consult your equipment provider for further information regarding to 2286m to 4000m
5. No corrosive gas and strong magnetic field around.

6 Scope of application:

1. For Medical Use: Medical oxygen supplied by the concentrator is beneficial to cure the disease or heart and blood vessel system, chronic pulmonary system, the brain and blood vessel system, chronic pulmonary tuberculosis, and other oxygen lacking symptoms, etc.
2. For Health care: Medical oxygen can be used for athletics and intellectuals and brainworkers, etc. to eliminate fatigue and also suit for the departments of health care, sanatorium, healthy, plateau military camps and hotels and other places where need oxygen.

7  Technical Parameters

Model	RE-M5L	RE-M5LW	RE-M10L
Rated  power(VA)	480	540	880
Operation voltage (V/Hz)	AC230/50
Oxygen  flow(L/min)	0.5-5	0.5-5	0.5-10
Oxygen concentration (%)	93%±3%
Outlet pressure (Mpa)	0.04—0.07
Alarm	Power failure; low&high pressure ; low purity; temperature
Noise(dB(A))	≤43	≤45	≤52

                                                                                5

Large LCD display	Pressure digital(accuracy:0.001MPa); accumulating timing(range:0-99999hours); present timing(accuracy:1 minute); presetting timing(accuracy:1 minute) temperature digital(accuracy:0.1);
Electrical category:	Class II, Type BF
Net Weight (kg)	16	22	27
Dimension(mm)	280(deep)*348(width)* 510(height)	300(deep)*360(width)* 600(height)	365(deep)"375(width)* 600(height)
Low purity alarm (OCSI)	When oxygen purity is ≥85%, the blue lamp is on, when oxygen purity is <85%, red lamp is on, indicating low purity Accuracy:±3%
Mains Fuse	F5AL/250V	F6.3AL/250V	F6.3AL/250V

8 Structures  and  Functions

 

                          Figure 1                                                                  Figure 2

 

                            Figure 3                                                             Figure 4

                                                                          6

           

                            Figure 5                                                             Figure 6

Figure 1 and  Figure 2 show the model RE-M10L;  
Figure 3 and  Figure 4 show the model RE-M5L; 
Figure 5 and  Figure 6 show the model RE-M5LW.

8.1  Indicating  Lamp

8.1.1 Total 8 indicating lamps and their indication for the model, such as RE-M10L  which is shown as Figure 1, are as follows:

1. P.O:  power switch  (green  lamp)
2. P.F.:  power  failure(red  lamp)
3. H.P::  high  pressure(red  lamp)
4. L.P:  low  pressure(yellow  lamp)
5. H.T.:  over  heated  temperature(red  lamp)
6. H.O₂:  oxygen  purity  is≥85%,(blue  lamp)(Accuracy:±3%)
7. M.O₂:  no  use
8. L.O..oxygen  purity  is<85%,(red  lamp)(Accuracy:±3%)

8.1.2 Total 6 indicating lamps and their indication for the model, such as JRE-M5L or RE-M5LW which is shown as Figure 3 or Figure 5, are as follows:

1. P.O.:  power  switch  (green  lamp)
2. P.F::  power  failure(red  lamp)
3. L.P::  low  pressure(yellow  lamp)
4. H.P./H.T:  high  pressure/  over  heated  temperature  (red  lamp)
5. H.O:  oxygen  purity  is  ≥85%,(blue  lamp)(Accuracy:±3%)
6. L.O₂:oxygen purity is <85%,(red lamp)(Accuracy:±3%)

8.2  Power  switch
8.3  Oxygen  flow  meter
The location of float in the oxygen flow meter shows the outlet oxygen flow (L/min.).

                                                               7

8.4 Knob of oxygen flow meter switch

• It adjusts and controls the outlet oxygen flow.
• Do not Switch it over-forced, or else it is easy to damage the valve core. Switch it
  counterclockwise to turn on, clockwise to turn off.

8.5 Outlet for Atomization (optional)
8.6 Intake air filter

• Once need to replace, refer to 11.2 on page12

8.7 Storage cabinet(as shown in Figure 2⑦) It is used for storage oxygen cannula
8.8 LCD display( Liquid crystal display )(as shown in Figure 1 ⑧ or Figure 3 ⑦ or Figure 5⑦)

• It can display some status of during operation of the oxygen concentrator, refer to
  7.on page 5
• When starting the oxygen concentrator, the LCD screen is lighted, and it will return to screen saver mode in 15 minutes. But if you press the right key during working, the screen will be lighted again.

8.9 Timing buttons(as shown in Figure 1 ⑨ or Figure 3 ⑧ or Figure 5 ⑧)

• The two buttons are used for timing adjustment, and each press of the left button(△) or(田) will increase timing by 10min, the max timing is 40 hours. And each press of the right button( ▽) or ( ⊙) will decrease timing by 10min. When the right button( ▽) or (θ) is pressed to reduce timing till"0", the oxygen concentrator will turn offautomatically.

8.10 Humidifier(as shown in Figure 1 ⑩ or Figure 3 ⑨ or Figure 5 ⑨)

• Humidifier which is used for humidifying oxygen and preventing throat and nasal
  mucosa stimulated by dry oxygen and dry hard sputum difficult to spit out.

8.11 Knob of Atomizer switch (optional)(as shown in Figure 1 ⑪ or Figure 3 ⑩ or Figure 5⑩)
8.12 Rating label (as shown in Figure 2 ⑪ or Figure 4 ⑪ or Figure 6 ⑪)
8.13 Appliance inlet (as shown in Figure 2 or Figure 4 ⑩ or Figure 6⑫)
8.14 Holder(as shown in Figure 2 @ or Figure 4 B or Figure 6 B)

9 Operation  instructions

• The plug is the disconnection device of the oxygen concentrator, when the plug is pulled, there is no power supply. In order to pull the plug easily , be certain to place the unit where all sides are at least 30 cm away from walls, draperies, furniture, or other obstructions. Do not place the unit in a confined area.

                                                                        8

• Do not turn on or off frequently. To restart the oxygen concentrator after turning off, no less than 5 minutes are necessary (namely, exhaust internal gas of the oxygen  concentrator completely, for if air compressor turns on with pressure, its life will be shortened)

9.1 If used with a humidifier, unscrew the flask from the humidifier in clockwise direction, pour in proper distilled water or cold boiled water within the scale between the max line and the min line(see 11.4), then re-connect the top cover to the humidifier bottle, as shown in Figure 7. The humidifier used with RE-M5L/RE-M5LW/RE-M10L must comply with the general requirement of the 93/42/EEC European                                           Figure 7                          Directive as appropriate.

9.2. connect the nasal oxygen canula to the
humidifier outlet nozzle or to the concentrator
outlet if a humidifier has not been prescribed.
Then set the nasal oxygen cannula over
patient's ears, insert the nasal oxygen cannula
into patient's nostrils to absorb oxygen; The
nasal oxygen canula should be limited to 20
meters long, in order to ensure that the oxygen
flow rate remains within specification values.
The best absorbing time for health care keeps
                               Figure 8                          40-50 minutes per time, absorbing time for
                                                                      medical treatment shall be followed doctor's
                                                                      advice, as shown in Figure 8.

9.3. Insert the power plug plug into the electrical outlet of the correct voltage and frequency as defined in 7(Technical Parameters)on page 5, and the power connector connected with the
appliance inlet of the oxygen concentrator,                                       Figure 9                          then set the l/O power switch to the"!"                                                                                    position  to turn the unit on, at the same time                                                                        the O.P.lampwill light(8.1a).

                                                                   9

 

9.4. To set the flow of supplemental oxygen, turn
the knob of oxygen flow meter switch left or
right until the ball inside the flowmeter centers
on the flow line number recommended oxygen
absorbing flow.(counterclockwise—on,
clockwise—off).

 

 

                           Figure 10

Flow value:

• 10 position flow value from 0.5～5L/min on flowmeter as shown in figure 10. 
• The maximum recommended flow: 5L/min.
• In compliance with the ISO 80601-2-69 standard, the flow supplied is equal to the flow set on the flowmeter, accurate to within 10% or 200ml/min, whichever is the larger of the two.
• The variation of the maximum recommended flow does not exceed 10% of the indicated value when a back pressure of 7kPa is applied to the output of the device. The maximum.

• outlet pressure is 70kPa。

Oxygen Concentration:
-at 2L/min:>90%
-at 5L/min: 93%(±3%)
:lt is very important to select only the prescribed level of oxygen. Change the flow selection only under the guidance of your physician.

 

    9.5.When finished the absorbing, set the I/O      power switch to the "O" position to turn off      the unit, if there is discontinuous use, please      unplug the power plug, as shown in                    Figure 11.

 

 

                         Figure 11             

9.6. If the patient needs timing oxygen absorbing, please refer to 8.9 on page 8

Atomization  operation  methods (for optional)

The atomization function of the concentrator is applicable to help to cure the sufferers of chronic pulmonary tuberculosis and respiratory system, etc. A:Atomization treatment must be under advice and suggestion of your physician. A:Atomization treatment must be under advice and suggestion of your physician. Using distilled water to do the atomization for several seconds after each operation may lighten the crystallization caused by medical solution.

                                                                   10

lf atomizing cannot work then open the cover of the bottle and add clean water in
small amount. Rotate the white ball which lies in the bottle with the gas resource connected and select the proper angle to gain a better atomization.

• Open the cover of medical cup, and add atomization remedy that needed, then close the cover.
• Connect the joint of atomization nozzle (or mask) with the cover of medical cup, and then connect the other end of atomizer connection tube with the atomization outlet  and turn on atomizer.
• Turn on the power of oxygen concentrator, and shut up flow meter, then it is ready for atomization  treatment.
• Do clean the atomization devices followed by the instructions of the atomization devices.

10 Alarms-Safety devices

10.1  Alarms

• Power failure  alarm: In case of a loss of mains power or when the power cord is not plugged into the wall outlet, an audible alarm is activated with red indicator on(8.1.1b  and 8.1.2b on page 7). The troubleshooting is referred to 12 on page 14.
• low&high pressure alarm: There is a pressure sensor on the main board to check the system pressure, when the pressure is lower than 0.1Mpa,there is an audible
  alarm with yellow indicator on(8.1.1d and 8.1.2c on page 7) and the oxygen
  concentrator is still working; When the pressure is higher than 0.23Mpa,there is an audible alarm with red indicator on( 8.1.1c and 8.1.2d on page 7) and the oxygen  concentrator is stopped. The troubleshooting is referred to 12 on page 14.
• Low oxygen concentration alarm(OCSI): The oxygen concentration will rise to the normal level in five minutes of operation. When oxygen purity is ≥85%, the blue
  lamp( 8.1.1f and 8.1.2e on page 7) is on, when oxygen purity is <85%, red lamp is  on for audible alarm, indicating low purity(8.1.1h and 8.1.2f on page 7). Refer to the troubleshooting on page 14. Or call your supplier to service the device
• Temperature alarm:  There is a temperature sensor on the main board to check the internal temperature, when the temperature is higher than 50°C in the oxygen
  concentrator, there is an audible alarm with red indicator on(see H.T. on the lamp) and  the  oxygen  concentrator  will  be  stopped.  The  troubleshooting  is  referred  to  12  on page  14.

                                                                  11

10.2 Safety devices
a. Compressor motor:
       Thermal  safety  is  ensured  by  a  thermal  switch  situated  in  the  motor                        winding(145±5℃).
b.Safety  valve:
This  is  fitted  on  the  compressor  outlet  and  is  calibrated  to  2.5  bar(250kPa).

11  Maintenance

• Disconnect  the  power  cord  from  the  electrical  outlet  before  you  clean  the  cabinet.
• Do  not  operate  the  concentrator  without  the  filters  installed,  or  while  filters  are  wet.
  

These  actions  could  permanently  damage  the  concentrator.

NOTE: If  legally  binding  regulations  govern  the  installation,  service  and/or  the
operation  of  the  product,  it  is  the  responsibility  for  the  operator  to  observe  and  follow these  regulations.
NOTE: Modifying  the  product  is  not  permitted.

11.1.  Clean  the  whole  body:  In the condition of power off,  make a clean for the outside body  by soft towel with  little  mild  household  cleaner  ,  and then wipe  it  up with  dry towel,  once  or  twice  per  month.

           

                                                            Figure  12

11.2.Clean  air  filter:  It  is  a  critical step for daily  maintenance to  clean  intake  air filter an interval  about  300  hours.
Detail  steps:  remove  the  two  intake  air filters  on  both  sides  of the  body,  clean  them with  mild  household  cleaner  and  clean  it  with  clean  water  completely,  get  ride  of  extra water and  dry  up  naturally, finally  set  back  after dry  up,  as  shown  in  Figure  13.

                                                             12

                                                                   Figure   13

11.3.  Clean  secondary  filter
Method  I:  Clean  secondary  filter  an  interval  about  800  hours,  open  the  top  cover  and  take out  storage  case,  Rotate  the  air  filter  with  counterclockwise  direction  as  Figure  14,take down  the  filter  cloth,  then  clean  it  with  detergent,  and  then  clean  it  out  with  clean  water completely,  get  rid  of the  extra water,  and  dry  it  naturally, finally  set  back  after dry  up.

                                                                 Figure  14

Method  ll:  First,  remove  the  silicone  tube  connected  with  oxygen  output,  take  down  the humidification  bottle,  Rotate  the  air  filter  with  counterclockwise  direction  as  Figure  15,take down  the  fiter  cloth,  clean  with  detergent,  wash  by  clean  water,  wipe  off  the  water.  and make it to be dry in air naturally ,then install back to the Air filter.

                                                                         13

                             

                                                                       Figure  15

11.4.  Clean  the  humidifier (if the humidifier is prescribed by a physician)
Daily:
- Empty the water from the humidifier.
- Rinse the humidifier flask under running water.  -Fill humidifier up to the mask with distilled water.
Regularly:
-Disinfect the  humidifier  parts  by  immersing them  in  a  disinfectant  solution(in  general, we recommend using water containing a small amount of chlorine bleach).
- Rinse and dry.
-Check that the humidifier lid seal is in good condition.

11.5.  Clean  Oxygen tubing  and  nasal  cannula

•  Follow  the  manufacturer's  instructions

       11.6.  Replacement  of fuse  tube
Remove the cover of fuse, which is in the
appliance inlet, dismantle the fuse tube off by small screwdriver. Close the cover of fuse
after fuse tube is replaced.
The other fuse tube is located at the intake of
internal power line; the method of
replacement is the same with that above.           

                              Figure16   

12  Troubleshooting

If your concentrator fails to operate properly, please refer to the troubleshooting chart on the following pages for probable causes and solutions.  If problems with the equipment continue,  please  contact  your  Equipment  Provider.
NOTE: If the unit has not been used for an extended time period, it needs to operate for several  minutes  before  power failure  alarm  can  become  activated.

                                                                    14

No.	Trouble	Causes	Solution
1	No operation after power connected and the P.F. lamp is light with audible alarm	1.No  connection between circuit of oxygen  concentrator and  power 2. Circuit of fuse protector broken. 3. There is no power supply	1. Check out whether switch, plug, power line in good connection. 2.Replace the fuse protector and find the cause
2	No oxygen out or tiny outtake flow	1. Folded inside oxygen tube, no smooth  outtake 2.Filter clogged, no smooth  intake 3.The cover of dampen bottle leaking	1.Connect the oxygen tube again 2. Clean the filter 3.Take off the cover, screw well the cover, block the outtake by thumb after turning on, and there will some sound from the humidifier after 5 second around (the safety valve of humidifier turns on)
3	No exhaust sound	1.Air controller cannot work 2. Electrical control board cannot work	1.Have air control valve replaced 2.Have electric control board replaced
4	Too noisy exhaustion	1. The joint of exhaustion muffler fallen off 2. Exhaustion muffler broken	1.Connect the joint well 2.Have the muffler replaced
5	The  oxygen concentrator is working but the L.P. lamp is light with audible alarm.	The system pressure is too low	Check every gas circuit connectors with soapy water whether there are air leakage.
6	The  oxygen concentrator is stopped and the H.T. lamp is light with audible alarm.	The temperature in the oxygen concentrator is too high.	1. Check the fan's connector on the main board whether it is bad contact. 2. turn off the oxygen concentrator and consult your Equipment  Provider.
7	The  oxygen concentrator is stopped and the H.P. lamp is ight with audible alarm.	The system pressure is too high.	Turn off the oxygen concentrator and consult your Equipment Provider.
8	The  oxygen concentrator is working but the L.O₂  lamp is light.	Oxygen  concentration is too low	1. Check every gas circuit connectors with soapy water whether there are air leakage 2. Turn off the oxygen concentrator and consult your Equipment  Provider.

                                                                         15

13  Information  on  Electromagnetic  compatibility

The RE-M5L/RE-M5LW/RE-M10L needs special precautions regarding and needs to be installed and put into service according to the EMC information provided in the accompanying  documents;
Portable and mobile RF communications equipment can affect the RE-M5L/RE-M5LW/RE-M10L. 
All cables and maximum length of cables, Transducers and other accessories with which the manufacturer of the RE-M5L/RE-M5LW/RE-M10L claims compliance with the requirements, Accessories that do not affect compliance with the requirements of these
sub clauses need not be listed. Accessories, transducers and cables may be specified either generically or specifically.
NOTE:
Transducers and cables sold by the manufacturer of the RE-M5L/RE-M5LW/RE-M10L as replacement parts for internal components need not be listed.
The use of accessories, transducers and cables other than those specified, with the exception of transducers and cables sold by the manufacturer of The RE-M5L/RE-M5LW/RE-M10L as replacement parts for internal components, may result in increased emissions or decreased immunity of The RE-M5L/RE-M5LW/RE-M10L.

Guidance and manufacturer's declaration - electromagnetic emissions

The RE-M5L/RE-M5LW/RE-M10L is intended for use in the electromagnetic environment specified below. The customer or the user of the RE-M5L/RE-M5LW/RE-M10L should assure that it is used in such an environment.

Emissions test	Compliance	Electromagnetic    environment-     guidance
RF emissions CISPR 11	Group 1	The RE-M5L/RE-M5LW/RE-M10L uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
RF emissions CISPR 11	Class A	The RE-M5L/RE-M5LW/RE-M10L is suitable for use in all establishments other than domestic, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. However, the following warning applies: WARNING: The RE-M5L/RE-M5LW/RE-M10L is for use by healthcare professionals only. This device/system may cause radio interference or interfere with the operation of nearby equipment. Mitigation measures may be required, such as reorienting or relocating the RE-M5L/RE-M5LW/RE-M10L or shielding the location.
Harmonic emissions IEC 61000-3-2	Class A
Yoltage fluctuations/ flicker emissions IEC 61000-3-3	Complies

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Guidance and manufacturer's declaration - electromagnetic immunity
The RE-M5L/RE-M5LW/RE-M10L is intended for use in the electromagnetic environment specified below. The customer or the user of the RE-M5L/RE-M5LW/RE-M10L should assure that it is used in such an environment.
IMMUNITY test	IEC 60601 test level	Compliance level	Electromagnetic environment- guidance
Electrostatic discharge (ESD) IEC 61000-4-2	± 8 kV contact ±15 kV air	± 8 kV contact ±15 kV air	Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %
Electrical fast transient burst IEC 61000-4-4	±2 kV for power supply lines ±1 kV for input/output Lines	± 2 kV for power supply lines ±1 kV for input/output Lines	Mains power quality should be that of a typical commercial or hospital environment.
Surge IEC  61000-4-5	± 1kV line(s) to line(s) ±2 kV line(s)to earth	± 1kV line(s)to line(s) ±2 kV line(s) to earth	Mains power quality should be that of a typical commercial or hospital environment.
Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4- 11	<5% UT (>95 % dip in UT) for 0,5 cycle 40 % UT (60 % dip in UT) for 5 cycles 70% UT (30 % dip in UT) for 25 cycles <5% UT (>95 % dip in UT) for 5 s	<5 % UT (>95 % dip in UT) for 0,5 cycle 40 % UT (60 % dip in UT) for 5 cycles 70 % UT (30 % dip in UT) for 25 cycles <5% UT (>95 % dip in UT) for 5 s	Mains power quality should be that of a typical commercial or hospital environment. If the user of the  RE-M5L/RE-M5LW/RE-M10L  requires continued operation during power  mains interruptions, it is recommended  that the RE-M5L/RE-M5LW/RE-M10L be powered from an uninterruptible power supply or a battery.
Power frequency (50/60 Hz) magnetic field IEC 61000-4-8	3 A/m	Not applicable Note: The RE-M5L/RE-M5LW/RE-M10L does not contain components susceptible to magnetic fields, such as Hall elements or magnetic field sensors. Therefore, the EUT is deemed to meet the requirement without actual testing.	Power frequency magnetic fields should be at levels characteristic of a typical  location in a typical commercial or  hospital environment.

17

Guidance and manufacturer's declaration - electromagnetic immunity
The RE-M5L/RE-M5LW/RE-M10L is intended for use in the electromagnetic environment specified below. The customer or the user of the RE-M5L/RE-M5LW/RE-M10L should assure that it is used in such an electromagnetic environment.
IMMUNITY test	IEC 60601 test level	Compliance level	Electromagnetic environment - guidance
Conducted RF IEC 61000-4-6       Radiated RF IEC 61000-4-3	3V 0.15MHz-80 MHz 6V in ISM bands between 0.15MHz and 80MHz 80% AM at 1kHz 3 V/m 80 MHz to 2.7 GHz 80% AM at 1kHz	3V 0.15MHz-80 MHz 6V in ISM bands between 0.15MHz and 80MHz 80% AM at 1kHz 3 V/m 80 MHz to 2.7 GHz 80% AM at 1kHz	Portable and mobile RF communications equipment should be  used no closer to any part of the RE-M5L/RE-M5LW/RE-M10L,including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance
			d=1.17 √P d=1.17  √P d=2.33 √P	80 MHz 800 MHz	to 800 to 2,7	MHZ Ghz
			where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than the compliance level in each frequency range." Interference may occur in the vicinity of equipment marked with the following symbol:
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.
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 electromagnetic site survey should be considered. If the measured field strength in the location in which the RE-M5L/RE-M5LW/RE-M10L is used exceeds theapplicable RF compliance level above, the RE-M5L/RE-M5LW/RE-M10L should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the RE-M5L/RE-M5LW/RE-M10L. 5 Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

   18

Recommended separation distances between portable and mobile RF communications equipment and the JAY-5AWIJAY-5BW/JAY-10
The RE-M5L/RE-M5LW/RE-M10Lis intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the RE-M5L/RE-M5LW/RE-M10L can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the RE-M5L/RE-M5LW/RE-M10L as recommended below, according to the maximum output power of the communications equipment.
Rated maximum output power of transmitter W	Separation distance according to frequency of transmitter m
	150 kHz to 80 MHz d=1.17 √P	80 MHz to 800 MHz d=1.17 √P	800 MHz to 2,7 GHz d=1.17 √P
0.01	0.12	0.12	0.07
0.1	0.37	0.37	0.22
1	1.17	1.17	0.70
10	3.69	3.69	2.21
100	11.67	11.67	7.00
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the equation applicable  to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1 At 80 MHz and 800 MHz, the separation distance for 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.

14 Accessories

1. Your concentrator includes the following components:

•  Intake air filter (two pieces, part number:G-01)
• Secondary filter (one piece, part number:G-02)

The concentrator comes with two air filters and one secondary filter already installed.
2. Please use the parts mentioned in this chapter, if the use of other parts can
degrade minimum safety and performance.
3. Please choose the suitable humidifier and Nasal oxygen cannula, they must:

• be oxygen compatible,
• be biocompatible,
• include a means to prevent the propagation of fire and accord with requirements of ISO 80601-2-69

                                                                     18

15  Condition for transportation and storage

• Environment temperature scale:-40~55 ℃
• Comparative humidity scale:≤95%
• Air  pressure  scale:  700-1060  hpa

16  Quality  Warranty

• Warranty  for  whole  unit:15  months
• Warranty  for  magnetic  valve:24  months
• Warranty  for  compressor:24  months

17  Contact  us

• Website: www.airoxygenconcentrator.com
• Email:  support@airoxygenconcentrator.com
• Tel/ Whatsapp: +86 18902540866

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