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Summary of Contents for Gima CONTEC21
- Page 3 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.
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Page 5: Table Of Contents
Contents IMPORTANT INFORMATION ....................1 CHAPTER 1 OVERVIEW ......................6 1.1 F .......................... 6 EATURES 1.2 A ......................... 6 PPLIED RANGE 1.3 E ........................6 NVIRONMENT CHAPTER 2 PRINCIPLE ......................7 2.1 B ......................7 ASIC PRINCIPLES 2.2 O (PSA) ..................7 XYGEN SWING ABSORBERS 2.3 U .............. -
Page 6: Important Information
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. - Page 7 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.
- Page 8 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.
- Page 9 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.
- Page 10 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. ...
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Page 11: Chapter 1 Overview
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. -
Page 12: Chapter 2 Principle
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. -
Page 13: Chapter 3 Technical Characteristic
Chapter 3 Technical characteristic 3.1 Main performance With turning truckle, easy to move. Remove the impurity by built-in filter. OCSI function. Function of accumulating time. Function of timing shutdown. Alarm for power failure. Alarm for low power supply. Alarm for high/low pressure protection. Alarm for low flowrate. -
Page 14: Safety Categories
output oxygen concentration in the plateau environment is lower than that in the plain environment. Oxygen concentration: % Altitude: m Figure 3 Dimension: 508 mm×260 mm×530 mm Weight: 21 kg 3.3 Safety categories Device class: class Ⅱ equipment The degree of protection against electroshock: type BF applied part(medical disposable nasal cannula) The degree of protection against ingress of water: IP21 Operation mode: continuous operation... -
Page 15: Chapter 4 Introduction For Parts And Functions
Chapter 4 Introduction for parts and functions 4.1 Parts name Figure 4 Front panel view Figure 5 Rear panel view... -
Page 16: Alarm
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. -
Page 17: Functions For Accumulating Time
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. -
Page 18: Filter
A User Manual A power cord (HSC-401+HSC-406) 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. -
Page 19: Chapter 5 Operation
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 The screw cap of top cover Over-pressure safety valve Oxygen outlet... - Page 20 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.
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Page 21: Chapter 6 Maintenance, Transportation And Storage
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. -
Page 22: Maintenance
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. -
Page 23: Transportation And Storage
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 The packed machine can be transported by ordinary conveyance or according to transport contract. -
Page 24: Chapter 7 Troubleshooting
Chapter 7 Troubleshooting Trouble Possible Reason Solution Turn on the The power plug is not power switch, the inserted well. Check the power plug. machine doesn't No live with the power Check the power. work or the socket. Please contact the dealer. indicator isn't The control board of light. - Page 25 Inspect the flowrate controller and LCD,if it is higher than 5 LCD display System low pressure L/min,rolling the knob "EL" clockwise to decrease it. Please contact the dealer. Inspect for kinks or blockages.Inspect the flowrate LCD display controller,if it is lower than 0.5 System high pressure "EH"...
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Page 26: Chapter 8 Symbol Meanings
Chapter 8 Symbol Meanings Symbol Meanings Follow instructions for use between 60 % to 82 % 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... - Page 27 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...
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Page 28: Appendix 1 Alarm Information
Appendix 1 Alarm information Grouping of Delay State Screen display Priority alarm conditions time Power failure —— Technical alarm delay Low power Technical alarm 10 s supply High temperature Technical alarm High High pressure Technical alarm High Normal Technical alarm 10 s High Low oxygen... -
Page 29: Appendix 2 Emc Guidance And Manufacturer's Declaration
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 ... - Page 30 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 such an environment.
- Page 31 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 such an environment Immunity Test IEC 60601 Test level Compliance level...
- Page 32 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 such an environment Immunity Test IEC 60601 Test level Compliance level...
- Page 33 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 IMMUN Test Band...
- Page 34 Bluetooth, Pulse 2 400 WLAN, modula 2450 – 802.11 b/g/n, tion b) 2 570 RFID 2450, 217 Hz LTE Band 7 5240 Pulse 5 100 WLAN modula 5500 – 802.11 tion b) 5 800 217 Hz 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.
- Page 35 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 such an environment Radiated fields in close IMMUNITY Test Test Frequency...
- Page 36 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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