Gima CONTEC21 User manual

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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
4.3FUNCTIONS FOR ACCUMULATING TIME............................................................................ 12
4.4FILTER.............................................................................................................................. 13
4.5FUNCTION OF TIMING SHUTDOWN ................................................................................... 13
4.6ACCESSORIES................................................................................................................... 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 SYMBOL MEANINGS .................................................................................... 21
APPENDIX 1 ALARM INFORMATION .............................................................................. 23
APPENDIX 2 EMC GUIDANCE AND MANUFACTURER’S DECLARATION............. 24