ESound Med

ESound Med Endotracheal Tube

•Made from imported medical grade material, non-toxic, no stimulation.
•The tube is smooth that can effectively prevent respiratory obstruction.
•Transparent tube allows identification for condensation.
•Excellent flexibility to prevent tube from kinking and blockage.

 

ESound Med Endotracheal Tube details

 

 

[Product]: Endotracheal Tube [Specifications]: 2.0#, 2.5#, 3.0#, 3.5#, 4.0#, 4.5#, 5.0#, 5.5#, 6.0#, 6.5#, 7.0#, 7.5#, 8.0#, 8.5#, 9.0#, 9.5#, 10.0#, 10.5#, 11.0#
[Production License Number]: No. 20160050 of Henan Food and Drug Administration Production License
[Registration Number]: Henan Medical Device 20182080624
[Product Technical Requirement Number]: Henan Medical Device Registration Certificate 20182080624
[Indications]: Used to Establish Artificial Airway in Clinical Anesthesia or First Aid.
[Structure and Components]: This Product Is Composed Of Connector, Tube, One-way Valve, Inflation Tube, Pilot Balloon And Cuff.
[Performance]:
1. Specification: The Specification Of Endotracheal Tube and Endotracheal Tube Connector Shall Be Marked With Nominal Inner Diameter (in mm). Endotracheal Tube Shall Be In Accordance With The Requirement Specified In Table 1 of YY0337.1-2002, And Endotracheal Tube Connector Shall Be In Accordance With The Requirement Specified In Table 2 Of YY0337.1-2002 Standard.
2. Specifications Of Endotracheal Tube And Its Connector:
2.1 Endotracheal Tube Dimension
2.1.1 The Dimension of Endotracheal Tube Shall Conform To The Requirement Specified In Table 1 Of YY0337.1-2002 Standard.
2.1.2. When The Dimension is Less Than Or Equal To 6.0, The Actual Inside Diameter Shall Be±0.15mm Than The Nominal Inside Diameter; When The Dimension is More Than Or Equal To 6.5, The Actual Inside Diameter Shall Be±0.20mm Than The Nominal Inside Diameter (7.0mm).
2.1.3 When The Dimension Is Less Than Or Equal To 6.0, The Actual Inside Diameter Shall be±0.15mm Than The Nominal Inside Diameter; When The Dimension Is More Than Or Equal To 6.5, The Actual Outside Diameter Shall Be (9.3mm) ± 0.20mm.
2.2 Endotracheal Tube Connector
2.2.1 The Specification of The Endotracheal Tube Connector Shall Conform to the Requirement Specified in Table 2 of YY0337.1-2002 Standard.
2.2.2 When the Endotracheal Tube Is Equipped With an Endotracheal Tube Connector, the Nominal Dimension of The Connector Shall Not Be Less Than The Nominal Dimension of The Endotracheal Tube.
2.2.3 Machine End Connector: The Machine End Of Endotracheal Tube Connector Shall Be A 15mm Conical Connector Conforming To The Requirement Specified in The YY91040-1999 Standard, and The Inner Diameter Of The Machine End Shall Not Be Less Than The Inner Diameter Of The Patient End Specified In Table 2. Its Inner Diameter Shall Be Smoothly Transited To Facilitate The Passage Of An Suction Conduit.
2.2.4 Basic Dimension: The Basic Dimension of the Patient End Connector Shall Conform to the Requirement Specified In Table 2 of YY0337.1-2002 Standard.
2.5 Angle: The Port At The Patient End Shall Be 90 ° ± 5 ° With The Axial Direction Of The Connector.
3. Bevel: The Endotracheal Tube Shall Have a 38 ° ± 10 ° Angle of Bevel.
4. Cuff
4.1 Cuff (If Any) Shall Be Closely Connected With The Tube Body.
4.2. Maximum Distance: The Maximum Distance From The Patient End of Endotracheal Tube To The Machine End of The Filling Length of Cuff Shall Meet The Requirements Specified in Table 1 Of YY0337.1-2002 Standard.
4.3. Cuff Diameter: When Measured According to Appendix A of YY0337.1-2002 Standard, the Cuff Filling Diameter Shall Be ±15% Of The Nominal Value (25mm).
4.4. Shrinkage Test: When he Shrinkage Test is Conducted According to Appendix B in YY0337.1-2002 Standard, the Steel Ball Shall be Able to Pass Through The Endotracheal tube Freely.
4.5 Protrusion Test: When the Protrusion Test is Conducted According to Appendix C in YY0337.1-2002 Standard, Any Part of The Filled Cuff Shall Not Exceed the Nearest Edge of The Slope.
5. Cuff Inflation Tube
5.1. The Outer Diameter of The Inflation Tube (If Any) Shall Not Exceed 3.0mm, and Its Separation Point Shall be Located In The Concave Direction of The Endotracheal Tube; The Tube Wall Around The Inflation Chamber Shall Not Account for More Than 10% of the Inner Diameter of The Endotracheal Tube Chamber; The Size of The Inflation Tube Shall Conform to The Requirement specified in Table 1 of YY0337.1-2002 Standard.
5.2 Included Angle: The Included Angle Between The Air Inflation Tube At The Separation Point And The Endotracheal Tube Shall Not Exceed 45 °.
5.3 Pilot Balloon: The Inflation Tube Shall Have A Device To Indicate The Balloon And / Or Other Devices That Can Indicate The Filling /Flattening Of Cuff.
5.4 Deflation: When The Gas In The Cuff Is To Be Discharged, The Inflation Pipe, Inflation Valve Or Any Other Closing Device Used As A One-Way Valve Shall Not Hinder Its Deflation.
5.5 Free End: The Free End Of The Inflation Tube Shall Be Either Open Or Sealed With The Closing Device Or The Inflation Valve, But In Any Case, It Shall Be Able To Cooperate With The 6% (Ruhr) Outer Conical Connector Conforming To The Requirement Specified In GB/ T1962.1-2001 Standard.
5.6. Distance Marking: If The Distance Between The Separation Point Of The Inflation Tube And The Endotracheal Tube And The Patient End Is Marked, The Actual Distance Shall Be ± 10 mm Of The Nominal Value.
6. Shape, Arc Radius
6.1 Endotracheal Tube Can Be Straight Or Arc-Shaped.
6.2. If The Endotracheal Tube Is Of “Magill” Type, The Specification of Its Arc Radius should be more than or equal to 6.5, And Its Arc Radius shall be (140 ± 20) mm.
6.3. If The Arc Radius Of “Magill” Endotracheal Tube with Specification is Less Than or Equal to 6.5, Its Arc Radius Should Be Allowed Within (140 ± 20) mm.
7. Murphy Hole
7.1. The Area Of Murphy Hole Shall Not Be Less Than 80% of The Inner Diameter Sectional Area Of Each Endotracheal Tube Specified in Table 1 of YY0337.1-2002 Standard.
7.2. The Murphy Eyelet Shall Be Located On The Opposite Side Of The Slope.
8. Sterility: The Endotracheal Tube Should Be Sterile.
9. Ethylene Oxide Residue: After Ethylene Oxide Sterilization, The Ethylene Oxide Residue Shall Not Be More Than 10 μ g / g.
10. Symbols: It Shall Meet The Requirements of YY0337.1-2002 Standard 7.
[Directions for Use]:
1.Check the External Packaging Before Using and Immediate Discontinue Use If Found Damaged.
2.Take Out The Endotracheal Tube, Use The Auxiliary Guide Wire To Insert The Endotracheal Tube To The Specified Depth Through The Nose And / Or Mouth.
[Storage]: Store in a Dry and Clean Warehouse with Excellent Ventilation and No Corrosive Gas Where the Relative Humidity is Less than 80%.
[Production Date]: On the Package Bag.
[Date of Expiry]: On the Package Bag.
[Contraindications]: Patients With Laryngeal Edema, Acute Airway Inflammation, Pharyngeal Abscess, Thoracic Aortic Aneurysm Pressing On The Trachea, And Severe Bleeding Constitution Should Use It With Caution; Those Who Are Allergic To The Raw Materials Of The Product Should Not Use It.
[Applicable Population]: The Products With The Specifications Between 2.0-3.5 Is Applicable To Newborn Infants; 4.0-6.5 Is Applicable To Children; 7.0-11.0 is Applicable To Adults.
[Cautions]:
1. After Ethylene Oxide Sterilization, the Sterility Remains Valid for Two Years.
2. The Date of Sterilization is Printed On the External Package Box.
3. Do Not Use the Products Beyond the Expiration Date of Sterility.
4. Do Not Use If Package is Damaged.
5. This Product is Disposable. Dispose in Accordance with “Medical Waste Regulations” After Single Use.
6. Under Normal Circumstances, If There Is No Mechanical Damage To The Oral Tissue, Oral Endotracheal Intubation Can Be Used; If Oral Endotracheal Intubation Cannot Be Performed, Nasal Endotracheal Intubation Can Be Used.
7. The Intubation Time Should Not Exceed 12 Hours, And The Respiratory Secretion Should Be Cleaned Up In Time.
8. For The Patients Who Stay For More Than 12 Hours, Closely Monitor The Movement Of The Tube After The Successful Placement, Pay Attention To Avoid The Bending And Folding Of The Tube, Keep The Tube Smooth; At The Same Time, Prevent The Tube From Slipping, And Fix The Belt After The Placement. Wash With Warm Water Before And After Nutrient Transportation, And Wash With Warm Water Intermittently During Use Interval To Prevent Tube Blockage. When The Patient Is Turned Over And Cleaned, The Reserved Tube Shall Be Placed To Prevent The Tube From Falling Off. When The Patient Is Aspirating Sputum, The Action Should Be Gentle And Rapid To Prevent Touching The Indwelling Tube And Causing Displacement. Keep The Patient’s Mouth Clean, Replace The Dental Pad And Clean The Secretion As Required Every Day, And Do Wet Mouth Care.
9. Residual Ethylene Oxide: After Ethylene Oxide Sterilization, Residual Ethylene Oxide Should Be No More Than 10μg/g.
10. Symbols: Symbols Should Conform to the Requirements in YY0337.1-2002.
[Directions for Use]:
1. Check the External Packaging Before Donning and Immediately Discontinue Use If the Product is Found Damaged.
2. Unpack and Take Out the Endotracheal Tube and Adjust it With Guide Wires. Insert the Endotracheal Tube into the Mouth or Nose to a Proper Depth.
[Storage]: Store in a Dry and Clean Warehouse with Excellent Ventilation and No Corrosive Gas Where the Relative Humidity is Less Than 80%.
[Production Date]: On the Package Bag.
[Date of Expiry]: On the Package Bag.
[Contraindications]: Use Carefully For Patients with Laryngeal Edema, Acute Airway Inflammation, Throat Abscess, Thoracic Aortic Aneurysm Compression of Trachea and Severe Bleeding; Do Not Use If Patients Are Allergic to The Raw Materials of The Product.
[Applicable Groups]: 2.0-3.5 are Applicable For Infants; 4.0-6.5 are Applicable for Children; 7.0-11.0 are Applicable for Adults.
[Cautions]:
1. After Ethylene Oxide Sterilization, the Sterility Remains Valid for Two Years.
2. The Date of Sterilization is Printed On the External Package Box.
3. Do Not Use the Products Beyond the Expiration Date of Sterility.
4. Do Not Use If Package is Damaged.
5. This Product is Disposable. Dispose in Accordance with “Medical Waste Regulations” After Single Use.
6. Under Normal Circumstances Where There Is No Mechanical Damage to The Oral Tissues, Oral Tracheal Intubation Can Be Used; When Oral Tracheal Intubation Is Not Applicable, Trans-Nasal Tracheal Intubation Is Used.
7. The Indwelling Time of Intubation is Generally No More Than 12 Hours, and the Respiratory Secretions Should be Cleared In Time During The Indwelling.
8. For Patients Who Have Been Indwelling For More Than 12 Hours, Closely Monitor The Movement of the Pipeline After Successful Tube Placement, and Pay Attention to Avoid Bending and Folding of the Pipeline and Keep the Pipeline Smooth; At the Same Time, Prevent the Pipeline From Slipping and Fix the Tube after Placement. Rinse with Warm Water Before and After Nutrient Delivery, and Regularly Flush with Warm Water to Prevent Pipeline Blockage. When Turning Over and Cleaning the Patient, the Indwelling Pipe Must be Placed First to Prevent It From Being Removed. When Sputum Suction is Performed on the Patient, the Movement Should be Gentle and Rapid to Prevent From Touching the Indwelling Tube and Causing Displacement. Keep the Patient’s Mouth Clean, Replace the Dental Pads and Clean Up the Secretions As Required, and Do Wet Care on the Mouth.
Single Use Only Sterile Ethylene Oxide Sterilization
[Registrant Name]: ESound Medical Device Co., Ltd.
[Address]: High-Tech Medical Device Industrial Park, Changyuan County
[Contact]: 0373-2153126
[After-Sales Service Unit]: ESound Medical Device Co., Ltd.
[Manufacturer]: ESound Medical Device Co., Ltd.
[Production Address]: High-Tech Medical Device Industrial Park, Changyuan County
[Date of Compilation]: 1st January, 2019

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