ESound Med

ESound Med Medical Laryngeal Mask

Laryngeal mask, Reinforced laryngeal mask, Two-way laryngeal mask (I -type), Iwo-way laryngeal mask (II -type),
Two-way laryngeal mask Ⅲ-type) Two-way Reinforced laryngeal mask. New-type Laryngeal mask.

•Imported medical silicone raw material, non-toxic no stimulation.
•Cover capsule of soft medical silicone raw materials.design outline and throat, utmost reduce the incentive for patients, improve the impermeability and throat,
•Exclusive soft seal cuff can be inserted comfortable, minimizing potential trauma and increasing sealing.
•Soft, transparent smooth tube.
•Different specifications for users to choose.
•Different sizes for neonate, infant, child, and adult.

[Product]: Medical Laryngeal Mask [Specifications]: Model: Single Cavity Common Type, Single Cavity Reinforced Type,
Double Cavity Ordinary Type, Double Cavity Reinforced Type
Size Codes: 1.0#, 1.5#, 2.0#, 2.5#, 3.0#, 3.5#, 4.0#, 4.5#, 5.0#
[Production License Number]: No. 20160050 of Henan Food and Drug Administration Production License
[Registration Number]: Henan Medical Device Registration Certificate 20182080879
[Product Technical Requirement Number]: Henan Medical Device Registration Certificate 20182080879
[Range of Application]: When The Patient’s Upper Throat Is Opened And Sealed, It Is Applied to Provide A Gas Channel In Patient’s Body For Spontaneous, Auxiliary Or Controlled Ventilation.
[Structure and Composition]: This Product Is Mainly Made of Silicone Rubber.
Single Cavity Common Type: Composed Of Ventilation Mask, Airway, Inflation
Tube, Pilot Balloon, Connector And Inflation Valve.
Single Cavity Reinforced Type: Composed Of Ventilation Mask, Airway, Inflation
Tube, Pilot Balloon, Connector, Inflation Valve And Steel Wire.
Double Cavity Common Type: Composed Of Ventilation Mask, Airway, Inflation
Tube, Pilot Balloon, Connector, Inflation Valve And Drainage Tube.
Double Cavity Reinforced Type: Composed Of Ventilation Mask, Airway, Inflation
Tube, Pilot Balloon, Connector, Inflation Valve, Drainage Tube And Steel Wire.
[Product Performance]:
1. There Are Nine Different Specifications For Laryngeal Mask. Check Table 1 And Table 2 For the Size Information.
2. 2. Appearance
2.1. The Appearance Of Laryngeal Mask Should be Clean And Free Of Visible Impurities And Foreign Matters.
2.2. The Laryngeal Mask Should Have Smooth Surface Without Manufacturing Or Forming Defects.
2.3. The Supporting Steel Wire Of Reinforced Laryngeal Mask Should Be Free From Exposure.
3. It Should Meet Up the Requirements Specified In Sheet 1 And Sheet 2 Of GB19082-2009 Standard.
3. Sealing Mechanism: The Air Filling System Of The Inflatable Laryngeal Mask Should be Well Sealed. And Under The Positive Pressure of 3kpa ± 0.2kpa, Each Bonding Part (Air Filling Tube and Laryngeal Mask, Unidirectional Valve, Balloon and Air Filling Tube) Should Not Leak.
4. The Outer Diameter Of The Inflation Tube Is 3mm ± 0.5mm, And The Length Is Not More Than 280mm ± 2mm.
5. Connector
5.1. The Machine End Should Be A 15mm Standard Connector, And Its Size Should Be In Accordance With The Requirements Specified in YY1040.1-2003 Standard.
5.2. The Conical Connector At The Inflation End Should Comply With the Corresponding Provisions Specified in GB/T1962.1-2002 Standard.
5.3. The Opening At The Patient End Should Have A Plane at 90°±5 °To The Long Axis Of The Patient End Of The Connector.
6. Inflation Device: The Laryngeal Mask Should Have A One-Way Inflation Device To Facilitate Inflation And Ensure The Inflation State Of The Ventilator. When It Is Needed To Discharge The Gas In The Ventilation Mask, The Gas In The Inflation Device Can Be Extracted Smoothly With A Syringe.
7. Connection Firmness: Each Connection of Laryngeal Mask Should Be Able To Bear 15N Static Axial Tension, And Should Not Be Loose Or Detached For 15 Seconds.
8. Scale Mark: The Scale of The Tube And The Marks Should Be Clear And Not Easy to Fall Off.
9. PH: The PH Value Of Laryngeal Mask Should be 6.5-7.5.
10. Sterility: Laryngeal Mask Should Be Sterile.
11. Ethylene Oxide Residue: Sterilized With Ethylene Oxide, The Ethylene Oxide Residue Of The Product Should Not Be More Than 10μg /g.
12. Bending Resistance: When It is Folded Back For 5 seconds, The Tube Should be Restored To Its Original State After Loosening Hands. And It Should Be Kept Unobstructed, Without Any Folding, Distorted phenomenon.
13. Internal Volume: The Internal Volume Of Each Model Should Meet The Requirements Specified in Table 2.
14. Marking of the Airway
14.1. The Name And /Or Trademark Of The Manufacturer or Supplier.
14.2. The Designated Size Should Be In Bold Type. Devices that Encompass A Range Of Sizes Should Be Marked With The Corresponding Range.
14.3. Should Mark The Words “SINGLE USE” Or Equivalent ;
14.4. The “Normal Depth Of Insertion Marking(s) Or Indicator(s) Visible Around The Shaft Of The Laryngeal Mask Corresponding To Patient’s Incisors Or Gums Is / Are To Show The Typical Range Of Intended Depth Of Insertion;
14.5. Ventilatory Opening: An Opening Intended To Allow Ventilation Should Be Provided At Or Near The Patient End Of The Device. (Only Applicable To The Laryngeal Mask With Ventilatory Opening). Auxiliary Ventilatory Openings May Be Provided To Reduce The Risk From Obstruction.
[Instructions]:
1. 1.0# For Infants Weighing Less Than 5kg; 1.5# For Infants Weighing 5kg-10kg; 2.0# For Infants Weighing 10kg-20kg; 2.5# For Infants Weighing 20kg-30kg; 3.0# For Children Weighing 30kg-50kg; 4.0 For Adults Weighing 50kg-70kg; 5.0# For Overweight Adults Weighing 70kg-100kg.
2. Check the External Packaging Before Use and Immediate Discontinue Use If Found Damaged.
3. Open The Package Through Tear-off Opening, Take Out The Laryngeal Mask, And Fill In Right Amount Of Air To Detect Whether There Is Air Leakage.
4. Before Conducting Insertion of the Laryngeal Mask, the Air In The Balloon Shall Be Pumped Out. And The Blind Probe Insertion Method Or Insertion Under The Guidance Of Laryngoscope Could Be Adopted In The Process Of Insertion. After Insertion, The Balloon Should Be Inflated To Meet The Clinical or Standard Requirements, And Then It Should Be Connected With The Supporting Equipment For Use.
5. The Operator Should Be A Professional With Rich Clinical Experience.
6. The Retention Time of Laryngeal Mask Is No More Than 12 Hours, During Which Respiratory Secretion Should Be Cleaned In Time.
7. Check Table 2 Of Technical Requirements For Internal Volume.
8. During Positive Pressure Ventilation, The Airway Pressure Should Not Exceed 20cm H2O, Otherwise Air Leakage Or Gas Into The Stomach May Occur.
[Directions for Use]:
Insertion Of Laryngeal mask
1. Use The Syringe with A 6% (Ruhr) External Taper, Complying With The GB / T1962.1, To Open The Air Valve And Exhaust The Gas In The Laryngeal Mask. (Fig. 1)
2. Apply A Small Amount of Water-Soluble Lubricant Cream On The Back Of The Laryngeal Mask, And Clamp The Laryngeal Mask Like Gripping A Pen. (Fig. 2)
3. Open The Patient’s Mouth And Place The Back Of The Laryngeal Mask At The Back Of The Patient’s Front Teeth. (Fig. 3)
4. With The Help Of Index Finger, The Laryngeal Mask Could be Inserted Backward Along The Patient’s Hard And Soft Palate, And It Should Be Pressed Continuously Backward Along The Head To The Hypopharyngeal Cavity, Until The Characteristic Resistance Could be Felt. (Suggesting To Reach The Upper Esophageal Sphincter). (Fig. 4)
5. Before Moving The Index Finger, Gently Press The Tube Of The Laryngeal Mask With The Other Hand To Prevent The Laryngeal Mask From Shifting. (Fig. 5)
6. Use The Syringe With a 6% (Ruhr) External Taper, Complying With GB / T1962.1 Standard, To Open The Air Valve And Inflate It To The Pilot Balloon To Show The Amount of Pressure (The Amount of Pressure Should Not Exceed The Indicated Maximum Inflation Amount), Place The Dental Pad, Fix The Position And Keep Ventilation. (Fig. 6)

how to use the laryngeal mask
how to use the laryngeal mask

Remove of The Laryngeal Mask
After Use, Use The Syringe With 6% (Ruhr) External Taper, Complying With GB /T1962., To Open The Air Valve And Exhaust The Air In The Laryngeal Mask Before Removing The Laryngeal Mask.

[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]:
1. Those Who Are Allergic To The Raw Materials Of The Product Should Not Use It.
2. Those Who Are Too Full or Have Not Eaten Or Have The Risk of Counter flow Should Not Use It With Caution .
3. Patients With Airway Obstruction After Anesthesia Should Not Use It.
4. Patients With Laryngopharyngeal Diseases That Lead To Airway Obstruction, Reduced lung Compliance Or High Respiratory Resistance Need Positive Pressure Ventilation Should Use It With Caution.
5. Patients With Laryngeal Edema, Acute Inflammation Of Respiratory Tract And Abscess Of Pharynx And Larynx Should Use It With Caution.
[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. When The Position of The Patient’s Head or Neck Changes, the Laryngeal Mask Should Be Confirmed Again.
[Symbols]

Single Use Only Sterile Ethylene Oxide Sterilization Cautions
[Registrant Name]: ESound Medical Device Co., Ltd.
[Address]: High-Tech Medical Device Industrial Park, Changyuan County
[Contact]: 0373-7152666
[After-Sales Service Unit]: ESound Medical Device Co., Ltd.
[Manufacturer]: ESound Medical Device Co., Ltd.
[Address]: High-Tech Medical Device Industrial Park, Changyuan County
[Production Address]: High-Tech Medical Device Industrial Park, Changyuan County
[Contact]: 0373-7152666 [Date of Compilation]: 18th July, 2016

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