[Product]: Disposable Anaesthetic Mask
[Types and Size]:
Types: Inflatable Type, Closed Edge Type, Detachable Breathing Type, Intubation Type
Size Codes: 0#, 1#, 2#, 3#, 4#, 5#, 6#
[Production License Number]:No. 20160050 of Henan Food and Drug Administration Production License
[Registration Number]: Henan Medical Device Registration Certificate 20182080885
[Product Technical Requirement Number]: Henan Medical Device Registration Certificate 20182080885
[Indications]: Applied to Use For Breathing During Clinical Anesthesia.
[Structure and Components]:
1. Inflatable Type is Composed of Housing, Cone Set, Gasket and Air-Filled Mouth
2. Closed Edge Type is Composed of Housing, Cone Set and Gasket
3. Detachable Breathing Type is Composed of Housing, Gasket and Cone Set
4. Intubation Type is Composed of Shell Cone Set, Gasket, Seal Cap, Air Inlet, Bellows and Joint.
Added Optional Accessories Hook Can be Added to Various Models.
1.Cover Shell Should be Transparent, Clean, Free from Impurities, Complete Without Damage, and the Part that Contacts with the Face Should be Soft and Smooth.
2.The Hook Shall Bear A Static Tension of 15N, and the Hook Shall Not Break or Be Seriously Deformed.
3.The Non-inflatable Gasket Shall Be Soft and Smooth for Close Contact with the Face. The Thickness of the Edge Wall Shall Be 1.0mm±0.2mm. The Inflatable Gasket Shall Also Be Subject to the Maximum Air Capacity as Specified in Table 1 and Table 2.
4.The Air Inlet Shall be Conical, and the Internal Taper Shall Be 6:100 According to GB/T 1962.1-2001.
5.The Cone Set Shall Conform to the 15mm Outer Cone Joint or 22mm Inner Cone Joint as Specified in YY1040-2003.
6.The Connector Shall Conform to the 15mm Outer Taper Connector as Specified in YY1040.1-2003
7.The Sealing Cover on the Intubated Oxygen Mask Should Fit Well with the Housing Body.
8.The Bellows are Closely Combined with the Hood Body and Joint, and No Air Leakage; Its Length Shall Not Be Less Than 150mm.
9.The Mask Shall Be Sterilized and Shall Be Valid for Two Years
10.Residual Ethylene Oxide Should Be No More Than 10μg/g.
[Directions for Use]:
Open the Package and Take Out the Mask. Connecting and fixing the Port of the Mask Machine to the Breathing Tube, and Place the Mask Over the Patient’s Mouth and Nose.
[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]: Not Found yet
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.
Single Use Only Sterile Ethylene Oxide Sterilization
[Registrant Name]: ESound Medical Device Co., Ltd.
[Address]: High-Tech Medical Device Industrial Park, Changyuan County
[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]: 18th July, 2016