■ Product Name / Approval Number: Respiratory Mask / Seoul Reception 08-980
■ Packaging Unit: 1EA
■ Model Name: XXXXX
■ Manufacturing Date: XXXXXX
■ Manufacturing Number: XXXXXX
■ Expiry Date: Within 5 years from the manufacturing date
■ Manufacturer: Intersurgical Ltd (UK, Crane House, Molly Millars Lane, Wokingham, Berkshire, RG41 2RZ)
■ Manufacturing License Number: License No. 308
■ The accompanying documents are provided in electronic form on the following website:
Insung Medical Customer User Guide
■ User Manual Creation Date: July 3, 2023 (rev. ~)
■ This product is a disposable sterilized medical device, and reuse is prohibited.
[Information on Attached Documents]
■ Intended Use
For supplying oxygen, using devices such as masks.
■ How to Use and Operating Procedure
- Fit the MASK closely to the patient's face and tighten the LOOP. For products with a NOSE CLIP, press it according to the patient's facial shape to enhance adherence.
- Connect the MASK to the TUBE connected to the oxygen supply. For products with an OXYGEN TUBE, connect the MASK CONNECTOR and OXYGEN TUBE CONNECTOR, then connect them to the oxygen supply.
- Operate the oxygen supply to provide oxygen to the patient.
■ Preparations Before Use
- Check for any abnormalities in the packaging.
- Check the expiration date.
- The operator must be familiar with the handling procedures and use them.
- The operator should have the experience and assurance of surgical situations, and only trained personnel should use the device.
- For model 1202000, before using it on a patient, connect the MASK CONNECTOR and OXYGEN TUBE CONNECTOR, then connect them to the oxygen supply to ensure that oxygen is stored in the RESERVOIR BAG, and contraction and expansion occur normally.
■ Precautions During Use
- Use the size suitable for the patient's age.
- Use LOOP to securely fit the mask to the patient's face.
- To expel CO2, supply at least 5L/min of O2.
■ Storage Method: Store in a cool, dry, and clean place.
■ Packaging Unit: 1EA
■ Manufacturer: Intersurgical Ltd (UK, Crane House, Molly Millars Lane, Wokingham, Berkshire, RG41 2RZ)
■ Manufacturing License Number: License No. 308
■ This product is a disposable sterilized medical device, and reuse is prohibited.
■ User Manual Creation Date: July 3, 2023
■ Product Name / Approval Number: Respiratory Mask / Seoul Reception 08-980
■ Packaging Unit: 1EA
■ Model Name: XXXXX
■ Manufacturing Date: XXXXXX
■ Manufacturing Number: XXXXXX
■ Expiry Date: Within 5 years from the manufacturing date
■ Manufacturer: Intersurgical Ltd (UK, Crane House, Molly Millars Lane, Wokingham, Berkshire, RG41 2RZ)
■ Manufacturing License Number: License No. 308
■ The accompanying documents are provided in electronic form on the following website:
Insung Medical Customer User Guide
■ User Manual Creation Date: July 3, 2023 (rev. ~)
■ This product is a disposable sterilized medical device, and reuse is prohibited.
[Information on Attached Documents]
■ Intended Use
For supplying oxygen, using devices such as masks.
■ How to Use and Operating Procedure
■ Preparations Before Use
■ Precautions During Use
■ Storage Method: Store in a cool, dry, and clean place.
■ Packaging Unit: 1EA
■ Manufacturer: Intersurgical Ltd (UK, Crane House, Molly Millars Lane, Wokingham, Berkshire, RG41 2RZ)
■ Manufacturing License Number: License No. 308
■ This product is a disposable sterilized medical device, and reuse is prohibited.
■ User Manual Creation Date: July 3, 2023