■ Item Name / Item Approval Number: In Vitro General-Purpose Probe / Approval No. 22-419
■ Packaging Unit: 1EA
■ Model Name: XXXXX
■ Manufacturing Date: XXXXXX
■ Manufacturing Number: XXXXXX
■ Expiry Date: Within 3 years from the date of manufacture
■ Storage Method: Store away from direct sunlight in a cool place.
■ Manufacturer: Inseong Medical Co., Ltd., 168 Industrial City-ro, Jijeong-myeon, Wonju-si, Gangwon Special Autonomous Province
■ Manufacturing License Number: License No. 838
■ Attached documents are provided in electronic form on the following website.
■ Date of User Manual Compilation: April 01, 2022
■ This product is a single-use sterilized medical device and reuse is prohibited.
[Information to be Included in Attached Documents]
■ Intended Use
In vitro general-purpose probe for transmitting and measuring signals such as transducers and detectors.
■ Use and Operation
① If aseptic access is required, remove the packaging under aseptic conditions.
② Attach or insert the sensor to the desired body part for temperature measurement.
③ Connect the connector to the patient monitoring device, etc.
④ Monitor the temperature measured on the connected device, etc.
■ Precautions before Use
① Be sure to understand the instructions for use before use.
② Confirm compatibility with patient monitoring monitors.
③ Check for product and packaging damage.
④ Check the specifications and expiration date of the product.
■ Precautions during Use
A. Warning
① Do not use if the packaging is opened, damaged, etc.
② This product is a single-use medical device and reuse is prohibited.
③ This product is for medical purposes only and should not be used for purposes other than intended.
④ Do not use if the product is damaged, deformed, etc.
⑤ For ear canal products, do not forcefully insert into the patient's ear canal.
B. General Caution
① Before use, familiarize yourself with the instructions for use, and only skilled medical personnel should use the product.
② Store away from high temperatures, direct sunlight, in a dry and cool place.
③ It should be used with compatible patient monitoring devices.
■ Storage Method after Use
① Dispose of according to hospital procedures after use.
■ Item Name / Item Approval Number: In Vitro General-Purpose Probe / Approval No. 22-419
■ Packaging Unit: 1EA
■ Model Name: XXXXX
■ Manufacturing Date: XXXXXX
■ Manufacturing Number: XXXXXX
■ Expiry Date: Within 3 years from the date of manufacture
■ Storage Method: Store away from direct sunlight in a cool place.
■ Manufacturer: Inseong Medical Co., Ltd., 168 Industrial City-ro, Jijeong-myeon, Wonju-si, Gangwon Special Autonomous Province
■ Manufacturing License Number: License No. 838
■ Attached documents are provided in electronic form on the following website.
■ Date of User Manual Compilation: April 01, 2022
■ This product is a single-use sterilized medical device and reuse is prohibited.
[Information to be Included in Attached Documents]
■ Intended Use
In vitro general-purpose probe for transmitting and measuring signals such as transducers and detectors.
■ Use and Operation
① If aseptic access is required, remove the packaging under aseptic conditions.
② Attach or insert the sensor to the desired body part for temperature measurement.
③ Connect the connector to the patient monitoring device, etc.
④ Monitor the temperature measured on the connected device, etc.
■ Precautions before Use
① Be sure to understand the instructions for use before use.
② Confirm compatibility with patient monitoring monitors.
③ Check for product and packaging damage.
④ Check the specifications and expiration date of the product.
■ Precautions during Use
A. Warning
① Do not use if the packaging is opened, damaged, etc.
② This product is a single-use medical device and reuse is prohibited.
③ This product is for medical purposes only and should not be used for purposes other than intended.
④ Do not use if the product is damaged, deformed, etc.
⑤ For ear canal products, do not forcefully insert into the patient's ear canal.
B. General Caution
① Before use, familiarize yourself with the instructions for use, and only skilled medical personnel should use the product.
② Store away from high temperatures, direct sunlight, in a dry and cool place.
③ It should be used with compatible patient monitoring devices.
■ Storage Method after Use
① Dispose of according to hospital procedures after use.